Validation of Sterilizing Grade Filters - ASQ Long Island Section

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Bacterial Challenge TestFilter Qualification by SupplierChallengeDocumentBacteria/Water SuspensionStand. Cond.Process-related Filter <strong>Validation</strong> by User/External LabChallengeDocumentProcess Cond.Bacteria/Product Suspension10
Bacterial Challenge TestFactors potentially affecting microbialretention include‣ Filter Construction (structure, membranepolymer, pore size distribution)‣ Formulation components‣ Formulation properties (pH, viscosity)‣ Process conditions (time, temperature, pressuredifferential, flow-rate)11
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: Filter Qualification TestsBacterial
Page 13 and 14: Bacterial Challenge Test‣ Challen
Page 15 and 16: Bacterial Challenge Test‣ ASTM 83
Page 17 and 18: Filter Medium vs. Device‣ The pur
Page 19 and 20: Pressure Differential and Flow Rate
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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