EU Annex 1 compliance for superheated water steriliser – Part 2
FMEA for Terminal Superheated Water Spray Sterilization - EU GMP Annex 1 Compliance Objective To identify and assess potential failure…
Pre-Use Post-Sterilization Integrity Testing (PUPSIT): A Risk-Based Approach to Implementation
Abstract This article examines the regulatory requirements and scientific basis for Pre-Use Post-Sterilization Integrity Testing (PUPSIT) in pharmaceutical manufacturing. By…
VHP Decontamination
VHP Decontamination in Pharmaceutical Isolators VHP Decontamination in Pharmaceutical Isolators A comprehensive visual guide covering cycle phases, validation processes, challenges…
Calculator for lethal rate (L) and F-physical (Fphys) values
How to Use the Sterilization Process CalculatorFor Lethal Rate (L), the formula given is: L = 10^((T-Tref)/z)Where:T = Temperature of…
Sterilisation choices for aqueous products
>>>Click here to try the tool<<< Sterilization Methods for Aqueous Products: A Decision-Making Framework The sterilization of aqueous pharmaceutical products…
Cycles for steam sterilisation and post-aseptic processing terminal heat treatment
Sterilization Process Advisor – Tool Overview and InstructionsThe Sterilization Process Advisor is a simple and interactive tool designed to help…
How can AI use to assure Sterility Assurance?
AI can play a crucial role in assuring sterility for sterile products manufacturing by improving various aspects of the process.…
Calculate Spore Log Reduction (SLR) for VHP (vaporized hydrogen peroxide) qualification studies in a pharmaceutical aseptic processing Isolator
Calculation of Spore Log reduction (SLR) from VHP (vaporized hydrogen peroxide) qualification in a pharmaceutical aseptic processing isolator The formula…
Q&A On Sterility Assurance
#1. Why sterility assurance need to be ensure for sterile pharmaceutical preparations ? Sterility assurance is a crucial aspect in…
Protected: Biological indicator failure during process validation is one of the critical events
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