Transcription of Operator Certification Course Integrity Testing …
{{id}} {{{paragraph}}}
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)ORZ3 UHVVXUH%3 GLIIXVLRQEXON IORZBioPharmaceutical DivisionDiscover the More in millipore .
BioPharmaceutical Division Discover the More in Millipore.™ Operator Certification Course Integrity Testing Methodology Hydrophobic filter Integrity Testing
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document:
{{id}} {{{paragraph}}}