LAL and Bacterial Endotoxins Testing

Endotoxins (type of pyrogen), are lipopolysaccharides present in the cell walls of gram-negative bacteria. Pyrogens are fever-inducing substances that can be harmful or even fatal if administered to humans above certain concentrations.

The LAL (limulus amebocyte lysate) Assay is an in vitro assay used to detect the presence and concentration of bacterial endotoxins in drugs and biological products.

LAL test ensures that injectable therapeutics are safe for human use.

Abiolabs performs the Kinetic Chromogenic LAL Assay, a sensitive colorimetric assay that can detect endotoxin levels in solutions at concentrations as low as 0.05 Endotoxin Unit/mL.

Water can also be a source of pyrogens. Therefore, it may be important to perform endotoxin testing to routinely monitor water systems.

Applied Standard:

  • European Pharmacopeia Chap.2.6.14
  • USP <85>

Method Process:

LAL testing validation

Protocol generation and validation

  • Study inhibitory or activating effect of the device
  • Study the endotoxin absorption by the device

Extraction

Extraction using PPI water Incubation at 37°C for a minimum of 1 hour

Test method

Kinetic chromogenic test method

Result

Endotoxin concentration (EU/mL or EU/device)

Permissible values: 

General medical device:

Device in contact with cerebrospinal fluid: 

Ophthalmic implants and OVDs:  

20.0EU/device

2 .15 EU/device.

0.5 EU/device or 0.5EU/mL.

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