ASTM F2559 Sterilizable Peel Pouch Package Testing
ASTM F2559 package testing defines flexible peel pouches meant to be sterilized for the containment of medical devices. As an ISTA and ISO 17025 certified lab, we realize the importance of ASTM F2559 sterilizable testing. Meeting the ASTM F2559 peel pouch requirements can be difficult. We understand the challenges and guide companies through the process.
Keystone Compliance partners with customers to achieve package compliance. When packages do not meet the requirements, we assist with finding solutions. Our proven process helps avoid product launch delays. Keystone creates an accurate test plan to eliminate expensive over-testing.
Summary of ASTM F2559 Sterilizable Peel Pouch Information
The pouches are generally made through heat sealing or cohesive cold sealing. Either way, the seal is meant to be peeled open. The pouch can be porous, nonporous, or a combination but must meet the printing requirements outlined in the standard.
Scope of ASTM F2559 Package Testing
ASTM F2559 test procedures give guidelines for writing a specification. 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.
Significance of ASTM F2559 Sterilizable Peel Pouch Testing
The supplier and purchaser of the pouches will agree upon specifications and requirements in the following areas:
- 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
- Fabricated in such a way that the seal will withstand sterilization, distribution, storage, and handling
- Specified seal strength- measured by tensile test method
- 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
- 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
- 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
- Traceability of materials
- Determine how changes will be handled in the future.
Expert Sterile Peel Pouch Package Testing
Keystone Compliance strives to give our customers more time and energy on product development instead of testing. Keystone also has a full lab of test equipment which permits us to provide short lead times on scheduling. We can accommodate flexible and rigid packages of all sizes, including large pallets.
Contact us to learn first hand why so many companies partner with Keystone to achieve their F2559 certification needs.