Making Strides in Sterile Medical Packaging
With medical device manufacturers looking to trim costs, converters are helping bring package weight and size down, and are even looking for their own in-house efficiencies. Such efforts align with sustainability.
Oliver Medical has installed an efficient, waste-reducing coating system at its Grand Rapids, MI, facility.
Developing sterile barrier systems that meet the needs of both the product and the end-users continues to be the primary packaging goal of medical device manufacturers (MDMs). Continuing industry trends toward optimizing value, however, may be stepping up as companies seek to further control costs in a down economy.
Downgauging has been a popular strategy in years past, with MDMs looking for thinner, lighter, or smaller structures for packaging. Sterile packaging manufacturers and other suppliers have worked to satisfy these demands with rigid-to-flexible switches, stronger-but-thinner films, and other solutions.
Recent supplier activities now include upgrades, consolidations, expansions, certifications, new material offerings, and other investments. Many seek to increase industrial efficiencies. Will these investments yield returns for the industry?
And, as the industry takes out weight and thickness where possible, it is reducing overall material usage. Such savings translate into reduced waste and energy use, helping companies keep pace with trends toward sustainability.
“Downgauging is and always has been one of the most efficient ways to achieve cost efficiency,” explains Brian Muehl, manager of materials technology for Alcan Packaging, Medical Flexibles. Muehl works in the global packaging company’s technical research center in Neenah, WI. “Downgauging is not a trivial point. Your goal is to make the most cost-effective package by using the least amount of packaging material yet meet product and consumer requirements. High-performance materials let you accomplish this.” He points to polyethylene films as being one of the more-efficient packaging materials to downgauge or downweight.
However, “downgauging by itself has limited opportunities,” points out Dhuanne Dodrill, president of Rollprint Packaging Products Inc. (Addison, IL). “The advances that we have made in material technology allow the creation of high-performance structures that provide the required durability with less material. In addition, new manufacturing techniques enable the replacement of complex structures with fewer layers, using less resin,” she explains.
Ed Haedt, vice president of marketing for Perfecseal (Oshkosh, WI), reports that its latest multilayer coextruded films are replacing older, laminated film technologies while offering cost savings and improved performance. “The level of engineering in our flexible forming films allows customers to not only downgauge, but save money, too. Our new foil laminate films, for use in strip packaging for quick-dissolve orals and for transdermal patch packaging, have provided a new package technology platform for preserving the efficacy of these products.”
Michael Barr, product manager for films & converted products for Amcor Flexibles (Mundelein, IL), says his company is “seeing a continued interest in materials that can help our customers shorten their sterilization cycle times and thus reduce costs. For form-fill-seal applications, medical device manufacturers can improve porosity up to 50% by transitioning from a forming film mated with an all-over coated Tyvek top web to a peelable forming film that peels directly to uncoated Tyvek, such as Amcor’s new CP Film. Some are seeing a reduction of 10–15% in the sterilization cycle time with this improvement in porosity.”
Dodrill reports that Rollprint’s Allegro T sealant allows MDMs “to move from coated Tyvek to uncoated Tyvek without any loss in performance. Because a coating is no longer needed, a manufacturing step and its associated waste is eliminated and overall material usage is decreased.”
Beacon Converters works with customers interested in reducing waste and improving product aesthetics with newer technology films that provide various degrees of high barrier to oxygen, moisture, and also UV light, explains Alison Tyler, technical director. “These films are much less bulky and can be as much as a 40% reduction in mass while providing the protection the product needs. Because they are clear, they also provide product visibility, eliminating the need for double labels in the case where the package must be labeled or printed on the outside because the product on the inside is not visible through a foil package.” Another benefit that one Beacon customer reported of using a high UV barrier material was increased shelf life of the product. “This was a significant savings because it allowed for larger batches to be produced and fewer losses of expired product,” she explains.
When developing a cost-effective package, one should not cut back on some of the specialty features needed for end use. For instance, explains Alcan’s Muehl, ensure the correct opening features remain in place—don’t eliminate easy-open features or seal evidence.
Oliver Medical (Grand Rapids, MI) has been expanding its operations ever since investment firm Mason Wells acquired the packaging producer in 2007. Oliver manufactures form-fill-seal rollstock as well as preformed pouches and lids. Looking for greater efficiencies at the plant level, Mason Wells armed Oliver with the capital needed to install energy-efficient, higher-speed converting equipment. Recent additions include a new slitter and a new hot-melt coating line. “The new coater is more efficient and reduces scrap,” explains Greg Myers, managing director for Mason Wells. “It is also more energy-efficient, as it does not require extensive ovens associated with competing technologies.”
Oliver’s new slitter and coater are both in the Grand Rapids facility. The pouch machine on order will also be installed in Grand Rapids. A new cleanroom was constructed in Oliver Medical’s Venray, Netherlands, facility. With the new equipment in place, Oliver engineers are “tweaking and adjusting adhesive application systems to provide the right seal strength and integrity,” he adds.
Extending its efforts toward lower scrap rates, Oliver has added new pouching equipment to its shopping list. Says Myers: “It will have scrap percentages at a fraction of what was historically run.”
Oliver’s most recent investment is the acquisition of Tolas Healthcare Packaging (Feasterville, CA). “The acquisition increases our presence in the market, broadens our product line, and expands our coating and manufacturing operations,” says Jerry Bennish, president and CEO of Oliver. “Combining both hot-melt and water-based adhesive technologies will provide a wide range of solutions from a single source.” Integration of the two operations is now taking place.
Manufacturers of sterile medical packaging are also emphasizing their progress in maintaining quality. ISO 11607 states that “the activities described within this part of ISO 11607 [Part 1] shall be carried out within a formal quality system. . . . ISO 9001 and ISO 13485 contain requirements for suitable quality systems.” However, “it is not necessary to obtain third-party certification of the quality system to fulfill the requirements of this part of ISO 11607.”
Perfecseal has recently announced registration to the ISO 13485:2003 Medical Device Quality Management System for its thermoforming facility in Mankato, MN. According to Matt Boswell, director of quality, “Perfecseal is in the process of upgrading its global ISO certifications from ISO 9001:2000 to ISO 13485:2003. We have plans for all locations to be certified to this new ISO standard in 2009.” The facility is the third Perfecseal plant to be registered to this standard. Two other plants were registered in 2007.
Can converter investments in quality and state-of-the-art technology translate into savings for MDMs? “It’s hard to give a simple answer because it is very situation/product/customer specific,” explains Myers. “But, in general, efficiencies and savings are shared with customers. The savings are also used to offset rising commodity and labor costs so those don’t have to be passed on to customers.”
From a converting standpoint, cost and sustainability can be tied together, emphasizes Muehl. Minimizing package weight and thickness as well as reducing manufacturing waste and expended energy can not only bring costs down, but also reduce environmental impact. Cutting waste and energy may be how MDMs tackle sustainability. There are concerns with other approaches. Says ISO 11607: “The source, history, and traceability of all materials, especially recycled materials, shall be known and controlled to ensure that the finished product will consisently meet requirements . . .with current commercial technologies, it is unlikely that anything other than virgin manufacturing waste will be used in recycled materials, due to insufficient controls to allow safe use of other recycled material in sterile barrier systems.”
In medical packaging, Myers sees “an opportunity for source reduction.” For instance, “the efficiency of new equipment impacts labor and speeds up cycle times. Three shifts could be cut to two shifts, and all the energy and labor for the third shift is eliminated.”
Rollprint has a multifaceted approach to promoting and encouraging sustainability, says Dodrill. “Internally, we are are continuously reviewing our production practices to ensure Lean manufacturing principles are in place. Aggressive use of Lean and Six Sigma tools have allowed improvements in efficiency, labor, and production rates. These have positively impacted our sustainability initiatives—most notably waste reduction,” she says. “We also work very hard to ensure the waste that we do create is recycled. We segregate our waste into seven recycling streams and have very stringent goals for the amount of material we recycle versus landfill.”
Alcan Packaging sees sustainability as a three-pillar approach: economic sustainability involves spending capital resources effectively, such as minimizing energy and material use to reduce costs; environmental sustainability involves the wise use of natural resources, with an eye on reducing environmental footprints; and social sustainability involves minimizing impact on communities, such as reducing CO or VOC output.
“Ensuring sustainability in these three ways helps us be a leader in the competitive market,” explains Muehl. “A sustainable company means a financially strong company, one that will be around next year and many years thereafter.”
Amcor Flexibles has been included in the Dow Jones Sustainability World Index (DJSI) based on social, environmental, and economic performance. DJSI looks at a company’s corporate economic, environmental, and social performance. It considers risk management, climate change mitigation, supply-chain standards, and labor practices.
Rollprint develops packaging options that will allow customers to meet their sustainability goals, such as Triad composite solvent-free barrier overwrap.