Parenteral preparations require rigorous sub-visible particle testing to ensure patient safety and meet stringent regulatory requirements. Traditional analytical testing methods can be limited in their ability to accurately and efficiently detect and characterize these particles, impacting drug formulation, stability testing, and in-process control during manufacturing.

The startup provides analytical testing devices leveraging combination light obscuration (LO) technology for precise sub-visible particle analysis. Their devices enable comprehensive characterization of particulate matter in parenteral preparations, supporting enhanced product quality and patient safety. By offering advanced analytical capabilities, the startup empowers pharmaceutical manufacturers to optimize drug formulation, conduct thorough stability testing, and maintain robust in-process control throughout the manufacturing lifecycle. This technology ensures compliance with regulatory standards and facilitates the development of safe and effective injectable medications.

Combination light obscuration technology for accurate sub-visible particle detection and sizing

Automated particle counting and characterization

Real-time data analysis and reporting

Compliance with USP <788> and other relevant regulatory guidelines

Integrated software for data management and audit trails

The primary customers are pharmaceutical manufacturers, compounding pharmacies, and research laboratories involved in the development, production, and quality control of parenteral drug products.