蒸汽滅菌和凍幹工藝的驗證及風險分析(PPT 131頁)

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
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