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