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EU Annex 1 compliance for superheated water steriliser – Part 2

Posted by By admin May 13, 2025Posted inSteam Sterilizer, Sterility Assurance, Technology, ValidationNo Comments
FMEA for Terminal Superheated Water Spray Sterilization - EU GMP Annex 1 Compliance Objective To identify and assess potential failure…
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Calculator for lethal rate (L) and F-physical (Fphys) values

Posted by By Palash Das February 5, 2025Posted inSteam Sterilizer, Sterility Assurance, Technology, ValidationNo Comments
How to Use the Sterilization Process CalculatorFor Lethal Rate (L), the formula given is: L = 10^((T-Tref)/z)Where:T = Temperature of…
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Calculate Spore Log Reduction (SLR) for VHP (vaporized hydrogen peroxide) qualification studies in a pharmaceutical aseptic processing Isolator

Posted by By Palash Das February 9, 2023Posted inSterility Assurance, Technology, ValidationNo Comments
Calculation of Spore Log reduction (SLR) from VHP (vaporized hydrogen peroxide) qualification in a pharmaceutical aseptic processing isolator The formula…
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UNDERSTANDING Fphy OR EQUIVALENT EXPOSURE TIME AT 121°C

Posted by By Palash Das November 21, 2020Posted inSteam Sterilizer, Sterility Assurance, Technology, Validation1 Comment
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How to Plan a Shutdown for Clean Room Air Handling Unit?

How to Plan a Shutdown for Clean Room Air Handling Unit?

Posted by By Palash Das August 30, 2020Posted inAir Handling System, Technology5 Comments
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With Pen and Paper

Posted by By Palash Das August 11, 2020Posted inInterview & Placement, News Updates, TechnologyNo Comments
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Growth in BI at Moist Heat Terminal Sterilization

Posted by By Palash Das July 11, 2020Posted inDrug regulatory and guidelines, Steam Sterilizer, Technology1 Comment
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COVID-19 vaccine human trials at India

Posted by By Palash Das June 30, 2020Posted inNews Updates, TechnologyNo Comments
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Handling Planned Shut Down in Water System and Return to Service

Posted by By Palash Das June 28, 2020Posted inTechnology, Validation8 Comments
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Vaccine manufacturing process

Posted by By Palash Das June 27, 2020Posted infnd and production, TechnologyNo Comments
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  • EU Annex 1 compliance for superheated water steriliser – Part 2
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  • Pre-Use Post-Sterilization Integrity Testing (PUPSIT): A Risk-Based Approach to Implementation
  • VHP Decontamination
  • Calculator for lethal rate (L) and F-physical (Fphys) values
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