NJ Labs research scientist Rachel Brick, PhD weighs in with the answer
A Sterility and Endotoxin testing overview…
As potent fever-inducing agents, it is especially important to ensure that any injectable and transplantable products introduced into the human body are endotoxin-free. Simply performing sterility or plate-count studies is inadequate, as non-viable gram-negative contaminants can still introduce endotoxins into a product and pose a serious health risk. The bacterial endotoxins test (BET) detects and quantifies endotoxins found on the surface of gram-negative bacteria. This test uses amoebocyte lysate from derived from of all things, the horseshoe crab.
NJ Labs currently offers all three methods of endotoxin detection described in the United States Pharmacopeia, General Chapter 85. Our highly qualified technicians perform and meticulously document endotoxin testing via the gel clot, turbidimetric or photometric methods. The sensitivity of these tests can be adjusted to suit the client’s needs. Detailed results are delivered to our clients so they can rest assured as to the quality of their products.
On the other hand, Sterility testing, as described in the United States Pharmacopeia, General Chapter 71, provides a method by which microbial contamination in sterile products may be revealed. This type of testing is especially important for medical devices meant to be transplanted or medication to be delivered into the bloodstream, such as pacemakers or IV fluids, as false negatives may lead to severe infection and health complications.
With our strict focus upon quality, NJ Labs places heavy emphasis on testing integrity. Using a state-of-the-art sterility isolation chamber and peristalsis pump, this testing process is performed by highly trained microbiologists, and rigorously monitored and documented. Easily readable results provide full confidence to our clients and ensure product quality.