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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About the Authors
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.