22-Feb-2012

LAL testing: endotoxin detection

The Endosafe PTS™ is a rapid endotoxin (pyrogen) assay that provides quantitative test results in 15 minutes

The Bacterial Endotoxins Test (BET) detects unsafe levels of microbial cell wall debris, from live or dead Gram-negative bacteria, which causes fever and symptoms of septic shock. The Endosafe division of Charles River has manufactured LAL reagents since 1987. The lysate is extracted from the circulating blood cells of the horseshoe crab, Limulus polyphemus.

Endotoxin is extremely potent, is heat stable, passes membrane filters and is present everywhere bacteria are or have been present. Of greatest concern are intraspinal infusion solutions because this route of administration is about 1,000 times more potent for endotoxin than is IV injection. Non-sterile components and water are the most likely sources of endotoxin in the compounding pharmacy.

It is important to check for endotoxin in:

  • Sterile Compounding or purified water production quality control (standard WFI: <0.25 EU/ml)
  • Dialysis: water for dialysis and dialysates
  • Injectable drugs and in-process raw materials
  • Medical devices: catheters, implants, prosthetics, and surgical material
  • Nuclear medicine for radiopharmaceutical products.

The Endosafe PTS™ is a rapid endotoxin (pyrogen) assay that provides quantitative test results in 15 minutes.

The PTS™ test system is very user-friendly and utilises a handheld reader and disposable cartridges preloaded with all of the materials needed to run a test. The PTS™ requires only a small amount of product and requires no preparation of endotoxin standards.

The cartridges used with the reader are licensed by the US FDA for in-process and final product release testing of parenterals such as Compounded Sterile Products (CSPs).

The PTS™ is fully compatible with USP chapters <85> Bacterial Endotoxins Test, <797> Sterile Compounding and also Europe Pharmacopeia chapter 2.6.14.

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