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Sterilization - validation, qualification requirements

1 ISPE Boston ChapterFramingham MA 19 Sep20131 Sterilization - validation, qualification requirementsDawn Tavalsky2 Sterilization - OverviewObjectives Discuss definition of Sterile Briefly describe Sterilization methods Describe approaches to be used for the validation of a Sterilization process using Moist Heat as an example Describe requirements for routine monitoring and control of Sterilization Review issues that are specific to other Sterilization processes23 Sterile Products - Overview Certain pharmaceutical products must be sterile injections, ophthalmic preparations, irrigations solutions.

Sep 19, 2013 · particular sterilization process in or on a carrier and enclosed in a protective package. – Organisms are in the form of endospores (not vegetative state) as these are most resistant to sterilization 28 Validation - Cycle Development Spore Strips - a narrow strip of fibrous paper impregnated with a bacterial spore suspension

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