Validation of Sterilizing Grade Filters - ASQ Long Island Section

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Recovery Membrane Selection‣ Either 0.45 or 0.2 micron-rated filter membrane can beused for recovery membranes‣ Studies indicate that 0.45 micron-rated membranes mightbe more efficient than 0.2 for this purpose‣ Cellulose Nitrate is the preferred membrane polymer –high affinity for proteins18
Pressure Differential and Flow Rate‣ Maximum process pressure differentials (P) across the filtershould be used in the challenge studies‣ Process flow-rate should be achieved in challenge studies‣ If pressure and flow rate cannot be simultaneously achieved,the user should determine which is more relevant and developa rationale to support the decision‣ Regulators tend to prefer higher pressure data rather thanflow-rate19
Page 1 and 2: Validation of Sterilizing Grade Fil
Page 3 and 4: Filter Qualification Tests‣ Physi
Page 5 and 6: Filter Qualification TestsViability
Page 7 and 8: Viability Test‣ Evaluation of pot
Page 9 and 10: Filter Qualification TestsBacterial
Page 11 and 12: Bacterial Challenge TestFactors pot
Page 13 and 14: Bacterial Challenge Test‣ Challen
Page 15 and 16: Bacterial Challenge Test‣ ASTM 83
Page 17: Filter Medium vs. Device‣ The pur
Page 21 and 22: BCT Set-up for Small Scale Pleated
Page 23 and 24: Possible BCT StrategiesDetermine &
Page 25 and 26: BCT Strategies - Method 1(Direct In
Page 27 and 28: BCT Strategies - Method 2(Process M
Page 29 and 30: BCT Strategies - Method 3(Time Peri
Page 31 and 32: BCT Strategies -Method 5(Preconditi
Page 33 and 34: BCT Strategies -Method 6(Bioburden
Page 35 and 36: Filter Qualification TestsFilter In
Page 37 and 38: Integrity Test Correlation37
Page 39 and 40: Product Wet Integrity TestingBubble
Page 41 and 42: Product Wet Integrity TestingDiffus
Page 43 and 44: Integrity Test FailureTR #26 includ
Page 45 and 46: FDA Guidance on Aseptic Processing
Page 47 and 48: FDAWarning letters and inspectiongu
Page 49 and 50: ISO: AP of Health Care Products —
Page 51 and 52: ConclusionRegulatoryRequirementIndu

Validation of Sterilizing Grade Filters - ASQ Long Island Section

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