Bacterial endotoxins

Our accurate test results provide a solid basis for informed decisions regarding the release of medical devices and contribute to improving patient safety.

With our extensive experience and expertise, we support medical device manufacturers and pharmaceutical companies in carrying out endotoxin tests in accordance with Ph. Eur., Chapter 2.6.14 and USP Chapter <85 > (LAL), as well as Ph. Eur., Chapter 2.6.32 (rFC) according to proven standards.

Endotoxins are a group of pyrogens with the highest potency. These are cell wall components of gram-negative bacteria, e.g. enterobacteria or pseudomonads. These are high-molecular complexes consisting of a polysaccharide, protein and lipid component.

Endotoxins are detected in animal experiments (rabbit fever test) or biochemically (LAL test). However, as animal testing is increasingly being discontinued, biochemical methods are now being used.

However, the LAL test cannot always be used due to certain interfering factors caused by materials that have inhibitory or amplifying properties. Validation of the LAL test, in particular the fixed gel method, is therefore essential.

The accurate determination of endotoxins in medical devices and pharmaceuticals is crucial to ensure the safety and efficacy of these products. At GfPS mbH, we have been leaders in the use of the LAL test for years and have recently started offering the rFC test for measuring endotoxins.

The LAL test is used for the qualitative detection of endotoxins using the solid gel method or even for quantitative detection using the kinetic-turbidimetric or rFC method. The test is highly specific and very sensitive – approx. 100 times more sensitive than the rabbit fever test – but only endotoxin-induced pyrogens can be detected. Therefore, testing for the presence of pyrogens using the LAL test after sterilization is an appropriate release criterion if the product is to be declared as sterile and endotoxin-free.

The performance of the LAL test is described in the Ph. Eur. described in chapter 2.6.14 and in the USP in chapter <85> “Bacterial Endotoxins Test”. Pyrogenic substances are fever-inducing, heat-resistant and dialyzable, i.e. tiny substances from apathogenic and pathogenic bacteria, fungi and viruses. These are effective in very small quantities: approx. 0.2 µg / kg body weight cause fever in higher animals and in humans after intravenous injections.

Pyrogens, especially the group of bacterial endotoxins, can have serious effects on the health of patients. Our test methods are based on the use of LAL and rFC reagents, which react specifically to endotoxins and can accurately quantify their presence in medical devices.

Guidelines:

• Limulus amebocyte lysate test (LAL) according to PH.EUR. 2.6.14
• Limulus amebocyte lysate test (LAL) according to USP<85>
• Recombinant Factor C method (rFC) according to Ph.Eur. 2.6.32

We are happy to support you with your questions about bacterial endotoxins at
freigabe@gfps.de
.