Standard Wraps Up Pouch Specs
by David Vaczek
Medical device manufacturers now have a standard to refer to when writing specifications for peelable pouches. At ASTM’s October meeting, Committee F02 on Flexible Barrier Packaging endorsed F2559-06, “Standard Guide for Writing a Specification for Sterilizable Peel Pouches.”
The standard earned approval following full-committee balloting in September 2006. The guide defines requirements and considerations for writing a peel-pouch material specification for porous and nonporous preformed barrier pouches for medical device packaging.
“Medical device manufacturers put a lot of different requirements into their pouch specifications. As a result, pouch manufacturers often end up doing extra testing that is not really necessary for making a good pouch,” says Hal Miller, chairman of Committee F02 and the standard’s author. Miller is president of the packaging consulting firm PACE Solutions LLC (Cape May, NJ) and a PMP News editorial advisory board member.
“This guide tells device manufacturers what some of the essentials are, simplifying matters for pouch converters,” says Miller.
The standard provides specification guidance on materials, method of manufacture, physical properties, performance requirements, dimensioning, appearance, and printing for pouch styles categorized as chevron, header, and corner peel.
Such packaging requirements as material barrier properties, sterilization compatibility, and printed materials should be evaluated during initial package qualification and do not typically require routine testing in production, the guide says.
“The initial qualification ensures that the materials you are going to use are acceptable. The key is to identify those things that can be qualified ahead of time [and] that don’t require in-process testing every time you make it. You want to minimize the amount of testing that is needed during manufacturing,” Miller says.
The standard includes package dimensions and tolerances for the three types of pouches, as published by the Flexible Packaging Association’s Sterile Packaging Manufacturers Council. “We are using these because the pouch manufacturers said these are the dimensional tolerances they are able to hold,” he says.
F2559-06 cites ASTM test methods that should be used for demonstrating package requirement compliance. The standard advises that manufacturers can use ASTM F2097, “Standard Guide for Design and Evaluation of Primary Packaging for Medical Products,” for guidance in selecting appropriate tests.
ASTM F2097 is being updated to incorporate recent standards, including F2559, says Dhuanne Dodrill, chairman of ASTM Subcommittee F02.50.
“F2097 is a great reference tool, providing a compendium of all the standards that are likely to be used when evaluating packaging for medical devices,” Dodrill says. New standards being incorporated into F2097 include the F2391-05 test method for measuring package and seal integrity using helium tracer gas, F2475-05 for determining appropriate package material biocompatibility testing, and F2476-05 for determining carbon dioxide gas transmission rate through barrier materials, she says.
F2559-06 references ASTM methods for tensile and burst seal-strength testing.
For tensile testing following F88, the guide notes that because test results vary with the sample-tail-holding method used, “consistent use of one technique should be negotiated with the supplier and indicated in the specification.”