Lonza has announced the global availability of the world’s first fully automated and integrated plate-based PyroTec™ PRO Robotic Solution for endotoxin testing. The system simplifies and accelerates endotoxin testing of parenteral pharmaceuticals regardless of sample complexity.
“At Lonza we are committed to developing new technologies to enable a safer and healthier living,” said Allen Burgenson, Global Subject Matter Expert for Testing Services at Lonza. “In line with this vision, our new PyroTec™ PRO Robotic Platform offers quick time-to-result to expedite the delivery of safe medicines to improve patient healthcare. Scientists at QC testing laboratories can feel confident that the generated results will result in a reduction in human error, which will ultimately benefit patient safety.”
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.
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“Less work for quicker and better results – that is Lonza’s simple yet profound goal for our endotoxin testing customers,” said Robert Porzio, Product Manager for Endotoxin Detection at Lonza. “Our PyroTec™ PRO Automated Robotic Solution reduces manual intervention considerably, minimizing the human error potential and the need for repeat test runs – all of which help enhance laboratory efficiencies. As a fully automated system, the PyroTec™ PRO Solution captures preparation metadata, adding traceability into tracking, trending and audit controls.”
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).
“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,” Dr. Jan Erik Rau, Head of the QC Microbiology Department at the site, said.
The platform has also been designed intrinsically to follow the U.S. Food and Drug Administration’s (FDA’s) Process Analytical Technology and Data Integrity Initiatives and to comply with the U.S. Pharmacopeia Bacterial Endotoxin Test guidance.