Healthcare Packaging Winter 2023 by PMMIMediaGroup

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CONTENTS

↑ pp.12 New Fiber Blister Collective Launched 18 UNIQUE DEVICE IDENTIFICATION

Geisinger Harnesses UDI for Precision and Patient Safety

Technological leap with Owens & Minor streamlines 10 hospitals and 125-plus medical facilities.

20 PRODUCT IDENTIFICATION

Fresenius Kabi Infuses Safety with Unit-ofUse 2D Barcodes

The Germany-based company enhances efficiency and patient care through innovative labeling solutions.

22 BUSINESS INTELLIGENCE

AI in Packaging to Reach $6 Billion by the End of 2033 AI’s role in packaging is set to soar, as it enhances quality control, aids in supply chain management, and advise on packaging design, but cost, security, and ethics concerns must be addressed.

24 UNIQUE DEVICE IDENTIFICATION

J&J Beating 2027 Sunrise on UDI From GS1 Connect: The healthcare giant continues its nine-year migration from UDI to 2D GS1 DataMatrix.

26 AUTOMATION

28 SERIALIZATION

What Does a DSCSA Stabilization Period Mean? From the HDA Traceability Seminar: FDA announced a DSCSA stabilization period through Nov. 2024 but is urging all trading partners not to take their feet off the gas. Consistent work will be needed from trading partners throughout the next 11 months.

30 WORKFORCE DEVELOPMENT

4 Tips for Connecting Remotely with Your Next Gen Workforce Remote and hybrid work have unquestionable perks. “Let me know if you have questions” won’t always suffice if you’re managing early career professionals.

32 MACHINE SAFETY

Clearing the Confusion on Machine Standards Applications

A single primary machine standard can involve several additional standards, so it is important to know what to follow for a given machine project.

COLUMNS AND DEPARTMENTS 04 KEREN SOOKNE’S PERSPECTIVE 06 QUICK HITS

Pharmaceutical Industry Enlists Packaging Robotics

07 QUOTABLES/BY THE NUMBERS

Two new robotic pick-and-place systems for pharmaceutical applications use a cobot and a 6-axis robot, respectively, to load blisters and to cap primary aseptic pharma packs.

10 COLD CHAIN CORNER

08 NEWS 12 MATERIAL DEVELOPMENTS 14 OEM APPLICATION NOTE 34 NEW PRODUCTS

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PERSPECTIVE

Traceability in the Spotlight From unique device identification to DSCSA requirements, we take a look at progress in life science traceability. Sometimes I feel like a broken record when I write about life science traceability. There’s always an element of concern that the community just isn’t far enough along. With FDA’s announcement of a one-year stabilization period for products under the DSCSA, it’s clear that regulators felt this, too. This period should be used to further efforts to connect with downstream partners and to exchange serialization data. FDA is clear in its messaging that this is not a time for pause. Personnel bandwidth and the sheer volume of connections with partners are still challenging the industry. I’ve noticed a few comments aimed at dispensers that cancelled contracts with serialization providers when the stabilization period

was announced. While I certainly don’t speak for dispensers, some have voiced concerns over the years that serialization is a necessary but expensive endeavor to meet regulatory requirements. Though not advisable, I can understand if some independent pharmacies operating on thin margins saw stabilization as a chance to delay. Product tracing progress is ongoing, and Sean Riley covers a set of case studies on barcode implementation to capture and store product data, and eliminate inefficiencies and risk from human error (pp. 18, 20, and 24). While we often focus on technologies, packaging is nothing without its people. If you’re managing early career professionals, check out pp. 30 for tips on connecting with and supporting new talent when working in remote or hybrid models. KEREN SOOKNE is the Editor-in-Chief of Healthcare Packaging. She may be reached at ksookne@pmmimediagroup or at linkedin. com/in/kerensookne

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QUICK HITS

FDA Warns Against 26 Eye Drop Products Over Infection Risk

NPR reports that the FDA has issued a warning to consumers to stop using certain over-the-counter eye drop products due to the risk of potential eye infections that could lead to vision loss. The alert includes 26 products from brands such as CVS Health, Leader, Rugby, Rite Aid, Target Up&Up, and Velocity Pharma. The FDA recommended the recall after finding bacterial contamination at a manufacturing facility. CVS, Rite Aid, and Target are removing the products as of press time, and no adverse effects have been reported in consumers so far. This is the latest in a series of FDA warnings regarding contaminated eye drop products. Past contamination events have led to infections and deaths.

2 3 4

Reusable Delivery System for Brain Drug

A recent Medgadget article discussed an innovative refillable drug delivery system that bypasses the blood-brain barrier. It’s called NeuroPASS, and was developed by Baltimore-based medtech company CraniUS. The device is implanted under the scalp, where it inserts catheters into brain tissue for controlled drug infusions. It’s wireless, refillable from the outside, and recharges wirelessly, offering a long-term, minimally invasive treatment option. It should be noted that the device is currently limited to investigational use and not available commercially.

Drugmaker Accused of Deadly Toxic Cough Syrup

Medscape reported that Indonesian drug manufacturer Afi Farma is facing severe allegations after its cough syrup was linked to over 200 child deaths. A court filing claims the company used toxic ingredients with concentrations as high as 99% in 70 batches of medicine. Specifically, two batches contained ethylene glycol instead of propylene glycol, a key ingredient in syrupy medicines. Afi Farma argues that rigorous ingredient testing was not mandatory according to Indonesia’s drug regulator, BPOM. Afi’s drug manufacturing license was revoked and four company officials—CEO included—face negligence charges.

First Blood Test for Hereditary Cancers

According to a recent Inside Precision Medicine article, the FDA has approved the first blood test for hereditary variants, called the Invitae Common Hereditary Cancers Panel. The test can find DNA variants in 47 genes associated with an elevated risk of developing certain types of cancer, while also identifying potential hereditary variants linked to cancer. The FDA granted de novo marketing authorization for the test, creating a new regulatory classification. The agency is establishing special controls related to labeling and performance testing. Potential risks include false positive or false negative results, as well as a risk of misunderstanding the test results.

TIM HAYES, CONTRIBUTING EDITOR, HCP

FDA: ‘CandyLike’ Children’s Drugs Need More Secure Packaging

A recent STAT News article covered the FDA’s recent meeting to discuss the use of “candy-like” nonprescription drug products, including gummies and other forms, particularly for children who may have difficulty swallowing pills. Though there were arguments in favor of using medicated gummies for dental sedation in children, most speakers highlighted potential pitfalls, such as accidental overdose. Historically, there has been an increase in pediatric overdoses linked to kid-friendly aspirin marketing, along with a rise in emergency room visits due to pediatric melatonin exposures. The group discussed improving child-resistant packaging, promoting unit dose packaging, and more.

Lollipop Eases Saliva Collection

Per New Atlas, researchers at the Univ. of Washington have tackled the process of collecting saliva for diagnostic purposes with the novel CandyCollect lollipop. Saliva collection is important for detecting various pathogens, and it’s less invasive than throat swabs. However, the act of manually collecting sufficient saliva can be unpleasant. Researchers designed the CandyCollect, a special lollipop with grooves that passively collect saliva as it’s consumed, with bacteria adhering to the grooves for later analysis. In tests of 28 adult volunteers, the lollipops effectively collected saliva for the detection of bacteria like Streptococcus mutans. The lollipops are shelf-stable for at least a year.

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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BY THE NUMBERS

$225 BILLION THE PROJECTED REVENUE

of the global healthcare packaging market by the end of 2035, up from approx. $125 billion in 2022. Source: Research Nester

940%

AN EPI STUDY found that from 1978 to 2019, CEO compensation expanded by 940% while median worker compensation grew by only 12%.

QUOTABLES

If governments and businesses are only “exploring reusable packaging in response to environmental problems or sustainability quotas, then the big picture opportunity with reuse and circularity is being missed. Designing products for durability and systems for lasting use means that we can invest and create packaging properties for optimized performance, add features for greater user experience, and embed technologies for smart, data-capturing outputs.

”

—TIM DEBUS, REUSABLE PACKAGING ASSOCIATION

Source: Close Up Foundation

64%

THE PERCENTAGE of supply chain professionals who agreed or strongly agreed that a lack of alternative suppliers impeded their ability to implement an effective dual or multi-source strategy. Source: WTW Global Life Science Supply Chain

Record heat waves across the country “could threaten access to effective pregnancy tests, condoms and emergency contraception pills. All of these items can sustain serious damage in extreme heat, rendering them ineffective when used.

”

—SHEFALI LUTHRA, VIA PBS ON CLIMATE AND REPRODUCTIVE HEALTH PRODUCTS

Risk Report 2023

$35

GOODRX has collaborated with Sanofi to offer the drugmaker’s most-prescribed insulin injection Lantus for only $35 through its digital marketplace in the U.S. Source: Reuters

We’re encouraged and relieved to see that “infections are rapidly decreasing in hospitals following the spike during the pandemic, but we remain very concerned about a number of major problems in hospitals.

”

—LEAH BINDER, PRESIDENT AND CEO OF NON-PROFIT PATIENT SAFETY WATCHDOG GROUP LEAPFROG, VIA USA TODAY

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NEWS

Registration Is Open for PACK EXPO East 2024 PACK EXPO East 2024 takes place March 18-20 (Pennsylvania Convention Center, Philadelphia). Now in its sixth edition, the three-day event from PMMI, The Association for Packaging and Processing Technologies, has expanded to an additional hall to accommodate the increasing number of solutions on display. Its Northeast location provides a convenient and rewarding opportunity for life sciences and CPG companies to explore packaging and processing technologies, connect with suppliers, and find the solutions needed to adapt and compete in a changing marketplace. The show will feature 400 exhibitors and a myriad of free educational sessions. Registration is $30 through Feb. 23, $130 thereafter. For more info and to register, visit packexpoeast.com —Gatwiri Muthara

Pilot to Recycle Used Medical Devices Through a pilot recycling program in the first half of 2023, Becton Dickinson (BD) and Casella Waste Systems successfully diverted 40,000 pounds of medical waste from disposal. This was the first large-scale effort to evaluate the feasibility of recycling medical waste found in red sharps containers (primarily syringes and needles, among other materials). The program assessed the practicality of mechanical and advanced recycling technologies, and showed that both are effective at recycling used medical devices. BD and Casella plan to expand the program regionally to additional hospitals and non-acute care facilities; add other types of medical materials for recycling; and look at reclaiming used devices and returning them to the manufacturing process. —Keren Sookne

Newly Revised ANSI/PMMI B155.1-2023 Safety Standard

DSCSA ‘Stabilization Period’ Not a Pause

Standards developer PMMI released the newly approved ANSI/ PMMI B155.1-2023, available for purchase through the ANSI webstore. This edition has undergone a meticulous revision to address evolving safety concerns, technological advancements, and changing operational landscapes. The standard guides users through a formal, documented risk assessment process designed to ensure that reasonably foreseeable hazards are identified, and corresponding risks are reduced to an acceptable level. Updates include refined responsibilities, co-packer/co-manufacturer concepts, updated legacy machinery requirements, and remote/ tele-operation enhancements. —Gatwiri Muthara

In August, the FDA announced two compliance policy guidances establishing a 1-year “stabilization period” to accommodate additional time that trading partners may need to adhere to the DSCSA requirements for electronic drug tracing at the package level. At the HDA Traceability Seminar, Connie Jung, FDA Senior Advisor for Policy, stated, “This does not mean to stop doing anything. We want you to continue to implement, we expect you to continue to implement because if you don’t, you will never get there... Our expectation is that we want you to test and exchange electronic data before the date.” For more, check out pp. 28. —Keren Sookne

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Benchtop unit

Design development

Pilot line (GMP Compliant)

Clinical

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Commercial line

Medium to high volume production

Technology transfer from benchtop to high volume

Experts in scaling processes and technologies for device assembly

FLEXIBILITY BUILT ON SOLID EXPERIENCE FULLY INTEGRATED ASSEMBLY SOLUTIONS FROM ONE SUPPLIER - FROM PROTOTYPING THROUGH INDUSTRIALIZATION AND BEYOND

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Pharma and medical device companies, and their CMO partners, need precision, high quality, and flexibility when it comes to assembly and packaging solutions.

State-of-the-art, fully integrated assembly and packaging lines that meet the requirements of both high-volume production and small batches are a Stevanato Group specialty. A high degree of efficiency and productivity comes as standard, along with reduced batch changeover time to meet the increasing demand for flexibility. The requirement for seamless commercial expansion calls for a line concept that is flexible enough to cope with everything from prototyping to large-scale production. That means technology ranging from benchtop equipment, through a GMP-compliant pilot line, to a full commercial line. The capabilities of the commercial line – such as labeling, inline laser engraving, inline inspection, and packaging – must be clearly defined and developed at the beginning of the project to avoid costly changes later on. The major challenge is the seamless scaling up of production capacity from the very beginning of a project to commercial

production. The selection of modules using the same assembly technologies and interfaces is just as important as a transportation system based on the same concept for pilot and commercial lines. All with the clear aim of ensuring line operator safety, streamlined line clearance, and minimal batch changeover time. Stevanato Group’s commercial scale-up assembly line program offers flexible, scalable, and efficient solutions for the assembly of a wide range of medical devices. The focus is on operator safety and convenience, a greatly reduced changeover time, and the ability to run multiple devices on the same assembly line. Packaging, optional in-line laser engraving, and labeling features further increase the versatility and suitability for a range of product scenarios. Monitoring and in-line inspections ensure the highest quality and reliability of the finished product. Overall, Stevanato Group’s standard assembly machine platforms are designed for manufacturers looking to improve the efficiency, flexibility, and quality of their device assembly processes to meet the demands of an ever-changing industry.

stevanatogroup.com

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COLD CHAIN CORNER

The industry is progressing to more compact temp-monitoring units, though smaller size may impact battery life in some cases.

9 Takeaways on Real-Time Monitoring in Pharma Logistics At the 2023 ISTA European Packaging Symposium, pharmaceutical brands and suppliers discussed trends in data logging technology. JOSEPH DERR, DIGITAL EDITOR, PMMI MEDIA GROUP The concept of real-time monitoring for pharmaceuticals and biologic products in the temperature-controlled supply chain presents several challenges to manufacturers along with its benefits. Limitations of battery life and communication disruptions during international shipments are just the beginning. Who owns the data, and how can data loggers be more sustainable? During a breakout session at the 2023 ISTA European Packaging

Symposium in Amsterdam, the Netherlands (September 27-28), suppliers and manufacturers gathered for a lively discussion about trends and ideas shaping real-time monitoring in the cold supply chain. For more on monitor qualification, visit hcpgo.to/428 1. Making devices compact One of the key challenges faced by the industry is the battery life

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COLD CHAIN CORNER

of real-time monitoring devices; long battery life is needed for international shipments. With the move away from bulky battery packs, the industry is progressing to more compact units, making them more practical for various applications. However, in some cases, the more compact size may impact battery life. 2. Determining precision Participants noted that while GPS provides precise location data, it’s not always necessary for all applications. For example, for some pharmaceutical data loggers, an accuracy of 10 to 20 or more meters is generally sufficient, while other manufacturers may need more precision. The level of precision factors into cost and battery life, among others. 3. Mobile IoT and geofencing To some, the term “real-time monitoring” is a misnomer because it is hardly instantaneous. Devices often transmit data every two hours—not truly in real-time—to preserve battery life. Mobile IoT technology has emerged as a game-changer, with devices communicating at preset intervals to conserve battery life. However, for international shipments, there are still concerns about battery drain, especially when devices are out of range of communication infrastructure. Geofencing was also a hot topic: once the device enters a certain preset geographic boundary, it triggers a signal for data transmission of temperature data. Geofencing can also be used to send an alert if the shipment goes outside of defined parameters. 4. Extreme temperature monitoring Most data loggers operate in conditions within the -32 to +55°C range. But manufacturers working with scenarios involving ultralow temperatures, such as -82°C, may require special loggers. For extreme temperature monitoring, external probes can be used, offering flexibility for tracking both internal and external temperatures. 5. Balancing cost and accuracy One evergreen and significant concern is the cost of implementing real-time monitoring in cold chain shipment. Some participants said the tradeoff between accuracy and frequency of sending data and cost is a challenge for international shipments. For example, the cost of sending signals from a ship at sea may be prohibitive for many—as high as $80,000/month for some data transfers, said one attendee. Manufacturers can consider also whether there are SOPs in place to act on real-time temperature excursions. For example, if there is no way for a 3PL employee to intervene and add dry ice to the shipper during transit when a high temperate alert is triggered, is

it worth paying the high relative cost? (Attendees also commented that they are interested in exploring the intersection of real-time monitoring and simulation or predictive analysis software.) Participants said they will be closely monitoring the development of emerging satellite networks such as Elon Musk’s Starlink for future solutions. 6. Sustainability concerns With the general move towards sustainability throughout the industry, we will most likely see a move away from single-use data loggers, which create electronic waste. Some suppliers offer multiuse loggers—considerations for end users here include returns logistics to retrieve the logger from its destination for reuse, and potential refurbishment needs. 7. Tracking the right data, safely Standard real-time monitoring devices can track factors such as vibration, tilt, light, temperature, humidity, and pressure within a load. One supplier noted that many users don’t take full advantage of the range of features available on their loggers. For end users, it’s important to consider the cost, complexity, and actual utility of logger features before incorporating them into monitoring devices. The group also discussed the challenge of data security, emphasizing the need for encrypted data transmission and secure data handling. 8. Who owns the data? Relatedly, the issue of data ownership was a point of debate. In some European regions, the owner of the device also owns the data it generates, while in other places, data ownership is not as clear-cut. This has significant implications for data sharing and collaboration between stakeholders. 9. The digitalization trend Digitalization trends also figured prominently in the discussion. For example, using real-time data to simulate temperature conditions during shipment can help predict issues before they occur. This technology could be particularly valuable in high-value shipments, allowing for proactive measures to be taken as products go on the pallet in the factory. Related reading: Predictive Technology Is the Future of Cold Chain at hcpgo.to/425 Real-time monitoring for temperature-sensitive products throughout the supply chain is evolving, with suppliers and manufacturers working hard to address ongoing challenges. Collaborative efforts and technological advancements, like those promoted at the ISTA European Packaging Symposium, will continue to shape the future of real-time monitoring in logistics.

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MATERIAL DEVELOPMENTS

Haleon and Bayer Join New Blister Sustainability Initiative The Blister Pack Collective aims to reduce single-use plastics in tablet packs for over-the-counter drugs, prescription drugs, nutraceuticals, and confectionery items. KEREN SOOKNE, EDITOR-IN-CHIEF In October, global consumer health company Haleon joined the Blister Pack Collective as a brand owner founding member. Days later, it was announced that the Consumer Health division of Bayer also joined. PA Consulting (PA) and PulPac, the Swedish R&D and IP company behind Dry Molded Fiber, launched the Blister Pack Collective in December 2022 with the aim of limiting the use of non-recyclable plastics in over-the-counter and prescription drug packaging through cross-industry collaboration. “The Blister Pack Collective brings together pharma, consumer health, and FMCG businesses to accelerate progress towards a world of more sustainable tablet packs, free from problem plastics like PVC,” says the Collective. “PA and PulPac have seeded the collective and developed the underlying technology needed to bring a functioning DMF tablet blister pack to life. The adoption of Dry Molded Fiber tablet packs provides an opportunity to cut back on the more than 100,000 tonnes [110,200 U.S. tons] of plastic medicine packaging used every year.” Dry Molded Fiber technology is reported to minimize CO₂ emissions—leaving up to an 80% lower CO₂ footprint than plastic and a 90% lower footprint than Wet Molded alternatives according to PulPac statements—and requires minimal water usage. Versatile tablet packs can be produced from the material, comparable to PVC packs in terms of physical design and tablet count. (Editor’s note: Not all traditional blister packs are clear, but product visibility through transparent thermoform packaging has been a benefit to consumers in the use of some plastic blisters.) “As the name implies, the primary benefit of DMF vs. wet molding is that it is a dry process—so essentially zero water use in production and then no need for additional energy to drive water off,” explains Keith Thornley, Commercial Lead for DMF Collectives at PA Consulting. “That leads to 2 key benefits: (1) a better sustainability profile as water use drops, so does asso-

ciated energy and (2) these drive down the per-unit costs making scale possible.” As Alex James Orchard, Head of R&D Packaging at Haleon, says, “Haleon intends to take a lead role in creating a future for consumer health packaging which is more sustainable and easier to use by all of our consumers. So, we’re excited to see an initial piece of upstream joint development work kickstarted by Haleon with PA Consulting and PulPac expand and become more impactful through the creation of the Blister Pack Collective. Through this initiative, we’re looking to partner and collaborate with other brands across consumer health and other sectors to develop new packaging solutions using alternative materials [that] help drive circularity.” Products, barrier, and production The Blister Pack Collective features a timeline on its site with steps including proof of principles on commercial equipment, inte-

↑ Haleon joined the Blister Pack Collective as a brand owner founding member.

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MATERIAL DEVELOPMENTS

gration of lidding and barrier, and more. PA Consulting designed the workplan to have value for both consumer health and pharmaceutical companies participating in the Blister Pack Collective, says Thornley. “That design includes critical flexibility—if the product currently goes in a blister pack, we are confident it makes sense to consider Dry Molded Fiber (DMF).” Barrier: In terms of shelf-life and barrier against oxygen and moisture, the Collective will be working directly with members to design packs that match their specific product barrier requirements. “To-date, we’ve done sufficient research and prototyping to have high confidence that in the near term our DMF packs should be able to match performance of common PVC/Alu packs. And longterm, we are investigating approaches that should enable us to have solutions for products with even the most aggressive barrier requirements (e.g., U.S. Pharmacopeia Grade A),” he added. Recycle-readiness: When asked if barriers might compromise recyclability, Thornley said, “For solutions with additional barrier layers beyond DMF, paper stream recycling should not be impacted. Physical sortation and reprocessing trials are pending to confirm. In addition, as the portfolio of suitable barrier and lidding options continues to expand, our approach will allow for easy incorporation of these materials so we are always future fit.” Lidding choices will be based on product requirements and desired consumer/patient experience—at present it is assumed most lidding will be paper-based. Equipment: Whether a material can run on existing machinery plays a role in how likely it is to be adopted. Many companies aren’t

ready to purchase entirely new machines or lines to accommodate a package with improved sustainability attributes. The DMF blister architecture is being designed to be compatible existing filling, lidding, and cutting equipment to minimize expenditure and changes to current manufacturing processes, says Thornley. “We will work in close collaboration with both the collective members and equipment suppliers to ensure plug-and-play wherever possible. The DMF process is suitable to both recycled pulp and other fiber inputs, including agricultural waste streams… we look forward to working on those challenges after demonstrating the foundational technology.” As Jesse DelGigante, Director Global Packaging Innovation at Bayer Consumer Health, explains, “We have a bold commitment to transform 100% of our packaging to be recyclable or renewable by 2030 and have committed to invest €100 million investment in changing how our products are made and consumed. Achieving this will require working with the best partners and we are proud to be a part of the Blister Pack Collective as we work to make a real impact for sustainability.” Leading companies like Haleon and Bayer Consumer Health lend validation to DMF’s potential, says Sanna Fager, Chief Commercial Officer at PulPac. She adds, “By joining forces, we can move faster and tackle challenges collaboratively and effectively. When we started PulPac, we set out to replace single-use plastics at scale by building an ecosystem of changemakers around Dry Molded Fiber. We are excited to see that vision come to life and be embraced by the industry.”

↘ Bayer has committted to transforming 100% of packaging to be recyclable or renewable by 2030.

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OEM APPLICATION NOTE

Integrator Project Sparks Switch from ‘Hard’ to Easy Automation Leadership at PharmaMed Automation is steeped in robotics, but robot deployment was often deemed out of scope for its many custom, one-off, “hard automation” projects. Then a build came along that put robots more prominently on the menu of options. MATT REYNOLDS, CHIEF EDITOR, PACKAGING WORLD

Integrator and original equipment manufacturer [OEM] PharmaMed Automation was asked to build case labeling equipment for a manufacturer of liquid level sensors and alarm systems. The client requested a fast, full-color, on-demand label printer and a fast, flexible, and precise means of affixing the labels. Answering the call, PharmaMed designed and built a self-contained labeling cell with a color inkjet label printer, a 6-axis robot, a custom label track, custom tool head, and a conveyor, with all logic residing in the robot’s built-in controller. This experience, with a specific request to investigate Epson robotics and printers, snapped PharmaMed out of what the integrator now considers to be an antiquated devotion to single machines accomplishing singular tasks. “We liked to call it hard automation because it’s hard to do,” jokes Justin Mattson, Sales Engineer for PharmaMed Automation. He’s riffing on that traditional process where factory integrators allocate machines and equipment to single, fixed tasks. “Hard automation is all about rigidity, about building something that does one thing, and it’s harder because there’s no flexibility.”

↑ Self-contained labeling cell features an Epson VT6L All-in-One 6-Axis Robot and Epson ColorWorks CW-C6000P Color Inkjet Label Printer and custom label track, toolhead, and conveyor.

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OEM APPLICATION NOTE

Dustin Hanson, PharmaMed President, agrees. “It’s frustrating because there are so many applications where a SCARA or 6-axis robot would be the way to go, but the budget doesn’t allow it.” Mattson’s and Hanson’s experience with Epson Robots and Epson Colorworks began in 2022, when a liquid level sensor and alarm manufacturer client distinctively asked them to look at Epson’s ColorWorks CW-C6000P Color Inkjet Label Printer in combination with an Epson VT6L All-in-One 6-Axis Robot to print and apply labels. Since that introduction, the integrator has used 10 more Epson robots in projects for other clients. “With Epson all-in-one platforms, our whole operation has opened up,” Mattson says.

↑ The 6-Axis Robot and Color Inkjet Label Printer work together to enable precise label placement on an assortment of corrugated cases.

↑ The components work seamlessly to print and apply labels.

Paradigm shifting project Hanson describes PharmaMed Automation, based in Fargo, ND, as a small and nimble engineering company that specializes in the most challenging factory automation projects. He says that, when he founded PharmaMed with Partner Walt Stewart in 2012, “the focus of the company was the manufacturing of custom, generally non-robotic, hard automation cells for pharmaceutical and medical device companies.” Yet Hanson was intimately familiar with robotics and had worked with almost every brand of industrial robot at one time or another during his career. “Actually, at the company I was at before we started PharmaMed, we developed our own SCARA robot and the software to control it. It was the first SCARA robot developed on the Rockwell platform.” He explains that “the job we do is very difficult, because we’re always trying to solve some new problem that no one else wants to touch. It’s a high-risk, high-reward type of business.”

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OEM APPLICATION NOTE

In 2018, he and Mattson founded another company, Vektor Designs, to serve a more general manufacturing base. They merged the two firms in 2022. Working under the Vektor brand, they took on this new client, the manufacturer of liquid level sensors and alarm systems. The client packages these sensors in corrugated cases of about 8 x 8 in. in length and width, and either 6 in. or 8 in. in height. It then labels these cases with a self-adhesive label that’s 6 in. wide and 4 in. tall. The client had been wanting to go to a full-color label to set itself apart from competitors. The company also wanted to create a more consistent look than is possible with hand-applied labels. Most importantly, the client was facing a huge staffing challenge, with a workforce that had dropped from about 700 prior to COVID19 to just 400, so an automated workflow was highly desirable. The client, Mattson says, had seen the Epson ColorWorks printer and wanted to use it in this application. “You can buy pre-printed labels and put them onto an off-theshelf labeling machine, but then every label on the reel is going to be the same,” he explains. “But this client might box up eight of their switches, then box up 10 more of another model, and so they need the flexibility to send any print run of any quantity to the system.” Mattson also says the CW-C6000P is fast and reliable, able to

print, trim, and peel labels 8 in. wide and any height at up to 5 in. per second. Completely digital, it can switch from one label design to another without pausing. Furthermore, it comes standard with an I/O port so it can easily be integrated onto an automated system. “Beyond the label printing,” Mattson adds, “they saw that it was a better option for them to use a robotic arm to pick and place it than any sort of fixed machine.” While hard automation is traditionally less expensive than robotics, the prices of the Epson robots were attractive to the client and the Vektor/PharmaWorks design team. “Once you can buy a high-quality SCARA for under $10,000, or a 6-Axis for under $15,000, that changes things,” Hanson says. The team designed a self-contained cell with the ColorWorks printer, a custom-built track to carry the labels, and a ceiling-mounted VT6L robot to pick up each label then apply it to the case, which is carried into position by a Dorner conveyor. The team designed and built their own pneumatic toolhead, which not only applies the label but then backs off and taps it to make sure it’s firmly applied. Then the conveyor brings up the next case. “We have a sensor embedded into the toolhead to verify that a label is present, and then we verify that it’s been applied to the case,” Mattson says.

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OEM APPLICATION NOTE

For now, he says, the client always applies the label into the same position on the side of each case, but by using a robot rather than a fixed labeling solution, they know they’ll be able to vary the case size and placement with just a simple software change. The client, Mattson says, originally ordered two of these self-contained labeling machines, but when they saw how well it worked, they soon ordered a third. Change in attitude Since starting on the project, PharmaMed has used Epson robots with three other clients, including two where they integrated Epson with a Siemens automation platform and one with Rockwell. “We actually used the Epson controller to power the entire labeling cell, but it’s a small cell with a couple of air cylinders, the conveyor, and this printer. But really when you start using a robot with the major platforms, that’s where the rubber hits the road,” Hanson says. “For us that’s big, and it’s mainly because we’re putting Epson robots into projects where we would not have used any robot in the past. You get to a price point where quantities can go up and you can get volume. Volume, in turn, is how you can get your cost down. I know that’s Epson’s play, and it’s our play as well… the reason we fell in love with the product.”

There are good and bad points with every product and every business, “but we know our pain points,” Hanson says. A big source of pain is the difficultly of designing and building fixed automation solutions. “We try to get rid of pain, and so we’re willing to make a change if we find something that works well. “An Epson robot,” he adds, “has the features and the price point we need. It’s a good, reliable product. Programming is straightforward using the Epson RC+ environment, and it integrates well with Siemens and Rockwell, which is important for us. And it has great support.” Would they recommend Epson for other clients’ and automation integrators’ packaging projects? “Yes,” Hanson says. “For sure.” For the latest in automation and labeling solutions, make plans to visit PACK EXPO East in Philadelphia, March 18-20, 2024. To register, go to: www.packexpoeast.com

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INNOVATE | FORMULATE | CREATE 11/21/23 9:47 AM

UNIQUE DEVICE IDENTIFICATION

Geisinger Harnesses UDI for Precision and Patient Safety SEAN RILEY, SENIOR NEWS DIRECTOR, PMMI MEDIA GROUP

From traceability to human factors, get the latest news straight to your inbox:

TOP THREE TAKEAWAYS 1. A technological leap streamlines 10 hospitals and 125-plus medical facilities.

2. Geisinger introduced QSight, a cloud-based inventory management system.

3. The groundwork is laid for efficient recall management and advanced analytics.

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UNIQUE DEVICE IDENTIFICATION

n the fast-paced world of healthcare, precision and patient well-being go hand-in-hand. At the GS1 Connect Ascend Conference in Denver in June, Kevin Capatch, Geisinger Healthcare’s Director of Process Engineering, and Vicky Lyle, VP Of Industry Associations at Owens and Minor, discussed Geisinger Healthcare’s collaboration with Owens and Minor in a session on leveraging the UDI barcode scan for healthcare innovation. Geisinger had long identified the limitations and risks associated with manual processes for storing and replenishing medical supplies across its 10 hospital campuses, 125 clinical sites, and nearly 24,000 employees. Eager to spearhead innovation and streamline its internal process, Geisinger invested strategically in technology that leverages the latest identification standards in medical devices. According to Capatch, their objective was clear: eradicate human error and simplify operations, starting with vital areas like heart catheterization labs. “Without end-to-end inventory management, a nurse in the OR might have to employ multiple tools to scan multiple implants, which is not just bothersome, it’s potentially dangerous,” said Capatch. “And without standards, none of the automatic identification of products is possible.” To embark on the extensive endeavor, Geisinger introduced QSight®, a cloud-based inventory management system from Owens & Minor. This system harnesses the power of barcodes affixed to medical devices, aligning seamlessly with FDA’s Unique Device Identification (UDI) Rule. Geisinger now effortlessly captures and securely stores critical information, including a product’s Global Trade Item Number (GTIN), the most widely used UDI standard, with a simple scan. The adoption of the QSight inventory management system brings forth a myriad of benefits, fundamentally transforming Geisinger’s approach to medical supply management.

Accuracy, efficiency, and productivity As a provider to multiple medical facilities in rural Pennsylvania, Capatch was glad to bid farewell to the era of error-prone manual record-keeping that long burdened numerous clinical professionals across the industry. Geisinger’s healthcare system now embraces a seamless workflow, where a quick barcode scan seamlessly places a product into inventory. Subsequent scans track its entire lifecycle, encompassing usage, disposal, returns, or recalls. This automated process guarantees precise documentation, freeing up valuable time for healthcare professionals to prioritize what truly matters—the well-being of their patients.

Optimized profitability Geisinger’s investment in advanced inventory management eliminates waste by preventing over-ordering and ensuring supplies are utilized before expiration. This calculated approach curtails unnecessary expenditure and facilitates automated centralized purchasing on behalf of large multi-facility institutions. Geisinger reaps significant fiscal benefits by streamlining procurement processes that positively impact its expansive healthcare ecosystem.

Elevated patient safety At Geisinger, Capatch explained that patient safety takes prominence. With the QSight system, healthcare professionals can rest assured that all vital tissue or implants required for treatment are readily available. Clinicians maintain meticulous and accurate records when interfacing with electronic medical records (EMRs) and individual electronic health records (EHRs). This record-keeping fortifies patient safety, ensuring comprehensive care while empowering healthcare providers with instant access to critical information.

Future-proof planning and implementation

↑ To embark on the extensive med device endeavor, Geisinger introduced QSight, a cloudbased inventory management system from Owens-Minor.

Geisinger’s inventory management initiative lays a solid foundation for systemwide data quality. This forward-thinking approach sets the stage for future operations and initiatives, including accurate and efficient recall management and advanced analytics. The provider envisions harnessing the power of data to optimize cost structures and enhance patient outcomes in an ever-evolving healthcare landscape. By embracing new technologies and bidding farewell to manual processes, Geisinger is creating high standards in accuracy, efficiency, and patient safety. Winter 2023 • Healthcare Packaging | 19

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PRODUCT IDENTIFICATION

Fresenius Kabi Infuses Safety with Unit-of-Use 2D Barcodes SEAN RILEY, SENIOR NEWS DIRECTOR, PMMI MEDIA GROUP TOP THREE TAKEAWAYS 1. The company enhances efficiency and patient care through innovative labeling solutions.

2. Vital info such as the GTIN, lot number, and expiration date is embedded within barcodes.

ntending to provide clinicians with easy access to crucial data, Fresenius Kabi revolutionized its product labels with GS1 DataMatrix barcodes to ensure patient safety and streamline healthcare workflows. The Bad Homburg, Germany-based global healthcare company is known for its commitment to innovation and decided to incorporate the GS1 DataMatrix into its entire portfolio of over 700 products. This two-dimensional barcode carries essential drug information in a compact format, enabling efficient identification and verification of medications. “We are embarking on this global project to provide clinicians the data they need to improve efficiency, accuracy—and for patient safety,” said Gwen Volpe, Senior Director of Medication Technology and Analytics, Fresenius Kabi. By embedding vital information such as the Global Trade Item Number (GTIN), lot number, and expiration date within the barcode, Fresenius Kabi supports safety checks during medication preparation, dispensing, and administration. Clinicians can quickly

3. Healthcare facilities can easily scan the GS1 DataMatrix barcode regardless.

verify the validity of medications, ensuring they are not expired or subject to recall. This streamlined process eliminates manual data entry and reduces the risk of human error, enhancing convenience for healthcare professionals. Additionally, including GS1 DataMatrix barcodes reinforces Fresenius Kabi’s commitment to supporting customers’ day-to-day operations. GS1 Standards, the global standards for product identification, provide a reliable and consistent framework for Fresenius Kabi’s labeling initiative. These standards ensure that healthcare facilities can easily scan the GS1 DataMatrix barcode regardless of the product’s destination and access the necessary information. The ability to gather critical data from a single dose of medicine, IV solution, or biological preparation is invaluable for a global operation like Fresenius Kabi. The company’s commitment to implementing GS1 Standards is not only driven by operational efficiency but also by its dedication to being a responsible corporate citizen. The success of a

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PRODUCT IDENTIFICATION

previous initiative involving radio frequency identification (RFID) tags inspired Fresenius Kabi to become the first manufacturer to utilize RFID “smart” labels, which include unique serial numbers, lot numbers, and expiration dates. Building upon this experience, Fresenius Kabi embarked on an extensive research and planning process to implement GS1 DataMatrix barcodes across its entire product portfolio. A cross-functional team comprising professionals from various departments collaborated to ensure the success of this company-wide undertaking. Customer feedback, barcode experts, and healthcare institutions were crucial in shaping Fresenius Kabi’s approach to GS1 DataMatrix barcodes. By enabling automatic identification and access to accurate information through the barcode at the unit of use, Fresenius Kabi aims to assist healthcare professionals in delivering optimal care. “In healthcare, it’s vital to continually innovate to improve patient safety,” said Volpe. “Proving the means to improve accuracy and efficiency to our healthcare providers allows us all to focus on what matters most, and that’s the patient.” Implementing GS1 DataMatrix barcodes presented unique challenges that Fresenius Kabi proactively addressed. Equipment

↑ The GS1 DataMatrix has the ability to encode a wealth of product information in a small footprint ideal for vials, syringes, and other small packaging.

compatibility was one such challenge, with imaging scanners initially favoring linear barcodes over 2D barcodes. However, adjustments to the scanner programming resolved this issue. Label design and application also required careful consideration, including leaving sufficient white space around the barcode to ensure accurate scanning. Highly reflective label papers posed another obstacle: they interfered with barcode readability. Additionally, printing labels for small packaging, such as the common 2-mm vial, necessitated precise attention to detail. “From a technical perspective, printing a very small 2D barcode on a very small label is harder than it looks and has, in some cases, required completely new labeling equipment,” said Jeanne Sirovatka, Senior Director of Packaging Design and Technical Projects for Fresenius Kabi. In addition to productivity and safety improvements, hospitals and pharmacies also conserve resources. Waste from the disposal of expired products is greatly reduced when looming expiration dates are clearly pinpointed. Streamlining in-hospital workflows through automatic identification and verification of products enhances compounding and inventory management of medications. If one clinical practice cannot use a product about to expire, perhaps another within the same system can. If a recall occurs, locating the medications is easier and suitable alternatives can be identified and implemented more quickly. Removing expired drugs from hospital systems is much more efficient. Once a nurse scans a medication before being given to a patient, the precise digital identity of the medication is automatically transmitted to the patient’s electronic health record (EHR). Should a subsequent recall occur, the patient who received the medication can be more easily identified and contacted. Despite what appears to be a daunting project, entry costs are not prohibitive, and a one-time investment in a scanner may be less daunting in an environment where the habit of scanning barcodes is firmly established. During its planning, Fresenius Kabi was pleasantly surprised by the number of hospitals and EHR vendors whose equipment was already capable of reading both types of barcodes. There are no shortcuts for the planning needed for a successful transition, however. “We knew what some of the issues would be: a preference for 1D versus 2D barcode scanners, size constraints, the need to upgrade or replace labelers based on printing technology,” Sirovatka says. “Issues of paper sheen and reflectivity, of truly understanding the spacing that would allow for a selective scan balanced with the mandated [human-readable] copy—those conceptual problems were more subtle.” As the first pharmaceutical manufacturer to do this across its entire portfolio, the lessons learned by Fresenius Kabi will help others in the industry take the same path using GS1 Standards. Winter 2023 • Healthcare Packaging | 21

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BUSINESS INTELLIGENCE

AI in Packaging to Reach $6 Billion by the End of 2033 ANNE MARIE MOHAN, SENIOR EDITOR, PACKAGING WORLD TOP THREE TAKEAWAYS 1. Artificial intelligence (AI) in packaging refers to the use of advanced technologies like machine learning and computer vision.

2. AI holds promise for quality control, supply chain management, and personalized packaging designs, more.

he use of artificial intelligence (AI) in the packaging market is projected to reach an overall value of $2.08 billion in 2023 and is expected to grow to $6.02 billion by 2033. That’s according to Future Market Insights, which adds that the sales of AI in packaging are anticipated to have a significant CAGR of 11.20% during the forecast period. As the report explains, AI in packaging refers to the use of advanced technologies like machine learning and computer vision to improve various processes in the packaging industry. AI systems can analyze images to detect defects in packaging materials, ensuring high-quality products reach the market. It also aids in supply chain management by optimizing production and distribution processes based on historical sales data and market trends, reducing costs and stockouts. In addition, AI algorithms can generate personalized packaging designs and recommend suitable materials based on consumer preferences, market trends, and product data. Future Market Insights adds that the demand for smart and sustainable packaging has created opportunities for AI-driven inno-

3. Cost, security, and ethics concerns—such as bias in algorithms and impacts on human labor—must be addressed.

vations such as active monitoring systems, temperature-sensitive labels, and interactive packaging experiences, enhancing product safety and consumer engagement. Key trends identified by the report include predictive maintenance; quality assurance through computer vision; supply chain optimization; voice and image recognition for hands-free operations; and data analytics for insights into consumer behavior and operational efficiency. The report points out, however, that there are a number of barriers to adoption of the technology, among them the high cost of implementation for smaller companies. In addition, data privacy and security concerns need to be addressed to ensure the protection of sensitive information. Integrating AI technologies with existing infrastructure can be also complex and pose a challenge for companies with established systems. The report also advises that ethical and legal considerations, such as bias in AI algorithms and the impact on human labor, also need to be carefully addressed.

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UNIQUE DEVICE IDENTIFICATION

J&J Beating 2027 Sunrise on UDI SEAN RILEY, SENIOR NEWS DIRECTOR, PMMI MEDIA GROUP TOP THREE TAKEAWAYS 1. The healthcare giant continues its nine-year migration from UDI to 2D GS1 DataMatrix.

2. The GS1 2D DataMatrix allows for application of UDI and serialization information.

he EAN/UPC barcode has offered price lookup functionality for decades. However, the traditional barcode no longer meets today’s growing demands for greater product information transparency, traceability, and authentication. Thus, industry is moving toward two-dimensional (2D) barcodes that can carry more information. 2D barcodes allow for a single standardized way to meet both supply chain needs and evolving consumer requirements, are much smaller than a linear barcode, can populate several fields at once in an inventory management system, and remain legible even when printed at a small size or etched onto a product. Industry has set a date to transition to accepting 2D barcodes at point-of-sale (POS)—referred to as Sunrise 2027. GS1 US is helping supply- and demand-side organizations and solution providers start migrating toward the “next dimension” of barcodes. Transitioning to 2D barcodes for POS is a multi-step process. The GS1 US Sunrise 2027 initiative lays out a plan to help ensure 2D barcodes will be usable at any retail POS by the end of 2027. With this plan as its impetus, Johnson & Johnson has fully embraced the change and moved products to the GS1 DataMatrix code. Johnson & Johnson’s Diane Riccardi walked the GS1 Connect 2023 audience through the transition and how Johnson & Johnson settled on the 2D code it chose. “Let’s talk about the QR code, introduced in 1994 and ideal in the consumer marketplace to help get information quickly,” said Riccardi. “In the medical and pharmaceutical space, Johnson & Johnson must comply with regulatory requirements: unique device identification and serialization of contents. For those reasons alone, Johnson & Johnson cannot use that QR code.” Johnson & Johnson chose the GS1 2D DataMatrix, first and foremost, because it can apply the UDI and serialization information. (The GS1 DataMatrix can store nearly 2,000 characters, including alphanumeric, GS1, and binary data, ensuring globally harmonized identification of products.) From a regulatory perspective, it was the most potent option for Johnson & Johnson to use because it can be

3. Ultimately, they want 100% of their products to feature the 2D DataMatrix.

printed directly on the package and contains more space to include additional package information. “When you think about it, in our regulatory markets, because we are a global company, we can have a customer in the United States that has one set of requirements that are different from our customers in Japan,” explained Riccardi. “That DataMatrix can handle that information.” For customers in the supply chain, by standardization, it will not matter if that customer buys the product from Johnson & Johnson or their competitors, she further explained.

↑ Diane Riccardi, Lead, GS1 Standards, Johnson & Johnson, at GS1 Connect Ascend in Denver.

24 | Healthcare Packaging • Winter 2023

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UNIQUE DEVICE IDENTIFICATION

↑ A sample 2D code, which can populate several fields at once in an inventory management system.

→ 2D barcodes are smaller than linear barcodes.

Need help?

“The ease in how they scan our product is standardized [with the DataMatrix,]” Riccardi noted. “This is huge, not only for all of our customers but for the industry, as well.” Johnson & Johnson tackled the project by dividing its products into two buckets: medical devices for its medical supply and pharmaceutical for its drugs. Ultimately, it wants 100% of its products with just the 2D DataMatrix on them, which is no small feat for a global multinational like Johnson & Johnson. “We have over 100,000 products in our medical and over 10,000 products in our pharmaceutical,” said Riccardi. “We can do it as a healthcare company, and so can others.” Johnson & Johnson has been on this journey since 2014, but its numbers prove it is trending toward completion well before GS1’s goal of sunrising 2D by 2027.

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AUTOMATION

Pharmaceutical Industry Enlists Packaging Robotics ANNE MARIE MOHAN, SENIOR EDITOR, PACKAGING WORLD TOP THREE TAKEAWAYS 1. Pick-and-place systems load blisters and cap primary aseptic pharma packs.

2. Tracking and vision systems ensure accuracy in production.

3. A single robotic cell can handle a range of products, offering flexibility to brand owners.

ust as COVID drove the growth of e-commerce, so too did it and-place solutions for a variety of applications. The new blisdrive a number of “essential businesses,” healthcare being ter-loading system uses a Fanuc CRX-10iA cobot, a 10-kg-payload primary among them. Before the pandemic, the pharmaceu- model with a 1,418-mm reach that is equipped with sensors and tical industry had been lagging in its adoption of automation and force controls to immediately stop the cobot’s motion if it contacts robotics, due to the highly regulated nature of the business. But the anything solid. pandemic resulted in a massive acceleration in the rate of adoption According to ESS, misfeeds, incomplete loading, and empty blisof pharmaceutical robots. ter feeding all represent sources of waste and line downtime for According to A3—The Association for Advancing Automation, blister packaging machines. The Fanuc cobot is equipped with line orders for robots from North American life sciences companies tracking and vision to ensure careful blister loading, minimizing increased by 69% in 2020 compared to 2019. And this growth shows machine faults. no signs of stopping. A report from Grand View Research predicts ESS can design a single robotic cell to handle a range of products, that the global market for pharmaceutical robotics will reach $357.9 depending on the manufacturer’s requirements. It can then create million by 2030, with the market expected to expand at a CAGR of EOAT [end-of-arm tooling] that can pick multiple products at a 9.2% from 2022 to 2030. Notes the report, this growth can be attributed to several factors, including the ability of automated systems to rapidly and safely perform repetitive tasks such as moving test tubes and fluids, counting pills and packaging them, and inspecting for quality control. Grand View also notes that, based on application, the picking and packaging segment dominated the market in 2021, owing to a rise in demand for personalized packaging. Meeting this need for picking and placing of pharmaceuticals are two new robotics systems: a cobot version of the TaskMate Robotic Systems Blister Loader from ESS Technologies and the Robotic 3D Control and Picking Solution from aseptic processing provider Steriline. ESS Technologies’ existing line of TaskMate Robotic Systems integrates Fanuc multi-axis robots and ESS-designed end effectors to create pick- ESS Technologies’ TaskMate Robotic Systems Blister Loader. 26 | Healthcare Packaging • Winter 2023

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AUTOMATION

time, with a spreading feature to populate multiple blisters with move it to its final destination. These paths are generated based each cycle. By incorporating quick-release pneumatic connections on the information received by the 3D vision system, which uses and thumbscrews, a robotic end effector can be quickly removed and a stereoscopic vision-based measuring technique in which an IR replaced with a new EOAT to handle a different product. Explains source emits an IR light pattern that is visible to visual sensors ESS, this has significant advantages in packaging lines that use and not to the human eye. The scattering of the light is detected, shorter runs for independent SKUs. acquiring a profile of the scene. This technology allows the system All TaskMate Robotic Systems are designed to be compact so to autonomously generate reliable trajectories for simpler and more they can be integrated seamlessly at the blister loading station to linear movements and avoid any collisions with the surrounding keep required floor space to a minimum. The robotic blister loader environment. can be integrated with new blister packaging machines, or it can be “In the pharmaceutical industry, limiting the release of particles used with existing blister packaging lines to automate previously during sensitive processes makes the difference because it reduces the risk of contamination,” says Fumagalli. “With this in mind, we manual loading processes. Another picking solution, this one designed for stoppering and looked for different solutions on how to remove the main parts that capping primary pharmaceutical packaging, was introduced by increased the dispersion of particles during, in this case, the stopSteriline at PACK EXPO International last year. The Robotic 3D pering and capping processes. So we chose to replace the hopper, Control and Picking Solution (3D CPS) includes both robotics and the vibrating cup, and the linear slide with robots combined with vision systems and was developed in partnership with ISS—Innova- a vision system.” tive Security Solutions, a spin-off company from technical univerThe partners also sought to simplify format changes. “Flexibility sity Politecnico di Milano in Europe. The solution is particularly is definitely an added value of robotic solutions,” adds Alessandro suitable for capping and stoppering packaging of small batches that Caprioli, Partner at ISS—Innovative Security Solutions. “In fact, require an aseptic environment, such as in personalized medicine with standard solutions, the production process and the relative and the production of cell and gene therapies. mechanical parts need to be reconfigured in order to manage or As Federico Fumagalli, Chief Commercial Officer at Steriline, handle a different container. With a robotic application, you generexplains, the company continues to innovate with robotics in its ally only need to set up a different recipe via the software.” aseptic filling machines, developing their robotic software in-house to offer intelligent motion and activities that are often performed Read Packaging World’s complete 2023 robotics manually. He says that in many cases, a robotic arm will move from report at hcpgo.to/427 and check out PACK EXPO A to B and B to A, but this application shows how robotics can be East (Philadelphia, Mar. 18-20): packexpoeast.com programmed by a 3D camera that scans, finds a good trajectory to move in, picks up the stopper, and places it on the vial. The 3D CPS is a mechatronic component equipped with a vision system that can detect tools within a defined area and adapt its function based on the relative feedback. It is composed of a robotic arm, a picker, an infrared ray (IR) stereoscopic vision system, and software for planning trajectories, accessing the recipe database, and interpreting the input data coming from the sensors. During operation, the robotic arm moves the picker throughout the working area, the dimensions of which can be modified based on the length of the levers. Next, sophisticated algorithms generate trajectories to allow the picker, located at the end of the arm, to reach an item, pick it up, and then Steriline’s Robotic 3D Control and Picking Solution. Winter 2023 • Healthcare Packaging | 27

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SERIALIZATION

What Does a DSCSA Stabilization Period Mean? KEREN SOOKNE, EDITOR-IN-CHIEF TOP THREE TAKEAWAYS 1. FDA announced a DSCSA stabilization period through November 2024.

2. FDA is urging all trading partners not to take their feet off the gas.

he HDA Traceability Seminar in late August opened with a packed house and a key message running through presentations: the DSCSA EDDS guidance that FDA released Friday, Aug. 25, is not to be looked at as simply enforcement discretion but as a stabilization period through November 27, 2024. As FDA’s Leigh Verbois said in her co-presentation with Connie Jung, “Let me just be really clear, we want to make sure that this time is used to implement, troubleshoot, and mature systems for trading partners and processes while supporting the continued availability of products. With the compliance policies in this new guidance, we want to focus on November 2023 and beyond.” Jung, FDA Senior Advisor for Policy, reiterated the message. “This does not mean to stop doing anything. We want you to continue to implement, we expect you to continue to implement because if you don’t, you will never get there,” she said. “Our expectation is that we want you to test and exchange electronic data before the date. This is what we were saying about November 2023—now, it’s before November 2024, you need to be exchanging that data electronically.” While some may still view this as a pause, Tish Pahl, Principal, Olsson Frank Weeda Terman Matz PC, highlighted a section which is actually underlined in the EDDS guidance: “This guidance is not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements.” As Pahl noted, “FDA doesn’t use typographical arts in the way that others might... so the fact that they underlined this is actually really unusual and very important.” She suggested that when dealing with companies that are calling up and canceling their contracts, show them this verbiage. Because of the cascading nature of an interoperable electronic system, a delay in manufacturer efforts leads to delays exchanging data with distributors/wholesalers, and then delays with dispensers. Some downstream trading partners expressed frustration that they’re left waiting for manufacturers to begin testing.

3. Consistent data exchange work will be needed throughout the next 11 months.

Industry response How a manufacturer uses the extra time depends on how ready they were before FDA’s August guidance announcement. As LSPedia’s Riya Cao explained, “Stabilization is for companies who have already gone live, so I don’t know how many of you are qualified to go into stabilization. I think a lot of people are still implementing, and then more are not even implementing yet. We’re very concerned about companies lagging behind… companies are just reading that discretion headline and making the decision not to work on this for another year. For those of you that are fortunate enough to go into stabilization, there’s so much work ahead. You have to really get into

↑ Tish E. Pahl of Olsson Frank Weeda Terman Matz PC and Brian P. Waldman of ArentFox Schiff LLP.

↑ FDA’s Connie Jung and Leigh Verbois addressed the crowd at the HDA Traceability Seminar.

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SERIALIZATION

the daily operations to uncover the scenarios you never thought about. Every day we’re learning new things.” Speaking on behalf of manufacturers at an onboarding panel were Blair Korman, Sr. Director, Digital Identification & Traceability at Johnson & Johnson Supply Chain, and David Mason, Supply Chain Compliance and Serialization Lead at Sandoz. Korman noted that this is a period to work on things that had to be sped through earlier. She hoped to be in talks with downstream trading partners by the end of November 2023 to exchange data so that internal groups could practice their skills to be ready for full volume come November 2024. Beyond an internal audit, she said something that needs more attention within the VRS [verification router service] is credentialing. “When we have all this great data out there, we have to protect it. We want to make sure that whenever we’re exchanging or sharing data, the EPCIS is secure, but in other ways, that we can use credentialing to help us and maybe that can be applied to the trace requests,” she explained. “Anil [Suresh] and I talked about that a little bit this week. And that’s important to protect that data —it’s now become a way to identify good-looking bad products. There may be some things that we can do with a trace request to have credentialing as well. This is a time to look at those things that you haven’t been focused on.” SOPs and staffing are areas for added focus. “We’re in the process of reviewing all the SOPs based off the process we have now,” said Mason. “I will be reaching out to people asking, ‘Where am I? When can I get data feedback?’ Because again, that’s going to be important. We are still putting people in place—I’m glad we got a little reprieve for the year. We will have quarterly reviews to see if our processes and everything are working. There are also the special processes everyone should be looking at: drop ships, replacements, PAPs [patient assistance programs]. It gives us a little more time this year to refine those processes. But my 2024 is error resolution for GS1, and data analysis and data management. That’s what I want to concentrate on.” William Carney, VP, Operations at Genetco, Inc., will also take a step back and look at SOPs. “We wrote [the SOPs] a couple of years ago when we started and we have to go through now and take what we’ve learned from receiving data and the errors we’re coming up with, and make sure that our policies and procedures align with the way we do it and it follows the law,” he said. They also plan to begin working on their outbound side to ensure policies are matching up with how they plan to handle errors. “We’re also taking this time to increase the number of people that we’re doing outbound checking with, because our outbound checking is going to become very labor-intensive, more than it is now,” adding that employees used to scanning a whole case will now need to scan all 12 bottles since they send individual units most of the time.

On the supplier side, SAP SE’s Anil Suresh said that from his perspective, they rushed into compliance to enable customers to implement. “I think we did a great job with respect to that. But now will be time to improvise all the processes. For me onboarding is the key—if there is no data exchange, the rest of things can fall apart, there’s no point. So the key would be to improvise processes in a way where we can automate all this onboarding and at the same time make sure everybody’s onboarded, at least by the end of this year. Then we can continue with standardization on other pieces, like error resolution. We can even talk about adoption of EPCIS 1.3, exception handling, and credentialing.”

Pharmacy owner/dispenser reactions Pharmacy owners may be breathing a sigh of relief, but the pharmacy trade association panelists noted that the message is still “don’t let up” and keep making progress toward compliance to be able to exchange data before November 2024. As Ilisa Bernstein, Sr. VP, Pharmacy Practice & Government Affairs, American Pharmacists Association, explained, “Across the dispenser community, there continues to be a big learning curve. If you look at most of the larger chains, they’re ready, or they [would have been ready] to flip this on in November, but not necessarily be getting data because their trading partners may not be ready to send data. But for the small dispensers, the independent pharmacies, which we share a lot of members, they were just not ready.” The pharmacy community has had a lot on its plate, dealing with COVID, state policy changes, and more. Bernstein highlighted that there are significant economic pressures, and that in Q4 of 2023 and Q1 of 2024, most pharmacies— typically independent pharmacies—are going to face critical economic hardship. “So what we’ve been hearing is that sigh of relief. But we can’t let that be a long sigh of relief,” said Bernstein. “I absolutely agree that we need to up our education and explain why this is stabilization—but you can’t stabilize unless you’re onboarded—and really explain what that onboarding means. Onboarding is not plug-and-play, but I think there are a lot of dispensers who think that they can wait until October and get a plug-and-play [solution], and that’s not going to happen.”

Other regulatory updates In addition to the EDDS and Waivers, Exceptions, and Exemptions guidance, FDA released the following: + Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act + Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product-Compliance Policies, Revision 1

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WORKFORCE DEVELOPMENT

4 Tips for Connecting Remotely with Your Next Gen Workforce KEREN SOOKNE, EDITOR-IN-CHIEF TOP THREE TAKEAWAYS 1. Remote and hybrid work have unquestionable perks.

2. There are challenges to overcome when connecting with new hires.

any in the processing and packaging community thrive on remote work, but where can managers bridge gaps and make early career professionals feel more confident and connected to their colleagues? When it comes to learning from managers, collaboration with the team, or becoming part of a company’s culture, there can be a pretty big difference between on-site and remote work. (Of course, some engineering and production work must be in-person, particularly when a new employee is learning about equipment/processes or during audits.) While newer generations of workers are adept at online communication, they need intentional relationship building in the absence of face-to-face interactions with their manager. At the PDA Annual Meeting in April, a panel of young professionals that participated in PDA’s Early Career Professionals (ECP) mentoring program and the Global Pharmaceutical Student (GPS) program shared their perspective on connecting remotely, their experiences in the pandemic, and more. (For more on these two programs, see the Get Involved sidebar. )

3. Early career professionals share advice and tips for managers.

and bother him with that. So I noticed the difference. It’s hard to get that connection,” she said. “The benefits of being remote are nice—you don’t have to commute. So now we’re hybrid. I really like the hybrid more… you don’t need to see your team every day. But I know that if I need support, and I’d like to talk to them in person, I know I’ll see them in the office soon.” Nina Rosso, Bioprocess Engineer at Novavax, Inc., had the experience of starting on COVID-19 vaccine operations in June 2020 when they were already remote. She met with her manager on the phone and on Teams, and the first time she met her in-person, they were traveling to a site. She explained, “I think that the drawback of that is that it’s really hard to first establish that relationship remotely. So

1. Accept that adjusting to remote work takes time As Robin Usselman, Business Development Manager at ACIC Pharmaceuticals Inc., explained, her company switched to remote work for a few months in 2020 and it felt completely different to her after having worked there in-person. With on-site work, she could walk into her manager’s office and ask to discuss a concern, and he’d listen right away. “Working from home, I wouldn’t want to call him

↑ Panelists (from left) at the PDA Annual Meeting: Kate Malachowski, PhD; Nina Rosso; Stephanie Lee, MBS; Robin Usselman; Tita Tavares; Kelly Waldron, PhD.

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WORKFORCE DEVELOPMENT

while now I feel perfectly comfortable calling my manager at home and saying, ‘Hey, I need help. I have a quick question. Do you have time?’ I do think that it took longer to get to that point. If we’d been in the office every day, I might have felt that comfortable in a week or a month, and instead it took maybe a couple of months— meeting in-person once or twice—to feel like I wasn’t bothering her, and that when she said it was okay to call, she meant that it was okay.”

2. Initiate more frequent contact Rosso noted, “I think that we’re constantly being told as early career professionals ‘Don’t be afraid to ask for help. Ask questions. If you make a mistake, admit when you made a mistake.’ You can say that, but it doesn’t mean that we feel comfortable doing that. So it’s really important for managers to be approachable and initiate some of those kinds of conversations.” As an example, she said a manager could proactively ask, “What questions do you have?” or after a meeting say, “Hey, I know that was a lot, did you understand that? What points can I clarify for you?”

3. Offer feedback in real-time Feedback, both positive and negative, is necessary for development and in general, the panelists said the sooner the better. “When you’re starting out, whether it’s hybrid, remote, or in-person, it’s helpful if your manager is setting regular checkpoints. Especially in the beginning whether it’s weekly—or however often the person that you’re managing needs—because like we all mentioned you don’t have that rapport yet, that trust. You need to build it,” said Stephanie Lee, MBS, Operations Manager at Amgen Inc. “You may need to meet more often at first, especially in a virtual environment. You have to be deliberate about it. You’re not going to just see them when you’re walking to get water.” Lee added that this helps establish a space to be able to talk about gaps in knowledge or work through issues, and allows managers to learn about the younger professional’s background and career interests. “Maybe you mention that you don’t really know too much about a certain subject, and your manager says, ‘I have these people that I can connect you to,’ or recommend you reach out to. Then as you go forward, you don’t necessarily have to have those [check-ins] at the same intervals, as you feel more comfortable to say, “Hey, I have a question, can you meet later on a Teams call?’”

4. Don’t overlook small compliments/critiques When you’ve been in your career for years, you don’t (necessarily) think about every email or task you’re getting done throughout the day. But for early career professionals, small feedback counts. Rosso noted of constructive feedback: “Even if it’s small, I have had managers who messaged me, ‘Can I give some feedback?’ The answer’s yes! If they say that when I answered this question, I could

have done it this way, that’s really helpful. Because it’s pretty low stakes—a Teams message—you can come to expect it rather than waiting and building up feedback after months of you doing your job.” She said the same is true for positive feedback. “I had a manager say, ‘This person interrupted you and I thought you handled that really well and got back on topic.’ You’d be surprised how much that means to someone who’s first starting out. You really take those little bits of positive feedback and hold on to them,” she added. Usselman agreed that small comments help—even complimenting a great email: “I think they want to make it clear that they notice the work I’m doing. It’s just the little things, and I think seeing their support every day makes such a difference compared to if I just heard it at a quarterly review, let’s say. “Another thing is they make it clear how I can progress within the company. If I thought I was going to be stuck in the same role for 10 years, I probably wouldn’t stay. But they make it clear what the opportunities are. When they give me new challenges, they may tell me how this will benefit a future role. They actually pushed me to go into business development, which I didn’t want to first, but now I’m enjoying it. They gave me that challenge, and they made it clear how it would benefit me. So, I think the career progression really ties in with their support.” Listen to this episode of the unPACKed with PMMI podcast featuring Kim Kizer, who moved from temp worker to packaging VP: hcpgo.to/424

Get Involved ECP Mentoring: For early career professionals, PDA features many opportunities to engage in scientific work, build networks, and learn about the topics important to daily work when starting out in a career. To facilitate this process, PDA has developed a mentorship program to help early career professionals get engaged on a more personal level (Contact: membership@pda.org). The PDA Global Pharmaceutical Student Network (GPS): Launched in 2022, the GPS is designed to provide support to students in pharmaceutical-related fields by connecting them with industry leaders and supporting their career development through unique opportunities such as interviews with industry experts and scholarships. PDA recognizes that there is a need to build a bridge between academia and the pharmaceutical industry to broaden career opportunities for students. Ultimately, the goal is to develop a talented workforce for the future and align pharma-focused students and the industry.

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MACHINE SAFETY

Clearing the Confusion on Machine Standards Applications CASEY FLANAGAN, DIGITAL EDITOR TOP THREE TAKEAWAYS 1. A single primary machine standard can involve several additional standards.

2. It’s important to know what to follow for a given machine project.

or the uninitiated, machine standards can seem like a tangled web of red tape, but machine manufacturers need to untangle this web to ensure safety and compliance. The decision about which regulations and standards apply to new machines rests with the machinery supplier and the component supplier, according to PMMI Business Intelligence’s 2023 report, The Impact of Global and Local Standards on OEMs and Suppliers. But even if you’re a purchaser of machines and not an OEM, it’s helpful to understand how safety standards apply. Starting points

3. Copies of relevant regulatory and normative standards should be maintained and updated.

in determining which regulations and standards apply to a project include the requirements of you, the customer, and the destination of the machine. Machines going to E.U. locations fall under ISO 12100:2010 Safety of Machinery—General Principles for Design—Risk Assessment and Risk Reduction. It’s important to note that the American National Standards Institute’s ANSI B155.1 Safety Requirements for Packaging and Processing Machinery is broader in scope than ISO 12100. Therefore, the ANSI standard is recommended for equipment

Table 1 - Primary Industry Machinery Standards to Know

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MACHINE SAFETY

destined for E.U. as well as U.S. destinations. From there, a careful reading of the standard will help determine what requirements must be met. These foundational standards also provide references to other standards that may impose additional requirements. Proper research and compliance depend on access to a library of standards. It’s not uncommon for a machine to be governed by one primary standard, as well as 10 related standards. Since many standards have been updated over the years, it is important to work with the most recent publication.

However, this knowledge can save time and money by ensuring compliance, preventing expensive design changes late in the process, and eliminating the potential negative consequences of noncompliance such as substantial fines, and in the worst cases, jail terms or significant civil liability. Standards compliance needs to be part of the product development process to ensure operator and environmental safety, as well as adherence to legal requirements and best practices.

Application strategies

Management must be onboard with standards applications. One person should be responsible for implementing procedures, the product liability program, and overseeing the team. Copies of releOEMs are so busy meeting deadlines and building machines that vant regulatory and normative standards should be maintained and meet performance objectives, so it can be a huge challenge to take updated, as necessary. Team members should include a combinathe time necessary to become familiar with the standards, determine tion of mechanical and electrical engineers, technicians, and sales, which ones apply to a project, and map a path to implementation. according to PMMI’s 2007 Guide to the Key European Directives for Packaging Machinery—Fourth Edition. When working to achieve a CE Mark to qualify for European sales, for example, the standards team should learn, implement, and document the process to comply with the directives, perform a risk assessment, address the essential requirements list, and create the files required for qualification. Documentation includes the Technical Documentation File, Declaration of Incorporation and/or Declaration of Conformity, the Hazard Analysis and Risk Assessment, and a list of the EHSRs [essential health ↖ Machines sold in and safety requirements] of the directive the E.U. must include that applies to the machine, the PMMI 2007 CE Mark certification. guide says. It should be noted that machine design changes and upgrades need to be analyzed to see if they impact compliance. If so, parts of the Declaration of Conformity may need to be redone. Re-testing should be done periodically to confirm compliance, per the PMMI guide. Download the free report, 2023 The Impact of Global and Local Standards on OEMs & Suppliers, at hcpgo.to/423

Saving time and money with machine standards compliance

→ Standards applications should involve management, a combination of mechanical and electrical engineers, technicians, and sales.

In August, PMMI released the newly revised ANSI/PMMI B155.1-2023 Safety Standard, available for purchase through ANSI at hcpgo.to/b155

Winter 2023 • Healthcare Packaging | 33

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NEW PRODUCTS

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34 | Healthcare Packaging • Winter 2023

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NEW PRODUCTS

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