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Articles from 2017 In May


DuPont launches a new global strategy for medical packaging

DuPont launches a new global strategy for medical packaging
Image courtesy of DuPont

Medical device packaging has truly become a global endeavor. Given the international collaboration behind ISO 11607, many medical device packaging professionals have had a global view for years. But packaging requirements have been increasing around the world, thanks to the emergence of Europe’s Medical Device Regulations and the global interest in Unique Device Identification. Another globalization driver includes the sheer nature of the multinational medical device manufacturing industry.

To align with these trends, DuPont Medical Packaging is implementing some organizational changes and adding new team members to help support the medical device community, reports Lori A. Gettelfinger, global communications and brand leader, DuPont Tyvek. These changes unfolded as DuPont kicked off its celebration of the 50th anniversary of Tyvek. DuPont will be on hand at the upcoming Medical Design & Manufacturing East 2017 expo June 13-15 to discuss these changes and the evolution of Tyvek over the years.

“The medical device industry—and also the sterile packaging manufacturing industry—is trending global, so we said, ‘let’s go global’ in how we are resourced to support the industry,” Meg Pyers, global marketing manager for Tyvek Medical & Pharmaceutical Packaging, tells PMP News. DuPont is also integrating with Dow this summer, so she said “it’s an opportunity to better match how the market operates.”

Pyers points to the increasing globalization of the industry, citing as an example the path of one medical device: “A product is developed in Israel, materials acquired in Germany, manufactured in Malaysia, and shipped back to the EU for sterilization,” she says. “You have to achieve safety and sterility throughout. It requires a balance of innovation, safety, and cost.”

There’s also ongoing consolidation through mergers and acquisitions among medical packaging converters. “We want to be where the market is and support them,” she says.

Globalization isn’t new for DuPont. It has maintained a global team for years, serving customers in three regions: the Americas; Europe, the Middle East, and Africa (EMEA); and Asia Pacific. “We have been present in these markets with technical, regulatory, and quality teams, even if we haven’t been selling in them,” Pyers explains. DuPont is now deepening that industry support, particularly in developing markets, she says. “We have invested to educate and support industry, so we want to share our knowledge,” she says.

Leslie Love is now serving as global sales leader, and Jose Arevalo is coordinating a global packaging science effort as business development manager at DuPont Tyvek Medical & Pharmaceutical Packaging. DuPont is also increasing the number of medical packaging specialists on its team. “We’re bringing in people from industry from Boston Scientific, Smiths Medical, and Nelson Laboratories,” she says.

“The knowledge base in the United States and Europe is deep, so we are exploring how to bring knowledge and expertise to emerging markets,” says Pyers.

Pyers says there is a hunger for knowledge on “regulations and proven standards,” especially in emerging markets. “They want to learn how to compete internationally and follow international standards,” she adds. “Part of our role is to ask, ‘what can we do to help emerging countries scale up?’ They are moving at a faster pace and urgency.”

There’s also an increase in requirements around the world. In addition to the aforementioned EU regulations, India has new regulations phasing in July 2017, Pyers notes. “We want to help the industry execute them without too much burden,” she says. 

And there are new engineers entering the medical device industry. “We want to enable and equip them,” she says.

DuPont’s goals to deepen its technical support could be seen as a continuation of its efforts to support industry during the Medical Packaging Transition Project (MPTP), which provided data to regulators and industry on the functional equivalence of Tyvek 1073B and 1059B produced on new manufacturing lines. “We invested a lot in the MPTP team,” says Pyers. “Lessons learned included having a dialogue with FDA and other regulators. As you look at things, you develop a relationship with regulators, so there are no surprises at the end. We partnered to support the development of safe medical devices.”

In addition, because the MPTP involved deep technical analysis, it fostered the use of “evidence-based analysis” in the industry, which also plays a role in healthcare, she adds.

The DuPont team is now looking at “what is next for the medical packaging industry, such as package optimization and sustainability,” she says. “For instance, we support the HPRC [Healthcare Plastics Recycling Council], so we are helping figure out how to tackle the issue of waste. There’s complexity with comixed polymers and contamination. These are important issues to consider over the next 20 years.”

In addition, the healthcare system is dealing with “patient safety and healthcare-associated infections,” she adds. And she sees growth in biopharma and therefore prefilled syringes. “Zero particulates and proven materials” are in demand, she says.

“We can bring our science and innovation and help address these issues,” she concludes.

For more details, visit DuPont at MD&M East Booth #1629.

 

EastPack venue packed with technology, robots and surprises

EastPack venue packed with technology, robots and surprises
The New York City Advanced Design & Manufacturing (ADM) event will be brimming with an array of special features, hands-on workshops and more for engineers.

We unpack some of the fun, free and forward-thinking activities that are part of the package deal you’ll find on-site in New York City June 13-15 during the EastPack/Advanced Design & Manufacturing show.

The New York City Advanced Design & Manufacturing (ADM) event will be brimming with an array of fun features, hands-on workshops and "3-D printed" pancake pops that move well beyond the booth to enhance the on-site experience for attendees across the spectrum including those specializing in packaging and innovation. 

Here are some expo highlights:

Keynote Event: A Conversation with Steve "Woz" Wozniak

Tuesday, June 13, 12-1 pm

Visionaries with big ideas backed by the brains to make them realities are the lifeblood of the advanced design and manufacturing industry. That's why UBM is proud to feature Apple co-founder and icon of innovation Steve Wozniak at the East Coast's largest industry event in what promises to be a lively and thought-provoking keynote event: A Conversation with Steve Wozniak. Complete with an opportunity for audience Q&A, Wozniak will cover topics at the intersection of his passions and trends in the advanced manufacturing industry, including innovation and creativity, robotics and automation, wearables, Big Data, the Internet of Things and more.

As an aside, moderator Suzanne Deffree will live out her dream fully enabled with Woz facts and arcane details that may work their way into the proceedings.

Build Your Own Pick-and-Place Robot

In small groups, build a robot arm with 5 degrees of freedom and a gripper. The first team to construct the arm wins a prize! Space is limited to 24 participants on a first-come, first-served basis, so arrive early to secure the spot.  This 1-hour activity will take place in The Robot Building Lounge, found at Booth #2145, at 11am.

Robot Building Challenge & Bot Battle

Meet new people while showing off your engineering prowess in this exciting two-part free activity. In Part 1, participants are put into small teams to collaboratively build a robot in record time while Part 2 then pits the robots against each other in a series of head-to-head battles at Center Stage with teams vying for a grand prize. Space is limited to 50 participants on a first-come, first-served basis, so arrive early to secure your spot. Runs daily from 1:30-3 pm in The Robot Building Lounge at Booth #2145.

Part 2 Bot Battle is preceded at Center Stage by a special guest...

Meet SubZero from BattleBots

Don't miss the chance to get up close and personal with a TV star. Learn about the engineering and design that goes into developing a rough-and-tough bot for combat and hear tales from the arena in this Center Stage presentation from 12:30-1 pm on Wednesday, June 14. Plus, see the bot's battle scars up close at Booth #1984.

Other highlights:

The World's First 3D-Printed Electric Vehicle

Don't miss the world's first 3-D printed electric vehicle on display in the event lobby. The byproduct of an open-source contest and pure innovation, the Strati, courtesy of Local Motors, was manufactured after just 44 hours of additive manufacturing on a large 3-D printer, 10 hours of subtractive milling and assembly of less than 50 components. See this manufacturing marvel in person and behold the future of the automotive industry.

The Museum of Interesting Things

Marvel at the treasure trove of bygone technology that makes up the Museum of Interesting Things. Let nostalgia wash over you as you explore antique and obsolete technologies that paved the way for modern advancements in this interactive exhibit and associated Center Stage presentations.

Nerds and prizes: Geek Trivia

Let your geek flag fly high and join us at Center Stage on Tuesday, June 13, at 2 pm, to show off your superior nerd knowledge. Question topics run the gamut from famous innovators to sci-fi to engineering. Win valuable prizes and bragging rights!

3D-Printed Pancake Pops

Start your day off right by picking up a "3D-printed" pancake pop in the lobby as you head into the expo halls. See the artistic flair and additive process of the PancakeBot.

https://www.youtube.com/watch?v=ZVUtOindQBo

Workshop: Build a 3D-Printed Prosthetic Hand for Charity

Make connections while making a difference and put your engineering skills to work for a good cause while meeting new people in this free and fun hands-on workshop. Using provided instructions, you'll collaborate in small teams to build a fully functional 3D-printed prosthetic hand. All hands are customized to recipients and will be donated to children in need through the charitable e-NABLE movement.

This 90-minute free workshop, produced by Corporate Motivation, runs daily from 1:30-3pm in the Hands of Gratitude 3DP space at Booth #329. Space is limited to 40 participants per session on a first-come, first-served basis, so arrive early to secure your spot.

For more information on all of the above and more, visit http://eastpack.packagingdigest.com.

Transparent Container Company Improves Production Time with New Heidelberg Dymatrix 106 Pro Die Cutter

Transparent Container Company Inc., an industry leader in retail packaging solutions, has added a new Heidelberg Dymatrix 106 Pro high performance die cutter to its growing list of recent equipment acquisitions. The Dymatrix 106 Pro is perfect for a variety of applications ‐‐ from short to long runs and from complex layouts to just‐in‐time packaging production. It has a maximum sheet size of 76 X 106 centimeters (29.92 X 41.73 inches); can handle paper, cardboard and corrugated board; and has an operating speed of up to 9,000 sheets per hour.

When it comes to sustainable packaging, embrace the fear

When it comes to sustainable packaging, embrace the fear
Fear of change can be a powerful motivator of innovation. Put it to work for you.

We don’t have to remind you that the packaging world is being shaken by many large-scale trends:

• The continued drive by legislators, non-government organizations (NGOs) and consumers for increased sustainability and waste reduction.
• Digital transformation and e-commerce shifting power across the value chain.
• Massive CPG consolidation that reduces jobs and increases uncertainty.
• Ongoing globalization and emerging market growth.
• New materials that challenge existing recovery channels.

Separately and together, these trends represent something that makes most of us afraid: change.

We hate change. Why? Because we’re addicted to the present, to the status quo. It’s comfortable. It’s predictable. It’s navigable.

But, here’s the thing: Change is coming.

And you know it. In fact, fear is your mind’s way of telling you it’s coming, because your unconscious has already accepted it. Otherwise, you wouldn’t be afraid.

Plus, the more you fear, the more certain you are deep down that things will be different. Possibly very different. Possibly very soon.

Don’t run from the fear.

Swallow it. Embrace it. And most importantly, use it.

Instead of mourning the past, celebrate the future. Envision what can be, rather than what is.

When you do so, you’ll turn the negative energy of fear into the positive energy of success. Why? Because innovation happens when we define, re-define, and solve problems and face our fears in both big ways and small.

Retort and aseptic packaging are examples of changes that created fear and uncertainty. So are the introduction of biopolymers and new package convenience features that enhance ease of use (think resealable closures). All started with a desire to create something better by solving a problem, enhancing existing benefits, or both.

Many have said, "If it ain't broke, don't fix it." They were content with the status quo. But visionaries embraced uncertainty and channeled their energies to imagine and create a future of possibilities.

So, if you want to protect and grow your packaging business, the first step is simple. But it’s also hard.

Face your fear. Admit that change is coming. Welcome it. And use it to prognosticate, invigorate, motivate and innovate.

Remember: Your most valuable asset doesn’t operate between your factory walls. It operates between your ears. Use it well and use it wisely.

Authors Robert (Bob) Lilienfeld (left) and Brian Wagner are senior directors at AMERIPEN, helping the packaging industry shape and benefit from the future. Lilienfeld has been involved with sustainable packaging for more than 20 years and is currently editor of The ULS (Use Less Stuff) Report.Wagner’s 30-year professional career as an entrepreneurial business and technical leader spanned Packaging Technology Integrated Solutions (co-founder of PTIS), Kellogg's, Sara Lee, Multiform Desiccants, Carton-Craft Corp., Burger King and General Foods.

Photo credit: Designed by Freepik

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Learn what it takes to innovate in the packaging space at EastPack 2017 (June 13-15; New York City). Register today!

Augmented Reality app complements egg carton redesign

Augmented Reality app complements egg carton redesign
Vital Farms' organic eggs redesign combines a distinctive design with clarity for key points.

Vital Farms’ atypical egg carton design shakes up the dairy category while raising consumer engagement through packaging-enabled Augmented Reality.

With consumers having an ever-stronger voice, packaging is increasingly at the forefront of labeling and transparency discussions when it comes to their purchase decisions.

Laying claim as the leading producer of pasture-raised eggs in the U.S., Austin, TX-based Vital Farms is taking labeling transparency a step further with an updated design that leverages the interactive power of smartphone-enabled augmented reality.

Amidst a background of confusing labels crowding egg shelves, Vital Farms’ goal was to create a unique, easy-to-read label design that highlights exactly what consumers are getting when they make a purchase: Pasture-raised eggs that are tended by hand on small family farms, from hens that are free to forage on 108 sq ft of space per bird, all day long, all year round.

"Historically our eggs have been popular in natural foods stores such as Whole Foods, but with today’s growing market for humane, ethically-produced foods, we’ve seen a huge increase in demand by consumers who are just now starting to buy more natural goods,” says Dan Brooks, creative director, Vital Farms.

Brooks notes that the company’s packaging designs have continuously evolved, but the most recent versions had been on shelves for almost 2 years.

The current redesign phase has focused on the egg cartons, and currently for the USDA Organic version as seen above. The Alfresco was done earlier this year as more of a refresh of the previous look that's been in-market since 2014 with new (top) and old (bottom) shown stacked below:

“Because we are streamlining our product range, we seized on that as an opportunity to create a more ubiquitous design aesthetic and brand hierarchy across our product range,” he notes. “We wanted to capture the same general aesthetic as we’d created for the black carton ‘Alfresco Eggs,’ but distinguish the Organic product as being more premium. The challenge was to find a look and feel that conveyed this, as ‘black label’ products are typically a brand’s premium label. By separating out the design elements into the key components we found a solution using a hand-painted look on kraft paper. The result felt familiar enough, but expressed the identity points we needed to make: premium, hand-crafted—associated with organic—and consistent.”

The new organic carton is a dramatic change from the colorful cartons used previously as seen below.

“Moving to this design involved a huge change in direction, but allowed us to more closely follow a design hierarchy that we had established with Alfresco in 2014,” says Brooks. “That redesign rollout was done by renowned chalk board artist Dana Tanamachi to create the now-iconic design. Since then have continued to work with her on that label as it has been modified.

“For this, our largest product redesign ever, we also engaged with Wes Woodell of Woodell Design to both project manage and create a more consistent brand and message hierarchy that we could implement across all our labels. Wes interfaced with our internal team to produce a solid framework, then briefed Dana against that.”

Brooks says the chalkboard approach conveyed a “farm-to-table” on-carton messaging with graphics and copy that spoke to the company’s philosophy and farming practices.

“It was both aesthetically pleasing and honest and transparent,” he adds. “What is written on our carton truly reflects how we farm.

“For the new organic design, we decided to pare down the messaging a little as befits the kraft look in comparison to a black chalkboard look.”

Finding the right balance of substrate and colors was difficult, Brook says. “Running counter to mainstream design evolution meant we had to really feel good about every part of the carton design. We’re not only looking for a design to jump off the shelf, we’re looking for an idea that connects with the consumer in a meaningful and authentic way.”

Augmented Reality reasoning

That consumer connection is solidified in a virtual sense with the AR app done through a partnership with ROAR. Because of the vendor’s proprietary image recognition technology, no changes were required to the packaging so the experience was seamless for the brand. The AR interface was enabled for the Alfresco product in February after Vital Farms uploaded its graphics artwork to the Roar website.

Brooks explains the brand’s use of the AR application.

“One of the challenges we constantly face as a brand is communicating to our customers what the space that we provide our hens ‘looks’ like by comparison to other egg label terms such as free-range, cage-free,” he says. “Knowing that AR experiences are becoming more common, we thought it would be fun to have the top of the carton lid represent part of our pasture so that customers could experience for themselves how much more space our ‘girls’ get to play in!

“This allows consumers to use the app to scan the top of the Vital Farms carton to uncover a virtual reality diagram of what a pasture-raised environment really looks like—further driving home the importance of purchasing pasture-raised eggs vs. any other category.  There will also be coupons available through the Roar app for users to receive an instantly redeemable coupon.”

The app is downloadable for either iphone or Android platforms for free at Roar.

On AR, hens and Pokemon

Vladislav Draganov, Roar’s business development manager, says consumers scan a package to see additional information about the product.

"They discover interactive AR experiences and can watch a fantastic brand video, follow a link to the company’s Facebook page or see a 3D model product view like Vital Farms used that shows the hens in a pasture,” he says. “With Roar, no QR code is needed—any physical asset can be scanned.” The assets are housed at Roar once a company such as Vital Farms is registered.

“Creating AR experiences should be easy and simple, which is why we built our platform for non-technical users,” he explains. “Once the AR experience is created and published on our website, it's available for a public launch.” He notes that it can take as few as 5-10 minutes to create an AR experience, subject to availability of the digital assets.

However, Vital Farms, which used 3D view, images and actions buttons such as coupons and Facebook likes, took several weeks to create the experience ahead of the campaign launch.

“Creating an AR experience on our website is free,” says Draganov, pointing out that Roar does not charge monthly fees, but instead uses a pay-as-you-go model.

The Roar database currently contains markers for thousands of food products and beverages, he adds.

Draganov says that interest in AR has increased following the wildly successful Pokemon Go campaign. “CPG brands see the great potential the technology has,” he points out. “You’ll see more uses by major brands like Apple that are making bets on augmented reality with Facebook and SnapChat aiming to bring the technology to the masses.”

Vital’s final thoughts

In Brooks view, the design is anything but lazy. “In a market space where the lazy design option is to show some version of hens out on grass, regardless of how misleading that may be for some brands that use that approach, we’ve gone the other way,” Brooks says. “ By focusing on what our brand ‘means’ we’re letting our customers discover the product for themselves, and connecting them via design rather than by images which anyone can use.”

By the end of 2017, Vital Farms pasture-raised eggs will be available in about 10,000 stores nationwide, including Whole Foods Market, Kroger, Target, Walmart, Publix, Sprouts and more.

Connected dispenser could transform ophthalmics clinical trials

Aptar Pharma and Kali Care are partnering to track patient adherence with ophthalmic drug regimens during clinical trials. Kali Care has developed a digital monitoring system for ophthalmic medications that Aptar Pharma will deploy on its drug dispensing solutions.

Silicon Valley-based Kali Care has developed a monitoring solution that integrates smart sensors, data analytics, and cloud services, allowing clinicians to collect real-time data.

Aptar Pharma offers a range of dispensing technologies. The company recently supported Allergan’s launch of what Aptar calls the first FDA-approved prescription preservative-free ophthalmic multidose product (Restasis MultiDose).

According to a statement issued by Aptar Pharma and Kali Care, the ability to see the medication adherence score of patients with glaucoma could be a powerful tool for managing treatment plans. “The Kali Care Adherence Score provides critical information for explaining the incongruity between recommended treatment and actual treatment outcomes,” it states. Such an understanding could result in shorter and more efficient clinical trials.

“Clinicians are now able to rely on objective and accurate data,” reported Salim Haffar, President of Aptar Pharma, and Sina Fateh, MD, Founder and CEO of Kali Care, in the joint statement. “Aptar Pharma’s leading dispensing technologies combined with Kali Care’s smart sensors, data analytics, and cloud services will help make clinical trials more efficient and effective. This allows ophthalmologists to improve risk strategies to distinguish patients requiring minimal support from those who require closer monitoring.”

Fateh added that because Aptar Pharma is well-respected for its proven regulatory expertise, this will help his company move forward through approval and compliance processes.  

For more information, visit aptar.com/pharma. Aptar Pharma exhibited at Booth #3102 at CPhI North America May 16-18 in Philadelphia.

User-centered design will be one of the major themes at the upcoming Medical Design & Manufacturing (MD&M) East 2017 conference in June. Check out these sessions and more:

To Err is Human, But How Do You Prevent It? Speaker: Michael Wiklund, General Manager, Human Factors Engineering, UL LLC, Wiklund R&D

Panel: What Does Usability Mean Today for Medical Device Engineers? Moderator: Stephen Wilcox, Principal, Design Science; Panelists: Daniel Kosoy, MD, Partner, Athenian Venture Partners; Jim Lebret, MD, Physician, New York University School of Medicine; and David Brick, MD, FAAP, FACC, Clinical Associate Professor, New York University Medical Center

5 ongoing challenges for UDI

5 ongoing challenges for UDI
“Control the input and management of auditable data through a life sciences specific and adaptive master data management system (coalescing database),” says Ardi Batmanghelidj, President and CEO of Innovatum.

Many of FDA’s Unique Device Identification requirements have already phased in. The labels and packages of Class III and Class II medical devices, for instance, must now bear a UDI.

“But UDI is not over,” says Ardi Batmanghelidj, President and CEO of Innovatum, a software and regulatory consulting company specializing in life science labeling and Unique Device Identification (UDI) compliance. “In contrast, it is just beginning.

“Although many medical device manufacturers have complied, on-going maintenance for previously submitted UDI data will soon be enforced,” he tells PMP News. “And the regulatory requirements of UDI variants by regulatory bodies around the world will continue to make global UDI compliance a challenge for quite some time.”

Batmanghelidj explains 5 common UDI challenges and potential solutions.

Communication. One of the challenges arises from miscommunication of labeling data. “Most medical device manufacturers inexplicably approach UDI by separating it into two different projects that are managed by two different departments,” Batmanghelidj says. “The labeling team is responsible for UDI data on the label, and the UDI team is responsible for UDI data management and submissions. Yet, most of the data overlaps and must be kept in sync! Think of a row in an Excel spreadsheet that contains fields with labeling specific data for an item. Now think of adding additional columns to house regulatory data within that same row. Since some of the data within that row is placed upon sticky labels and some of that very same data is also being submitted to regulatory bodies, this data can be stored once and reused. This ensures data quality. The problem of having to prevent a likely mismatch between the information that is submitted and the information used on the label is now gone. With an extension to what is traditionally considered to be enterprise labeling software, it is now possible to bring these capabilities to life.” 

Using a common enterprise labeling software systems could promote better communication among packaging and labeling professionals. “Packaging and labeling is most often a symbiotic relationship. It is surprising how much cross training and mutual understanding of related business processes exists between these individual realms of expertise. But can software increase the synergies between these groups even further? Enterprise labeling software systems (ELS) provides incredible benefits to both groups by spanning cross functional needs with data that is common to both pursuits.”

The key is to “control the input and management of auditable data through a life sciences specific and adaptive master data management system (coalescing database),” he explains. “Life sciences specific extensible data management that is an integral part of an ELS allows this to happen. Each group gets a functional window into the approved data belonging to the other group. But that data is not limited to a small number of groups. It's reach and value can easily be expanded to other departments for other related pursuits. Packaging specifications, materials, sterilization approaches, etc. can be communicated across departments and corresponding label types and symbols can be assigned and managed utilizing online data access instead of Excel spreadsheets and emailed input forms.” 

Integration. Integration can also be a challenge, so it requires careful consideration, Batmanghelidj says. “Not just the technical considerations that surround the way that each integration will be accomplished, e.g., push vs. pull, direct or through an intermediary, etc.,” he explains. “At a much higher level, one must consider the number of integrations that medical device manufacturers are being asked to make and at what point will it make sense to make just one integration. An integration that will allow all future communications needs to be satisfied from that one integration. Various supply chain partners subscribe to various data pools. Many of those data pools have unique communication requirements. Implementing and maintaining specific integrations to specific data pools to satisfy various supply chain partners are difficult and expensive to sustain. It makes more sense to get all data that needs to be communicated into a coalescing database first. Once the data is coalesced and available, plug-ins can be used to communicate according to the guidelines of various protocols. Flexibility is optimized, and the need to revalidate the entire system with the addition of a new supply chain partner is eliminated. Integration now becomes plug-in installation.”

Data Management. Data management can bring up issues, too. “The primary data management issue with UDI is deriving and maintaining a single source of truth," Batmanghelidj says. "Data validity and synchronization through reuse play a key role in ensuring that data being submitted and data being placed on the label match each other. These factors have much bigger implications when looking at the bigger picture.”

And “without a coalescing database, UDI will continue to create the greatest challenges for data management that medical device manufacturers have ever encountered,” he believes. “Excel has sufficed in getting companies to a starting point of compliance. The real challenge now is data maintenance and sustainability through reuse as other regulatory bodies around the world begin to announce their variations on the U.S. FDA UDI approach.”

Location. Many of today’s medical device companies have more than one location or entity involved in supporting UDI, potentially in more than one country. Multiple players can compound the aforementioned challenges. But strides are being made in helping medical device companies address destination labeling, localization, and globalization challenges, Batmanghelidj says. “Company divisions, contractors, suppliers, etc. can safely and effectively manage their own data through a browser, and this idea is truly revolutionary,” he says. “Built-in task dependency management and reporting, as well as granular auditability for changes to data, make the ‘manage the data that you are responsible for approach’ practical. Beyond the input and upkeep of data, great strides have been made in the ability to exploit the power of data in storage through interesting new associations. Versions of electronically stored documents can be associated with versions of item information and changes can be automatically reflected in the electronic posting of documents such as electronic instructions for use (eIFUs).”

Security. Thankfully, security doesn’t seem to be a huge issue for UDI, according to Batmanghelidj. “To date, security issues brought about by UDI have largely been a product of perception. A copious number of responses to initial drafts of the UDI rule ensured that information that could be used to a competitor’s advantage has been kept off the list of GUDID product attribute submission requirements. What remains is the level of confidence that medical device manufacturers have that data pool providers will maintain the confidentiality of their production data. Some companies go as far as to not trust data pool providers to submit to the GUDID and also share related production information with their supply chain partners. These medical device manufacturers have opted to set up separate threads of communications.”

Innovatum offers the ROBAR family of products to help with label design, management, and printing; regulatory data management and submissions; and eIFUs. “A comprehensive approach to labeling necessarily involves the sharing of data for the management of closely related pursuits,” Batmanghelidj says. “ROBAR is a robust enterprise labeling software system that includes a tightly integrated series of modules. These modules can be used in unison to manage the full labeling life cycle using shared data.”

ROBAR also includes a coalescing database, “and this opens a world of possibilities,” Batmanghelidj adds. “With an emphasis on a coalescing database at its core, the ROBAR family of products includes column level controls for data so departments, contracts manufacturers, and subsidiaries can fill in and maintain their own data. This capability streamlines and synchronizes both labeling and regulatory data. Label design and print integrates industry leading BarTender technology yet controls it in a 21 CFR Part 11 (title 21 of code of federal regulations) compliant way. Automated approval workflow and electronic submissions are made available at the click of a button. And eIFU management and posting is automated with information, which is correlated and synchronized from the coalescing database.”

For more details, visit www.innovatum.com.

 
Don't miss the 2017 MD&M East Keynote Speaker: Steve "Woz" Wozniak Co-Founder of Apple and Chief Scientist at Primary Data. He'll be speaking June 13, 2017, at 12:00 p.m. at New York City's Javits Center.

 

What story does your recycled plastics tell consumers?

What story does your recycled plastics tell consumers?
So you're using recycled content in your plastic package...what is its story?

If branding is all about telling a story, generic post-consumer recycled content may be lacking in that department. Sourced from recycled material suppliers selling resins aggregated from one or many municipal recycling facilities, generic recycled materials (that is “rPET” or “rHDPE”) contain plastic from many different types of products and packaging, come from any number of places and have no traceability back to the original product or where the material was generated or collected.

Identifying the key values that drive significance with customers and consumers is a huge factor in crafting a narrative. Many companies branding for sustainability have publicly stated goals and have made commitments to increase the amount of post-consumer recycled (PCR) resins in their product packaging. This is because one of the most important factors consumers cite in their selection of eco-friendly products is the use of recycled content

Branding shapes public perception and enables consumers to make connections. It is the critical human element distinguishing businesses and brands from competitors in the marketplace. But one of the greatest challenges companies face today is creating and effectively communicating a narrative that inspires trust and demonstrates authenticity. Today’s consumer is highly discerning, increasingly concerned with things like supply and production chain sustainability and product recyclability, and highly allergic to ethical claims that are inauthentic, vague or misleading.

What kind of story does a company tell by using generic “recycled materials” that the consumer cannot connect to?

Enter “storied plastics,” PCR with a history. Recycled resins sourced by waste stream and sorted by material type (that is “recycled beach plastic” or “recycled cosmetics packaging”), “storied plastics” carry a narrative and can be traced to point of origin. At my company TerraCycle, we specialize in the capture and collection of common but difficult-to-recycle streams like personal and beauty care packaging, juice and snack pouches, water filters and more, putting us in the unique position to supply to manufacturers dozens of different storied plastics, sourced from our many collection streams.

The models we have developed to collect traditionally non-recyclable waste include free, nationwide programs, in-store retail activations and city-wide programs, to name a few. Because TerraCycle has found that nearly every waste stream can be recycled for use in new products, the selection of storied plastics available are varied, the possibilities endless. But what these resins all have in common is that they have the critical elements that people can connect with and want to talk about because we engage directly with the collectors and collect pure waste streams.

There remains a “green-gap” between turning changing attitudes into actions despite consumers increasingly reporting that they are more likely to patronize companies committed to making positive social and environmental impacts. Cost is one prohibitive barrier to more sustainable purchases and habits since many consumers are of the opinion that eco-friendly products cost more money. The thing is, they often do—sustainably sourced content, quality materials and more arduous, but quality, production processes tend to drive up costs. Thus, to market sustainability in a successful way, consumers must see sustainable products as comparable or exceeding standard market products in the functional, emotional and social benefit areas.

Many consumer packaged goods (CPG) companies today are using PCR, but using storied plastics provides the exceptional opportunity for manufacturers and major brands to differentiate and command a premium. The traceable, “origin story” component of material comprised of products and packaging people have interacted with in their own lives can be communicated clearly and effectively to today’s consumer, who will find value in their ability to relate to the product and the story behind it.

Consumers seek reward by buying products and using services that they believe say something about who they are. It is possible to make authentic, lasting impressions in your sustainability branding and circular business practices through the use of storied plastics. Recycling is one of the most accessible and easily understood aspects of sustainability, and most consumers have experience with the process, but have little connection to where their recycled items go; storied plastics provide the opportunity for brands to be that connection.

Author Tom Szaky, founder and CEO of TerraCycle, has won more than 50 awards for entrepreneurship, writes blogs for Treehugger and The New York Times, published a book called “Make Garbage Great” in July 2015 and is the star of the television show “Human Resources.”

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Learn about the latest developments in sustainable packaging at PackEx Toronto 2017 (May 16-18; Toronto, Ontario, Canada). Register today!

5 advances and packaging trends in the beauty universe

5 advances and packaging trends in the beauty universe
New packages, tools and technology are transforming the cosmetics market.

From new beauty tools like application sponges to a digital era that powers personalization and customization, the cosmetics market is leveraging innovation in packaging to delight consumers.

The cosmetics universe is always looking for innovative products. From all over the world, new trends and new packaging materials are providing ideas for new products [1-see references below].

Global cosmetics trends differ a bit by country: In the U.S., for example, the emphasis is on perfect skin, as labeled by Hollywood stars; Italians wonder about green and sustainable cosmetics; Germans are pragmatic and seek natural beauty and practice; in the UK, the main importance is on following the dictates of social networks (appearance reigns supreme); and the Japanese mix high-tech, efficiency and tradition.

One major global trend in cosmetics is the burgeoning market for men [2]. In prestige and mass combined, men’s global skincare sales grew 6.9% to $3.5 billion, a mere fraction of the total global men’s grooming market of $34.4 billion, according to Euromonitor. A lot of innovations in the men’s category are coming from Asia, as that remains the trendsetter for skincare. Despite a slowdown in the Western market for prestige men’s skincare, the market grew by double digits in Asia last year. For the men’s market, brands have a high level of expectation to emphasize control, performance and mastery.

At first, as the main purpose, packaging must contain the product, and separate and prevent it from touching or being exposed to the environment. As a second purpose, packaging must protect the product and prevent any physical damage. And now, packaging also must consider branding, distribution control and anti-counterfeiting [3, 4].

Packaging has a huge impact on all products (82%) and particularly for cosmetics (92%), according to a study from the observatory of packaging presented at WordPack 2014. Looking to the levers of innovation for the next two years, three have been identified: Sustainability, 59%; Ergonomics, 52%; and Protection and Transportation, 41%.

Plus Materials (48%) and Wording (20%) are particularly important for cosmetics packaging.

1. Combining form and function

For a long time, design has been associated with the look and the form. But in the mid-2000s, it appears associated with the function, so it adds value to the product.

Design encompasses ease of use and product performance—and it is essential for cosmetics. Some specific systems are much more than packaging, because they can change the product formulation [5]. For example, with a spray or foam, the physical form of a product can be modified. With a spray, the main ideas are to disperse the droplets, to create jet, to scatter the particles. With foam, there is production of small bubbles of gas, the gas is suspended in a liquid, there is effervescence, it can fizz or form bubbles [6].

Definitely, an aerosol is much more than just a package, because it is a pack that contains, protects, delivers a dose and is allowed to modify product textures. Sometimes it offers new sensations associated with visual and audible interactions.

With an aerosol package, a liquid-like substance can vary from the food area (liquid in bottle) to the care product area (water in spray) [6]. An aerosol spray uses gas or a mechanical pump process and can improve the product application on a larger surface easily (say, for perfume or sunscreen). The spray can modify the texture of product because gel, cream or foam can be created with this packaging system. Many new high-tech pumps empower the user to transform liquid formulas in a single press to produce a greater volume of luxurious foam that spreads easily onto the skin (foam color) (see Figure 1: Spray and foam examples).

Figure 1: Spray and foam examples.

Another clever package—the airless system—provides real safety to the formulation. An airless system is define as a tamper-proof unpressurized delivery system that associates a manual (mechanical) actuation pump with a container that, after filling and closing under vacuum conditions, delivers the product without air return.

The container, deformable or rigid, may be fitted with a piston or pouch, according to thedefinition proposed by Airless Pack Assn. (APA). An airless distribution system delivers and protects the product from all contaminations, such as oxidation, microbial attacks and pollution by allergens [7, 8]. Airless offers many benefits: a high product restitution, smoothness of pump and ease of use: in one push  it’s done, with a possible distribution of 360-degrees, a precise and constant dosing, for a range of formulas, including viscous and unstable ones [9].

Airless systems have always been popular for the cosmetic market. Historically, the first airless systems appeared for toothpaste and were developed some years later for cosmetics. At first, airless packages were used for high-value products (to protect active cosmetic ingredients from oxidation). In 1996, airless packs using a pouch arrived and became more affordable. Now, airless packages are used for mass-market products. The technology also meets a real need for protecting natural and organic products.

A lot of new ideas are arriving, because airless allows new formulations that avoid preservatives. Definitely, airless systems have the wind in their sails with a market growth rate of 10% per year and 700 million units for cosmetics and pharmaceuticals. Main airless systems are: piston (85%); airless tube (8%); airless bag (6%); and airless jar (1%) [9].

Airless packaging [10] can use two to five times fewer preservatives—or totally avoid preservatives—from formulas. Airless allowed imagining and producing a new range of “sterile dermo-cosmetics.” There is sterilization throughout production, and the containment system guarantees the product remains sterile during its whole use.

The airless market is an aggressive sector with many innovations, such as new push-buttons that close as soon as the dose is delivered; new pumps; and clear containers that showcase the formulations (see Figure 2: Examples of innovation in the airless market) [7,10].

Figure 2: Examples of innovations in the airless market.

Sometimes the formula doesn’t require such a high degree of protection but brand marketers still choose an airless package because it’s an attractive container with a functional applicator. It is also easy, safe and quick in use.

2. Helpful tools

First there was an evolution in brushes. Now there is a real partnership of tools. Various new cosmetic products are specifically made to camouflage, contour and sculpt. Brands create brushes that meet a make-up product’s functionality and can be flexible in any position, or in various shapes that combine ergonomics and design. Rotating brushes are available and enable everyone to blend like a professional [11, 12, 13].

New tool materials are also helpful, like silicone used in various shapes and surfaces (smooths or textured). New “all-in-one” products allow deposition and application, like the patented microbristle applicator system (MBA) from Geka.

In the world of sponges, products can bedesigned for better functionality. Sponges apply product but also contain make-up. This is the new world of cushion, a tendency (once again coming from Asia) that comprises a spongy formula applied to the face with a pillow, which provides easy and flawless coverage [15]. Products now have multiple functions, with an added bonus of integrated sun protection (SPF), wrinkle prevention and antibacterial properties (see Figure 3: Tools with various shapes and materials).

Figure 3: Tools with various shapes and materials [1, 13, 14, 15].

 

Packages that contain and apply are another great tendency for cosmetics and, in the world of tube and applicators, a great diversity can be found with integrated pumps that allow adjustable side actuation and continuous formula dispensing.

3. Crossover ideas

Packaging from different fields (food, pharmacy) could deliver innovative systems for use with cosmetics. The idea of caviar for cream seems suitable with pearl delivery systems that keep various formulas separate to protect fragile active ingredients. However, packaging can move from the food market to cosmetics with sometimes dangerous ideas. Shampoos that look like a fruit juice pack or cleansers that mirror whipped cream containers can cause confusion, which can lead to problems for children.

Healthcare packaging is always in fashion. Pharmaceutical blisters and droppers can add a lot to cosmetics. Definitely, droppers give cosmetics a lot of new functionality. For example, airless droppers deliver a safe and precise dose of products, and twin-and-mix droppers help consumers reconstitute a formulation just before its use. We’re now seeing simple patches for cosmetics and make-up for nails and eye-liner (see Figure 4: Interconnections from pharmaceuticals to cosmetics) [1, 16].

Figure 4: Interconnections from pharmaceuticals to cosmetics.

Many interconnections from other markets provide interesting ideas for cosmetics—like pencils coming from schools and offices that are currently used for make-up or nail art.

4. New movements

Cosmetics marketers are thinking differently these days about their products and their uses. One great evolution in the nail area is not only new colors, but also textures of nail polish. “Nail art” has developed as a true fashion statement and presents beneficial seasonal opportunities for suppliers to create innovative products in this area.

Regarding hair care products: foam, creams and gel improve hair care. But how about hair perfume? Or specific make-up for hair, such as a new root concealer packaged as an eye shadow? Definitely, on that target, new proposals are arriving with interconnections from make-up. (See Figure 5: “Nail art” examples.)

Figure 5: From nail art to make-up for hair or new sampling packs.

New materials can add various functionality to the packaging, allowing consumers to heat the product just before use, or acknowledging the consumers’ nomadism (such as lipstick that opens with one hand, or an on-the-go package that blends formulations and lets consumers use them where and as they want) [17, 18, 19].

For sampling, cosmetics companies have created clever systems for perfume and make-up. Printed spray samples are used for olfactory marketing, connecting to ideas in a scientific study from the Rockefeller center that revealed human beings can remember 35% of what they feel (only 5% of what they see and 2% of what they hear). This neuro-sensorial marketing approach uses a camera in real time to see the impact of brands on the consumer’s face. And the tests are not in a lab, but in real shops. The neuro-marketing approach uses physiological measures, and analyzes target audience (conscious/unconscious) levels (such as a sensor that can measure on a smartphone the parameters of wellbeing on a woman who breathed a perfume).

5. Impact of the digital era [1, 20, 21]

We are living in a digital era and, for at least 10 years, people have widely integrated the internet into their daily lives. This huge development of a simplified digital world (affordable prices, simplified access) helps people consider computers as a part of their universe, which can facilitate exchange (between generations, scattered families)and the knowledge in all fields.

It is not a short fad but definitely a mutation. Going digital in all fields (including beauty and cosmetics) leads to a real change in consumer behavior: with ecommerce (40% growth estimated regarding sales figures for L’Oreal first half 2015);blogs or “vlogs” (video blogs)that stimulate sales; and “click and reserve,” a hybrid trade between physical sales and web which is developed by brands.

There is also the use of digital tools that modifiedas a revolution—the relationships between brands and consumers. Various personalized skincare devices let consumers take control of their skin. Smartphone and tablet applications with similar principles: Take a photo and add different colors for hair or various face make-up (such as lip gloss or foundation)—and virtually test different make-up [22]. Digital packaging enables people to create their own customized package on line by choosing color, for example, or a message or video.

Digital can also help consumers diagnose their skin with new measuring devices, like a cosmetic shape memory mask with sensor that can identify the level of face hydration. After analysis, the mask triggers a boost effect on demand, enhancing the effect of formulation applied under the mask.

Following the era of electronic tattoos (that is, non-invasive and flexible medical patches for monitoring health [23]), L’Oreal introduced at CES 2016 the connected “MY UV Patch,” a flexible 2.5 cm2 patch, no thicker than a simple electronic circuit, with photosensitive elements that react to exposure to UV radiation. The color of the patch changes depending on the exposure time. The purpose is to protect consumers by educating them on best practices regarding exposure to the sun [24].

Another system is a “Nespresso-like cosmetic machine” that ingests small capsules with different functions (such as for hydration or anti-ageing) and mixes them into a bespoke serum. This allows consumers to personalize their care depending on age and skin specificities [25]. For manufacturing make-up, 3D printing can be seen as a new way for producing either cosmetic make-up or packaging, so there is a lot of opportunities in the near future with digital offers [26] (see Figure 6: Digital era and cosmetic products, some examples).

Figure 6: Digital era and cosmetic products, some examples. [1, 23, 25]

 

Conclusion

The cosmetic industry is a real innovative factory always in flux for offering dreams and pleasures to its user, and helping to create an ideal world of beauty. Efficiency should not be forgotten and all the new active products and ingredients, as well as new materials and forms, are perfectly represented in the cosmetic sector.

Preserving and improving this beauty capital that is so important in our image-centric world is a huge challenge that seems to be brilliantly successful partly because of innovative packaging.

References

1 – Gauthier, P., “Beauty enhancement, which advance and packaging challenges for which trends.” Beauty and make-up enhancement, the packaging innovation hub, 12thEdition Packaging of Perfume, Cosmetics and Design, ADF-PCD Oriex, Paris, Feb. 3, 2016.

2 – “Men’s market is changing his marks,” Expression Cosmétique, 205 N°34, 28-40.

3 – Bauer, E.J. “Pharmaceutical Packaging Handbook.” Ed Informa 2009, 585 p.

4 – Gauthier, P. “Much more than packs! Overview of innovative packaging that changes life of drugs forms.”Pharmapack Europe 2015, Paris, UBM Canon, Paris, 11-12th February 2015.

5 – Gauthier, P. “Formulation and packaging design for new chemical entities: Examining specific population and product repositioning,” Therapeutic Delivery, 2011, 2(7), 845-848.

6 – Gauthier, P. “Spray and foam, overview of products and use,” 7th Aerosol and Dispensing Forum, ADF-PCD Oriex, Paris, Feb. 6-8, 2013. “Spray and foam, overview of products and use.” Aerosol Europe, 2013, vol 21, N°6, 12-17.

7 – Gauthier, P. “Airless, when less is more, overview of products.” 12th Packaging Perfume Cosmetics and Design PCD, ADF-PCD Oriex, Paris, Feb. 3, 2016. “Airless, when less can be more.” Aerosol Europe, 2014, 22, 5, 23-27.

8 – Hellbardt, S. and Degenhard, M., “Trends in skin medication dispensing.” Drug Development and Delivery, 2013, vol 13, Sept., 40-45.

9 – “Airless vers des niveaux de qualité plus élevé.” Doses, 2015, N°59, 62-71.

10 – Airless links: http://www.yonwookorea.com/m/page/product_list.asp?s_local=AS; http://www.lablabo.com/lablaweb/index.php; http://www.lumson.it/en/airless-system/tag-system

11 – http://www.beautypackaging.com/issues/2015-06-01/view_features/applicators-evolve

12 – http://www.premiumbeautynews.com/en/six-key-packaging-trends-set-to,9091

13 – http://www.doll10.com/collections/brushes-and-tools/products/blendsmart-blush-brush-no-11

14 – https://www.linhardt.com/en/products/application-pens/medicpen-2/

15 – http://www.neopac.com/fr/innovations-neopac/innovations.html

16 – http://news.aptar.com/solutions/aptar-pharma-leverages-serumony-airless-dispensing-technology-from-aptar-beauty-home/

17 – http://www.webpackaging.com/en/portals/cosmogen/assets/11033994/cosmogens-new-self-heating-tube/

18 – http://www.variblend.com/

19 – http://www.premiumbeautynews.com/en/axilone-a-one-hand-lipstick,8433

20 – Gauthier, P. “Gaming: How can it advance drug delivery, digital health and a better world?” Drug Delivery Congress Europe, DDP, Berlin, Sept. 16-17, 2015.

21 – “les tendances du marché cosmétique,” 2015, Innovation Review, 88, 30-32.

22 – http://www.loreal-paris.fr/makeup-genius.aspx   

23 – http://www.digitaltrends.com/wearables/loreal-my-uv-patch-hands-on/

24 – http://www.mintel.com/blog/personal-care-market-news/innovative-smart-bandage-aims-to-heal-first-aid-market

25 – http://wwd.com/beauty-industry-news/skin-care/romy-paris-a-next-generation-beauty-concept-10238267/

26 – http://www.orleans-cosmetics.com/#!actualits/c1dl4

Author Dr. Pascale Gauthier is a pharmacist with a Ph.D.and is in charge of marketing and design courses at Auvergne University, serving on the Biopharmacy & Pharmaceutical Technology Departmentfaculty of Pharmacy Clermont-Ferrand in France. Reach her by email at [email protected].

Ecommerce/Supply Chain

The 'added benefits of standardized serialization and supply-chain visibility'

The 'added benefits of standardized serialization and supply-chain visibility'
Mike Rose, Vice President of Supply Chain Visibility, and Chris Reed, Lead, Product Serialization and Traceability, both with Johnson & Johnson Supply Chain

Johnson & Johnson Supply Chain (JJSC) and AmerisourceBergen Corporation (ABC) recently collaborated on a pilot study on implementing GS1 traceability standards. PMP News asked Mike Rose, Vice President of Supply Chain Visibility, and Chris Reed, Lead, Product Serialization and Traceability, both with JJSC, a few questions about the pilot.

PMP: What were the goals of the pilot program between Johnson & Johnson Supply Chain and AmerisourceBergen? Why did the two companies decide to work together?

Rose: FDA’s 2013 Drug Supply Chain Security Act (DSCSA) requires the pharmaceutical industry to implement end-to-end traceability by 2023. Johnson & Johnson Supply Chain (JJSC) and AmerisourceBergen (ABC) are two of the largest manufacturers and wholesale distributors of prescription drugs in the United States. Both companies understood the importance of implementing and testing GS1 Standards-based solutions—in particular the GS1 Electronic Product Code Information Services (EPCIS) in a real-world pilot to meet the DSCSA deadline for interoperability.

This pilot was an opportunity to not only help develop the industry solution, but also provide insights that may help our customers use it and leverage it beyond just compliance, to introduce new efficiencies in the supply chain that will ultimately benefit all stakeholders and improve patient safety.

PMP: When did the pilot program begin? How many products and what type of products were coded? Is it still ongoing?

Rose: The pilot with AmerisourceBergen began in October 2015 and concluded December 15, 2015. JJSC opted to utilize 40 serialized SKUs comingled with unserialized product in regular, recurring shipments. The goal was to utilize full production products, shipments, and transactions. We exchanged serialized information and products in an additional pilot from June to August 2016 for six weeks as well. We intend to move this exchange of information and product to an on-going basis later in the year.

PMP: How is the pilot different from any previous pilots that JJSC had held? Why was this new pilot necessary?

Rose: JJSC initiated a pilot in 2013 with two large wholesalers. In this early pilot, JJSC opted to retrofit one manufacturing line, one product, and leverage one-off shipments with significant hand-holding. This pilot with AmerisourceBergen included additional manufacturing sites, distribution centers, and products in a full production environment.

PMP: Both a GS1-128 linear bar code and a GS1 DataMatrix bar code are used on products from the Janssen Pharmaceutical Companies of Johnson & Johnson. Is the same information included in each code, making them redundant codes?  Are there any challenges to employing both codes, and if so, how are they addressed?

Rose: Our primary packaging utilizes both a UPC-A bar code, which uniquely identifies a product for retail checkout, and GS1 DataMatrix, which is a two-dimensional matrix symbol that requires image-based scanners and is currently specified for healthcare items. There are two reasons for this. First, the FDA Linear Bar Code guidance specifies the UPC must be applied in linear machine-readable format. Second, retailers are accustomed to scanning the UPC-A with their point-of-sale systems. In the short term we will continue to apply a linear bar code encoded with the GTIN-12 to ensure readability.

There are several challenges with employing both bar code formats. First, processes were put in place to ensure that what is encoded is synonymous in both symbologies. The GTIN-12 in the UPC-A on the fixed artwork is systemically aligned with the variably printed GTIN-14 in the GS1 DataMatrix. There are also significant space constraints on some of our smaller packaging. Labels contain a significant amount of regulatory data. We must get creative to apply an additional GS1 DataMatrix and human-readable GTIN, serial number, lot number, and expiry date.

PMP: Is the use of both codes a temporary solution until the supply chain can read 2D DataMatrix barcodes?

Rose: Exactly. By 2023, the law states that all serialized products must carry a DataMatrix (2D) bar code. Between now and then, until all supply-chain partners have the 2D readers, some will continue to rely upon the GS1-128 bar code for product identification. Also, products with the linear bar code that are already in the supply chain will remain in inventory until they are sold or expire. So while the market transitions to unit-level serialization, we will continue to see linear bar codes on products, and some products will have both codes at the same time.

PMP: Can you detail any packaging or labeling changes that were made to accommodate the pilot study? Were any made as a result of the study’s findings?

Reed:  As our serialization efforts were already in flight for the U.S. and 45 other markets globally, no additional changes were made to the labels at the primary and case level to support this pilot specifically. As a result of this pilot though, we and AmerisourceBergen realized that the placement of one of the GS1 DataMatrix symbols on the wrap-around case sat in a very vulnerable position. During normal logistics, the corner of the corrugated shipper is often dented as it moves from node to node. The internal contents are fine but the GS1 DataMatrix sitting close to the corner of the case frequently is rendered unreadable.

Working with AmerisourceBergen and the Healthcare Distribution Alliance, the recommendation was put forward to the industry to move the GS1 DataMatrix symbol to adjacent corners, safely away from the edges of the case. We are working right now to update these labels for our U.S. products.

PMP: How is GS1 EPCIS data shared?

Reed: The GS1 Electronic Product Code Information Services (EPCIS) is an open standard that allows businesses to capture and share supply-chain information about the physical movement and status of products as they move throughout the supply chain, from business to business and ultimately to consumers. The data is stored in a cloud, administered predominantly by solution providers that contract with individual companies. If those solution providers upload the data to the GS1 Global Data Synchronization Network (GDSN), interoperability is improved through a standards-based approach to storing item information, ensuring that the information is properly defined and formatted, and keeping that information up-to-date. Trading partners have access to the same information through the GDSN.

The GS1 Healthcare US Initiative’s Rx Secure Supply Chain workgroup is acting to encourage and facilitate migration of EPCIS data to the GS1 GDSN, where interoperability can be maintained and data can be updated in real time. The GS1 Healthcare US Initiative recently updated its GS1 US Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability to provide guidance on best practices.          

PMP: Were any process, equipment, or product changes made as a result of the pilot findings, and why or why not?

Reed: Several. In addition to the case label change referenced above, we saw some delay in the EPCIS information arriving at AmerisourceBergen’s DC. Several times, due to the short duration of transit between our Kentucky Distribution Center and their Columbus, OH, site, the product arrived before the data. The issue stemmed from the cadence of batching that queued between three systems. The ECC, WMS, and enterprise serialization solution were adjusted to sync data exchange more efficiently and ensure the data arrived ahead of the product.

PMP: Did the pilot demonstrate benefits of serialization beyond regulatory compliance? If so, what are they?

Reed: Supply-chain stakeholders are primarily focused right now on the path to compliance, since that is a pressing need. However, there will be added benefits to standardized serialization and supply-chain visibility. Accuracy and efficiency of tracking, tracing, and managing product inventory will improve at all points throughout the supply chain.

Using EPCIS message standards provides for a more streamlined process, in that systems are established with similar data file expectations across the supply chain. Interoperability is important to provide crucial supply-chain visibility for trading partners on both ends of the transaction. It allows real-time sharing of consistent, compatible data detailing product attributes, source, current location, and destination. All of this data helps the supply chain run smoothly and efficiently. Just as important, it means that prescription drugs can be traced back to their original source and every stop along their journey to point of sale—which enables high-assurance validation of the drugs’ authenticity, preventing acceptance of counterfeit products at the pharmacy destination. It also means that if a serious problem does occur, a recall can be efficiently executed and the source of the problem can be quickly identified.

Leveraging GS1 Standards also is intended to improve patient safety and helps provide a means to investigate counterfeit and diverted products. It improves our internal and external supply-chain integrity. With the implementation of serialization and traceability, we will have the opportunity to trace a serialized product from a specific wholesaler to the end customer. We can use these capabilities to further ensure that our patients and customers receive quality, genuine products. We also believe that they will provide additional benefits to our business such as being able to more effectively manage and verify returns.

PMP: What challenges remain?

Reed: Data formatting using GS1 Standards is important. And it’s absolutely essential to begin with high-quality data. We cannot overstate the need for companies to cleanse existing master data and establish robust data governance going forward, to ensure the communication of accurate information between trading partners.

Every bit of data needs to be accurate and complete. Even a small omission like a dosage form or a letter in the product description can severely compromise the supply chain integrity and efficiency. We strongly recommend companies begin with a rigorous cleansing of existing master data and establish robust data governance going forward. 

Collaboration and communication are critical to alignment on objectives and resolution of issues. Trading partners throughout the industry will have to work together to make this work, so that we all will be prepared for the DSCSA requirements and continue providing safe, effective medicines to our patients.

PMP: Will there be future pilots?

Rose: We will continue to pilot here in the U.S. and abroad to ensure we are prepared for the regulatory requirements without disrupting supply to patients.

PMP: What should other pharmaceutical companies do differently as a result of this pilot?

Reed: A key take-away from this pilot was the need for more practice and testing by all stakeholders in the industry. A lot can happen during the process of applying a unique identifier, aggregating that product to a case and pallet, exchanging that hierarchy internally, and then passing it to the customer. The more practice you have, the more tuning you can accomplish. This is a very green space and the ‘unknown unknowns’ are found almost weekly.

To learn more about the pilot, please see this case study.

GS1 Connect will be in Las Vegas June 20-22. Click here for more details.