Robotic Solution Simplifies and Speeds Endotoxin Detection

Lonza’s fully automated and integrated plate-based PyroTec PRO Robotic Solution for endotoxin testing simplifies and accelerates endotoxin testing of parenteral pharmaceuticals regardless of sample complexity. 

Conventional endotoxin detection methods for parenteral pharmaceuticals involve manual data entry and template set-up steps, which can be labor-intensive and error prone. The robotic system, however, minimizes the potential for human error and the need for repeat test runs. Because it is fully automated, it captures preparation metadata, adding traceability into tracking, trending, and audit controls.

The system can be operated without any programming or scripting knowledge. Lonza’s WinKQCL Software v6.0 receives and saves the results and then transfers them into and out of laboratory information management systems or Lonza’s MODA Solution.

The platform has been designed to follow FDA’s Process Analytical Technology and Data Integrity Initiatives and to comply with the US Pharmacopeia Bacterial Endotoxin Test guidance.

Source: Lonza