Aseptic Sampling Best Practices - Endotoxin Binding Affinity

By Charles Meadows, Sartorius Stedim North America Inc.

This technical report describes a study to evaluate binding affinity of Control Standard Endotoxin (CSE) to different plastic sample collection containers.

This scope of this study is limited to four different plastic containers and a glass control. Each was inoculated with a 0.5 endotoxin units per mL (EU/mL) CSE solution. Test articles were incubated between 18° and 25° Celsius. Samples from each container were pooled and measured for endotoxin using the Kinetic Turbidimetric test method with sensitivity of 0.005 EU/mL.