This booklet covers below chapter that is taken from PDA's bestselling Laboratory Validation, and offers a complete overview of a specific topic and provide practical advice for anyone interested in current aspects of laboratory validation.

Validation Procedures for the Bacterial Endotoxins Test

Bacterial endotoxin is the most significant pyrogen in the Parenteral drug and medical device industries because of its extreme potency and ubiquity in nature. Pyrogen is found on every site or substance where bacterial growth takes place. Bioburden and endotoxin testing are the critical means for assessing control of pyrogens. This chapter describes the two types of LAL-test procedures that are used to validate applications of the Bacterial Endotoxins Test (BET) in the parenteral industry. Regulatory and compendial documents that pertain to the control and measurement of endotoxin are reviewed here to identify specific requirements.

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Table of Contents :

I. Introduction
II. Bet Validation for a Drug or Device

LAL-Test Guideline

Harmonized Bacterial Endotoxins Test (HBET)

Validation of a BET Method for a New Chemical Entity (NCE)

Compatibility Profile by Gel Clot and Kinetic LAL Methods
VI. Validation of Depyrogenation Processes by Bet Methods

Methods of Depyrogenation

Validation of a Water for Injection (WFI) System

Validation of Depyrogenating Oven Cycles

Calculation of Endotoxin Reduction from Thermal Exposure

Validation of Washers for Elastomeric Closures

Accessories, Materials and Software
VII. References
VIII. Glossary
IX. About the authors