Sterile Products_GMP无菌产品的GMP_2009March26.pptVIP

* Environmental Monitoring (1)环境监视 Microbiological 微生物的 Air samples 空气样品 Surface swabs 表面取样 Personnel swabs 操作人员的取样 * Environmental Monitoring (2)环境监视 Physical 物理性的 Particulate matter 微粒 Differential pressures 压差 Air changes, airflow patterns 空气交换率，空气流动分布 Clean up time/recovery 清洁或恢复时间 Filter integrity 过滤器的完整性 Temperature and relative humidity 温度和相对湿度 Airflow velocity 空气流动速度 * Environmental Monitoring (3)环境监视 General Written Program Well Defined Use Risk Assessment Detailed Sampling Information Require Identification Trending Levels and Trending Meaningful Alert/Action levels No Averaging of Results Trending for Reassessment Evaluate Significant Changes * Environmental Monitoring (4)环境监视 Disinfection Efficacy Quality of Disinfectants Efficacy of Disinfectants Limitations of Disinfectants Evaluate Disinfectant Against EM Trend Monitoring Methods Active vs. Passive Equipment Used Microbiological Media Incubation Identification * Non-viable Monitoring Regular monitoring should be performed during each production shift vs. Continuous monitoring requirement in EU Annex 1 Non-viable particle monitoring is recommended to be conducted with a remote counting system Remote counting systems are less likely to interfere with airflow. * Supporting Clean Area Area immediately adjacent to the aseptic processing line meet, at a minimum, Class 10,000 (ISO 7) standards under dynamic (operational) conditions Many supporting area function as zones in which non-sterile components, formulated products, in-process materials, equipment, and container/closures are prepared, held, or transferred. The purpose is to minimize the level of particle contaminants in the final product and control the microbiological content (bioburden) of articles and components that are subsequently sterilized * Removing Particles The air distribution portion of the AHU Supply the air from the ceiling in a non-aspirating manner to reduce air turbulence and remove air from the