Risk-Based Sampling Strategies for Bacterial Endotoxin Testing
Posted on December 17, 2013
By: Christian Supina, Research Scientist; Sangeetha Ravindran Nair, Research Associate
Baxter Healthcare Corporation
Introduction The implementation of a scientifically sound and appropriate sampling plan for pyrogens is one of the most important elements of a microbial control plan. Although a variety of pyrogenic materials have, or have the potential to, contribute to quality issues1-4, bacterial endotoxins rem...
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Bacterial Endotoxin Testing, Baxter Healthcare Corporation, closures, Coatings, Critical Control Points (CCP), drug product containers, drying processes, Endotoxin Testing, Failure Mode and Effect Analysis (FMEA), FDA, hazard analysis and critical control points (HACCP), in-process materials, labelling, lipopolysaccharides (LPS), microbial control plan, microbiology, pyrogens, Risk-Based BET Sampling Plan, Risk-Based Sampling Strategies
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