灭菌的方沈法及注意事项.pptVIP

* Steam Sterilization Validation: Preparation of PQ protocol 蒸汽灭菌验证：PQ方案的准备 5. Acceptance criteria for temp. pressure, Fo where appropriate, vacuum and destructions of BIs 温度压力，相关Fo，真空及生物指示剂灭活的验收标准 6. A requirement for 3 consecutive, successful runs 3次连续成功运行的要求 The drain is the coldest point and is outside of the sterilization zone, not included in the calculation of mean chamber temperature and not subject to chamber distribution requirement. 排水口是最冷点，在灭菌区外，且不包括在平均腔体温度计算内，不受限于腔体分布要求 Thermocouples should be placed at the same location for empty chamber and loaded chamber heat distribution studies. 热电偶应置于相同位置，进行空腔体和满载腔体热分布研究 Uniformity is expected only at the steady state. 仅在稳定状态下要求均一性 * Steam Sterilization Validation: Execution of PQ 蒸汽灭菌验证：PQ执行 1. Temperature sensor shall: 温度传感器应： For heat penetration data, be located such that they penetrate the equipment, or the product container and are immersed in the product 对于热穿透数据，应置于能穿透设备或产品容器处，并包含在产品中 For heat distribution data, be evenly distributed within the load or system and shall not contact metal surface 对于热分布数据，平均分布在负荷范围内或系统中，且不能接触金属面 2. The BI shall:生物指示剂应： Be placed near the tip of the temperature sensor used for penetration 置于靠近用于穿透的温度传感器的顶端 Include the identification that links to the number of the appropriate temperature sensor of the BI 包括与相关BI温度传感器数量有关的识别 The D value of the BI shall be determined in the product BI的D值应在生产中确定 * Steam Sterilization Validation: Execution of PQ 蒸汽灭菌验证：PQ执行 The autoclave shall be loaded and operated in accordance with SOP 高压灭菌器应按照SOP进行装载并运行 Using 121.1 oC as the base temperature and 10 oC as the Z-value, Fo shall be calculated 121.1 oC 作为基底温度， 10 oC 作为Z值， Fo应为计算值 Acceptance criteria shall be based on no growth on exposed BIs and growth on the positive control BI 验收标准应依据暴露的BI上未生长和阳性控制BI上的生长 Failure to m