Multi-Cartridge Endotoxin Testing System

The Endosafe nexgen-MCS endotoxin testing 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 with the Endosafe nexgen-MCS, you can run your LAL testing samples as needed and not wait for a full batch of samples for testing, obtaining results in approximately 15 minutes.

  • VIDEO TRANSCRIPT

    (00:07)

    Welcome to the Endosafe Nexgen-MCS virtual demonstration. The Endosafe Nexgen MCS is a multi cartridge endotoxin detection system that utilizes FDA licensed Endosafe cartridges for fast, quantitative, and accurate endotoxin results. The Nexgen MCS comprises five individual spectrophotometers built into a unit with an ethernet connector that links to a computer running our endotoxin measuring software, Endoscan V version 5.5.5 or higher. This bench top test system can test up to five samples in about 15 minutes.

    (00:52)

    In order to begin your testing, you will need to ensure ethernet and power cords are plugged into the Nexgen MCS and power supply respectively. Once powered on, the LEDs over the bays will illuminate to green. Turn on your computer and launch Endoscan V endotoxin measuring software version 5.5.5 or higher.

    (01:17)

    In addition to your Nexgen MCS reader, to begin testing, you will need a calibrated fixed volume 25 microliter pipetter, pipette tips certified to be free from endotoxin, Endosafe cartridges with the certificate of analysis and your sample. We recommend you use a calibrated fixed volume 25 microliter pipetter with Eppendorf bio pure pipette tips. However, if you do not have a 25 microliter pipetter please note, do not use pipette tips with a cotton plug or filter. Please allow your cartridges to come to room temperature before removing them from the patch.

    (02:00)

    The system will perform a self test and will take approximately five minutes to reach the appropriate 37 degrees Celsius. Remove your cartridge from its pouch. Take care to touch only the handle or edges of the cartridge. The desiccant included in the pouch with the cartridge can be discarded. Once the cartridge is fully removed, touch only the handle end of the cartridge as you begin to place it in the first bay of the reader with the wells facing up. The reader has an engagement mechanism to ensure the cartridge is securely inserted into the system. Using Endoscan V, within the first box enter the lot number, which is the cartridge lot number on the certificate of analysis supplied with the cartridge. Calibration code, sample lot number, dilution factor and endotoxin limit if applicable.

    (02:58)

    After entering your information, you are now ready to add your sample. Select send setup with Endoscan V. Carefully pipette 25 microliters of sample into all four sample reservoirs of the inserted cartridge. To do so, hold the pipette so that the tip is at an angle and not completely at the bottom of the sample reservoir. Press start within Endoscan V after each sample has been added to the cartridge. Repeat this procedure for four additional samples. For reliable results, it is important that you pipette the sample correctly. You need exactly 25 microliters of sample before the test is started. Do not under or overfill the well and do not pipette straight up and down touching the bottom of the well. Also be careful not to create bubbles when adding the sample.

    (03:58)

    Once the assays are complete, you can retrieve results through the Endoscan V, endotoxin measuring software.

    (04:09)

    Once your results have been received through the Endoscan V, you can easily import your data into Charles River Cortex, a client server based data management platform that allows you to securely consolidate, query, and analyze all real time endotoxin data. Cortex allows you to effortlessly elevate your compliance status, gain complete QA QC oversight, increase visibility into key performance indicators, and proactively manage the operational integrity of your equipment fleet. Cortex should be set up to automatically import data from Endoscan V. From within cortex, click on the icon for view and trend data.

    (04:55)

    From within this screen, utilize the gray filter area at the top of the screen to choose all Nexgen MCS results from under device type. You can also use the date filters in the section to filter data down to a specific day. Once data has been filtered, select the assays required and right click on them in the main view screen. From here, the user can print individual reports, summary reports, and apply electronic signatures.

    (05:27)

    Please note, the user must document if they will print and sign reports in cortex or in Endoscan V. They cannot do this in both. This data can be filtered further to include only the columns of data the user wishes to see. The user can carry out this function by clicking on the view dropdown box in the top right hand corner of the main view and trend data screen. Click on custom view to edit the view you wish to customize. This custom view can then be named. Users can also use the trending pane by clicking on view, trending pane. Under the trending pane, users can produce multiple graphs depending on their requirements.

    (06:12)

    Once completed, the filtered data can be exported from cortex by clicking on file, then export data as a CSV or XML file, which can then easily be uploaded to a LIMS. It's as simple as that.

    (06:29)

    The Endosafe Nexgen MCS is the ideal bench top system for efficiently, accurately, and rapidly detecting endotoxin in multiple samples simultaneously. Contact us today to discover how easy it is to transform the way you manage your endotoxin data and maintain a centralized state of control throughout your manufacturing facility.

  • PRODUCT VALIDATION

    The Charles River Endosafe nexgen-MCS and our FDA-licensed LAL cartridges are validated for bacterial endotoxin testing and can be used for product validation for both previously validated samples and new products.

  • PRODUCT DETAILS
    • Test multiple samples simultaneously
    • Samples run independently, allowing for random access
    • High throughput for real-time endotoxin detection results
    • Single-step, quantitative LAL testing
    • Uses FDA-licensed LAL endotoxin testing cartridges
    • LAL testing components all included in cartridges
    • Results can be analyzed via EndoScan-V endotoxin measuring software
    • Sophisticated endotoxin detection data management and reporting capabilities
    • Samples can be traced to the individual spectrophotometer used to perform endotoxin testing
    • Four levels of sensitivity are available as endotoxin testing options: 0.005, 0.01, 0.05 and 0.10 EU/ml
    • No microbiology training is required; anyone can run this simple endotoxin detection assay
    • System qualification and validation support is provided if needed
       

    View the product sheet

  • DATA INTEGRITY

    The nexgen-MCS runs with EndoScan-V version 5.5.5 or higher, our 21 CFR Part 11 compliant-ready endotoxin measuring software. Find out more on EndoScan-V to increase your confidence in the accuracy and security of your release testing data.

  • PRODUCT CODES
    Product Code
    Endosafe nexgen-MCS instrument
    Power supply
    Ethernet cable
    One-year warranty
    MCS150K
    Endosafe nexgen-MCS package
    nexgen-MCS instrument
    EndoScan-V software
    Power supply
    One-year warranty
    Ethernet cable
    MCS650K
    EndoScan-V software M1250

Did You Know Endosafe LAL Cartridges
Are a Compendial BET Method?

Charles River's comprehensive biologic testing solutions includes stability testing.

FDA-licensed Endosafe LAL cartridges are a kinetic chromogenic LAL method as specified in the EP/USP and JP. See the regulatory requirements here:

FDA Guidelines
USP BET <85> or EP BET <2.6.14>

 

 

Frequently Asked Questions (FAQs) About the Endosafe nexgen-MCS

 

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