Transcription of Aseptic Area Validations STERILIZATION …
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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.
Content: • Definition of Sterilization and Depyrogenation • Microbiological aspects of Sterilization and Depyrogenation, Lethality calculation,
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