Endosafe Nexus 200™: Automation Through Robotics for Bacterial Endotoxin Testing ® Features and Benefits of the Endosafe Nexus 200 Endotoxin testing has traditionally required extensive assay and standard curve preparation, sample preparation, reagent • Fully automated walkaway robotic testing system reduces human intervention and optimizes resources errors made during sample processing, leading to potential data integrity violations and gaps. As expectations continue • Fully enclosed platform with safety locking features With this paradigm shift of introducing automation in the lab, keeping up with product demand, regulatory compliance, • Increased sample throughput capability, testing up to 120 diluted & undiluted samples per run instrumentation for automating endotoxin testing and data management are driving operational efficiencies, data integrity • Process complex and serial dilutions with multiple diluents, allowing for water, in-process, and final product testing The advantages of implementing automation are no longer just for high-volume, large manufacturing organizations. • Utilizes FDA-licensed LAL cartridge technology for simple, accurate, and quantitative testing rehydration, and multiple dilutions to be made for a successful result. These tasks increase the inherent risk for human to evolve within the pharmaceutical and biotech industry, microbiological quality control and production environments are setting the standard for implementing reliable, compliant, and cutting-edge testing methods and technologies. and technological advances in this industry can seem like a never-ending task. However, developments in machine-driven compliance, and ultimately eliminating hands-on testing to relieve analysts from repetitive and manual, although necessary, duties. Tangible benefits go beyond just an increase in production, and include mitigating your firm’s risk for human error, optimizing SME resources, and harmonizing training, software, and systems across global sites. Since the launch of the first fully automated robotic Endosafe Nexus in 2014, transformations in technology and innovation have inspired our Research and Product Development team to reimagine the next iteration of automated endotoxin testing with the Endosafe Nexus 200. The next generation of our data integrity compliant, walkaway automated robotic instrument can test up to 120 samples per run and perform complex and serial dilutions via Endosafe® cartridge technology in a fully enclosed system. Increase Productivity and Employee Efficiency Performing endotoxin testing on large numbers of samples using traditional methods can be both time-consuming and vulnerable to outside influences such as technician errors and standard curve anomalies. Manual processes, or those with numerous manual steps, often lead to inefficiencies within the lab, which can lead to costs in terms of both time and money, as well as pose a risk to product quality. The training required for an analyst to become proficient in running these

Benefits of the Endosafe® Nexus 200™ (con’t) assays can be considerable and adds to the overall cost and complexity of performing endotoxin testing. Having highly • Powered by Endosafe EndoScan-V™ version 6.1 software allowing for LIMS integration and improved traceability, security, and data management skills and can lead to increased rates of human error and staff turnover due to lack of satisfaction in their work. • Integrated touch screen PC for easy, all-encompassing testing and monitoring time, and resources of performing both laboratory and out of specification investigations. educated...

Additionally, we offer validation services to assist customers to speed up bringing their automation online. We can offer this service remotely for customers who want to send their samples into one of our global labs or can offer the service on-site as an additional week of training at the initial install of the Nexus system. Endosafe® Nexus™ & Nexus 200 Feature Comparison Chart Feature Endosafe Nexus Sample capacity per automation session Up to 120 diluted or undiluted samples Dilution ratios Number of Pipette Heads 4 (increases speed of sample handling) Number of Pipette Tips Over 700 total...

Endosafe® Nexus 200™ Ordering Information Product Product Components Enclosed Nexus 200 platform with cabinet Endosafe nexgen-MCS 3x cartridge dispensers 6x 20-position racks Embedded Windows 10 touchscreen PC CO-RE II Nested Conductive Tips, 300µL, Non-sterile (Case) CO-RE II Conductive Tips, 1000µL (Case) Nexus 200 Reagent Containers (28 per case) Nexus 200 Deep Well Plates (50 per case) Annual service Annual service: Full service IQ/OQ/PQ service On-site basic service EndoScan-V software validation package Contact Information Charles River Endosafe®, Celsis® and Axcess® Products and Services...