Charles River Laboratories has launched two new products in its microbial solutions portfolio including an update to its Endosafe EndoScan-V software, which, when combined with the company’s Endosafe instruments and reagents, provides “a complete endotoxin detection system,” said Julie Sperry, senior director, microbial solutions product management and strategic marketing, Charles River.
The software was designed with flexible capabilities and performance options, such as instrument management, an accessories database, and electronic signature, according to the company.
Said Sperry, “The software encompasses all the pillars of data integrity compliance – a fully searchable audit trail, flexible user control and management, and reliable data generation and backup.”
“With the industry heavily focused on the compliance to regulatory requirements, EndoScan-V meets the highest standards of data integrity and provides users confidence in the quality of their endotoxin detection data and therefore the quality of their drug products,” she added.
The company also has introduced its ‘Celsis’ automated detection solution for sterility, which Sperry said delivers quality control results in six days – compared to the 14-day industry average.
This two-week ‘wait’ can introduce “unnecessary risk into the production process in the event of a contamination failure, additional inventory storage requirements, product hold times, and delays to market,” said Sperry.
“This time savings allows manufacturers to quickly confirm the presence or absence of microbial contamination, and ultimately, release critical therapies to patients faster and more safely,” she added, “since there are no changes to the established sample prep method compared to the traditional test, validation and training are straightforward.”