A Decade of Technology and Growth
Advances in materials and processes help flexible packaging keep its promise to be the most cost-effective style for medical device manufacturers.
|Die-cut insert cards from Beacon Converters can serve as an alternative to inner trays.|
The past decade in flexible medical packaging has been marked by better-performing products at lower cost, increased attention to quality, and new options in automation. Cost-reduction pressures have prompted many medical device manufacturers to convert from rigid to flexible packaging for their products, fueling tremendous growth.
“Cost-reduction pressures spur engineers to look at the package to find ways to reduce cost and bulk,” says Kathleen Daly Mascolo, vice president and director of sales and marketing for Beacon Converters (Saddle Brook, NJ). “More is being accomplished with flexible packaging now, versus rigid. Outer trays are being replaced by pouches and header bags. Some inner trays are being replaced by our custom die-cut insert cards.”
Flexible packaging with high moisture and oxygen barriers experienced increased demand during the 1990s due to the advent of drug-coated diagnostic devices and growth in the orthopedics sector. But while foil continues to be the dominant flexible packaging material for these applications, clear barrier films have made significant inroads.
Silicon oxide (SiOx)–coated polyester film commercialized in the late 1980s and aluminum oxide (AlOx)– coated polyester film introduced a few years later “offer several unique advantages over aluminum foil composites,” says Robert Dodrill, president of Rollprint Packaging Products Inc. (Addison, IL).
|Advances in Tyvek and clean-peel technology have helped converters like Tolas produce low-cost, durable pouches.|
Clear films allow products to be visually inspected at any time, and eliminate the need for a label on the overpouch. This removes one potential for mislabeling—one of the major reasons for costly recalls. The materials also offer barrier properties approaching those of foil. “The best clear-film barrier composites are now equivalent to foil composite using 0.00035-in. aluminum foil,” says Dodrill. “New clear barrier-film development will most likely be able to approach the barrier levels of 0.0005-in. aluminum foil composites in the future.”
Brian Rosenburg of Technipaq (Crystal Lake, IL) says that high-barrier films offer improved puncture resistance when laminated with nylon. Some can now even be used in high-temperature applications such as autoclave sterilization. “It seems almost on a monthly basis they’re improving,” says Rosenburg. “Barrier levels that could previously only be achieved with two-ply film can now be created with just one layer.”
New resins and resin-blending technologies have also given packaging companies options. Metallocenes, introduced around 1991, and new and improved polyesters and polyolefin resins “have tremendously expanded the tools in our box for developing new flexible packaging materials,” Dodrill explains. The resulting improvements in peelable film composites and the creation of materials with increased strength and durability have fueled another of the decade’s big trends—downgauging.
Jeff Murak, director of sales and marketing at Oliver Products (Grand Rapids, MI), explains that downgauged products offer the same strength, with less material, at a better price. “You get more for less,” says Murak. “Any time you’re able to downgauge, you can get or maintain the same strength requirements, but for less money.”
This is especially true in the case of multilayer nylon forming films, which gained a foothold in the U.S. market around 1995. The films reduce mass in packaging and offer “good cost savings for customers,” says Chris Osborn, rollstock product manager for Perfecseal (Oshkosh, WI).
A LIGHTER FORM OF TYVEK
|Automatic pouchers offer |
a cost-effective alternative
to form-fill-seal machines (photo courtesy Beacon Converters).
The expansion of DuPont’s Tyvek line with the introduction of Tyvek 2FS in 1999 also brought manufacturers an alternative packaging option. But the company has had to “educate the industry on a few misconceptions,” says John Richard, DuPont’s North American business manager. Though 2FS is manufactured in a fashion similar to the more commonly used medical-grade Tyvek styles, its performance characteristics are different, Richard says.
“The material should be more aptly compared with medical-grade coated papers, weighing both cost and performance, when medical device manufacturers are evaluating Tyvek 2FS use in different form-fill-seal applications,” he says. “Used alone or with a peelable film, it can make a cost-effective solution that combines the best attributes of Tyvek in a lower-cost package.”
Acceptance of 2FS is “picking up steam,” says Carl Marotta, president of Tolas Health Care Packaging (Feasterville, PA). It has helped converters such as Tolas “get more mileage out of Tyvek,” he adds. Beacon Converters has used the new material as a replacement for paper in some form-fill-seal applications, and even in some pouch applications that previously used Tyvek 1059B or 1073B, says Daly Mascolo.
SEALANT FILMS AND CLEANER PEELS
Along with Tyvek 2FS came the introduction of resin-based sealant films designed to seal to both coated and uncoated Tyvek. Perfecseal, Rollprint, and Amcor Flexibles Healthcare, formerly Rexam Healthcare Flexibles (Mundelein, IL), have all developed such films. These can be tailor-made to seal to different bottom webs, says Tolas’s Marotta. Whereas most sealants don’t work well with rigid plastic, “the coatings are more universal. Almost any plastic you would find used in the industry will work with them.”
When used with uncoated Tyvek, or in film-to-film pouches, these peelable films also offer cost savings. “They let you drop off the heat-seal coating in some instances, which saves people big, big dollars,” says Rosenburg.
Uncoated Tyvek’s increased porosity also makes it more efficient for use in EtO sterilization applications, says Osborn. The ability to pump EtO gas in and out of the package more quickly saves manufacturers time and money. “We have a lot of customers who are interested in reducing their outgas time,” Osborn says.
CLEANLINESS, PERFORMANCE, AND INTEGRITY
To improve the performance of sealant films with uncoated Tyvek, advances in clean-peel technology have also been made, allowing seals to be peeled without generating fiber tear in the Tyvek.
“Cleanliness has become more of an issue,” says Jerry Bennish, global marketing director of Amcor Flexibles Healthcare. “FDA has really become concerned with particulate contamination, so customers want to see cleaner packaging. The less bioburden and the less contamination you have, the better.” He believes trends toward even cleaner peels will continue as the United States takes its lead from the more-demanding Japanese market.
The decade’s accompanying trend toward higher performance and integrity standards largely began with the establishment of ISO 11607 in 1995. “The industry became more conscious of standardized procedures for measuring quality and performance,” says Marotta. “When we have a new customer for Tyvek, for instance, we almost without exception now have to show that it goes through all its testing successfully.”
|Over the past 10 years, header bags have gotten stronger, such as these from Oliver Products.|
Along with better materials and higher standards came increased automation of flexible-packaging operations. For some device manufacturers, switching to form-fill-seal operations was a matter of economics, says Rollprint’s Dodrill. “Form-fill-seal packaging provides cost savings over premade pouches even in low-labor-cost regions of the world,” he explains. “Today, 80–90% of flexible medical packaging uses rollstock on various form-fill-seal packaging equipment.”
For device manufacturers looking for something between manual operations and form-fill-seal lines, automatic bagging and pouching machines available in the last two years offer an alternative. “Automatic bagging and pouching machines assist device manufacturers in filling packages more efficiently,” says Beacon’s Daly Mascolo. “Form-fill-seal machines are expensive, and the device manufacturer then has to become an expert at making a package. Preformed packages, which arrive fully certified, take the responsibility off the device manufacturer to focus on the package. This trend will continue in my opinion, as there is more downsizing and less resources available.”
Advances in flexible materials and packaging equipment should continue as technologies improve. And as medical device manufacturers consolidate, and cost-reduction pressures increase, Oliver’s Murak says that customers are more inclined to embrace these advances. “The technology is really the place to reduce costs,” he says.
By 2007, the U.S. market for flexible plastic packaging is expected to grow to 13 billion lb, according to a report from Business Communications Company, Inc. Medical packaging will no doubt have a sizable slice of this pie. A recent study by The Freedonia Group (Cleveland) projects that demand for sterile pouches will grow 5.5% by 2006.
Demand like that generates enthusiasm. “Both on the materials and equipment side, you see investment,” says Bennish. “And they’re going to keep investing. It’s a segment that’s exciting to be in.”