Development of Methods for Recovering Endotoxins from Surfaces and from Air in Production Environment of Injectable Drugs

Abstract

The aim of this work is to develop and validate methods for quantifying endotoxins on surfaces and in the air of the manufacturing environment of injectable drugs, in order to use them to evaluate the quality of the process and the risk for the products processed therein. The method for recovering endotoxins from surfaces is a direct method that provides sampling surfaces by swabbing and extraction of endotoxins from the swabs with an appropriate diluent, while the method for airborne endotoxins provides an air-active sampling on a glass fiber filter and endotoxins extraction with an appropriate diluent. Bacterial endotoxins are present in the environments devoted to the manufacturing of injectable drugs and could be a real risk for the quality and the safety of such drugs. So the quality control laboratories should have analytical methods to recover bacterial endotoxins from environmental samples. The aim of this publication is to show how we succeeded in developing and validating methods to quantify bacterial endotoxins on surfaces and in the air.