Transcription of Aseptic Area Validations STERILIZATION …
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Aseptic Area Validations STERILIZATION …
validation OF STERILIZATION EQUIPMENTSA septic area Validations Ph armaceutic al & Chemic al Indu st ry Research an d Developmen t Foundation Slide: 1/51 Content: Definition of STERILIZATION and Depyrogenation Microbiological aspects of STERILIZATION and Depyrogenation, Lethality calculation, D-Value, FH& F0 Values Z-Value and use of microbiological indicators. Slide: 2/51 Content:- Dry Heat Ovens- Dry Heat STERILIZATION Tunnels- Steam Sterilizator ( autoclaves ) 1. Design Qualification2. Installation Qualification3. Operational Qualification4. Performance aspects of Distribution and Heat Penetration studies. Slide: 3/51 Definitions: 1. STERILIZATION : Validated process used to render a product free of living microorganisms including bacterial endospores. 2. Depyrogenation: Removal or inactivation of bacterial endotoxin. Slide: 4/51 STERILIZATION Only: The cycle is designed to assure that the probability of survival of the native microflora is no greater than one cell in one million units of the commodity.
Content: - Dry Heat Ovens - Dry Heat Sterilization Tunnels - Steam Sterilizator (Autoclaves) 1. Design Qualification 2. Installation Qualification
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