The Bacterial Endotoxins Test: A Practical Guide

This unique book is a collection of interdependent chapters that are part lab manual, part essay, part historical context, part consultant and part plain sage advice that provide a practical and compliant approach to the execution and use of BET. Full of sensible technological and compliance advice that comes from the contributors` collective experience of over 200 years with BET, the book explains how standard compliance and control measures apply to this seemingly hybrid technology. It offers advice on setting appropriate process action and alert limits, controlling variability, efficient and value-added test methodology, setting limits for non-compendial materials and applying medical device testing strategies to screening of testing accessories and much more. Lab managers and analysts will find this book indispensable as they view their current processes with a goal of continuous improvement.