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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…
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Pre-Use Post-Sterilization Integrity Testing (PUPSIT): A Risk-Based Approach to Implementation

Posted by By Palash Das May 4, 2025Posted inIndustrial Microbiology, Interview & Placement, Sterility Assurance, ValidationNo Comments
Abstract This article examines the regulatory requirements and scientific basis for Pre-Use Post-Sterilization Integrity Testing (PUPSIT) in pharmaceutical manufacturing. By…
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syringe, pill, capsule-1884784.jpg

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…
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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…
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Protected: Biological indicator failure during process validation is one of the critical events

Posted by By Palash Das November 19, 2022Posted inIndustrial Microbiology, Sterility Assurance
This content is password protected. To view it please go to the post page and enter the password.
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Fault tree analysis

Posted by By Palash Das November 15, 2022Posted inUncategorized
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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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Chance of Positive BI during Sterilization

Posted by By Palash Das July 25, 2020Posted inIndustrial Microbiology, Steam Sterilizer, Sterility Assurance, Validation1 Comment
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  • EU Annex 1 compliance for superheated water steriliser – Part 2
  • EU Annex 1 compliance for superheated water steriliser – Part 1
  • 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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