Bacterial endotoxin can be introduced to the human&animal body by medical devices , biological and pharmaceutical products through direct or indirect contact with blood, lymph nodes, and with cerebral spinal or brainstem contact if they are not properly manufactured or cleaned. Bacterial Endotoxin Testing is also referred to as the Limulus Amebocyte Lysate (LAL) Test. Bacterial endotoxin contamination can present high fever and potentially cause death among humans.
Since Gram negative bacteria, which produce endotoxin, are dangerous to the human body in either a dead or living state, it is imperative medical device manufacturers conduct bacterial endotoxin testing on their medical devices in the finished form. Testing may be performed before or after the sterilization process. We recommend testing pre-sterile for those devices that undergo radiation sterilization—to ensure minimal delay in getting the device shipped to market. The validation study should reflect whether the devices evaluated were pre or post the sterilization process. Traditional industrial sterilization generally does not reduce the bacterial endotoxin content on or in product