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Complying with ISO 11607: What will TIR 22 do for you?
(part 2)
The new 11607-2 standard and the accompanying TIR 22 provide new clarity regarding the requirements of process validation for manufacturing processes. This article—the second in a two-part series published in Pharmaceutical & Medical Packaging News—explains test method validation; sterilization procedures; process validation responsibilities; how to define worst case requirements of ISO 11607; and when revalidation is required.
The article was written by Geoff Pavey and other members of the Sterilization Packaging Manufacturers Council (SPMC). Pavey is Principal Engineer, Packaging Development at Oliver-Tolas, a member of the Oliver-Tolas Answer Team, and a member of the SPMC technical committee, ASTM, IoPP, and AAMI WG7 on packaging.
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