This article serves as your comprehensive guide to endotoxin testing—covering key principles, methods, and best practices.
The novel Sievers Eclipse BET platform reduces endotoxin assay setup time by as much as 85% and decreases the use of Limulus Amebocyte Lysate (LAL) reagent by up to 90%. At the same time, it fulfills ...
AGAWAM, Mass., Oct. 24, 2012 /PRNewswire/ -- A new white paper is available to assist medical device manufacturers with understanding recent changes to the U.S. Food and Drug Administration's (FDA) ...
The presence of harmful bacteria in parenteral drugs or implantable devices can cause inflammatory responses such as fever and, in some cases, may even be fatal. As a result, robust bacterial ...
Lonza announces the release of a new FAQ Tech Tip, “Data Integrity for Endotoxin Testing” for its QC Insider™ Toolbox. Since data integrity is a fundamental component of the pharmaceutical industry, ...
Endosafe ® Trillium™ recombinant cascade reagent (rCR) cartridges from Charles River Laboratories were designed to provide an alternative option to bolster commitments to sustainability and animal ...
In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss ...
This webinar will help the attendee gain an understanding of the requirements of current USP <85> Bacterial Endotoxin Test (BET) European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia ...
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