Bacterial Endotoxin Testing

Bacterial Endotoxins Test (LAL test)

Accredited method

Endotoxin is a toxin that is released from gram-negative organisms, the tests determines whether these organisms are present (alive or dead) through the presence or lack thereof of those toxins.

 

The Bacterial Endotoxins Test is an in vitro technique tests for the presence of bacterial endotoxin in or on medical products which will come in contact with the cardiovascular or lymphatic systems or cerebrospinal fluid. Injectable pharmaceutical products must also be tested for bacterial endotoxins. Routine monitoring of water systems and incoming materials can help to ensure that the process does not contribute endotoxins to the final product.

 

This method is used to determine if products or substances are “endotoxin free”.

 

Standard:

  • Europeae Pharmacopoeia <2.6.14>
  • USP <85> & <161>
  • Polish Pharmacopoeia <2.6.14>

Method:

  • Gel clot technique – method A – limit test (qualitative)
  • Gel clot technique – method B – quantitative test

Requirements:

  • Validation methods for each medical device
  • for validation 3 batches of 3-10 devices
  • for routine analysis 3-10 devices