With Endosafe cartridge technology, any user can generate rapid, automated BET results in about 15 minutes, minimizing manual effort while aligning with regulatory standards and corporate sustainability goals.

Company Background
Charles River supports pharmaceutical manufacturers with tools that reduce contamination risk, simplify quality control, and protect patient safety. For over 30 years, Charles River Microbial Solutions has enabled QC labs to modernize through innovations in bacterial endotoxin testing, rapid microbial detection, and microbial identification.

Trusted by organizations worldwide, our platforms support regulatory compliance, streamline workflows, and cut waste. Backed by decades of experience in drug development and manufacturing, Charles River helps laboratories meet today’s expectations — and prepare for tomorrow’s challenges.

Product Overview
Endosafe cartridge technology streamlines bacterial endotoxin testing by automating critical steps — mixing, incubation, and detection — within a self-contained, single-use format. Each cartridge uses just 25 μL of sample and delivers results in approximately 15 minutes using kinetic chromogenic methods. Built-in wells for duplicate samples and positive product controls (PPCs), combined with an archived standard curve, eliminate the need for manual curve preparation, reduce analyst variability, and simplify training.

Cartridges are available in a range of sensitivity formats from 0.005 to 10 EU/mL and meet global regulatory standards, including USP <85>, EP 2.6.14, and JP 4.01. They support traditional LAL and animal-free recombinant cascade reagent (rCR) methods — helping labs reduce false positives from β-glucans and transition to more sustainable testing practices.

Fully compatible with the Endosafe instrument suite — including the portable nexgen-PTS™, benchtop nexgen MCS™, and high-throughput Nexus 200™ — these cartridges allow QC labs to scale their testing efficiently while reducing waste, streamlining operations, and supporting compliance across diverse manufacturing environments.

Instruments Overview
Endosafe cartridges are supported by a suite of instruments designed to scale with laboratory needs.
Endosafe nexgen-PTS is a portable system optimized for point-ofsample testing, raw material screening, and in the-field QC. With a touchscreen interface, real-time result display, and secure user access, it’s ideal for fast, decentralized decisions.
Endosafe nexgen-MCS brings cartridge testing to the benchtop with moderate throughput and independent sample processing. It supports multiple simultaneous tests and integrates with EndoScan-V™ for streamlined data transfer and audit readiness.
Endosafe Nexus 200 automates high-throughput testing for up to 120 samples per run. Barcode tracking, walkaway operation, and LIMS integration minimize manual handling while supporting 21 CFR Part 11 compliance.

All systems are fully compatible with the complete Endosafe cartridge lineup, helping labs scale intelligently while meeting regulatory demands.

Markets Served
Endosafe cartridge technology is used by quality control labs across pharmaceutical, biotech, cell and gene therapy, compounding pharmacy, medical device, and nuclear medicine sectors. Labs performing raw material, in-process, and final release testing rely on Endosafe to meet global regulatory requirements while reducing test time and operational burden. Its flexibility and compliance-ready design make it suitable for regulated environments requiring consistent, validated results — highthroughput or low-volume products.

Trade Shows/Meetings Attended
Charles River regularly shares insights and solutions at leading conferences, including Interphex, ISPE Annual Meeting, PDA Pharmaceutical Microbiology, Pharma Microbiology Congress, PharmaLab, Pharmig, A3P Microbiology, and the Kilmer Conference. These events focus on regulatory trends, environmental monitoring, and practical solutions for QC labs adapting to modern testing demands.

Ordering Information
Access our catalog and implement any of our sustainable offerings from our industry-leading Endosafe portfolio.

Learn why over 5,000 organizations have adopted this rapid and compendial technology to streamline their manufacturing processes.

Get more information at criver.com/endosafe.