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PHARMAVEN @UCBw4vHQM0Fp6len5G60PJUw@youtube.com

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Pharma Knowledge Sharing Channel #usfda #pharma #injectables


What is First Air? @PHARMAVEN #aseptic #sterilization #validation #qualification #pharmaven #gmp Bubble Point Integrity Testing @PHARMAVEN #pharmaven #validation #qualification #sterilization Guidelines for Media Fill @PHARMAVEN #pharmaven #aseptic #validation #qualification 483s related to smoke study @PHARMAVEN #validation #qualification #asepticprocessing #aseptic What is the pressure of Pure Steam Generator? @PHARMAVEN #sterilization #steam #validation What to simulate in Media Fill? @PHARMAVEN #sterilization #validation #qualification #aseptic How Media Fill detects Microorganisms ​⁠ #pharmaven #validation #qualification #sterilization Why Media Fill Required? @PHARMAVEN #pharmaven #validation #qualification #sterilization #aseptic Why Air Need to Be removed from Autoclave? @PHARMAVEN #sterilization #validation #qualification Aseptic Area Practices ​⁠ #validation #qualification #cleanroom #classification #sterile Why SOP not followed? @PHARMAVEN #pharmaven #validation #qualification How 3 Process Validation Results Should be? @PHARMAVEN #validation #processvalidation Why 3 Process Validation Batches? @PHARMAVEN #validation #qualification #pharmaceuticalindustry How 0.2 micron filter retains bacteria? @PHARMAVEN #validation #qualification #sterilization Media Fill Acceptance Criteria @PHARMAVEN #validation #aseptic #qualification Media Fill Acceptance Criteria @PHARMAVEN #validation #qualification 483s Related to Smoke Studies @PHARMAVEN #validation #qualification #sterilization 483s Related to Smoke Studies @PHARMAVEN #asepticprocessing #validation #qualification Why 3 Process Validation Batches? @PHARMAVEN #validation #qualification #fda #sterilization #gmp What is Population 1 & 2 in Media Fill? @PHARMAVEN #validation #qualification #sterilization What is PUPSIT? #validation #qualification #pharmaven @pharmaven #pupsit #sterile Can we Repeat F0 Value Based Terminal Sterilization Cycle? #sterilization #validation Autoclave qualification or Validation? @PHARMAVEN #validation #qualification #pharmaven #sterile Autoclave, How Endotoxins Removed? #sterilization @PHARMAVEN #validation #pharmaven #qualification Why Non Viable Particle Count Required when We are Doing Viable Count? @PHARMAVEN #validation Media Fill Failure Investigation #validation #qualification #sterilization #asepticprocessing Aseptic area entry, #asepticprocessing #validation #qualification #pharmaven @PHARMAVEN #aseptic What is Material of Construction of Tunnel HEPA Filter? #validation #pharmaven #qualification What is material of Depyrogenation Tunnel HEPA Filter? #tunnel #HEPA #pharmaven #validation #aseptic Do we need Recovery Study in Dynamic Pass-box? ​⁠ #pharmaven #validation #qualification Recovery Study in Dynamic Passbox #pharmaven #validation #passbox #qualification Grade B Change Room Classification @pharmaven #pharmaven #cleanroom #qualification #validation #iso Grade B Change Room Classification @pharmaven #pharmaven #cleanroom #qualification #validation #iso Particle counts for area classification #pharmaven ​⁠ #qualification #validation #iso Particle counts for area classification #pharmaven @PHARMAVEN #qualification #validation #iso Area Classification @PHARMAVEN #hvac #grade #iso #qualification #validation #pharmaven Equilibration Time in Autoclave #pharmaven #validation #qualification #sterilization #autoclave SIP VALIDATION #sterilization #validation #qualification How to Prevent Deviations? @PHARMAVEN #pharmaven #sop #qualification #validation What is SAL and PNSU? @PHARMAVEN #pharmaven #qualification #validation #sterilization How many Change Control can be taken per month? #pharmaven #qualification #change #validation #gmp How Many SOPs can be revised with One Change Control? @pharmaven #pharmaven #gmp #qualification What is unit of F0 value? #sterilization ​⁠ #qualification #validation #autoclave #aseptic What is meaning of Three Media Fills? #pharmaven #sterilization #validation #aseptic #mediafailure Full Lyo Cycle in Media Fill? #pharmaven #freezedrying #validation #qualification #sterilization F0 explained in Detail #pharmaven #validation #sterilization #qualification #aseptic #sterility #gmp NVPC Recovery Study in Static or Dynamic? #pharmaven @PHARMAVEN #validation #sterilization #hvac Visual Inspection of Injectables #pharmaven #visual #sterilization #validation