If you are developing a new medical device, do you need to purchase a shelf life testing protocol in accordance with ASTM F1980?
Shelf Life Testing Protocol
The current standard for accelerated aging studies is ASTM F1980:2021, “Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices has been revised and recently released to include medical devices.” Jan Gates explains that the “and” used to say “for.” The language was updated with more information on product humidity effects to go with the title. Jan was kind enough to write a 13-page Shelf-life Testing Protocol for us based on this new standard version. The protocol includes requirements for real-time and accelerated age testing of a product.
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.
Do you need more help with the validation of your packaging process?
For companies interested in packaging process validation, our procedure for process validation (SYS-014) includes an example from the GHTF for validating a packaging process. Jan Gates was kind enough to develop two other related validation protocols for our company that are available for purchase:
- Distribution Conditioning Shipping Qualification (20 pages)
- Packaging Performance Testing Protocol (18 pages)
View Our Process Validation Procedure
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About Jan Gates
Jan is the owner and founder of PackWise Consulting. She has 30+ years of experience in package engineering for foods, pharmaceuticals, detergents, and medical devices. Her work has included individual contributions and leading teams for packaging material and systems design/development to meet regulatory, product protection, and customer use requirements.
Her work includes packaging system validations, cold chain shipping, several types of sterilization methods, increased production line efficiency, packaging equipment, sustainable packaging, documentation procedures, policies, and project management with multiple packaging materials types and production lines.
Over the last 20 years, she has worked in the medical device industry with European (EU)/FDA/Japanese and other countries’ requirements. She was a task group leader for the AAMI TIR 22 document, a US guidance document on compliance with EN ISO 11607-1 and EN ISO 11607-2, Terminally Sterilized Medical Device Packaging. The ISO/EN 11607-1 & -2 standards were adopted as ISO/TIR 16775. She is also a member of the ASTM D10 and F2 (rigid and flexible packaging) groups that develop industry standard test methods and guidance and the IoPP Southern California chapter revitalization group.
The companies she has worked for include:
- Abbott Vascular/Guidant Corporation
- Dade Behring/Syva
- Lever Brothers
- ConAgra/Hunt Wesson Foods
- Bristol-Myers Squibb/Mead Johnson
If you need help with packaging design or developing the testing plans for packaging verification and validation, don’t hesitate to contact her by email or phone at (650) 743-5780.