Endotoxin Testing on Medical Devices Added to Lonza QC Insider™ Toolbox
Lonza have announced the release of two new additions to its QC Insider™ Toolbox that aim to help QC professionals perform endotoxin testing on medical devices according to the latest compendial requirements. The two new tools include a “Medical Devices Quick Guide,” which is a step-by-step guide that describes sampling, the extraction procedure and testing of the extract, as well as a webinar recording entitled “Medical Devices: Guidelines for Performing the Bacterial Endotoxins Test (BET).”
In the medical device industry, endotoxin testing is performed for the final release of products, including pacemakers, syringe needles, transfusion bags and artificial heart valves. Although the regulations regarding endotoxin testing vary between the United States and Europe, many manufacturers worldwide adhere to the testing procedures defined in USP Chapter .
Katrin Hoeck, Head of Marketing Analysis and Testing at Lonza Bioscience Solutions explained: “The USP released an amendment to Chapter that became effective 1 August 2015. The new tools in our QC Insider™ Toolbox help ensure that our QC Insider™ Experts are testing medical devices for endotoxin according to the current compendial requirements.” Important changes include product unit descriptions, sampling and suitability testing.
The QC Insider™ Toolbox, launched in 2015, is an internet portal designed to provide expert online support for QC professionals responsible for endotoxin testing. Accessible at anytime and anywhere in the world with internet access, it offers comprehensive support tools, training resources and a library of information that will help QC professionals achieve success with bacterial endotoxins tests.
More information is available by visiting: www.lonza.com/qcinsider.
Date Published: May 24, 2016
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