Charles River Microbial Solutions

www.criver.com/products-services/qc-microbial-solutions Charles River Microbial Solutions

251 Ballardvale Street
Wilmington
Massachusetts
MA 01887
United States

+1 781 222 6000

Activities

Regulatory | Analysis

Summary

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guides us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe

Profile

Who we are

We’ve purposely built our QC Microbial Solutions portfolio to bring you progressive products and services that deliver accurate, relevant and reliable data to fuel confident decisions on product quality and contamination control. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial detection, and Accugenix® microbial identification keeps your manufacturing operations running efficiently and smoothly, lowers your cost to manufacture, and protects your reputation.

Our products

The Endosafe nexgen-MCS is a multi-cartridge endotoxin detection system that uses FDA-licensed Endosafe<sup>®</sup> LAL cartridges for fast, quantitative, and accurate endotoxin results

The Endosafe nexgen-MCS is a multi-cartridge endotoxin detection system that uses FDA-licensed Endosafe^® LAL cartridges for fast, quantitative, and accurate endotoxin results

Our 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 Endosafe® products increase efficiency in the LAL laboratory by delivering rapid, accurate results. Every system we sell is backed by our skilled technical team who can provide training and maintenance.

Learn more about our automated solutions HERE.

A Celsis® rapid microbial detection system can provide accurate micro results in 18–24 hours, cutting days from your production cycle and helping to significantly reduce costs—without sacrificing quality. By confirming product quality significantly faster than traditional methods, product moves more quickly and efficiently into distribution. In the event of a contamination, you can accelerate corrective action and get back on track sooner. Celsis® instruments are in use in over 600 locations worldwide by the world’s largest manufacturers, including Proctor & Gamble, Unilever, and many more.

Learn more: Rapid Sterility Testing Solutions for Sterile Pharmaceutical Products | Charles River (criver.com)

Charles River’s Accugenix® microbial identification and strain typing services offer unparalleled accuracy in identifying microbes with the most relevant reference libraries of bacteria, filamentous fungi, and yeasts. Specialising in bacterial and fungal identification and strain typing of environmental isolates, we use the latest DNA sequence-based and MALDI-TOF technologies to provide accurate and reliable microbial identification services to more than 1,000 facilities worldwide. Our flexible solutions allow clients to outsource to our experts or use our services in-house.

Specialised services

With more than 70 sites around the globe, Charles River is strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving your product’s unique challenges. Our focus on timeliness and accuracy in every stage of development means you can count on reliable, reproducible results, every step of the way.

Accugenix® Support:

For over 30 years, Accugenix® has delivered accurate microbial identifications from our validated library and provided a 99% on-time delivery rate. We are continuously expanding our global laboratory service to ensure that no matter where you are in the world, you have convenient access and benefit from the expertise, sample analysis process controls and convenient tools like tracking & trending. With eight microbial identification laboratories worldwide, our global footprint of technical support laboratories operates with a shared network of expertise and experience, dedicated to identifying your microbial isolates and increasing your laboratory efficiency and accuracy in resolving contamination risks. As the partner of choice for managing microbial quality control, Charles River’s products and services facilitate confident and objective decision-making, ensure the integrity of your microbial data, reduce risk, build efficiency, and improve your bottom line while assisting in the
journey to bring products to market. Many of our sites not only provide Accugenix Identification Services but also encompass, Celsis® Rapid Microbial Detection, Endosafe®LAL support, instrumentation services, and hands on client training.

Tracking & trending environmental monitoring data

Highly regulated industries are required to establish comprehensive and reliable quality systems and environmental monitoring programs that measure the state of control of their manufacturing facility and ensure data integrity. The Charles River Customer Web Portal includes a Tracking and Trending solution for all environmental isolates identified with Accugenix®. Recent enhancements offer customisation features for data entry fields and reports while meeting requirements of 21 CFR Part 11 and GAMP5 standards.

Learn more: Introducing AccuPedia™: A Deeper Look into Microorganisms | Charles River (criver.com)