Bacterial Endotoxin Test

Bacterial Endotoxin Test or Limulus amebocyte lysate test (LAL test) is used to detect endotoxin in a substance. It is primarily used in blood products, pharmaceuticals, water purification, and other areas where it is important to test for the presence of endotoxin. The LAL test can also be used to measure the effect of endotoxins on other biological systems.

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Endotoxin Test for Medical Device

Endotoxin test is used to predict the release of endotoxins from medical device. It is important to know whether an endotoxin test indicates an implant that has been contaminated or normal as the release of endotoxins from such implants can pose a risk to those receiving them. Endotoxin test has many applications such as assessing the safety of medical devices, the effect on health among those who receive those items and during manufacture.

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Endotoxin test is required for medical devices with direct or indirect contact to the cardiovascular system, lymphatic system, or cerebrospinal fluid or when the device’s label claim specifies a certain endotoxin limit.

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In SaniChem Resources, we can help you to:

• Understand Bacterial Endotoxin Testing

• Perform analysis on Bacterial Endotoxin Testing

• Fulfill regulatory requirements for USP 85 & USP 161

• Ensure safety of products released

Our kinetic turbidimetric test method is based on the requirements of:

1. USP 85 & USP161

2. AAMI ST72