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LAL, BACTERIAL ENDOTOXIN, AND PYROGEN TESTING -
MEDICAL DEVICE

Medical devices and lab equipment often need to be certified as pyrogen free. Pacific BioLabs can perform device pyrogen or endotoxin testing.

Pyrogens are fever-inducing substances, of which bacterial endotoxins are a subset. Bacterial endotoxins are lipopolysaccharides present in the cell walls of some bacteria. Radiation, ethylene oxide, or steam sterilization are often not sufficient to destroy endotoxins present on products or in substances. Therefore it is important to ensure that items are free of endotoxin contamination - even for products that will ultimately be sterilized.

The Rabbit Pyrogen test is an in vivo procedure to detect the presence of pyrogens on a device or an extract from a device. The LAL Kinetic Chromogenic Method is an in vitro procedure to detect the presence of bacterial endotoxins, and is often used for lot release testing of products.

LAL tests are based on the guidelines set forth in USP <85>. The Kinetic Chromogenic Method has a sensitivity to detect as low as 0.005EU (Endotoxin Units) per mL.

For more information on pyrogens, endotoxins, and LAL testing, visit our Learning Center section on Bacterial Endotoxins Testing.

Available Endotoxin/Pyrogen Test Services

• Kinetic Chromogenic LAL Method (for bacterial endotoxins) - in vitro
• USP / JP / EP / ISO (material mediated) Rabbit Pyrogen Test - in vivo

Please contact Pacific BioLabs if you need sample collection containers.