Why Endotoxin Testing Is Critical

February 23, 2021

Companies in the pharmaceutical and food industries must operate with extreme care to prevent their products from causing more harm than good. One of the most insidious threats these businesses must watch for comes in the form of bacterial endotoxins. These are pieces of bacterial cells that are found on the outer cell membrane of certain microorganisms. Although they are harmless when outside of the body or in the alimentary canal, it is when these endotoxins find their way into the bloodstream that the true danger is revealed.

As pyrogens, endotoxins are known to cause fevers and headaches. In high enough concentrations, however, the effects can be devastating. Lung and kidney failure have been reported, as well as blood clots. In the most severe cases, endotoxins can cause a complete inflammatory response in the body that could eventually lead to septic shock or death.

Protecting Pharmaceutical Production

Preventing outbreaks of illnesses caused by these pathogens is of critical importance to drug manufacturers. Unfortunately, these endotoxins are common in nature. Because of this, they may be found throughout the process of creating pharmaceuticals, which includes everything from the water and raw ingredients to the processing equipment and packaging. Making matters more complicated is the fact that endotoxins cannot be detected by a sterility test.

Both the FDA and USP <797> have set limits on the levels of endotoxins allowed in pharmaceutical products. Each drug has its own acceptable level of these pathogens, which is determined by human tolerance and the route of administration. It is critical for every manufacturer to ensure that they comply with these regulations for a number of reasons. Not only should pharmaceutical companies strive to release the safest drugs possible, but they should also make sure to avoid fines and legal repercussions that may be related to an outbreak of illness.

Technical Safety Services is proud to offer this type of testing alongside our extensive range of solutions for high-purity water systems used in laboratories and manufacturing facilities across the country.

Why Technical Safety Services is Your Go-To Source

Companies across multiple industries turn to Technical Safety Services for our expertise when it comes to testing and certification of cleanrooms and other controlled environments. We stand apart as one of the leaders in this space thanks in no small part to the depth of our expertise and the comprehensive lineup of services we provide.

In everything we do, we strive to give our clients a commitment to the absolute highest standards of quality and strict protocols. We have the experience and capabilities needed to ensure companies that require the strictest levels of purity have everything they need. To learn more about our services, get in touch with us and find out what we can do for you.

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