Bacterial Endotoxin Testing (BET) is an in vitro technique used to detect and quantify bacterial endotoxins in medical devices and water systems. The industry leader can provide reliable and compliant procedure results in as little as one day. They can also assist with failure investigations and the evaluation of the production process, ensuring all tests comply with the FDA Guidelines.
Bacterial Endotoxins Test
Testing for bacterial endotoxins, known as the Bacterial Endotoxin Test (BET), is an in vitro technique. It is used as part of lot release testing for medical devices that come into contact with the lymphatic, circulatory, or cerebral fluid systems. Medicinal products and water systems are also regularly screened for bacterial endotoxins to ensure that none are present in the final product.
This test is sometimes referred to as the pyrogen test or the Limulus Amebocyte Lysate (LAL) test, due to bacterial endotoxins’ ability to cause a fever in mammals. However, it should not be confused with the USP chapter 151 rabbit pyrogen test.
When it comes to testing for bacterial endotoxins, the industry leader is the one that can provide the most reliable and compliant procedure. With more than 25 years of experience, the firm can provide test results in as little as one day, and routine testing results in four business days. They can also assist with failure investigations and the evaluation of the production process, as well as answer any concerns about the test criteria. All tests comply with the FDA Guidelines for Industrial Pyrogen and Endotoxins Testing: Questions and Answers, USP chapters 8.5 and 161, ANSI/AAMI ST72:2011, EP 2.6.14, and JP 4.01.
Video 01: Endotoxin Testing
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