FSS Boosts In-House Sterility with Rapid Testing Technology

Fagron Sterile Services (FSS), a leading 503B pharmaceutical compounder, has partnered with Charles River Laboratories to install the Celsis® Rapid Detection System. This innovative approach allows FSS to address the challenges of quality control and strengthen healthcare supply chain resiliency to better support healthcare systems.

Quality is at the core of Fagron Sterile Services' operations, ensuring the highest standards of pharmaceutical care in compliance with cGMP operations, as well as all FDA and DEA regulations. The growing demands of the healthcare system require implementing cutting-edge technologies that streamline processes while maintaining compliance with strict regulatory standards.

To meet these challenges, FSS has brought sterility testing in-house to increase efficiency and reduce turnaround times for patient delivery. Central to this initiative is the implementation of the Celsis® Rapid Detection System, a state-of-the-art solution provided by Charles River Laboratories.

“Our collaboration with the Charles River team was instrumental in seamlessly validating and implementing the Celsis technology. Their expertise ensured that we met rigorous compendial standards and established a reliable framework for routine testing, reinforcing our commitment to excellence in pharmaceutical quality,” said Phillip Smith, Director of Laboratory Services, FSS.

By reducing the traditional 14-day sterility test to 6 days, this new technology enables FSS to deliver sterile compounded medications more quickly. The collaboration with Charles River was crucial in validating and installing this advanced system, ensuring FSS met rigorous industry standards and reinforced its commitment to pharmaceutical excellence.

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