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Articles from 2016 In May


Are you ready for changes to the USP Packaging Chapters?

Are you ready for changes to the USP Packaging Chapters?
Image source iStock

If you are using a particular plastic packaging system for a drug already on the market, its use is most likely USP compliant under the recently finalized USP Chapter <661> Containers-Plastics. But when will you need to subject that same plastic packaging system to new tests when using it for a new drug?

We plan to address this question and others on June 16 during the Pharmaceutical & Medical Packaging conference. USP <661> Containers-Plastics is only one of the USP packaging chapters changing—Chapter <381> Elastomeric Closures is up next for revision, and there’s talk of a new chapter that will cover packaging systems and components made of metal. Are you ready for all these changes, with more to come?

To help you understand how these changes might impact packaging development and testing, we've invited Desmond G. Hunt, PhD, USP's Senior Scientific Liaison, to speak June 16 at EastPack in “Materials Qualification & Performance: How Will Changes to USP Chapters Impact Packaging Professionals & Drug-Delivery Device Design?”

In this session, learn:

•   The history of <661> Containers Plastic and rationale for revising.

•   The focus of <661.1>, the testing the materials of construction and <661.2>, the testing of drug products in their final packaging system.

•   Testing requirements outlined in the chapters and the impact on "low-risk and "high-risk dosage forms.

•   Applicability of the chapter to current products, products in development, and situations in-between.

•   Impact of revisions to <87> Biological Reactivity, In Vitro and <88> Biological Reactivity, In Vivo.

•   Plans for developing a new packaging chapter that will focus on packaging systems and components made of metal.

•   Direction of a new Expert Panel that will further modernize <381> Elastomeric Closures.

Following his presentation, Hunt will join the panel discussion: “Putting the Changing USP Packaging Chapters to Work” moderated by Dwain L. Sparks, Strategic Advisor & Expert Consultant, YourEncore (Eli Lilly & Co. Retiree). They’ll be joined by Dan Malinowski, Senior Director of Package Technology & Innovation, Pfizer; and Brandon Zurawlow, Associate Director of Container Qualification & CCIT, Whitehouse Laboratories, a division of AMRI.

We are working on a few questions for the panel discussion already, in addition to the one above, such as:

•  What if new USP <661.1/661.2> testing has not been completed for the originally approved drug?

•  Should suppliers pre-certify their materials that have passed <661.1> testing? If precertification is allowed, would material suppliers need to provide data to pharmaceutical companies for inclusion in their application, or would a statement of certification be sufficient? 

•  For packaging systems with multiple layers or components, such as a blister (3-layer film (PVDC, PE, PVC) and lidding foil (aluminum and lacquer)), what are the materials of construction (MOC) that should be tested according to <661.1>?

•  Does <661.1> testing happen at every stage of a material’s life, such as raw material; converted/formed into film, blister, bottle, tube, vial, syringe, etc.; combined with other materials (homopolymer to copolymer) or used with additives; or after sterilization, aging, or processing? 

•  How will the new requirements in <661.1> impact the introduction of new materials of construction?

•  If a pharma company can simply do 661.2 testing, why should an MOC company do <661.1> testing?

•  Does <661> testing adequately address the testing needed to evaluate a change from a glass container to a plastic container?

•  Are there any changes or updates planned for USP <671> or are all users happy with it the way it is?  Is there any evidence that users are using alternate methods and submitting them in their application, as allowed for in <671>?

•  What is the status of resolving the use of "tight container" in Monograph storage statements and the definition of "tight container" that still exists in <671>?  

Please join us June 16 for the Pharmaceutical and Medical Packaging conference, which in addition to including the USP Chapters session also covers FDA’s new electronic Drug Master File system, the PROTECT dosing safety initiatives, and emerging packaging and drug-delivery technologies. Use promo code NY16PMPN to get 20% off the Pharmaceutical & Medical Packaging conference on June 16th.  

Packaging engineer’s star potential realized at Coty

Packaging engineer’s star potential realized at Coty
Whether at Rutgers University or Coty, Damen Soriente continues to learn about packaging.

Damen Soriente, Millennial, Rutgers packaging engineering Rising Star and 2015 graduate, talks about what his career looks like working in packaging for Coty’s Sally Hansen brand.

First there was our Rising Star series of notable packaging students—see below—and now we’re launching a spinoff, so to speak: We follow up with those star students and other Millennials working within the wide world of packaging in a new series.

Kicking things off is Damen Soriente, a 2015 Packaging Engineering graduate who had been recognized by Rutgers University as a Rising Star. When we reached out to him to see how things were going, we found out that Soriente had landed a position at Coty shortly after our article was published last spring (see Engineered for packaging by Rutgers University).

“I accepted a job as a developer for the packaging concept development team at Coty,” Soriente says. “To my good fortune, I have been able to utilize a great deal of the information and techniques that I learned while at Rutgers to support me on my projects and tasks.”

Soriente responds to our questions about his work in packaging in this Q&A:

What do you do in that positon?

Soriente: I work on the development of the packaging primary and secondary from the conception phase through the execution phase for the Sally Hansen brand. I work cross-functionally with multiple departments as well as outside sources in order to deliver a product that is imagined by the marketing and creative teams. I also work on prototyping of new designs with CAD drawings using Solidworks and other available resources.

What do you like the most about your job?

Soriente: The team I work with and the open environment. There is such a wealth of knowledge of the packaging industry and technologies through the leader and directors in my department. I have had the opportunity to pick the brains of each of the people I work with and learn new information. They are always nearby to answer any questions that I may have, or help me through something I have never done before.

Also, the company has put a great deal of investment into me through different trainings and classes that I have taken. With the popular mindset that work is terrible, I would say I am lucky enough to enjoy what I do every day.

Coty brands and packaging on display.

What’s it like to be a Millennial in packaging working for a major brand owner?

Soriente: It has been an incredible experience so far. Being such a large company there is such an abundance of information to take in. Coty has such a diverse employee base in both age and culture, which allows the company to explore an enormous customer base. It is really rewarding that I can walk into a store and see items on the shelf that I had a hand in working on and developing.

What has been the biggest work-world surprise?

Soriente: That is being able to make such an immediate impact. Since the day I started, the ideas that I have come up with have been taken into serious consideration, which pushes me to better myself and create an even larger impact in the company. It’s also incredible how well that “it’s a small world”, applies to the packaging industry. At almost every industry event that I have attended, colleagues of mine have known a ton of people at the event from either working with them in the past or them working for Coty in the past.

What’s been your most rewarding or stimulating project?

Soriente: Working on blue sky development, which is designing something that has never been done before. With the resources I have available I can design something and prototype it the same day. The stimulating part of these projects is getting to watch the potential customers test out the prototypes during panel testing and give immediate feedback on the designs.

What’s your next challenge?

Soriente: I look forward to receiving more project roles and responsibilities as we move forward. There is always something new to learn and challenges that arise because Coty covers so many different types of products in the beauty industry. Going forward, I hope to receive new types of projects that will expand my knowledge of different types of materials and packaging methods and to really test what I know and have learned.

Our virtual reunion, Rising Stars shine a light on packaging education, features our first six Rising Stars.

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Interested in continuing your professional education in packaging? Join like-minded professionals at EastPack in New York City June 14 to 16 in New York City.

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The recycling myth: Collection versus reuse rates

The recycling myth: Collection versus reuse rates
Regardless of collection rates, nations that are "good at recycling" have essentially the same reuse rates as the U.S., claims an expert in environmental science.

When it comes to environmental science and supply chain issues, if you don’t know Jack, here’s your opportunity to learn a thing or two about the truth of low recycling rates in the United States.

On Earth Day this year, media brand Fusion published the article “Happy Earth Day! America officially sucks at recycling.” The headline certainly captured my attention and I tweeted the link, adding the comment “Blunt & hard 2 argue.”

Jack Buffington agreed. He’s a supply chain executive at MillerCoors, the second largest beer manufacturer in the U.S., and a post-doctoral researcher in the fields of environmental science and supply chain for the Royal Institute of Technology in Stockholm, Sweden.

He’s also the author of “The Recycling Myth: Disruptive Innovation to Improve the Environment,” so he knows a thing or two about this subject that most people might not.

After seeing my tweet, he sent me this email:

You probably know that it is true that America is about 18th in recycling, but what you may not know is that nations that are "good at recycling" have essentially the same reuse rates as the U.S. (e.g., plastic bottles). I know this to be true because not only have I been a leader in the U.S. consumer products industry, I am also a Ph.D. researcher in Sweden, often known as the most successful recycler. So I know a lot about what happens in nations that "don't suck."  

The belief that "if we collect more, it will be easier for companies to reuse materials" is just not true for most materials (it's true for aluminum), based on science and economics, not opinion. Given the chemical and economic properties of a plastic polymer, it has a cost equilibrium point at approximately 10%; in Europe, where there are higher mandated collection rates/subsidies, the average recycled content in a PET bottle is only 11.7%, per the European PET Bottle Platform (EPBP). A lot of packaging waste is incinerated as "waste to energy," and this refutes the conventional argument that collecting more will solve the problem. The truth of low recycling rates of plastic bottles is related to its polymer design not for recycle and the petrochemical supply chain. Unfortunately, efforts continue to focus on collecting more rather than redesigning the bottle and supply chain process.

To prove my case, I'm working with scientists to reverse engineer the supply chain system of a PET bottle to achieve a 100% reuse system in five years. We think we can do it, including agreement with the consumer product industry. I just published a book titled, "The Recycling Myth: Disruptive Innovation to Improve the Environment" that ties to this approach of transformation, and I have yet to have a scientist or economist dispute my findings.

Although I have support from chemists, economists and even environmental organizations, I have offered to have a debate with many of the well-known recycling organizations, and none of them have accepted my offer. This is because there remains a conventional belief, even after 40 years of trying, that we can collect our way from out of this problem, which is refuted based on economics and science. 

I have long wondered how the recycling collection rates jive with the amount of actual recycled material.

So I asked Jack, “Do you have any ‘reuse’ numbers in other countries? I have to admit that I don’t know who monitors reuse numbers in the U.S. All I’ve ever seen are collection numbers or percentages of materials available for collection.”

He was, again, fast and passionate with his response, sending me a presentation he delivered in March 2016 at the Congreso Internacional de Sustentabilidad Ibero in Mexico—along with this message:

You hit the nail on the head in your question! Yes, not much data on reuse rates, and how to define "reuse," but a lot on recycling. [See his slide above on recycling facts for the U.S., Sweden and Mexico.]

For example, I consider "reuse" to be "bottle to bottle," or even "can to car" (upcycling). But in some nations, a "zero waste" moniker is earned if reuse comes in the form of incineration via waste to energy!! So if one nation incinerates 50% of its waste while the other landfills 50%, it's clear that they both share poor reuse rates in a closed loop model, right?

And in Europe, there's a new EU [European Union] directive requiring nations to achieve a real 75% recycling rate by 2030 that won't be possible because they focus on eliminating packaging waste through “waste to energy.”  That's not environmental success to me!!

To Jack, environmental success means a revolution in new materials development, including materials that are 100% recyclable, reusable or that can be thrown away and reused by nature. For example, let’s convert monomer to polymer and back using bio-materials with the potential to be a true reusable plastic.

He’s a proponent of the circular economy method and thinks technology (not regulation) will help increase recycling rates and recycled-content use.

And he wants your help in figuring all this out.

I welcome any conversations and debates on the topic. I actually went to Sweden to get my Ph.D. expecting to bring back an approach that works, but I found that the problem lies in beverage container design and its supply chain, not recycling rates. And I'm focusing research to fix this problem in five years. Unfortunately, too many are locked into this conventional solution that doesn't and can't work.

Jack shared many of these thoughts recently on Radio Ecoshock, the largest "dark green" environmental podcast/radio program, which (he tells me) has more than 94 subscribing stations in North America. “Getting into a dialogue beyond ideology is important to solving the problem, and when a dark green environmentalist reads my book and then wants to talk means that we're heading in the right direction,” Jack says.

Reach him via LinkedIn at https://www.linkedin.com/in/jack-buffington-明-张杰-7042034, Twitter at @jbuffi1 or leave your comments below.

Jack Buffington

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See a host of new ideas in sustainable packaging at EastPack 2016, June 14-16, in New York City.

Sustainable packaging and the bathtub-shaped curve

Sustainable packaging and the bathtub-shaped curve
What does a bathtub on a graph have to do with sustainability for packaging? Read on…

Eco-Insights expert Robert M. Lilienfeld points out the invaluable lesson learned from a bathtub-shaped curve and what it means for sustainable packaging.

A bathtub shaped curve indicates that both too little and too much of something can be bad: Too little water causes dehydration. Too much causes drowning. As the old saying goes, the dose makes the poison.

What does this have to do with sustainability for packaging?

Consider PET bottles. For marketing and production efficiency reasons, some contain more plastic than is needed to safely protect the liquid within. Obviously, too much plastic is wasteful when it’s not actually needed.

On the other hand, in an effort to reduce waste through source reduction, some PET bottles have been light-weighted to the point that they burst when being warehoused, spilling the far more valuable products contained within.

The same situation exists for recycling. Example: Paperboard that does not contain high levels of recycled fiber is considered less sustainable, as virgin fibers have a larger environmental footprint. Yet, cartons made of too much recycled (and thus shorter, weaker) fiber may not effectively protect what’s inside, once again increasing the potential for far more costly damage to the product itself.

For all materials and packages, there comes a point of marginal utility where too much (or too little) of a good thing actually becomes a bad thing. At that point, the goal is no longer to do more with less, or less with more, but to use innovation to create new, more efficient product delivery systems and paradigms.

I doubt that I’m telling you anything you don’t already know.

The problem is, well-meaning consumers and policymakers who call for less virgin material and/or more recycled content don’t know what we know.  They probably think we’re always on the downhill slope of the bathtub curve.  Thus, as they work to pass laws requiring 100% recycled content, 100% compostability, 100% bio-polymers, etc., they are also putting in motion the laws of unintended consequences.

Ironically (and sadly), while our deep subject knowledge puts us in a good position to know where to draw the line, our dependence on the materials and packages in question makes our expertise suspect: We are accused of trying to protect our existing businesses, rather than working to protect the environment

How do we overcome this situation? What similar material or packaging examples are out there? How do we educate policymakers, the media, and consumers about the bathtub shaped curve? Most importantly, how do we convince them that we actually have the knowledge and experience to help achieve the goals in question?

Over the next year, I’ll be exploring these issues. I invite you to explore them with me and help discover other examples of the “too much of a good thing” syndrome, along with ways to prevent the syndrome from occurring.

AMERIPEN and its Technical Advisory Group (TAG) are analyzing examples of this “all or nothing” thinking in order to develop better “design for sustainability” strategies, and to communicate to policymakers the benefits of these innovative new ideas.

Please join us. We’ll all benefit if you do.

What do you think? Please comment below.

 

Robert (Bob) M. Lilienfeld has been involved with sustainable packaging for more than 20 years. He is currently editor of The ULS (Use Less Stuff) Report, a marketing and communications consultant to AMERIPEN and other organizations, and is a professional photographer.

Biometrics: When science is applied to packaging design

Biometrics: When science is applied to packaging design
The eyes have it: Biometric tools include eye-tracking study heatmaps that indicate exactly what specific places on packaging draw the most attention from consumers.

Biometric research, including eye-tracking and facial expressions, is a useful tool to lift the veil on the truth of packaging at the point of sale—and help guide effective designs.

Biometrics refers to metrics related to human characteristics. Biometric identifiers are the distinctive, measurable characteristics used to label and describe individuals.

-Wikipedia

The average new product launch costs $1 million and 22 months’ development. Yet, after two years, only 6% of those new launches remain on the shelf. Many brands still evaluate their packaging through focus groups with their target market, friends, family or employees. According to Sara Shumpert, director, The Packaging School, this approach is less effective because decision-making is "nonconscious.”

Humans simply are not aware of why they like something, and ultimately what triggered their purchase decision, she explains. Thus, biometric research such as eye-tracking and facial expressions are a useful tool to "lift the veil" on the truth of packaging at the point of sale.

It is important for brands to utilize packaging to help consumers visually interact with their products faster and longer than the competition. Ultimately, effective product packaging enables the consumer to quickly find the brand and specific product or other variant they desire to make a swift and safe decision. To design effective packaging, research must be performed to discover what will resonate with the target market.

Shumpert will be presenting on the application of biometrics in packaging and more during her presentation, Designing with Shelf Space Strategy in Mind - Packaging Trends in Industry Categories, on Tuesday, June 14, at 10:30AM at the Packaging for Food & Beverage conference during EastPack. Shumpert responds to our questions in this preview of the topic:

What remains the value of focus group studies in new product/package development?

Shumpert: For many brands, focus groups are seen as a valuable tool for acquiring direct feedback on new products and packaging from the target market. Focus groups, like most research methods, do have their downsides. “Groupthink” is a common phenomenon that can occur when a group of people make irrational decisions based off of their desire for harmony or conformity. There’s moderator bias, where a facilitator may incidentally move people to a predetermined idea. It’s also not contextual, meaning the consumer is not at the point of purchase. What someone thinks they will buy, and what they will actually buy in those seconds at the shelf are two completely different things.

Where are you looking? Eye-tracking heatmaps indicate where consumers eyes land while looking at shelf displays of various brands and packaging.


What’s a brief overview of what biometrics are about?

Shumpert: Biometrics are tools—devices, sensors, hardware, etc.—that measure human activity. Like a calculator, these are tools that can be used to answer questions. Also like a calculator, they can be used incorrectly. They provide data and answers to questions on the intersection between humans and activity.

What companies can benefit from using biometrics?

Shumpert: Everyone can use biometrics, whether brand owner, packaging supplier or design agency. Anyone interested in how people interact with objects needs to be informed on biometrics. Eye-tracking technology can now be used to effectively collect quantitative data on the effectiveness of point-of-purchase marketing in a controlled environment with a set methodology.

How can companies with smaller budgets benefit from biometrics?

Shumpert: Pricing is completely based on the questions you want to answer. The more detailed the question, the less-expensive the study. Cost is related to the number of participants, the location, the number of samples tested, and what insights need to be extracted. The more refined the list, the cheaper the study. Exploring data and sifting through things is time intensive and costly.

What’s new in biometric studies?

Shumpert: It’s an emerging market, similar to rapid prototyping. Eye tracking was used prior to the 1960s. However, new technologies, such as lighter weight devices, advanced code, cloud processing and computer vision are big topics for biometric device manufacturers and users.

What one sentence piece of advice do you have for brand owners?

Shumpert: Design, test, and redesign every single time.

About

As director of The Packaging School, Sara Shumpert provides training and continuing education to professionals looking to advance their career or companies interested in developing training solutions for their employees. Over her young career, she has worked with multiple consumer good brands on marketing and package design. From packaging innovation brainstorms to digital marketing plans, Sara has seen first-hand the vital role packaging plays in the marketing mix. She may be reached at [email protected].

For biometric study inquiries, please contact The Packaging School’s partner company, Package Insight, via [email protected]

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Interested in a packaging and packaging design? Join like-minded professionals at EastPack in New York City June 14 to 16 in New York City.

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Helping users dial the right dose

Helping users dial the right dose
Users draw liquids into Dial-the-Dose and then dial to the appropriate volume, explains Alfredo Paredes of Balda C. Brewer.

Caregivers may not always have two hands available when administering pharmaceutical liquids, so delivering accurate doses could be challenging. When it comes to syrups and suspensions for pediatric applications in particular, “we’ve heard the call for a device for administering them effectively,” reports Alfredo Paredes, marketing manager for Balda C. Brewer. The company, known for its expertise in medical plastics injection molding and contract manufacturing, has just introduced its solution, the Dial-the-Dose liquid medicine dispenser that caregivers can use to deliver an accurate dose with one hand.

Dial-the-Dose can dispense a liquid in volumes ranging from 0.5 mL to 3.0 mL in 0.5-mL increments, all from the same device. “Users draw the syrup into the dispenser and then dial to the appropriate volume,” explains Paredes. “There’s a hard stop when users pull on the plunger. The accuracy tolerance is within +/-10%, whereas the requirement is +/-20%.” 

The device can be used multiple times for the same product, but cannot be disassembled for cleaning for use with different products, says Paredes. “This is a plus when you are promoting the integrity and accuracy for a given product,” he says.

The plunger of the device could be modified to support preloaded doses, but according to Paredes, this would not be considered a prefilled device. “A bolus could be loaded into the dispenser, 5 mL for instance, and then each turn could give another 1 mL, as indicated with a click,” he says. “We could supply these devices in bulk to pharmaceutical customers for preloading. Prefilled devices [face] a more rigorous set of regulatory requirements, and we could help customers go for a prefilled device.”

Dial-the-Dose can also be customized. “We are offering it as a platform that can be modified to suit the needs of a particular product,” he says. “We can also come up with a design from the ground up. There’s also the possibility of interfacing with smart devices, which could be worked on with a partner or customer.”

The device may also find utility in other markets. “Although our Dial-the-Dose product is initially developed for the pharma industry, it demonstrates Balda’s vision and capabilities to provide innovative, custom solutions for the pharma, diagnostic, and medical device industries,” explained Christoph Klaus, Balda’s CEO for U.S. operations, in a statement.

Balda has launched other dosing aids. At CPhI Worldwide last year, the company introduced the Smart Pill Dispenser, which employs Bluetooth technology for interfacing with iPhone 6 platforms through texts to caregivers. It also launched the Mini-Tablet Dispenser for tablets as small as 2 mm in height.

Innovations in glass ampules, vials, and cartridges may also be forthcoming, given Balda’s recent acquisition by Stevanato Group. “We have a history of working with pharma on plastic dispensers, and now we have the component of glass. The impact will be favorable,” says Paredes. “We’re going to bring a new set of service offerings to the pharma market.”

Paredes will present a case study about drug-delivery devices at the Pharmaceutical & Medical Packaging conference at EastPack on June 16th, and Klaus will take part in the panel discussion immediately following entitled “Macro Trends in Digital Technology + Human Factors: Combination Sensors, Apps, & Behavioral Science to Design for Emerging Markets,” which also features FDA’s Connected Health expert Bakul Patel, Eric Dessertenne of Biocorp, and Patty Britton of Thin Film Electronics ASA.

Balda C. Brewer will be exhibiting in Booth #1257 at the co-located MD&M East 2016 show June 14-16

Use promo code NY16PMPN to register to get your free expo pass. With that code you’ll also get 20% off the co-located conference Pharmaceutical & Medical Packaging conference on June 16th

Testing and sterilization support, integrated

Testing and sterilization support, integrated
Image of a burst test in process courtesy Nelson Labs

Plans for a “broader array” of testing services from Nelson Laboratories LLC are in the works, reports Jeffery Nelson, President. Recently acquired by contract sterilization company Sterigenics International LLC, Nelson Labs is integrating Sterigenics’s existing microbiological and analytical testing and consultancy SteriPro Labs, with all labs now operating under the Nelson Labs name.

“This is a reverse integration, combining SteriPro labs and consultancy into Nelson Labs,” Nelson tells PMP News. “For customers trying to get a sterile medical device to market, our availability to customers will now be greater. Prior to the acquisition, Nelson Labs’s operations were only in Salt Lake City, and now combined, we have 10 lab facilities worldwide. Sterigenics also has an additional 48 sterilization facilities in 13 countries across the globe.” The result could be what the two companies describe as “the largest fully integrated global sterilization and lab services firm in the world.”

Nelson Labs currently performs more than 400 microbiological and analytical tests, and SteriPro has been offering ten microbiological and analytical tests as well as consulting with customers on developing and optimizing sterilization solutions in the medical devices, tissue/implantable products, and pharmaceuticals and biologics fields.

Nelson says his team is now coordinating with their new partners to learn about the new locations, opportunities, and synergies. “We are working to become a more comprehensive solution provider for our customers,” says Nelson. “It will take us about 90 days to finalize our integration plans, but I’m already excited by the early prospects and opportunities that we are recognizing. The two companies have highly complementary values, and we are working to build an offering that can be a difference maker for our customers into the future. It’s gratifying for me to be a part of such a capable, global team, and I’m very excited for what we will be able to accomplish together.”

These discussions also include evaluating exactly what services to provide at their different laboratory locations, Nelson says. When asked whether the lab services division would be adding any new services, Nelson says: “I expect that we’ll be doing everything we can to offer more services. In addition to new geographies, we’ll continue to add complementary services to meet the full range of our customers’ needs.

“Sterigenics will be a great partner and will provide the global access and ongoing investment necessary to ensure long-term growth of the lab services business,” he says.

Adds Michael Mulhern, CEO of Sterigenics International: “This is a significant strategic acquisition to help build out Sterigenics’s lab testing and service capabilities on a global scale, enabling us to better serve our multinational customers. We will continue to explore additional expansion opportunities for our lab services to meet our customers’ growing needs. We are incredibly impressed with Nelson Labs’s leadership, culture, customer oriented service, and commitment to quality.”

Nelson will continue its work on the DuPont Medical Packaging Transition Project for DuPont Tyvek out of its Salt Lake City location. “We’re honored to be involved with this project,” says Nelson. “It’s going very well, with DuPont having received confirmation from FDA that their new Tyvek is functionally equivalent to the prior version.  It is really quite remarkable that DuPont put their customers in a position where most MDMs don’t have to revalidate their packaging. This created real time and dollar savings for our industry.” For more details on the MPTP, please see "DuPont MPTP team shares long-awaited regulatory news during webcast, explains plans for commercialization of Transition Tyvek.

For more details on Nelson Labs and Sterigenics, visit Booths #1838 and #1915, respectively, at the upcoming MD&M East 2016 show in New York City June 14-16

Use promo code NY16PMPN to register to get your free expo pass. With that code you’ll also get 20% off the co-located Pharmaceutical & Medical Packaging conference on June 16tha full day of presentations and panel discussions covering the latest in packaging standards and regulations as well as emerging packaging and drug-delivery technologies. Hear from FDA, USP, Pfizer, Perrigo, and other experts.

Are drones a viable package delivery option?

Are drones a viable package delivery option?
Will packages be delivered by drones soon? How will product packaging change to accommodate this type of handling?

In February 2016, Amazon CEO Jeff Bezos confirmed that the global online retailer will be testing the use of drones for package delivery in Canada, the U.K. and the Netherlands. The goal of Amazon Prime Air is to “get packages to customers in 30 minutes or less” and using drones for the last leg of product delivery might be the most time and cost effective way of doing that.

Other companies have drone package-delivery programs, too. Google expects its Project Wing to be up and flying by 2017. And Walmart has asked the FAA for permission to test drones for package delivery, according to the FlexPort blog.

Some markets seem to have a jump on FAA acceptance. Last summer, the aviation agency approved the first drone drug delivery service in Virginia from a company called Flirtey, according to Pharmacy Times.

We'd like to know what you think about this emerging technology and its viability as a package delivery option, especially as ecommerce shopping continues to grow at astonishing rates.

Please take a few minutes to give us your opinion in this short poll. Thanks.

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See a host of new ideas in packaging machinery, materials and more at EastPack 2016, June 14-16, in New York City. Use the promo code NY16PD to get free expo admission and 20% off conference passes.

DuPont MPTP team shares long-awaited regulatory news during webcast, explains plans for commercialization of Transition Tyvek

Four years ago DuPont announced plans to update its manufacturing process for Tyvek 1073B and 1059B. Mindful of the steps that medical device manufacturers must take when faced with a packaging material change, DuPont’s Medical Packaging Transition Project (MPTP) team set out to establish the functional equivalence of Tyvek 1073B and 1059B produced with the newer flash-spinning technology, now called Transition Tyvek. 

In an October 6 Webcast, the MPTP team discussed “lots of good news,” as Mike Scholla, PhD, global regulatory director, explained the implications of the U.S. FDA’s recent affirmation of the functional equivalence of the Transition Tyvek as well as the recent transition guidance from Health Canada. He also provided updates on working with Notified Bodies and on Japan’s new rules. 

Bruce Yost, PhD, global technical director, updated attendees on the latest test data results, while Karen Polkinghorne, packaging engineer and MDM specialist, and Meg Pyers, global marketing director, discussed DuPont’s plans for commercialization and on-going support. 

Scholla urged attendees to review FDA’s letter of affirmation, which states that "absent a specific request or notice from FDA or a risk analysis to the contrary, it is not necessary for medical device manufacturers to submit a new 510(k) or PMA supplement for a change solely in packaging from the Legacy Tyvek to the Transition Tyvek manufactured using the upgraded spinning process, including both coated and uncoated styles 1073B and 1059B."

Scholla also quoted the agency’s expectations of medical device manufacturers, which he described as “nothing new—you’ve been hearing us say these three things for four years now:”

  • Conduct a risk analysis to determine whether a premarket submission is needed due to a change in risk.
  • Implement change control procedures in accordance with Quality System regulation.
  • Document activities associated with the change and update Device Master Records with the rationale for acceptance of Transition Tyvek.

Scholla then walked attendees through the guidance from Health Canada, which provides MDMs with a form to complete by the end of the year depending upon their use of Tyvek.

Scholla also offered tips for handling submissions to Notified Bodies. Competent Authorities give Notified Bodies their rights, and each country’s Competent Authority has its own expectations and rules depending on that country, Scholla explained. Such differing expectations may result in varying requirements from Notified Bodies. “The first thing that is really important that you have to understand is that Notified Bodies are auditors; they are not regulators,” he said. FDA and Health Canada “changed the way they were going to handle regulatory submissions for the Tyvek transition because they are regulators and they have the ability and the right to do that. Auditors can only follow the rules, and their job is to assess your rationale and explanation and etc. So the first step is to have very specific discussions with your Notified Body regarding referencing reports or requirements to include reports.”

However, Scholla asked that the MDMs who participated in the MPTP studies (one of the 78 cells) “be mindful that the regulatory reports you received are confidential documents between DuPont, the converter, and device manufacturer, and to submit those to a Notified Body you need a release from DuPont and the converter or sterile packaging manufacturer. We have that mechanism in place, so we encourage you to respect that confidentiality and abide by it.”

After DuPont’s meetings with five Notified Bodies, Scholla noted that one of their major concerns was that some submissions by MDMs simply cite DuPont reports without any analysis on how they apply to specific medical devices.

Scholla also explained that recently passed guidance in Japan allows MDMs to take no action. DuPont has translated the new law and posted it to www.transition.tyvek.com.

Yost then gave an update on MPTP Industry Summary Reports, pointing out that six reports are currently available on DuPont’s Web site. These cover pre- and poststerilization test results; accelerated aging results (simulating one-, three-, and five-year conditions); one-year real-time aging; and an executive summary.

“These testing results indicate functional equivalence,” he said.

While reports for 7-year and 10-year accelerated aging are expected to be complete in 2016, Yost did share some interim test results. And additional new transition protocol material data can be found on DuPont’s Web site, he said.

“All the information on the www.areyouready.tyvek.com site as well as in the regulatory library will be remain available online at a minimum through the 5-year real-time aging industry report, which is scheduled for completion in 2019,” added Polkinghorne.

Polkinghorne then covered some steps for MDMs to take to before switching commercially available medical devices from Legacy Tyvek to Transition Tyvek.

DuPont is also extending the availability of Legacy Tyvek. “The U.S. FDA’s letter of affirmation . . . was DuPont’s requirement to begin selling Transition material commercially in the United States,” she said. “However, we do realize that due to some of these other regulatory submission requirements in other parts of the world and because of the current supply constraints, some MDMs may not be ready to transition. So to help MDMs work through these remaining hurdles from a regulatory perspective and as a result of specific customer requests, DuPont is extending the availability of Legacy Tyvek through June 2016.” She advised that MDMs contact their direct Tyvek suppliers (sterile packaging manufacturers) regarding their own inventory plans.

DuPont has not announced a specific date for the full discontinuation of Legacy Tyvek, she added. “It has not yet been determined, and it will depend on many, many factors. As we head into the middle of 2016, the exact timing and information associated with discontinuing that product will become a lot clearer.” DuPont will continue to communicate openly and often, she said.

MDMs who have developed programs supporting interchangeability among Legacy and Transition Tyvek may find some supply chain benefits, Polkinghorne noted, sooner than those who are continuing to need only Legacy products. “So we are encouraging everyone in the supply chain to work toward the goal of interchangeability,” she said.

The MPTP demonstrates DuPont’s significant commitment to the industry, Pyers noted. “Within DuPont . . . well over a hundred people across multiple functions over many years have worked on this,” she said.

The team answered several questions during the live Webcast, including several on submissions to Notified Bodies as well as on the commercialization of Transition Tyvek.

DuPont emphasized its plans for ongoing support. As Scholla explained at the beginning of the Webcast, “We’re not going away, and we’ve got stuff to do, and we’re going to be around to help you through the process.”

Please view the on-demand version of the October 6 Webcast as well as past events by visiting the Medical Packaging Community.

Package engineering grad’s next stop is Nestlé

Package engineering grad’s next stop is Nestlé
Packaging engineering graduate Erica Wysocki of Rutgers University shares her story.

Our third Rising Star of Packaging from the 2016 Rutgers School of Engineering in New Brunswick, NJ, graduating class is Erica Wysocki. Wysocki graduated May 15 with an Applied Sciences in Engineering with a concentration in Packaging Degree. You can find out more about her two classmate/friend Rising Stars at the bottom. 

Rutgers was a natural choice for Wysocki's education because, for as long as she could recall, she grew up rooting for Rutgers. For that she can thank her alumni father, but it was more than a bloodline connection that drew her to Rutgers.

“While researching engineering schools, I noticed Rutgers was always in the top for almost every type of engineering,” she says. “Rutgers was the obvious choice and I’ve never looked back.”

Tell us about yourself and your interest in packaging.

Wysocki: I am a senior at Rutgers University majoring in Packaging Engineering.  I have been very involved in the Society of Women Engineering for all 4 years of college and I have been on the e-board for Packaging Club. I also joined intramural sports teams as well as participated in many of the events held at Rutgers like the Mud Run, The Big Chill, and the Rutgers Unite Half Marathon. 

I went to Rutgers set on studying Civil and Environmental Engineering. Environmental science sparked my interest in high school and civil engineering seemed to be hands on, which I wanted. After learning more about packaging during my sophomore year, I realized it encompassed everything I was passionate about.  I learned more about the work they did and switched to become a packaging engineering major. 

What’s been your most valuable course?

Wysocki: That’s been manufacturing engineering. It is broken up into two semesters to learn about the wide variety of types of packaging and the processes necessary to make these packages. The course provides a good overview of what it takes to go from raw materials to distribution of final goods while teaching specific details involved in each step. This information helped during my internship at Nestlé where I worked under the Packaging team at the Freehold (NJ) Beverage Plant. I developed standard routines to improve efficiencies on the packaging line and performed a mass balance to determine quantity and location of powder losses in packaging process. I also conducted lab testing to validate an improved design of new jar closure by testing the secondary seal's moisture barrier. All this experience will help when working full-time in a manufacturing plant as well. 

What’s the general reaction from people who know you’re studying packaging? 

Wysocki: “You need to be an engineer to do that?”

I respond saying the technical skills of an engineer are needed to create packages.  The critical thinking skills that we learn and develop in school help during every problem-solving session I’ve done at work. 

What’s been the most surprising thing you learned about packaging?

Wysocki: I never realized the size and scope of packaging.  Once you become involved, you start looking at every product and package differently.  It was also interesting to learn what brands are owned by what companies.  As a consumer, it is not always obvious who makes the product. 

What aspect of packaging do see making an impact over the next 5 years?

Wysocki: I personally have always enjoyed working on sustainability projects.  I think overall, packaging has been able to make great strides in becoming more eco-friendly.  It will be fun and challenging to continue to decrease the carbon footprint packaging has on the world. 

However, in my opinion, the newest trend is consumer engagement.  With only a few seconds to capture the consumer’s attention in stores, companies strive to quickly attract the shopper with new technology.  New advancements in this area will consist of Active Packaging and Smart Packaging.  I’m excited to be able to start innovating new designs based on the latest technologies being developed.

What market segment in packaging interests you the most and why?

Wysocki: It was the cosmetic industry that initially caught my interest because of its luxurious looks and complex processes involved in making the package. However, the first co-op I had sent me to the food industry in Chicago and I fell in love. The food industry offers its own set of challenges and the familiarity with the products makes the work fun. 

What are your post-graduation plans?

Wysocki: After graduation I will be starting my full-time job at Nestlé.  It is a 5-year rotational program that allows me to try out multiple engineering roles, although ultimately I’m sure I’ll stick with packaging engineering.

Wysocki is available at [email protected] and through LinkedIn.

Wysocki (right) joins classmates Ann Cierpial (Co-ed packaging engineer graduates to L’Oreal), left, and Janina Pirela (Rising Star speaks packaging, engineering and 4 languages) as Rising Stars in Packaging and freshly minted Rutgers graduates heading into the work world.

Click here for more information on the packaging engineering program at Rutgers University.

Read about last year’s Rising Star from Rutgers University, Damen Soriente, in Engineered for packaging by Rutgers University.

And read our virtual reunion, Rising Stars shine a light on packaging education, which features our first six Rising Stars in Packaging.

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Interested in continuing your professional education in packaging? Join like-minded professionals at EastPack in New York City June 14 to 16 in New York City.

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