Validation of Sterilizing Grade Filters - ASQ Long Island Section

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Product Specific Integrity Test – Diffusive Flowa b cFlush with Watere.g.15 ml/minDFL PW = 15 ml/min x 1.77xDFL PW = 26.5 ml/minDF PW /DF WW16 ml/min/9/9 ml/minTest a, b, c with MTP WWTP PW= MTP WWx PBP avg/WBP avgCalculate average, DF WWFlush with ProductTest a, b, c with TP PWCalculate average, DF PWDFL PW = DFL WW x Correction Factor42
Integrity Test FailureTR #26 includes a Trouble Shooting Guidein case <strong>of</strong> Integrity Test Failures:Determines when a filter has to be classified as failedFilter fails first time Measurements & ActionsFilter fails second time Wetting with solventFilter fails third time = Filter failed43
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 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: Product Wet Integrity TestingDiffus
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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