Testing the quality of pharmaceutical-grade water is important for drug product quality and safety and is strictly enforced by regulatory bodies around the world, such as the United States Pharmacopeia (USP).

Enhance operational efficiency for bacterial endotoxin testing with reduced pipetting, quick validation, and training. Enable rapid implementation for immediate quality control improvements.

Bacterial endotoxin testing (BET) is undergoing a significant transformation with the introduction of recombinant technologies. As these new methods gain traction, pharmacopeia guidance is evolving to accommodate and regulate their use.

The validation of alternative microbiological methods (RMMs), guided by USP and other regulatory standards, is crucial for ensuring the safety and quality of pharmaceutical products. These methods offer advantages in speed, sensitivity, and automation over traditional culture-based techniques, but require rigorous validation to demonstrate their reliability, accuracy, and equivalence to compendial methods for their intended purpose.

Pharmaceutical and medical device manufacturers traditionally use limulus amebocyte lysate (LAL), derived from horseshoe crab blood, to test for bacterial endotoxins. While critical for detecting dangerous contaminants, this practice raises sustainability concerns for the horseshoe crab population. Alternative methods like recombinant Factor C (rFC) and recombinant cascade reagents (rCR) have emerged to address these concerns. However, the Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform offers a compromise by using FDA-licensed horseshoe crab LAL while reducing its consumption by up to 90% compared to traditional methods.