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Endotoxin, sometimes called pyrogen, causes fever and can, in extreme cases, lead to death due to sepsis and septic shock when introduced into the bloodstream of a patient. The removal of endotoxin from any system or substance that will come in contact with patients during medical therapies, implantation of a device or injection of a substance is critical to patient safety.

This article reviews the nature of endotoxin and briefly discusses the potential sources of both bacteria and endotoxin within several types of environments from hospitals and clinics to biopharmaceutical plants. Included in the discussion are the conditions that might lead to endotoxin and bacterial contamination of a product or system and the commonly used methods of detecting that contamination.

The bulk of the article addresses the protection of products from bacterial and endotoxin contamination. Since the complete prevention of bacterial and endotoxin contamination of facilities is generally not practical, industry attention has focused on remediation. That remediation is in the form of either the destruction of any contamination after the fact, or, in most cases, the building of barriers that prevent contamination from reaching a final product and, as a result, reaching the patient.

The article focuses on the limited number of technologies available that provide the barriers that can prevent bacteria and/or endotoxin from reaching final products. The advantages and disadvantages of each technology are explored and a general recommendation presented.

Click here to download this complete technical report in PDF format.