您现在的位置: 精品资料网 >> 企业管理 >> 风险管理 >> 资料信息

蒸汽灭菌和冻干工艺的验证及风险分析(PPT 131页)

所属分类:
风险管理
文件大小:
7419 KB
下载地址:
相关资料:
冻干工艺,风险分析
蒸汽灭菌和冻干工艺的验证及风险分析(PPT 131页)内容简介
GMP & VALIDATION
GMP & VALIDATION
Validation
Terminal Moist-Heat Sterilization
What is being Sterilized?
Porous Loads
Hard Goods
Equipment Parts
Components
Glass
Stainless steel
Polymeric Materials
Waste Liquids
Defining the sterilization process
Balance must be Maintained
Attaining sterility must not be accomplished with loss of
product stability.
Maintaining stability must be accompanied with adequate
assurance of sterility.
Validation approaches
Biological Indicator Evaluator Resistometer
Validation issues
Validation – Calibration
Validation – leak test
Heat distribution and penetration
Temperature mapping
Lethality maps
Possible failure causes
OPERATIONAL QUALIFICATION
Verification of shelf temperature
..............................