Automated Plate-Based Robotic Solution for High-Precision Endotoxin Detection

Lonza’s PyroTec PRO is a fully automated, plate-based robotic solution for endotoxin detection. 

Integrated with the latest version of Lonza’s proprietary dynamic control WinKQCL 6.0 Software platform, the new system is suited to meet the needs of changing requirements of quality control (QC) testing laboratories for fully automated processing of simple to complex sample matrices, according to the company.

System features include:

• improved data integrity with the capture of new metadata from the automated preparation, adding traceability into tracking, trending, and audit controls

• taking any new and existing templates and dynamically ‘script’ the instructions to an automation template with relatively minimal effort from the end user, regardless of how complex the sample type or testing requirements

• enhanced assay robustness and reproducibility for increased confidence in the accuracy and precision of results

• reduced manual intervention, simplifying QC testing workflows, and eliminating the human error potential

• reduced re-test rates, as well as out-of-specification and out-of-trend deviations

• integrates with laboratory information management systems or Lonza’s MODA Solution, facilitating fully paperless workflows and traceability of sample lifecycle

• considerable cost savings compared with conventional cartridge-based systems, which require the use of expensive reagents, according to the company

• aligns with FDA’s Process Analytical Technology Initiative and Data Integrity requirements and is fully compliant with the US Pharmacopeia Bacterial Endotoxin Test guidance.

“The introduction of the PyroTec PRO Automated Robotic Solution and WinKQCL 6.0 Software marks a milestone in endotoxin detection, allowing pharmaceutical manufacturers to replace manual, error-prone processes with a fully automated solution,” said Robert Porzio, product manager for endotoxin detection at Lonza, in a company press release. “We look forward to demonstrating at SLAS2019 how the system can elevate endotoxin testing to a whole new level of efficiency, regardless of the complexity of sample/diluent types and analytical requirements.”

Lonza’s experts will provide specialist consultation and live product demonstrations at SLAS2019 International Conference and Exhibition at booth 749 on Feb. 2­–6, 2019 in Washington, DC.

Source: Lonza