Bacterial Endotoxin Testing for Product Safety and Compliance
Ensure the quality of your products with our endotoxin testing services. Endotoxins are a type of bacterial toxin known to cause serious illness, especially in people with weakened immune systems. Bacterial endotoxin testing (BET) is crucial to uphold the quality and safety of your products. Our experts are able to detect endotoxins in a variety of products, including parenteral drug formulations, medical devices, raw materials, excipients, water, water for injection, and APIs.
Industry Standards and Guidance
Each product development pathway requires the application of various industry standards and guidance. Our highly experienced team collaborates with you through your product lifecycle to develop phase appropriate testing suited your needs. We are familiar with standards and guidance around the world and offer support specific to a variety of approval pathways.
The United States Pharmacopoeia (USP) General Chapter <1085> provides general guidance for the assessment of pharmaceutical materials, components, and products. USP General Chapter <85>, Bacterial Endotoxins, and European Pharmacopoeia (EP) general chapter 2.6.14, Bacterial Endotoxins, provide method guidance to detect and quantify the levels of bacterial endotoxins present in or on the sample.
Endotoxin Testing Methods
With our state-of-the-art facilities and current Good Manufacturing Practices (cGMP), we offer comprehensive bacterial endotoxin testing assays for pharmaceutical, biopharmaceutical, and medical device industries. Our capabilities include both the traditional 96-well plate and cartridge system method for the kinetic methods.
Chromogenic LAL
AssayTurbidimetric Assay
Gel-Clot LAL assay
Integrated Laboratory Services
When your team needs additional support, our scientists are ready. Our state-of-the-art facilities and highly trained experts add power to your project.
Additional Resources
Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.
Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.
Pace® adheres to current Good Manufacturing Practices (cGMP), ensuring that our laboratory facilities and processes meet the highest quality standards set by regulatory authorities for the pharmaceutical, biopharmaceutical, and medical device industries.
Pace® is accredited to ISO/IEC 17025, the international standard for competence in testing and calibration laboratories, validating our technical competence and commitment to delivering accurate and reliable results.