Charles River is a global provider of comprehensive and innovative microbial QC product and testing solutions. For over 30 years, Charles River has been dedicated to the development of precise, robust micro QC solutions that help bring your products to market safely and efficiently. Our mission is to provide industry-leading scientific and technological advances that not only meet ever-changing regulatory guidelines but also set a new standard in the way you perform testing. We’ve purposely built our portfolio of progressive products and services that deliver accurate, relevant, and measurable data to fuel confident decisions on product quality for release. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial detection, and Accugenix® microbial identification can help standardize your microbial QC testing needs and carry out your comprehensive microbial quality assurance program.
Product Name: Endosafe® Nexus™
Product Description: The Endosafe® Nexus™ is an automated robotic system designed specifically for endotoxin testing in the central QC lab. Ideal for high-volume water testing or samples that require dilutions, consistent testing with the Nexus™ eliminates a laboratory’s risk for human error, data integrity violations, and the need for subsequent investigations. Utilizing our FDA-licensed LAL cartridge technology, a state-of-the-art liquid handling system, and simple data management software, the robotic system can test up to 60 samples per run with minimal preparation and supervision.
Product Name: Endosafe® nexgen-PTS™
Product Description: The Endosafe® nexgen-PTS™ is a rapid, point-of-use handheld spectrophotometer that uses USP/BET-compliant, FDA-licensed disposable LAL cartridges for real-time endotoxin testing, glucan concentration determination, and Gram identification. The enhanced features address the need for decreased assay run time, simplified data entry, reduced user variability, and heightened administration control. User Management and password protection functionality improves QA oversight on the manufacturing floor and ensures compliance with the FDA’s 21 CFR Part 11. The nexgen-PTS™ is ideal for a quick read of stat samples, raw materials, and small volume, point-of sample testing on the manufacturing floor.
Product Name: Endosafe® nexgen-MCS™
Product Description: The Endosafe® nexgen-MCS™ is a stackable, multi-cartridge endotoxin detection system that utilizes FDA-licensed LAL cartridges for fast, quantitative, and accurate endotoxin results. This benchtop system is comprised of five individual spectrophotometers built into a unit with a single Ethernet connector that links to your computer running EndoScan-V™ version 5.5.5 or higher, our 21 CFR Part 11 compliant-ready endotoxin measuring software. Since each cartridge runs independently, you can run your samples as needed and not wait for a full batch of samples for testing, obtaining results in approximately 15 minutes.
Product Name: Endoscan-V™
Product Description: Enabling accurate, intuitive data analysis, EndoScan-V™ performs endotoxin calculations and generates secure data files and batch reports for product release as required by the FDA. The software’s flexible networking configuration works with Microsoft Excel™, LIMS, or centralized databases. EndoScan-V™ is also fully compatible with our Cortex™ software, allowing generated data to automatically transfer.
Product Name: Cortex™
Product Description: With an increase in FDA warning letters and cGMP violations, the need to investigate out-of-specification results continues to be one of the most commonly observed issues during QC lab inspections. Therefore, having access to accurate, relevant, and reliable data is essential to support confident decisions on product quality while satisfying regulators. Charles River Cortex™ provides an integrated solution to securely consolidate, query, and analyze all real-time endotoxin data for necessary internal QA and FDA trending reports. As a data and investigation analysis tool, Charles River Cortex™ allows users to monitor, record, approve, and track equipment and system performance, so you can make informed, confident decisions to maintain a complete state of control in your facility.
Product Name: Kinetic Turbidimetric LAL (KTA)
Product Description: Our FDA-licensed kinetic turbidimetric reagents yield quantitative endotoxin values when used with an incubating reader equipped with endotoxin-measuring software. KTA is licensed for both kinetic and gel-clot analyses and permits a direct correlation between methods. Our second-generation kinetic turbidimetric reagent, KTA2 offers faster reaction times and tests to sensitivities of 0.005 EU/mL.
Product Name: Kinetic Chromogenic LAL (KCA)
Product Description: Endochrome-K™, our optimized Kinetic Chromogenic LAL offers a 0.001 EU/mL limit of detection and provides greater linearity and superior interference resistance for quantitative endotoxin values. Delivering results in roughly an hour, its use of reconstituted LAL allows for extended bench time and reuse, making it a highly cost-effective solution.
Product Name: Endosafe® Gel-Clot LAL
Product Description: With a sensitivity level to 0.015 EU/mL, our gel-clot assay is a simple qualitative LAL test that is best used in low-volume laboratories. Our lysate is buffered and features a firm gel, which provides better interference resistance for routine testing.
Product Name: Celsis Accel®
Product Description: The Celsis Accel® system takes the functionality of the widely adopted Celsis Advance II™ platform and packages it into a compact footprint for small to mid-size pharmaceutical and consumer product manufacturing facilities.
Product Name: Celsis Advance II™
Product Description: The Celsis Advance II™ is designed to keep up with the demands of high throughput pharmaceutical and home & beauty manufacturers, delivering definitive microbial detection results quickly. The Celsis Advance II™ runs up to 120 tests per hour with the option of combining multiple batches into a single run.
Product Name: Celsis Innovate®
Product Description: Designed specifically for the dairy, beverage, and food manufacturer, the Celsis Innovate® system delivers definitive product release testing results in less than 1 hour, replacing traditional subjective tests with a confident presence/absence assay.
Accugenix® Microbial ID & Strain Typing: Accugenix® microbial identification and strain typing services offer unparalleled accuracy in identifying microbes with the most relevant reference libraries of bacteria, fungi, and yeast. Our ID and Strain Typing services use DNA sequence-based and MALDI-TOF technologies to provide accurate and reliable microbial identification services to more than 1,000 customers worldwide. Tracking and trending features are included in the customer web portal to monitor changes in microbial flora and simplify reporting for environmental monitoring programs.
AccGENX-ID®: Comparative DNA sequencing of the 16S rRNA gene in bacteria and the ITS2 rRNA region in fungi is recognized across the industry as the most accurate and reproducible method for identifying unknown microorganisms. AccuGENX-ID® utilizes this technology through our BacSeq identification for bacteria and FunITS identification for fungi to produce reliable results in as little as six hours.
AccuPRO-ID®: AccuPRO-ID® offers a first-in-industry polyphasic approach to microbial identification utilizing proteotypic MALDI-TOF mass spectrometry technology supported by our AccuGENX-ID® sequencing method at no additional cost.
AccuGENX-ST®: We perform DNA sequencing of targets outside of the standard regions sequenced for microbial identification (16S, D2, or ITS2) to provide you with data to resolve differences and/or similarities at the strain level. Identification to the strain level allows you to definitively track the source of contamination or simply verify your known production strains.
Product Name: Axcess® System
Product Description: Featuring the precision of the Bruker MALDI Biotyper instrument and Accugenix® microbial libraries through a secure online network, the Axcess® System allows for instantaneous identification of isolated colonies from a plate. The Accugenix® MALDI-TOF Reference Library is the largest curated database focused on identification of microorganisms in aseptic and non-sterile manufacturing environments, which gives you the best chance of getting an accurate identification the first time. Tracking and trending features are included in the customer web portal to monitor changes in microbial flora and simplify reporting for environmental monitoring programs.