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Evelyn Orona, ARL Bio Pharma Associate Microbiology Laboratory Supervisor Andrew Taylor, ARL Bio Pharma Microbiology Laboratory Supervisor ARL Bio Pharma utilizes the kinetic turbidimetric method described in USP <85> Bacterial Endotoxins Test to provide results. An endotoxin test detects toxins that are released from the cell wall of disrupted gram-negative bacteria. This is a reaction

Andrew Taylor, ARL Bio Pharma Microbiology Supervisor In recent years, there have been instances of endotoxin-caused illness resulting from contaminated compounded sterile preparations. In 2015, an incident occurred where seven cases of endotoxin poisoning were related to contaminated glutathione infusions. In this case, patients were symptomatic within 2 hours of administration. Most cases reported fever, rigor, and headache. An

How are endotoxin limits calculated? How do my endotoxin test results relate to those limits? Endotoxin limits for drug products specify the amount of endotoxin that can safely be present. Limits are based on human tolerance and generally specified in the USP monograph or if no monograph exists, calculated via USP <85> Bacterial Endotoxin Test.

Andrew Taylor, ARL Bio Pharma Microbiology Lab Supervisor Pyrogens are a group of fever causing substances which can be found in compounded sterile preparations (CSPs) if appropriate actions are not taken to reduce or remove them. One of the most widely known groups of pyrogens are bacterial endotoxins.  Bacterial endotoxins are: USP <797> requires a

Andrew Taylor, Microbiology Lab Supervisor Rapid sterility testing is an alternative test method to USP Chapter <71>, which allows for shortened incubation times compared to the traditional sterility testing method. Where USP <71> requires between 14 and 18 days of incubation before a final test result, a rapid sterility test result can be generated after

Kerri Hirst, Microbiologist, ARL Bio Pharma A sterility test detects microbial contamination and provides data to determine if your product is ready for release.  A “Sterile” result indicates no contaminating microorganism is found in the sample. A “Not Sterile” result indicates microbial growth and the product examined does not comply with the test for sterility, unless it