September 16, 2019 PR-M09-19-NI-039
WILMINGTON, Mass.--(BUSINESS WIRE)-- Charles River Laboratories International, Inc. (CRL) today 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.
EndoScan-V: Enabling Data Driven Decisions
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. The program was designed with flexible capabilities and performance options for gaining operational efficiencies. All aspects of the software form the pillars of data integrity compliance: a fully searchable audit trail, flexible user control and management, and reliable data generation and backup.
When utilized in concert with Charles River’s suite of endotoxin detection products, including Charles River Cortex™ software and Endosafe’s® bacterial endotoxin testing systems, EndoScan-V supports the secure, automated transfer of generated data, ensuring laboratory and manufacturing processes stay in a state of constant control within a single, end-to-end risk management environment.
Celsis for Sterility: Automated Sterility Results In Just 6 Days
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 just 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 optimize the safe release of pharmaceutical and consumer care products. The new platform includes the following enhancements:
These new product offerings complement the currently available Celsis rapid microbial detection automated instruments and reagents, which deliver definitive results and data integrity, including:
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Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them.