Endotoxin Detection and Analysis Software

We are pleased to announce the release of WinKQCL^® Endotoxin Detection and Analysis Software version 6.3 which introduces the Lonza Nebula^® Multimode Reader to bring absorbance and fluorescence technology together in one easy-to-use instrument. This 96-well microplate reader allows users to utilize traditional LAL assays and recombinant Factor C technology such as PyroGene^® rFC Assay with one instrument. The Nebula^® Multimode Reader is optimized for all of Lonza’s quantitative endotoxin detection assays, bringing new and improved technology to the laboratory.

The WinKQCL^® Software version 6.3 PyroTec^® PRO System Software module integrated with the LoadingID on deck barcode scanning module strengthens compliance and efficiency in automated bacterial endotoxin testing.

Our WinKQCL^® 6 Software offers a fully integrated solution for your quantitative endotoxin detection testing, data management and reporting needs and can be utilized with the various endotoxin test methods:

> Request Info

WinKQCL® Software Automation

Lonza has been providing endotoxin detection products since the 1970s, and we've been pushing the boundaries of software innovation to help meet customers' ever evolving testing needs.

As experts in digital control systems, we have always embraced data integrity by providing quantitative endotoxin detection systems that are easy to use and help ensure reliable, reproducible, and accurate electronic results in accordance with the strictest regulatory standards.

Our endotoxin detection and analysis software has been one of the first CFR 21 Part 11 solutions, built with a robust framework to satisfy all data integrity needs and requirements. Our WinKQCL^® 6 Software includes the essential components to meet the latest data integrity requirements:

Metadata
Searchable logs and audit trails
Trending
Fine grain user management
Archiving
Active Directory and Single Sign-on user access support
Bidirectional LIMS integration
Automated assay support
Barcode ready

Request Info

Nebula^® Multimode Reader – One reader, two detection methods

Learn about conducting traditional kinetic LAL Assays and recombinant Factor C technology in one easy-to-use instrument.

Find Out More

WinKQCL^® Software demonstration

Get a closer look to see how our WinKQCL^® Software works, and how it can optimize your QC processes, improve your workflow and help you ensure compliance in your endotoxin testing.

Request a Demo

QC Insider™ Toolbox

Access the full suite of technical resources for the WinKQCL^® Software in our QC Insider^TM Toolbox.

Become a QC Insider^TM Expert now

WinKQCL^® Software v6 Features
Upgrading Your WinKQCL^® Software
Automation

WinKQCL^® Endotoxin Detection and Analysis Software Version 6 Features

WinKQCL^® Software guides the user through the process of setting up a microplate template and running an assay to determine the amount of endotoxin in a sample solution. WinKQCL^® Software can be used with a compatible microplate reader to run the template and perform common endotoxin tests such as initial qualification, routine tests, inhibition/enhancement tests and an RSE/CSE test.

The WinKQCL^® Software uses the run data to calculate the results for the sample solutions and their associated positive product controls. All data will be displayed in an easy to read configurable report and can be electronically reviewed and signed. Since WinKQCL^® Software stores all template and test information in a single Microsoft^® SQL Server^® database, all sample data, including linked standard, accessory, reader, and user information, can be trended and recalled for review from any WinKQCL^® Software client. In addition to endotoxin tests, WinKQCL^® Software allows reader-specific validation tests to be performed to ensure the instrument is operating properly.

The WinKQCL^® Software Package can be easily ordered on line and e-delivered along with any additional workgroup or reader licenses required to expand database access and management in your specific laboratory, across your facility or within your entire global microbiology QC organization.

Our endotoxin detection instruments and software are fully supported with Installation, Operational and Performance Qualification (IOPQ) manuals. In addition, a trained specialist from Lonza can perform the IQOQPQ of the complete system to help you with your system validation process.

Our WinKQCL^® Endotoxin Detection and Analysis Software can be installed as a simple standalone system, or it can interface with multiple robots and readers in multiple labs around the world, all storing data in a single database.

Designed for enterprise environments with wide area network support, ability to work across time zones, application virtualization, Active Directory^® integration, data segregation by lab and localization into English, French, German, Italian, Japanese, Spanish, Portuguese, Simplified Chinese and Traditional Chinese.
Robust data integrity solutions meeting 21 CFR Part 11 technical requirements and providing fine grain user access controls, extensive metadata, bidirectional LIMS and MODA^® Solution interfaces, and a SQL Server^® backend.
Advanced analytics and flexibility with interactive trending tools providing actionable results on-demand, helping you easily detect drift and enabling you to make proactive decisions, configurable reports to meet your labs’ needs and assay design features to fit your processes.
Workflow optimizations with barcode scanning, Kinetic SmartStop^TM monitoring feature to establish dynamic end conditions, and integration with PyroTec^® PRO System, a fully automated, walkaway endotoxin testing solution for kinetic chromogenic, kinetic turbidimetric, and endpoint fluorescence assays.
Compatibility with a wide range of microplate readers including:
- Agilent^TM ELx808^TM IU Absorbance Plate Reader (Catalog # 25-315S)
- Agilent^TM FLx800^TM TBIE Fluorescence Plate Reader (Catalog # 25-344S)
- Tecan Sunrise^TM Reader,
- Lonza PyroWave^® XM Fluorescence Reader (Catalog # 25-345S)
- Lonza Nebula^® Multimode Reader (Catalog # 25-375S)
- Lonza Nebula^® Absorbance Reader (Catalog # 25-365S)
  The following readers can interface with the WinKQCL^® Software, but the user may need to re-optimize the operating parameters for optimal performance:
- Agilent^TM Synergy^TM 2 multimode reader
- Molecular Devices SpectraMax^TM multimode series readers: M2, M2e, M3, M4, M5, M5e, and FlexStation
- SpectraMax^TM absorbance only readers: VersaMax^TM, 340PC, 190PC, 340PC384, and 384plus
- SpectraMax^TM fluorescence only readers: Gemini^TM EM, Gemini^TM XPS and Gemini^TM XS

To download and trial our latest WinKQCL^® Software Release, please submit the Information Request Form.

Upgrading your WinKQCL^® Endotoxin Detection and Analysis Software

WinKQCL^® Software version 6.3 released in August 2022 introduces the Lonza Nebula^® Multimode Reader to bring absorbance and fluorescence technology together in one easy-to-use instrument.

The following general enhancements were also included since the release of WinKQCL^® Software version 6.1 in June 2021:

General System Configuration and Usage:

Support added for the Lonza Nebula^® Multimode reader.
Support added for a solid state Fluorescence Test Plate for use with the Lonza PyroWave^® XM fluorescence reader
removing the need for time consuming Fluorescein wet testing for system performance testing.
Support added for the Windows^® 11 operating system (LTSB and LTSC editions).
Updated installer technology to replace a legacy component.

Lonza PyroTec^® PRO Automated Robotic Solution Software Module:

Support added for the LoadingID module for the PyroTec^® PRO System
Updated user access controls for the PyroTec^® PRO System.
Enhanced robustness for the PyroTec^® PRO System initialization process
Enhanced audit report entries and filtering for the PyroTec^® PRO System
Introduction of a re-optimized new deck layout for the PyroTec^® PRO System.
Option to configure alternative starting endotoxin concentration for automated standard curve preparation on the PyroTec^® PRO System
Explicit device level temperature configuration added for the Tecan^® Sunrise^TM absorbance reader.
Support added for the WinKQCL^® Software PyroTec^® HT software module

Current Users of WinKQCL^® 6 Software

Upgrade to WinKQCL^® Software version 6.3 is available for download at no charge for existing WinKQCL^® Software v6 customers. All data from WinKQCL^® Software version 2 and higher can be imported into WinKQCL^® Software version 6.3.

Please contact Scientific Support for the following supporting information:

WinKQCL^® Software version 6.3 compatibility matrix
WinKQCL^® Software version 6.3 revision history
A WinKQCL^® Software version 6.3 download link and upgrade installation qualification procedure for existing WinKQCL^® Software version 6 users
WinKQCL^® Software version 6.3 download link to evaluate the fully functional software version for 30 days before upgrade or purchase

Endotoxin testing traditionally involves a number of manual laboratory preparation steps that are inherently prone to human error. To address these issues, we created the PyroTec^® PRO Automated Robotic Solution. Now compatible with the PYROGENT^® 5000 Assay, Kinetic-QCL Assay and the PyroGene^® rFC Assay, the PyroTec^® PRO System provides laboratories the ability to reduce errors and increase throughput using rFC and LAL assays to suit all your testing needs. The PyroTec^® PRO Automated Solution is fully integrated with the WinKQCL^® Endotoxin Detection and Analysis Software ensuring that data integrity requirements are met.

The WinKQCL^® Software version 6.3 PyroTec^® PRO System Software module integrated with the LoadingID on deck barcode scanning module strengthens compliance and efficiency in automated bacterial endotoxin testing. The module determines sample location by 1D barcode on sample tubes in LoadingID tube sliders and cross references with the selected WinKQCL^® Software template(s).

LoadingID enhances data integrity by:

Ensuring the correct samples are picked, processed and plated correctly
Detecting duplicate samples
Alerting users to missing samples and unreadable barcode labels ensuring all samples in the selected WinKQCL^® Software template are included in the run

Learn more about automating BET with our PyroTec^® PRO Automated Robotic Solution.

All trademarks belong to Lonza and are registered in CH, EU or USA, or belong to their respective third party owners and are only being used for informational purposes.

WinKQCL® Endotoxin Detection & Analysis Software

WinKQCL® Software Automation

Nebula® Multimode Reader – One reader, two detection methods

WinKQCL® Software demonstration

QC Insider™ Toolbox

WinKQCL® Endotoxin Detection and Analysis Software Version 6 Features

Upgrading your WinKQCL® Endotoxin Detection and Analysis Software

WinKQCL^® Endotoxin Detection & Analysis Software

Nebula^® Multimode Reader – One reader, two detection methods

WinKQCL^® Software demonstration

WinKQCL^® Endotoxin Detection and Analysis Software Version 6 Features

Upgrading your WinKQCL^® Endotoxin Detection and Analysis Software