PDA TR 22 无菌工艺模拟（2011）【中英对照】

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1、1TechnicalReportNo.22(Revised2011)2TechnicalReportNo.22(Revised2011)Tableofcontents目录1.0Introduction简介1.1Scope范围1.2PreviousPDAPublications先前的PDA出版物1.3reasonforrevision再版的理由1.4purpose目的2.0Glossaryofterms术语表3.0processsimulationconceptsandprinciples工艺模拟的概念和原理3.1numberandfreq

2、uencyofsimulations模拟的次数和频率3.2worsecase最差条件3.3riskassessment风险评估3.4ongoingevaluation持续评估4.0processsimulationforsteriledosageforms无菌制剂的工艺模拟4.1asepticcompoundingactivities无菌混合4.2solutions液体4.3lyophilizedproducts冻干产品4.3.1simulatedload/unloadwithshortenedholdtime模拟进/出箱的最短保留时间4

3、.3.2simulatedlyophilization模拟冻干4.3.3specialconsiderationsuniquetotheproductionoflyophilizedproducts冻干产品特殊考虑的事项4.3.3.1freezingofmedia培养基的冷冻3TechnicalReportNo.22(Revised2011)4.3.3.2vacuumlevelsandduration真空度和持续时间4.3.3.3anaerobicconditions厌氧条件4.4suspensions混悬剂4.5ointments/cr

4、eams/emulsions/gels软膏/乳膏/乳剂/凝胶4.6powder粉针剂4.6.1liquidmediumfilledbythepowderfillingequipment使用固体灌装设备进行液体培养基的灌装4.6.2drypowderfillerwithsupplementaryliquidfillcapability增加液体灌装能力的干粉灌装机4.6.3on-lineliquidfillfollowedbyon-linepowderfill在线的液体灌装然后在线的粉末灌装4.6.4on-linepowderfillfoll

5、owedbyon-linemediafill在线的粉末灌装然后进行在线的液体灌装4.6.5specialconsiderationsuniquetothesimulationofasepticfillingofsterilepowders模拟无菌粉末的无菌灌装的特殊考虑4.7otherdosageformsanddevice/drugcombinations其他剂型和器械/药物制品4.8otherasepticprocessingtechnologies其他的无菌处理技术4.8.1restrictedaccessbarriersystem

6、s限制进入屏障系统4.8.2form-fill-sealandblow-fill-seal自动成型-灌装-封口和吹-灌-封4.8.3isolationtechnology隔离技术5.0documentation文件5.1processdefinition工艺定义5.2protocol/procedurepreparation方案和流程准备5.3APSexecutionrecord工艺模拟研究执行记录5.4finalreport最终报告5.5processsimulationobservation工艺模拟观察4TechnicalReport

7、No.22(Revised2011)6.0microbiologicalenvironmentalmonitoring微生物环境监测7.0elementsofasepticprocesssimulations无菌工艺模拟原理7.1facilityandfillingmachineconsiderations设施及灌装设备注意事项7.2equipmentset-up设备装配7.3mediaselectionandpreparation培养基筛选及制备7.4inertgassing惰性气体处理7.5containersize容器规格7.6co

8、ntainer/closureconfiguration容器/密封件的形状7.7fillingspeed灌装速度7.8fillvolume灌装体积7.9interventions干预7.10d