 Corey Hensel DDL Inc. Director of Operations Visit Website |
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.
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Package Testing Q&A
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Asked July 17th, 2009
For terminally sterilized medical devices for compliance to ISO 11607, Packaging for Terminally Sterilized Medical Devices, it is required to evaluate any changes that may impact sterile barrier integrity and determine whether a revalidation is required. So your focus should be on continuously evaluating material, process, and device changes that could negatively impact sterile barrier integrity and establishing a revalidation plan if such changes can be rationalized as impacting sterile barrier integrity. If no changes have occurred in materials, processes, or device, then it may be prudent to consider a 5-year revalidation plan in conjunction with any major shifts in regulatory policy and testing methodologies.
