Bioburden & Endotoxin Validation Methods: A Complete Guide for Pharmaceutical Manufacturers <meta name="description" content="Learn how to validate bioburden and endotoxin testing methods in pharma. Covers LAL, USP //, acceptance criteria, microbial hold time, and water system validation.”> Comprehensive Guide to Bioburden and Endotoxin Validation in Pharmaceutical Manufacturing Introduction Microbiological contamination control is critical in pharmaceutical manufacturing, especially for sterile and parenteral products. Bioburden and bacterial endotoxins are two major threats to product quality, patient safety, and regulatory compliance. Regulators like the FDA, EMA, and WHO expect validated methods to detect, quantify, and control microbial load and endotoxin levels at multiple…