Testing medical disposables using the Limulus Amoebocyte Lysate (LAL) test.
Plastic, single-use devices intended for the administration of drugs or for the removal or transfer of body fluids must be free of pyrogenic contaminants.  Unfortunately, very little information is available regarding tests to detect such contaminants.  For this reason, many manufacturers of medical disposables must rely on their own discretion when they devise methods for extracting these substances from their products.  This article discusses the use and value of the Limulus Amoebocyte Lysate (LAL) test for estimating the concentration and extraction of bacterial endotoxins in disposable medical devices.  When bioburden-control procedures are applied to products manufactured to GMP requirements, batch testing of products for pyrogenicity may not be essential.
B. Braun Melsungen AG, Federal Republic of Germany.
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D000818:Animals; D001431:Bacteriological Techniques / Q000592:standards; D004209:Disposable Equipment / Q000592:standards*; D004731:Endotoxins / Q000302:isolation & purification* / Q000592:standards; D004866:Equipment Contamination / Q000517:prevention & control*; D005858:Germany; D006801:Humans; D008033:Limulus Test / Q000379:methods; D011749:Pyrogens / Q000302:isolation & purification*; D011786:Quality Control; D011817:Rabbits; D013242:Sterilization / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards