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Testing Services > Tests > Packaging Validations

Packaging Validations

Packaging Validations demonstrate the strength, integrity, and microbial barrier properties for porous and non-porous packages. These validations are required by FDA/ISO regulations before products can be sold. Nelson Labs has a streamlined validation process that meets these requirements and complies with the ISO 11607 “Packaging for terminally sterilized medical devices” standard.

A packaging validation addresses the following areas and includes the following tests:

Please see our Packaging Validation matrix for more information.
“The entire process at Nelson Labs is incredibly straightforward and easy from receiving a quote to sending in samples. I especially appreciate the on‐time turnaround because the testing timeline usually has a direct impact on my project timeline.”

Winnie , R&D Engineer , Medical Device Manufacturer


Packaging Validations


ISO 11607 Part 1 Requirements for materials, sterile barrier systems and packaging systems indicate that manufacturers choose one test from each category. Our packaging validation matrix can assist you.


MN:BARRACUDA