ANSI AAMI ST72 Standard Test for Bacterial Endotoxins, Test Methods, Routine Monitoring, and Alternatives to Batch Testing

EUROLAB laboratory provides testing and compliance service within the scope of ANSI AAMI ST72 standard. This standard specifies general criteria to be applied for the determination of bacterial endotoxins on or in medical devices, components or raw materials using bacterial endotoxin testing (BET) methods using amebocyte lysate reagents from Limulus polyphemus or Tachypleus tridentatus. The standard does not apply to the assessment of pyrogens other than bacterial endotoxins.

Complete inactivation of endotoxin is not possible by autoclaving because of its heat resistance and stability. Dry heat sterilization must be completely deactivated for at least 250 minutes at a temperature of 30°C or higher. It is present in the environment (e.g. water, air) where gram-negative bacteria live, and bacterial endotoxins (LPS) remain even after the bacteria die.

Compared with classical exotoxins of bacteria, endotoxins are less potent and less specific because they do not act enzymatically. Endotoxins are heat stable (boiling for 30 minutes does not destabilize the endotoxin), but some strong oxidizing agents such as superoxide, peroxide, and hypochlorite have been reported to neutralize them.

EUROLAB assists manufacturers with ANSI AAMI ST72 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.