Pharmaceutical and Medical Packaging News
Magazine
PMPN Article Index
Originally Published PMPN July 2005
Package Testing
Simplifying
Testing
Package testing programs can
sometimes be simplified
and still be safe.
Christina Elston
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Protecting medical devices and ensuring that they remain sterile is no simple matter. And with equipment that can provide more information to interpret, awareness of more factors to be measured, and more-exacting demands and new standards, testing isn’t simple, either.
But while the package testing industry offers more complex and sophisticated testing, their customers often are looking to simplify their operations, primarily for time and cost reasons. And though the tests themselves cannot be simplified, several packaging experts say that testing programs often can.
REMOVING SUBJECTIVITY
More consistent and accurate advice from testing companies could simplify the challenge of designing testing programs, says Barry Kazemi, president and CEO of Life Science Outsourcing Inc. (Brea, CA). Sometimes, he finds that labs convince clients that expensive tests are required, perhaps so they can help pay for their own expensive equipment. “There’s a lot of biased advice disguised as ‘the safer approach’ out there,” he says. Labs routinely suggest, for instance, that clients perform a random vibration test when a less expensive and simpler fixed vibration would have met the real package needs, he says.
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The industry as a whole could simplify package testing by making it less subjective for operators performing the tests, says Gregg Mosely, president of BioTest Laboratories (Minneapolis). He would like to see AAMI or ASTM offer direction as to the amounts of variance that are satisfactory in certain tests. “Historically, there hasn’t been a lot of guidance in terms of what is acceptable or what is not acceptable,” he says. “It would be wonderful if the industry could agree on some numbers.”
Standardizing requirements for sample sizes and for the types of tests for various packages would also eliminate the need for test labs to negotiate these issues with customers, believes Gary Benson. He is manager of sterilization and laboratory sales and service at Ethox (Buffalo, NY). “We would like to see more guidance, because it would assist us in communicating with customers,” he says. Jason Voisinet, senior project coordinator, agrees. “People always ask, what’s the very minimum I can do?” he says. “Currently, packaging standards leave that open and subjective.”
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More-consistent feedback from FDA would also simplify testing by eliminating misconceptions about what is required. If inspectors had more-thorough training and solid guidelines to work from, they would “ask the same questions and expect to see similar methodologies,” says Kazemi. “It needs to be more harmonized.”
Some experts, however, caution against having regulators get too specific. “It is better for people who best understand the product and the package to work with knowledgeable instrument manufacturers that have a sophisticated understanding of testing capabilities,” says Stephen Franks of T.M. Electronics (Boylston, MA). “They can then determine the needed testing parameters and sample sizes and show that their thinking is sound.”
Better Information
While packaging materials are often dictated by product requirements, certain types of testing can also help designers create packaging specifications that are “just enough,” reports Herb Schueneman of Westpak (Oceanside, CA). While current medical device packaging testing is based on challenging only the package, he would like to see the products themselves challenged first.
In other industries, such as electronics, the unpackaged product is challenged to see how fragile it is. Then the product is challenged in the package. This way, technicians know how much headspace there is and can determine how much packaging is enough. Some packages offer five or 10 times more protection than is needed to protect the product, Schueneman says. Companies should protect the product without overkill.
Measuring the Environment
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| Fixtures for testing open packages (top) and closed packages can be custom built by Test-a-Pack. |
Accurate measurement of what goes on during shipping and distribution can help developers design packages right the first time, making the later testing process more effective, according to Dave Huntley, Instrument Group general manager at Lansmont Corp. (Monterey, CA). He says the old adage “measure twice, cut once” can here be adapted as “measure the environment, test right.”
“Years ago, vibration testing consisted of putting a packaged product on a platform and bouncing it up and down,” he explains. Now, it is possible to accurately measure such factors as humidity, temperature, shock, vibration, drop, and pressure. “You can then use that information to develop real test standards for your specific environment,” he says.
Continuously monitoring these factors once the product is on the market can bring environmental changes to light before problems occur. “Previously, it was the occurrence of a problem, generally severe damage, that signaled a change in the distribution environment,” Huntley says. Instruments for this purpose are now palm-sized rather than car-battery-sized, and cost hundreds rather than thousands of dollars, he adds.
Trimming Testing
Programs
If a customer does not want to allocate the budget to perform every test available, testing companies can sometimes simplify and trim programs down, Voisinet says. For instance, customers might choose to perform either burst or tensile testing for seal strength, but not both. They could choose either whole-package microbial testing or microbial-barrier testing. And ship tests could be performed only at the final point in the accelerated aging process, rather than at several points along the way.
Choosing nondestructive testing methods, such as vacuum decay or airborne ultrasound, can also make package validation simpler, according to Tony Stauffer, PTI’s president. “Validation using many destructive methods is very time-consuming, costly, and inefficient because of the lack of reliable, quantitative test data,” he says. “PTI manufactures equipment using only components that are calibrated according to national (NIST) reference standards, another factor supporting simpler validation.”
SIMPLER BY SEQUENCE
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| Conducting distribution testing (shown above at DDL) before aging studies may save time and money. |
Considering the sequence of events when developing test protocols can sometimes make the complete process simpler. One example is the sequence of aging and distribution simulation, according to Patrick J. Nolan, COO of DDL Inc. (Eden Prairie, MN). “If aging is performed first, then fewer packages with actual product are required,” he says. “If distribution simulation is done before aging, all the packages need to have actual product, since this is a dynamic test and we are evaluating the dynamics of the product inside the package. [However,] the advantage of doing distribution simulation first is that we may find problems with product-package interaction and correct them before wasting time and money on aging.”
In some cases, time and money can be saved by stopping work on a package that failed initial testing, according to Renee Dearborn, group leader of environmental services at MicroTest Laboratories, Inc. (Agawam, MA). The company offers accelerated aging, physical package testing, and transportation testing for the medical device market, as well as testing for the pharmaceuticals market. Dearborn explains that sometimes customers request notification if the first packages fail initial testing so that problems can be solved before the rest of the testing program is carried out.
Simplification can also be achieved by understanding what needs to be accomplished during the operation qualification (OQ) and performance qualification (PQ), according to Don Barcan of Donbar Industries (Long Valley, NJ). “For example, the package product produced during the PQ is usually a larger quantity than needed for package-process testing. In many cases, the test quantity can be less than 10% of what is produced,” he says. “The balance is held in quarantine until completion of the testing. If the results are satisfactory, that product is available for sale.”
Simpler Equipment
In some cases, easy-to-operate testing equipment designed to perform multiple types of package testing can simplify the process. Vacuum-decay leak-test systems from PTI are approved to test flexible, rigid, and semirigid packaging with porous and nonporous lidding materials, according to Stauffer. “Testing different package types often requires a simple tooling change,” he says. “We’ve designed features, such as a self-teach function that simplifies setting up testing criteria for each type of package. Again, [we are] catering to the operator and helping to increase productivity.”
The F100-2600-3 Seal Strength Tester from Test-a-Pack, Carleton Technologies (Orchard Park, NY) performs burst, creep, and creep-to-burst tests. It offers fixtures to test both open and closed packages, says Tom Wachala, product engineer. Testing parameters can be preset and locked in memory so that the operator only has to place the package and hit start. “It was designed for simplicity,” Wachala says.
The company has started to receive inquiries from customers who want to put their equipment on a network, so that one master computer could control it, Wachala says. And while that degree of automation isn’t yet cost-effective, automated monitoring of test data is often available. Test-a-Pack has a Windows-based data collection software package that helps the 2600 interface with a PC.
In some cases, the medical device industry is just beginning to embrace these tools. Equipment from T.M. Electronics has had built-in data gathering and statistical analysis since 1990. “But 95% of the industry still isn’t using it,” says Franks. “However, people are moving toward more and better use of statistical information provided by instrument manufacturers.”
Experts across the board caution that when it comes to package testing, reliability can never be sacrificed for the sake of simplicity. Sophisticated testing and equipment can provide information needed to protect medical products—and patients. But as long as package integrity is the first priority, some aspects of testing can be simpler and still keep products safe.
Copyright ©2005 Pharmaceutical & Medical Packaging News
