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Endotoxin Test for Medical Device

Updated: May 26, 2022

What is endotoxin?

Endotoxin is a type of toxin that is produced by gram-negative bacteria. It can also be introduced into the body through food, contaminated water, or touching surfaces that have gram-negative bacteria on them. Endotoxins can come from anything with an outer membrane. Once endotoxin enters the body it triggers a number of different biological responses such as fever and inflammation followed by septic shock and death if not treated quickly.

LAL 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.

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 because 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.

In Sanichem Resources, we could help you to:

  • Understand Bacterial Endotoxin Testing

  • Performing analysis on Bacterial Endotoxin Testing

  • Fulfill regulatory requirements for USP 85 & USP 161

  • Ensure Safety of products released.

Our test method are based on requirements of:

  1. USP 85 & USP161

  2. AAMI ST72

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