Bacterial Endotoxin (LAL) Testing
Bacterial LAL Testing
STERIS Laboratories provides contract analysis of bacterial endotoxins using methods compliant with EP, USP and ANSI/AAMI ST72 to meet FDA and MHRA requirements.
Endotoxins are fever-inducing toxins present in the cell walls of bacteria. For many medical devices, it is a requirement for endotoxin testing to be performed to enable release of the lot.
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 kinetic chromogenic method of testing and runs a PPC test with every sample, so the Customer is not required to have an LAL method validation. Testing is performed according to USP <85>, USP <161> and ANSI/AAMI ST72.
USP and ANSI/AAMI ST72.
Bacterial endotoxin testing
- Turbidimetric method – 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
Contact our team of experts to find out more about Bacterial Endotoxin Testing (LAL)