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Mérieux NutriSciences AQ provides endotoxin testing to ensure that pharmaceuticals and medical device products are safe for human use.
What is endotoxin testing?
Endotoxin is a toxic, heat-stable lipopolysaccharide substance present in the outer membrane of gram-negative bacteria that is released from a lysed cell. This substance is toxic if introduced in the bloodstream or spinal fluid via a parenteral drug or through a medical device, causing a pyrogenic reaction. Bacterial endotoxins are ubiquitous in nature and very difficult to remove once introduced into a finished parenteral product.
Pharmaceutical and medical device products can be contaminated by bacterial endotoxins. This poses a risk to product integrity and patient safety. As part of microbiological quality control programs, Endotoxin tests can detect the presence or absence of bacterial endotoxin in samples to ensure patient safety.
Bacterial Endotoxin Health Implications
- Fever (Pyrogenic reaction) – temperature increase potentially leading to inactivation of enzymatic reactions in the human body.
Regulation – Therapeutic Goods Administration (TGA)
Microbiological quality of prescription and over-the-counter medicines, TGO 100, specifies the minimum microbiological requirements that medicine should comply with throughout its shelf life. In Australia, when applicable, a sterile medicine should comply with the harmonised requirements of the Bacterial Endotoxin Test in the current edition of a default standard, as specified in Clause 9 of TGO 100.
Products from the categories below require endotoxin analysis:
- Parenteral products – sterile preparations in the form of injections, intravenous infusions, concentrated solution for injection, or medicaments for injection.
- Compounding Pharmacy
- Irrigation solutions
- Therapeutic devices
- Goods – where a test for pyrogen or endotoxin content is part of a statutory requirement
- Water – AS4187 water quality compliance
Available Endotoxin Testing Methods
The Bacterial Endotoxin test or the LAL (Limulus Amebocyte Lysate) is the most sensitive and specific means available to detect and measure bacterial endotoxin. It involves the use of a Limulus Amebocyte Lysate (LAL) obtained from the circulating amebocytes (blood components) of the horseshoe crab, Limulus polyphemus, which coagulates in the presence of bacterial endotoxins.
There are several LAL test techniques recognised as compendial methods by both the USP and BP. Merieux NutriSciences AQ offers the Kinetic-Chromogenic method and Gel-Clot method. Learn about our methods below and discover which one can support your product quality control plans:
Confirming the microbiological safety of your product and medical devices is a vital step to protecting brand integrity and meeting regulatory obligations. Contact us to discuss your testing needs.
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