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 sterilization testing. Meeting the ASTM F2559 requirements can be difficult. We understand the challenges and guide companies through the process.
Keystone provides comprehensive reports shortly after completion of the testing. When packages do not meet the requirements, we assist with finding solutions. Lastly, Keystone takes a consultative approach throughout the entire test program. Our proven consultative process helps avoid product launch delays.
Summary of ASTM F2559 Sterilizable Peel Pouch Lab Compliance
This guide defines the requirements and considerations for flexible peel pouches with one open, unsealed end that are
intended to be sterilized containing medical devices. These are also known as preformed sterile barrier systems. Medical device peel pouches are universally used by the industry and produced by a myriad of suppliers. Above all, the pouches must contain and protect the device while maintaining sterility during all physical handling.
For more information on Medical Device Package Testing, please follow the link: KeystonePackage.com – Industries – Medical Devices
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 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 gives guidelines for writing a specification is required to address materials, method of manufacture, physical properties, performance requirements, dimensioning, appearance, and printing.
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 the sterilization process.
- Pouches should be manufactured in a formal quality system.
- Materials should demonstrate compliance with requirements during initial package qualification.
- Validate the manufacturing 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 the 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 scuffs on the 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 the 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 Integrity Testing
In addition to sterile barrier testing, Keystone has a full scope of expertise including leak penetration, vibration, and drop. Our team strives to give our customers more time and energy on product development instead of testing. 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 ASTM package certification needs.
For more referenced ASTM standards and similar testing, please follow the links below:
- ASTM E122 Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process
- ASTM F17 Terminology Relating to Flexible Barrier Packaging
- ASTM F88 Seal Strength Testing of Flexible Barrier Materials
- ASTM F1140 Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
- ASTM F1886 Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- ASTM F2054 Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
- ASTM F2097 Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
- ASTM F2203 Test Method for Linear Measurement Using Precision Steel Rule
- ASTM F2250 Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
- ASTM F2475 Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
- ASTM T437 Dirt in Paper and Paperboard