无菌工艺培训(默沙东).pdf

ASEPTIC PROCESSING ASEPTIC PROCESSING 无菌工艺 无菌工艺 CLEANROOM – CLEANROOM – CLEANING EQUIREMENT CLEANING EQUIREMENT 洁净室-清洁设备 洁净室-清洁设备 清洁模块 CLEANING MODULE 1 清洁模块 CLEANING MODULE 1 OBJECTIVES 目的 OBJECTIVES 目的 At the end of this module At the end of this module 在完成此模块培训后应明白： 在完成此模块培训后应明白： Understand the materials and disinfectants used. Understand the materials and disinfectants used. 所使用的材料及消毒剂 所使用的材料及消毒剂 Why we clean in a particular way Why we clean in a particular way 为什么我们用特殊的方式来清洁 为什么我们用特殊的方式来清洁 How to clean in the correct way. How to clean in the correct way. 如何正确的清洁 如何正确的清洁 清洁模块 CLEANING MODULE 2 清洁模块 CLEANING MODULE 2 CLEANING 清洁 CLEANING 清洁 Cleaning within a Pharmaceutical processing plant is a critical Cleaning within a Pharmaceutical processing plant is a critical activity activity 清洁对一个制药厂来说是一个关键工序 清洁对一个制药厂来说是一个关键工序 There must be dedicated equipment for the cleaning process There must be dedicated equipment for the cleaning process 必须明确清洁程序所使用的设备 必须明确清洁程序所使用的设备 Detailed procedures on how to clean, which disinfectants to Detailed procedures on how to clean, which disinfectants to use and the dilutions to be used for the cleaning process use and the dilutions to be used for the cleaning process 应有相应规程来详细说明：清洁方法，清洁程序所使用的消毒 应有相应规程来详细说明：清洁方法，清洁程序所使用的消毒 剂及其配制。 剂及其配制。 清洁模块 CLEANING MODULE 3 清洁模块 CLEANING MODULE 3 CLEANING CLEANING 清洁 清洁 Cleaning has to be a validated process Cleaning h