湿热灭菌的介绍〔参数放行〕.ppt

Baxter Confidential * Sterile/Non-sterile Segregation灭菌/未灭菌产品隔离 Physical Barriers 物理隔断 Load reconciliation – count to ensure the quantity of product entering the sterilizer equals the quantity exiting sterilization area 装载平衡 – 数量计算以确保进入灭菌器的产品数量等于到达已灭菌区域产品数量 Sterilizer product truck design prevents loss of a unit - sidescreens or tray design 产品灭菌车设计防止产品丢失– 侧窗或者板设计 Chemical indicators on every product truck – demonstrate exposure to a sterilization cycle 化学指示剂放置在每个灭菌车– 证明产品曾经暴露于灭菌循环 Baxter Confidential * Chemical or Biological Indicators (BI’s)化学或生物指示剂（BI） Must be included in each truck, tray or pallet of each sterilizer load 每个灭菌循环内每载车必须放置化学或生物指示剂 Time and/or temperature response characteristics and stability of the indicator are documented 记录指示剂对时间及温度的反应特性和稳定性 Minimum degradation values or color change (e.g. autoclave tape) required for each sterilization cycle are established 建立每个灭菌循环的最小降解值 Chemical indicators cannot be used to evaluate cycle microbiological lethality 化学指示剂不能用于评估灭菌循环的杀灭能力 BI’s are typically not used for routine release of moist heat sterilized pharmaceutical products 生物指示剂通常不用在湿热灭菌产品的日常放行 Chemical indicators are a visual aid used to demonstrate that product has been exposed to a sterilization process 化学指示剂只是帮助目视管理证明产品曾经暴露于灭菌循环 Baxter Confidential * Risk Assessment / FMEA风险评估 / FMEA Performed for each sterilization process to ensure risk of undetected failures is eliminated 针对每个灭菌过程进行评估，确保未发现的失败已被消除。 Evaluates probability of a failure, risk associated with that failure, and the detectability of that failure. 评估失败的可能性、相关风险及失败的可检测性。 Baxter Confidential * Upcoming Documents即将被批准的文件 US FDA Guidance for Industry Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes 美国FDA指引- 工业申请文件，用于申请最终湿热灭菌的人用药和兽用药参数放行 PDA has provided industry comments FDA已经批准工业注释 Compliance Policy Guide also expected to be updated 符合性指导政策也需要被更新 PDA TR 30 (Parame