Bacterial endotoxin testing is a critical safety requirement for pharmaceutical and biomedical products. Bacterial endotoxins are released from Gram-negative bacteria when the microorganism dies or the cell wall is denatured. Endotoxins are commonly found everywhere in our environment and it is the most significant pyrogen in parenteral drugs and medical devices. These endotoxins can cause fever and septic shock if they enter a patient’s bloodstream. Thus, any products that enter the human body must be tested for the presence of endotoxins prior to market release. MTS offers different bacterial endotoxin methods that utilize limulus amebocyte lysate (LAL). LAL is the most sensitive and specific method available for the detection of endotoxins.
Gel Clot Method
*All methods are based on the following guidances: per AAMI ST72, USP 161, USP 85
Upon completion of test, a final report will be issued and all records and raw data will be held for five years.
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Millstone Testing Services offers comprehensive regulatory testing services backed by more than 90 years of combined experience in the medical device and pharmaceutical sectors.