Caveats of Bacterial Endotoxin Testing (single user digital version)

Mar 2007
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This chapter is taken from the book Pharmaceutical Contamination Control: Practical Strategies for Compliance

A 'caveat' has been described as both a warning or caution, and a qualification or explanation. The word is used here with both meanings to help form a list of issues to have in mind when devising and performing tests for bacterial endotoxins. In its broadest sense the goal of such testing is to preclude the occurrence of significant levels of pyrogens from drugs, drug constituents, and drug containers/closures. Any oversight that impedes or lessens the likelihood of such preclusion or misjudges the levels that can be considered as ‘significant’ can be viewed as deserving of a caveat. Furthermore, any historical context or elaboration of test mechanism that broadens our views or deepens our understanding of the test deserves mention as well.

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Table of Contents

Table of Contents:

  • Using the In-Plate Spike Method
  • Dosing/Specification Development/Safety Factors
  • Starting a Lab
  • Appreciating the Sensitivity of the Test/Avoiding a Skewed View of the Associated Error
  • Container Closure Testing/Differentiating Depyrogenation Destruction and Removal
  • Developing an Endotoxin Control Strategy
  • Having Awareness of Various Bacterial Endotoxin Testing Risks
  • Endotoxin Aggregation Issues (ie ‘Stickiness’)/Proteases and Proteins as Assay Development Tools
  • Know When a Method is Optimised (Using Polynomial Regression)
  • Appreciating the Historical Direction of the Use of LAL
  • Awareness of the Potential for Non-Endotoxin Pyrogens
  • Appreciating the Relevance of Limulus (and Other Arthropods) in Medical Science
  • References
  • About the Authors

    About the Authors

    Kevin Williams
    is Associate Pharmacological Consultant. Eli Lilly & Co., Indianapolis, Indiana. The author or co-author of several books and peer-reviewed articles. Mr. Williams is a member of ASM International and the Parenteral Drug Association. He received the BS degree (1982) from Texas A&M University, College Station, USA.