The fundamentals of endotoxin testing for medical device manufacturers — from definition to assay acceptance criteria —are detailed in new technical brief available from Microtest Laboratories.
Bacterial endotoxins cause fever, septic shock, and other disease symptoms — and thus attract considerable regulatory scrutiny from such organizations as the U.S. Food & Drug Administration (FDA) and the United States Pharmacopeial Convention. Regulations require that devices that contact circulating blood or cerebrospinal fluid, or are used with intraocular products or in vitro fertilization procedures, are required to be endotoxin-free.
“The Fundamentals of Endotoxin Testing,” available for download at http://microtestlabs.com/endotoxin-testing, is a step-by-step information resource for medical device manufacturers discussing and detailing the:
- Definition of endotoxins;
- Various tests used for their detection;
- Use of depyrogenation and other ways to remove endotoxins;
- Types of devices that should be tested;
- Preparation and testing of samples;
- Options for sampling containers;
- Acceptance criteria for each of the assays; and
- Sources of official information, reference, and guidance.
“The Fundamentals of Endotoxin Testing” is authored by Steven Richter, PhD, president and scientific director of Microtest Laboratories, and a former FDA official.
The paper is one in a series about testing, manufacturing, and regulatory issues of concern for medical device manufacturers from Microtest Laboratories, a leader in testing services and contract manufacturing for medical devices, pharmaceuticals and biotechnology.
Source: Microtest Laboratories