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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 Medical, a member of the Oliver Answer Team, and a member of the SPMC technical committee, ASTM, IoPP, and AAMI WG7 on packaging.
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