PDA TR1 湿热灭菌验证(CN2007)

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1、ValidationofMoistHeatSterilizationProcesses:CycleDesign,Development,QualificationandOngoingControlTechnicalReportN01(Revised2007)SupplementVol.61,N0S-1c2007byPDAPDAParenteralDrugAssociation湿热灭菌的验证：灭菌程序的设计，开发，确认和日常监控2007年增补，第一卷N0.S-1美国注射剂协会制药科学及技术杂志编写委员：中国医药设备工程协

2、会技术委员会发行单位：中国医药设备工程协会1湿热灭菌程序的验证：灭菌程序的设计、开发、确认以及日常控制目录1.0引言.............................................................................................................................................41.1范围.........................................................

3、.............................................................................42.0术语.............................................................................................................................................53.0灭菌科学..............................

4、.....................................................................................................113.1灭菌模式...........................................................................................................................123.1.1耐热参数（DT）..............

5、.......................................................................................133.1.2温度系数（z值）...................................................................................................153.1.3灭菌率（LethalRate）和累计杀灭时间（lethality，F）...................

6、.................163.2灭菌指示剂........................................................................................................................203.2.1生物指示剂（BIs）................................................................................................20

7、3.2.2化学监测器.............................................................................................................213.3热力学和蒸汽质量............................................................................................................223.3.1温度和热量..........

8、...................................................................................................223.3.2蒸汽..........................................................