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, irrigations solutions, haemodialysis solutions Two categories of sterile products those that can be sterilised in final container (terminally sterilised) those that cannot be terminally sterilised and must be aseptically prepared 4 Sterilization - OverviewWhat is the definition of sterile ?
Sep 19, 2013 · Sterilization - validation, qualification requirements Dawn Tavalsky 2 Sterilization - Overview Objectives – 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
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