Endotoxin Testing and TIR-34 Compliance
How often are you testing for endotoxins?
Endotoxins are lipopolysaccharides (LPS) found within the cell wall outer membrane of Gram-negative bacteria. It is typically shed by the bacterium during rapid periods of growth or as a byproduct of lysis. Endotoxins are not a pathogen, but a component of a bacteria that when present in the body can produce a toxic, inflammatory response in the host. The level of inflammation varies depending on the host and the bacteria the endotoxin originated from, however even low levels of endotoxins can cause acute inflammation.
It is important to understand that gram-negative bacteria and their endotoxins can be present in a potable water system (whether from the facility’s utility water or reverse osmosis systems). Some of these microorganisms can form biofilms that promote endotoxin shedding into systems and offer protection from biocides. Controlling these microorganisms and potential biofilm formation is an important factor in reducing endotoxin exposure. The Association of the Advancement of Medical Instrumentation (AAMI) in conjunction with the ISO have developed the following guidelines for medical device reprocessing and dialysis water:
* Per TIR-34, testing is only required upon system installation, modification, repair or identified problem with high-level disinfection.
EST provides monitoring services to help detect the presence of endotoxins and endotoxin-producing bacteria before they become detrimental to your facility’s operations. Our laboratory and our staff are fully equipped in the interpretation of endotoxin levels using the gel clot LAL assay. By monitoring endotoxin levels, you can maintain TIR-34 compliance in your critical water systems. For persistent contamination of a system, Metagenomic testing is also available for a more comprehensive analysis of the complete microbial biofilm community. Our endotoxin screening will assess the presence and level of activity of the following:
In-House Endotoxin Screening
- Detect the presence of endotoxins at 20 EU/ml or 10 EU/ml.
- Complies with TIR-34
- Turnaround: 3-5 Business Days
General Guidance on Endotoxin Screening
EST recommends that a facility should test their water systems according to the standards above that are applicable to water type and usage. Additionally, EST recommends that endotoxin testing be done on a quarterly basis, to ensure adequate, year-round surveillance of the water system. If a potential issue is found, EST recommends that a follow up sample should be done shortly after remedial action is taken. Since these numbers represent a point-in-time of testing, it would be prudent to establishing testing on a routine basis to identify trends and potentially prevent an endotoxin issue that may be evolving.
For additional reading on endotoxins, click here.