Validation Procedures for the Bacterial Endotoxins Test (single user digital version)

Sep 2004
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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

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
  • About the Authors