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Material and Sterile Barrier Systems

"Incoming Inspection of Packaging Materials"

Do I need to check the porosity of the Tyvek during incoming inspection?

Last Updated On May 15, 2008

Typically, incoming inspection is required to verify the identification and the performance of the purchased product. This can be accomplished through physical inspection and/or by Certificate of Analysis or Certificate of Conformance provided by the supplier. Through historical performance, a rationale may be provided that would allow for reduced or skip lot inspection or auditing of porosity, or other variable measures at incoming inspection. The amount of risk one is willing to accept predicates the degree to which inspection is performed.