Sterilized medical devices are indispensable to doctors and surgeons around the world. Peel pouches, otherwise known as preformed sterile barrier systems, are used to keep these devices sterile during all physical handling. These pouches can be made with a wide variety of material and are produced by many different suppliers, but the trait all pouches must share is the ability to protect devices and keep them sterile.
In order to minimize confusion about how pouches should be specified by users and manufacturers, ASTM International Committee F02 on Flexible Barrier Packaging has developed a new standard, F 2559, Guide for Writing a Specification for Sterilizable Peel Pouches. The new standard is under the jurisdiction of Subcommittee F02.50 on Package Design and Development.
Hal Miller, president of PACE Solutions LLC and a member of the task group that developed F 2559, notes that the guide differentiates between requirements that should be evaluated during initial qualification, which ensures that the materials are acceptable, and those that should be part of routine testing during production. “The key is to identify those things that can be qualified ahead of time that don’t require in-process testing every time you make the pouches,” says Miller. “You want to minimize the amount of testing that is needed during manufacturing.”
Guide F 2559 includes package dimensions and tolerances for three types of pouches: chevron, corner peel and header bag. Tolerances listed in the standard have been agreed to by the Flexible Packaging Association’s Sterilization Packaging Manufacturers Council.
Miller says that both manufacturers and users of sterilizable pouches will find the new standard useful. “Sterile pouch manufacturers will most likely refer their customers to this standard when developing a pouch specification,” Miller says. “Users of peel pouches intended to be sterilized should reference this standard when initially developing a new pouch or material.”
Technical Information: Hal Miller, PACE Solutions LLC, Cape May, N.J.
ASTM Staff: Kevin Shanahan
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