The Bacterial Endotoxins Test: A Practical Guide

Jan 2015
PDA Item Number
Digital: 17997
Member Price
Nonmember Price

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.

Book written in April, 2011

Table of Contents

Table of Contents:

Click here to download >>>Detailed Table of Contents

  1. Discovery and Acceptance of the Bacterial Endotoxins Test by James F. Cooper
  2. Understanding Reaction Basics by Michael E. Dawson
  3. Constructing and Interpreting Standard Curves for Quantitative BET Assays by Karen Zink McCullough
  4. Qualifying the Laboratory by Ronald N. Berzofsky
  5. Calculating Endotoxin Limits, Maximum Valid Dilutions and Minimum Valid Concentrations by Karen Zink McCullough
  6. Assigning Endotoxin Limits to Noncompendial Articles by Michael E. Dawson
  7. Applying USP Test Requirements: Medical Devices by Marilyn J. Gould
  8. Verifying USP Test Methodology by Karen Zink McCullough
  9. Resolving Test Interferences by John Dubczak
  10. Performing Routine Tests by Alan Baines
  11. Investigating Out-of-Specification (OOS) BET Results by Karen Zink McCullough
  12. Structuring a Depyrogenation Study by John Dubczak
  13. Setting Alert and Action Limits by Ronald N. Berzofsky
  14. Identifying Critical Control Points in Manufacturing by Karen Zink McCullough
  15. Auditing the BET Laboratory by Karen Zink McCullough
  16. Regulatory Summary by Karen Zink McCullough

About the Authors

About the Editor

Karen Zink McCullough, is principal consultant at MMI Associates, a consulting firm specializing in Endotoxin and Microbiology testing compliance. Ms. McCullough has over 35 years of experience in the Bacterial Endotoxins Test, and was the first to publish on the use of the LAL test for release of small volume parenterals. She teaches globally on Endotoxin and microbiological testing. Her current interest is the use of the BET assay as a tool for process control. She is a charter member and current Chair of the LAL Users` Group, a member of the United States delegation to TC209, WG02, ISO 14698 (Biocontamination) standard revision, and also a member of the Microbiology General Chapters Expert Committee of the United States Pharmacopeia.