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:
Click here to download >>>Detailed Table of Contents
- Discovery and Acceptance of the Bacterial Endotoxins Test by James F.
- Understanding Reaction Basics by Michael E. Dawson
- Constructing and Interpreting Standard Curves for Quantitative BET Assays
by Karen Zink McCullough
- Qualifying the Laboratory by Ronald N. Berzofsky
- Calculating Endotoxin Limits, Maximum Valid Dilutions and Minimum Valid
Concentrations by Karen Zink McCullough
- Assigning Endotoxin Limits to Noncompendial Articles by Michael E.
- Applying USP Test Requirements: Medical Devices by Marilyn J. Gould
- Verifying USP Test Methodology by Karen Zink McCullough
- Resolving Test Interferences by John Dubczak
- Performing Routine Tests by Alan Baines
- Investigating Out-of-Specification (OOS) BET Results by Karen Zink
- Structuring a Depyrogenation Study by John Dubczak
- Setting Alert and Action Limits by Ronald N. Berzofsky
- Identifying Critical Control Points in Manufacturing by Karen Zink
- Auditing the BET Laboratory by Karen Zink McCullough
- Regulatory Summary by Karen Zink
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.