07.25.23 -- Key Considerations In Selecting A Robotic Solution For Endotoxin Testing

The U.S., European, and Japanese Pharmacopoeias require testing for bacterial endotoxin in pharmaceutical products, water, intermediates, and medical devices. This article shares key criteria for those of us who are looking to select an automated/robotic endotoxin detection system.

ASTM E3106 emphasizes that cleaning agents and cleaning processes should not be adopted randomly, nor should they be chosen simply based on what has been used in the past. In this article, part of the Cleaning Validation For The 21st Century series, let's look at which cleaning parameters are critical and what are the optimal cleaning parameter settings, through the lens of design of experiments (DoE).