LAL Analysis

“Limulus Amebocyte Lysate” or LAL is an extract from the blood cells of the horseshoe crab that reacts when it comes into contact with endotoxins. LAL is performed for the purpose of identifying the pyrogen levels of medical devices in accordance with the United States Pharmacopoeia Guidelines.

The Food and Drug Administration requires that the bacterial endotoxin levels be determined prior to the sale of any device that is labeled “Pyrogen Free. Pyrogen levels are established to determine if the product is safe for its intended use.

Dynatec’s staff is available to assist you with your LAL Analysis needs. Call 915-849-1322 (ext. 107) or email us.

LAL testing is performed in various ways. Dynatec uses in-vitro methods when conducting LAL testing, such as:

  • Gel-Clot Method: A pass/fail method that determines a threshold of endotoxins in a medical device. It can be used for product release.
  • Kinetics Methods: Two methods, Turbidimetric and Chromogenic, that can determine a specific amount of endotoxins in a sample.

Other applications for LAL:

  • LAL is used to detect endotoxin levels in processed water and biological solutions.
  • Biocompatibility studies for new products, revised manufacturing processes, and R&D processes.

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