New platforms for endotoxin detection and sterility testing join the laboratory's product line
Charles River Laboratories has announced the launch of two new products in its Microbial Solutions portfolio. An updated EndoScan-V software platform for endotoxin detection and measurement, and the introduction of the Celsis automated detection solution for rapid sterility to ensure continued product quality and contamination control for pharmaceutical manufacturing clients.
Each year, over 80 million endotoxin detection tests are performed, and endotoxin detection test platforms require software that generates accurate raw data analysis for reporting, tracking and trending of test results.
Charles River’s EndoScan-V is a validated endotoxin detection and measurement software used to generate and report quantitative test data. The software performs the requisite measurements, calculations, and creates test reports with the convenience of digital signature report approval.
In compliance with regulatory requirements, it generates secure data and audit trails on all actions.
“We believe in the power of data. EndoScan-V meets the highest standards of data integrity, and provides users confidence in the quality and safety of their endotoxin detection data,” said Nicola Reid, Associate Director, Microbial Solutions Product Management, Charles River.
Traditional sterility testing to detect microbial contamination typically requires 14 days of non-value-add incubation. This wait introduces unnecessary risk into the production process in the event of a contamination failure, additional inventory storage requirements, product hold times, and delays to market.
Charles River’s Celsis rapid sterility test delivers quality control results in 6 days, allowing manufacturers to quickly confirm the presence or absence of microbial contamination.
The Celsis detection platform for rapid sterility combines Celsis’ rapid microbial detection instruments and reagents with innovative partnerships to provide a robust solution for rapid microbial methods (RMM) to optimise the safe release of pharmaceutical and consumer care products.
These new product offerings complement the currently available Celsis rapid microbial detection automated instruments and reagents, which deliver definitive results and data integrity.
Commenting on the new product, Julie Sperry, Senior Director, Microbial Solutions Product Management & Strategic Marketing, Charles River, said: “The Celsis automated detection platform for rapid sterility is unlike anything else available in the industry. While maintaining the established sample prep aspects of the traditional test, the technology delivers definitive sterility results in 6 days, less than half the time of the compendial test allowing manufacturers to release critical therapies to patients faster and more safely.”