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Endotoxin Automation

For decades, you have relied on us for our trusted endotoxin testing products, services and software to meet the ever-changing needs of regulated manufacturing environments.

Endotoxin automation improves your lab efficiency and enhances 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.

Integrated with our robust WinKQCL^® Analysis and Detection Software, the Lonza PyroTec^® PRO Robotic System, streamlines your testing program for the long run.

In 2019, WinKQCL^® Software version 6.1 expanded the PyroTec^® PRO Automated Endotoxin Detection System to include automating the recombinant Factor C (rFC) sustainable testing method with an integrated PyroWave^® XM Reader for PyroGene^® rFC Assays. Endotoxin automation of the kinetic LAL and rFC methods simultaneously on the PyroTec^® PRO System is truly unique and an industry first for BET.

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Overall Benefits of Endotoxin Automation with the PyroTec^® PRO System

Elevate patient safety through better control of QC processes leading to quicker results
Improve reproducibility through elimination of many manual steps
Reduce repeat testing rate with robotic handling
Reduce technician training and qualification requirements
Increase results output and productivity per technician
Maintain existing workflow steps minimizing revalidation requirement
Future-proof with a sustainable automated rFC testing method whilst making your routine kinetic-LAL testing more efficient
Improve data integrity and analytical capability with capture of endotoxin automation process logs
Reduce costs with a positive impact on operations, quality, and time to results

Let’s see how endotoxin automation will improve your QC testing program, together.

Streamlining Your QC Testing: Automated Endotoxin Testing and Process Optimization

View our webinar to learn how automating the liquid handling aspect of the endotoxin test helps you save time and reduce manual pipetting errors and retests.

White Paper: Automating the BET with Dynamic Scripting

Released in our QC Insider^TM Toolbox

Learn how the PyroTec PRO^{^®} Robotic System can easily accommodate process changes and fully automate the endotoxin assay, reduce plating and pipetting errors, and allow analysts more time to perform higher value tasks.

White Paper: It’s All Mixed Up

Available in our QC Insider^TM Toolbox

Results of a study that demonstrates endotoxin standard series preparation by automated pipette mixing on the PyroTec^{^®} PRO System is equivalent to manual preparation of standards using vortex mixing.

WinKQCL^® Software - 25 Years of Evolution

Lonza has been providing endotoxin detection products since the 1970s, and we have been pushing the boundaries of software innovation to help meet customers' ever evolving testing needs. Find out how WinKQCL^® Software can enhance compliance and improve efficiency for BET in your organization.

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Endotoxin automation of the rFC method
Implementation
Determining Return on Investment

The PyroTec^® PRO Automated Solution combined with the PyroWave^® XM Fluorescent Reader option expands the range of endotoxin automation methods available on the platform to include the PyroGene^® Recombinant Factor C Assay. The addition of the PyroWave^® XM Fluorescent Reader complements the existing absorbance readers used in traditional LAL-based assays. Full integration with the WinKQCL^® Endotoxin Detection and Analysis Software enables testing using endotoxin automation that better meets your data integrity requirements.

This new addition to our established PyroTec^® PRO Solution provides laboratories with greater ability to reduce errors and increase throughput while retaining their trusted endotoxin method. Customers can utilize the best method for your specific sample requirements while also furthering their efforts to more fully automate the QC lab and increase utilization of sustainable solutions.

Let’s futureproof your endotoxin testing program, together.

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When planning the implementation of endotoxin automation with a PyroTec^® PRO System in your facility, allocation and scheduling of responsible persons as early as possible in the process is critical to success. In particular, assigning a project manager to coordinate efforts, IT resource for software installation and configuration and QA resource for documentation review and system go live sign off impact right first time project completion.

The IQOQPQ of the PyroTec^® PRO System follows a specific sequence with controlled documents for building, testing and qualifying the mechanical, electronic and software components by Lonza approved certified engineers.

Typically, a few weeks before engineers attend site, the installation of the PC Workstation and PyroTec^® PRO System WinKQCL^® Endotoxin Detection and Analysis Software components take place. Once on site engineers uncrate and assemble the robot which is followed by IQ and OQ testing of the mechanical performance of the readers and endotoxin automation robotic system components. The PyroTec^® PRO System configuration for endotoxin automation commences with installation of the on deck HeatPlates and IQOQPQ of the plate readers for each assay method that will be used on the system. The robotic deck is then configured for endotoxin automation and the robotic arm movements fine-tuned to allow optimal alignment and performance. In order to test the full functionality of the system, Lonza carries out a standardized PQ assay protocol for each assay method that will be automated.

It is recommended that you prepare your own PQ protocol for endotoxin automation based on knowledge of the types of samples to be tested and the results obtained by the current manual method.

The PyroTec^® PRO System is both simple to operate and to maintain. Users carry out a few simple procedures, through the WinKQCL^® Endotoxin Detection and Analysis Software, at specified intervals to ensure efficient daily operation. The system is protected by purchasing a Lonza maintenance contract that provides for both routine annual maintenance and emergency call out in the event of breakdown. Troubleshooting and support is accessed through our trusted Scientific Support Team.

Lonza can assist evaluation of a customer’s current workflow using return on investment (ROI) modelling to support business case proposal for endotoxin automation with the PyroTec^® PRO System. Details such as sample throughput, repeat testing rates, shift rotations, methods in use, sample types and manipulations required and future growth will all influence a successful ROI determination. Aspects such as enhanced data integrity, reduction in repetitive strain injury risk, and simplified end user training needs should also be considered as part of any business case for endotoxin automation.

This table illustrates the estimated time-savings, reduction in repeat testing rate and consumables cost savings for a laboratory testing 20,000 water samples per annum using a manual kinetic chromogenic plate-based method including interference controls (positive product control, PPC) with each sample. The Return on Investment for this example is 1.9 years, well below the typically targeted 3 year ROI.

We realize the budget process requires ample justification for your investment in endotoxin automation; our sales team are available to help support and justify your time and monetary investment.

Let’s see how automation will improve your endotoxin testing program, together.

Please contact our Scientific Support Team to start exploring a business case for endotoxin automation in your organization.

Endotoxin Automation

Overall Benefits of Endotoxin Automation with the PyroTec® PRO System