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…
EU Annex 1 compliance for superheated water steriliser – Part 1 Posted by By admin May 9, 2025Posted inSteam Sterilizer, Validation1 Comment "There should be routine checks on the equipment to ensure that nozzles (where the water is introduced) are not blocked…
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…
Sterilisation choices for aqueous products Posted by By Palash Das January 21, 2025Posted inSteam Sterilizer, Sterility Assurance, ValidationNo Comments >>>Click here to try the tool<<< Sterilization Methods for Aqueous Products: A Decision-Making Framework The sterilization of aqueous pharmaceutical products…
Cycles for steam sterilisation and post-aseptic processing terminal heat treatment Posted by By Palash Das January 14, 2025Posted inSteam Sterilizer, Sterility Assurance, ValidationNo Comments Sterilization Process Advisor – Tool Overview and InstructionsThe Sterilization Process Advisor is a simple and interactive tool designed to help…
UNDERSTANDING Fphy OR EQUIVALENT EXPOSURE TIME AT 121°C Posted by By Palash Das November 21, 2020Posted inSteam Sterilizer, Sterility Assurance, Technology, Validation1 Comment
Chance of Positive BI during Sterilization Posted by By Palash Das July 25, 2020Posted inIndustrial Microbiology, Steam Sterilizer, Sterility Assurance, Validation1 Comment
Mystery of Bio-burden over moist heat terminal sterilization process journey Posted by By Palash Das July 18, 2020Posted inSteam Sterilizer, Sterility Assurance9 Comments
Growth in BI at Moist Heat Terminal Sterilization Posted by By Palash Das July 11, 2020Posted inDrug regulatory and guidelines, Steam Sterilizer, Technology1 Comment
Trouble with Equilibration Time Posted by By Palash Das January 15, 2020Posted inSteam Sterilizer, Technology3 Comments