Transcription of Operator Certification Course Integrity Testing Methodology
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Operator Certification Course Integrity Testing Methodology
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 Integri
BioPharmaceutical Division Discover the More in Millipore.™ Operator Certification Course Integrity Testing Methodology Hydrophobic filter Integrity Testing
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