Bacterial Endotoxin Testing
Bacterial endotoxin testing is a critical safety requirement for pharmaceutical and biomedical products. Bacterial endotoxins, such as gram-negative bacteria, 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. Ethide uses limulus amebocyte lysate (LAL) for bacterial endotoxin testing. LAL is the most sensitive and specific method available for the detection of endotoxins.
Our Tests
B100
BET, Gel-Clot, Medical Device Extract w/CSE FDA Method
B100A
BET, Gel-Clot, repeat test – Quantitative Dilution Assay to determine product endpoint (5 dilutions)
B100B
BET, Gel-Clot, Medical Device Extract w/RSE USP Reference Method
B101
BET, Gel-Clot, Inhibition/Enhancement, 4 replicate FDA Method
B104
BET, Photometric – Turbidimetric Method, 3 replicate FDA Method
B105
BET, Photometric – Turbidimetric Method, USP Method
B105A
BET, Turbidimetric – repeat test to determine product endpoint/inhibition removal, per dilution
B106
BET, Photometric – Chromogenic Method, USP
Sample Submission
Purchase Order
In line with current ISO/QSR purchasing requirements, all orders should be sent with a signed completed Purchase Order. This will help expedite the processing or your order. Standing Purchase Orders will be gladly accepted for routine continuing orders.
Sample Submission Form
Final Reports
Upon completion of test, a final report will be issued and all records and raw data will be held for five years.
Highlights For You
How Do You Perform Endotoxin Tests And Pyrogen Tests?
Learn how to perform endotoxin and pyrogen tests for your medical device, and identify which tests will be needed for your device.
Depyrogenation And Sterilization For Medical Devices
Learn about depyrogenation, steam sterilization, and if steam should be used to sterilize your medical device or product.
Depyrogenation By Radiation Vs. Sterilization By Radiation
Learn the differences between sterilization and depyrogenation processes that use radiation and when to use each process to sterilize medical devices
