Endosafe® nexgen-MCS™ Key Features The Endosafe® nexgen-MCS™ is a multi-cartridge endotoxin detection system that utilizes FDA-licensed Endosafe®- • Test up to five samples simultaneously PTS™ cartridges for fast, quantitative, and accurate endotoxin results. The nexgen-MCS™ comprises five individual • Samples run independently, allowing for random access version 5.5.5 or higher, our 21 CFR Part 11-compliant ready endotoxin-measuring software. This benchtop test system can • High throughput for real-time results spectrophotometers built into a unit with a single Ethernet connector that links to a desktop computer running EndoScan-V™ test up to five samples in about fifteen minutes. Test Technology • Uses FDA-licensed Endosafe®-PTS™ cartridges The nexgen-MCS™ uses LAL kinetic chromogenic methodology that measures color intensity directly related to the • USP/EP BET-compliant reagent, chromogenic substrate, and control standard endotoxin (CSE). The cartridges are manufactured according to rigid • Four levels of cartridge sensitivity: 0.005 EU/mL, 0.01 EU/mL, 0.05 EU/mL, 0.10 EU/mL • Results can be obtained via EndoScan-V™ version 5.5.5 or higher • Utilizes new cartridge locking mechanism to ensure accurate cartridge positioning endotoxin concentration in a sample. The disposable cartridges used to run an assay contain precise amounts of LAL standard operating procedures promoting test accuracy, consistency, and product stability. Test Procedure To perform the test, the user simply pipettes 25 μL of a sample (at a non-interfering dilution) into each of the four sample reservoirs of the cartridge. The reader draws and mixes the sample with the LAL reagent in two channels (the sample channels), and with the LAL reagent and positive product control in the other two channels (the spike channels). Lastly, the sample is mixed with a chromogenic substrate. After mixing, the change in color is measured and analyzed against an internally-archived standard curve.

The nexgen-MCS™ can test five cartridges simultaneously, or any combination from one to five. Samples are run independently, allowing for random access. Multiple nexgen-MCS™ or portable nexgen-PTS™ units can be connected to a single PC for high throughput of samples with real-time results. By design, the cartridge automatically performs a duplicate sample/duplicate positive product control LAL test, thereby satisfying the harmonized USP/EP Bacterial Endotoxin Test (BET) for LAL testing. FDA-Licensed LAL Assay The cartridge used with the nexgen-MCS™ system is approved by the FDA for in-process...

Product Line Endosafe® nexgen-MCS™ instrument Power supply Ethernet cable One-year warranty Endosafe® nexgen-MCS™ Endosafe® nexgen-MCS™ package Endosafe® nexgen-MCS™ instrument Power supply Ethernet cable One-year warranty Endosafe® nexgen-MCS™ Accessories On-demand labor Annual qualification service Endosafe nexgen-MCS™ Service and Support IQ/OQ/PQ document Annual on-site qualification service plus on-site basic service Annual qualification: Full service Additional units for annual calibration certification Additional units for annual qualification plus on-site basic service Additional units...