91´óÉñ

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.

TOC monitoring allows plants to detect organic contamination from source water, identify treatment deficiencies, find leaks, and troubleshoot other issues. For example, measuring changes in organic content can identify breaches in system processes, and monitoring control points can help troubleshoot and identify sources of pollution. The information and data obtained from TOC monitoring allows for fast decision making to protect valuable equipment and achieve operational goals.

TOC monitoring plays a crucial role in optimizing water treatment processes in the food and beverage industry. It helps ensure compliance with regulations, minimize costs, and maximize profit. By monitoring and controlling the organic load in waste streams, manufacturers can achieve efficient water management and avoid the negative consequences of improper treatment. TOC analysis provides real-time data that enables quick adjustments and helps maintain water quality throughout the manufacturing process.