483 – Pharmaceutical Resource & Education Services

F0 Calculator (Basic)

By Palash Das October 15, 2025Quality Assurance, Steam Sterilizer, Sterility Assurance, Technology1 Comment

F₀ Calculator F₀ Calculator- Steam Sterilization Introduction: This tool allows you to determine the sterilization lethality parameter F₀ using temperature…

CAPA Assessment Report – High-Level Review of FDA 483 Observations

By Palash Das July 10, 2025Audit, Drug regulatory and guidelines, News UpdatesNo Comments

Introduction This report presents a high-level assessment of the Form FDA 483 issued to Sun Pharmaceutical Industries Ltd., Halol, dated…

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

By Palash Das November 19, 2022Industrial Microbiology, Sterility Assurance

This content is password protected. To view it please go to the post page and enter the password.

Fault tree analysis

By Palash Das November 15, 2022Uncategorized

UNDERSTANDING Fphy OR EQUIVALENT EXPOSURE TIME AT 121°C

By Palash Das November 21, 2020Steam Sterilizer, Sterility Assurance, Technology, Validation1 Comment

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

By Palash Das August 30, 2020Air Handling System, Technology5 Comments

With Pen and Paper

By Palash Das August 11, 2020Interview & Placement, News Updates, TechnologyNo Comments

Chance of Positive BI during Sterilization

By Palash Das July 25, 2020Industrial Microbiology, Steam Sterilizer, Sterility Assurance, Validation1 Comment

Mystery of Bio-burden over moist heat terminal sterilization process journey

By Palash Das July 18, 2020Steam Sterilizer, Sterility Assurance9 Comments

Growth in BI at Moist Heat Terminal Sterilization

By Palash Das July 11, 2020Drug regulatory and guidelines, Steam Sterilizer, Technology1 Comment

F0 Calculator (Basic)

CAPA Assessment Report – High-Level Review of FDA 483 Observations

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

Fault tree analysis

UNDERSTANDING Fphy OR EQUIVALENT EXPOSURE TIME AT 121°C

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

With Pen and Paper

Chance of Positive BI during Sterilization

Mystery of Bio-burden over moist heat terminal sterilization process journey

Growth in BI at Moist Heat Terminal Sterilization

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