Validation Procedures for the Bacterial Endotoxins Test (single user digital version)
- Published
- Sep 2004
- ISBN
- 1930114737
- Pages
- 28
- PDA Item Number
- 17908
- Format
- PDF Single user
- Member Price
- $55.00
- Nonmember Price
- $69.00
- Government Price
- $30.00
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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.
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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Format: PDF (1 file - 3.06 MB)
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Table of Contents
Table of Contents :
I.
Introduction
II. Bet Validation for a Drug or Device
VI. Validation of Depyrogenation Processes by Bet Methods
VII. References
VIII. Glossary
IX. About the authors
About the Authors