Transcription of Sterilization - validation, qualification requirements
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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.
Sep 19, 2013 · Validation - Performance Performance Qualification • Demonstrating that sterilizing conditions are achieved in all parts of sterilization load • Physical and microbiological Physical • Heat distribution studies on empty chamber – maximum and minimum cycle times and temperatures – to identify heat distribut ion patterns including slowest
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