Validation – Page 2 – Pharmaceutical Resource & Education Services

Cycles for steam sterilisation and post-aseptic processing terminal heat treatment

By Palash Das January 14, 2025Steam Sterilizer, Sterility Assurance, ValidationNo Comments

Sterilization Process Advisor – Tool Overview and InstructionsThe Sterilization Process Advisor is a simple and interactive tool designed to help…

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…

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

Cycles for steam sterilisation and post-aseptic processing terminal heat treatment

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?

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