ASTM F2559 Standard Guide for Writing a Specification for Sterilizable Peel Pouches

ASTM F2559 is intended to define the requirements for flexible peel pouches that are meant to be sterilized for the containment of medical devices. The pouches should have an open, unsealed end. They are also known as preformed sterile barrier systems. For this test, the peel pouches are categorized as chevron, header, and corner peel. The pouches are generally made through heat sealing or cohesive cold sealing. Either way, the seal is meat to be peeled open. The pouch can be porous, nonporous, or a combination but must meet the printing requirements outlined in the standard.

ASTM F2559 gives guidelines or writing a specification. The specification is required to address materials, method of manufacture, physical properties, performance requirements, dimensioning, appearance, and printing. Peel pouches are used universally by the medical device industry and it is imperative that regardless of the manufacturer or material, they maintain their sterility during physical handling. Pouch requirements are divided into “initial pouch and material qualification” and “routine production and receipt requirements”. In most cases, initial pouch testing is only needed prior to the first order to ensure that the product is up to standards. Routine production requirements must be adhered to for every order to ensure that the customer is receiving the proper product.

The supplier and purchaser of the pouches will agree upon specifications and requirements in the following areas:

  • Classification
    • The pouch will be categorized by style: chevron, corner peel, or header bag
  • Materials and Manufacture
    • Non-toxic, microbial barrier, appropriate physical barrier, and compatible with sterilization process
    • Pouches should be manufactured in a formal quality system
    • Materials should demonstrate compliance with requirements during initial package qualification
    • Validate manufacture process to ensure it is reproducible with consistent results that adhere to all standards
  • Physical Properties
    • Fabricated in such a way that the seal will withstand sterilization, distribution, storage, and handling
    • Specified seal strength- measured by tensile test method
  • Performance Requirements
    • Peeled pouch seal characteristics and requirements
    • The seal should be opened to conduct a performance peel assessment that will evaluate a pouch’s ability to withstand different environments
  • Dimensions and Tolerance
    • Dimension requirements should be decided based on product fit and function
  • Workmanship, Finish, and Appearance
    • Loose foreign matter limits (inside and outside the pouch)
    • Wrinkle free to eliminate voids in the seal
    • No scratches or scuffing on film
    • Smooth, cleanly cut pouch edges
  • Printing
    • Determine if the inks should meet standards such as water resistant etc.
    • Ink color
    • Includes all correct legible print
    • No smears or smudges
    • Specify placement and location of print
  • Sampling
    • Testing should be done on an appropriate number of samples to be representative of actual production
  • Packaging and Package Marking
    • Packaging should include multiple wraps and be packed in a shipping case that meets weight requirements
    • Staples and high box stacking are not recommended
    • Cases should be strapped to a pallet for secure shipping
  • Supplementary Requirements
    • Traceability of materials
    • Determine how changes will be handled in the future.

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Other ASTM Standards: