What’s your opinion on the expected shelf-life of metal and/or polymeric needles that are double pouched in Tyvek, which have been sterilized by either EO or Gamma? We have established accelerated and real-time aging studies for our parts but have not gone out past two years yet and are wondering what to expect in terms of sterility. We are also curious if a full-blown sterility test protocol is needed for three- and four-year time points or if package integrity and peel-strength testing will suffice, considering our package configuration and basic parts contained therein. @ Ask The Experts

Corey Hensel
DDL Inc.
Director of Operations
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Corey Hensel has more than 14 years of experience in the package and product testing industry. As Director of Operations, he is responsible for DDL’s processes and operational efficiency across all three of DDL’s facilities. He is also responsible for ensuring all tests are performed in accordance with the most current industry standards and meets the quality standards established through DDL’s ISO 9001 certification. Hensel is Chair of the ASTM D10.23 committee, a member of the Institute of Packaging Professionals (IOPP) and TAPPI.

Package Testing Q&A

What’s your opinion on the expected shelf-life of metal and/or polymeric needles that are double pouched in Tyvek, which have been sterilized by either EO or Gamma? We have established accelerated and real-time aging studies for our parts but have not gone out past two years yet and are wondering what to expect in terms of sterility. We are also curious if a full-blown sterility test protocol is needed for three- and four-year time points or if package integrity and peel-strength testing will suffice, considering our package configuration and basic parts contained therein.

Asked July 13th, 2009

I’ll take the answer from ISO 11607-1:2006, “Packaging for Terminally Sterilized Medical Devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems,” Section 6-Design and Development Requirements for packaging systems, 6.1.4. It states the sterile barrier system shall maintain sterility until the point of use or until the expiry date. And 6.1.5 Maintenance of sterile barrier integrity may be used to demonstrate maintenance of sterility.

A device sterility protocol is executed at time zero to demonstrate that your selected package design, selected sterilization method, and dosage result in a sterile device per your predetermined requirements. As ISO 11607 allows that–6.1.5 Maintenance of sterile barrier integrity may be used to demonstrate maintenance of sterility–an accelerated and real-time aging study whereby package strength and integrity are evaluated at the your desired label expiry dating and shelf-life claim, there is no requirement for performing a device sterility evaluation at any aging interval. The zero time sterility validation addresses the device sterility per package design, sterilization method and dosage.

An Accelerated Aging or Shelf Life Study for the package per ASTM F 1980 with a corresponding Real-Time Aging Study (real-time aging is the requirement) will suffice for demonstration of package sterility. The Package Accelerated and Real-Time Aging Studies provide the requisite data to demonstrate that the selected package design can provide a physical integrity barrier for the device. If physical package integrity is demonstrated over the real-time claimed shelf life, then sterility inside the package is presumed.

Corey Hensel, Karen Greene, Pat Nolan

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