Lonza Announces Two New Additions to QC Insider™ Toolbox Focused on Endotoxin Testing for Medical Devices

Walkersville, MD, USA / Cologne, Germany, 10 May 2016 – Today, Lonza 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 <161>.

Katrin Hoeck, Head of Marketing Analysis and Testing at Lonza Bioscience Solutions explained: “The USP released an amendment to Chapter <161> 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 .
 
About Lonza
Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. We harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life.
 
Not only are we a custom manufacturer and developer, Lonza also offers services and products ranging from active pharmaceutical ingredients and stem-cell therapies to drinking water sanitizers, from the vitamin B3 compounds and organic personal care ingredients to agricultural products, and from industrial preservatives to microbial control solutions that combat dangerous viruses, bacteria and other pathogens.
 
Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 40 major manufacturing and R&D facilities and approximately 9,800 full-time employees worldwide. The company generated sales of CHF 3.8 billion in 2015 and is organized into two market-focused segments: Pharma&Biotech and Specialty Ingredients. Further information can be found at www.lonza.com .