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Posts by Palash Das

Home » Archives for Palash Das
About Palash Das

Pharmaceutical OOS Investigation Decision Support Tool

Posted by By Palash Das June 15, 2025Posted inUncategorizedNo Comments
Purpose: This interactive decision matrix provides a structured, risk-based approach for evaluating Out-of-Specification (OOS) test results during pharmaceutical manufacturing investigations. The…
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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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VHP Decontamination

Posted by By Palash Das March 9, 2025Posted inSterility Assurance, ValidationNo Comments
VHP Decontamination in Pharmaceutical Isolators VHP Decontamination in Pharmaceutical Isolators A comprehensive visual guide covering cycle phases, validation processes, challenges…
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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…
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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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Slogans or Quotes of the day

Posted by By Palash Das January 15, 2025Posted inNews UpdatesNo Comments
1. Earning is the by-product of learning.
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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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How can AI use to assure Sterility Assurance?

Posted by By Palash Das July 19, 2023Posted inSterility AssuranceNo Comments
AI can play a crucial role in assuring sterility for sterile products manufacturing by improving various aspects of the process.…
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Calculate Spore Log Reduction (SLR) for VHP (vaporized hydrogen peroxide) qualification studies in a pharmaceutical aseptic processing Isolator

Posted by By Palash Das February 9, 2023Posted inSterility Assurance, Technology, ValidationNo Comments
Calculation of Spore Log reduction (SLR) from VHP (vaporized hydrogen peroxide) qualification in a pharmaceutical aseptic processing isolator The formula…
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Q&A On Sterility Assurance

Posted by By Palash Das February 8, 2023Posted inSterility AssuranceNo Comments
#1. Why sterility assurance need to be ensure for sterile pharmaceutical preparations ? Sterility assurance is a crucial aspect in…
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Recent Posts
  • Pharmaceutical OOS Investigation Decision Support Tool
  • 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
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  • pro dentim on HOSTING REMOTE INSPECTION AT PHARMACEUTICAL FACILITIES
  • Personal finance blog on Get copy of 483’s, Non-compliance report and GMP certificate online from Agencies
  • Palash Das on How to Plan a Shutdown for Clean Room Air Handling Unit?
  • zoritoler imol on Trouble with Equilibration Time
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