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Endotoxin Testing
Published in Sandeep Nema, John D. Ludwig, Parenteral Medications, 2019
LAL is an extract from the blood cells (amebocytes) of the horseshoe crab, Limulus polyphemus. LAL contains the proteins of the blood clotting system and clots in the presence of endotoxins (and also (1→3)-β-D glucans, which are not pyrogens). Unlike the blood of mammals, which contains all of the components required for clotting, horseshoe crab blood requires exogenous stimulus from endotoxin (or glucans) in order to clot.
Sterilization Support Testing
Published in Anne F. Booth, Sterilization Validation & Routine Operation Handbook, 2017
In the medical device industry, LAL testing is performed as a batch release test on products that come into contact with blood or cerebrospinal fluid. Testing is performed on sterile product samples randomly selected from the sterile load. The FDA and USP have recognized the validity of various approaches to using LAL for endotoxin testing.
Validation of Dry Heat Sterilization and Depyrogenation
Published in James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, Handbook of Validation in Pharmaceutical Processes, 2021
George Sheaffer, Kishore Warrier
The LAL test is an important monitoring procedure to test for the presence of endotoxin. The LAL test is based on the initiation by endotoxin of a blood-clotting cascade in the horseshoe crab. Clotting is measured and related to endotoxin concentration by one of three common in vitro methods: gel clot, turbidimetric, and chromogenic [27].
On the interpretation of bioaerosol exposure measurements and impacts on health
Published in Journal of the Air & Waste Management Association, 2019
Hamza Mbareche, Lidia Morawska, Caroline Duchaine
The Limulus amebocyte lysate (LAL) test, which uses an extract from the amebocytes of the horseshoe crab (Limulus polyphemus) and reacts with bacterial endotoxins, is probably the technique most used for endotoxin quantification. However, multiple factors, from the type of filters used for collection to the storage conditions, affect the outcome of quantification (Douwes et al. 1995; Hoppe Parr et al. 2017). Some variations to the standard LAL assay can be applied under particular conditions. For example, measurements of the turbidity of the LAL extract can be used instead of an end point chromogenic LAL assay (Neun and Dobrovolskaia 2011). Several other commercial kits have been developed for endotoxin detection. Pyrogene by Lonza ((Valais, Switzerland) and Endolisa by Hyglos (Bavaria, Germany) use the recombinant factor C (rFC) to detect the presence of LPS. HEK-Blue by InvivoGen (San Diego, CA, USA) uses the membrane receptor Toll-like receptor 4 (TLR4), which makes cellular culture necessary. PyroDetect by Merck (xx, xx) quantifies the LPS using interleukin-1β.