Healthcare Packaging July/August 2022

+ UDI Implementation Highlights Global Challenges + Back to Basics: ISTA Standards 7E and 20 + Robots-as-a-Service for Med Device Pad Printing + Addressing Redundant Package Testing in Material Stability

JULY/AUGUST 2022

PMMI Media Group | www.HealthcarePackaging.com

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CONTENTS

↑ pp.19 Delphon Puts Robots-as-a-Service to Work 22 TRACEABILITY

A Digital Fingerprint to Combat Counterfeit Goods Alitheon’s optical artificial intelligence system can authenticate products by simply taking a picture. With DSCSA deadlines approaching, the company is working with a pharmaceutical manufacturer.

24 UNIQUE DEVICE IDENTIFICATION

UDI Implementation Highlights Global Challenges

At times, the hardest parts of UDI implementation are not about data matrices and linear barcodes at all. In this Q&A, Jay Crowley talks global databases, portfolio evaluation, and labor issues.

27 WORKFORCE

Great Resignation Driving Employee Poaching

It’s a buyer’s market for job seekers as over 80,000 left manufacturing from Aug. 2020 through Aug. 2021. Manufacturers are climbing over each other to poach workers to meet increases in production.

29 MEDICAL DEVICE PACKAGING

34 SUSTAINABILITY

Pharmaceutical Manufacturers Can No Longer Take a Pass on Sustainable Packaging

A new white paper from PMMI Business Intelligence talks about the challenges for drug makers to strike a balance between regulated packaging efficacy and sustainability goals.

37 BLISTER PACKAGING

Turntable Machine Packages Prefilled Syringes Seeking new equipment for a customer packaging prefilled syringes, contract service organization Sharp implemented a machine offering energy efficiency, flexibility, and easy handling.

COLUMNS 06 KEREN SOOKNE’S PERSPECTIVE 12 COLD CHAIN CORNER DEPARTMENTS 07 QUICK HITS 08 QUOTABLES/BY THE NUMBERS

Addressing Redundant Package Testing in Material Stability

10 NEWS

What began as a chat over coffee has led to work on a hypothesis and a white paper with far-reaching potential in saving time and resources in medical device packaging stability testing. Efforts were presented at the[PACK]out’s inaugural event in Austin.

19 OEM APPLICATION NOTE

17 MATERIAL DEVELOPMENTS 35 NEW PRODUCTS

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Editorial

DIRECTOR OF EDITORIAL CONTENT Keren Sookne

ksookne@pmmimediagroup.com

CONTRIBUTING EDITOR Melissa Griffen CONTRIBUTING EDITOR Tim Hayes

Art

ART DIRECTOR Jonathan Fleming UX/UI DESIGNER Maggie Wilson CREATIVE DIRECTOR Dave Bacho

Publishing

PUBLISHER Elizabeth Tierney, 815.861.2992 MANAGER, STRATEGY & COMMUNICATIONS Courtney Nichols AD SERVICES/PRODUCTION MANAGER George Shurtleff

Audience & Digital

SENIOR DIRECTOR, DIGITAL & DATA Elizabeth Kachoris DIRECTOR, WEBSITES + UX/UI Jen Krepelka

Advertising

VICE PRESIDENT, SALES Wendy Sawtell

wsawtell@pmmimediagroup.com SENIOR DIRECTOR, CLIENT SUCCESS & MEDIA OPERATIONS Kelly Greeby DIRECTOR, PRODUCT STRATEGY Alicia Pettigrew

PMMI Media Group

PRESIDENT Joseph Angel EXECUTIVE VICE PRESIDENT Dave Newcorn DIRECTOR, MARKETING Sharon Taylor SENIOR MARKETING MANAGER Amber Miller FINANCIAL SERVICES MANAGER Janet Fabiano FOUNDING PARTNER Lloyd Ferguson

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Healthcare Packaging® (ISSN # 21543666) is a registered trademark of PMMI, The Association for Packaging and Processing Technologies. Healthcare Packaging® is published bi-monthly by PMMI with its publishing office, PMMI Media Group, located at 401 N. Michigan Ave, Suite 1700, Chicago, IL 60611; 312.222.1010; Fax: 312.222.1310. Periodicals postage paid at Chicago, IL, and additional mailing offices. Copyright 2022 by PMMI. All rights reserved. Materials in this publication must not be reproduced in any form without written permission of the publisher. Applications for a free subscription may be made online at www.healthcarepackaging.com/ subscribe. Paid subscription rates per year are $55 in the U.S., $80 Canada and Mexico by surface mail; $130 Europe, $200 in all other areas. Single copy price in U.S. is $20. Free digital edition available to qualified individuals outside the United States. POSTMASTER; Send address changes to Healthcare Packaging®, 401 N. Michigan Avenue, Suite 1700, Chicago, IL 60611-3789. PRINTED IN USA by Quad. Volume 16, Number 4 The opinions expressed in articles are those of the authors and not necessarily those of PMMI. Comments, questions and letters to the editor are welcome and can be sent to: editors@healthcarepackaging.com. Mailing List: We make a portion of our mailing list available to reputable firms. If you would prefer that we don’t include your name, please write us at the Chicago, IL address.

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PERSPECTIVE

Making Traceability Accessible One system on the horizon creates a digital fingerprint of an item for authentication with the ubiquitous smartphone.

The quest for real-time authentication is necessary and beneficial, but the packaging community is still overcoming the challenges of implementing on a massive scale.

Individual manufacturers employ traceability systems that must work interoperably with downstream platforms, trading partners, and sometimes end users, whose technology they don’t control. Understandably, it can be a headache—but the industry will get there.

Our cover story from Stephanie Neil on pp. 22 focuses on Alitheon’s optical artificial intelligence system that can authenticate products by taking a picture with a mobile phone—a piece of tech that any downstream partner has. “FeaturePrint” identifies minute

differences on the surface of an item, even individual tablets, and the image taken on the line is stored to create a digital baseline for future reference.

Also in traceability news, we talk with a unique device identification (UDI) expert about hurdles in implementing UDI on the global stage (pp. 24). Many of the issues that come up have nothing to do with coding and marking, but with how companies manage their med device portfolios across markets.

In design, check out our coverage of a burgeoning effort in reducing redundant med device packaging stability testing on pp. 29. This work may lead to a new minimum floor of stability for well-established materials under certain conditions, and allow for process upgrades more easily, provided the data supports claims.

KEREN SOOKNE is the Director of Editorial Content of Healthcare Packaging. She may be reached at ksookne@pmmimediagroup or at linkedin.com/in/kerensookne

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1

TIM HAYES, CONTRIBUTING EDITOR, HCP

First CRISPR Drug Could Launch Next Year

A recent Fast Company article discussed a new development in the world of gene editing. Though the tech won Jennifer Doudna and Emmanuelle Charpentier the 2020 Nobel Prize in Chemistry, we still haven’t seen a practical application we can wrap our heads around. Until now. Vertex, a company focused on rare diseases, teamed up with CRISPR Therapeutics to develop a therapy to treat rare genetic blood disorders like beta thalassemia and sickle cell disease. The drug is called exa-cel, and it cost nearly a billion dollars to develop. It reportedly eliminates the need for blood transfusions and their complications. Exa-cel is expected to seek regulatory approval in the U.S., UK, and Europe by the end of 2022, so it could receive marketing authorization in 2023.

2

Patient Receives 3D Printed Ear Transplant

A recent Reporter Wings article discussed a new procedure in which doctors corrected a microtia defect by transplanting a 3D printed ear made of human cells. The procedure was conducted by a pediatric ear reconstructive surgeon in San Antonio, and the trial was funded by 3DBio Therapeutics. Executives at the company noted that with further research, the technology could be used to replace other body parts including spinal discs, noses, knee menisci, rotator cuffs, and reconstructive tissue for lumpectomies. Eventually it could lead to 3D printed complex vital organs such as livers or kidneys.

3 4

Impossibly Small Robot to Perform Tasks in the Body

A recent Medgadget article covered an innovative new medical robot that resembles a crab and measures just half a millimeter wide. Capable of jumping, twisting, bending, turning, and walking, the remote-controlled crab robots were developed by engineers at Northwestern University. They do not require electricity and are made of a shape-memory alloy. For video of the tiny crab robots in action, visit hcpgo.to/404

Nephron Pharma Recalls 2+ Mil Products

A recent WIS News article discussed that 2.1 million doses of medicine and medical equipment (including syringes and bags) from Nephron Sterile Compounding Center were recalled due to “lack of assurance of sterility.” “Out of an abundance of caution, Nephron is proactively cooperating with the Food and Drug Administration on a voluntary recall of a limited number of product lots. We do not take this lightly,” said a statement from the CEO and Owner. “While there has been no impact to patient safety, and there is no evidence of contamination, Nephron has decided in the interest of patients to proceed with this recall process.”

QUICK HITS

5

California is Making its Own Affordable Insulin

A recent article from The Verge covered California’s plan to combat the skyrocketing prices of life-saving insulin by making its own.

Some people are paying $300 to $500 a month to treat their diabetes, and it’s estimated roughly 25% of people are forced to ration their doses. The initiative is part of Governor Gavin Newsom’s CalRx plan from 2020, aimed at lowering medication costs by partnering with manufacturers or creating their own. Newsom hasn’t announced when the insulin will be available or how much it will cost, but he’s hinted that monthly costs could be—at a minimum—cut in half.

6

FDA Describes Baby Formula Plant Conditions

By now you’re probably well aware of the nationwide baby formula shortage crisis, linked to the Feb. shutdown of Abbott Nutrition’s plant in Sturgis, MI. A New York Times article outlined FDA commissioner Dr. Robert Califf’s description of plant conditions to lawmakers. He described “egregiously unsanitary” conditions including a leaking roof, water pooled on the floor, and cracked production equipment that created breeding grounds for bacteria. Califf took responsibility for how slowly the agency responded to the plant’s problems, but noted that the agency worked with Justice Department officials to outline corrective steps for Abbott. The plant reopened on June 4, closed for flooding briefly, and reopened July 9.

To keep up with the latest news bits from around the world visit healthcarepackaging.com to subscribe and get Quick Hits sent right to your inbox.

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QUOTABLES

BY THE NUMBERS

Due to limited supply of virgin fiber, now is an “excellent time to conduct a structural design engineering review. We often see this due diligence translates into material usage savings through the use of lighter weight paperboard materials as well as a smaller packaging footprint.

”

LISA PRUETT, PRESIDENT, RRD PACKAGING SOLUTIONS

With so much change in every industry “vertical in the last few years, we felt that it was important to launch the Emerging Brands Summit at PACK EXPO International to serve as a roadmap to help startup manufacturing companies take their operations to the next level.

”

—KIM OVERSTREET, DIRECTOR OF THE EMERGING BRANDS COMMUNITY, PMMI MEDIA GROUP

438

THE NUMBER of COVID-19 tests and sample collection devices authorized by the FDA under emergency use authorizations (EUAs), including 308 molecular tests and sample collection devices, 85 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test.

$625 BILLION

THE INJECTABLES segment of the global pharmaceutical market is expected to grow to approximately $625 billion in 2022, a 100% increase from 2016.

Source: Pharmaceutical Manufacturer via PMMI

20

TECHNOLOGY DEVELOPERS have announced more than 20 advancedrecycling projects in the past few years, often in partnership with petrochemical players.

Source: McKinsey & Co.

Institutes of Health-funded study, “ledThebyNational researchers at the University of California, Los Angeles, said the issue of fixed-amount vials [1.7 and 3.0 ml] might cause large volumes of aducanumab to be discarded unused.

”

— JUDY PACKER-TURSMAN, UNITED PRESS INTERNATIONAL [VIEW THE STUDY: HCPGO.TO/405]

70%

THE PERCENTAGE of today’s medical decisions that depend on lab test results. Safety, quality, and costeffectiveness are required for the 14 billion tests ordered annually. Patients in rural areas often experience barriers to healthcare and lab services.

Source: CDC

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NEWS

New Nordic Sustainability Criteria Poised to Expand in Europe The newly released Common Nordic Criteria for More Sustainable Packaging in Healthcare document was developed as a spin-off from previous efforts at Aarhus University Hospital to improve hospital recycling rates in a meaningful and scalable way. Presented by Susanne Backer at a LyondellBasell event in June (pictured), the criteria aim to: (1) reduce [material waste], (2) increase recycling, and (3) increase the usage of recycled or renewable materials. The document covers primary, secondary, and tertiary packaging materials and the main materials used for packaging. Recommendations are divided in three levels: Basic, Advanced, and Spearhead for those at the forefront of the industry’s sustainability initiatives. View the 25-page document at hcpgo.to/403 —Keren Sookne

Capsule Dispenser Doses One at a Time

Survey: Supply Chain, Sustainability, and E-Commerce Effects

The Packsys Capsule Dispenser—named a World Star Packaging Winner 2022—was designed by Packsys GmbH especially for consumers with declined motor functions, as the lockable actuator can be pressed with little force to release the capsule into the dosing cap, one capsule at a time. This is done without the need for the capsule to be touched. The dispenser is manufactured from pharmaceutical-compliant PP (polypropylene) combined with a steel spring and is reported to be both recycle-ready and refillable. The dispenser can be equipped with a desiccant fitment for moisture-sensitive products. The force of one finger is sufficient to press the actuator, although it is large enough to be pressed using the whole hand, or even the forearm or elbow if necessary.

—ThePackHub

RRD, provider of packaging, supply chain solutions, and more, released survey results from mid-to-senior level procurement, brand marketing, and packaging engineering professionals across sectors. For 57% of respondents, e-commerce has increased over the past 1 to 2 years. Meanwhile, 35% developed an e-commerce-specific package design/structure. The majority (66%) said they have shifted to more sustainable packaging than what was used previously, and 55% said recent supply chain disruptions moved their companies closer to their carbon emissions goals (see RRD chart above). Overall, there was a broad willingness to pivot to different packaging materials in light of industry challenges—81% made changes to packaging design over the past 1 to 2 years.

—Keren Sookne 10 | Healthcare Packaging • July/August 2022

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NEWS

CPG Cobot Use Expected to At Least Double in the Next Five Years The barrier between robot and cobot has continued to blur over time, especially as cobots become more versatile in their overall application and increase their weight tolerances. Some vendors are even exploring dual-mode robots capable of switching between an unguarded cobot mode and a more traditional heavy industrial mode. This blending of capabilities indicates the potential for some robotic deployments to fulfill both roles, according to a new report from PMMI Business Intelligence, 2022 Robots and Cobots: An Automated Future (hcpgo.to/cobot22).

Processing Operations: Cobots have seen their role in processing steadily expand as IP69k construction standards, AI/machine learning, and enhanced robot vision systems become more common and affordable. Adoption in processing has also accelerated as a result of COVID-19 restrictions.

Primary Packaging: In just the last few years, robotic capabilities in primary packaging have expanded significantly. With the advent of tactile sensors, AI-supported vision, and innovative EoAT (end of arm tooling) designs, cobots are finding new roles in primary packaging and expanding their reach into new manufacturing markets. An ongoing challenge for manufacturers will be understanding the depth and breadth of these new capabilities and how to most efficiently apply them.

Secondary Packaging: Cobots are playing a key role in improving the efficiency of secondary packaging operations. From secondary packaging material handling to visual inspection, robots are driving new levels of efficiency and speed that help manufacturers manage production costs and increase throughput.

—Sean Riley

Also in the News + Sanofi launched its first digital accelerator to foster its ambition to become a leading digital healthcare company. + Klöckner Pentaplast and Syntegon were awarded Ecovadis’ Sustainability Ratings of Gold and Silver, respectively. + Antares Vision Group won a Manufacturing Excellence Award at the 2022 PHARM Connect Congress in Warsaw for its VRI large volume blow-fill-seal automatic visual inspection and leak detection system. + CivicaRx selected Profil as its clinical trial partner for its insulin initiative, aiming to produce three insulin biosimilars in vials and prefilled pens at lower prices than currently on the market. + PCI Pharma Services is making a $100 million investment at its New Hampshire campus to expand aseptic liquid fill-finish and sterile lyophilization technology. They also announced an expansion in the UK to support production for highly potent oncology treatments.

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COLD CHAIN CORNER

Back to Basics: ISTA Standards 20 and 7E The ISTA Pharma Committee held a virtual Technical Exchange to help shape the future of ISTA Standard 20 and 7E. KEREN SOOKNE, DIRECTOR OF EDITORIAL CONTENT

There are numerous standards to help life science companies manufacture and ship products safely. Today, we’re talking two common ISTA standards which may be updated soon—Standard 20 and 7E. For background: • Standard 20 (STD-0020) is a design and qualification process that provides the structure and path to design, test, and verify a specific Insulated Shipping Container (ISC) for use. “It’s really intended to set a minimum requirement for qualifying insulated shippers in a standardized way,” explained AJ Gruber, ISTA President and CEO, at the Pharma Committee Technical Exchange in February.

• Standard 7E (STD-7E) is a testing standard for thermal transport packaging used in parcel delivery system shipments. It includes hot and cold profiles developed from data gathered in real-world transport in North America through a parcel carrier.

It’s intended to address the issue of gauging ISC performance for designs across manufacturers by offering a standard profile for performance testing. “I think nuance that gets lost in the discussion sometimes is that it was really intended to be a standardized profile that companies can use to get an applesto-apples comparison of ISC performance when you compare them head-to-head,” noted Gruber.

At the Exchange, Gruber also provided context behind different types of certified labs. “We have two different kinds of lab certifications: one for a transport lab and one for a thermal lab. A transport testing laboratory certification assures that the laboratory is properly equipped to conduct our pre-transit package performance testing for parameters like shock and vibration that a package incurs when it’s being shipped through your distribution environment,” he explained. “The thermal testing lab certification is ensuring that the

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lab is capable and compliant with ISTA Standard 20.”

A certified lab that utilizes that process, in conjunction with the ISTA 7E profiles, can qualify packaging solutions as certified to ISTA Standard 20.

There are a few additional requirements for a lab to become certified as a thermal lab—there’s a requirement for training and certification of the lab personnel themselves, and there’s an in-person audit requirement for the initial certification and for re-certification.

These two aspects are unique to the thermal lab certification process and aren’t required for the transport lab certification.

The future of standard 20 and 7E ISTA is looking into ways of ensuring that these standards are up-to-date and providing as much value to the industry as possible.

“One of the things we’ve identified is that it might need a bit of a reorganization and the key areas that we’ve identified for future improvement and wider adoption is the accessibility, flexibility, and relevance and intent,” said Bill Mayer, Director of Research and Development at Peli BioThermal. Mayer shared some of the topics that came up in feedback from pharma end users: • The availability for review for packaging end users came up as an area for improvement. Also on the accessibility front, the documentation package is time-consuming and quite large, which makes it tough to share easily.

• The large and ongoing investment for the packaging solution providers and independent labs can be a hurdle.

• Regarding flexibility, some respondents wished for flexible levels of participation in the standard based on their particular organization’s maturity level and cost-benefit analysis. The second issue around flexibility was being able to choose the amount of value that an organization wants and allow those levels to change, based on individual company growth and industry need as they change over time.

• Relevance and intent: The intent is to provide a document and standard that is relevant to the industry. “We can drive that and increase the relevance by driving the flexibility and the accessibility and encouraging a technical standards review committee that reviews the technical data of the standard, where all stakeholders are allowed a voice,” said Mayer.

Voices of the industry Attendees at the Exchange offered varying perspectives on Standard 20 as it currently stands.

Packaging suppliers noted that the standard is valuable to the industry as a whole, offering best practices and procedures they use and providing standardization on running packaging qualifica-

tions so that the end users understand what is being put in front of them. They also noted that it could benefit from a refresh in how it’s applied and structured.

From the auditor perspective, Carolyn Williamson, President at Parenteral Supply Chain, said, “I really like the structure that it provides. Also, for some of the test labs using this, it really helps them if they’re just starting off because some of them are small. It’s a good foundation for what they need from all the perspectives like quality systems, training, etc. There are places we can work on, I think. Working with these test labs, they sometimes find the training a little cumbersome and we can probably work on that… I’d be very open to helping to improve the system, but I find tons of value in it.

If the lab goes to this trouble, there’s a lot of value to that, and I think it’s important for end users to understand that if they don’t know.”

Bryan Cardis, Sr. Consultant Engineer, Eli Lilly and Company, noted that when you have the ability to use a certified lab, it strengthens the position of the company to know that you’re getting validated results. “Then compound with that, you have a strong position when you’re going to an auditor that (1) you have validated results and (2) you have a certified lab and it generally appeases auditor concerns about what kind of data you have and what kind of facilities you’re using,” he added.

From a supplier perspective, demand among pharma manufacturers is a key issue. One president of an independent test lab noted that while they are already ISTA-accredited, they’re not Standard 20 accredited and they haven’t yet seen the value in incurring the extra costs associated. Another independent lab president echoed those concerns, explaining that it’s a “chicken and egg” issue for them to invest the time and work to get accredited. “We need to have our customers ask for it. That hasn’t hit a critical mass yet for the investment, but that’s also why I’m on these calls to feel out if we’re at a tipping point and if we should start the process,” she explained.

Reorganizing standards ISTA is looking at reorganizing the standards to offer a tiered approach. At this point, a direction is not set in stone, but the group is focused on improving the accessibility, investment level, and flexibility based on how companies want to apply it and the maturity level of the organization.

At base of the pyramid are Standard 20 and 7E. “What’s being proposed is to be able to give broader access in making that available to all ISTA members with their annual dues and for minimal purchase cost for non-members. Very much like buying any other standards, like 3A for example. Maybe there’s an abstract that can be available to everyone. But the bottom line was making the base standard widely available and reviewable by all those that might

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↑ While a direction is not set in stone, the group is considering a tiered approach to improve the accessibility, investment level, and flexibility of standards for the industry. (Credit: ISTA)

have interest in it,” Mayer said.

Then stepping up the pyramid, access to the templates and the appendices may be added, which would be the minimum level that a company would need to execute the standard and document it properly. Mayer explained, “That would assume that you already have an existing quality system. So, something like ISO 17025 and a training program in place that is adequate for developing it and conducting these tests.”

For the next level on the pyramid, there is discussion of adding access for Standard 20 to the recently developed ISTA digital platform, PackSight, to help with the documentation process. “Since some of the issues around Standard 20 had to do with the documentation level, this could certainly help fill some of those documents out,” Mayer said. “We could have some of those pre-filled, we could have it as a sharing site, for documentation sharing benefits.”

The next layer would feature levels that add value to the companies that might not have a certification for their lab or a certification for personnel. “If you already have an existing lab accreditation and you want to add additional lab certification value, then that can be added, or if you don’t have any lab certification value, you’re new to the industry, then that can certainly be added as well. And then

a lot those lines can be done with the personnel certification, too,” Mayer noted.

At the very top of the pyramid is package certification, allowing for the ISTA certification mark to be used on the package after ISTA review.

The idea is to allow for broad access to the standard base for minimal cost, and then create a technical review committee that’s allowed to review this on a normal basis like any other standard and offer input.

One audience member noted that personnel certification might be beneficial before the lab certification part of the pyramid. Another attendee asked if they wanted to purchase the lab certification, would they also need to purchase the digital platform access, or would the pyramid levels be a la carte?

Gruber explained, “This is just a concept at this point, and we’re looking for feedback on the approach. The concept, though, is that it’s an a la carte type of pyramid. But in order to get to the top of the pyramid, you would need the pieces to fill in underneath as well.”

This approach could allow companies to step up based upon the value proposition and the maturity level of their organization, being able to switch between those levels as they progress over time.

14 | Healthcare Packaging • July/August 2022

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MATERIAL DEVELOPMENTS

Dove Debuts Reusable Body Wash Packaging System Unilever introduces a new packaging option for its Dove Body Wash products, with a reusable system comprising a petite bottle of concentrate paired with a ‘too beautiful to throw away’ refillable, reusable bottle.

ANNE MARIE MOHAN, SENIOR EDITOR, PACKAGING WORLD

↑ The Starter Kit for the Dove Reusable Body Wash Bottles + Concentrate Refills system comes with either an aluminum or a plastic bottle and one bottle of concentrate.

In January 2021, Unilever’s Dove deodorant brand redefined reusable retail packaging, creating a sleek and sophisticated design-forward system with a refillable stainless-steel deodorant case and compact refills. With its new Dove Reusable Body Wash Bottles + Concentrate Refills, the brand has taken a page from the household cleaning category by offering concentrated product refills paired with two “too beautiful to throw away” reusable bottles.

According to a Dove spokesperson, the brand currently has more than 100 different projects running across the world looking at every facet of its packaging, across the three dimensions of no/better/less

plastic. “We know that reusables are of huge interest to consumers,” the spokesperson says, “and as industry leaders, it’s our responsibility to drive innovations that incentivize purchase behaviors with products that enable people to consume more consciously.”

The body wash system, which was launched in January 2022, is available in a starter kit that comes with a reusable 16-oz bottle, made from either aluminum or 100% recycled high-density polyethylene, depending on consumer preference, with a reusable plastic dispensing pump. Dove says it created the two bottle choices to help meet consumer preferences regarding price and material. “For July/August 2022 • Healthcare Packaging | 17

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MATERIAL DEVELOPMENTS

those who would prefer to purchase the least amount of plastic, the aluminum bottle is available at a higher price point,” a brand spokesperson explains. “Alternately, the recycled plastic bottle is available at a lower price point than the aluminum bottle.”

Also in the starter kit is a 4-oz HDPE bottle of concentrated product in one of three varieties—Daily Moisture, Shea & Warm Vanilla, or Cucumber—fitted with a proprietary Quick Connect Cap that allows for mess-free filling of the reusable bottle. Says Dove, “The innovative technology allows the cap to easily connect and seamlessly release the concentrated formulation without pouring. The cap was designed originally by our Homecare division and is used on brands like CIF [household cleaning products] globally.”

Design for easy refills To use the concentrate refills, the consumer begins by twisting both the refill and the cap onto the neck of the reusable bottle until they hear a “click.” This indicates the refill is now open and ready to dispense by simply squeezing the refill contents into the bottle. A view strip on the refill indicates when the bottle is empty, for complete evacuation of the concentrate.

Next, the consumer fills the bottle with water and then shakes the contents to mix. The aluminum container incorporates a groove to indicate the fill line, while the plastic bottle has a view strip.

Partnering with Dove, international design agency JDO was tasked with designing the reusable bottles as well as the concentrate refills and starter kits. According to the agency, the creative solution needed to embrace Dove’s iconic design principles while also conveying the innovative sustainable proposition in a clear and compelling way.

For the reusable bottles, JDO shares that it developed an elegantly modern illustration with botanical imagery to adorn the packages.

“Layered green fronds against the silver of the premium aluminum bottle give off a spa-like quality,” the agency says. “The final touch is a Dove icon in gold with the instructions, ‘Refill, Reuse, Repeat,’ an understated accent that keeps the design simple, sophisticated, and absolutely stunning.”

Comments Bronwen Westrip, Creative Director at JDO, “This innovation is so easy to use, and Dove products are so renowned for their quality that there was no need to over-clutter the bottles or the concentrate refills with too much information. This allowed us to really focus on creating a clean aesthetic that appealed to the consumer desire for more sustainable solutions as well as their desire for beautiful products. Our hope is to inspire them to use Dove’s new Body Wash Reusable Bottle & Concentrate Refills for a new personal care routine that looks good in the bathroom, feels good on the skin, and does good for the planet over time.”

The refillable/reusable system, with the aluminum bottle, is said to reduce plastic by 50% after two refills versus Dove’s standard plastic bottle. The HDPE bottle reduces plastic by 50% after four refills. In addition, the system results in 80% less water shipped per refill and 21% fewer greenhouse gas emissions from manufacturing over a year. The reusable bottles were manufactured to be durable, and as part of Dove’s consumer promise of “buy once, refill for life,” the containers carry a lifetime guarantee. Says Dove, “We’re proud that consumers have a new, reusable option for both products without having to compromise on the product experience they expect from Dove.”

Now available at retail, the starter kit with aluminum bottle is $14.99 as of press time; the kit with plastic bottle is $9.99. Refills sold individually are $6.49 apiece.

↖ The refill bottles use a proprietary Quick Connect Cap that attaches directly to the reusable bottle for mess-free transfer of the concentrate to the container.

Companies are searching for sustainable e-commerce innovations to meet growing demand. In this video, Packaging World’s Matt Reynolds and U.K. sustainable packaging expert Paul Jenkins of ThePackHub discuss a trend known as ‘re-commerce.’

18 | Healthcare Packaging • July/August 2022

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OEM APPLICATION NOTE

Delphon Puts Robots-as-a-Service to Work Delphon hires the Rapid Machine Operator from Rapid Robotics to improve production in its TouchMark and Gel-Pak operations.

DAVID GREENFIELD, DIRECTOR OF CONTENT, AUTOMATION WORLD

Medical device printing done by TouchMark includes syringes, catheters, tubing, cannulas, and more.

Through its TouchMark business, Delphon (a Hayward, CA-based manufacturer) provides high quality, precision pad printing services to the medical device and electronics industries. Pad printing is a printing process that can transfer a 2D image onto a 3D object. The company’s cleanroom manufacturing facility enables it to handle prototypes ranging from small clinical trials and engineering lots to large production volumes, and capabilities include syringes, catheters, tubing, cannulas, and more.

Like most manufacturers today, Delphon has been finding it difficult to find machine operators for its production operations.

“Recruiting operators has been next to impossible. It only got harder once the pandemic hit,” says James Garner, Director of TouchMark’s Manufacturing Operations.

In response, Delphon has been looking to automate various aspects of its production operations for some time now. The problems Delphon encountered in its mission to automate were multiple: the robotics systems the company investigated all cost too much, took too long to install, or delivered too little value.

“TouchMark had considered robotic automation in the past, but the ROI never made sense,” Garner says. “Other cobots (collaborative robots) worked at the same rate as a human operator, needed constant supervision, and came with a big sticker price. Choosing one of these cobots would mean that TouchMark’s labor costs and throughput would have stayed the same, while its capex would have increased.”

Despite its lack of success finding suitable robotic automation July/August 2022 • Healthcare Packaging | 19

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OEM APPLICATION NOTE

technologies for its operations, Delphon continued its search and found the Rapid Machine Operator (RMO) from Rapid Robotics to be different. A key factor for Delphon is that RMOs with built-in computer vision and pre-trained artificial intelligence to operate the kinds of machines TouchMark used could be hired for $2,100 per month.

Garner noted that the RMOs took only a few days at most to set up and needed only light supervision from an operator who could work another machine at the same time.

TouchMark put the RMO to work on a task it had been running the same way for 30 years—applying pressure-sensitive adhesive to semiconductor packaging. With the RMO ↑ Rapid Robotics RMO assists with pad printing operations. successfully automating this procedure, TouchMark brought in another RMO to work a pad printer alongside the first RMO. “Production became less expensive and more consistent,” notes Garner. “TouchMark’s RMOs worked at the same rate, hour by hour, day by day. That steady pace proved invaluable during the pandemic when other manufacturers were struggling to staff their machines.”

Prior to the RMO deployments, an operator was assigned to each pad printing machine. Now, one employee can supervise both RMOs while operating a third machine at the same time. The other two operators were redeployed elsewhere in TouchMark’s operations. With the two RMOs in place, TouchMark was saving $15,640 per month.

Based on the success of the RMO at ↑ With two RMOs doing the work of five Gel-Pak operators, the company is saving $20,400 per month, and the operators were redeployed to other activities.

TouchMark, Delphon began using the RMO at its Gel-Pak facility, which manufactures containers and films to protect electronic materials and compo- Vice President of Delphon’s manufacturing operations, says, “If you nents. Gel-Pak uses the RMO to clean molded parts with an ionized don’t have a massive engineering staff and you want to start saving air knife prior to assembly. With two RMOs doing the work of five immediately, this is the business model for you.”

Garner adds, “We don’t have a ton of engineering resources. We Gel-Pak operators, the company is saving $20,400 per month, and the operators were redeployed to other activities. don’t have any robotics engineers or software engineers. For us, Speaking to the value that robots-as-a-service have brought to the RMO was an easy, quick, and incredibly rewarding entry into Delphon’s operations across two of its divisions, Philip Haseltine, the world of robotics.”

20 | Healthcare Packaging • July/August 2022

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TRACEABILITY

Read this story on the HDA Research Foundation’s latest EPCIS Implementation Benchmarking Survey for meeting DSCSA requirements.

A Digital Fingerprint to Combat Counterfeit Goods STEPHANIE NEIL, EDITOR-IN-CHIEF, OEM TOP THREE TAKEAWAYS 1. This optical artificial intelligence system can authenticate products by simply taking a picture with a smartphone.

I

2. ‘FeaturePrint’ captures minute differences in the surface of an item. Beyond authentication, it can determine place and time of orgin.

ndustry experts have estimated the current global value of counterfeit and pirated goods exceeds $2 trillion. This, of course, causes concern for the economy, personal health and safety, legal implications, and brand reputation. Manufacturers have tried to combat the counterfeit crisis with ways to track goods through the supply chain, with approaches that include barcodes, taggants, special labels, or the addition of features that are difficult to duplicate.

The problem with these anti-counterfeiting tactics is that identification tags can be removed, get damaged, or be counterfeit themselves. And the hard-to-duplicate features are an expensive approach.

For the pharmaceutical industry, there’s an even bigger problem looming. By 2023, the Drug Supply Chain Security Act (DSCSA)

3. With potential implications for DSCSA, Alitheon is currently working with a pharmaceutical manufacturer.

mandates that prescription drugs be traceable at the package level (vs. lot level).

The good news is there’s a technology available now from Alitheon that can solve the problem of inefficient and somewhat antiquated tracking mechanisms. Through the use of an optical artificial intelligence (AI) system, the technology can identify counterfeit goods—right down to an individual tablet—just by snapping a picture with a mobile phone. Not only can it determine if the product is authentic, but it can determine place and time of origin in a matter of milliseconds.

“It is amazing technology that will disrupt quite a few industries, but it will especially disrupt bad people’s behavior,” says Alitheon CEO Roei Ganzarski.

Rather than tracking a tag, the optical AI identifies physically

22 | Healthcare Packaging • July/August 2022

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TRACEABILITY

inherent characteristics of goods, even if they appear identical. “Even with an identical pattern, they are not truly identical,” Ganzarksi explains. “Even identical twins have different fingerprints.”

With that in mind, Alitheon created an algorithm that captures a “FeaturePrint” which can identify minute differences in the surface of an item. That image is stored in the Alitheon system to create a digital baseline for future reference.

According to the company, the optical AI algorithms identify and codify the unique attributes and features inherently created on the surface area during the manufacturing process. From those, the system automatically creates a one-of-a-kind digital FeaturePrint that can be used for authentication, identification, or traceability.

With the DSCSA deadline right around the corner, the company is currently working with a pharma manufacturer. It starts

F1 Fingerprint.indd 23

with installing cameras on the production line which take a picture and upload the FeaturePrint to the cloud to be stored. Now, as the item travels from the manufacturer to the distribution center to the retailer, and eventually the end user, each person on the receiving end can take a picture of the item using their cell phone that has the Alitheon app and they will know right away if the product has been tampered with during its travels.

In the automotive industry, this could solve recall problems, which today require that all cars in question are brought back to the shop so that every part is checked. But if the mechanic could simply take a picture of the part and know where and when it was manufactured, it would save a lot of time and money.

There are many other potential applications, but for now Alitheon is focused on high-value items like bars of gold that go

through world banks, as well as safety-related items such as medication, and car or airplane parts. The end goal is to have even consumers registering their own valuable items so that in the event it was stolen, they could prove it belongs to them.

“The only thing we can’t do now is something reflective, like a mirror, or spheres, like a ball,” Ganzarski explains. But, the company is working on solving that.

Actually, although Alitheon is about five years old, the team has extensive experience, Ganzarski says, noting that the founders of the company are mathematicians who understand machine vision and even developed the mailroom systems that can read handwritten addresses and turn it into clear data. And, as such, they’ve created this technology to be easily deployed. “All you need is at least one camera on the production line.

We don’t touch the product, we just take a picture of it. It’s so simple.”

8/2/22 9:54 AM

UNIQUE DEVICE IDENTIFICATION

UDI Implementation Highlights Global Challenges KEREN SOOKNE, DIRECTOR OF EDITORIAL CONTENT TOP THREE TAKEAWAYS 1. At times, the hardest parts of unique device identification (UDI) implementation are not about data matrices and linear barcodes at all.

2. Many manufacturers that became compliant in the U.S. are now addressing global UDI label requirements.

3. UDI implementation is causing companies to evaluate their portfolios—what they sell and where.

A

t GS1 Connect in San Diego in June, Jay Crowley, VP, Medical Devices and UDI Practice Lead at USDM Life Sciences, presented insights on unique device identification (UDI) implementation for medical device manufacturers. We talked with Jay about implementation challenges, timelines, and how UDI is causing companies to evaluate their product portfolios.

Healthcare Packaging (HCP): What are a few of the main current hurdles or considerations for manufacturers who still need to implement UDI in a given market?

JC: A lot of it really depends on where an organization is today, what products they’re making, and where they’re distributing. ↑ A big challenge for manufacturers distributing global products is figuring out if existing UDI labeling will be extendable to the global market as new requirements come into play.

Most of what we see—because it’s the people who are active from my perspective—are manufacturers who are distributing products globally base, GUDID. It’s pretty static and well-understood in terms of and are trying to address the global UDI label requirements. We have what needs to be submitted. In Europe, EUDAMED is an evolving idea and structure. requirements in play in the U.S. and in Europe. But there’s a number of other countries that are active—China, Korea, Saudi Arabia, and Other countries have their own databases, some of which we underothers, as well those who are beginning or in various stages of the stand how they’re going to work, and some we don’t. We’re trying development of UDI requirements. to figure out what that’s going to look like for manufacturers, how I think the big challenge for manufacturers distributing global prod- are they going to collect and manage the data, submit the data to ucts is trying to assure that (1) if their products are UDI-compliant these global databases, and maintain it over time. There’s lots of today, that that works for products globally, and (2) if they’re still other nuanced challenges going on, but for manufacturers in that on the journey towards UDI compliance, that what they’re doing global space, that’s the really big challenge and one that we’re all with UDI labeling will be extendable to the global market as new still struggling to understand. requirements come into play.

The more interesting and almost more ambiguous problem is trying HCP: Are there any issues you’re encountering with the to figure out how the data portion—the UDI database portion—of coding and marking technology/hardware itself at this point? this is going to work. In the U.S., we have FDA’s Global UDI Data- JC: I think that part is pretty well understood, though it may not 24 | Healthcare Packaging • July/August 2022

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UNIQUE DEVICE IDENTIFICATION

JC: A lot of it is certainly compliance with be applied. Certainly, manufacturers are regulations. Even here at the GS1 Connect always making changes and improvements to production lines with the dynamic nature Conference, there’s a lot of discussion of of the device industry. There’s still improvehealthcare provider uptake and use of UDI. There are pockets of people who are using ments to how products are marked. it, and some who aren’t.

At the same time, there’s a debate going on around the 2D data matrix in healthcare. We Companies are seeing supply chain benefits have some manufacturers who are either in terms of order reconciliation. They can migrating or considering migrating from answer questions like, “What did I order? linear barcodes—sometimes multiple linear Did I order what I wanted? Did I get what I ordered? How many do I have?” There are barcodes—to a data matrix.

It’s the “chicken and egg” kind of debate certainly benefits to those organizations about whether anyone is ready to scan 2D. who have done that, both healthcare orgaDo they have imaging scanners? Where’s the ↑ Jay Crowley, VP, Medical Devices and UDI nizations as well as device manufacturers, Practice Lead at USDM Life Sciences. broader ecosystem from that perspective? who are leveraging UDI and the data associated for distribution control.

There’s also a lot of manufacturers who continue to use proprietary barcodes for various purposes and Both from a visibility and a recall perspective, organizations are they may not want to change that. These existed before UDI to better off if they’ve implemented. But not everyone’s doing it and support warehouse management or a distribution control system. not everyone’s engaged. Organizations are at different levels of So, they have proprietary barcodes along with a UDI barcode, and maturity in terms of UDI. that confuses downstream users. There’s a lot of hand wringing—is For me, the interesting, unexpected benefit is not directly related that the best thing to do? Can we migrate? When should we migrate? to UDI (I have a whole talk track explaining that the problems with implementing UDI have nothing to do with UDI).

HCP: At conferences, we see bigger players talking about A lot of manufacturers have challenges in understanding their prodrobust pilot projects. But small and mid-size companies may uct portfolio. What do I sell where? What do I even sell? What’s an only have one person working on UDI implementation while active SKU and what’s obsolete? At least in the companies that we wearing other hats. What labor issues are you seeing lately? work with, and have worked with for a long time, they have a better JC: This goes back to the “migration to global” conversation. Many basic visibility and control of their products at a much more specific companies moved through U.S. implementation five or six years ago. and granular level.

They got their products for the U.S. market compliant and then, as They typically have the ability—without going through three or happens (particularly in the medical device space), those people left. four different systems or talking to however many departments— So now, Europe and other countries’ programs are coming along, to know what they produce, where products go, and what products can go to what domains. I think, for a lot of companies, that level and the people at a given company that handled this—and underof visibility and control of hasn’t existed, hasn’t needed to exist. stood what they did and why—are gone.

Many companies are having to start over. Either what they did before As we look globally, you need to understand what products can go to isn’t extendable to other markets or they don’t really know why what markets. With Europe, companies are really doing some ratiothey did what they did. This can vary from DI [device identifier] nalization of their product portfolios because moving to certify your (GTIN) assignment, to label changes, data collection and manage- products to the new regulations is a lot of work. They don’t want to ment, and—maybe more importantly—change control. There’s a do that with everything. lot of workforce movement. Between the mergers and acquisitions There are very specific language requirements now from a label IFU in the device space, hiring and layoff cycles, people promoting out (instructions for use) perspective that didn’t really exist even under of one group into another, or people picking a different job, there’s the directive. So now, there’s this much better handle on, “I sell to a lot of loss of that history of what they did and rationale. So that’s these four European countries, and therefore, I need to be sure that an interesting dimension to it. my language requirements for those four European countries are met,” as opposed to saying, “Well I distribute to Europe.” So, there’s HCP: Have you and the companies that you help already a lot of those organizational benefits to companies that didn’t exist. begun seeing benefits on this level of traceability? Has the There’s some parallel ideas there as well. One of the challenges in focus mostly been on the success of becoming compliant? the medical device space is understanding what is a device, an accesJuly/August 2022 • Healthcare Packaging | 25

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Differences Across Markets HCP: How do compliance activities differ across markets? With differing requirements in the U.S., EU, and other markets, are companies following the most stringent guidelines or is it more granular?

JC: My idiom or analogy is sort of the middle of the road. Many companies stay in the middle of the road, so that what they’re doing from an identification, marking, label, and packaging perspective can work globally. There are certainly differences when you get into certain types of products and product classes, there are other exceptions and requirements that come into play.

To some extent, we do focus on the most stringent. For example, if we use a data matrix, that’s accepted everywhere while some places don’t want multiple linear barcodes. Today, it’s largely a combination of the EU and U.S. requirements that produce that middle of the road or that most stringent case.

For the other country regulations, they aren’t so concerned with changing the UDI, or making more requirements on how products are identified, or the application to labels and packages. Where we see a difference in global requirements is the data—what data they want to see and how much.

Europe’s EUDAMED device registration and UDI database requirements are much more extensive than the U.S. requirements. The EU has concerns about substances in products so that gets labeled and put into the database, as well as how products are disposed of.

Those differences then spill over into how the devices are labeled, which spill over into information that needs to get into the database.

sory, a spare/replacement part, or something else.

When we say ventilator or infusion pump, people understand what that is. But there’s a lot of other “stuff ” that manufacturers sell and distribute. Back to the previous comments about visibility and control, this really highlights what I actually physically distribute, and knowing the regulatory status of those things, which is important.

HCP: Do you interact with a range of new and existing products on the UDI compliance journey? What deadlines are manufacturers working toward?

JC: We work with a combination. Sometimes it’s new companies with new products. Some companies don’t have global products, they have products for the U.S. market, products for the European market, products for the Asia Pacific market, etc., so all they did was U.S. implementation. Now we have to look at the rest of world and that’s a combination of conversations because they have to ask if

↑ Some manufacturers continue to use proprietary barcodes for various purposes that existed before UDI along with a UDI barcode.

This can confuse downstream users.

they want three different products, or if they can have one. It’s back to my comment before… it has nothing to do with UDI, but with how you want to manage your product portfolio.

This year, September 2022 is the Class I compliance date for UDI in the U.S. The date has undergone enforcement discretion twice now.

• First in 2018, because of some concerns about GUDID, they postponed it to 2020.

• Then because of COVID-19, they postponed it to September 2022.

There’s a group of companies in the U.S. who make only Class 1 medical devices. They’ve been working on this and, if they’re not complete, then they’re on their way.

But there are a lot of manufacturers who only make low-risk medical devices—orthotics and other products. They may not have big clinical departments, or even a full-time regulatory affairs person.

They tend to struggle more with what these regulations are. They’re a hard group to understand or reach because they’re not the people at conferences, engaged in the conversations, or in working groups, etc.

It’s an interesting group in and of itself and it exists globally—some may make things for multiple industries. For example, a plastics manufacturer makes tubing for the automotive industry and others, and they also happen to sell tubing for IV pumps. There’s some unique challenges that lie ahead in getting them onboard, having them understand what they need to do, and making that a bit of more systemic than it might normally be for them.

26 | Healthcare Packaging • July/August 2022

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8/1/22 1:02 PM

WORKFORCE

Great Resignation Driving Employee Poaching SEAN RILEY, SENIOR NEWS DIRECTOR, PMMI MEDIA GROUP TOP THREE TAKEAWAYS 1. It’s a buyer’s market for job seekers as over 80,000 left manufacturing from Aug. 2020 through Aug. 2021.

2. Manufacturers are climbing over each other to poach workers to meet increases in production.

C

PGs at PMMI’s Top to Top Summit were almost unanimous in pinpointing the labor shortage caused by employees not returning to work after COVID-induced shut-downs as a critical challenge. Furthermore, turnover of staff who have returned is high.

While quit rates in manufacturing are lower than in certain poorly paid service sectors, the number of people leaving manufacturing jobs accelerated from 1.9% of the workforce in Aug. 2020 to 2.5% in August 2021—a loss of over 80,000 workers in an industry that was already in crisis mode pre-pandemic.

To make matters worse, many CPGs continue to cite a lack of skilled labor capable of operating and troubleshooting complex packaging machinery. As one respondent noted, “We continue to struggle with workforce shortages and the difficulty in training on

3. Automation is viewed as the long-term solution to labor shortages, as long as the technology also engages staff.

equipment. As things become more complicated, it becomes more difficult to ‘plug and play’ when training new employees.”

CPGs suggested that OEMs need to provide more and better online training resources, but training takes time, and staff turnover—even of trained staff—continues to rise. As a result, facilities are racing faster to poach each other’s workers to increase production.

↑ Per the U.S. Bureau of Labor Statistics, from Aug. 2020 to August 2021, manufacturing experienced a loss of over 80,000 workers in an industry that was already in crisis mode pre-pandemic.

Top to Top Summit is an annual networking event of high-level CPGs and OEMs in the packaging and processing industry, who meet to discuss industry problems and solutions with the aim of improving industry outcomes. Sponsored by PMMI, this year’s meeting was held in March 2022 in Florida.

↑ It’s not just young employees taking part in the Great Resignation.

July/August 2022 • Healthcare Packaging | 27

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WORKFORCE

CPGs consider automation the long-term solution to the labor shortage as long as the technology also engages staff, keeping them on board. In the words of one CPG team leader, “We need to automate every operation we

can. Frankly, any manual operation is being discussed, as labor appears to be a challenge for the foreseeable future.”

But the situation is already critical in some areas. Food industry production lines are

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reportedly standing idle because of a lack of staffing, where processors specifically pinpointed high retirement rates.

Visier data from January to August 2021 (represented in the chart) highlights that it’s not just young people quitting jobs. There has been a significant increase in the number of people leaving in the 40 to 45-year-old age group and who have five to fifteen years of tenure.

While automating less attractive manual jobs coupled with upskilling workers to retain labor in more attractive roles was seen as a solution, CPGs also mentioned the need for OEMs to offer more intuitive equipment. The head of engineering at a major personal care products company with aseptic processes and lines said that automated machines need to be easier to operate and maintain. Another respondent called for “high-speed automation that has the dexterity and decision-making of a line worker in the space of a line worker.” However, as was pointed out by a representative from the food industry, ensuring that machines operate with minimum downtime remains a risk.

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28 | Healthcare Packaging • July/Aug 2022

LOOKING BACK. PRESSING FORWARD. ALWAYS INNOVATING.

F3 Resignation.indd 28

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MEDICAL DEVICE PACKAGING

Addressing Redundant Package Testing in Material Stability KEREN SOOKNE, DIRECTOR OF EDITORIAL CONTENT TOP THREE TAKEAWAYS 1. Device package stability testing is often redundant, with common materials rarely failing.

2. Industry efforts may lead to a new minimum floor of stability for a given material.

3. From early talks, regulators have been receptive of the approach.

W

hat began as a chat over coffee has led to work on a hypothesis and a white paper with far-reaching potential in saving time and resources in medical device packaging stability testing.

Efforts were presented at the[PACK]out’s inaugural event in Austin in May. If we know that commonly used sterile barrier systems are inherently stable after years of aging studies, why is the burden of stability testing still so great? Wicked Stability, an ongoing project under the “Let’s Speed Things Up” focus area for volunteer-based Kilmer Innovations in Packaging (KiiP) is taking aim at the topic. [Editor’s note: If you’re not familiar with the KiiP initiative, check out our primer at hcpgo.to/402] Approximately two years ago, KiiP group members from Medtronic, J&J, and Boston Scientific discussed common challenges over coffee and looked for opportunities to ↑ Henk Blom explains that long-term material stability has been observed for decades, including after events such as extrusion and heat sealing. Note: The sterilization method focus their time and energy. One sticking point: regulators’ expectations for repetitive chosen affects degradation of the film. (Image taken at the[PACK]out) stability testing activities on the same materials of construction going to provide value to patients and users of the products,” says Montgomery.

(MOCs) over and over, particularly in the face of changes in sealing They asked themselves what they could do to offer the industry equipment, minor changes to sterilization processes, or laminate layer material changes for equivalent polymers. better access to known material stability information and began The team noted they were never failing aging studies when bringing in materials experts to think about mechanisms of degradaconducted, and as Jordan Montgomery, Distinguished Packaging tion, and the major factors that drive aging from a material perspecEngineer at Medtronic, explains, they wondered why it’s benefitive. It’s now blossomed into a white paper effort, as part of Wicked cial to spend so much time, resources, effort, money, etc. repeating Stability, says Rod Patch, Sr. Director, Package Engineering & Prodthese studies as a simple compliance activity, when the materials uct Labeling at Johnson & Johnson. Over time, the paper evolved through a few different titles into its current focus about modeling themselves have a proven track record of stability in actual use conditions. the material aging mechanism for the purpose of stability testing of “We all have these redundant stability test activities, and we could common sterile barrier packaging systems. focus our resources on more significant challenges that are actually In the big picture, Patch explains, “This is about how to think July/August 2022 • Healthcare Packaging | 29

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MEDICAL DEVICE PACKAGING

↑ At the[PACK]out, presenting ‘Wicked Stability: Predicting the Aging Degradation of Materials’ were speakers (from left): Dan Burgess, Henk Blom, and Rod Patch with moderator Seema Momin.

about the predictive nature of these common sterile barrier systems and the ability to model and predict how effective they would be from an aging perspective following exposure to expected hazards.”

Oxidative induction time When PAXXUS’ Henk Blom arrived, the big challenge was how they would demonstrate the materials’ stability. “They’re not going anywhere in the five-year shelf life. I had the idea of using the technique called OIT, short for oxidative induction time,” he says.

OIT is a relative measure of the resistance of a stabilized material—in this case, packaging material—to oxidative decomposition, which can be measured by using analytical techniques such as differential scanning calorimeters (DSC) or thermal gravimetric analysis (TGA). Stabilizers are intentional additives that provide resistance to mechanisms of degradation present in the environment. These include ultraviolet light (UV), heat, humidity, etc.

“The basic theory is that the materials we use are purposely stabilized by the resin manufacturer. So, whoever’s making a particular resin, say polyethylene for instance, puts additives into the resin that help stabilize the material after conversion. OIT is a way of measuring how much of that stabilizer is still there or how much of it is left after it’s been sitting for a while. So that’s what we’ve been exploring with the Wicked Stability team,” Blom says.

At a high level, the team wants to demonstrate the correlation between OIT measurement and functional mechanical stability over time for well-established materials.

This work may lead to a new minimum floor of stability for a given material, enabling a company and regulatory bodies to have consen-

sus that a film material is good for at least two or three years under a given set of assumptions.

Montgomery says, “We haven’t had the ability or the know-how to take credit for a lot of that stability that’s pre-engineered into these types of plastics by polymer suppliers. The other elephant in the room is a lot of these materials are so stable that they won’t go away. If you look for literature on how to get them to go away, you’re reading about landfill technologies and how to force degradation onto materials… these systems just aren’t degrading, and I think there’s common knowledge to that, but we really haven’t had an avenue to take credit for a lot of that inherent material science built into the stability of the materials.”

Fil

Easing changes Often in life sciences, companies will shy away from making technological or efficiency changes because it would require rigorous testing post-change. This method may one day preclude the need for stability testing of small changes such as adding new heat-sealing equipment. As Blom explains, “Some of the regulatory agencies say you have to start the aging process all over again for this new heat sealer. One of the things we hope to be able to demonstrate with this project that is that, from a scientific perspective, we can measure the OIT at the heat seal and somewhere toward the middle of the pouch where it wasn’t heat sealed, and there is no difference between the OIT in those places.”

Based on the data, they hope to approach regulators to explain that redoing stability tests for every change on the heat seal may not be necessary in favor of demonstrating a few key points of data. This

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MEDICAL DEVICE PACKAGING

would allow companies to make material process upgrades more easily, provided the data supports claims.

Conserving time and money The packaging community tends not to talk in absolutes, but the potential savings in time and money are substantial. As Jennifer Benolken, MDM & Regulatory Specialist, Packaging Engineering at DuPont, explains, the rule of thumb is about a month—six weeks of accelerated aging testing per year of shelf life (but it really depends on how you’ve set the conditions around accelerated aging); you also have to factor in sample procurement and preparation. It can also take several months to synthesize data and generate a report post-testing. “It’s not just the oven time for acceleration.

People like to think it’s five months for five years’ shelf life, but you have a few months ahead of that and a few months afterwards,” she says. “When you put that all together, it can get you close to a year.

That’s really tight when you’re working with new product development, and you can’t even get the representative samples until close to the end of the design of the project. The last thing that the company wants to do is wait for that oven time to finish.”

While much focus is placed on what it takes to get to market launch with accelerated testing, MDMs also have to back up claims

with real-time studies. “We should not forget that whatever we put on the label for a claim of stability, it’s a combination of the device and its stability, as well as the stability of the packaging system.

Whichever one of those is the least resistant to aging is the maximum you can label your product at,” Patch notes. “Whenever we put a duration out there—some products are three years, a lot of products are five, orthopedics you can find 10 years—there is an ongoing, active, real-time study. That’s taking resources, costing money to support that real-time claim. If I have 10 years on the label, I probably have product waiting 11 years in some type of stability program.”

Holding product for numerous years for real-time study requires physical space and personnel to manage it. Benolken notes that with company turnover, mergers, and limited guidelines on how to manage these product/packaging systems, companies must be vigilant about sample management which expends resources.

Regulatory reception Attend any life sciences conference with regulatory speakers, and they’ll tell you that they want to work with companies to modernize the industry. Beginning with the end in mind, the team talked early on with some subject matter experts about whether the concept and approach had merit before getting too far in testing

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and feasibility assessments. The pursuit has been well-supported by packaging, chemical, and OIT experts. Says Patch. “Once OIT was identified as a proven method for measuring thermodynamic material degradation factor—and that being the degradation factor of greatest concern—we started exploring with some SMEs, including regulatory agencies, their thoughts and their feedback on that approach and that has kept us guided.”

They’ve received early feedback from FDA, as well as notified body representation the EU market. From these talks, regulators have been receptive of the approach to answering the stability question. Montgomery notes, “They understood our perspective as material manufacturers and device manufacturers on just how redundant this space is becoming, and it only looks like it’s getting worse. We had good dialogue with them on what we’ve been proposing, and I ↑ As Rod Patch explains, packages notoriously sit in engineers’ offices for a long time without think there was some optimism from them spontaneously disintegrating. There is significant stability in these materials. in terms of potential data we’d be able to offer. There are remaining hurdles in terms of how we translate ness and then really encourage others to apply it to other MOCs.” an OIT result into something tangible that a packaging engineer Currently, the team is designing the protocol, fine tuning the test or a regulator can take away with a meaningful interpretation as method and parameters—including conditions such as temperato the stability of the packaging system. So, there’s a lot of work ture—for what is most repeatable and reproducible across sites for to do there, but I think they were aligned that the time is right and the two different methods of measuring OIT. Different materials it’s appropriate to be looking at more advanced and better ways of will need slightly different conditions in order to achieve the most doing the work.” accurate result.

COVID-19 has also brought, as a byproduct, potential for openThe timing is right, with the industry having recently undergone ness. SmartStart Medical’s Chris Sarantos says, “Perhaps people the intensive functional equivalence assessment (which includes are more receptive from a regulatory perspective to consider these material stability testing) known as the Medical Packaging Tranthings because of all the EUAs. One of the cool things about this sition Protocol (MPTP) that DuPont led for the transition to the method is that OIT is not a new technique. It’s an established new Tyvek®. science with a lot of history being applied in a new way to enhance “The amount of data points that went into that study, the number packaging science. The environment is more receptive from a regu- of samples, different structures, sealing processes, sterilization, and latory perspective to consider breaking the norm and moving faster.” modalities… all of that, and at the end of the day, how many of those failed stability? Zero, not one. And what was their common denomiInitial steps nator? They all had Tyvek,” says Patch. “So that was a founding geneThe team is taking a “usual suspects” approach, studying a few sis conversation to ‘Are we really adding value repeating this testing common MOCs first that are widely used across the device packagover and over again?’ The project demonstrated wholeheartedly and ing community, both rigid and flexible. While there are any number effectively that these materials are extremely stable. This is not the of combinations of materials for performance—multi-layer or challenge we have in a sterile barrier packaging system, so how can coated structures—the goal is to focus resources and keep things we show and prove that? And where else can we focus our efforts?” as foundational as possible to start. Blom adds, “What we’re trying What could be possible with time and resources freed up from to do here is outline an approach and demonstrate its appropriate- eliminating redundant stability testing will be different for each 32 | Healthcare Packaging • July/August 2022

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MEDICAL DEVICE PACKAGING

Key Takeaways Through experiments at both Medtronic and Boston Scientific, initial data has looked promising in being able to demonstrate significant resid-

organization. Montgomery and Patch note that time could be devoted to packaging sustainability projects, or tackling issues related to supply chain disruptions and material shortages in the marketplace, among other things.

Stay tuned for updates on this ongoing project. The Kilmer Group presented at MD&M West and the[PACK]out. Interested in volunteering with the Kilmer Group? Reach out via the KiiP group on LinkedIn: hcpgo.to/kiip

ual stability in the material after a fiveyear shelf life. “If the data continues to say what we think it will say, ultimately what we hope to do is not get rid of aging studies, but as Jordan likes to say, ‘Right-size the aging studies,’” explains Blom.

Montgomery adds, “It’s the Goldilocks approach. We’re doing way too many tests. We want to find the right amount of shelf-life testing for MDMs and suppliers, and we don’t think the industry knows that today.”

If all goes according to plan, the project will deliver some needed evidence-based practicality to med device package testing. “To apply a bit of logic and common sense—packaging engineers are notorious for having packages sitting in our offices or spaces for a long time. They don’t spontaneously disintegrate. It’s inherent that there’s a lot of stability in these materials,” Patch says. “From a regulatory market access perspective, we treat packages as if they’re very fragile and anything can break them, and you have to prove their performance over and over again. That just doesn’t match up to the practicality of the materials themselves. If anything, this method has an opportunity to show how over-engineered the materials are for their stability performance, and with a good method, potentially in the future state, you could design the material to degrade at the rate that you want it to degrade at. If you only need to have a certain level of performance characteristics and stabilization, then it may be okay for it to end its useful, functional life sooner.”

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SUSTAINABILITY

Pharmaceutical Manufacturers Can No Longer Take a Pass on Sustainable Packaging KIM OVERSTREET, DIRECTOR, EMERGING BRANDS ALLIANCE TOP THREE TAKEAWAYS 1. Drug makers hope to strike a balance between regulated packaging efficacy and sustainability goals.

2. Lightweighting remains a popular choice for manufacturers, with 67% of respondents pursuing this strategy.

3. Sustainably sourced packaging to reduce usage of tree-based materials is also a focus, including hemp and sugarcane board.

F

or consumers, the most obvious gauge of sustainability is packaging. While manufacturers are also seeking to lower overall energy usage through more efficient machines and processes, these improvements are not very visible to the average consumer.

In contrast, recycle-ready, recycled, and plastic-alternative packaging materials are powerful sustainability messages that are highly visible to consumers, according to Pharmaceutical Manufacturing, Trends Shaping the Future from PMMI Business Intelligence.

One example of this is PLAs, or bio-based plastics, which are combustible (for disposal of surfaces contaminated by drugs), easily temperature controlled, and require 65% less energy to produce.

Sustainably sourced packaging aiming to reduce usage of treebased materials are also gaining in popularity. These “tree-free” alternatives—such as hemp, recycled cotton fiber, and sugarcane board—are effective ways for pharmaceutical manufacturers to communicate their commitment to sustainability.

“We are always looking to be more sustainable by using more recyclable materials and lightweighting,” said a sr. manager, global technology at a large Rx and OTC manufacturer.

Perhaps the most direct way to communicate sustainability messaging to consumers is by including it right on the label of the product. Prominent messages touting sustainability are clear, unambiguous signals to consumers that a company takes environmental stewardship seriously. Something as simple as a “Recycle Me Again” message included on a label can communicate to consumers that the packaging is both made from recycled materials and is recyclable itself, conveying a succinct sustainability message.

This concept can even be applied to physical properties of the

label itself: smaller, plastic-free labels are quick visual cues to consumers that a company is seeking to minimize material usage and improve the sustainability of their products.

“We are moving away from using only plastic packaging to other materials,” said one associate director, packaging technology at a large biopharmaceutical manufacturer.

“Overall, we are using more recycled content and lightweighting our packaging to achieve our sustainability goals,” noted a packaging engineer, SME at a solid and liquid product manufacturer.

According to the new study, the vast majority of pharmaceutical manufacturers interviewed have sustainability on their radar and are using more recycled content in their packaging, lightweighting packaging, seeking more energy efficient equipment, and changing packaging formats.

Market shifts have spurred manufacturers to reevaluate priorities when it comes to machinery for filling, packaging, labeling, and coding. Download the free report Pharmaceutical Manufacturing Trends Shaping the Future 2022 at: hcpgo.to/trends22

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Turntable Machine Packages Prefilled Syringes KEREN SOOKNE, DIRECTOR OF EDITORIAL CONTENT TOP THREE TAKEAWAYS 1. Sharp sought a new machine to handle prefilled syringes gently and cost-effectively.

2. Syringes and needles are manually inserted into preformed, automatically fed blisters.

3. An inspection system checks for correct positioning of the products in the blister.

W

ith over 65 years in business, Sharp is a contract packaging company offering assembly, labeling, and packaging of pharmaceutical and biopharmaceutical products.

They sought a new system for packaging filled syringes with priority placed on high cost-effectiveness, maximum flexibility, and easy handling.

The contract packager selected a line based around the KDT medplus® turntable machine from KOCH Pac-Systeme based in Pfalzgrafenweiler in the Black Forest in Germany. The KDT is a compact, GMP-compliant system for the safe handling of sensitive medical technology products.

“We held talks with three potential suppliers for this project,” explains Toon Verstraeten, Project Engineer at Sharp Packaging in Hamont-Achel, Belgium, where the machine would be installed.

“KOCH delivered the best concept—both in terms of the line itself, as well as the support and overall pricing. We had an extremely ambitious schedule due to our customer’s deadline, as well as the additional challenge presented by the COVID pandemic. KOCH was highly motivated and flexible in supporting our aims.”

Efficient and secure processes The syringes and needles that Sharp packs are manually inserted into preformed, automatically fed blisters on the KDT medplus.

These prefabricated, PET blisters come from a supplier in Switzerland. During this process, the line uses an inspection system to check for correct positioning and integrity of the products in the blister—a critical step with such a sensitive product. An integrated thermal inkjet printer, in conjunction with a further inspection system, ensures that the Tyvek® lid material is printed accurately with the customer’s logo and variable product-specific information.

Once the presence of the lid forming material has been checked, the filled blisters are thermally sealed using a sealing tool patented

by KOCH. In general, the KDT medplus achieves an output of 12 cycles/min, depending on packaging material and shape, along with

↑ The syringes and needles that Sharp packs are manually inserted into preformed, automatically fed blisters on the KDT medplus.

sealing duration.

The KOCH Audittrail Pack–a digital service package–ensures full monitoring of machine data in compliance with GMP and 21 CFR Part 11 requirements. It’s one of nine service packages from KOCH–called K4.0 smartpacks–which were introduced in 2020 and designed to offer more productivity, increased availability, and optimized overall plant effectiveness.

Flexible adjustments Simple format changes and high energy efficiency also contribute to the system’s economical operation and uptime. While the line is currently dedicated to Sharp’s customer, the KDT medplus machine was built with flexible adjustments in mind for the future—the machine can be flexibly converted to accommodate new package and product sizes down the road.

Says David van Loo, Global Account Manager at KOCH, “In this project, we were able to assist Sharp in an advisory capacity and thus tailor the KDT to individual requirements. With this order, we hope to have laid a foundation for further exciting projects with Sharp.”

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