The Endotoxin Testing Blog
CMD blog posts is your source for guidance, regulatory insight, and practical strategies in endotoxin testing.
Whether you're working in pharma, biotech, diagnostics or medical devices, this blog is built for scientists, QA teams, and regulatory leads. Each post is authored by our team of scientific and regulatory specialists to help you make informed, compliant, and cost-effective decisions.
Endotoxin testing for critical water in compliance with ANSI/AAMI ST108:2023
ANSI/AAMI ST108:2023 is an American National Standard that applies to water used in cleaning, rinsing, disinfection and sterilisation of medical devices. It sets out quality specifications for three classes of water, and establishes specifications (e.g., endotoxin limits) and control measures to ensure that the quality consistently meets defined parameters.
Endotoxin Testing Requirements for Haemodialysis
Endotoxin contamination is the most critical safety concern in haemodialysis. Since dialysis patients are exposed to large volumes of dialysis fluid several times per week, ensuring strict control of endotoxin levels is essential. In this article, we address the endotoxin limits, testing methods, and routine monitoring required by ISO 23500 and ISO 13959.