By Zachary S. Anderson, LAL Department Manager, Nelson Laboratories, Inc.
Some sample treatments can inhibit the recovery of bacterial endotoxins from the LAL test solution. This can be the result of either the removal or inactivation of the endotoxin molecules. When this happens, there is a significant risk of a false negative result. Because of this issue, manufacturers are required to validate that the treatment used does not remove or inhibit the recovery of endotoxin in the test solution. This validation is performed in addition to the test for interfering factors and the inhibition and enhancement (positive product control) performed in routine product analysis.
By Zachary S. Anderson, LAL Department Manager
The revision of the FDA guideline on LAL from December 1987 has been a point of discussion for many years now. The guideline was rumored to be withdrawn as early as the end of February 2011 and replaced with Question and Answer style information.
SALT LAKE CITY – April 4, 2011 –
Nelson Laboratories’ (
www.nelsonlabs.com) experts will present four strategic testing topics to medical device manufacturers attending the
BIOMEDevice Boston show. The presentations outline ways to minimize risk and meet regulatory agencies’ expectations.