[Use of the LAL-test (parenterals, medical device, dialysis solution)] [Article in German]

Abstract

This article describes the use of the LAL-Test as a product release test for parenterals, medical devices and dialysis solutions. Since the LAL-Test has been established in the pharmaceutical industries, the possibility to use this test as product release test in lieu of the classical test for pyrogens in rabbits has been discussed: The supporters of the LAL-Test argued with its high sensitivity, easy to use, low costs and last but not least with the possibility to avoid experiments with animals. Those who disapproved of the test to be used as a product release test mainly for parenterals feared that - due to the high specifity of the LAL-Test - non-endotoxin pyrogens could no longer be detected. Since some years the LAL-Test has been introduced into the monograph "Parenterals" of the European (German) Pharmacopeia and is mentioned under the tests the parenterals have to comply with.