Microbiological Test Required to Product for Sterilization

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BET TEST: Endotoxin Testing (LAL)

Lipopolysaccharides (LPS) are bacterial endotoxins and present in Gram-negative bacterial cell walls known to cause fevers and diseases. Endotoxin testing of medical devices manufactured, and pharmaceuticals produced is necessary to ensure that the product is endotoxin free. It required on various stages of product life cycle:

  • Bulk Lot Release Testing
  • Final Product Release Testing
  • Raw Material Testing

Limulous amoebocyte lysate (LAL) is a test performed as this is based in the biology of the horseshoe crab which produces LAL enzymes in blood cells to bind and inactivate endotoxin from invading bacteria. This method is accepted worldwide. USP <85> requires testing of a production lot for the presence of bacterial endotoxin.

LAL - endotoxin tests with a variety of assay options including:

  • Quantitative and qualitative testing
  • Gel-clot method (LAL test)
  • Chromogenic methods (USP Chromogenic)

The Gel-clot method and the chromogenic method are approved for all phases of therapeutic product development. It is appropriate for multiple types of therapeutics including monoclonal antibodies, vaccines, recombinant proteins, cell therapy and gene therapy.

The gel clot test with the LAL test is for endotoxin detection only with GMP format typically being used for lot release testing of final products for injection in humans. 


 
  Fig-1: Confirmation of label lysate sensitivity 

The USP chromogenic method is based on the activation of a serine protease (coagulase) by the endotoxin, which is the rate-limiting step of the clotting cascade. This is a quantitative method and measures the activation of the serine protease as opposed to the end result of this activation, which is clotting.

Contact an expert about your Endotoxin testing needs.

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