Healthcare Packaging Spring 2025

What’s Behind Inclusive Design in Packaging

MATERIAL DEVELOPMENTS

12 Bayer’s New Blister Pack Bids Adieu to PVC

The shift from PVC to PET, while helping the company meet its sustainability goals, was met with challenges, including concerns over usability.

SUSTAINABILITY

16 The Many Facets of Sustainable and Recyclable Blister Packaging for Pharmaceuticals Primary Packaging

Exploring sustainable blister packaging from the lens of material selection, quality regulations, machinability, and printability.

HUMAN FACTORS

22 Inclusive Design in Packaging: Insights from the Arthritis Foundation

The Foundation’s inclusive design program emphasizes its impact on medical device and pharmaceutical packaging design for enhanced usability.

HUMAN FACTORS

26 Designing for an Emergency Alper Hulusi, from ClariMed, discusses how to design medical device packaging for use in an emergency setting.

AUTOMATION

28 Cannabis Entrepreneurs Take a Shine to Automation

A combination scale, bagger, checkweigher, and coding and marking operations production efficiency.

TECHNOLOGY

32 Moving On From EO: Experiencing the Evolution of Today’s Sterilization Methods

As the medical device and pharmaceutical industries face pressure to phase out or move away from ethylene oxide, new sterilization trends are emerging.

PROMINENT PEOPLE IN PACKAGING

36 Insights from a Senior Systems Engineer

James Hamerslag reflects on his long tenure at Siemens Healthineers, and the critical role of team collaboration in driving innovation.

REGULATORY

38 FDA Warning Letters in Packaging: How Testing Can Help Prevent a 483

While testing doesn’t always prevent an FDA warning letter, doing so helps you stay in compliance and check the boxes the FDA is looking for.

PACKAGE DESIGN

42 How to Stand Out: What’s Make a Great Design for Wellness Brands Today?

Package design to attract today’s savvy wellness product shoppers should include inclusivity, brand trust, and a nod to sustainability.

BUSINESS INTELLIGENCE

96 Four Ways Packagers and Processors Can Optimize Employee Training

Packaging and processing professionals share their thoughts on how to use technology to optimize employee training.

COLUMNS & DEPARTMENTS

MINI W I

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Content

EDITOR-IN-CHIEF Elisabeth Cuneo ecuneo@pmmimediagroup.com

CONTRIBUTING EDITOR Joseph Derr

DIRECTOR OF CONTENT Kim Overstreet

ART DIRECTOR Norman Smith

CREATIVE DIRECTOR David Bacho Advertising sales@pmmimediagroup.com

DIRECTOR, CLIENT SUCCESS & DEVELOPMENT Courtney Nichols cnichols@pmmimediagroup.com

SENIOR MANAGER, PRINT OPERATIONS Lara Krieger lkrieger@pmmimediagroup.com

FINANCIAL SERVICES MANAGER Janet Fabiano jfabiano@pmmimediagroup.com

PMMI Media Group

PRESIDENT David Newcorn

VICE PRESIDENT, DIGITAL Elizabeth Kachoris

SENIOR DIRECTOR, MEDIA OPERATIONS Kelly Greeby

SENIOR DIRECTOR, EVENTS Trey Smith

DIRECTOR, DIGITAL MEDIA Jen Krepelka

DIRECTOR OF MARKETING Amber Miller

DIRECTOR, AD TECH AND SEARCH Joan Jacinto

FOUNDING PARTNER AND EXECUTIVE VICE PRESIDENT, INDUSTRY OUTREACH, PMMI Joseph Angel

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Remove inserts or samples before recycling.

Sustainable packaging solutions built and supported locally

Blister Machines

Custom Automation/

Product Handling

Rebuilds

Vision Inspection

Cartoning

Bringing the Human Factor to Package Development

Explore package development tips for inclusivity, designing for an emergency, and more.

Welcome to our spring issue! There is something about spring and the arrival of warmer days and abundant sunshine. Spring brings new life and in this issue I tried to bring some new life to topics we regularly cover like industry regulations, package design, automation, medical device sterilization, and of course, our cover story: designing for human factors.

We cover this topic on an ongoing basis, but on the heels of Pharmapack earlier this year, it remains top of mind. At the show, many sessions included experts weighing in on designing pharmaceutical and medical devices with the user in mind. This included designing for an emergency, designing for inclusivity for people with dexterity limitations, as well as designing to ensure patient adherence. In this issue we feature insights into designing for

human factors from experts from the Arthritis Foundation, as well as ClariMed, so check those out if this topic intrigues you.

At Pharmapack I had the pleasure to hear from various speakers from companies like AstraZeneca, Bayer AG, and BD Medical that talked about how and why they tackle this issue and create the products they do. Turns out that a ton of user research, focus groups, and product studies go into each device.

If designing for human factors isn’t your bag, flip through and read about new sterilization method alternatives to EO, how to avoid an FDA warning letter, and Pfizer’s take on recyclable blister packaging.

Liz Cuneo is the Editor-in-Chief of Healthcare Packaging. She may be reached at ecuneo@pmmimediagroup.com.

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“Automated data integration, for example, has shown the potential to significantly reduce time-to-completion for regulatory reports by streamlining workflows and minimizing manual interventions. In some cases, organizations have reported reductions of medical review time by up to 50 percent, along with improved collaboration across cross-functional teams, as AI simplifies complex data management and enhances communication.”

—EMMANUEL WALCKENAER, CEO OF YSEOP, A FRENCH SOFTWARE COMPANY, IN AN ARTICLE FOR THE MEDICINE MAKER TITLED, “HOW AI IS CHANGING MEDICAL WRITING.”

“From cancer-causing pollution from plastic manufacturing facilities, to increasing industry’s accountability to take back recycled plastic packaging, to capturing waste before it ends up in our bodies and the environment, this strategy lays out the path forward for EPA and our partners to tackle this persistent challenge.”

—MICHAEL REGAN, ADMINISTRATOR FOR THE EPA, IN AN ANNOUNCEMENT FROM THE EPA ON THE RELEASE OF THE FINALIZED NATIONAL STRATEGY TO PREVENT PLASTIC POLLUTION, AS REPORTED BY WASTE DIVE IN AN ARTICLE, “EPA CALLS FOR DEVELOPING NATIONAL EPR FRAMEWORK.”

“Don’t take your eye off the ball because there are many requirements in effect now and the exemptions do not affect these: you can only transact with authorized trading partners.”

—BRIAN P WALDMAN, PARTNER AT ARENTFOX SCHIFF LLP, ON THE HEALTHCARE DISTRIBUTION ALLIANCE’S RECENT WEBINAR ON PHASED DSCSA IMPLEMENTATION.

$550 MILLION

THE PREDICTED SIZE of the Internet of Things (IoT) healthcare market in the next eight years, according to Polaris Market Research. Popular areas of investment include connected wearable devices and implanted medical technologies.

Source: Polaris Market Research

32%

THE RETURN RATE in 2024 for Novo Nordisk’s take-back initiative for injection pens in Denmark.

Source: Novo Nordisk, in a presentation at Pharmapack Europe

75%

THE PERCENTAGE of American voters who support national policies that reduce single-use packaging, according to a nationwide survey conducted by Ipsos for Oceana.

Source: Ipsos

$644 MILLION

THE EXPECTED SIZE of the syringe filling machine market by 2034, increasing from $425.5 million. One of the primary drivers is the increasing need for prefilled syringes, especially in self-administration of medications like insulin, vaccines, and biologics.

Source: Future Market Insights

Global Sterile Packaging Market to Reach $48,415.9

Million by 2034

 The sterile packaging market is poised for remarkable growth, with its valuation expected to rise from $27,550.6 million in 2024 to $48,415.9 million by 2034, according to Future Market Insights. This surge represents a steady CAGR of 5.8% over the forecast period from 2024 to 2034. In 2023, the market generated $26,040.3 million in revenue, underlining its consistent upward trajectory.

The pharmaceuticals and biologics sector is anticipated to dominate the market, capturing over 45% of the share during the forecast period. This growth can be attributed to the sector’s stringent requirements for contamination-free conditions to preserve the efficacy, safety, and shelf life of drugs, vaccines, and biologics throughout manufacturing, storage, and transportation. Sterile packaging solutions play a critical role in meeting these exacting standards.

Temperature-Controlled Vaccine Packaging Market to Surpass $2,016.9 Million by 2033

FUTURE MARKET INSIGHTS reports the global temperature-controlled vaccine packaging market is projected to experience substantial growth over the next decade. According to market projections, the industry is estimated to be valued at $917.1 million in 2023 and is expected to surpass $2,016.9 million by 2033, representing a robust compound annual growth rate (CAGR) of 8.2% during the forecast period.

As the demand for vaccines continues to rise due to global health initiatives and immunization programs, the need for advanced packaging solutions capable of maintaining stringent temperature requirements has become critical. The U.S. has strong growth potential in the global temperature-controlled vaccine packaging market due to its advanced healthcare system, robust vaccine R&D, and production capabilities. Its extensive cold chain infrastructure, efficient logistics, and high regulatory standards further support market expansion.

AAMI Updates Materials Compatibility Guidance for EO, VHP, Other Modalities

 Whether a material is compatible with different sterilization methods is a serious concern for medical device manufacturers and sterile processing professionals. After all, cleaning or sterilization should not damage medical products. Newly updated AAMI guidance addresses this issue by clarifying how sterilization affects products and packaging.

The Association for the Advancement of Medical Instrumentation (AAMI) has published AAMI TIR17:2024; Compatibility of materials subject to sterilization. Last updated in 2017 to address an urgent need for information sharing, AAMI TIR17 is relevant to medical device manufacturers, product designers, and sterilization professionals. TIR17 applies to new alternatives to ethylene oxide (EO) like chlorine dioxide and vaporized hydrogen peroxide, and addresses the selection and qualification of polymers, ceramics, and metals subject to sterilization.

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Shrink Sleeve Labels Market to Hit $21 Billion by 2034

THE GLOBAL shrink sleeve labels market, valued at $14.7 billion in 2024, is poised for substantial growth, reaching an estimated $21 billion by 2034. This reflects a steady CAGR of 3.6% over the forecast period, driven by innovations in the packaging industry across diverse sectors. Prominent drivers of the shrink sleeve labels market include:

1. Rising demand for customization and branding

2. Increased adoption of sustainable labeling solutions

3. Advancements in printing technology

4. Rising demand for tamperevident packaging.

CALENDAR OF EVENTS

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PACK EXPO Las Vegas (Sept 29-Oct 1) Las Vegas, NV

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Cold Chain Packaging 101: Explore ISTA’s Principles of Cold Chain Packaging Course for Deeper Insights

uCold chain packaging is essential for the safe transport of temperature-sensitive products, ensuring they remain within optimal temperature ranges throughout their journey. Originating in the food industry, the concept has expanded to include pharmaceuticals and other industries requiring strict temperature control.

The International Safe Transit Association (ISTA) provides protocols for testing various hazards that packaged products may encounter, such as temperature, humidity, compression, shock, and vibration. These protocols help ensure that packaging systems can effectively manage temperature fluctuations and maintain product integrity. ISTA’s training course, CC 101 | Principles of Cold Chain Packaging, breaks down the basics of cold chain packaging.

Cold chain packaging combines insulation packaging materials with other system components to control temperature during shipping. As a system, it must function across all handling, transport, and storage operations from the point of manufacture or harvest to the end user.

Thermal shippers, insulated shipping containers (ISCs), temperature-controlled packaging, and thermal shipping systems are all terms used interchangeably for a shipping system or solution that maintains a temperature-controlled environment, which includes passive, active, hybrid, and/or thermal covers.

Then there is the concept of “last mile.” Last mile refers to the last segment of the cold chain when the thermal packaging system is out to be delivered to its end user. This final delivery may be at the pharmacy, doctor’s office, hospital, or someone’s home. This can be challenging for three reasons:

1 . The environmental conditions inside and outside delivery vehicles are unpredictable,

2 . If left on a porch or loading dock, conditions may be extreme for several hours (hot or cold, solar radiation)

3 . The thermal shipper may approach the limit of its designed autonomy (diminished refrigerant reserves) in the most detrimental conditions of its journey.

“Understanding the intricacies of cold chain packaging is vital for professionals involved in the design and development of packaging systems. A comprehensive knowledge of temperature management, material properties, and distribution challenges can significantly impact the effectiveness of these systems in preserving product quality,” explains ISTA course instructor, Dr. William Pelletier.

CC 101 course sections focus on “principles,” including:

• Hazards in the Distribution Environment

• Introduction to Cold Chain Packaging

• Fundamentals of Heat Transfer

• Temperature-Sensitive Products

• Phase Change Materials

• Cold Chain Packaging Solutions

• Cold Chain Packaging System Testing

• Cold Chain Packaging Temperature Monitoring

• Pre-Qualified Cold Chain Solutions

• Quality Control for Cold Chain Solutions

ISTA’s mission is to empower organizations and their people to minimize product damage throughout distribution and optimize resource usage through effective package design. ISTA’s CC 201 and 301 were recently held in-person at the ISTA Forum in Orlando, Florida. ISTA CC 101 is available via ISTA’s online learning platform. https://ista.org/cold_chain_cc.php

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Bayer’s New Blister Pack Bids Adieu to PVC

The shift from PVC to PET, while helping the company meet its sustainability goals, was met with challenges, including concerns over usability.

By Liz Cuneo, Editor-in-Chief

Bayer has launched a first-of- itskind in the healthcare industry, polyethylene terephthalate (PET) blister packaging on its well-known brand, Aleve. Realized in partnership with pharmaceutical packaging specialist, Liveo Research, the new package has a significant reduction in emissions (38% CO2 by unit) and is 18% lighter compared with the current packaging, which is a blend of PVC and aluminum.

The updated pack is a mono-material PET that aligns with the company’s long-term goal of moving away from using PVC.

The updated pack is a mono-material PET that aligns with the company’s long-term goal of moving away from using PVC. Four years ago, before legislation surrounding sustainability intensified, Bayer defined its sustainability ambitions and in 2021, these goals were publicly released, focusing on removing PVC and moving toward recycle-ready packaging.

Blister packaging, a key challenge, is a major focus area for the company as a substantial proportion of the company’s non-recycle-ready packaging consists of blister packs. By focusing on mono-material solutions, Bayer aims to implement solutions to enable recycling processes and contribute to packaging circularity.

“In addition to our commitment to sustainable practices, we are facing significant pressures from consumers, customers, and legislative bodies,” says Chris Padain, VP, Global Head of Product Experience, Design & Packaging at Bayer Consumer Healthcare. “The most urgent of these pressures stem from initiatives such as the Packaging and Packaging Waste Regulation (PPWR) and the extension of California’s Proposition 65. While Europe benefits from more cohesive legislation, various states in the U.S. are also advancing their own regulations. The challenges associated with blister packaging are particularly pertinent as we approach the next years, and addressing these issues remains a critical focus for us.”

“Our goal is to reduce PVC and make leading steps toward recyclable, or recycle-ready solutions,” says Padain.

Overcoming challenges

Blister packaging, widely used in over-the-counter products, has long posed a challenge for environmental sustainability due to its multilayer composition of plastic and aluminum, which makes it hard to sort and recycle. And since 30% of Bayer’s products are packaged in blister packs, this became a priority focus. Bayer and Liveo Research were able to create a mono-material blister that offers the product protection and user friendliness the pack needed. Plus, the materials required minimal changes to existing infrastructure (packaging machinery). Since the processability of PET is similar to PVC, this allowed simple adaptations rather than replacement of equipment.

“From a manufacturing standpoint, no major adjustments were needed,” says Padain.

This doesn’t mean that the project did not have its trials. Padain says that the team had to over come obstacles in managing actively regulatory approvals and even some hiccups in the printing, but the biggest one was the usability of the PET.

Bayer has launched a PET blister packaging on its well-known brand, Aleve.

The new package is 18% lighter compared with the current packaging.

KEY TAKEAWAYS

The goal was to reduce PVC and make leading steps toward recycle-ready solutions

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“The biggest challenge was achieving a consistent and userfriendly approach to pushing tablets through the plastic lidding, as plastic doesn’t naturally wish to be perforated like aluminum does,” says Padain.

“ ”

The team at Bayer had to be sure that the PET would allow the pills, whether gel caps or hard tablets, to puncture the material for access to the medication. So, the company focused on consumer research across different tablet forms and dimensions.

“Seventy percent of the R&D went to how to achieve a consistent and acceptable experience for the consumer,” says Padain.

This R&D helped the company understand user experiences and preferences, guiding adjustments to the design. In the case of the Aleve blister packs, Padain says the performance is great, but this current specifi cation may not be a solution for the company’s entire blister portfolio.

“It won’t necessarily cascade everywhere,” says Padain. “We have soft chewable tablets, for instance, in our portfolio, that this PET solution will not necessarily solve.”

THE BIGGEST CHALLENGE was achieving a consistent and user-friendly approach to pushing tablets through the plastic lidding, as plastic doesn’t naturally wish to be perforated like aluminum does.

Bigger goals

While transitioning over-the-counter medicine packaging from PVC to PET is a step forward in sustainable packaging, change within the recycling industry is required to ensure innovations like this become part of the circular economy. Bayer is working across the industry in partnership with the Global Self-Care Federation and the Blister Pack Collective, and recently joined The Recycling Partnership, to accelerate progress and create systemic change.

“We’re often asked why… ‘why do this if, if there’s still work to be done?’ But our perspective is certainly this is the first step, and I think we’ve got to make that first step,” says Padain.

Launching first in the Netherlands, in the coming years, the company has the ambition to replace all its blister packaging with more sustainable alternatives. This supports the company’s broader goals of carbon reduction as it works toward larger Net Zero ambitions.

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The Many Facets of Sustainable and Recyclable Blister Packaging for Pharmaceuticals Primary Packaging

Exploring sustainable blister packaging from the lens of material selection, quality regulations, machinability, and printability.

By Evan Kamph, Sriman Banerjee, and Julie Ennis on behalf of the PMF Working Group on Sustainable

Blisters

KEY TAKEAWAYS

A cross-industry workstream was established by the Pharmaceutical Manufacturing Forum to identify the key challenges in the transition to alternate blister packaging.

Several pharmaceutical companies are actively assessing PVC-free alternatives, such as mono-polymer.

OThe regulatory requirements for replacing PVC-based blister materials vary globally.

ver the last 50 years , blister packs have become the preferred packaging choice for oral solid-dose medicines across Europe and many other parts of the world. These packs are predominantly composed of combinations of Polyvinyl Chloride (PVC) and aluminum, materials that have been widely accepted due to their excellent attributes, including their ability to protect products from physical damage, compatibility, manufacturability, capability to accept film laminations/coatings or improved barrier performance, and economics.

However, from an environmental standpoint, PVC has been a cause of discussion as a plastic material of concern over the past few decades. Its lifecycle, from production and use to disposal, releases potentially concerning chemicals. Additionally, due to its composition, PVC is challenging to recycle in standard waste streams. It requires separation for effective recycling, and even small amounts can contaminate other polymer recycling streams.

There are also industry headwinds that may impact the viability of using PVC as a packaging material. This shift may lead to the discontinuation of PVC by suppliers or significant premiums for its use in pharmaceuticals. This scenario is not hypothetical; multiple examples of compounds, such as Barex* and various PFAS#, have been phased out in the food market and subsequently discontinued worldwide. As demand for PVC products

decreases over time, the economic viability of PVC may diminish, risking reputational damage for those who continue to use it. Further, regulators have started introducing restrictions on PVC applications. E.g. South Korea.

In light of this situation and the pharmaceutical industry’s focus on sustainability initiatives, a cross-industry workstream was established by the Pharmaceutical Manufacturing Forum (PMF) to identify the technical and regulatory challenges and opportunities for initiating and accelerating the transition to alternate blister packaging. The core aim is to optimize the costs, timeline, and efficiency to implement while mitigating technical, regulatory, financial, and reputational risks. This paper presents the findings of this workstream, focusing on the key areas: design for recycling, reduced carbon footprint, manufacturability and printing, quality, and regulatory strategy.

Design for Recycling

The pharmaceutical industry has long relied on PVC-based blisters for solid-dose form packaging, but recycling these materials has consistently posed a challenge. Current initiatives have been limited to examples of pharmacy-led schemes or pharmaceutical company-initiated take-back programs. These schemes typically utilize non-circular ‘one-off recycling’ pilots using specialist recyclers. However, these efforts often lead to higher costs, low take-back rates, and difficulties in upcycling.

Several pharmaceutical companies are actively assessing PVC-free alternatives, such as mono-polymer and aluminum options that are PVC-free. Mono-polymer blisters made from plastics that take advantage of established recycling streams offer the most significant potential for widespread recyclabil-

1: Each LCA factor, such as GHGe, is scaled 1-10 (1 being the lowest environmental impact), and then the factors are accumulated to give the total for each material.

“ ”

PVC

IS DIFFICULT

to recycle in regular waste streams as it requires separation for effective recycling, and small amounts can contaminate other polymer recycling streams.

ity of blister packages. Three key mono-polymer formats are being evaluated across the industry:

• Polypropylene (PP)

• Polyethylene (PE)

• Polyethylene Terephthalate (PET)

Technically, manufacturing mono-polymer blisters is feasible with currently known machine setups and tooling. Design for recycling depends on many factors beyond just polymer type, including dimensions, inks, ink coverage, adhesives, and plastic additives. Frameworks such as RecyClass in the EU and APR in the US guide the requirements for packaging to be considered recyclable, but these are primarily aimed at the Fast-Moving Consumer Goods (FMCG) sector. A practical assessment of the sorting behavior of blisters against standardized testing methodology is required, presenting an opportunity to partner with these organizations to develop specific guidance for pharmaceutical formats. However, achieving technical recyclability does not guarantee that the components will be recycled at scale, which is essential for true circularity.

There also needs to be market demand for the recyclate to drive the circularity of the system. Take-back schemes may address collection challenges and partner with recycling facilities with

GRAPH

Table 1 Compares the alternative plastic materials proposed for blisters.

more specialist capabilities. CiPPPA^ (Circularity in Primary Pharmaceutical Packaging Accelerator) and other associations, including recyclers, are evaluating blister and pharma packaging recycling options via take-back schemes. These systems need to be sustainable both from an environmental and business perspective. Residual contamination of the blister and the risk of release of APIs into the environment through wastewater from cleaning steps or risk to operators working in recycling and reprocessing should be considered.

Life Cycle Analysis

Life Cycle Assessment (LCA) is a critical tool for supporting design and material selection. ISO 14040 provides a standardized framework for holistically modeling a product’s environmental footprint. One LCA impact assessment method is carbon footprint, expressed as CO2 equivalents, which assesses a material’s contribution to climate change. However, a holistic decision on material choice should consider a range of environmental impacts, as exemplified by the Product Environmental Footprint (PEF). (See graph 1)

The available LCA data above on alternative materials to PVC show that PP, PET, and PE materials have a carbon footprint similar to PVC when compared to fossil fuel versions of each material. From a carbon footprint perspective, eliminating aluminum-based lidding foil in favor of plastic material can reduce at least 50% of CO2 equivalents. Moving from high-barrier, large-size Alu/Alu blisters to smaller mono-polymer blisters with an overwrap can reduce the carbon footprint further, up to 70%. This move also introduces the opportunity to use more sustainable feedstocks to produce plastic materials, such as bio-based plastics, chemically recycled polymers, or those manufactured from carbon capture utilization or other technologies, all of which can enable significant reductions in carbon footprint relative to the traditional, virgin versions of the same types of polymers.

Manufacturability and Printing Machine Processability

FROM a carbon footprint perspective, eliminating aluminum-based lidding foil in favor of plastic material can reduce at least 50% of CO2 equivalents. “ ”

Implementing sustainable packaging solutions will introduce new material combinations, impacting current equipment, tooling, and process parameters. Achieving high machine speeds will require materials that seal quickly, withstand high sealing pressures, and offer a wide process window. New tooling could include forming tools with adjusted cavity geometry and low friction coating to prevent unwanted adhesion. Packaging lines may need extra features, such as pre-heating or plug assist, to optimize performance. Films exposed to heat during forming, sealing, or pre-heating may soften on machine stops, affecting packaging integrity. Platen sealing presents additional challenges due to its intermittent process and the fragile and flexible polymer films.

Printing

According to regulatory requirements, pharmaceutical blisters must be labeled with product specific information and batch data. Thus, the lidding film must be printed either by a thirdparty vendor or in-line via a UV-flexo or UV-inkjet module. Digital printing technologies allow new approaches for processing and printing blisters, such as printing after sealing and punching, serialization of single units and color-coding different strengths which would eliminate the need for pre-printed stock. Replacing the reflective metallic surface of aluminum lidding with a dull white lid film enhances readability, making it easier to identify correct print images, codes and batch information. UV laser technology for marking of blisters has the potential to eliminate the need for consumables and inks and the concerns related to extractables and leachables. However, the current state of the technology does not deliver sufficient power for the required production speed. (See table 1)

TRANSITIONING to sustainable blister packaging involves significant regulatory considerations, as changes to primary packaging materials generally require regulatory submissions.

”

Quality

There are several considerations to note which may affect product quality and/or compliance. Sustainable blister solutions will likely be 100% polymeric and may present challenges in achieving equivalent barrier properties to existing blister packs; opportunities exist to engage with regulators to utilize simulation models and reduce the stability testing required. Although the intent is to leverage materials whose safety has already been established by the food industry, it is possible that extractable and leachable testing may be required for materials not yet established in the pharmaceutical industry. Compliance with food packaging regulations and pharmaceutical compendial standards is required.

Regulatory

Transitioning to sustainable blister packaging involves significant regulatory considerations, as changes to primary packaging materials generally require regulatory submissions. The regulatory requirements for replacing PVC-based blister materials vary globally and depend on their potential impact on the product’s quality, safety, and efficacy. Factors such as the nature of the dosage form, the extent of the change, and the novelty of the packaging materials will influence the exact requirements, which may also vary by market.

Key Points:

1. Regulatory Submissions: Changes to primary packaging materials will require regulatory submission. The data and submission pathways for these changes can differ globally, depending on their potential impact on product quality, safety, and efficacy.

2. Multi-National Regulatory Strategy: A cross-business, multi-national regulatory strategy is essential for successfully implementing sustainable blister packaging. This strategy should accommodate changes to multiple products and various PVC blister packaging alternatives within the same framework.

3. Post-Approval Change Management Protocol (PACMP):

The proposed strategy includes developing a multi-product PACMP that defines a standard set of data and commitments and establishes a simple notification pathway for post-implementation of supporting data. This protocol will exploit science, risk-based principles, and prior knowledge to streamline product-specific quality data requirements.

4. Regulatory Endorsement: It is crucial to gain endorsement and support from influential regulators, particularly the European Medicines Agency (EMA), which has supported industry efforts.

Due to environmental concerns about PVC-based blisters, the pharmaceutical industry proposes transitioning to alternative blister packaging materials. Alternatives like mono-polymer blisters are being explored for better recyclability, reduced carbon footprint, and elimination of PVC. This transition involves considering environmental impact, quality, regulatory compliance, manufacturing, and market demands, showcasing the importance of industry collaboration.

* https://news.3m.com/2022-12-20-3M-to-Exit-PFASManufacturing-by-the-End-of-2025 # https://themedicinemaker.com/manufacture/finding-the-new-barex ^ https://cipppa.org/

Evan Kamph is the Senior Manager, Packaging Technology and Industry Intelligence, Pfizer.

Sriman Banerjee is the Head of Diagnostics, Software Devices & Packaging R&D Pharma Sci, Takeda Pharmaceutical Company Limited.

Julie Ennis is the Vice President, Technical Operations Science & Innovation, AstraZeneca.

The PMF Working Group on Sustainable Blisters was founded according to its statutes in February 2008, as a pre- and non-competitive Non-Profit Organisation in Basel. Bayer is one of the founding members as Novartis or Pfizer is. Individual personal members are the TechOps leaders of the top BioPharma companies. Across industry and across BioPharma, experience sharing, learning, providing solution of equal benefit to all members and also beyond the PMF, also in cooperation with earlier or later parts of the BioPharma value chain as well as common action in crisis situations (hurricane, earthquake, tsunami, Covid, disaster,) are communalities. PMF Members include: AbbVie, Amgen, AstraZeneca, Bayer, Biogen, Boehringer Ingelheim, Lilly, GSK, Merck, Merck Group. Novartis, NovoNordisk, Pfizer, Roche, Sanofi. Takeda, UCB, BMS, J&J.

Inclusive Design in Packaging: Insights from the Arthritis Foundation

Deb Gokie discusses the Arthritis Foundation’s inclusive design program, emphasizing its impact on medical device and pharmaceutical packaging design for enhanced usability.

By Liz Cuneo, Editor-in-Chief

The Ease of Use Design guides offer pharmaceutical and medical device companies guidelines to create inclusive products.

Companies are moving beyond sustainability to consider accessibility, often making small design changes to enhance inclusivity. KEY TAKEAWAYS

HCP: Hi Deb, can you tell us a little bit about yourself, your position, and what your focus is at the Arthritis Foundation?

I’m Deb Gokie, Vice President of Consumer Health Ease of Use at the Arthritis Foundation. I oversee the inclusive design program, certifying products and packages that are easier to use for people with arthritis and chronic pain. This initiative benefits all consumers by making products more accessible. It’s an exciting opportunity to be able to work with not only medical & pharmaceutical companies, but consumer brands too, that are thinking about how to bring inclusive design into their products and packaging. How long has this initiative been going on?

As populations age and conditions like arthritis increase, the demand for products that accommodate these needs will rise.

The Arthritis Foundation has been involved in this since the seventies. But about four years ago, I was tasked with evaluating the program to enhance engagement with companies. A year ago, I began focusing solely on this program, transitioning from a background in non-profit corporate development to working closely with companies on inclusive design.

HCP: Can you talk about your partnership with Target as well as other brands?

Gokie: So, we test a lot of products and packages and, if a company has a product that is already in market and they go through testing and they don’t pass, we’ll offer some design updates. But, if they’re in market already, it can cost six figures to go back in and redesign a specific item so that it is eligible for certification. And so, what we were looking at and working on was ‘how do we get in the front of that and how do we really fill a gap and help engineers and industrial designers as they start to think about package design in the beginning and how can we provide resources to them?’ So, we had been working with Target on some particular projects around that, and my collaborator there and I both felt like it was really important to bring that education into the early stages of design. So, we created the Ease of Use Design guides.

HCP: How do these guidelines translate into the medical device or pharmaceutical industry?

Gokie: Working with pharmaceutical or medical devices, I noticed they’re really looking at medical devices that are easier

“ ” BY PRIORITIZING INCLUSIVITY,

companies can create products that not only meet regulatory standards but also enhance user satisfaction and loyalty.

—Deb Gokie, Vice President of Consumer Health Ease of Use at the Arthritis Foundation.

for people to use. And they come to us because we test for people that have arthritis or chronic pain. But if the device passes and they certify, it will help all people, really, not just those with arthritis.

One of the things I think that’s so exciting is that pharmaceutical companies are really starting to think about how to design devices that are easier for people with arthritis and chronic pain. And there are so many great examples of this. If you make a package easier to use for somebody with dexterity issues, it really becomes easier for everyone.

Have you seen any interesting examples of medical device or pharmaceutical packaging that is accessible to those with arthritis? There’s a lot of different and creative ways that pharmaceutical companies bring devices to market. AbbVie has RINVOQ, which has a really wonderful bottle and cap design, and the pill itself is certified also because of a unique indentation that makes it easy to pick up. So, I think that pharmaceutical companies really are trying to think about how to meet the needs of not only the arthritis patient, but their patients in general; they are coming up with some very, very great inclusive designs to be able to meet those needs.

HCP: Can you describe the testing process for packaging?

Gokie: We collaborate with Intuitive Design Applied Research for testing. We work with Dr. Brad Fain, and he does all of the testing for us. He’s a human factor engineer, and he has worked at Georgia Tech for many years and has also worked with us on our testing for several years. He evaluates products through lab and human factor assessments, focusing on usability for arthritis patients. Based on these evaluations, he’ll write up a very detailed report and then give the products a pass or fail, with design guidance provided if necessary.

HCP: In the last decade, have you been hearing more about designing for human factors and usability?

Gokie: Yes, there’s a growing trend toward incorporating human factors in design. Companies are moving beyond sustainability as a sole focus to consider accessibility, often making small design changes to enhance inclusivity. And sometimes all it takes is a small change to make it more inclusive.

HCP: What do you think is fueling this growth?

Gokie: When you start looking at the number of people that live with arthritis today, not only in the U.S. but in Europe and Asia, those numbers are extremely high. Two hundred and twelve million people in Asia, 83 million in Europe and 60 million in the U.S. They’re projected to grow 40% by 2030 and their spending power today in just the 45-age group is 8.3 trillion in the U.S. and 2.3 in Europe and Asia respectively; that’s expected to double by 2030. So, as you are a company looking to meet consumer needs, know that it’s an aging population, it’s an arthritis population, and their spending power continues to get higher and higher. I think it’s really important to start thinking about ‘how do we meet the needs of that community who is able to purchase products that are designed with inclusive design that they will need as they continue to age out.’

HCP: How do you see the role of inclusive design evolving in the future?

Gokie: The role of inclusive design is set to expand as awareness grows about the diverse needs of consumers. As populations age and the prevalence of conditions like arthritis increases, the demand for products that accommodate these needs will likely rise. Companies that integrate inclusive design principles early in their development processes will be better positioned to meet these demands and capture a broader market share.

We’ve done a lot of statistics and surveys around the ability to open packages. One question that we asked in a recent survey (and we did this with both consumers and people that live with arthritis), was asked, “do you get any injuries at all from trying to open products or packages?” And 98% responded with yes. It was chipped teeth, bruises, cuts… which is insane. And it not only comes from people with arthritis that provide ideas for us to look at, but it also comes from other consumers.

HCP: Do companies approach you for help, or do you reach out to them?

Gokie: Companies often approach the Arthritis Foundation, recognizing it as a leader in inclusive design. We also receive feedback from consumers and arthritis patients, suggesting products for certification or improvement. A lot of companies come to us early

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on looking for help to create a more inclusive design. We work with companies from the design stage to market entry, off ering guidance throughout. That’s why the design guides came out— so companies can have a framework to design their products in a more user-friendly way.

HCP: What advice would you give to companies looking to incorporate inclusive design?

Gokie: Start by understanding the specific needs of your target audience, including those with disabilities or chronic conditions. Engage with experts in inclusive design early in the development process to identify potential challenges and solutions. Consider conducting user testing with diverse groups to gather feedback and refine designs. By prioritizing inclusivity, companies can create products that not only meet regulatory standards but also enhance user satisfaction and loyalty.

Designing for an Emergency

Alper Hulusi, from ClariMed, discusses how to design medical device packaging for use in an emergency setting.

By Liz Cuneo, Editor-in-Chief

KEY TAKEAWAYS

ClariMed works in simulating emergency scenarios to help in designing medical devices for human factors.

AIt’s helpful to speak directly with people that have in the past administered emergency care and learn from their experience.

t Pharmapack Europe 2025 this past January, Alper Hulusi – Head of Market Insights at ClariMed, gave a Lightning Talk on ‘Designing for an Emergency: Considerations for emergency use product design.’ He shared a real-life story about his son that forced him to have to use a life-saving device, a Glucagon pen. Through the experience he learned that even with all the necessary experience and knowledge about the product, he still faltered, because “a real emergency setting is far different from the simulation scenarios.” And while ClariMed works in simulating these emergency scenarios for designing for human factors, through this, Hulusi learned that we cannot fully and accurately simulate an emergency.

“We need to look beyond the physical device. We need a better understanding of the experience and emotion of real-life emergency use,” said Hulusi at Pharmapack.

Hulusi says, “a real emergency setting is far different from the simulation scenarios.”

He also talked a lot about incorporating empathy into medical device design through not only the packaging but the product itself, as well as the instructions, to help users handle them correctly when operating under pressure.

Hulusi shared tons more about designing for an emergency, as well as the emerging trends in the medical device space.

HCP: At Pharmapack you spoke on emergency use devices, and how to design for these heightened emotional situations. Can you tell us a little more about this?

Hulusi: Medical device companies obviously try to design for real-world situations. Take a Glucagon pen for example, which is used to save lives during a glucose slump. In a formative or summative research session, we strive to have people handle the device in an environment that, as accurately as possible, mimics the real deal. But how can we successfully simulate the emotional and cognitive burden someone experiences when they use a device like this? Imagine, a parent confronted by their son or daughter mid-seizure, having to prepare and inject a Glucagon pen, as intended by the manufacturer. It’s an acutely stressful event and medical products need to be designed with that in mind. But how do we develop and ‘test’ these devices in a simulated scenario and know that they’ve been designed in a way that will give people a fighting chance of handling them correctly?

HCP: Can you explain a bit more about what an emergency scenario might look like?

“

” WE NEED TO LOOK beyond the physical device. We need a better understanding of the experience and emotion of real-life emergency use.

— Alper Hulusi

Hulusi: More often than not, this takes the form of a study moderator introducing the study to the participant and, at some point in the session, asking the participant to imagine they are in a certain scenario. They are then asked to go ahead and use the product (and anything available to them), imagining this is real life. So, there’s an attempt to recreate the pressure someone might experience during an emergency, maybe even stating the time in which they need to complete the device handling steps. An effort is also made to recreate environmental and audio conditions that someone might experience in this situation – so if they were at home, there might be a TV sounding in the background, or children playing. In the case of a Glucagon pen, the person will have the instructions in front of them, should they choose to use them, and will then likely go through the steps of opening the packaging, reading the instructions, preparing and then injecting the device into a mannequin. The question here is, during device development and ultimately, summative testing, how do we accurately replicate real-life situations? And how do we ensure a dose of reality is incorporated into product design from the outset? It’s an important question, and one that needs further attention.

HCP: So, what might be the lessons we can take forward?

Hulusi: One of the many things we can do is to speak directly with people that have in the past administered emergency care and learn from their experience. What did it feel like? How did they find handling the device? What did they find easy, what did they find challenging, and why? It’s these insights that will place us in a better position when it comes to developing emergency use medical devices and instructions.

HCP: Shifting gears, what are the overall trends in devices you expect to see this year?

Hulusi: The big trend we continue to see is the increased focus on device connectivity – as this technology provides a potentially rich source of data and information that can benefit people who live with medical conditions. To take just one real-world example, for people who live with Type 1 Diabetes, monitoring of

glucose levels can now not only be done automatically, but the devices themselves can gather and transmit data to the wearer and their HCP team and provide all parties with information and data to help optimize how they manage their glucose levels. Increased connectivity, as well as the way that data is used, is absolutely the big trend and a proven approach to improve clinical outcomes and quality of life. More widely, sustainability is another enduring trend concerning the production, recyclability, and appeal of medical products.

HCP: Do you see any trends in behaviors and the usability of devices – are patients changing how they manage conditions?

Hulusi: One big shift we see is the empowerment of people with conditions, as they increasingly take ownership of their condition through better devices, connectivity, and device/therapy-related data. This places people with conditions and HCP teams in a far better position to make positive condition and therapy decisions. The only slight risk I see here is that developers need to be careful not to over-design devices and avoid building in features and functions that either aren’t needed, won’t be used, or at worst, compromise device usability.

But there are many positives, especially in the world of Type 1 Diabetes, as these devices not only provide condition management insights, but also provide therapy recommendations.

Cannabis Entrepreneurs Take a Shine to Automation

A combination scale, bagger, checkweigher, and coding and marking operations accelerate packaging production efficiency.

By Pat Reynolds, Contributing Editor

In 2023, the firm installed a High Tek bagging machine. Integrated with the High Tek combination scale, it lets a team of two operators package nearly 6,000 units per day.

Founded in 2017 by a group of cannabis entrepreneurs with the goal of creating a robust and efficient supply chain of legal cannabis throughout California, lbs. Distribution has lately been on an automation journey. In the early days, the West Sacramento, CA-based firm managed to manually fill and seal 300 pre-made bags per person per day. So with a team of five, that was about 1,500 units/day.

A significant improvement was made in 2020 when the firm installed a 14-bucket combination scale from High Tek. Operators held the premade bags beneath the discharge chute of the scale and manually put the bags through a heat-sealing system, an approach that got a team of five to 2,200 units per day.

Then in January of 2023, the firm installed a High Tek bagging machine. Integrated with the High Tek combination scale, it lets

The company offers both 3.5- and 14-g sizes, which are produced on the weigher/bagger

lbs. Distribution had the goal of creating a robust and efficient supply chain of legal cannabis throughout California.

The team went from manually filling and sealing bags (1,500 units a day) to 2,200 units per day with the addition of a 14-bucket combination scale. KEY TAKEAWAYS

Integrated with this combination scale, the new bagger lets a team of two operators package nearly 6,000 units per day.

system.

At Pacteon, we work as one team providing integration and service for life’s products. ESS Technologies makes cartoners, case packers, robotic palletizers and pick-and-place solutions for the pharmaceutical, nutraceutical, and health and beauty markets. S IN L I IN S C NOLO I S

a team of two operators package nearly 6,000 units per day. The bagger uses vacuum pickup cups to pick a premade pouch from a magazine feed and place the pouch in a shuttle. The pouch is mechanically pinched to help open it. Then a puff station blows a burst of air into the pouch to fully open the bottom gusset. At this point the pouch is ready to receive product from the discharge funnel of the High Tek combination scale. Next is a station where the pouch is aggressively shaken to settle the product down into the bottom of the pouch.

All that remains is a station where two wheels come together to pinch the zipper reclosure shut. The pouch then passes through checkweighing, executed by a component made by High Tek. Finally, heat sealing jaws produce a heat seal above the zipper reclosure.

Both 3.5- and 14-g sizes are produced on the weigher/bagger system. Director of operations John Perrino says throughput is in the range of

“THROUGHPUT now is in the range of 10 pouches/min., which is an improvement from strictly hand packing, which was closer to 40 units/hr.

”

10 pouches/min. He calculates that with strictly hand packing one person could produce something like 40 units/hr. “Now we run a team of two and they knock out almost 600 parts/hr,” notes Perrino. “So that’s 300 parts per labor hour, up from 40 parts per labor hour.”

Perrino is greatly pleased by improvements like this, and he adds that one more upgrade is on the way: a Videojet thermal-transfer overprint unit for lot and date code information that will be integrated with the High Tek bagger.

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Moving On From EO: Experiencing The Evolution of Today’s Sterilization Methods

As the medical device and pharmaceutical industries face pressure to phase out or move away from ethylene oxide, new sterilization trends

By Joe Darrah, Contributing Editor

KEY TAKEAWAYS

A proven, effective sterilization method since the 1950s, EO has been linked to harmful environmental and public health effects.

Ware emerging.

After steam and EO, the most common sterilization is irradiation, which is traditionally performed with gamma rays.

hen a recent rally in Memphis, TN, brought together community residents advocating for better protection of the environment, several accomplishments were celebrated. Chief among them was acknowledging the closure of a local facility that since 1976 had operated as a contracted sterilizer of medical equipment and materials. But the company has joined a growing number of plants that have shut down in response to ongoing scrutiny related to the use of ethylene oxide (EO), the colorless gas that, according to the U.S. Food and Drug Administration (FDA), is responsible for the sterilization of approximately 50% of all medical devices. A proven, effective sterilization method since the 1950s known for its ability to sterilize items that can’t withstand the heat associated with steam sterilization, EO has been linked to harmful environmental and public health effects.

Although the Environmental Protection Agency (EPA) still lists nearly 90 EO-active facilities nationwide (and in Puerto Rico), the prevailing sentiment is that more appropriate alternatives for sterilization are being developed for manufacturers to pivot toward as regulations become more stringent and as more facilities close for noncompliance.

“There has been much pressure focused on ethylene oxide sterilization because some processors have not done enough to ‘scrub’ the sterilant gas when vented from the sterilization vessels at the end of a sterilization cycle,” says Len Czuba, president of Czuba Enterprises Inc., a product development organization based in Lombard, IL, that specializes in plastics and medical devices. “This has led to many facilities closing, resulting in more pres -

Other trending options for sterilization include NO2, CIO2, high-concentration CO2, and VHP.

sure on other facilities that are fully in compliance with eliminating toxins from effluent gas emissions. But there are other options for sterilization being offered. The product will dictate the type of sterilization that is most appropriate.”

Common Sterilization Methods Today

After steam and EO, the most common sterilization is irradiation, which is traditionally performed with gamma rays or electron beams, aka beta irradiation. A radioactive particle that kills “bugs” equivalent to what EO achieves through high-energy, high-penetrating electromagnetic rays, gamma (Cobalt-60) is challenging to contain and is not abundantly available.

Still, for those who can source it, gamma provides great versatility, says Paul J. Serio, president at Accumedix Inc., a medical device contract manufacturer based in Libertyville, IL, that develops and commercializes medical, dental, and surgical products. “We have had great success with gamma,” Serio said. “We do our work in the 25-40 kilogray cycle and it is far and away our preferred method of sterilization.”

While the revalidation process to ensure that items that are sterilized with EO can withstand gamma is time consuming and expensive, Serio said more manufacturers are investing in the modality because the testing for suitability is not difficult. “We’ll place a sample of the product in with a sterilization batch, and it’s quickly evident to see if there are any issues, such as discoloration or crazing in a plastic,” he said. “Anybody who’s currently using EO should be looking for alternative options. You need to weigh and consider that, increasingly, EO facilities are becoming

“

less available. Those continuing to go with EO could very well be in a position where, without much notice, there’s no longer a place to conduct sterilization.”

With beta irradiation, a stream of high-speed electrons sterilize products with similar sterilization effectiveness although the beta-particles have less penetration energy. Product is placed in layers on conveyor belts to pass under a curtain of particle, enabling sterilization to occur in seconds as opposed to the hours required for gamma. “With beta, the time factor is a positive over gamma since there is less time for oxygen to seep into the product, resulting in less oxidation of the polymers of construction,” Czuba said. “And when power is switched off the particle accelerator, the system has no harmful radiation, as does gamma. That’s a big advantage. I believe beta is the wave of the future.”

As methods of radiation sterilization evolve, Czuba also sees x-ray as one of the more recent developments to gain significant traction. “This is where you irradiate a specific metal target that, as with beta, you turn on the energy to the accelerator source,” he said. “The source generates a high-energy beam that energizes the target, which generates x-rays that sterilize the product to which it’s exposed. This is still in final development, but companies are investing in it and x-ray looks like it will be available commercially as the industry moves away from EO, as companies conduct proper qualification tests, and as the FDA gives its approval.” Among the benefits of x-ray is that it’s somewhat stronger and provides better penetration compared to beta, and similarly only emits rays when the power is turned on to the source, making it less dangerous than gamma. “The only drawbacks as of now would be cost related and that there would be many qualifications required to transition to it because it’s in the early stages of adoption,” said Czuba.

” THE MOST important thing is that the industry as a whole – the sterilizers and the regulators – be completely transparent with regards to the direction that things are going.

—Brian McCollum, principal consultant, GSD Medical Device Consulting

Additional Sterilization Alternatives: An Overview

Other trending options for sterilization include nitrogen dioxide (NO 2), chlorine dioxide (CIO 2), high-concentration carbon dioxide (CO 2), and vaporized hydrogen peroxide (VHP).

At Noxilizer, an organization based in Hanover, MD, that provides sterilization services and equipment to pharmaceutical, biotech, and medical device manufacturers, a proprietary NO2 sterilization process is helping to solve sterilization challenges throughout the process.

According to Maura O. Kahn, senior vice president of commercial products, and David Opie, PhD, senior vice president of research and development, NO2 is best suited for drug-device combination products, including biotech drugs in pre-filled syringes, biotech and other drugs in auto-injectors, custom orthopedic medical devices, and glucose sensors. The benefits of NO 2 are said to include ultra-low temperature processing that can extend the shelf life of biologics, minimal degassing required, maintaining of drug integrity, shorter processing time compared to EO, and better room air quality, as all NO 2 is captured within the scrubber.

Lack of compatibility with NO2 is seen with cellulosic materials. As such, high-volume, pre-packed surgical kits are not candidates. For those seeking a potential transition to NO2, Kahn and Opie suggest evaluating options as early in product development as possible. Currently marketed products also have options for testing material compatibility, sterilization feasibility, and validation studies.

Although CIO 2 can also be hazardous, its ability to achieve high levels of sterilization at lower temperatures and shorter exposure times compared to other traditional methods makes it another viable option. Other benefits of CIO 2 are that, as compared to EO, it is non-flammable, non-explosive at use

That said, not all sterilization methods are created equally or are appropriate universally, especially considering liquids, which cannot be sterilized with gas or radiation. “Gas cannot penetrate liquid to kill microorganisms, and the energy of radiation affects the chemical components of the liquid, causing them to degrade, whether it’s gamma, beta, or x-ray,” explains Czuba. “This would lead to byproducts in the solutions that are not intended. Virtually all liquids, including IV bags, blood bags, surgical lubricants, and wound rinses must be sterilized with steam through an autoclave.” The exception to using something other than steam to sterilize liquids is for those products that are aseptically made, a process in which products are made sterile before being packaged in a sterile environment – suitable for materials that do not require refrigeration.

Minimizing Bioburden Along the Pathway

concentrations, and can be exhausted in almost all locations, says Czuba. “I think we have better ability to scrub this away today [compared to previously],” he said.

High-concentration CO 2 (or supercritical CO 2) sterilization has also gained notoriety as a safe and efficient modality with multiple applications for both synthetic and biologic devices and drugs. An inert, non-reactive molecule, it sterilizes at low temperatures, as with NO 2, and does not require outgassing.

VHP, an antimicrobial sterilization “cocktail” that works via a combination of hydrogen peroxide vapor and water vapor for devices and other items including implants, pharmaceutical containers, parenteral drug delivery systems, and other products that are sensitive to high temperatures, could be an especially attractive option for small-to-mid-size manufacturers due to available lower-cost options, says Brian McCollum, principal consultant at GSD Medical Device Consulting, Redwood City, CA. However, while McCollum sees some promise regarding alternatives, he said a lack of infrastructure for industry is concerning. “The most important thing is that the industry as a whole – the sterilizers and the regulators – need to be completely transparent with regards to the direction that things are going,” he said. “If I’m going to have billions of dollars worth of product that must now be revalidated in a few years, then I’m going to have to start that process as of yesterday. For any dramatic change that’s headed our way, we need to have visibility on where the direction is going.”

Regardless of the sterilization method, minimizing bioburden is a significant aspect of patient safety, says Steve Laninga, managing director of devices, at Ascential Medical & Life Sciences, a design, development, and manufacturing solutions company based in Minnesota.

“An often-underappreciated step in the process is the upstream activity that occurs ahead of the actual sterilization,” Laninga said. “This is critical to the effectiveness and efficiency of the sterilization – the minimization of pathogens that would be a result of sterilizing a higher bioburden load. Our focus is on how to improve and maintain the most sterile environment upstream to minimize the generation of any bioburden to begin with.”

Best practices for reducing bioburden include cleanroom manufacturing, strict gowning procedures for staff members, aseptic technique, and monitoring of the environment, as well as performance of personnel. With contamination through human contact being a common cause of bioburden, identifying ways to automate cleanroom processes upstream is a trending aspect for reducing risk. “Robotic material handling reduces the need for human contact in advancing material to the next unit operation within a clean room,” Laninga said. “Automated inspection eliminates the need for human contact at inspection points.”

Laninga said cleanroom design is also critical. “That starts with the initial concept of the suite,” he said. “Making sure that you have the right material flow. The suite should be designed so that air flow is appropriate to create a sterile environment. And with the way that the materials and the people are moving throughout the cleanroom, the product should be isolated from any people or other contaminants.” Training operators on the reasoning behind certain procedures is also essential, according to Laninga.

After drying, items are inspected and wrapped for steam sterilization in autoclaves before drying again and cooling to room temperature for storage.

“

Garrett Mitchell, MSN, RN, CMSRN, CNOR, an operating room (OR) nurse based in Arizona, also assists sterilization processes upstream. “We follow Joint Commission standards for onsite sterilization, as well as protocols defined by manufacturers,” he said. Sterilization for Mitchell’s OR follows a detailed process in which items are handwashed with bactericidal chemical non-foaming soap and placed on trays in washers that run higher than 180 degrees. After drying, items are inspected and wrapped for steam sterilization in autoclaves before drying again and cooling to room temperature for storage.

Indicators are placed onto wrapped products that change colors if contamination occurs.

Moving Forward With EPA & FDA Regulations

While EPA and FDA officials acknowledge that EO remains the only method to sterilize certain devices, the EPA has finalized a rule to reduce its emissions. By installing proven and achievable air pollution controls that many facilities have implemented, commercial sterilizers will reduce emissions by more than 90%. EPA officials said the ruling considers the latest data and science. “And it cannot be overstated: The science behind sterilization is exponentially more complicated than

” AN OFTEN-underappreciated step in the process is the upstream activity that occurs ahead of the actual sterilization.

—Steve Laninga, managing director of devices, Ascential Medical & Life Sciences.

virtually anything else that we do in the med-device industry,” said McCollum. “So the expectations are very high. To come up with something novel, that can be utilized, will mean the method will have to be as good or better than something that’s been studied for decades. That’s a big ask, even for modern technology.”

Joe Darrah is an award-winning freelance journalist based in the Philadelphia region who covers a variety of topics, including healthcare and medical technology, across all multimedia.

PROTECT WHAT MATTERS MOST

From syringes to diagnostic kits, Ossid’s packaging solutions are designed to handle the unique challenges of medical product packaging — keeping safety, sterility, and efficiency front and center.

Insights from a Senior Systems Engineer

James Hamerslag reflects on his long tenure at Siemens Healthineers, the evolution of packaging and automation in medical device manufacturing, and the critical role of team collaboration in driving innovation.

By Liz Cuneo, Editor-in-Chief

James Hamerslag is a Senior Systems Engineer at Siemens Healthineers, where he has spent the last 40 years developing and implementing product, process, and manufacturing systems. In this interview, he shares insights into the industry’s greatest challenges, the skills he has honed over his career, and the importance of cross-functional teamwork in the diagnostic device manufacturing field.

HCP: Hi, Jim. Could you introduce yourself and tell us about your role and experience?

Hamerslag: I’m James Hamerslag, a Senior Systems Engineer at Siemens Healthineers. I’ve been working in engineering for 40 years. My journey began at DuPont Medical Products, where I entered the diagnostic device manufacturing industry as an engineer. Throughout my career, I’ve focused on product, process, and manufacturing systems development, contributing to various advancements in the field.

HCP: You have a background in microelectronics. How did you transition into medical devices?

Hamerslag: After completing graduate school, I started in microelectronics with a company that specialized in wire and die bonding equipment. I later transitioned to developing products and manufacturing systems for laser transmitters and receivers used in fiber optic applications. During this time, I developed expertise in thick film technology, which ultimately became crucial in the development and commercialization of a medical device designed to measure electrolytes in bodily fluids. This was my entry point into the medical device industry, and I’ve been working in this field ever since.

HCP: What types of medical devices do you work with now?

Hamerslag: I currently focus on clinical chemistry and in vitro diagnostics (IVD). For instance, when a doctor orders lab tests, the blood sample is processed through an analyzer located in a hospital laboratory, testing company lab, or doctor’s office. Much of my work revolves around the packaging and manufacturing systems to produce consumables used in these analyzers.

HCP: Having spent four decades in the industry, what changes stand out most in your career?

Hamerslag: The biggest change has been the advancement of engineering and manufacturing tools, especially the personal computer. When I first started, I used a Digital Equipment Corporation (DEC) PDP-11 for computational work. Then, in 1981, the IBM PC revolutionized the way engineers work. Today’s personal computers are far more powerful, offering faster processors, vast memory and storage, advanced graphics, and the capability to run resource-intensive applications. They’ve truly transformed how engineers approach their job.

HCP: In packaging, how do you balance sustainability, cost reduction, regulatory compliance, and customer usability?

Hamerslag: When designing packaging for medical devices, we must consider both product and regulatory requirements. Key factors include ensuring the product is user-friendly and compatible with the customer’s workflow. It’s vital that the packaging not only meets regulatory standards but also provides a seamless experience for the end-user. For example, does the packaging support easy integration into the customer’s environment, and does it ensure the product is easy to handle and use?

HCP: Is sustainability a growing concern in your field?

Hamerslag: Absolutely. There is constant pressure for sustainable packaging, especially as our products are sold globally. For instance, the European Union has more stringent environmental regulations than the U.S. As a result, sustainable packaging materials are an integral part of our product requirements.

HCP: You’ve mentioned the importance of collaborating with packaging, manufacturing, and automation teams. Could you expand on that?

Hamerslag: Collaboration between the product development, manufacturing, and automation teams is crucial, especially during the product development phase. It’s common for product development teams to focus primarily on the product itself and overlook the practical aspects of manufacturing. If manufacturing and automation constraints aren’t addressed early on, you may find yourself in a situation where the design is incompatible with existing manufacturing equipment or difficult to automate. Engaging these teams from the outset ensures that the product is both manufacturable and scalable, avoiding costly and time-consuming delays later in the process.

HCP: What are the biggest challenges and opportunities in packaging within the industry?

Hamerslag: The main challenges lie in meeting product specifications while adhering to stringent regulatory standards. Packaging must be designed to work within the customer’s operational environment, which may include considerations like refrigeration requirements. Regulatory hurdles also play a significant role, especially as the IVD industry is governed by multiple regulatory bodies, such as the FDA in the U.S. and regulatory authorities in other countries. Navigating these varying regulations can be one of the most challenging aspects of packaging design.

HCP: Switching gears a bit… What skills have been most essential in your career?

Hamerslag: Several skills have been pivotal in my career. First and foremost, statistical analysis of manufacturing data has been invaluable. By analyzing data, you can identify areas for improvement and make informed decisions. I’ve found that automation of data collection is critical, as manual data collection is prone to human error, often leading to questionable results. Another essential skill for me is being able to comprehend process control software. While I’m not a software engineer, I can write and understand process control software, which has been a vital tool in my work.

“IF MANUFACTURING and automation constraints aren’t addressed early on, you may find yourself in a situation where the design is incompatible with existing manufacturing equipment or difficult to automate. Engaging these teams from the outset ensures that the product is both manufacturable and scalable, avoiding costly and time-consuming delays later in the process. — Jim Hamerslag

”HCP: What advice would you give to someone just starting in medical device development?

Hamerslag: My advice would be to, as early in your career as possible, find a mentor who is passionate about teaching and guiding you. It’s important to leverage existing knowledge and focus on solving new challenges. I often encounter young engineers who hesitate to explore the work of others. Gaining insight into their successes and failures allows one to build upon their experiences and avoid common pitfalls. Don’t fear failure – view it as a learning opportunity and a necessary step toward finding the right solution.

FDA Warning Letters in Packaging: How Testing Can Help Prevent a 483

While testing doesn’t always prevent an FDA warning letter, doing so helps you stay in compliance and check the boxes the FDA is looking for.

By Liz Cuneo, Editor-in-Chief

KEY TAKEAWAYS

The warning letter, also known as a 483, identifies the concern(s), such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.

EWhile ISO 11607 is a voluntary standard, it is FDA recognized, making it the easiest and clearest route to follow to get clearance.

ach year, the FDA sends out hundreds of warning letters, which is really just the FDA’s way of notifying a company when it is in violation to federal requirements. Some letters address honest mistakes or oversights, while others address bigger issues like false label claims, selling an unapproved drug, and even refusing an inspection.

The warning letter, also known as a 483, identifies the concern(s), such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter provides an opportunity for the company or individual to address the FDA’s concerns and request a response with a certain timeframe. According to the FDA, this response could consist of plans for correction and the FDA would then check to ensure that the corrections are adequate. To the extent the company or individual disagrees with the FDA’s concerns, the company or individual has the opportunity to supply the agency with its reasoning and supporting information. These communications and other actions by FDA and/or the recipient of the letter may change the regulatory status of the issues discussed in the letter.

While companies may not directly think about how to avoid an FDA warning letter, and there are some key steps to take to do just that. One is keeping your facility clean, the next is never

One mistake is over-reliance on the pre-qualification of the packaging. The FDA expects you to do your own qualification work on that package.

refusing an inspection. Also on the list is being sure to follow all cGMP (current good manufacturing practices), don’t advertise unapproved products, and lastly be sure your product has passed compliance testing.

Wendy Mach, Sr. Director, Technical Services, and Sarah (Rosenblum) Ptach, President, Canyon Labs, off er insights into how proper testing can ensure a letter doesn’t come your way. Canyon Labs off ers consulting services and medical device and pharmaceutical compliance testing. Packaging testing methods have been developed by industry experts and regulatory agencies with the purpose to ensure safety and integrity up to the point of use.

“An FDA warning letter is usually the result of a condition that violates a regulation. Some of the most common I have seen are failure to follow procedures, inadequate training, and then not understanding the requirements of published standards (e.g. incomplete validations),” says Mach.

These test methods demonstrate how a package will perform after being exposed to different conditions experienced throughout the product lifecycle such as storage, handling, and transit conditions. Ensuring the device is safe and effective for market use is the goal. “If any aspect of this is deemed as insufficient, the result is an FDA warning letter,” says Mach.

Common mistakes

Mach and Ptach both agree that one common FDA strike that med device/ pharma companies encounter as it relates to the packaging is misbranding or incorrect labeling.

“According to the 2023 FDA Inspection Observations Database, multiple 483s were issued for not having a Unique Identifier (UDI) or incorrect accuracy of the UDI,” says Mach.

“Labeling is often glossed over, and key compliance items are missed. It contributes to the situation that labeling guidance has changed quite a bit over the last 10 years and there are more and more specific compliance requirements depending on where you are selling your product (the EU, USA, etc.),” says Ptach.

Another one? Inadequate control and management of packaging materials, or poor testing practices.

“Additionally, inadequate control and management of packaging materials is cited. Most of the citations from these types of issues are focused on poor testing practices that don’t ensure the materials demonstrate they can adequately protect the product prior to its use,” says Mach.

Both subject matter experts I spoke with agreed that some packaging fails or problems are only found through rigorously testing of the product.

“I’ve always heard the stat that over 30% of packages fail the first time they undergo distribution simulation,” says Ptach. “Typically speaking these failures are pin holes or cracks in trays or pouches. We see a lot of trays that have seal flange failures caused by drops. This means that when the package with the tray inside is dropped, the lid on the trays are popping upon impact due to poor distribution of the dynamic forces caused from the drop. Often, this can be solved by inserts that help make that impact not so pin-pointed on the tray. For orthopedics, people will often overlook how a device can be abrasive against a package during vibrations. I’ve seen knee implants rub like sandpaper against their PETG trays. The result is plastic flakes everywhere and a device that is contaminated and package that is broken. For pouches, people often fold these to get them to fit into cartons. These folds create an opportunity for cracks and voids as the fold compromises and stresses the structural integrity of the film of the pouch. All of these failure modes are typically caused by vibration and drop testing, but they are discovered once

AN FDA WARNING LETTER is usually the result of a condition that violates a regulation.

Some of the most common I have seen are failure to follow procedures, inadequate training, and then not understanding the requirements of published standards.

”

—Wendy Mach, Sr. Director, Technical Services, Canyon Labs. “

you conduct integrity testing such as visual (ASTM F1886) and bubble leak (ASTM F2096) testing.”

Gary Hutchinson, EVP, Managing Principal, Modality Solutions, a contract transport simulation lab, shares his insights into FDA warning letters that pertain to thermal shipping, and a common mistake he sees.

“One mistake is over-reliance on what we call, pre-qualification of the packaging,” says Hutchinson.

As he explained, a thermal packaging supplier can only test to one use case, and the supplier will come up with one that it thinks is most appropriate. The company then publishes data that says the packaging will meet a certain standard: duration/ temp range, etc. But that isn’t where testing should end.

“The FDA expects you to do your own qualification work on that package as well,” says Hutchinson. “We use the vendor (supplier) data as a baseline to get started. But you have to look at it yourself and confirm the packaging is adequate for your drug product in your shipping lanes. If the client accepts that data package and doesn’t do the appropriate technical review

ISO 11607 is a road map to ensure you are thinking and testing for all the variables that your packaging will experience in the real world.

”

—Sarah Rosenblum Ptach, president, Canyon Labs.

or follow up testing with their product, their lanes, they run into challenges.”

Advice

So then how do you incorporate testing as a best practice to prevent a warning letter? Part of it may be changing how you think of packaging.

“While ISO 11607 is a voluntary standard, it is FDA recognized making it the easiest and clearest route to follow to get clearance,” says Sarah Rosenblum Ptach. “The standard provides a road map to ensure you are thinking and testing for all the

variables that your packaging will experience in the real world. These stressors include the rigors of shipping your products to hospitals and the aging process of sitting on the shelf of a hospital while it waits to be used. It is vital that packages are strained to a worst-case level before they go experience the real world so that there are no surprises once the device is used. It’s not always evident that packages are damaged or no longer maintaining their sterile barrier, so a device could be used and cause a hospital acquired infection if the sterility is compromised. This can lead to terrible infections and even deaths of patients. This stresses the importance of understanding these pouches and trays are not ‘just packages’ and should really be viewed as the shining armor of devices getting to patients safely.”

Another aspect is prevention, like the adage says, “an ounce of prevention is worth a pound of cure.” To prevent a 483, it’s imperative to take the right steps well before a 483 is issued.

“If you have a new product, and you’re opening up a new lane, the first thing we recommend is that you validate the original risk assessment in that lane to confirm that nothing has changed; none of the risk profiles have changed,” says Hutchinson.

“Conduct a risk assess to understand the challenges that are going to be both in shipping lane itself and potentially the packaging.”

After the risk assessment, Hutchinson says then you can determine the packaging.

“How do you confirm you have adequate packaging? First is to do some sort of in-chamber testing. Sometimes the testing done by the thermal packaging supplier may be adequate. But there needs to be some technical assessment to confirm what they did meets your own internal requirements when it comes to validation.”

The second thing is confirming that the thermal mass testing is relevant to your product and that the thermal mass directly correlates to what you’re shipping. It is up to the pharmaceutical manufacturer to then re-test it with a more suitable mass. Hutchinson says these companies may not necessarily have to re-test, but they must use thermal mass/ heat transfer calculations to see how that impacts the performance of the shipper.

Confirming the data yourself gives you the knowledge and assurance that the testing is relevant to your product and your shipping lane. Don’t give the FDA an excuse to send you a 483.

“If a drug product manufacturing company takes a data package provided by the thermal packaging supplier but doesn’t do its due diligence to confirm in some meaningful way that the tests that were done matches what they‘re doing, the agency can come back to you and say, ‘You can’t just accept this on face value, you have to do something to confirm that it works in your specific use case for the drug we’re approving and in the lanes you’re going to ship it,’” said Hutchinson.

Luckily, he also shares that companies can do this most of the time with the data provided by the thermal packaging supplier, as long as the data is reviewed internally and the quality team signs off on the review.

Through the proper testing, companies get the assurance that their product and packaging will perform in the intended way to safely move through the supply chain and safeguard public health. And 483s? Forget about ‘em.

How to Stand Out: What’s Make a Great Design for Wellness Brands Today?

Package design to attract today’s savvy wellness product shoppers should include inclusivity, brand trust, and a nod to sustainability.

By Liz Cuneo, Editor-in-Chief

KEY TAKEAWAYS

Consider your users’ motivations, challenges, and desires, and the emotional associations you want consumers to connect to your brand.

TWith over 70 million adults living with some type of disability in the U.S., designing for inclusivity opens up your brand to a wider audience.

o determine what makes a wellness product like OTC medicines, deodorant, and pediatric care items stand out on shelves (and screens), we spoke with Carrie Dufour, Founder and Creative Director at Truly Creative, a brand strategy and package design agency in Petaluma, CA. She shared the tried-and-true best practices for package design and talked about how wellness brands need to grow with changing demographics, while building trust and designing with sustainability in mind.

HCP: Great design is about more than the graphics. What other considerations should wellness brands consider?

Dufour: You’re right, there’s a lot to consider leading up to the visual elements. Great design caters to the wants and needs of its intended users, so it’s important to start with a deep understanding of the target audience and then think about how your design will connect and resonate with them on a personal level.

We believe that empathy-driven design is key to creating truly meaningful connections. With that in mind, wellness brands can start by thinking of their users’ motivations, challenges, and desires, and then identify the top 1-2 emotional associations they want consumers to connect to their brand. Is it relaxation, vitality, or trust? These associations should guide the graphics, messaging, and overall brand experience.

HCP: What are the tried & true best practices for a great design?

Younger generations are prioritizing sustainability, self-care, and unique experiences.

Dufour: That’s a big question! Here are four foundational elements that help brands stand out, remain memorable, and get talked about…

1. Be Authentic: Let your mission and core values steer the ship. Being consistently authentic leads to trust and loyalty.

2. Be Different: Do the work to position your brand uniquely and then express that through your visuals, tone-of-voice, and product offerings that stand out.

3. Keep it Simple: In today’s world, you will rarely have your consumer’s full attention. Narrowing down the messages, then expressing them in a clear and concise way makes it easier for people to understand and repeat.

4. Connect Emotionally: Feelings are remembered longer than words or even actions, so you want to make sure you convey and reinforce the emotions you want to leave your consumers with.

These principles focus on human-centered design, which is relevant across both B2C and B2B, as each involves connecting with and appealing to real people who make decisions based on trust, clarity, and emotional impact.

HCP: In the wellness space, brand trust is paramount. How can design elements help build trust?

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Dufour: While trust is typically established through consistent reliability over time, brands can optimize that journey in a few ways.

The first is by being thoughtful about the first impression they are making. A brand’s design is like its wardrobe—it communicates identity at a glance. The right choices in logo, color palette, packaging, and tone of voice should create a strong initial impression that aligns with the brand’s values. By using well thought out, authentic design choices, brands can convey a clear, genuine message, avoiding overpromising or trend-chasing that doesn’t reflect their core identity. This honest approach forms a good foundation for a trusting relationship.

Displaying third-party endorsements, certifications, and customer reviews can also provide a type of social proof that is more likely to build trust.

Mommy’s Bliss is a great example of a brand that has built trust through a high-quality ingredient promise, transparency, and consumer validation. These types of messages establish credibility and are reinforced throughout their package design via a “#1 selling brand” seal (providing social proof), and certifications from reputable organizations like Environmental Working Group (EWG), which assesses product safety and ingredient transparency.

They also have a heartfelt founder’s story conveyed on their packaging and other marketing touchpoints. Consumers much prefer to buy from a relatable person rather than a faceless company. An impactful founder’s story can humanize your brand and create a stronger sense of trust and loyalty.

HCP: Is it important for a package’s design to showcase that it is sustainable? What’s the benefit?

Dufour: I do think it’s beneficial to showcase sustainability efforts, but how and where should be carefully thought out. From the consumer’s perspective, there are “reasons to buy”, and “reasons to love”. Typically, “reasons to buy” are more immediate and self-centered (this will help me lose weight, increase my energy, improve my mood, taste delicious, etc.). Sustainability typically falls under “reasons to love”, adding depth to the brand’s story, creating a deeper connection and loyalty among consumers. A brand needs both, but when you put yourself in the consumers shoes you realize that those immediate needs (reasons to buy) are the ones that need to be up front and while sustainability messaging often plays a supporting role.

HCP: How can brands make packaging more inclusive? How important is this?

Dufour: With an aging population and more than 1 in 4—over 70 million adults (according to the CDC) living with some type of disability in the U.S., not only is it helpful for society, it opens up your brand to a wider audience. We are seeing a trend with brands taking a more proactive approach with accessibility and inclusivity in their packaging. We’re seeing braille and QR codes being incorporated to support people with visual impairments, and packaging developed to be easier to open and close—an advantage for individuals with disabilities and those experiencing age-related challenges like arthritis. Inclusivity in packaging is both meaningful and increasingly essential in today’s society, where people with disabilities are a large part of every community and population.

Examples:

• Kelloggs Navilens QR Codes

• EEASY twist off lids

• Matel Uno with braille

• Degree Deodorant

• Cleanlogic braille

HCP: What’s changed in the last 10 years that directly impacts your work?

Dufour: The first thing that comes to mind is the shift in demographics and societal changes that influence our brand positioning work and shape the design trends we’re seeing.

By using well thought out, authentic design choices, brands can convey a clear, genuine message, avoiding overpromising or trendchasing that doesn’t reflect their core identity. Source: Mommy’s Bliss, via Truly Creative

For nearly 40 years...

Trusted Strength

Proven Solutions

Providing a range of today’s finest packaging and processing equipment.

• Capsule fillers

• Capsule check-weighers

• Capsule banding machines

• Pouch fillers

• Cartoners

• Tray formers

• Case packers

• Palletizers

• Packaging line integration

• Metal detectors for capsules

• Bottle unscramblers

• Bottle fillers/cappers

- Tablets/capsules & liquids

• Bottle labelers

• Bottles: Carton coding, verification, serialization

• Bin blending equipment

• Material handling equipment

• Blister machines

• Thermoformers

• Washers

• Sterilizers

• Depyrogenation

Younger generations are prioritizing sustainability, self-care, and unique experiences. They’re choosing purchases that offer an escape from daily stress, providing a self-indulgent “treat” that feels restorative or luxurious. This desire for escape also drives the nostalgia trend, inspiring throwback products and retro design styles. Additionally, their demand for convenience and tech integration has spurred growth in online shopping, making it crucial for brands to shine on small screens as well as on shelves. All the more reason for designs to be simple, impactful, and distinct.

On the flip side, with Millennials having fewer children and the Baby Boomer generation aging, we have more people over 65 than ever before. Today’s older adults are more determined than ever to stay healthy, active and independent all the way through life. We’re seeing more clients, like Synbiotic Health, helping people achieve this through probiotics that support longevity and healthy aging. Even younger generations are embracing practices like ice baths and other wellness hacks geared toward long-term health. Over the next decade, I believe we’ll see a rise in brands focused on enhancing healthspan and promoting healthier aging.

“

” A BRAND’S DESIGN is like its wardrobe—it communicates identity at a glance.

— Carrie Dufour

HCP: Are you seeing AI change the way designers work?

Dufour: Definitely. It’s been a useful tool in our research work, developing better messaging, analyzing a target audience, etc. We’ve also used it for product innovation brainstorming to generate images of new product or recipe ideas. As of now, our process remains largely the same, but it’s layered with some of the benefits that AI brings.

Carrie Dufour is the Founder and Creative Director at Truly Creative, a brand strategy and package design agency in Petaluma, CA.

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This exclusive Leaders in Healthcare Packaging section includes profiles and product listings for a variety of companies serving the healthcare and pharmaceutical industry.

COMPANY INDEX

All Packaging Machinery Corp.

Complete, Visible Validation for Medical Pouches

Validatable Band Sealers

Supplied with verification ports for process validation of pressure, speed, and temperature. Embossing coder available. 3/8” wide hermetic seal.

• Fully Framed Stand Model Includes crank handle for height adjustment of sealing head to position over existing variable speed conveyor. • Conveyorized Model Shown with synchronized conveyor to support pouches while travelling through dual heating and cooling zones. www.allpackagingmachinery.com

A pressure wheel can be added to provide flat seals on Tyvek® pouches. Dual heating and dual cooling bars offer faster sealing of difficult materials. Compressed air is required. Seals Tyvek® pouches at up to 40 feet per minute.

• Tabletop Model

Designed for

and

PRESIDENT, CHIEF APPLICATIONS ENGINEER: DAN WOOD

SALES & MARKETING MANAGER: LYNN MIRANDA

All Packaging Machinery Corp. manufactures medical pouch sealing machinery with validation features. Additional machinery lines include USDA-approved vertical and horizontal conveyorized band sealers, bag loaders and tabletop portable band sealers.

APM machinery is user friendly and manufactured to be durable and efficient. With over 75 years of successful packaging experience, our quality machinery is proudly made in The United States of America.

www.allpackagingmachinery.com

Anritsu Product Inspection & Detection

701 Innovation Drive, Suite A, Elk Grove Village, IL 60007

847-419-9729

detectionperfection@anritsu.com

www.anristu.com/product-inspection

Anritsu provides high-quality inspection systems for the Pharmaceutical and Nutraceutical industries to help ensure the safety and integrity of your products. Our systems are designed to detect foreign objects as well as verify product integrity and quality in tablets, capsules, cartons, cases, sachets, sticks, patches, tubes, pouches, bottles, cans, and medical devices.

With our X-ray systems, it’s possible to detect even the smallest metallic and non-metallic contaminants in products even in sealed areas. Anritsu X-rays also perform a wide range of quality checks on opaque and thin packaging. All models come with standard HD imaging and safety design features that ensure minimal leakage.

Our line of SSV Checkweighers features models that are specifically designed to check the exact weight of capsules, small bottles,

aerosol inhalers, blister packs, or cases with the greatest accuracy. We also offer multi-lane checkweigher models that can easily handle high production volumes of capsules, pouches, and other products.

The Anritsu M6 Tablet Metal Detector can detect metal contaminants as small as 0.22mm in tablets and capsules. In a pharmaceutical production line, this equipment can inspect up to 30,000 items per minute without being affected by vibrations, electromagnetic noise, or static electricity.

Combination systems consist of a checkweigher and a metal detector united into a single unit – saving space and reducing the total cost of ownership. The option of vertical metal detector heads allows for the inspection of vertical packaging such as bottles or stand-up pouches.

There is no greater priority than the safety and security of your customers. Our commitment to developing unique inspection solutions of the highest value advances the food and pharma industries and assures consumer safety. It’s our goal to continue a level of precision, reliability, and support that truly advances the quality of your product and the efficiency of your operation.

Delivering a Positive Anritsu Customer Experience is at the core of everything we do. We are a global team, supporting each other’s families and those of future employees. We are dynamic and agile. The market is ever-changing, and we are too! We hold ourselves to the highest standard – always striving for flawless execution. We strive to maximize the performance of our technology and ultimately that of our customers.

Antares Vision Group

200 Century Parkway, Suite C, Mount Laurel, NJ 08054

www.antaresvisiongroup.com

Antares Vision Group’s advanced inspection technologies ensure product quality, integrity, and safety while meeting regulatory requirements. Our next-generation vision systems inspect any container and product content from any angle at multiple production stages, delivering precision and efficiency.

Our Prefilled Syringe Inspection Machine processes up to 400 syringes per minute, handling SVP glass and plastic syringes up to 24mm in diameter. It inspects liquids across all viscosities, from water-like solutions to emulsions and gels. An additional camera on a secondary carousel enables 100% surface inspection, while single-point handling with motorized grippers and vacuum-operated starwheels minimizes breakage and scratches.

The VRI VI series delivers high-speed vial inspection at up to 400 liquid-filled vials per

minute, combining particle and cosmetic detection with closure integrity verification. It inspects water-like, oily, suspension, gel, emulsion, lyophilized, powder products, crimping quality, stopper position, and neck-shoulder sidewalls. Molded glass and plastic containers can also be inspected.

Beyond inspection, DIAMIND, our integrated ecosystem, provides comprehensive production management, enabling end-to-end traceability and real-time data insights. Operating across the line, factory, warehouse, enterprise, and supply chain, it leverages AI, blockchain, and cloudbased data management to optimize operations and ensure holistic transparency.

Discover how Antares Vision Group is shaping the future of pharmaceutical and life science inspection at www.antaresvisiongroup.com.

Antares Vision Group is advancing the digitalization of products and supply chains through leading traceability, inspection, and data management solutions. We help companies achieve safety, quality, efficiency, and sustainability, enabling Trustparency®.

Our DIAMIND ecosystem simplifies production and fuels business growth with AI and blockchain-powered insights.

Serving Life Sciences (pharma, medical devices, hospitals), Food, Beverage, Cosmetics, Chemicals, and Packaging, AV Group operates in 60+ countries, with 1,300+ employees and a global network of 40+ partners.

BELL-MARK

331 Changebridge Road Pine Brook. NJ 07058

973-882-0202

connect@bell-mark.com

www.bell-mark.com

Bell-Mark has established itself as a leading designer and manufacturer of advanced in-line coding and printing systems, serving a wide range of packaging applications across critical industries. With over 65 years of experience, the company has developed deep expertise in various printing technologies, including thermal inkjet, piezo inkjet, thermal transfer, flexographic, and traditional ink coders. This diverse knowledge allows Bell-Mark to tailor solutions to meet the specific needs of its clients.

A core principle of Bell-Mark’s philosophy is to deliver high-quality and reliable printing and coding systems that meet the stringent demands of industries where precision and traceability are essential. These industries include medical device, pharmaceuticals, meat and poultry, prepared foods, paper converting, and extruded plastics. Their InteliJet LPc is a prime example of their commitment to innovation, represent-

ing a significant advancement in thermal inkjet technology.

To ensure customer satisfaction, Bell-Mark offers a comprehensive range of support services. This includes 24/7 technical assistance available in-house, remotely, and on-site, as well as a complete in-house facility for testing, repair, and service. The company also provides thorough training programs both in-house and on-site. Bell-Mark’s global presence is supported by a strong worldwide sales distribution network and direct sales channels, ensuring that customers around the globe have access to their cutting-edge solutions. Furthermore, Bell-Mark takes pride in offering solutions that can be easily retrofitted to all packaging machines, helping customers comply with the evolving requirements of UDI GS1 and other industry-specific coding regulations.

At Bell-Mark, our mission is to empower customers in critical industries with innovative, reliable, and cost-effective in-line coding and printing solutions. With over 65 years of expertise, we develop a diverse portfolio of technologies—piezo inkjet, thermal inkjet, thermal transfer, flexographic, and ink coders—to meet the evolving needs of medical device, pharmaceutical, food, and packaging sectors. We ensure regulatory compliance, enhance operational efficiency, and build brand integrity through exceptional service, lasting partnerships, and a commitment to quality. We strive to be the trusted leader in driving progress and excellence in the packaging industry.

Chase-Logeman Corporation

303 Friendship Drive, Greensboro, NC 27409

336.665.0754

info@chaselogeman.com

www.ChaseLogeman.com

For over 63 years, Chase-Logeman Corporation has been building monoblock-style filling/ closing machines and support equipment. From our offices in Greensboro, North Carolina, ChaseLogeman custom designs every machine to maximize production quality without sacrificing throughput.

This equipment reliably serves the Chemical, Cosmetic, Diagnostic, Homeopathic Medicine, Nutraceutical, and Pharmaceutical markets with machines that are easy to use and durable.

All of Chase Logeman’s machines are washdown capable. There are designs available for flammable materials and processes requiring isolators. Every machine begins from a cGMP thought process.

Chase Logeman incorporates filling, plugging, capping, and labeling capabilities into the mono-

block machine as requested to save space and minimize the number of operators needed. Product changes can be accomplished in 15 minutes or less, often without tools.

Specializing in fill sizes from microliters to 125ml, every Chase-Logeman machine prevents repetitive stress injuries by incorporating proven automation processes into the machine.

Contact Chase-Logeman and let our years of experience help automate your filling process.

Manufacturer of Monoblock Style Filling and Closing Equipment for volumes from microliters to 125ml in glass and plastic containers.

Colbert Packaging Corporation

Colbert Packaging is an independent, womenand family-owned business. As a premier provider of paperboard packaging for more than 65 years, we work each day to produce safe, smart and sustainable secondary packaging for our customers who include some of the biggest names in the pharmaceutical, healthcare and consumer goods markets. With extensive R&D capabilities, continual investment in the latest equipment and technology, and a solid reputation for excellence, Colbert Packaging provides customers with top quality products and services, in an environment where our employees find opportunity for career fulfillment.

Colbert Packaging is a dynamic high-volume producer of sustainable paper-based packaging. We produce offset and flexographic printed folding cartons, formed paper trays, pressuresensitive roll labels and informational package inserts. Our in-house services include structural

design, full-service prepress, paperboard sheeting, ink blending/matching and die making/ cutting. We will help you meet your healthcare packaging goals, whether it’s an F=1 rating for child-resistant packaging, senior-friendly solutions, creative patient adherence features, or secure storage.

We’ll work with you to design earth-friendly, secondary packaging solutions that satisfy today’s sustainability requirements. Everything from right-sizing materials to 100% inline vision inspection for fully integrated quality control, sets you on a course to The Total Package. Add to the equation fully recyclable paperboard, along with water- and agri-based inks, coatings and adhesives, and you’ll have The Total Package in One Clean Carton®!

At Colbert Packaging, we consider sustainability an inherent aspect of our business. We’re passionate about our vision for the future and committed to focusing our efforts on doing the right things to create a sustainable future for our business, our customers, our employees, and our world.

Our packaging solutions are paperboard-based, a basic element in sustainability. You’ll find many patented solutions, a testament to our unique design capabilities. Colbert Packaging employees are trustworthy and known for their strong work ethic, along with a passion for supporting our customers.

For product marketers, Colbert Packaging applies industry heritage, innovative technology, and design to create Safe, Smart, and Sustainable delivery solutions in which our customers’ products shine.

Columbia Machine, Inc.

107 Grand Blvd., Vancouver, WA 98661

www.loadtransfer.net pallsales@colmac.com 360.694.1501

REDUCE CONTAMINATION—The Load Transfer Station (LTS) product line, offered by Columbia Machine, helps to reduce contamination from entering production areas, streamlines operations & reduces costs. Columbia manufactures a complete line of pallet transfer solutions including stand-alone stations to fully automatic solutions that allow pallet load transfer to be completed in less than one minute, without requiring the operator to leave the safety of the forklift.

INDUSTRY LEADING STANDARD SAFETY—

Columbia Machine’s LTS solutions come standard with the latest safety features. These include Category 3 electrical safety components, upstacker guarding with A-B SensaGuard RFID interlocked door switches, multiple emergency stops, and muted light curtains on the automated systems. Every Columbia Machine LTS has been engineered to exceed the requirements of

pharmaceutical processors who are working to meet FSMA regulations.

FLEXIBLE PRODUCT HANDLING— Columbia’s LTS is capable of transferring products that are packaged in cases, super sacks, glass vials, pails, barrels, drums and bags from one pallet type to another, including Plastic, Chep and GMA pallets that are commonly used in both receiving and shipping applications.

COLUMBIA MACHINE, INC.— The Load Transfer Station (LTS) product line is part of the Palletizer Division of Columbia Machine, a leading American palletizer manufacturer. For more than 80 years, Columbia has manufactured complete palletizing and material handling solutions.

The mission at Columbia Machine is to be the preferred supplier of engineered product solutions in the targeted markets we serve. We provide exceptional customer value through strategic marketing, innovative product development and unparalleled customer service. We value safety, integrity, trust, fairness, professionalism and teamwork in relationships with our customers, employees, business partners, suppliers and shareholders. We “always” see our business through “the eyes of our customers,” and provide them with superior solutions through innovation, quality, reliability and continuous improvement.

We support the pharmaceuticals and personal care industries with reliable automation for a wide range of product types. Position your company for growth with end-of-line systems that offer flexibility to change as your production needs do.

301 Grove Street, Vancouver, WA, 98661

+1 (877) 204 7444

micstu@colmac.com

www.columbiaokura.com

For nearly 30 years, we’ve been helping our customers become more competitive, cost-effective, and productive in a fast-changing world with robotic end-of-line palletizing systems. With our focus on integration, we design robotic palletizing systems to meet your needs. Our range of solutions solve end-of-line challenges for operations of all sizes–from small, familyowned businesses to large corporations–always with the highest levels of safety and performance.

Industrial robotic palletizers are less costly, take up less space, and provide more flexibility than legacy palletizing systems. Whether you’re replacing an older system, outfitting a new facility, or wondering if it’s possible to retrofit your existing operations with robotic solutions, our experts can walk you through the possibilities–including costs, ROI, and integration with existing equipment. Our dynaPAL™ robotic palletizers

come in a range of models that we can customize to meet your unique needs. They can handle a variety of applications up to 350 kg. Safe, durable, and reliable, dynaPAL™ models decrease downtime by automating tasks that are often repetitive and harmful to workers.

Collaborative robots, also known as cobots, are a cost-effective way to improve end-of-line efficiency. They are compatible with multiple product types and packaging applications. Compact cobots are easy to integrate into existing systems, even where space is limited. Our miniPAL® cobots can bridge operational gaps and take over high-risk tasks. Easily and safely working in collaboration with employees, they free operators to do other tasks, allowing for higher production without having to hire additional people.

- Demo: Send us your product, and we’ll prove we can stack it.

- Cost: Prove automation’s ROI with our support, we’ll build your business case.

For nearly 30 years, we have been a leading provider of robotic palletizing systems, delivering custom engineered solutions to meet demanding customer requirements.

Econocorp

72 Pacella Park Drive, Randolph, MA, 02368

781.986.7500

info@econocorp.com

www.econocorp.com

Since 1964, Econocorp has been at the forefront of secondary packaging innovation. Our mission? To unlock the power of automation for businesses that crave flexibility in their operations and have an eye for growth. Specializing in low- to moderate-speed cartoning, case packing, and tray forming solutions, we’ve got all your secondary packaging needs covered. From single machines to integrated systems, Econocorp delivers excellence, every time.

Our solutions cater to a diverse range of industries, including:

• Healthcare, Nutraceuticals & Pharma

• Personal care & Cosmetics

• Contract Packaging

• Craft Beverages & Beer

• Dairy, Snacks, Cereals & Frozen foods

• Industrial Goods & Household Items

• And more!

When it comes to secondary packaging, Econocorp has your back with solutions designed to move at the speed of your businesses’ changing needs. We don’t just make packaging machinery–we’re your trusted partner in automation dedicated to providing the high level of support and service necessary for growth.

Let’s unlock your potential together!

The types of solutions we provide include:

•Horizontal and vertical cartoning machines: Whether you’re end loading or top loading cartons, or a mix of both, we’ve got your needs covered. From countertop carton sealers to continuous-motion cartoners, our economical cartoning machines are developed with the highest quality standards and are easy to operate and maintain.

•Case packing: Our case packing solutions are designed to meet your unique needs. Some of our products include semi-automatic horizontal case packers, automatic carton packers, and wrap-around systems for cartons, trays and cases. Focusing on user-friendly functions that are simple to operate and provide cost-effective maintenance.

•Tray forming and sealings solutions: Econocorp tray formers can form corner glue, corner lock or simplex style locking trays with a hinged cover, and seal them using hot melt glue.

Formost Fuji Corporation

Your Trusted Partner for Efficient Packaging Solutions in Healthcare.

Formost Fuji is a leading manufacturer of horizontal flow wrap machines and bagging machines. Our equipment stands out for its quality, dependable parts and service, and engineering expertise. With a dedicated focus on efficiency and reliability, our horizontal-form-fillseal wrappers (HFFS) deliver strong, dependable packages.

The integrity of the seal is crucial in preventing contamination. Our B16 Box Motion End Seal Technology delivers high-performance hermetic seals even on challenging films.

Packages produced by the Formost Fuji Flow Wrapper offer exceptional barriers against moisture, air, and microorganisms. Furthermore, our flow wrap packaging protects medical devices from damage during handling, storage, and transportation, thereby minimizing the risk of physical damage that could compromise sterility

or functionality. This protection is also essential for maintaining the potency, stability, and shelf life of pharmaceutical products, including tablets, capsules, and liquids.

Our flow wrapper is ideally suited for creating unit-dose packaging, ensuring that patients receive the correct dosage and minimizing the risk of errors. High-speed automation aligns seamlessly with a Formost Fuji Flow Wrap Packaging Machine, resulting in efficient and cost-effective production by reducing labor and increasing line speed.

Formost Fuji offers comprehensive product and film testing services designed to save time and reduce costs in your production process. We invite you to inquire about our training programs, which are tailored to assist your team in effectively operating and maintaining your Formost Fuji equipment.

You can rely on us to develop the ideal packaging solution tailored to your needs.

Dedicated to Your Packaging Needs, we prioritize you, the customer.

With over 60 years of industry experience, we are committed to delivering exceptional value and surpassing your expectations in design, manufacturing, and service.

Our team of experts collaborates closely with you throughout the process to provide reliable packaging solutions, including; horizontal wrappers, baggers, automation lines, and special applications. We take pride in producing sustainable and efficient packaging equipment for the healthcare industry.

“First and Formost”, you can rely on Formost Fuji for top-tier packaging solutions. Contact us today to find out how we can meet your packaging needs.

Greydon

A ProMach Product Brand

391 Greendale Road, York, PA, 17403

Greydon provides advanced printing systems, including thermal transfer, digital, thermal inkjet, continuous inkjet, and code daters. These systems can be custom built to withstand harsh environments and are UDI-compliant for medical devices, pharmaceuticals, personal care, consumer products and many more industries.

Greydon solutions include advanced highspeed digital printing systems for a fully digital workflow to handle multiple SKUs and short production runs in today’s modern packaging lines. With traversing and inline printing capabilities, versatile mounting options, and scalable designs, our solutions can print graphics directly onto packaging substrates and interface with serialization and manufacturing software to ensure complete UDI and DSCSA compliance –compatible with GS1 and HIBCC standards.

• Ink & Consumables www.greydon.com

Printing & Coding Solutions For:

• Pharmaceutical / Nutraceutical Packaging

• Medical Device Packaging • Blister Packaging

• Flexible Packaging • Cartons & Cards

Printing & Coding Capabilities:

• Digital Printing

• Inline Flexographic Printing

• Traversing Thermal Transfer Printing

• Late-Stage Customization

As part of ProMach Labeling & Coding, Greydon designs, manufactures, and integrates innovative solutions, ranging from simple to complex product identification, tracking, brand protection, and compliance with industry standards in today’s modern packaging lines.

Industries We Specialize In:

• Pharmaceutical

• Nutraceutical & Vitamin

• Medical/ Medical Device

• Personal Care & Cosmetics

• Animal Health

• Consumer Products

Harpak-ULMA Packaging, LLC

85 Independence Drive, Taunton, MA, 02780

800.813.6644

info@harpak-ulma.com

www.harpak-ulma.com

Harpak-ULMA packaging systems can handle all your medical primary and secondary packaging equipment requirements – from single components through completely automated systems. Our full-service solutions address installation, training, spare parts, service and customer support, while capabilities span robotics and automation, thermoforming, tray sealing, filling, flow pack, stretch, blister, skin pack, and vacuum. Our secondary equipment can prepare products for retail ready displays, create multipacks for bundling of products, and erect and load cartons to get your product out the door. We provide the total solution – from beginning to end, product to pallet – for the medical industry.

Our medical packaging solutions offer maximum product protection, hermetic sealing, the ability to customize the package shape, blister packs for retail sale, hygienic individual and multipacks, easy open options, and protection during transport and handling. These solutions

meet the strictest standards required by the medical sector. We can meet them all, like ISO 11607, EN 868, ASTM D1585, ASTM F2097 and ASTM F3475-11. Packages are suitable for sterilization processes and maintain these conditions until opened. You can also expect to be in accordance with CFR 21 Part 11 for documentation.

We have in-process controls like vision inspection for product and printing, product in package height detection, and automatic rejection. Process monitoring includes alarm conditions for critical parameters out of range like time, temperature and pressure. There’s also a data integrity option for track and trace of operator in the HMI, plus trending of critical parameters. When it comes to calibration, our critical parameter equipment comes calibrated from the factory, and access points are provided for routine calibration.

Look to Harpak-ULMA Packaging to prototype, design, build, implement and maintain packaging automation solutions for today’s complex, rapidly changing packaging landscape.

Heat and Control, Inc.

21121 Cabot Boulevard, Hayward, CA, 94545

510 259 0500

info@heatandcontrol.com

www.heatandcontrol.com

Detect metal contaminants with confidence by choosing the world’s leading metal detection solution. CEIA®, is a leading innovator of industrial metal detection systems for products such as powders, capsules, tablets, and liquids. Quality control is at the core of CEIA development of the most advanced electronic and mechanical technologies for detection of contaminants accidentally present in products. CEIA metal detection systems meet high level industrial metal contaminant detection standards. Are fully-HACCP and GMP compliant, ISO 9001 certified and constructed of EC and FDA approved materials and is a available for free-falling product applications.

Find what you don’t see with the latest Ishida X-ray solutions. The photon counting dual energy IX-PD series X-ray machine employs an alternative sensor and accompanying image processing technology to give our highest sensi-

tivity and accuracy of low-density and minute foreign object contaminant detection. This technology differentiates with high accuracy between product and foreign objects, reducing the rate of erroneous detection. All models offer exceptionally sensitive foreign body contaminant detection and additional benefits such as the ability to identify damaged and missing products or components, helping the pharmaceutical industry achieve a rapid return on investment.

Check out Ishida high-precision weight checking you can rely on. Checkweighing is key for delivering what consumers expect by providing accurate verification of a package’s weight or count and detecting missing components. Promote quality control and customer satisfaction with Ishida’s extensive know-how in weighing technology.

Providing safeguards that help ensure your products match the prescription. Anywhere along the line, protect your consumer and your equipment. Efficient detection of foreign objects is critical to consumer safety, brand survival, and will also protect machinery and prevent downtime. We offer a complete line of metal detectors, checkweighers, and X-ray inspection systems from our strategic partners: CEIA and Ishida.

Providing sales, service and spare parts expertise across the globe for metal detection, X-ray and checkweighing anywhere along a production line.

12420 Gold Flake Court, Rancho Cordova, California 95742

www.hightekusa.com

Precision Weighing for Pharmaceuticals & Nutraceuticals

At High Tek, we provide industry-leading packaging solutions focusing on accuracy, efficiency, and reliability. Our advanced facility manufactures high-performance equipment designed to meet the evolving needs of the pharmaceutical and nutraceutical industries. With 24/7 technical support, we ensure expert assistance is always available to keep your operations running smoothly.

The High Tek Mini Weigher is engineered for the stringent demands of pharmaceutical and nutraceutical packaging. With over 20 years of industrial weighing expertise, we’ve developed a compact yet highly precise system that delivers unmatched accuracy and performance. Featuring 0.01g load cell precision, the Mini Weigher ensures consistent, repeatable results. It handles

target weights from 1g to 28g and dispenses up to 60 units per minute, seamlessly integrating into various packaging lines. Its versatility allows it to handle pills, capsules, powders, soft gels, and supplements with optimal efficiency.

Designed to meet strict regulatory requirements, the Mini Weigher safeguards product integrity while ensuring compliance. Its fully enclosed structure maintains a controlled environment to prevent contamination. Tool-free removable components allow for quick, efficient cleaning, meeting industry hygiene standards.

Whether you’re handling pharmaceuticals or nutraceuticals, the Mini Weigher is a trusted, cost-effective solution that delivers unmatched precision and dependability. Backed by cuttingedge technology and a dedicated support team, we ensure your success every step of the way.

High Tek Best Selling Pouch Bagger

James Alexander Corp.

CEO

Francesca Fazzolari

PRESIDENT

David Robinson

James Alexander Corp. has expanded its operations floorspace, adding 18,000 square feet to its warehousing capacity and 2,000 feet apiece to manufacturing and office space. The expansion provides additional capacity for servicing key markets including pharmaceutical (OTC & Rx), medical devices, health & beauty products, first aid and diagnostics.

Currently, James Alexander is developing new and innovative materials for JAC’s plastics ampoules. Among other aims, the goal is to make the containers compatible with alcohol-based liquids.

JAC’s patented single-use plastic ampoules, which have undergone various enhancements since their initial market introduction, are available in a variety of colors and with an array of applicators, offering single-handed activation in a customizable format. Meanwhile, the company’s glass ampoules can be filled and assembled in single-use swab or dropper packages. JAC also recently introduced a winged device, THE ACTIVATOR™, which provides easier activation for these glass formats. Other services include autoclave sterilization for glass ampoules, blister packaging and formula compounding.

Plastic Unit-Dose Dispensing Systems

James Alexander Corp.’s revolutionary plastic ampoule combines style and ease of use through single-handed activation. With just a gentle squeeze, the inner membrane ruptures, allowing the contents to be dispensed by the user. The plastic ampoule is available in sizes up to 5ml, as well as a range of colors and applicators.

Unit-Dose Glass Swabs

James Alexander Corp.’s unit-dose swabs offer the stability of glass in one- or two-part systems allowing for convenient application of pharmaceuticals and health aids. JAC also produces single-use glass ampoules for inhalation and dropper tip assemblies for the dispensing of liquids.

The DuoDispersion System® Tandem Package

James Alexander Corp.’s DuoDispersion System® is a refinement to the company’s well-regarded tandem swab package. Safe and easy to use, the tandem dropper or swab can be customized to hold two separate liquids, or a powder and a liquid; each individual formula is hermetically sealed in its own ampoule. The DuoDispersion System® can hold a combined volume of 1.2mls that are kept separate until the point of application. Two versions of the DuoDispersion System® are available: a dropper tip and a swab for topical application. www.james-alexander.com

Located in northern New Jersey, James Alexander Corporation (JAC) is a leading contract manufacturer and custom filler of single-use crushable glass and plastic ampoules. Founded in 1976 by Francesca Fazzolari and Alexander Davidson, JAC is a privately-owned, ESOP company that still services several of the same customers it originated with 45 years ago.

James Alexander Corp.’s manufacturing facility features unique, company-designed equipment and produces its patented plastic ampoules, among other product offerings. The company makes great efforts to ensure that most of its components are made in the USA, aligning with its goal of investing in local communities, regional job markets and the American manufacturing sector at large.

METTLER TOLEDO

1571 Northpointe Parkway, Lutz, FL 33558

813.889.9500

pi.marketing@mt.com

www.mt.com/pi

METTLER TOLEDO is your single source for product inspection solutions offering metal detectors, x-ray inspection systems, checkweighers, and machine vision systems. Our broad product inspection line ranges from very basic and economical systems to sophisticated, stateof-the-art systems with customized material handling solutions. Systems can ensure perfect product presentation, create codes, verify package and label integrity, ensure weight range compliance, detect physical contaminants and inspect contents inside the closed package.

CI-Vision machine vision systems perform accurate label and package quality inspections on all types of packaging, including label quality, 1D, 2D, and alphanumeric text, proper sealing, cap and lid placements, and tamper band presence.

Safeline metal detection systems are extremely sensitive, easy to use, and prevent costly recalls by ensuring your products are free of ferrous, non-ferrous and stainless-steel contaminants which can be introduced during processing. Safeline X-ray inspection systems can detect contaminants including stone, glass, and ferrous, non-ferrous, and stainless-steel metals, as well as detect mass and check for missing or damaged product inside closed packages.

Hi-Speed checkweighers are available in a wide range of sizes and configurations to handle nearly any container type or package design at high speeds to ensure accurate product delivery, reduced giveaway, and an optimized production process.

An OMAC member, we are committed to connectivity as well as data storage and retrieval, with methods including EthernetIP and OPC, as well as METTLER TOLEDO’s ProdX data collection. ProdX facilitates the collection and storage of production data across multiple lines and facilities. All data is easily accessible and exportable to other systems, facilitating compliance with all regulatory requirements.

Our solutions supported by the most comprehensive engineering solutions, product testing, and training in the industry, with 24/7 telephone support and nationwide field service.

MG America

31 Kulick Rd, Fairfield, NJ 07004

973-808-8185

sales@mgamerica.com

www.mgamerica.com

Headquartered in Fairfield, New Jersey, MG America is a subsidiary of MG2 of Bologna Italy, a company that was founded in 1966 and today is one of the world’s three leading manufacturers of capsule filling equipment.

MG America is a leading supplier of an innovative family of precision-crafted processing and packaging machinery that includes capsule fillers, material handling, sterilization equipment, primary packaging equipment, secondary packaging equipment, checkweighing/weight control systems, tablet & capsule inspection, and line integration solutions. From sales, field service and spare parts to machine trials and local service/support representation, MG America offers a true “Partnership for Success.”

Packaging equipment from MG America can be found throughout North America in industries such as pharmaceutical, medical device,

diagnostics, nutritional products, and OTC products. Our lineup of premier, European-made machinery has earned a global reputation for reliability, precise performance, and superior craftsmanship.

BIN BLENDING

WASHING/DRYING

STERILIZATION

CAPSULE FILLING

CAPSULE WEIGHT CONTROL

VISION INSPECTION

CHECKWEIGHING

FILLING/CLOSING FOR:

VIALS, BOTTLE, TUBES

STICK PACKING

SACHET PACKING

BLISTER PACKAGING

THERMOFORMING

CASE PACKING

TOP-LOAD/SIDE-LOAD CARTONING

TRAY FORMING/LOADING

SERIALIZATION

PALLETIZING

LINE INTEGRATIONS

MULTIVAC Group

11021 N Pomona Ave, Kansas City, MO 64153

800.800.8552

sales@multivac.com

multivac.com/us

MULTIVAC is your partner for providing fullline healthcare packaging solutions. We offer an extensive range of packaging technologies, automation solutions, labeling, inspection, handling, and quality control systems.

MULTIVAC is one of the world’s leading suppliers of packaging solutions for various medical and pharmaceutical products and consumer and industrial goods. Our portfolio covers all packaging design, performance, and resource efficiency requirements. In addition, it encompasses an extensive range of packaging technologies, automation solutions, and labeling and quality control systems.

Thanks to our comprehensive line solutions, all MULTIVAC machines can be integrated into holistically designed systems. This ensures maximum line operating and process reliability, high efficiency, and low Total Cost of Owner-

ship (TCO). With this in mind, we are consistently driving forward digitalization through real-time analysis tools such as MULTIVAC Smart Services targeted towards predictive maintenance and machine learning. Thinking and acting sustainably, we are dedicated to the responsible use of resources and energy in terms of manufacturing our products and their use at your site.

Ultimately, we see ourselves as a partner who makes a decisive contribution to your business success – whether you are a start-up or a large company, when you decide on a MULTIVAC packaging solution, you opt for the highest level of quality and efficiency, comprehensive customer care, and perfect service. As a worldwide group with 85 subsidiaries, we are closely linked with our customers and their markets, allowing us to identify trends and developments early. As our customers, you benefit from our highly qualified sales and service team in your area.

As one of the leading worldwide providers of packaging and processing solutions for over 60 years, the MULTIVAC Group takes great pride in setting the industry standard in innovation & technology, efficiency, and reliability through our expertly engineered product range of packaging and processing equipment. With the most experienced team in the industry, we help you develop the perfect package and full line solution for your product, your brand, and your objectives for profitability.

The MULTIVAC Group is a family-owned business from the Allgäu region in Germany with over 80 sites and more than 7,000 employees worldwide. Our US headquarters is located in Kansas City, Missouri. As an additional way to support our customers, we have five Regional Customer Support Centers throughout the United States: Denville, NJ; Irvine, CA; Lisle, IL; Charlotte, NC; and Dallas-Fort Worth, TX.

NITA Sentient Labeling Systems

1051 Du Viger Street, Terrebonne, Quebec, Canada, J6B 6W6

1.855.668.NITA (6482)

Welcome to NITA Sentient Labeling Systems, the original 100% Servo Labeler that dramatically REDUCES OPERATOR TOUCH-TIME and increases productivity - all while integrating the latest next-gen technology, the most intuitive user experience, best-in-class responsive support, and truthfully, pure labeling joy.

We love UPTIME. We’re so driven by it we’ve designed all the features on every NITA to create it. How? By meticulously analyzing your labeling pain points – then solving them – with innovation, technology, and certifiably flawless execution.

And how do we keep you running? By building these incredible UPTIME features into every NITA:

- Parts ordering directly from the machine via built-in 3D drawings that scale down to your specific required item.

- A self-diagnosing system that identifies possible issues and suggests fixes & parts needing change or servicing before they become a problem.

- Daily Preventative Maintenance schedules and video tutorials with tiered-level tasks.

Nita Labeling PROMISES to do anything and everything required to make your labeling life as easy and productive as it can be. It is why we exist.

Experience for yourself what the best labeling company and labeler will bring to your productivity numbers.

We cannot wait to meet you.

For the love of labeling!

Your NITA Team

- Ultra-fast & precise color-coded changeovers with in-screen 3D location maps or even our incredible Servo-driven FULLY AUTOMATIC product changeover system at the push of a button.

- NitaCare, our signature In-Screen Wi-Fi enabled login program for instant operator issue resolution. www.NitaLabeling.com sales@nita.ca

NJM, A ProMach Product Brand

www.NJMPackaging.com

NJM Products Include:

Line Integration – NJM can integrate a tablet, powder, or liquid packaging line. We provide equipment and then integrate turnkey systems at the customer’s plant.

Unscramblers – NJM unscrambling equipment is compact and designed for round, rectangle, square, or oval bottles.

Cappers & Retorquers – NJM cappers include inline belt, inline disc, and rotary continuous models. Compact design makes our cappers easy to incorporate into your packaging operation.

Cottoners – NJM cottoners are simple yet precise, with a guillotine tearing device as standard equipment, and options such as missing cotton detection and wisp detection.

Labelers – NJM labelers are robust, reliable, and versatile, with electronic controls and up-todate container handling features.

Liquid Filling & Closing – Aseptic liquid filling & closing systems for the pharmaceutical liquid

dose industries are offered by our partner, Dara Pharmaceutical. NJM is Dara Pharma’s exclusive sales partner in the USA and Canada.

Washing & Sterilization Systems - NJM is the exclusive Canadian representative for Steelco’s Pharma and Biopharma products.

Print & Apply – NJM print & apply labelers label cases, cartons, bags, pallets, drums, and tires. Purchase individually, or as part of a turnkey system. RFID tagging is also available.

Tablet Counters – NJM offers tablet counters from our partner, Cremer. Cremer counters feature thoughtful design, robust construction, quality, and accuracy. Cremer tablet counters are also simple to take apart for cleaning, without tools.

NJM, part of ProMach Pharma Solutions, has been a trusted automated packaging systems manufacturer, integrator, and support resource for over a century. We offer a broad range of technologies and applications, specializing in the needs of pharmaceutical, nutraceutical/vitamin, and personal care product packagers. Complementing NJM’s manufacturing and integration expertise, we supply quality packaging line equipment from other leading manufacturers.

The full range of NJM’s services – manufacturing, representation of NJM’s distributed brands, and integration – makes NJM a one-stop packaging solutions provider offering expert knowledge and experience from the earliest stages of planning through implementation and production.

Ossid, LLC

4000 College Rd, Battleboro NC 27809

www.ossid.com Ossid@ProMachBuilt.com 252.446.6177

Ossid LLC, a ProMach brand, is dedicated to delivering high-quality, reliable medical packaging solutions that prioritize sterility, safety, and efficiency.

As a leading manufacturer of high-speed packaging and labeling equipment, Ossid’s medical packaging product portfolio includes thermoform fill seal machines, tray sealers, and flow wrappers. These systems provide versatile solutions for flexible and rigid medical packaging, secure and efficient sterile packaging, and hermetic sealing for applications requiring protective coverings.

Ossid understands that medical device packaging demands precision and compliance with strict industry regulations. Our thermoform fill seal machines are designed for flexibility, accommodating various package types while adhering to UL 508A standards.

These machines feature an auto web aligner for consistent performance, a static eliminator to maintain product integrity, hinged upper tooling and servo-actuated presses for precise forming and sealing, and a robust framework and guarding to ensure safety and durability.

From syringes and pharmaceuticals to dental kits and surgical instruments, Ossid’s solutions ensure that every medical product is packaged securely and efficiently.

As a master distributor of Reepack, Ossid expands its medical packaging solutions with advanced flow wrapping technology, which accommodates applications requiring hermetic seals or protective coverings.

Our mission is to provide high-performance packaging solutions that help customers maintain product integrity, meet regulatory requirements, and build consumer trust. We aim to offer our customers a complete flexible packaging solution, backed by responsive customer service nationwide.

Our team members work in tandem to quickly and effectively address customer needs, ensuring minimal downtime and maximizing equipment performance. Ossid is committed to building long-term relationships with our customers, offering not only exceptional packaging solutions but also ongoing support.

Through ProMach, we provide end-toend capabilities, helping customers address any packaging project or application needs. ProMach offers best-in-class equipment, combined with industry-leading customer support, ensuring the success of every project.

PACTEON

5370 Guy Young Rd, Brewerton, NY 13029

(540) 961-5716; (315) 753-8770

contact@pacteon.com

www.esstechnologies.com; pacteon.com

PACTEON offers a responsive and committed single source solution to design, integrate, and service complete packaging solutions. Through the acquisition of businesses offering complimentary products and shared core values, PACTEON, currently Schneider Packaging Equipment, ESS Technologies, Phoenix Wrappers, and Descon Conveyor Systems is your one source for end-of-line packaging solutions.

ESS has extensive experience in high precision handling systems for Pharmaceutical, Nutraceutical, and Health & Beauty industries.

ESS Solutions Include:

• Cartoners

• Case Packers

• Robotic Pick and Place Systems

• Robot and Cobot Palletizers

• Integration

• Service and Parts

Easily Integrate:

• Serialization

• Track-and-Trace

• Product Inspection

• Leaflet Placement

• Labeling

• IQ/OQ Compliance

All PACTEON equipment and integration support services are backed with the PACTEON Promise: We Make It Right!

• Cartoners

• Case and Tray Packers

• Conveyor Systems

• Robotic Palletizers

• Pick and Place Applications

• Pallet Stretch Wrappers

• Integration

• Service and Parts

Pharmaworks, A ProMach Product Brand

2346 Success Drive, Odessa, FL 33556

www.Pharmaworks.com

Pharmaworks Products Include:

• TF1 Blister Machine – A simple and cost-effective blister packaging solution. The TF1 blister machine is perfect for entry-level packagers where budget matters.

• TF1e Blister Machine – Features a compact footprint, quick changeover, and the latest in servo technology. The TF1e is perfect for small, medium, or clinical production.

• TF1pro Blister Machine – The latest in blister packaging technology, the TF1pro is built for today’s demanding cGMP and changeover requirements.

• TF2 Blister Machine – A medium output workhorse that is great for deep-draw medical devices and consumer products.

• TF3 Blister Machine – All the features expected in a high output machine.

• BlisterMate – A standout semi-automated blister machine that is great for R&D, low volume type production.

• Vision Systems – Scanware blister and print vision inspection systems.

• Feeding Systems – Pharmaworks provides a variety of feed systems.

• Blister Machine and Cartoner Rebuilds –Pharmaworks is the clear leader with over 20 years of experience rebuilding and upgrading third-party equipment.

• Tooling & Change Parts – Pharmaworks is the go-to source for tooling for any supplier’s equipment.

Pharmaworks, part of ProMach Pharma Solutions, is the premier supplier of blister packaging machinery for North America and has a worldwide installed base. Backed by the power of ProMach, Pharmaworks can turnkey any size blister project from our expanded production facility in Odessa, FL. For 20 years, Pharmaworks has set ourselves apart from other OEMs by not only selling our line of blister machines and equipment, but by rebuilding and upgrading other OEM brand equipment. This uniquely positions Pharmaworks to be a full-service provider for our packaging customers.

Industries served:

• Pharmaceutical

• Medical/ Medical Device

• Animal Health

• Nutraceutical & Vitamin

• Personal Care

• Consumer Products

ProSys Fill LLC.

426 East Fountain Road, Webb City, MO 64870

417-673-6542

info@prosysfill.com

www.ProSysFill.com

ProSys is a premier manufacturer of semiautomatic and fully automatic equipment for filling, Squeeze Tubes, Syringes, Airless Pumps, Cartridges, Jars, Custom Containers & Hot Melt applications for the Pharmaceutical industry. A global supplier of filling equipment since 1985 with U.S. sales, manufacturing and customer service facilities located in Southwest Missouri.

FEATURES & BENEFITS

• Fill Accuracy of +/- 0.1% by Volume

• Turnkey & Custom Designs

• Air-Free Vertical Bottom-Up Filling

• Custom Mix Solutions (Eliminates Batching)

• Drum & Pail Presses

• SERVO Solutions

• Explosion Proof Controls (Class 1 Division 1&2 ATEX 0&1)

• Tool-free Release System for Simple Change -

overs • “Digital Readout Indicators” for Fast & Accurate Adjustments

• Multiple Service Technicians for Less Down

Time & Preventive Maintenance

• On-line Service & Support

• Recipe Storage & Recall

• Creams, Lotions & Viscous Pastes to 3 Million Centipoise

• Designed & Built in the U.S.A.

MAJOR MARKET GLOBAL INSTALLS

• Pharmaceutical • Cosmetic

• Chemical

• Adhesive/Sealant

• Lubricant

• Food

Building Quality, Integrity & Value In Our Team, With Our Customers, & In The Equipment We Design, Build & Deliver.

FLEXIBLE COMBO FILLING SYSTEMS

• Plastic & Metal Tube Filling Systems

• Tube & Airless Pump Filling Systems

• Tube & Cartridge Filling Systems

• 10, 14 & 30 oz. Cartridge Filling

Systems Squeeze Tube Filling Machines speeds from 15 to 300 per minute.

Syringe Filling Machines speeds from 20 to 300 per minute.

Airless Pump Filling Machines speeds from 15 to 300 per minute.

Cartridge Filling Machines speeds from 10 to 250 per minute.

Custom Filling Systems

Sepha Ltd.

10100 Progress Way, Harrison, OH 45030

44 2890 48 48 48 / USA 616-888-9081

info@sepha.com

https://sepha.com

Sepha provides a range of innovative leak testing solutions, deblistering machines, and small-scale blister packing machines for pharmaceutical and healthcare products.

CCIT & Leak Test Solutions

Sepha offers a range of non-destructive and deterministic CCIT & Leak Test solutions for various types of parenterals, blister packs and medical device packaging.

• Enable to identify defects as small as 1μm

• In line with ASTM standards & USP 1207 guidelines

• Can form part of 21 CFR Part 11 compliant system

Small-scale Packaging Solutions

Sepha offers a range of blister packaging machines, that can handle thermoform and cold-form materials, to package tablets, capsules,

medical devices and other products. Designed with full 21 CFR Part 11 capabilities. Ideal for:

• Clinical trials and stability studies

• Package development

• Low volume production of specialist drugs

Deblistering Solutions

Sepha provides a range of automatic, semiautomatic, and manual deblistering machines for the safe recovery of drugs from all blister pack types.

• Suitable for push-through, child resistant and peelable blisters

• Deblistering capacity up to 50 blister packs per minute

• Handles thermoform/alu and coldform/alu blisters

• No product or foil contamination

With over 40 years’ experience in the pharmaceutical packaging industry, Sepha has a great understanding of the packaging requirements and role primary packaging plays in bringing new drugs to market.

We have established a global reputation for innovation and development of tailored, highquality equipment for use in the manufacture of pharmaceutical blister packs, parenterals, medical devices and healthcare products.

In line with our philosophy to ensure quality and safe products for patients and their families, we have partnered with hundreds of pharmaceutical companies across the globe. We understand their needs to ensure product security through package integrity and the importance of extended shelf life and speedto- market. Their success is our success.

SpotSee

5000 Quorum Dr. # 550, Dallas, TX 75254

800.846.2468

orders@spotsee.io

www.spotsee.io

At SpotSee, every degree matters. As a global leader in condition monitoring and sensing solutions, the company helps customers identify changing conditions to protect life sciences and ensure supply chain integrity. SpotSee provides products that enable more than 4,500 customers and partners in 62 countries to detect changes in the condition of everything from vaccines to spaceships. The company’s solutions include temperature, impact, tilt, vibration, humidity, and liquid detection monitoring devices, available via visual, RFID, QR code, cellular or satellite connection. Its products such as WarmMark, ColdMark, HemoTemp II, ThermoStrip, Thermax, BriteLine, ShockWatch, ShockLog, and TiltWatch are widely used in the life sciences, energy, transportation, aerospace, defense, food, manufacturing, and consumer products sectors. The company is headquartered in Dallas, Texas, and operates five facilities in Texas, Illinois, Mexico, and the United Kingdom.

SpotSee uncovers hidden risks with realtime impact, temperature, and condition monitoring. Protect shipments, medical equipment, and assets with our smart indicators and data recorders—because what you don’t know can impact your bottom line.

See our ad on page 7

STARVIEW PACKAGING MACHINERY, INC.

1840 Boulevard Saint Régis Dorval, Quebec H9P 1H6

514-920-0100 ext.310

sales@starviewpackaging.com

www.starviewpackaging.com

Starview Packaging Machinery, Inc. is the leading manufacturer of packaging machinery for high-visibility packaging with over 30 years of supplying standard and custom packaging systems to our customers. Providing the Medical Device and Pharmaceutical Industry with innovative packaging machines for:

• Medical Device Packaging

• Pharmaceutical Packaging

• Blister & Clamshell Packaging

• Customized Packaging Equipment

• Integrated Automated Systems

We design, engineer, and manufacture a comprehensive line of manual, semi-automatic, and automatic sealing machines. Available in shuttle, rotary, carousel, and inline conveyor configurations, a variety of standard and custom sealing areas are available to meet the specific requirements of customers and maximize

productivity. Machines are configured to suit the specific application such as carded packages, sterile medical device packages, or pharmaceutical wallet packages.

Our distinct competitive advantage is in providing a complete range of both standard and customized quality packaging systems backed by solid machine designs, robust machine construction, and superior service. Starview offers many value-added features for our machines such as product sensing, printing and/or verification, hydro-pneumatic cold seal presses, robotic product loading, automatic packaging materials loading, automatic inline fold-over, finished package unloading with reject features. Quick-change mechanisms for tooling sets, on-screen sealing press adjustments, machine performance tracking, and ANSI Class 4 safety make Starview machines an excellent choice.

The owners, management, and staff of Starview are dedicated to designing and manufacturing packaging machines in North America with the highest quality fit, and finish backed up with industry leading customer service.

Starview’s directive is to produce a full range of sealing machines for medical device packaging, pharmaceutical packaging and retail high visibility packaging. We offer standard machines with an array of custom and in demand options to provide our clients with machines to match their manufacturing requirements.

STEVANATO GROUP

9701 Giovanni Stevanato Dr, Fishers, IN, 46038, USA

www.stevanatogroup.com/en

Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery, and diagnostic solutions to the pharmaceutical, biotechnology, and life sciences industries. Stevanato Group delivers an integrated, end-to-end portfolio of products, processes, and services that address customer needs across the entire drug life cycle at each of the development, clinical, and commercial stages.

Stevanato Group boasts unique expertise in providing advanced pharmaceutical containers from glass tubing. Its comprehensive portfolio covers every customer need, from those related to small molecules to highly sensitive drugs. Stevanato Group produces vials, syringes, and cartridges for different applications, such as monoclonal antibodies, GLP-1 & peptides, RNA-based drugs and vaccines. Glass containers are available both in bulk and in EZ-fill®, the market-recognized ready-to-use configuration.

With regards to drug delivery systems, Stevanato Group proprietary devices include: Alina®, a disposable pen injector for variable and multidose treatments, the Aidaptus®, a 2-step, singleuse auto-injector accommodating both 1mL and 2.25 mL pre-filled glass syringes in the same form factor and Vertiva®, a pre-filled and pre-loaded on-body delivery system platform. Stevanato Group can also offer analytical and device testing services to support customers all the way, from early-stage to launched combination products through its Technology Excellence Centers.

Its capabilities range from modular assembly platforms and packaging lines to advanced vision inspection machines, including manual, semi-automatic, and automatic. Stevanato Group equipment can inspect a wide range of liquid, emulsions, viscous, gel-like, powder, and lyophilized drugs, catering to the needs of both small firms and big pharma.

We are fully committed to being the best, objective-focused partner in the research and delivery of innovative solutions to support the success of our customers.

And we never stand still.

It’s our continual innovation and pioneering of new trends in the pharmaceutical industry that ensures we produce the world’s most advanced solutions year after year, enhancing the level of product integrity that can be guaranteed to patients and always seeking to exceed customer expectations.

Our mission is to cooperate deeply with our partners all over the world, providing our know-how, resources, and enthusiasm to turn every project into an achievement.

See our ad on page 13

TechniBlend, A ProMach Brand

21800 Doral Road, Waukesha, Wisconsin 53186

262-484-4090

contact@techniblend.com

www.techniblend.com

Turnkey Solutions for Blending, Filling, & Packaging of Oral Liquid Dosage Products

TechniBlend’s advanced processing solutions excel in oral liquid dosage batching, enabling pharmaceutical manufacturers to achieve precise ingredient measurement and combination for consistent product quality. With state-ofthe-art systems, these batching solutions ensure that formulations meet rigorous industry standards while minimizing waste and enhancing production efficiency. For companies producing a variety of oral liquid medications, TechniBlend offers scalable and customizable systems tailored to specific processing needs.

TechniBlend also provides innovative oral liquid dosage blending, ensuring homogeneous mixing of complex formulations. This capability is critical for maintaining product efficacy and uniformity across batches. Designed for

flexibility, the blending technology supports a wide range of pharmaceutical applications, from simple syrups to multi-ingredient liquid formulations, making it a cornerstone of pharmaceutical liquid batching operations.

TechniBlend’s comprehensive approach to oral liquid dosage processing and pharmaceutical liquid processing integrates batching, blending, and filling into efficient workflows. These systems streamline every step of the production process, ensuring compliance with stringent regulatory standards while maximizing throughput. By combining precision engineering with user-friendly operation, TechniBlend empowers manufacturers to deliver safe and effective liquid medications at scale.

TechniBlend is a proud member of the ProMach family of brands. ProMach offers more than a century of experience in designing, manufacturing, integrating, and supporting the most sophisticated and advanced pharmaceutical and medical packaging solutions in the marketplace. ProMach’s technologies can meet the most challenging requirements with minimal downtime, higher productivity, and true pharmaceutical packaging performance, with compliance built right in.

For blending, we have vast experience in product density measurement, precise blending control, and pumping and flow engineering. From there, we provide bestin-class filling, capping, labeling, cartoning, insert feeding, tamper evidence, case packing, palletizing, digital intelligence, and anything else your particular needs require.

Uhlmann Packaging Systems, LP

44 Indian Lane East, Towaco, NJ 07082

973.402.8855

info@uhlmann-usa.com

www.uhlmann.de

PTC 200

Our packaging solutions with the parenteral tray center PTC 200 address the special needs of pharmaceutical companies, doctors and patients in a particularly sustainable manner. Cardboard trays enable visually appealing and clear packaging, simple and ergonomic, product removal as well as protected and space saving storage. The gentle product handling and the simplified cleaning of the machine guarantee you even greater safety when packaging parenterals.

Thanks to the proven cartoning technology, trays and folding boxes can be erected in the packaging process, while our proprietary systems ensure correct and complete storage. The Uhlmann inspection system provides you even greater flexibility at favorable conditions. The modular machine concepts are therefore suitable for different or changing product application as well as for new or seasonal product

launches. Side loading allows you to save on machine length and for you to implement any packaging requirement with top opening. The PTC 200 acts quickly, safely, and reliable, just the way you need them to. The feeding of the products transportation system, the components can be supplied on a vertical, horizontal or suspended basis, Sensitive components such as ampoules, vials, syringes or medical devices benefit from our versatile and customizable feeding options.

As a leading global systems supplier for the packaging of pharmaceutical products in blisters, bottles, and cartons, we provide flexible integral solutions for international pharmaceutical companies, generics manufacturers, and contract packers.

From its northern NJ-based U.S. headquarters, Uhlmann provides sales support, service technicians, on-site training, parts inventory, and onsite engineering for line integrations. The company’s 600,000-sq.-ft. world headquarters is located in Laupheim, Germany.

Equipment includes:

• Blister machines, from compact models to complete, full-featured, highspeed blister lines

• Cartoning systems for blister, bottle, pouch, vial and kits

• Integrated bottling lines

• Casepackers, overwrappers, bundlers and palletizers

• System engineering + line integration

• Validation and training service

• Inspection systems, peripheral products + services

• Custom-designed tools + format parts

Weiler Engineering, Inc.

847-697-4900

www.weilerengineering.com

Weiler Engineering, Inc., a leading provider of aseptic custom Blow/Fill/Seal liquid packaging equipment for pharmaceutical and healthcare applications, is committed to the highest standards of excellence and to expand products and systems to enhance patient care. Weiler’s proprietary ASEP-TECH® B/F/S packaging machines produce shatterproof, durable, aseptically-packaged products in one uninterrupted operation. This hands-free manufacturing process ensures that parenterals, ophthalmic solutions, and respiratory drugs reach the marketplace sterile, in the most cost-effective manner possible. The ASEPTECH® System is the culmination of 66 years of innovation in machine design and sterile process development, producing the most advanced aseptic liquid packaging process machinery.

The Weiler design incorporates the process of blow molding, aseptic filling, and hermetic sealing of liquid products in one sequential

operation on a compact machine frame. Weiler’s patented electronically controlled fill system, automatic sterilization system with integral data collection, andfilter integrity test system arestandard equipment for each machine configuration. Each machine is equipped with a HEPA air shower to ensure a Class 100 environment under dynamic conditions in the nozzle shroud area.

Weiler’s latest innovation is the NEW compact ASEPTECH® LAB+ Blow/Fill/Seal machine, which is ideal for Stability and Clinical batches for pharmaceutical products and/or small development batches using advanced aseptic technology. This revolutionary small footprint design focuses on ease of changeover and product range flexibility.

ASEP-TECH® Blow/Fill/Seal machines are proudly manufactured in the USA, designed, and built by Weiler Engineering, Inc. in a 140,000 ft², state-of-the-art building.

Facts:

• Recognized as an advanced aseptic technology by the USFDA

• 65 years serving global markets

• Experience gained from 25 years of operating a captive pharmaceutical CMO

• Cooperation with regulatory authorities – compliance is key

• Quality + Operational Knowhow + Integrity

Goals:

• Focus on the science of the technology for maximum customer benefit

• Simplicity of design to maximize product flexibility and minimize footprint

• Optimum service support throughout the markets we serve = high customer satisfaction

Wipotec. Inc.

825 Marathon Parkway, Lawrenceville, GA 30046

678.344.8300

info.usa@wipotec.com

www.wipotec.com/us

Wipotec is a global leader in weighing technology and inspection solutions, specializing in high-precision equipment designed for in-motion product weighing, X-ray scanning, product inspection, parcel dimensioning, package marking and labeling, serialization, and aggregation. Our EMFR weigh cells and track and trace solutions are widely used across various industries, including pharmaceuticals, food, chemicals, cosmetics, healthcare, e-commerce, and logistics.

Our dynamic checkweighers incorporate advanced weighing technology, ensuring unmatched accuracy and effective reject systems. Wipotec’s X-ray scanners are essential in many applications, known for their versatility in detecting contaminants in products. Our TQS traceable systems adopt a modular design, accommodating all common packaging forms such as folding boxes and bottles—and include

critical functions for serialization and aggregation, combating counterfeiting, particularly in the pharmaceutical sector.

Additionally, our TQS machines are versatile enough to be utilized in both pharmaceutical and food industries, marking and verifying products for enhanced safety and compliance.

With our weigh cells providing highly accurate measurements, Wipotec is synonymous with innovative technology, exceptional service, and unparalleled performance in the inspection and weighing market.

Driven by our corporate philosophy “Innovation. Passion. First.”, we develop and produce unique machine solutions and technologies for OEM and end users in a wide range of industries at our head office in Kaiserslautern. As a founder-managed, solid company with 30 years of experience, we value enduring, long-term partnerships and always put our customers first. “First” as in top priority.

Our integrated solutions come from “a single source” and cover the entire value chain from hardware and software development, in-house production with a level of vertical integration exceeding 85 %, to after-sales service.

“Designed, engineered and manufactured in Germany” means premium quality and derived customer benefit in highperformance applications.

WLS, a ProMach Product Brand

1256 North Church Street, Moorestown, NJ 08057

856.273.3377

WLS@ProMachBuilt.com

www.WeilerLS.com

Rotary Labelers – Pressure-sensitive labelers for labeling a variety of product shapes vertically.

Vertical In-line Labelers – Pressure-sensitive labelers for labeling a variety of cylindrical products vertically.

Horizontal In-line Labelers – Pressure-sensitive labelers for labeling a variety of cylindrical products horizontally.

Label Heads – Pressure sensitive label heads with label print and inspection options including serialized codes and RFID tags.

Label Coders – For stand-alone or integrated high-speed coding of labels, including serialized codes.

Label Printers – Autonomy® drop-on-demand digital ink label printers with UV curing and full label inspection.

Vial Coders – For code printing on vials or bottles using ink jets or lasers.

Documentation & Certifications – DDS, FAT, SAT, IQ/OQ and Trace Matrix documents as well as UL, Seismic and CE certifications.

Field Service – US and European field service team also offering equipment training courses and maintenance contracts.

ProMach Pharma now offers sales and service capabilities through our European office.

WLS, part of ProMach Pharma Solutions, is an industry-leading designer and manufacturer of high-speed rotary and in-line labeling machines and serialization, coding and label printing solutions for the pharmaceutical and medical packaging markets as well as the food, beverage, personal care, and consumer markets. With over three decades of experience, our mission is to improve our customer’s labeling capabilities and ensure that our labelers provide them with the highest possible OEE.

Industries Served:

• Pharmaceutical

• Medical/Medical Device

• Nutraceutical & Vitamin

• Food

• Beverage

• Consumer Products

Learn more about WLS at WeilerLS.com

Validatable Medical Pouch Sealer

Supplied with verification ports for process validation of pressure, speed, and temperature. Embossing coder available. A pressure wheel can be added to provide flat seals on Tyvek® pouches. Requires clean compressed air. Seals Tyvek® pouches up to 40 feet per minute.

Vision Group

Next-Gen Inspection for Unmatched Product Quality

Ensure quality, integrity, and safety with Antares Vision Group’s next-gen inspection technologies. Our 360° solutions inspect any container and contents from every angle, helping you meet rigorous regulations with confidence. Discover more: www.antaresvisiongroup.com

InteliJet LPc Thermal Inkjet 4.0 Printer; Redefining Serialization

The InteliJet LPc features next-gen thermal inkjet technology, providing incredible 1200 DPI print quality, ultra-fast print speeds up to 732m/min and a 22mm wide print head that can print crypto-codes without stitching heads. The built-in ink system reduces downtime and provides significant cost savings.

Chase-Logeman Corporation

Precision Filling, Closing, & Labeling Equipment

For over 60 years, Chase Logmean has designed and manufactured precision monoblock-style filling and finishing equipment. Processing microliters to 125ml, Chase-Logeman has semi and fully automatic for almost every container size and shape. Let Chase-Logeman be your automation partner.

For clean secondary packaging, our water- and agri-based One Clean Carton® is lab tested for safe, indirect contact with food and pharmaceutical products. Independent testing provides proof that Colbert Packaging’s One Clean Carton is your cleanest, most sustainable secondary packaging solution.

AntAres

Greydon

High-Speed On-Demand Fully Digital Label Printing Solution

The L-Max digital label printer delivers high-speed, highquality label printing for various industries. It produces highresolution coding and marking, images, and text on demand. Serialization-ready, the L-Max meets the rigorous needs of pharmaceutical and medical device industries.

packaging, LLc

Reliable, Reproducible, Traceable Medical Packaging Solutions

Looking for validation-ready medical packaging solutions that meet all required standards? We help to provide maximum product protection and hermetic sealing, offering customizable package shapes, hygienic individual or multi-packs, easy-open options and vision inspection for quality control.

Heat and Control, InC.

Inspection performance for total product quality confidence

Anywhere along the line, protect your consumer and your equipment. Efficient detection of foreign objects is critical. We offer a complete line of metal detectors, checkweighers, and x-ray inspection systems from our strategic partners: CEIA® and Ishida.

Tek USA

The Perfect Prescription for Precise Weighing!

When it comes to nutraceuticals and pharmaceuticals, every milligram matters. The High Tek Mini Weigher ensures spot-on accuracy for capsules, powders, and supplements - delivering consistency you can trust. Compact, efficient, and built for precision, it’s the perfect solution for dosing done right.

JAMES ALEXANDER CORPORATION

our profile on page 63

CONTRACT FILLING: SINGLE-USE GLASS AMPOULES FOR UNIQUE DISPENSING SOLUTIONS

We’ll help you develop a customized dispensing system for your formulations with a variety of tips and in a range of different sizes/colors. You get: Extended shelf life, formulation stability, tamper resistance, quality assurance and two-part mixing. PROUDLY MADE IN THE USA. www.james-alexander.com

Harpak-ULMa

See our profile on page 60

HigH

Boost Profits, Comply With Regulations, and Safeguard Your Brand

Offering a full range of metal detectors, checkweighers, vision and x-ray inspection systems and data collection and management software to ensure product quality and regulatory compliance, increase productivity, ensure operational excellence, boost profits and protect your brand.

Packaging equipment from MG America can be found throughout North America and across the life sciences industry. Our lineup of premier, European-made machinery has earned a global reputation for reliability, precise performance, and superior craftsmanship.

Packaging Line Solutions for Medical & Pharmaceutical Products

MULTIVAC is your partner for providing full line healthcare packaging solutions. We offer an extensive range of packaging technologies, automation solutions, labeling, inspection, handling, and quality control systems.

Beltorque® inline cappers feature servo-driven cap sorting and feeding, as well as the ability to add real-time application torque monitoring. With the use of synchronized belts, this versatile and innovative machine applies cap torque without cap scuffing.

Protect What Matters Most

From syringes to diagnostic kits, Ossid’s packaging solutions are designed to handle the unique challenges of medical product packaging — keeping safety, sterility, and efficiency front and center. Protect your products today, visit www.ossid.com

MG AMericA

MULTIVAC GroUp

Beltorque® Capper BT-IC

NJM PackagiNg

• Flexible for product variety

• Easy integration with serialization, vision inspection, labeling

• Small space design

• Made In USA High Precision Cartoning and Case Packing

TF1, Entry Level Blister Machine

The TF1 is a cost-effective blister machine that is perfect for low-volume production. Built with simplicity in mind, this entry-level machine requires minimal training and minimal maintenance. It can thermoform many types of materials and can optionally be set up to cold form.

RELIABLE & ACCURATE FILLING SYSTEMS

ProSys is a premier manufacturer of semiautomatic and fully automatic equipment for filling, Squeeze Tubes, Syringes, Airless Pumps, Cartridges, Jars, Custom Containers & Hot Melt applications for the Pharmaceutical industry.

Our best-in-class temperature indicator is now connected at every step. Eliminate manual record-keeping with automated cloud reporting and gain complete visibility into your cold chain with detailed excursion data. Plus, it integrates easily with your existing systems for streamlined operations.

The recently updated SB/PH1-1012 sealer now comes with a color HMI screen to give you full access to on screen heat and optional pressure calibrations. Includes exclusive data validation/data download port and class 100 clean room filter. Operational log is CFR21 Part 11 compliant

•

•

STEVANATO GROUP

Flexibility Built on Solid Experience!

Our GMP-compliant device assembly equipment can be configured to adapt to your production requirements, providing technology transfer from prototyping to high-volume production. This modularity enables different devices to be run on the same line, reducing time-to-market.

Turnkey Solutions for Blending of Oral Liquid Dosage Products TechniBlend, A ProMAch BrAnd

TechniBlend’s advanced processing solutions excel in oral liquid dosage production, enabling pharmaceutical manufacturers to achieve precise ingredient measurement and combination for consistent product quality.

PACKAGING SYSTEMS

READY FOR MORE THAN ONE FUTURE

Uhlmann parenteral packaging in plastic or paper tray.

Rely on Uhlmann’s decades of experience in packaging for the latest innovation in safe, sustainable and highly flexible packaging technology.

Weiler engineering, inc.

Weiler Engineering, Inc.’s Blow/Fill/Seal sterile-filled containers

Weiler Engineering, Inc.’s Asep-Tech Blow/Fill/Seal machines produce plastic aseptically packaged sterile-filled containers. Fill volumes range from 0.2mL vials to 1000mL LVP bottles. Typical resins used are LDPE, HDPE and P.P. The B/F/S process creates sterile finished product in a matter of seconds.

AUTONOMY® Digital Label Printer Weiler

AUTONOMY® is a state-of-the-art, high-speed, full-color, stand-alone digital label printer with integrated full-label inspection system. Printing variable and serialized data with label artwork. Providing in-house, on-demand, high-quality inspected labels ready for application.

Precision-Driven Heat Sealer

PackworldUSA

PackworldUSA’s 3400

Series Heat Sealer is manufactured from cleanroom-friendly materials such as stainless steel and anodized aluminum, ensuring it meets strict sterility requirements. The design eliminates the need for fans, reducing the risk of aerating particulates, and is wipe-down ready for standard cleanroom sterilizing solutions. The 3400’s intuitive touchscreen control panel simplifies the programming and monitoring of all sealing parameters, including time, temperature, and pressure.

New Barrier Eco Line

LOG

Pharma Primary Packaging

LOG Pharma Primary Packaging showcases it barrier eco line for innovative and generic drug companies that significantly reduces production costs of eco-friendly barrier bottles and offers optimal moisture and oxygen protection for pharmaceuticals. LOG uses innovative pharma-grade HEALTH + resins, powered by Dow. Combined with superior gas barrier properties, this development has allowed LOG to reduce bottle weight by up to 30% without compromising on WVTR (Water Vapor Transmission Rate).

Modular Belt Conveyor System

Bosch Rexroth

Bosch Rexroth is expanding its VarioFlow conveyor system to include the new VarioFlow belt conveyor variant, which features a fine-meshed chain surface. It ensures the smooth transport of pharmaceutical and healthcare products. The VarioFlow belt conveyor is a stand-alone conveyor system for delicate products and diverse items. The modular belt chain has a fine-meshed, almost closed and flat surface. This makes it suitable for the mass transport of unstable or bulk, film-packed products such as small sealed-edge bags.

Cut-Through Indicator for Closure Seals

Schreiner MediPharm

Schreiner MediPharm introduces a cut-through indicator functionality for closure seals that makes tampering attempts clearly visible. The solution’s special design enables flexible integration of the security feature, offering an effective and cost-efficient solution for product protection, and helping to secure the broader pharmaceutical supply chain. The new cut-through indicator function leaves any attempt at tampering readily and irreversibly apparent.

Automatic Desiccant Inserter Deitz Co.

The Pharmafill PS1 Packserter desiccant inserter from Deitz Co. automatically drops silica gel, clay, and other desiccant packets into flexible packaging pouches. Suitable for use with stand-up pouches, gusseted pouches, pillow pouches, and other flexible pouch packaging configurations, the PS1 Packserter automatically detects the formed pouch on the companion conveyor, feeds it under the discharge, and inserts the desiccant packet into the pouch. After insertion, the automated machine then directs the filled pouch downstream ready for sealing and cartoning.

Robotic Labeling Cell with Fully Integrated Servo Gripper HERMA

Featuring the market’s smallest fully integrated servo gripper, the HERMA 211R HC robotic labeling cell is specifically designed for small batch sizes and products with complex shapes. Employing optimized robotics, the 211R HC significantly reduces downtime while maintaining consistently high output levels, as well as unsurpassed performance and efficiency. Ideal for pharmaceutical applications, the module delivers enhanced accuracy by minimizing operator-related errors and eliminating the need for time-consuming manual reworks.

EXPERIENCE INNOVATION

in packaging for life sciences

Break out of the ordinary and discover your next big idea at PACK EXPO Las Vegas 2025. Explore innovative equipment tailored to pharmaceuticals, biologics, nutraceuticals and medical devices. Collaborate with experts and uncover game-changing solutions for scaling operations, protecting your products and answering market demands.

SPECIALIZED MACHINERY and materials for your needs

NEXT-LEVEL TECHNOLOGY from 2,300 exhibitors

VISIONARY INSIGHTS

shared in free on-floor sessions

SOLUTIONS & EXPERTISE from industryleading suppliers

REGISTER NOW AND SAVE!

New Surface-Treated Medical Paper

Billerud

Billerud launches MediKraft SealBase, a high-quality surface treated medical paper designed to meet the growing needs of the medical packaging industry, marking a significant extension of Billerud’s current medical paper product line. Made of pure virgin fiber, the 38 gsm grade MediKraft SealBase is tailored to be a base paper for medical synthetic cold seal coatings, offering an innovative solution for medical applications where a sterile barrier system is not required.

Wood-Based PET Pharmaceutical Bottle

UPM Biochemicals, Selenis, Bormioli Pharma

UPM Biochemicals, Selenis, and Bormioli Pharma have partnered to produce what is said to be the world’s first pharmaceutical bottles made from partially wood-based PET. As the high regulatory and performance requirements for pharma packaging may limit the use of new or recycled materials, this bottle uses standard PET which is made with UPM’s world first wood based BioMEG, UPM BioPuraTM, to take a real step forward in the sustainable transformation of the pharmaceutical sector. The new pharmaceutical bottles, containing UPM’s carbon negative BioMEG, are made from Selenis’ Selcare’s partial BioPET resins.

Next Evolution of a Syringe Closure System

Vetter

Vetter announce the development and upcoming launch of the new version of its proprietary V-OVS®syringe closure system. Similar to the original system, the design of V-OVS® next will be optimized to protect the integrity of the injectable product secured by the closure. For customers with products in glass-barrel syringes, this new closure will be an opportunity to integrate gold-standard Luer Lock features with even easier handling characteristics and an even more intuitive opening mechanism.

A single Columbia palletizer can handle all of these products and more with ease.

Nondestructive Package Leak Detector

Labthink

Labthink’s C690H Nondestructive

Package Leak Detector is based on the testing principle of the vacuum decay method, designed and manufactured according to ASTM F2338 and other standards. It is suitable for batch sealing leak detection of vials, and trace leakage detection of ampoules, cartridge bottles, infusion bottles, prefilled syringes, and other pharmaceutical packaging. This instrument is designed with many useful features to meet user needs and can be customized for non-standard test requirements.

Collaborative Study of Product Combo Further Advances Sustainability

UPM Raflatac

UPM Raflatac and Corning Pharmaceutical Technologies announce the results of a collaborative study that shows a combination of the two companies’ products performs well in a variety of challenging drug product storage conditions and offers significant sustainability benefits for pharmaceutical industry innovators. The combinations included Corning® Viridian® Vials, made of externally coated Type I borosilicate glass, and UPM Raflatac’s Forest Film™ labels, alongside PHARMAGLOSS and PHARMALITE downgauged paper options.

The Traceable Quality System's modular design allows for extensive customization to fit various needs. By adjusting modules for a product's size, weight, and speed, we create tailored solutions. This commitment extends after installation, with all functions integrated into one system. For larger items like shipping cartons, we scale modules to fit and use the Track & Trace module for their unique serialization, aggregation, and shipping requirements.

Automatic Assembly and Vial-filling Machine

TurboFil Packaging Machines LLC

TurboFil Packaging Machines LLC introduces an automatic version of its assembly and vial filling machine for unidose liquid nasal devices. Capable of producing up to 100 devices per minute, the company’s UDS Vial Filling & Assembly System features a racetrack format with vibratory product feeding. After an air jet and vacuum system cleans all vials, the UDS Vial Filling & Assembly System’s initial inspection station checks for cracks in each. To perform this step, vials are raised and rotated, allowing for 360-degree high-resolution camera inspection.

Javits Center, NYC April 1 - 3, 2025 Booth 2261

RFID-enabled Digital ID Solution for Prefilled Syringe Traceability

Avery Dennison

Avery Dennison unveils an RFID (radio frequency identification) pre-filled syringe (PFS) authentication solution in partnership with Turck Vilant Systems, whose software applications enable the reliable identification of syringes. Branded as BD iDFill™ Individual Prefillable Syringe Identification, the new traceability solution is created by Becton, Dickinson and Company (BD) in collaboration with Avery Dennison. RFID tags are embedded into the rigid needle shield of the syringe, forming an intrinsic part of the product. While allowing the fundamental design of the syringe barrel to remain unchanged, the smart needle shield gives a digital identity to the PFS. The integrated RFID carries the container’s unique identifier (CUID) that enables unit level traceability through the entire life cycle of the PFS.

Horizontal Flow Wrapper

Harpak-ULMA Packaging, LLC

Harpak-ULMA introduces the ARTIC SS Chevron, an advanced horizontal flow wrap machine designed specifically for medical and pharmaceutical packaging applications. This innovative system minimizes film usage without compromising sterility or easy-open features to redefine packaging efficiency. By dramatically reducing material waste, the ARTIC SS Chevron helps producers achieve sustainability goals while lowering operational costs. Unlike traditional thermoforming solutions that require two films, the ARTIC SS Chevron uses a single roll of film, folded to create a secure, aseptic seal. This design eliminates the need for premade bags, reducing costs and giving producers greater control over their packaging process. The solution is well-suited for low-height medical devices such as bandages, gel pads, or wound care products.

2024 Technology Excellence Awards Winners

Attendees at PACK EXPO International last fall cast their votes for the most innovative solutions across various categories. Produced by PMMI, The Association for Packaging and Processing Technologies, the Technology Excellence Awards recognize the best innovations in packaging and processing being shown for the first time at a PACK EXPO event.

General Packaging & Processing

Pressure Filler by Fogg Filler Company

Fogg’s PF Pressure Filler Series is an advanced hybrid system combining contactless electronic metering with closed-loop controls for CIP/SIP cleanability, resulting in a simpler, more hygienic filling process. By using fixed stainless-steel tubes instead of flexible hoses, it reduces temperature loss in hot-fill products and minimizes moving parts for easier maintenance. Designed to enhance filling speed and accuracy, it’s especially suited for distilled spirits and hot-fill beverages, merging multiple previously separate features into one innovative machine.

Personal Care/Pharma

Omni-IR™ by Pace Packaging, LLC

The Omni-IR™ series is an advanced linear unscrambler designed for high-speed container handling, meeting diverse manufacturing needs. Suitable for various plastic and fiber containers, it efficiently processes up to 650 bottles per minute across industries like personal care, beverages, automotive, and household products. With customizable features, the Omni-IR™ offers a flexible, cost-effective solution for manufacturers of all sizes.

Sustainability

PPK Natura: World’s First PET Resin Made from Waste Carbon by Plastipak Packaging, Inc.

Plastipak Packaging, Inc. integrates innovation and circularity by producing PPK Natura, the world’s first PET resin made from captured carbon emissions, using LanzaTech’s carbon capture technology. This sustainable resin, suitable for food, personal care, and pharmaceutical packaging, reduces greenhouse gas emissions without needing land or food resources. PPK Natura can be fully recycled, keeping carbon in a circular cycle.

Vial Closure

West Pharmaceutical Services

West Pharmaceutical Services, Inc. introduces Daikyo PLASCAP Ready-to-Use Validated (RUV) closures in a new nested format. This marks West’s latest product offering supporting the needs of advanced therapies, one of the fastest growing areas, driven by continued innovation in cell and gene therapy treatments. The PLASCAP closure is a metal-free polypropylene cap with an integrated stopper. This one-step press-fit solution for vial closure is offered in ready-to-use, validated formats compatible with vials with 13mm and 20 mm crowns. The new 6x8 nested tub configuration supports the West 10ml nested CZ vials as well as selected nested vials with a 20mm crown.

Medical Packaging Solutions

ProAmpac

ProAmpac offers a diverse range of high-performance medical packaging solutions, serving multiple sectors including diagnostics, non-wovens, pharmaceuticals, nutraceuticals, medical devices, and hygiene products. The portfolio includes:

• Tyvek® pouches, header bags, and bags on a roll – Ensuring durability, breathability, and sterile barrier integrity for medical device packaging.

• Sustainable high barrier – Offering protection against moisture, oxygen, and contaminants to extend product shelf life.

• MP-1000 desiccant film technology – This solution helps maintain product stability by effectively managing moisture levels.

Patient safety is on the line, so you need equipment that’s more than just good. Anritsu systems deliver precision, compliance, and low total cost of ownership. Plus, we back our advanced technology with unparalleled service and support.

missing. Learn

All Packaging Machinery 14, 49, 82 www.allpackagingmachinery.com

ANRITSU INFIVIS INC 50, 94 www.anritsu.com

Antares Vision North America 25, 51, 82 www.antaresvisiongroup.com

BELL-MARK 52, 92, 82 www.bell-mark.com

Chase-Logeman Corporation 53, 82 www.chaselogeman.com

Colbert Packaging Corporation 19, 54, 82 www.colbertpkg.com

Columbia Machine, Inc. 55, 90 www.palletizing.com

Columbia/Okura 14, 56 www.columbiaokura.com

Econocorp, Inc. 57, 93 www.econocorp.com

Formost Fuji Corporation 24, 58 www.formostfuji.com

Greydon 47, 59, 83 www.greydon.com

Harpak-ULMA Packaging LLC 4, 60, 83 www.harpak-ulma.com

Heat and Control, Inc. 9, 61, 83 www.heatandcontrol.com

High Tek USA, Inc. 2, 62, 83 www.hightekusa.com

James Alexander Corp. 15, 63, 83 www.james-alexander.com

Mettler Toledo North America 64, 84, 95 www.mt.com/pi

MG America, Inc. 45, 65, 84 www.mgamerica.com

Multivac Inc. IFC, 66, 84 www.multivac.com

Nita Labeling Systems 30, 67 www.nitalabeling.com

NJM Packaging 5, 68, 84 www.njmpackaging.com

Ossid 35, 69, 84 www.ossid.com

Pacteon Corporation 29, 70, 85 www.pacteon.com

MT_HealthcarePackaging_Interphex_HalfPage_PrintAd_20250226-02_PRINT-READY.pdf 1 2/26/2025 4:04:36 PM

Pharmaworks LLC 3, 71, 85 www.pharmaworks.com

PMMI 43, 87, 89 www.pmmi.org

Prosys Innovative Packaging Equipment Co. 41, 72, 85 www.prosysfill.com

Sepha Ltd. 46, 73 www.sepha.com

SpotSee 7, 74, 85 www.spotsee.io

Starview Packaging Machinery 40, 75, 85 www.starviewpackaging.com

STEVANATO GROUP 13, 76, 86 www.stevanatogroup.com

TechniBlend, Inc. 77, 86, OBC www.techniblend.com

Uhlmann Packaging Systems 31, 78, 86 www.uhlmann.de

Weiler Engineering 79, 86, IBC www.weilerengineering.com

WIPOTEC-OCS, Inc. 80, 91, 86 www.wipotec.com/us

WLS 21, 81, 87 www.weilerls.com

Four Ways Packagers and Processors Can Optimize Employee Training

Packaging and processing professionals share their thoughts on how to use technology to optimize employee training.

By Christopher Smith, Assistant Editor

Arecurring theme amongst packaging and processing professionals is the need to use technology to hone employee training. Using tools to individualize training materials to the needs of operators and tasks is key, and there are four ways industry professionals believe the goal can be achieved.

That’s according to PMMI Business Intelligence’s “Technology & Workforce: Using Smart Technologies to Bridge the Skills Gap,” a report that captures insight from packaging and processing end-users and OEMs on the role technology can play in addressing the increasing skills gap and the burden of costly training periods for new hires. The report stems from a Q&A session and roundtable discussions between expert panelists and industry participants at PACK EXPO International 2024.

Individualized training, data instrumentation, an ‘exploded view,’ and automation

One group from the first roundtable discussion suggested individualizing training to match each operator’s learning style, using media and animations to make content more engaging. High turnover rates call for training on fundamentals and troubleshooting to be delivered in a succinct, engaging format.

Building upon this idea, one table suggested embedding a multilingual avatar, or “personal assistant”, into the human-machine interface (HMI). This avatar would provide a personalized user interface, adapting to the operator’s language preference, skill level, and capabilities, and offering tailored instructions and feedback.

Another group highlighted data instrumentation to enhance task-specific training. Organizations can analyze training

effectiveness by tracking metrics such as user weak points, time taken to complete tasks, or clicks needed to reach the correct module/page. This information can then inform the creation of more targeted and successful training.

A third group suggested employers display an “exploded view of the machine” for training and troubleshooting. This can form part of the user interface and provide a realistic, 3D simulation that shows all the intricate parts of the machine. One participant said it could be “a step towards the digital twin concept,” training new operators in how machines work or serving as a guide for locating and fixing problems.

Lastly, the most popular suggestion among participants was automating repetitive tasks to free employees for high-impact responsibilities. This provides the additional benefit of making roles more enjoyable and gives employees more control over their time and career development.

SOURCE: PMMI Business Intelligence: Technology & Workforce: Using Smart Technologies to Bridge the Skills Gap

For more insights from PMMI’s Business Intelligence team, find reports, including “2024 Data Acquisition, Sharing and Utilization” and “2024 The AI Advantage in Equipment: Boosting Performance and Bridging Skills Gap” at pmmi.org/business-intelligence.

Christopher Smith is an assistant editor for PMMI Media Group, supporting ProFood World and other PMG brands. Before joining PMG in December 2024, he served as an associate editor and reporter for ClutchPoints. Smith earned his BA in philosophy with a focus on ethics from Creighton University in 2021.

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