Validation Archives - Pharmaceutical Resource & Education Services

Calculate Spore Log Reduction (SLR) for VHP (vaporized hydrogen peroxide) qualification studies in a pharmaceutical aseptic processing Isolator

By Palash Das February 9, 2023Sterility Assurance, Technology, ValidationNo Comments

Calculation of Spore Log reduction (SLR) from VHP (vaporized hydrogen peroxide) qualification in a pharmaceutical aseptic processing isolator The formula to calculate Spore Log Reduction (SLR) from VHP (vaporized hydrogen…

UNDERSTANDING Fphy OR EQUIVALENT EXPOSURE TIME AT 121°C

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

Chance of Positive BI during Sterilization

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

Handling Planned Shut Down in Water System and Return to Service

By Palash Das June 28, 2020Technology, Validation8 Comments

Rationale for using triplicate biological indicators during VHP decontamination in Isolator

By Palash Das January 15, 2020News Updates, Technology, Validation274 Comments

Global Challenges for Indian Pharmaceutical Industry

By Palash Das August 15, 2017Interview & Placement, News Updates, Quality Assurance, Steam Sterilizer, Validation2 Comments

GAMP 5 computer system categorization

By Palash Das July 7, 2016Validation10 Comments

Discussion for establishment of risk based approach on airflow visualization in cleanrooms

By Palash Das November 21, 2015Validation

Where should airflow velocity measurements be taken, with respect to a filling line or other aseptic processing areas?

By Palash Das September 8, 2015Validation3 Comments

Few qualification facts of Sterilization and Depyrogenation tunnel

By Palash Das December 6, 2014Validation2 Comments

Calculate Spore Log Reduction (SLR) for VHP (vaporized hydrogen peroxide) qualification studies in a pharmaceutical aseptic processing Isolator

UNDERSTANDING Fphy OR EQUIVALENT EXPOSURE TIME AT 121°C

Chance of Positive BI during Sterilization

Handling Planned Shut Down in Water System and Return to Service

Rationale for using triplicate biological indicators during VHP decontamination in Isolator

Global Challenges for Indian Pharmaceutical Industry

GAMP 5 computer system categorization

Discussion for establishment of risk based approach on airflow visualization in cleanrooms

Where should airflow velocity measurements be taken, with respect to a filling line or other aseptic processing areas?

Few qualification facts of Sterilization and Depyrogenation tunnel

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