Operator Certification Course Integrity Testing …
BioPharmaceutical DivisionDiscover the More in millipore . Operator Certification CourseI ntegrity Testing MethodologyHydrophobic filterIntegrity TestingBioPharmaceutical DivisionDiscover the More in millipore . Integrity Testing overview Particle basednMicroorganismnAerosols Liquid property based nAlcoholsnWater+\GUR&RUUBioPharmaceutica l DivisionDiscover the More in millipore . Microorganism - Destructive TestnAerosol microorganisms or liquid bacterial challengenPhage (T1, T3, phiX)nBacteria (B. diminuta)Aerosol Based - Non-destructive Testn"Smoke : (Di-Octyl Phthalate), Glycerol, Corn oil (Dispersed Oil Particulate)etcnMethylene Blue, Sodium FlamenIssueslParticle Distribution must be uniformlMust have correlation of particles vs microorganismslHigh equipment costlDifficult to perform in-situ (particle counter downstream of filter)Particle Based Integrity TestingBioPharmaceutical DivisionDiscover the More in millipore . Alcohol testTraditional Testing Principles Typical wetting liquids are Isopropyl Alcohol ( or Propanol-2), Methanol, Tert-butyl Alcohol, or a mixture of one of these and water Uses same principles as a hydrophilic testDiffusion & Bubble pointFRPSUHVVHGDLU*DV)ORZ3UHVVXUH%3GLIIX VLRQEXON IORZBioPharmaceutical DivisionDiscover the More in millipore .
BioPharmaceutical Division Discover the More in Millipore.™ Operator Certification Course Integrity Testing Methodology Hydrophobic filter Integrity Testing
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