AGAWAM, Mass., May 19, 2014 (GLOBE NEWSWIRE) -- The fundamentals of endotoxin testing for medical device manufacturers — from definition to assay acceptance criteria — are detailed in a new technical brief 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 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 brief is authored by Steven Richter, Ph.D., president and scientific director of Microtest Laboratories — and a former FDA official. Download the "The Fundamentals of Endotoxin Testing" at http://microtestlabs.com/endotoxin-testing. Or, request a copy by calling 1-413-786-1680 or toll-free 1-800-631-1680.
About Microtest Laboratories
Microtest Laboratories is a leader in testing services for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Facebook at http://facebook.com/MicrotestLaboratories, on LinkedIn at http://goo.gl/H8ZLnM or on Twitter at http://twitter.com/MicrotestLabs.