Looking Back over 20 Years of Sterile Medical Packaging

Thanks to ISO 11607 and other milestones, medical device packaging has gained definite stature over the last two decades.

In 1993, medical device manufacturers sought packages that would maintain sterile product safety and efficacy, reduce hospital and supply chain waste, and offer cost efficiencies to prepare for healthcare reform.

Twenty years later, the goals are pretty much the same. But the means and methods have definitely changed. “The whole process of developing and testing packaging has become more scientific,” observes Dhuanne Dodrill, president of Rollprint Packaging Products Inc. “Validation is a way of life.”

Dwane Hahn, vice president of sales and marketing, agrees, adding that “we rarely ever heard DOE [Design of Experiments] mentioned 20 years ago, but now it’s almost always part of the design process.”

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Investing in Technology, Quality, to Meet Industry’s Needs
Outstanding quality has always been a requirement of medical device manufacturers, reports Dhuanne Dodrill, president, Rollprint Packaging Products Inc. (www.rollprint.com). However, with the increasing complexity of devices, a regulatory environment that has never been more demanding, and a focus on manufacturing efficiency and reducing costs, today, quality is a fundamental expectation. Sterile medical packaging manufacturers like Rollprint have relied on technology to deliver quality and value. While the company is more than 75 years old, the last 20 years alone have seen tremendous investment.

In 1998, Rollprint installed a revolutionary coextrusion coater/laminator, allowing Rollprint to cast up to five layers onto a web in one pass.

 

Such investments enabled Rollprint to develop a range of new coextrusion-coated peelable sealants, Allegro® and PropaPeel®, produced from polyethylene, polypropylene, and polyester resins.

“The ability to coextrusion coat multiple layers meant we also could create a broad range of peelable webs, such as Allegro T for uncoated Tyvek, which behaves as if sealing to a coated Tyvek, eliminating fiber tear and producing an extremely consistent seal strength with a bright white seal indicator. This has evolved into our most recent product introduction, Chameleon® color changing sealant. We were the first to extrusion coat polyester onto films and the first to develop peelable polyester extrusion coatings providing chemically clean and very high temperature resistant sealing solutions,” says Dodrill. “Today, our StreamOne® technology provides an all-polyester lidding alternative to meet industry’s sustainability goals.”

Also in the 1990s, Rollprint enhanced development of clear high barrier films, thanks to technology strides made in the 1980s. Rollprint’s ClearFoil® range of ultrahigh barrier clear films expanded to feature SiOx and Al2O3, allowing the films to effectively compete with aluminum-barrier films.

In 2002 Rollprint forged a global partnership with Acme Packaging Co. (Pte) Ltd. in Singapore to provide customer support throughout Southeast Asia. In 2005, the partnership evolved into a joint venture, Alliantz, with an expanded facility in 2006 and a new blown coextrusion film line.

Rollprint has also made investments in quality. The company’s new 6000-sq-ft cleanroom for converting pouches is certified to ISO Class 8 and is fully operational, reports Dwane Hahn, vice president of sales and marketing. Using rollstock produced on site in Addison, IL, the cleanroom houses five production lines capable of producing header bags and pouches.

Quality has become an expectation, says Dodrill. Adds Hahn: “Today, we can measure quality and inspect and evaluate it much better.”

And there has been an increased emphasis on cleanliness and risk mitigation leading to improvements in process control, validation, and supply-chain risk management, notes Jerry Bennish, now president of Oliver-Tolas Healthcare Packaging who in 1993 was with DRG Medical Group and later Rexam Medical Packaging. “Medical device companies are more active with the frequency and scope of packaging supplier audits,” he says. “Customers want to understand all potential risks and mitigate them.”

“Packaging is now taken more seriously from my perspective,” adds Tony Paolino, president of SteriPack USA. “It isn’t just a necessary evil anymore thought about at the end of the program just before the product launch. The amount of field complaints due to packaging failures pushed this, too. To lose an entire lot of product because your $0.20 pouch leaked was crazy and costly. The changes caused everyone to look harder and test more of their packaging. Now the idea of packaging has to be factored in at the beginning of the programs.”

And medical device packaging is not a “dust cover,” says Nicholas Berendt, director of global market development for Sealed Air. “The key focus has been in improving the overall performance of sterile barrier medical device packaging. This relates to elements such as physical properties, sterile barrier performance, aged package stability, ease of opening, and materials clarity. Packaging today is stronger, more functional, and lower cost. Sterile barrier medical device packaging is an integral part of a comprehensive and effective healthcare delivery system.”

So how did sterile medical device packaging become a science in its own right?

Hal Miller, principal of PACE Solutions, who was J&J’s director of packaging technology in 1993, believes the emergence of the European Medical Device Directives in June 1993 prompted significant changes in medical device packaging. As medical device manufacturers began seeking CE marks for their products, notified bodies began asking questions about packaging. “This led to ISO 11607, Packaging for Terminally Sterilized Medical Devices, published in 1997, and CEN’s packaging standards,” says Miller. Since then, ISO 11607 has evolved into the main standard guiding medical device packaging operations around the world.

“The whole ISO 11607 effort started in 1992,” shares Curt Larsen, principal, Spartan Design Group. “It just seems like yesterday. It really was a cornerstone document for our industry and still is—even more so today.”

After these standards emerged, Miller went to ASTM saying that the medical device industry needed testing standards to support medical device packaging development. “We had F88 and F1140, but no standard integrity tests for medical device packaging,” says Miller. “Prompted by ISO 11607, visual inspection and dye penetration were the initial methods developed.”

AAMI, the Association for the Advancement of Medical Instrumentation, later developed TIR 22 as a companion guidance document for ISO 11607. Nick Fotis cochaired AAMI TC198 Working Group 7 on Packaging for several years and oversaw a major revision to TIR 22. “We were successful in seeing a greater adoption of the work that John Spitzley, Hal Miller, Curt Larsen, and Mike Scholla did in formulating the original 11607 documents,” says Fotis, who is currently Director, R&D - Surgical and Lab for Cardinal Health. (Fotis notes that TIR 22 will be replaced by the emerging ISO TS 16775, the accompanying international technical specification for guidance for ISO 11607. Jackie Daly Johnson, president of Beacon Convertors and Co-Chair AAMI TC198 WG7, is leading the U.S. effort behind ISO TS 16775. David Johnson of Kimberly Clark serves as Co-Chair as well.)

“Harmonization of EN and ISO to a harmonized ANSI/AAMI/ISO 11607—along with the AAMI TIR 22—was most helpful for packaging compliance,” says Eric Carlson, senior manager at CHAINalytics LLC. “This helps [with] compliance as there became a single standard; this helps all MDMs not only in compliance but in reducing the vagaries of the way the notified bodies would interpret the standards.”

Manufacturers of sterile medical packaging took their role seriously. In 1995 at a Packaging Strategies event, Kathleen Daly Mascolo, then national sales manager for Beacon Converters, discussed the implications of a proposed revision to Good Manufacturing Practices (GMPs) that would extend them to the suppliers to registered medical device manufacturers. “While the final revised GMPs are thus unlikely to include this provision, an expectation has arisen among medical device manufacturers for their suppliers to comply,” she said. “As a packaging supplier, it is imperative that we host audits of our facility by our customers, and that at each step in the process we demonstrate our knowledge of the requirements and our adherence to them. Our systems must meet the regulatory requirements and exceed the customer’s expectations.”

Jackie Daly Johnson points out that the 1996 Quality System Regulation includes section 820.50 on purchasing controls, which says that “Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants.” Since then, suppliers have typically been expected to have a defined quality system, one that would meet GMP requirements, whether defined as such or based on an ISO standard, she says.

In 1996, FDA released its Quality System Regulation (QS Regulation) introducing design control. “Prior to the QS Regulation, packaging was an afterthought,” says Miller. “As a result of this regulation, packaging must be considered during design control.”

Jan Gates, principal packaging engineer for PackWise Consulting, calls the QS Regulation “major news in the last 20 years for medical devices.” Gates has served as a packaging engineer in the medical device industry for more than 20 years, and in 1993 she was a packaging engineer with Dade Behring, formerly Syva Company. “The more specific requirements and paperwork [documentation] needed changed things tremendously. There are other noteworthy things I can mention, but the QS Regulation was the main game changer. It seemed to have driven many other changes.”

In 1997, Congress passed the FDA Modernization Act. “FDAMA expedited reviews for premarket approval applications, which brought about FDA recognized consensus standards in 1999,” says Miller.

Marie Tkacik, director of product optimization for Beacon Converters Inc., says that “as U.S. and European standards developed, guidance for selecting the criteria for testing, measurement, and acceptance of packaged devices became more defined. Consensus standards built within the medical device industry became accepted methods for use by the U.S. FDA.”

Timeline of Milestones

1992
The formation of AAMI WG (Working Group) 7, Packaging, within the U.S. TAG for ISO/TC 198. According to Curt Larsen of Spartan Design Group, “WG 7 was formed [with] the purpose to support an effort to write a global standard to define the requirements for packaging for terminally sterilized medical devices.” Under the guidance of the 1st co-chairs of Larsen and John Spitzley, a draft of major portions of what now forms Part 1 of the two-part standard ISO 11607-1:2006 and -2:2006 was brought forward. The final balloted standard was published in 1997.

1993
European Medical Device Directives

1994
Sterilization Packaging Manufacturers Council Debuts. Kathleen Daly Mascolo, Beacon’s vice president, director of sales and marketing, says that “in the years prior to the founding of the SPMC in 1994, it was very common for customers to request a recommendation on testing procedures and ask for industry standards. As a result of that need, the SPMC was formed, as a subcommittee of the FPA chaired by Bill Daly, our president at that time. The members of the SPMC have worked together to publish “SPMC Standards and Test Methods,” a manual that includes “standard test methods, specifications, practices, and a guide for the design and evaluation of primary flexible packaging materials for medical products, as well as FAQs.” Some of these standards are referenced by the International Organization for Standards (ISO) and a few have been incorporated into ASTM standards, which have been accepted by FDA as Consensus Standards. It is amazing how hard the technical committee has worked and how far our industry has evolved in the almost 20 years of competitors working together to further the industry as a whole.”

1994
European Packaging and Packaging Waste Directive
“This developed a broad awareness of environmental issues,” says Miller. “For global companies, it was a big issue.”

1996
FDA’s Quality System Regulation (QS Regulation)

1997
ISO 11607, Packaging for Terminally Sterilized Medical Devices. In January 1996 in MD&DI, Denis Dyke, then vice president for technical and regulatory affairs at PM Health Care Group, wrote of ISO 11607 and EN 868: “The medical device packaging community has recently made major strides in the direction of globalization with the completion and balloting last year of two new standards designed especially for the international marketplace. Together, these standards establish a new state of the art for device packaging that is likely to have an effect both internationally and within the United States.”

1997
EN 868 Part 1: Packaging Materials and Systems for Medical Devices which Are to Be Sterilized, General Requirements and Test Methods

1997
FDA Modernization Act (FDAMA)

1999
First FDA recognized consensus standards

2000
Universal Hip Stem Package Wins Ameristar. Smith & Nephew and Prent win Best of the Medical Device category for a package that protects and suspends products of varying lengths and profiles.

Package from Cordis Corp., Div. of Johnson & Johnson, wins Ameristar. The Downsized Global PTCA reduces weight by 53% and volume by 62%, simplifies secondary package label, and saves approximately $1 million. 

2001
Orthopedic Implant Skinpackage Wins Ameristar
Stryker Howmedica Osteonics and Ivex Technical Packaging win Best of the Medical Device category for the skinpacked sterile inner blister inside a tray, which reduced packaging time and cost by 50% compared with a conventional double blister.

2002
Tome Family Clamshell Wins Ameristar in Medical Device Category
Boston Scientific Corp. wins Ameristar for its clamshell system used to replace multiple packages in one product line.

2003
Metaphyseal Implant Package Wins Ameristar and 3M Integrity Award
A double barrier thermoformed tray system from Exactech and Perfecseal wins Ameristar the Medical Device category and the 3M Integrity Award. The package reduces costs by 40% as well as reduces labor and inventory.

2004
Medtronic Resting Heart System Package Wins Ameristar in Medical Device Category
The Medtronic Resting Heart System from Medtronic and Prent wins the Ameristar. The package replaces a series of four packages.

Ethicon Inc.'s TVT-Obturator Package by Prent Corp. Wins Ameristar in Medical Device Category
Tray protects, suspends, and presents delicate instruments and provides sterile workstation during surgery.

Precision Thermoformed tray from Boston Scientific Wins Ameristar in Medical Device Category
Tray meets requirements in small, cost-effective space.

2005
Sterile Vent Wins Ameristar in Medical Device Category
The Sterile Vent from Cardinal Health and Multivac wins the Ameristar in the Medical Device category. The package for sterile drapes and gowns helped streamline production, reduce packaging materials, eliminate paper inserts, and reduced sterilization cycle time.

2006
ISO 11607 became two documents: Part 1, “Requirements for Materials, Sterile Barrier Systems and Packaging Systems” and Part 2, “Validation for Forming, Sealing, and Assembly Processes.”
In MD&DI August 2006, John Spitzley and Nick Fotis wrote: “The two-part ISO 11607 standard harmonizes the requirements of ISO 11607:2000 and EN 868-1 into one global standard. The recently published standard should make it easier for manufacturers to meet the packaging requirements for terminally sterilized medical devices.”

Clear Die-Cut Insert for Cardiovascular Fabrics from Boston Scientific Corp. Wins Ameristar in Medical Device Category
Insert replaces thermoformed tray and saves cost, improves sterile transfer, and increases manufacturing throughput.

C.R. Bard ReadyLink Delivery System Wins Ameristar in Medical Device Category
Package by Prent Corp. provides access and sterile workstation for using cancer-fighting instruments.  

Ethicon Endo-Surgery's MRI Tube Set Package by Prent Corp. Wins Ameristar in Medical Device Category
Two-piece design protects product and maintains sterile barrier. Modular tooling and semiautomatic product loading saves cost. 

2007

Universal Thermoform from Perfecseal Wins Ameristar in Medical Device Category
Design consolidates more than 300 devices into two tray systems

 2008-2009

Medtronic Stylet Kit Package Wins Ameristar Best of Show and in the Medical Device Category
New package eliminates PVC, reduces package waste by 54%, and is 80% smaller than previous design. Label symbols reduce final product configuration from 237 to 42.

Anspach Bone Dissection Clamshell Wins Ameristar in the Medical Device Category
Anspach worked with Plastic Ingenuity to develop an innovative clamshell.

2009-2010

Cook Urological Nitinol Basket Thermoform Wins Ameristar in Medical Device Category
Clamshell by Prent holds various products, eases use, and aids in identification.  

2011

ConforMIS Drill and Pin Kit Wallet Wins Ameristar in Medical Device Category
Multitiered HDPE wallet from Beacon Converters replaces dual tray, reduces space by 93%, and requires less energy to produce and transport.

Resolute Single Pouch for Drug Eluting Stent from Medtronic Cardiovascular Wins Ameristar in Medical Device Category
Single pouch is 46% smaller, reducing waste by 50%.

2012

Harvest Technologies SmartPreP2/BMAC2 Package from Sealed Air Corp. Wins Ameristar in Medical Device Category
Package footprint is 30% smaller than its largest predecessor, and the sterilized portion of the package was reduced by 30% in volume and 50% in weight.

Thoratec HM2 Tray Set by TEQ Wins Ameristar in Medical Device Category
Design uses Denset lugs allowing removal of inner trays to ease use.

Cook Urological Bakri kit by Prent Wins Ameristar in Medical Device Category
Tray and retainer holds products of various lengths and reduces prep time.  

As such standards developed, “design inputs became more defined and differentiated resulting in the refinement of materials to provide more highly specialized material functions,” says Tkacik. “For example, multi-layered structures designed to provide moisture, gas, and UV protection with product visibility came over a series of stages in material development driven by the growing need to protect medical products in a very distinct way. The viewpoint of what defined protection changed as the medical device moved through process stages. Standardized testing evolved to estimate the ability of a package to be compatible to sterilization exposures, to go through distribution cycles, and to maintain integrity over the period of time expected for viable shelf-life.”

In ASTM, Dodrill, who is currently the chair of ASTM F02 committee on Flexible Barrier Packaging, says that there was “a conscious decision to make sure that test methods had precision and bias statements.”

And the QS Regulation really drove validation of the package and of the packaging process, adds Miller. “Validation had always existed, but the QS Regulation gave it a greater emphasis during packaging.”

Interest in a Six Sigma approach emerged, reports Dodrill, along with solid statistics. “FDA was using science and statistics to ensure that products are safe and effective and that processes are consistent,” she says.

And today, “companies test more diligently,” Dodrill continues, so packaging requirements continue to change. “Companies are looking at the product and packaging shelf life over its life cycle, and some are finding a need for barrier,” she says. “Packaging is becoming more sophisticated to meet requirements and cost efficiency.”

The revisions of ISO 11607 have also made an impact, says Bill Wetzel, marketing director, medical devices, for Perfecseal Inc., a Bemis Co. "This change has made it more arduous for MDMs to make changes to their packaging formats. As a result, it places a greater importance on partnering with vendors who have technology platforms that can provide long-term, sustained savings."

ARE WE THERE YET?
In 1993, in PMP News’s premiere issue, then-editor Melissa Larson offered a wish list for sterile medical device packagers:


· Radiation-resistant plastics, especially PVC grades.
· Coextrusions and laminations that can be separated for recycling.
· For radiation sterilization, plastics that degrade only with certain high,      predictable exposures.
· Better puncture resistance.
· Better ease-of-opening, while still maintaining lid integrity.
· Packaging that can take more abuse.

So how’d industry do? Pretty well, it appears. “A lot more can be done today with technology,” observes Dodrill of Rollprint. For puncture resistance, “we have ways to combine materials today, and more material choices.”

Miller points to the emergence of high-barrier performance coextruded blown films as a significant development in flexible packaging. In terms of thermoforming, “rapid prototyping and CAD/CAM changed a lot, improving time to market,” he adds.

Adds Carlson: “The rise of very good new flexible materials such as metallocenes have opened the way for many more products to be safely shipped in flexibles. I expect to see continued development of niche materials.”

Partnerships have produced much innovation. “The collaborative efforts between the chemical/polymer resin companies and medical device packaging converters have resulted in new technologies,” says Berendt. He points to “metallocene linear-low density polyethylene with greater seal integrity and robust performance, new oxygen and moisture-barrier resins that are autoclave sterilization compatible, and new polymer chemistries that permit improved thermoformability performance in both speed and quality.”

Coextrusions have provided “a lot of options for peelable materials,” says Dodrill. In the late 1990s, Rollprint began offering coextrusion coatings in up to five layers to impart sealant and barrier capabilities to standard materials.

Clear barrier films also emerged in the early 1990s, reports Dodrill, such as those with AlOx and SiOx to compete with thin barrier aluminum films.

For thermoforming trays, Carlson says that a “fairly rapid turnover from PVC to PETG for tray material occurred to comply with waste and incineration of PVC material.”

In 1993, Klöckner Pentaplast of America only offered PVC, recounts Justin Glass, business manager, food and medical packaging films. “Today, we offer PVC as well as PETG, APET, styrenes, and polypropylene. Over the years we have migrated to materials for the best solutions. PETG, for instance, offers gamma sterilization compatibility—it can take two to three times the standard dose. We are even offering a coextrusion of PETG/APET for secondary packaging applications offering enhanced sealability at a reduced cost.”

Klöckner Pentaplast also offers Eastman’s latest copolyester Tritan, which Glass says has ten times the impact strength of Eastar 6763.

Carlson expects that some MDMs will “move into new rigid materials in the coming years as they have with flexibles as new materials with greater performance characteristics become available.”

DuPont Medical Packaging’s Tyvek has dominated flexible applications (pouches) and lidding material for trays, notes Carlson. For instance, in the August 2004 issue of MD&DI, Carl Marotta, then-president of Tolas Healthcare Packaging, wrote that “DuPont’s medical-grade Tyvek redefined packaging for the late 1970s and throughout the 1980s and 1990s “continued to lead the market by working closely with major medical device manufacturers and packaging converters. The market for sterile device packaging expanded, particularly in the development of film-based pouch and form-fill-seal (FFS) packaging.” He pointed to the development of heat-seal coatings for specific uses as well as sealant films for use with uncoated Tyvek as “a cost-effective solution for pouches and FFS forming webs.”

In 2011, DuPont announced that it was moving manufacturing of Tyvek 1073B and Tyvek 1059B to its latest flash-spinning technology (already used for Tyvek 2FS and Tyvek Asuron) to production lines at its Richmond, VA, and Luxembourg facilities. In a 2011 Webcast, Roseann Salasin, global marketing director, DuPont Medical and Pharmaceutical Protection, said that “We are making the transition to the latest flash-spinning technology in order to increase capacity to ensure continuity of supply. Our goal is to provide a seamless transition and to prove functional equivalence. Based on our experience with Tyvek 2FS and Tyvek Asuron, we are confident that we will be able to prove that Tyvek 1073B and Tyvek 1059B made with the newer flash-spinning technology are functionally equivalent to those produced using previous technology.”

Another important development from Perfecseal was its Clean Peel Transfer (CPT) film used to seal and peel from uncoated DuPont Tyvek, says Wetzel. “This film enables MDMs to use DuPont’s medical grade Tyvek without the coating, which significantly lowers the cost of the packaging. CPT is a high performance seal interface with Tyvek 1073, Tyvek 1059, and Tyvek 2FS products.”

Perfecseal’s Ed Haedt, vice president, marketing, adds that “development of improved uncoated medical papers and films designed to seal to them have provided packaging system cost savings while allowing for higher peel strengths that traditional direct seal paper/film systems provide. Perfecseal’s Paperlock CP forming film and paper lidding system provides cost effectiveness without sacrificing seal strength or fiber free clean peels.”

And for packaging containing combination products, Glass reports demand for rigid barrier films such as copolyester/Aclar and PVC/Aclar, which can protect products from oxygen and moisture.

Berendt expects the trend toward active packaging and materials offering better passive and/or active barriers to accelerate. “This can include the integration of nanotechnology; materials capable of scavenging oxygen, moisture, or even odors; as well as combinations of these. For example, Sealed Air’s new Nexmark film for “inkless printing” or its OS (Oxygen Scavenging) materials are examples of active packaging solutions where the packaging has reactive chemistries built into it and so it is doing more than just being a sterile barrier.”

Miller says that the availability of “validatable machinery with parameter controls and recipes” has enabled medical device packagers to control processes with “minimal operator interference.” Interestingly, he says that before the QS Regulation, “there wasn’t a lot of validatable equipment.”

Paolino agrees, saying that “the ability to control the process led to advanced controls for fine tuning a sealing, manufacturing process and ensure a higher level of quality and consistency in products provided.”

And “as these processes became more controllable, it became clearer the raw materials needed to be better controlled and made more consistently,” Paolino adds. “This pushed the whole ‘process validation’ aspect of our business to new heights. No more black magic to get thermoforms to be made right and consistently. Process control became king, so did the quality guru’s like Edward Deming and then of course the Six Sigma, black belts, Kaizen events.”

QUALITY
Twenty years ago plants in the packaging industry were clean by production standards, says Bennish. However, “there has been a shift from clean to ‘white room’ and now to registered cleanroom manufacturing that measures bioburden,” he says. “Oliver-Tolas began this evolution to registered cleanrooms in Europe in 1997 where the entire manufacturing footprint is in a registered cleanroom. In the United States, the Oliver-Tolas transition to registered cleanrooms began in 2000 for select final package converting operations. Over the past several years, additional packaging converting was upgraded from white rooms to registered cleanrooms.”

In 2011, Perfecseal certified its Oshkosh, WI, sterile medical pouch and bag manufacturing facility to Class 7 cleanroom standards. The company claims it had been operating the facility at a Class 7 cleanroom standard since 1997, but had not sought certification until 2011.

In 2012, Rollprint Packaging Products Inc. completed construction of a 6000-sq-ft ISO Class 8 cleanroom for converting pouches. The cleanroom will be using rollstock produced at the same facility in Addison, IL.

Bennish adds that vision inspection technology has also transformed sterile medical device package manufacturing. “Twenty years ago, printing presses did have vision inspection technology, but it has since advanced rapidly. In 2008 we added it to a coating line, and we budget every year for expanding our use of vision technology.”

With the above wish list and all the other requests from medical device manufacturers come increased requests for material data, reports Fabio Bogni, market development manager for specialty plastics, medical packaging, Eastman Chemical Co. “Data on the track records of materials allow users to do their validations,” he notes. “There are more-demanding applications today such as heavy implants that are pushing the limits of conventional designs.”

Glass says that years ago Klöckner Pentaplast elected to establish Drug Master File-like records with FDA called Medical Application Files on its medical packaging films to provide more performance data. “Should there ever be a question, users can petition FDA for the files,” he says. “It allows oversight of our process.”

FOCUSING ON THE USER
As medical device packagers have come to master the science behind package development, testing, and validation, they have become increasingly more comfortable with tackling the most recent challenges: user friendliness and waste and cost reduction.

Hospitals are more cost focused today, reports Dodrill, but they also are interested in reducing errors and infections.

HealthPack helped share the end-user perspective with medical device manufacturers through its panels of nurses and annual nurses survey focused specifically on packaging. According to Curt Larsen, who has been moderating HealthPack with John Spitzley, “the first survey was presented by Jennifer Neid (now Benolken) March 5, 2008, in San Antonio, TX. The first Nurses Focus Group (panel) was the following year, March 4, 2009, in Memphis. Jennifer was also the lead presenter and organizer of that, and she later turned the survey over to Jennifer Blocher (now Foreman).”

In addition, Bennish says that Michigan State University’s Healthcare Packaging Immersion Experience (HCPIE) program, which began in 2010, helped medical device manufacturers understand packaging’s role in hospital operating rooms and emergency departments. Oliver-Tolas helped pilot the event in 2010 “as a method to help bridge visibility between end users, medical device manufacturers, and packaging experts and launched a full event in 2011. This interaction was simply easier to do 20 years ago,” says Bennish. “It’s now far more difficult to get end user input. At this event we heard from doctors and nurses, who said they need easier to grab headers to peel open or easier to read labeling.” HCPIE 2013 is planned for October 2013 (https://www.msu.edu/~hcpie/index.html).

Glass of Klöckner Pentaplast says that he sees many more sterile kits being prepare for home use. “Practitioners are now in the home, whereas traditionally they may have been a nurse. Manufacturers are responding to such user needs.”

COST
Cost pressures have appeared to be pretty constant over the years, but they may be ramping up. “There’s an expectation for quality, but there are more conversations about cost today,” says Dodrill.

“Folks feel pretty comfortable downgauging,” says Bogni of Eastman. “Eastman’s technical support team can assist end-users with engineering designs to meet fitness for use criteria.”

Fifteen years ago, the industry was beginning to see some movement out of rigid thermoformed trays. William Daly, then-president and CEO of Beacon Converters Inc., was quoted in the February 1998 of PMP News as saying: “We are experiencing a shift in interest among our customers from rigid to flexible packaging. Flexible packaging provides source reduction, i.e., less material is put in the waste stream, shipping weights are reduced, and, not incidentally, flexible packaging is less expensive than rigid.” Daly was the chair of the Sterilization Packaging Manufacturers Council of the Flexible Packaging Association (Washington, DC).

 
The evolution of sterile packaging manufacturing, courtesty Oliver-Tolas Healthcare Packaging. At top, Oliver Medical's manufacturing process in the 1990s. In the middle, a portable cleanroom or soft walled cleanroom used before permanent wall cleanrooms were installed. At bottom, current manufacturing practices in Oliver-Tolas's certified cleanroom.

Alison Tyler, technical director for Beacon Converters, says she sees “packaging of large heavy sharp and fragile devices moving away from the standard thermoformed tray solution.

“Ten years ago, it wasn’t a conversation to consider packaging certain categories of devices, especially fragile, large, complex devices—or devices with sharp, heavy components—in anything other than a rigid system,” she continues. “Now, we see more companies embracing the idea of replacing thermoformed trays with custom die-cut inserts that protect their products as well or better than trays. It is a more-sustainable solution, using less material, reduced transportation costs and less energy to manufacture, quicker to produce than trays, and best of all has more utility to protect 360 degrees around the product without the need for additional packaging components.”

Paolino reports seeing “thinner materials that are stronger come out of necessity to reduce cost and minimize what goes into the waste stream. While Tyvek remains the strongest material to protect medical devices, companies and engineers are not settling so much for that status quo on what results are required from packaging challenge testing and instead starting to take a more practical approach to prove and define what is going to protect the package and offer the shelf life.”

Paolino adds that “1-lb minimum seal strength flew out the window several years ago. Now, folks look to find out what the minimum really needs to be. This has helped other materials get a foothold in the industry, like papers and thinner films.”

In addition to noting a move from rigid to flexible, Paolino recalls “the big quest to reduce cost and the process improvements that allowed converters to be able to provide an uncoated Tyvek pouch that had minimal fiber tear, omitting the coating and reducing cost. This seemed to be a slow burn starting in the late 1990s. It’s still in the transition period. Not all have moved but, many have.”

Perfecseal’s Wetzel believes that “cost pressures often drive technology innovation in the flexible packaging industry. Medical packaging is no different, and Bemis’s development of high-performance nylon forming films has met the cost removal needs of MDMs without sacrificing the package performance. It also provides a level of sustainability through source reduction.”

In terms of cutting, Bennish warns that some medical device manufacturers “could be coming close to the edge of where the risk-versus-reward benefit ratio comes into question.” He says that “it is important to mitigate the risk of any failure, because the cost of failure can be significant.”

Medical device manufacturers are also turning to universal packaging, which can “take cost out of engineering and tooling, rather than the material,” notes Bogni.

Materials with “wider operating windows” are also helping to “reduce costs,” he adds. Eastman introduced Tritan in 2010, and it can handle higher and lower temperatures than the company’s mainstay, Eastar 6763. However, “Eastar 6763 continues to meet needs, even as they have changed,” says Bogni. “Even though Tritan outperforms it, Eastar 6763 still meets most customers’ FFU requirements.”

In addition to downgauging or reducing the weight and thickness of packaging, Bogni says that medical device manufacturers “have been pushing the limits of EtO to get more products through sterilization.” This is having an impact on packaging. “Speeding processes up may involve increased temperatures. Tritan might be able to help in this regard, as it can withstand higher temperatures.”

Bennish says that 20 years ago, vented packages from Baxter, for instance, had a 4-in. vent for EtO sterilization, and then it changed to a 6-in., and then to two 6-in. vents, to “get the EtO gas in and out efficiently.”

And for lidded packages, as companies worked to optimize sterilization, Oliver Medical’s Dot-Coat Adhesive technology took off about 20 years ago, shortly followed in 1995 by Tolas Healthcare’s Zone-Coated lids in which only the sealing areas are adhesive coated, says Bennish.

“Over the last 20 years, different adhesive coatings have been developed to match applications to overcome ever-changing product requirements,” says Bennish. “Aggressive EtO cycles required packaging that would remain sealed during the process yet peel easily at the time of use. Better coating technology was developed to meet these aggressive cycles that focus on reducing sterilization costs.”

Wetzel has seen “substantial growth” in the use of “gamma sterilization as well as the level of gamma exposure.” He says that “this has influenced the development of multilayer film structures, which are more stable to gamma.”

SUSTAINABILITY
Paolino reports seeing “hospitals and industry in general looking to minimize their carbon footprint on the planet. Hospitals have influenced packaging by demanding more recyclability from the materials we provide for sterile packaging. Coupled with the ever ongoing desire for lower costs/pricing, have driven a variety of new innovations in our industry with materials and packaging designs.”

While cost is an “important factor,” agrees Bogni, “sustainability is coming up as important now, too.”
“Sustainability wasn’t in the vernacular in 1993, but today, larger medical device manufacturers have defined sustainability programs,” observes Dodrill.

One of the wishes from 1993 was coextrusions or laminations that could be separated for recycling. While coextruded films have become popular, the industry hasn’t headed in the direction of separating material layers—rather the material streams.

Instead, “our approach has been to provide materials with properties that can be recycled in one waste stream, such as Stream One,” reports Dodrill.

In 1994, the Healthcare Resource Conservation Coalition came together to reduce and control medical waste, DuPont reported in its April 1994 issue of Tyvek Rx. DuPont helped form the HRCC, along with Eastman, DRG Medical Packaging, J&J, Smith & Nephew, and others.

In 2009 the Healthcare Plastics Recycling Council (HPRC) emerged to promote plastics recycling in hospitals. Founding members included DuPont, Becton, Dickinson and Company, Cardinal Health, Engineered Plastics, Hospira, Johnson & Johnson, Kimberly Clark, and Waste Management. Eastman Chemical later joined, along with Baxter, Philips, SABIC, and Covidien. HPRC released its Design for Recyclability in 2011, and according to an article PMP News published in December 2011, HPRC expressed that “under packaging, monomaterial flow wrap flexible packaging, monomaterial rigid trays, and breathable plastics such as spunbound PP and nonwoven high-density PE (HDPE), which can be utilized as alternatives to paper, are listed as 'desirable design practices.' Paper/film combinations and metalized plastics, metal screws, and grommets in plastic are listed as 'less desirable.' ”

Eastman's Tritan copolyester

Paolino notes that some companies have been “attempting to keep poly families together and increase the ability to recycle the whole package under the same symbol.”

Beacon became a member of Practice Greenhealth and also a corporate sponsor of their “Greening the OR” initiative, reports Tyler. “Practice Greenhealth is an organization of businesses and hospitals in the healthcare industry that focus on making hospitals more sustainable. One of their key initiatives is to prevent, reduce, and otherwise make less waste in the healthcare sector, increase recycling, and reduce waste to landfills and incinerators. A staggering statistic from Practice Greenhealth research is that hospital Operating Room can generate between 20-30% of the facility’s waste – and much of that is packaging. We see this as an opportunity to work with our customers to find creative ways to reduce their packaging footprint, collaborate with hospitals and waste outcomes. Reducing the amount of waste is critical and managing the waste that is generated more sustainably are critical paths. Medical Device companies are ethical by nature so embracing of sustainable objectives is widespread. Working together with Practice Greenhealth, device manufacturers, end users, and waste recovery companies have allowed Beacon to truly be impactful.”

Beacon’s die-cut cards, for instance, are cut from one sheet of HDPE, Tyler explains. “At the end of its life, HDPE is fully recyclable and depending on waste stream management, HDPE can also be one of the most desirable soft plastics for feedstock in flexible packaging waste recovery.”

Beacon is also working with Agilyx Corp. to create a healthcare plastics recovery pilot that will reduce mixed flexible packaging waste to landfill. Agilyx, an alternative energy technology company, provides technology that converts comingled (resin types 1-7) plastic destined for landfill into synthetic crude oil. “Their proprietary technology does not compete with recycling; instead this complementary technology recovers the unused and untapped energy contained in mixed flexible packaging waste. When the pilot is full scale, 100% of Beacon’s soft, flexible, multi-layer, medical plastics will provide preferable feedstock for this alternative fuel source.”

Eastman’s Bogni believes that “it is possible to address both cost and sustainability in one project if the overall system is reviewed, including manufacturing, labor, set up, materials, and resource use.” However, he fears that “if cost issues become the primary concern, sustainability could take a back seat.”

WILL WE EVER CHANGE?
Despite the promise of performance benefits and increases in cost efficiencies, medical device manufacturers still tend to shy away from packaging changes. And some argue they are even more risk averse.

“Medical device companies conservatively approach packaging changes with very thorough testing and evaluation,” says Dodrill. “This allows them to ensure patient safety and effectively handle FDA enquiries.”

Glass of Klöckner Pentaplast believes that many companies have “unintentionally pigeonholed themselves into what they are comfortable working with traditionally. But it never hurts for us to present newer options that can enhance performance and lower cost while maintaining integrity.”

But in the last five years, Glass says that he has seen medical device manufacturers “substantially interested in new materials and willing to consider changes, especially if they can reduce failures in the field and scrap.”

The ability to make significant changes to packaging does “depend upon staff resources,” reports Bogni. “If the medical device tax remains in place, it could cause a reduction in innovation activities and companies could shift their efforts to cost reduction strategies.”

Berendt expects to see “initiatives across the supply chain from resin supplier to end user to match unmet needs and to respond with solutions that enhance user performance while also lowering overall cost.”

To prepare for the next 20 years, medical device manufacturers will need to address globalization, patient safety concerns, and sustainability. Packaging-related decisions may influence company success. “Globalization will continue as the world becomes smaller and DuPont Tyvek will prevail as the world markets evolve and require the same high quality standards for their medical device applications,” says Bennish. “And as the emphasis on patient safety continues to increase and developing nations bring healthcare online, scrutiny of data, cleanliness requirements, bioburden monitoring, and automated visual inspection requirements will continue to be areas of investment within the industry. Finally, as green initiatives will begin to take action as medical device packaging as hospitals seek ways to reduce their waste.”

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