Lonza announced the global availability of a fully automated and integrated plate-based PyroTec PRO Robotic Solution for endotoxin testing. It combines a liquid handling platform with version 6.0 of Lonza’s WinKQCL Software.
Conventional endotoxin detection methods for parenteral pharmaceuticals are labor-intensive and error-prone, as they involve manual data entry and template set-up steps. As a consequence, the reliability of results can be compromised, and the retest rate increased. At the same time, no metadata is associated with the manual steps, which limit traceability and the laboratory’s audit capability.
The PyroTec PRO Solution is being tested for ease-of-use in a trial carried out at Lonza’s Chemical and Microbial Manufacturing site in Visp (CH).
Dr. Jan Erik Rau, Head of the QC Microbiology Department at the site, explained: “The user will be able to operate the system without any programming or scripting knowledge. The robot automatically executes all processing required to complete an analytical run, while the intuitive 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.”
Additionally, the platform has been designed intrinsically to follow the FDA’s Process Analytical Technology and Data Integrity Initiatives and to comply with the U.S. Pharmacopeia Bacterial Endotoxin Test guidance.