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.
Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file - 3.06 MB)
Paper version is not available
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