We hosted a live interview where Jan Gates will explain distribution conditioning, shelf-life tests, and packaging validation.
Packaging should not be an “afterthought.” Packaging protects your device and ensures the product performance is maintained for the desired shelf-life. Many of our customers will use pre-validated packaging that demonstrates the primary sterile barrier will maintain sterility for 3-5 years. “Design testing” is also needed before shipping the product. The design testing assures that the product’s packing, handling, and shipping do not cause holes or other issues for the sterile product. However, when you submit a 510(k) you are required to provide shelf-life testing data for the device, too–not just the packaging. If your device is sterile, you must perform age-testing on the sterile product. This only addresses the shelf-life. It does not address the requirements of packaging process validation, and it does not address the need to demonstrate that the packaging will protect the product during transit. Most companies are also unclear about which testing needs to be included in their 510(k) submission and which testing needs to be ready for an FDA inspector.
Packaging Validation – Shelf-life Validation Testing is part 1
When Jan writes a procedure for shelf-life validation, she has to consider the length of time, potential humidity, and temperature effects on the product before developing an accelerated aging and real-time aging testing plan. Distribution conditioning before or after aging also needs to be considered. For those of you that need help with shelf-life validation, Jan has created a procedure specifically for this.
Packaging Validation – Distribution Testing is part 2
ASTM D4169 is Jan’s distribution conditioning test of choice because it can be used for any transportation method, including the ISTA 3A and 3B. ISTA 3A or 3B are suitable for explaining the distribution environment simply for the single parcel product shipment, and the FDA now accepts the testing standards. Please note Jan also used the phrase “distribution conditioning” instead of “distribution testing.” When the word “testing” is used, people tend to forget that the product functionality needs to be tested. The packaging must protect the product as the first significant requirement. Ease of use and communication tend to be the subsequent requirements for packaging.
Registration for Packaging Validation Webinar with Jan Gates
If you are interested in listening to the interview with Jan and asking your questions, please register using the form below.
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What you will learn in this interview with Jan:
- What is shipping validation (i.e., transit testing or distribution conditioning)?
- What is shelf-life validation?
- What is packaging process validation?
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 also was kind enough to develop three different validation protocols for our company that are available for purchase:
- Distribution Conditioning Shipping Qualification (20 pages)
- Shelf-Life Testing Protocol (13 pages)
- Packaging Performance Testing Protocol (18 pages)
View Our Process Validation Procedure
CLICK HERE OR IMAGE BELOW:
About Jan Gates
Jan is the owner and founder of PackWise Consulting, with 30+ years of experience in package engineering with 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, production line efficiency increases, packaging equipment, and sustainable packaging, as well as 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, please contact her by email or phone at (650) 743-5780.