Bacterial endotoxin (LAL) testing
Cost-effective analysis – our laboratories provide express contract analysis of endotoxins
STERIS Pharmaceutical Laboratories provide express contract analysis of bacterial endotoxins using methods compliant with EP, USP & ANSI/AAMI ST72 to meet with FDA & MHRA requirements. Bacterial endotoxin (LAL) are fever inducing components of gram-negative bacteria cell membranes, which upon cell death (sterilization), are released into the surrounding environment. It is therefore critical to control the bacterial endotoxin (LAL) levels through the medical device/product manufacturing process and to ensure that post-sterilization devices/products have endotoxin levels below the required regulatory limit.
STERIS Pharmaceutical Laboratories provides express contract analysis of bacterial endotoxins using methods compliant with EP, USP and ANSI/AAMI ST72 current revisions to meet with FDA and MHRA requirements.
Bacterial endotoxin testing
- Turbidimetric method – quantitative with low limits of detection
- Gel clot method – qualitative
- Bespoke method development and validation
Flexible timely service
Analysis of products/devices for bacterial endotoxin with lead times to suit any release requirements.
8 hours (same day)
Industries and products suitable for bacterial endotoxin testing
Medical device and pharmaceutical manufacturing, packaging manufacturers and raw materials producers.
Quality and methods used
EP, USP and ANSI/AAMI ST72 current revisions to meet with FDA and MHRA requirements.