9 - Validation of Steam Sterilization for Filtration Equipment书籍.pdf

Validation of Steam Sterilization for Filtration Equipment Module 9 Copyright Merck Millipore 2011. 1 Overview Examples of regulations Steam and autoclave equipment engineering guidelines Thermal qualification theory and practice Biological qualification theory and practice Validation practices for filter sterilization by autoclaving and SIP Copyright Merck Millipore 2011. 2 US Regulatory Requirement1 – 1 Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products, Nov 1994 A. Description of the Process and Product B. Thermal Qualification of the Cycle 1. The Drug Product and Container-Closure 1. Heat Distribution and Penetration Studies System 2. Thermal Monitors 2. The Sterilization Process 3. The Effects of Loading on Thermal Input 3. The Autoclave Process and Performance 4. Information Included in the Batch Record Specifications 4. Autoclave Loading Patterns C. Microbiological Efficacy of the Cycle 5. Methods and Controls to Monitor 1. Identification and Characterization of Bioburden Production Cycle