Endotoxins: A Danger to Pharmaceutical & Medical Device Manufacturing Industries

Introduction

Pharmaceutical and medical device manufacturing personnel must cope with endotoxins – a contamination source unique to their industries. Endotoxins, also known as pyrogens, originate from dead (!) gram negative bacteria.

When this strain of bacteria are killed by antibacterial reagents (say phenolic or quaternary ammonium compounds), radiation, steam sterilization, etc. the cell wall detritus that is released is toxic to humans. Yes, the bacteria are dead, but the material that they shed are deadly. That material – the endotoxins – if introduced into the body can cause fevers; hence the name pyrogens, meaning fever-producing.

So pharmaceutical and medical device companies are faced with a difficult problem: Kill the bacteria, but also remove the dead bacteria.

Enter Wipers

Clean-room wipers are instrumental in solving this problem. If wipers are wetted with antibacterial agents, the bacteria are rendered non-viable. But just as important, the wipers entrap the dead bacteria and remove them from the wiped surfaces. This removal process is compounded when the treated surfaces are wiped with fresh wipers wetted with WFI (water for injection, itself filtered to remove any endotoxins) to remove the antibacterial solutions. A perceptive reader would point out that the wipers must also be low in endotoxins. Very true. Wipers are tested for endotoxin content to ensure that they don’t add significant amounts of pyrogens to the wiped surfaces to become part of the problem.

It is worth noting that electronics and semiconductor manufacturers, which also utilize cleanrooms, do not concern themselves with endotoxins, since their products do not find their way into the human body. Endotoxins are primarily important to the health care industries. As an example, medical device manufacturers are VERY concerned about endotoxins, because their products are meant to enter the body, either for diagnostic or remedial purposes. For further information on this, please see the Berkshire Technical Brief “Medical Device Contamination”.

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