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Endotoxin Testing Equipment and Software

Setting up your endotoxin testing workstream

No matter if you want to perform quantitative endotoxin testing assays by using one of the classical kinetic LAL assays (turbidimetric or chromogenic) or the more sustainable rFC assay, there are solutions available that support you and make the results reliable and compliant.

Let’s go over a quick guide on how to set up your workflow for bacterial endotoxin testing.
 

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Steps for an optimal endotoxin testing workstream

Start with the five main steps to set up
your workstream:


  1. Choose the quantitative endotoxin assay you want to implement
  2. Incorporate a compatible microplate reader based on your assay selection
    Optional: incorporate an automated assay setup
  3. Implement analysis tools to measure outcomes
  4. Qualify and validate your setup
  5. Start running your assays

  1. Choose the quantitative endotoxin assay you want to implement

    Turbidimetric LAL Assay: Kinetic measurement of turbidity development is a cost-effective way of BET testing water samples or large volume parenterals.

    Chromogenic LAL Assay: Kinetic measurement of color development allows a quantitative readout of the endotoxin concentration in the sample measured.

    Recombinant Factor C Assay: Sustainably synthesized alternative to LAL assays based on the recombinantly produced form of Factor C, the first component in the horseshoe crab clotting cascade. Does not rely on horseshoe crab blood as the source testing reagent.
     

  2. Incorporate a compatible microplate reader based on your assay selection

    Microplate readers, in general, are able to detect and quantify light photon emitted by a sample upon excitation with light at a specific wavelength. Depending on the endotoxin assay of choice, you have different requirements for the microplate readers and their optical setup. You could either choose a single-mode reader (for either absorbance or fluorescence measurements) or a multimode reader, in case you need both detection methods.

    For more information, visit WinKQCL® Endotoxin Detection and Analysis Software.

    (Optional) Incorporate an automated assay setup

    Endotoxin automation can improve your lab efficiency and enhance compliance. Implementing the PyroTec® PRO Automated Robotic Solution in your laboratory can reduce the potential for human error substantially, and enhance the accuracy, reliability and traceability of results. 

    For more information, see Endotoxin Automation.


  3. Implement analysis tools to measure outcomes

    Once your data collection is complete, you need a tool that will help you measure the outcomes of your testing. An easy-to-use software can make life easier. The WinKQCL® Endotoxin Detection and Analysis Software offers a fully integrated solution for your quantitative endotoxin detection testing, data management and reporting needs. It helps to ensure reliable, reproducible, and accurate electronic results in accordance with the strictest regulatory standards.

    WinKQCL® Software can perform the following endotoxin tests:

    • Initial qualification
    • Routine tests
    • Inhibition/enhancement tests
    • RSE/CSE test

    For more information, visit WinKQCL® Endotoxin Detection and Analysis Software

  4. Qualify and validate your setup

    Enjoy peace of mind knowing that the risk of downtime on your instrumentation can be minimized thanks to our complete service offering. On-site service and preventative maintenance contracts help ensure that your endotoxin testing equipment is working properly. Trained service professionals can provide installation, qualification and preventative maintenance to keep your instruments and software qualified and functional.
     

  5. Start running your assays

    Our goal is to provide a complete testing solution for your laboratory where all elements work in symphony. Lonza not only provides a full range of BET assays and microplate readers but also analysis software, automation solutions and surrounding installation and preventive maintenance services for all hardware so you can keep your lab running efficiently and with minimal downtime. 

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