 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 October 8th, 2009
Unfortunately, there are no specifications as to how your process needs to be validated. As you stated, it is required that you do it and but it is up to medical device manufacturers to show how they prove it.
I would suggest that you do seal-strength testing at the beginning and the end of your production runs. This would include each lot of product as you inquired about. I would also suggest that you continue to do integrity testing at a minimum at the end of the run.
Should you have additional questions regarding process validations, please contact Scott Levy at scott.levy@testedandproven.com
