Pressured to reduce costs, medical device manufacturers should fully understand ISO 11607 requirements and move forward with an educated approach to cost cutting.
Medical device manufacturers are often pressed to take costs out of a product over its lifetime, but they cannot risk any threats to quality.
Packaging is often looked at as a source of potential savings, but reductions must be thoroughly vetted. Lapses in packaging can lead to serious product recalls. For instance, in 2010, a few medical device packages with “weak or open seals” and “pin holes and punctures” led to Class 1 recalls, FDA’s most serious type of recall. While we do not suggest that any of these recalls were associated with any cost-cutting measures, we do emphasize the importance of maintaining packaging quality.
“One packaging-related recall can more than wipe out any package cost savings as well as potentially affect the device maker’s market share for years to come,” says Ed Haedt, vice president, marketing, Perfecseal. “We find some companies willing to consider sourcing from packaging suppliers that are not experts in sterile medical packaging. Often times these packaging suppliers recommend materials that are at best, marginally suitable for the application. We believe it is important for the device company to look for packaging cost reduction options from companies that are dedicated to the medical device market such as those from the Sterilization Packaging Manufacturers Council membership (sterilizationpackaging.org/). These companies understand the risks and have experience with proven products that can make the difference between a highly successful costs savings and a catastrophic product recall.”
“Balancing cost reduction with quality requires packaging suppliers and medical device manufacturers to work in partnership to thoroughly understand and analyze the product to be packaged and the challenges presented throughout the product life cycle,” advises Joel Schmidt, senior market manager, Perfecseal. “These challenges include production, packing, shipping, distribution, and consumption. [These considerations] allow material suppliers and packaging engineers to optimize the package design for cost reduction without compromising product quality.”
So, how does a medical device packaging engineer balance cost reduction with quality?
Some companies are investigating newer material combinations. Michael Barr, product manager, Amcor Flexibles (www.amcor.com), reports that he has been working to transfer companies from material laminations to coextruded options.
“Use of nylon materials coextruded with barrier materials such as EVOH is eliminating the need for laminations,” he explains. “The switch helps reduce costs while addressing recent raw material supply concerns in the market.” Those supply issues could be characterized as the result of “an increase in material demand concurrent to a decrease in capacity for certain materials,” he adds.
Amcor’s NPB and NCB films, launched in 2010, can typically be used in coextruded formats for chevron pouches. “They can be used to replace other films or laminations for an all-film peelable pouch or with Tyvek or paper structures,” Barr adds.
Perfecseal, too, is devising coextruded options. “We continue to roll out stronger yet thinner coextruded films for thermoform, fill, and seal applications as well as premade bag applications,” says Haedt. “Most recently, we introduced our ShieLLD QE bag film, which uses a highly engineered coextruded film technology that allows a 40% thickness reduction versus our strongest LLDPE bag film while maintaining or improving on puncture resistance, abrasion resistance, and flex crack resistance.”
Material converters have launched new package designs to help manufacturers reduce their amount of more-costly materials. As an alternative to employing more-expensive puncture-resistant films, Oliver-Tolas Healthcare Packaging (oliver-tolas.com) introduced Ostasis in 2010. The pouch is reinforced with Tyvek strips on each end of the clear film to increase puncture resistance without changing the film.
In addition, Oliver-Tolas is working on potential new coatings for VisiSeal. Introduced as a packaging concept in 2010, VisiSeal is intended to ease seal verification in the healthcare field in order to help prevent intact packages being mistaken for breached ones. VisiSeal will be commercialized in 2011, reports Jane Severin, director of technology for Oliver-Tolas. In addition to developing new coating science, Oliver-Tolas is working with technology providers in order to deliver a total packaging solution. The company plans an announcement in mid 2011.
Understand ISO 11607
Ensuring compliance with ISO 11607 from the outset can save medical device packaging engineers time and money spent correcting mistakes.
Building a package-testing program is a challenge, and one area in particular seems to confuse a number of professionals, report Curt Larsen and John Spitzley of Spartan Design Group. “People are still subjecting the same package samples to both aging studies and performance testing,” Larsen says. “These are two separate endeavors, clearly spelled out in ISO 11607 as well as in the ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Medical Device Packages. Aging is intended to determine the stability of the sterile barrier system (SBS) materials as well as the stability and integrity of the seals throughout a dating period, while performance testing determines whether the packaging system design provides adequate protection to the sterile barrier system and its contents through the hazards of handling, distribution, and storage.”
Trouble can occur when samples are exposed to the elevated temperatures for extended periods of time of accelerated aging (conditions packages would normally never see in the real world) and are then subjected to the stresses of compression, shock, and vibration. Material failures are likely, say Larsen and Spitzley, and those failures could lead to overpackaging and more testing, and possibly delayed product launches—all of which cost companies more money.
If companies do their homework, they may in fact be able to reduce some of their testing. “If you’ve done aging studies on a given material combination sterilized in a particular methodology, you do not need to repeat it when using it again for a new product. SBS stability testing is separate from studying device material/SBS material interaction, where you are not looking at stability, you’re looking for material interactions. This material compatibility relationship needs to be determined well in advance of starting the design, aging, and performance testing,” adds Larsen.
Medical device manufacturers may also accept supplier aging data, as long as they have documented compliance with ISO 11607, Larsen says.
Spitzley adds that medical device manufacturers do need to give a bit more thought to devising their sampling programs. "If your unit of test is a box, which contains 10 sterile barrier systems, and you test three boxes, your sample size is not 30—it is still three," says Spitzley. "ISO 11607 requires you to test the packaging system—not just the sterile barrier system."
Just-in-time medical device manufacturing has been moving the industry toward leaner inventory of finished goods, and that, in turn, has been influencing materials inventory. Although medical device/pharmaceutical packaging is typically custom manufactured to individual customer specifications, they can sometimes be referred to as a commodity, observes Kathleen Daly Mascolo, vice president and director of sales and marketing for Beacon Converters (www.beaconconverters.com). “When purchasing actual commodity stocked parts with low usage, it often makes sense to purchase in small volumes. When purchasing components of a custom sterile barrier system, customers are also finding cost/benefit opportunities in purchasing low volume parts less often and thereby taking advantage of lower price per piece incentives. In certain situations, this reduces the number of incoming receiving inspections required, which can offset the additional cost of inventorying low volume items.”