The Packaging Sector Responds to Challenges from Industry

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI August 1998 Column

PACKAGING

Spurred by economic and regulatory pressures, device packaging is going through an upheaval that's leaving innovative materials and improved service in its wake.

Compared to other arenas in the healthcare industry, medical device packaging might seem mundane to the disinterested observer. However, these are interesting times for medical device packaging—all too interesting for some people's liking.

Steve Franks, executive vice president of TM Electronics (Worcester, MA), explains, "There are a lot of issues, from testing to materials to process quality control. Packaging has become a significant part of product development and the process control cycle in the past few years."

A slew of economic and regulatory pressures, combined with the increased attention medical device manufacturers have given to packaging in recent years, have led to packagers being scrutinized like never before. The demands, some of which seem contradictory, in turn are leading to innovations and improvements in many areas.

The U.S. medical packaging market is expected to reach $3.8 billion by the year 2000, an annual growth rate of 5.8%, according to a study by the Freedonia Group, Inc. (Cleveland), titled "Medical Packaging: Supplies & Devices." This study supports the feeling among most in the industry that the gains are from an increase in volume, not an increase in profit margin. The study says that real growth, as measured in the number of containers consumed, is expected to increase 3.3% annually.

It is imperative for packaging suppliers to keep costs down while increasing production capacity and maintaining the same quality standards. But significant changes to the manufacturing process require revalidation, which can be costly in its own right.

Medical device manufacturers are facing the need for cost reduction because of managed health care, according to William P. Daly, president and chief executive officer, Beacon Converters, Inc. (Saddle Brook, NJ). They are asking their suppliers to come up with new ideas to reduce packaging costs while simultaneously providing increased service to their customers by assisting with package development, doing increased testing associated with dock-to-stock programs to ensure package stability during shipping, and providing ongoing technical support.

In many cases, manufacturers have consolidated or formed buying groups and are looking for suppliers to fill large orders at low cost. "If you're not changing along with them, you will be left out of the ball game," says Dick Simmons, vice president of medical marketing at Plastofilm Industries (Wheaton, IL), the medical, electronic, and consumer packaging division of Ivex Co. "Margins will always be under attack. You have to be more efficient in order to maintain profitability."

Perfecseal's (Philadelphia) Bill Singer, director of global marketing, acknowledges the difficulty of changing packages when material has to be validated or qualified. A device company's ideal situation is to approach a current supplier and attempt to lower its price. "Some suppliers are able to bring savings by offering new products, but the challenge is to bring cost savings to existing products, which don't add problems with regulations."

Such a challenge can be frustrating. "Manufacturers think they can milk a lot of money from a medical device by changing the packaging," says Curt Larsen, principal packaging engineer, SIMS Deltec (St. Paul, MN). "That may be true some of the time, but packaging affects a small part of the price, so sometimes they're missing the boat."

A well-thought-out plan, however, proves that changes in packaging can indeed help. "Going to a soft pack, with EVA/Surlyn film, has had a sweeping impact," says David Schleder, director of manufacturing, Burron OEM Div., B. Braun Medical Inc. (Bethlehem, PA). "The soft packs give a little bit, so you can put more into smaller boxes and have less volume, which leads to decreases in storage and shipping costs."

NEW MATERIALS

Hal Miller, director of packaging technology, Johnson & Johnson (New Brunswick, NJ), says that the true challenge is reducing packaging costs without necessarily resorting to whatever has the cheapest price. Suppliers must learn to think differently and not just make new materials that improve needs, but ones that truly have an impact on the industry. The development of metallocene catalyst polymers is one example. "It's an economical polyethylene material with the properties of polyester and nylon, but at a much-reduced price."

The advantage of those materials, says Michael Scholla, medical packaging segment leader at DuPont Nonwovens (Wilmington, DE), is that "one can produce film with the same strength at a lower gauge, because of the narrow molecular weight range of the polymer." One such material is Perfecseal's SheiLLD, a linear low-density polyethylene (LLDPE) film that is 150% stronger at 3-mil gauge than conventional 4-mil LLDPE film. Scholla adds that he sees "a lot of companies working on developing film, both flat and flexible, that works well with Tyvek that hasn't been coated." These films often have an adhesive built in that functions like a traditional Tyvek coating, thereby eliminating the need to coat the Tyvek and consequently saving money.

Rexam Medical Packaging (Mundelein, IL) has been using polymer blend systems to make peelable seals. "Several variants of this technology have grown significantly in areas such as syringe and glove packaging for radiation sterilization," says Joe Spitz, vice president of technology. "We have also expanded the use into foil laminate structures."

Another development is the first new version of Tyvek in 20 years. Tyvek 2FS is expected to debut this summer after DuPont files a patent application. Tyvek 2FS is designed for flexible form, fill, and seal applications and has a lower basis weight than its predecessors—1.6 oz/sq yd versus 1.9 and 2.2 oz/sq yd.

For device manufacturers that do not use Tyvek packaging, there have also been innovations in paper, including tighter weaves, unique coatings, visible seals, and better seal integrity.

STERILIZATION

After packagers choose a material, they must determine the best sterilization method for it. New ISO 11607 standards will influence this decision. While ISO 11607 calls for material producers to determine which sterilization methods to use for their products, many say that in the end it is the packaging engineer's call. The most common types of sterilization are EtO, gamma and E-beam radiation, plasma, and high-energy pulsed light.

"Companies that want to sell internationally have to meet those new standards," says Bill Young, director, Griffith Analytical (Burr Ridge, IL), a division of Griffith Micro Sciences, a contract testing and consultative laboratory. "What's critical is that you understand where the overlaps are between FDA regulations and ISO, and also where the differences may be."

Burron's Schleder explains that "sterility validation is an issue because of federal regulations on parts-per-million exposure levels to protect the people who handle sterilized product. The parts-per-million went down from 50 to 1. It's costly, but it's not that complicated."

Bruce Hergert, vice president of research and development at Perfecseal, says that the challenge hasn't been coming up with new kinds of sterilization but rather a more porous material to lower the cost of sterilization.

TESTING, TESTING

ISO 11607 will also have an impact on seal-strength and integrity testing. There is pressure on manufacturers to come up with easy-to-use quantification methods and methods with the same type of testing, but improved for speed. "When testing porous packages," TM Electronics' Franks says, "there will be a bit of change in the way one approaches test methods. A company may have to change the range that its testers can handle" because of the increasing use of uncoated Tyvek and paper.

"The FDA has pretty much bought into the [ISO] standard, so we will see a step up in quality," says John Spitzley, associate fellow of packaging, Medtronic (Minneapolis), and a member of the U.S. working group that helped develop ISO 11607 and its guidance documents. "Overall, sensitivity levels and the reliability of the tests will improve."

The new standards make process validation crucial for a packager, says Donald Barcan, president, Donbar Industries, Inc. (Long Valley, NJ), a package engineering consulting firm. "If one can show that the processes have high reliability and are under control, one can reduce the quantity and type of testing required to release the product for sale," he says. "The manufacturers will benefit in the long run because they will have a higher level of confidence in what they're producing. If everything goes well, it would lower the cost of producing the package. Unfortunately, at the present time many companies look at the new standards as a burden, cost-wise and time-wise."

MORE REGULATIONS

Many manufacturers and packagers are equally frustrated with several other European and U.S. governmental regulations. For example, the industry is still trying to come to grips with the European Union's (EU) Packaging and Packaging Waste Directive, which was adopted in 1994 but still has not been written into law by several member nations. The directive requires that packages be designed to increase reuse and recovery and limit the amount of material used to the required minimum, and seeks to minimize the amount of heavy metals contained in printing inks. Companies that cannot recover their own materials may fund the recovery and recycling of others.

Most European countries place this responsibility on the company who serves as the packer, which is usually the device manufacturer. But the United Kingdom spreads the responsibility among the raw material suppliers, the converter, the packer, and the retailer, who is usually the manufacturer. Manufacturers are thus placing pressure on suppliers to use lighter materials that can be reused or recycled.

Paul Fielding, regulatory affairs manager at Rexam, says that this pressure highlights a conflict of interest because while lighter materials are less expensive, recycled materials are more expensive.

There are also gray areas concerning which devices need to meet these standards. For example, a blood bag is considered a device when it is empty, but packaging when it is filled. The same is true for a syringe. But European medical device and packaging trade associations have been unable to get these products exempted from the directive.

However, that does not excuse manufacturers who ignore the regulation, says Howard Dobbs, group director of international regulatory affairs, Smith & Nephew, Inc. (Memphis). "If you have not implemented the directive quite as quickly as it should have been, you can say, 'I quietly forgot about it because everybody else has.' You may be able to get away with that for six months to a year," he says. "But my advice is to go back to your suppliers and get the necessary documentation to prove you're meeting the necessary requirements."

The other European regulation that has everyone up in arms requires packaging labels to have descriptions in as many as 13 languages. This regulation could drive up printing costs and lead to other problems. "The amount of labeling is dictating the size of the package, rather than the device and the device's needs," says SIMS Deltec's Larsen. "That costs money."

At the MD&M West Conference and Exposition (Anaheim, CA) in January, Dobbs explained, "I basically told manufacturers that they may be able to get away with using five languages on the label—English, French, German, Italian, and Spanish. I would probably rethink that today. I think it depends on the product. Those five languages account for 80% of the European population, so if you're just selling to those five, that's all you need. But if you sell to all EU member states, you will likely want to add other languages, for example, Dutch and Swedish."

Dobbs said that the state of confusion can be attributed in part to the European regulatory authorities having been preoccupied with other matters while this regulation was being established. However, he predicts that the industry will probably see more enforcement over the next few years, although the chief means of enforcement might be companies blowing the whistle on their competitors, a thought which he calls rather depressing.

One way for American companies to handle the labeling situation would be to print labels with the five basic languages at its main plant and have its European distributors affix additional labels with any other relevant languages. Another solution is to use symbols as much as possible.

U.S. device manufacturers and packagers have their hands full with FDA's new rule requiring that all devices and packaging with natural-rubber latex be labeled as such. Natural rubber can pose a health risk to people who are sensitized to natural latex proteins.

"This regulation is causing our customers a great deal of turmoil," says Spitz. "Many are spending significant resources to change materials to avoid the need for a labeling change. On the packaging side, it affects the devices that are packaged in cold- seal packaging, which uses natural-rubber latex as one of the significant ingredients in the peelable coating. This has also impacted the dressings industry and packaging of devices that use cold-seal banding to hold coils of tubing and the like." Rexam is working on developing natural rubber–free cold-seal coatings to address the problem.

Finally, everyone is waiting to see how FDA will implement the Modernization Act of 1997 as pertains to medical device packaging. Cathy Nutter, senior scientific reviewer, FDA Center for Devices and Radiological Health, told attendees of the medical packaging symposium at the MD&M East Conference and Exposition (New York City) in June that medical device packagers may not need to present as much data to FDA as they used to, but they will have to make sure they have thorough documentation in their own files.

The agency will incorporate international standards where it can, and in some cases all a packager will need to do is send FDA a document showing how proposed changes to packaging conform to the regulatory requirements. However, all supporting data, including all documents showing the company's internal thought process, must be kept on file in case agency inspectors want to see them.

CONCLUSION

Despite the many upheavals and new regulatory challenges that medical device packagers are faced with, the changes have benefited the industry as a whole. While trying to meet these new regulations that would put companies more on a par with one another, packagers have found ways to decrease costs while increasing production and maintaining—or even improving—quality.

"Things like quality and service used to separate some suppliers from the pack," says Plastofilm's Simmons. "Now they are necessary to get in the door."

Erik Swain is senior editor of Pharmaceutical & Medical Packaging News, a sister publication to MD&DI.

Photo by Roni Ramos

Copyright ©1998 Medical Device & Diagnostic Industry