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Bacterial Endotoxin Testing: History, Inhibition/Enhancement, & Process Control

Published Date: October 2, 2020

The bacterial endotoxin test (BET) is an important part of assuring safety of parenteral pharmaceuticals and medical devices that contact blood or cerebrospinal fluid. Endotoxin (in the form of LPS) is a naturally occurring product of bacterial metabolism, most often shed from gram negative bacteria such as E. coli. The most utilized method for detection and quantification of bacterial endotoxin is the Limulus amebocyte lysate (LAL) test. In this webinar, a brief history of the LAL test and why it is such an important part of quality control will be given. The factors that come into play while selecting a test method, determining sampling size, and performing validation of the test method will be explored. Viewers will learn: – A brief history of the LAL test – Why this testing is important – Validation testing – Inhibition/Enhancment – What a testing program looks like – Common complications

This webinar is part of our 2-day live, pharma webinar series “Pharmaceutical Sterility Assurance, Contamination Control, and Extractables & Leachables.” These webinars, presented by Expert Advisors from Sterigenics, Nelson Labs and Noxilizer are designed to bring you insights into the latest developments and innovations in Pharma Sterilization (Sterilization technologies & sterility assurance), Extractables & Leachables testing (Instruments & techniques & regulatory requirements), as well as Bacterial Endotoxin testing.

Webinars in this series include:


Daniel Loverro

Study Director

Dan has been with Nelson Labs since October of 2013. He started in the molecular biology department, performing cleaning validations on reusable medical devices and the associated biological marker assays. Within a few months he was moved to the BET department, of which he is currently the manager. He also oversees Particulate Matter Method I and Water Activity testing. Not one to shy away from opportunity, he has had a hand in the management of many other departments including Shipping/Receiving and Procurement.

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