Bacterial Endotoxin (LAL) Testing

Bacterial LAL Testing

STERIS provides contract analysis of bacterial endotoxins using methods compliant with EP, USP and ANSI/AAMI ST72 to meet FDA and MHRA requirements. Testing is performed according to USP <85>, USP <161> and ANSI/AAMI ST72.

Endotoxins from gram-negative bacteria are the most common cause of toxic reactions due to contamination of products with pyrogens; these endotoxins belong to category lipo-polysaccharides.

Endotoxins may decrease the effectiveness of a therapeutic product; they can cause adverse reactions such as fever, hypotension, pulmonary edema and disseminated coagulation events in humans and animals, by release of inflammatory mediators, such as cytokines and interleukins.

Although there are a small number of pyrogens with a different chemical structure, the conclusion is generally justified that the absence of bacterial endotoxins in a product implies the absence of pyrogenic compounds, provided the presence of non-endotoxin pyrogenic substances can be ruled out.

According to AAMI ST 72:2011, products that have direct or indirect intravascular, intralymphatic, or intrathecal contact or have the potential for similar systemic exposure (e.g., solution administration sets, transfer sets, catheters, implants, and infusion assemblies), or ophthalmic products for intraocular use (e.g., silicone oil, viscoelastic products, intraocular lenses) shall be evaluated for the presence of endotoxin.

According to USP <161>, the requirements apply to sterile and nonpyrogenic assemblies or devices in contact directly or indirectly with the cardiovascular system, the lymphatic system, or cerebrospinal fluid. This includes, but is not limited to, solution administration sets, extension sets, transfer sets, blood administration sets, intravenous catheters, implants extracorporeal oxygenator tubings and accessories, dialysers and dialysis tubing and accessories, heart valves, vascular grafts, intramuscular drug delivery catheters, and transfusion and infusion assemblies. These requirements do not apply to orthopedic products, latex gloves, or wound dressings.

STERIS Laboratories uses the chromogenic, kinetic turbidimetric and gel clot testing method.

Bacterial endotoxin testing

  • Turbidimetric method – quantitative with lowest limits of detection
  • Kinetic Chromogenic – quantitative with low limits of detection
  • Gel clot method – qualitative
  • Custom method development and validation

Bacterial Endotoxin testing is used for:

  • Medical device manufacturing
  • Pharmaceutical manufacturing
  • Packaging manufacture
  • Raw materials production
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