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The Role of the Clean Room in LAL Production

The standard endotoxin test utilises a reagent called Limulus Amoebocyte Lysate (LAL). This test is the most widespread test of bacterial endotoxin in parenteral injections and medical accessories. In the production of LAL, many invisible factors contribute greatly to the quality of the product. Since it is the de-facto standard for the vital detection of endotoxins in pharmaceuticals and medical instruments, the production of the reagents must be of the highest order of cleanliness. The development of cleanroom technology has created an environment that allows for large scale production of an extremely effective endotoxin test. As clean rooms allowed the LAL test to become a widely produced pyrogen test, Timothy Francis at FUJIFILM Wako Chemicals U.S.A. Corporation reckons that clean rooms also allow for the continued development of the next generation of endotoxin tests.