灭菌的方法和注意事项.ppt

灭菌的方法和注意事项

2Outline讨论纲要2

3PresentationOutline

概要USRegulations美国法规MoistHeatSterilization湿热灭菌DryHeat/Depyrogenation干热/去热原法SterilizationProcessValidation灭菌工艺验证OtherSterilizationMethods其他灭菌措施

4CodeFederalRegulation

美国联邦法规

5CodeFederalRegulation

美国联邦法规211.113(a)and(b)sterilization灭菌(a)Appropriatewrittenprocedures,designedtopreventobjectionablemicroorganismsindrugproductsnotrequiredtobesterile,shallbeestablishedandfollowed.应该建立并执行用于预防非无菌药物被致病菌污染旳有关书面程序。(b)Appropriatewrittenprocedures,designedtopreventmicrobiolog