ASTM F2559 aims to define requirements for flexible peel pouches intended to be sterilized for the storage of medical devices. The bags must have an open, unsealed tip. They are also known as pre-formed sterile barrier systems.
For this test, peeling pouches are categorized as chevrons, headers and corner peels. The bags are usually made by thermal insulation or sticky cold sealing. In both cases, the seal is the one that should be peeled off. The pouch can be porous, nonporous or a combination, but must meet the printing requirements specified in the standard.
ASTM F2559allows writing instructions or a specification. Specification materials are required to address production method, physical properties, performance requirements, sizing, appearance and printing. The peeling bags are universally used by the medical device industry and are required to maintain their sterility during physical use, regardless of manufacturer or material.
Bag requirements are divided into "starting bag and material qualification" and "routine production and receipt requirements". In most cases, the first pouch test is only required before the first order to make sure the product meets the standards. Routine production requirements must be followed for each order to ensure that the customer receives the appropriate product.
The supplier and buyer of the bags will agree on the specifications and requirements in the following areas:
Classification
The pouch will be classified by style: Chevron, corner shell or hood bag
Materials and Manufacturing
Non-toxic, microbial barrier, compatible with appropriate physical barrier and sterilization process
Bags must be produced in the official quality system
Materials must comply with requirements during initial packaging qualification
Verify the production process to make it reproducible with consistent results that meet all standards
Physical properties
The seal is manufactured to withstand sterilization, distribution, storage and handling.
The specified sealing strength is measured by the tensile test method
Performance requirements
Peeled pouch seal properties and requirements
The seal must be opened to perform a performance peel assessment to evaluate a bag's ability to withstand different environments.
Dimensions and Tolerance
Size requirements should be determined by product fit and function
Craftsmanship, Finish and Appearance
Loose foreign matter borders (inside and outside of the bag)
Wrinkle-free to eliminate gaps in the seal
No scratches or scratches on film
Smooth, clean-cut bag edges
Printing
Inks are water resistant and so on. Determine if it meets the standards.
Ink color
Includes all legible accurate prints
No stains or smudges
Specifying the placement and location of the print
Sampling
The test should be carried out on an appropriate number of samples to represent actual production.
Packaging
The packaging should contain more than one wrap and be packed in a shipping box that meets the weight requirements
Staple and high box stacking are not recommended
Crates should be attached to a pallet for safe transportation
Additional Requirements
Traceability of materials
Determine how changes will be handled in the future.
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