How Charles River Ac...
10th March 2020 Content supplied by: Charles River Microbial Solutions
The Most Expensive Test Is the One You Have to Do Twice.
Charles River has been at the forefront in the evolution of endotoxin testing, investing in the development of new technologies and innovative products to improve the quality of testing. We’ve purposely built our portfolio of FDA-licensed products for rapid and traditional bacterial endotoxin testing to increase data integrity compliance, reduce retest rates, and streamline manufacturing processes so you can make prompt confident decisions.
Bacterial Endotoxin Testing Systems: Endosafe® systems simplify endotoxin detection from in-process to final lot release testing with flexible solutions to meet the needs of every customer, regardless of sample volume or industry. Our easy-to-use systems increase efficiency in the lab by delivering rapid, repeatable, and accurate results.
- Endosafe® nexgen-PTS™ – A rapid, point-of-use handheld spectrophotometer that uses USP/EP BET-compliant disposable FDA-licensed LAL cartridges for accurate, convenient, and real-time endotoxin testing and glucan concentration determination.
- Endosafe® nexgen-MCS™ – A multi-cartridge benchtop endotoxin detection system that uses the same FDA-licensed LAL cartridges as the nexgen-PTS™ for fast, quantitative, and accurate endotoxin results.
- Endosafe® Nexus™ – A fully automated robotic system for high-volume testing that reduces human input errors, streamlines data management and unlocks the full potential of the Endosafe® LAL cartridge technology. The integrated software provides a full audit trail enabling a reconstruction of all events giving your firm more insight into your investigations.
Endotoxin Measuring & Analysis Software: Our endotoxin measurement and analysis software is designed specifically to help reduce variability and increase operational efficiencies by achieving quantitative results.
- EndoScan-V™ – Compatible with our Endosafe® instrumentation and a variety of microplate readers, Endoscan-V™ is an endotoxin measuring software that performs the requisite calculations and reports for product release or in-process testing. As EndoScan-V™ utilises a Postgres database, digital signatures, searchable audit trails, and comprehensive user management, it conforms with 21 CFR Part 11 data integrity requirements.
- Charles River Cortex™ – An all-encompassing endotoxin software platform for data and instrument management, investigation analysis, and process monitoring. It provides an integrated solution to securely consolidate, query, and analyse all real-time endotoxin data for necessary internal QA and regulatory authorities’ trending reports, effortlessly elevating compliance status.
Contract Endotoxin Testing Services: Our bacterial endotoxin testing services laboratory can support you with performing your critical tests to help streamline the process to final product release. You can be confident that our experienced specialists can help improve the compliance and efficiency of your endotoxin testing program and help you achieve control, consistency, and precision in your laboratory.
- Product validation programs – one and three lots
- Regulatory compliance consultation
- Methods development
- Product release/stability testing
- Sample preparation
- Routine endotoxin detection for non-release applications
Date Published: 10th March 2020
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