Thermo Fisher Scientific, Siemens join to enable greater process insight for drug manufacturers

Thermo Fisher Scientific (Madison, WI) says its Antaris Fourier-transform near infrared (FT-NIR) analyzers are built from the ground up to suit the specific requirements of the pharmaceutical industry. Now Thermo Fisher is partnering with Siemens to enable the systems with that company's SIPAT (process analytical technology) software platform. The goal is to further help pharmaceutical companies--by offering advanced process understanding and continuous control and improvement in both development and production.

Thermo Fisher says the integration will allow pharma companies to further extend the capabilities of their FT-NIR analyzers. The outcome, says the company, is better process insight, real-time product release, improved manufacturing performance, and enhanced quality--all while maintaining regulatory compliance. This initiative creates a solution tailor-made to the needs of the pharmaceutical industry that seamlessly migrates process analysis from the laboratory into production, effectively mitigating risk and is intended to drive significant cost-savings.

The Antaris FT-NIR analyzers include internal calibration standards that allow instrument qualification without having to stop the process or remove the probe from the culture media. With features like a flex-pivot interferometer and pinned-in-place optics inherent in the analyzers, each scan of the samples is the same as the last one, Thermo Fisher says, providing accurate, precise and reliable measurements.

SIPAT supports PAT implementation by acquiring data from multiple analyzers and other data sources. It can focus on either specific units or total batch quality. The software promises improved and faster product development, and shorter time-to-market.

"We believe that the collaboration between Siemens and Thermo Fisher Scientific represents a great step forward in advancing process control in the pharmaceutical industry," said Dr. Jeffrey Hirsch, NIR product manager, Thermo Fisher Scientific. All of the Antaris FT-NIR analyzers are built from the ground up to suit the specific requirements of the pharmaceutical industry. They include internal calibration standards that allow instrument qualification without having to stop the process or remove the probe from the culture media. With features like a flex-pivot interferometer and pinned-in-place optics inherent in the analyzers, each scan of the samples is the same as the last one, providing accurate, precise, and reliable measurements.

For more information, go to www.thermo.com/nir or www.siemens.com/sipat.