News

Posted On: 12/22/2004

Invensys and Mathis Forge PAT Pact

Invensys Validation Technologies and Mathis Instruments recently signed a memorandum of understanding aligning their expertise to offer a complete package for monitoring and automating drying control for the pharmaceutical and life science industries. This new initiative will provide a system for on-line moisture monitoring during drying and will also provide automated control of the fluid bed dryer (FBD). The goals are directly in line with the FDA guidance on process analytical technologies (PAT) issued in September 2004.

At the heart of the new automated PAT solution is Mathis’s effusivity sensor. “This is a natural extension of the sensing technology we developed for effusivity measurement. Integrating this into a fully automated on-line system gives users far more control over critical drying functions than they have ever had. By partnering with Invensys, a company with extensive experience in developing, deploying and validating pharmaceutical process automation systems, we are better able to help our customers move from sensor measurements to process understanding and control,” said Dr. Nancy Mathis, president and CEO of Mathis Instruments.

Effusivity-monitoring technologies jointly developed by Invensys and Mathis Instruments automated PAT solution reduces costs and time to market while ensuring consistent product quality and effective compliance. Photo courtesy of Mathis Instruments.

The two companies have just completed a six-month development phase for their joint offering. The offering provides a compliant control system for on-line end point measurement of product moisture in a fluidized bed dryer. This is especially valuable for manufacturers who make multiple products and seek high throughput and consistent product quality.

Mathis sensors utilize a bypass system developed by Invensys Validation Technologies that automatically removes and returns the product directly to the production unit with absolutely no human intervention.  Compared with competing methods which can sometimes take several years for method development or require complex analysis, effusivity provides a distinct advantage. With effusivity, it only takes a few days to profile a new product, ultimately shortening development time. The measurement is on-line, eliminating the need to shut down the process or to remove samples to a laboratory for analysis. No product is lost and containment is not compromised.

“Too much moisture jeopardizes product stability. If there is too little moisture, the product can become brittle and crack. Mathis offers a superior solution for precise measurement of moisture at the critical drying phase of production. We integrate a real-time control system, which together with the on-line sensor, controls moisture levels very closely. This automated PAT solution reduces costs and time to market while ensuring consistent product quality and effective compliance,” said Norman Dubuc, director, Pharmaceutical Solutions, Invensys Validation Technologies.

“Integrating Mathis sensors into a comprehensive process analysis and automation program is a win for everyone. Mathis gains an on-line regulatory automation and implementation solution; we add unparalleled analytical depth to our automation offerings and customers improve the quality and performance of their manufacturing processes,” said Mark Cupryk, vice president, Invensys Validation Technologies, North America.

Among the first companies to implement the new technology is Confab Laboratories, in St-Hubert, QC. “This PAT solution gives us a systematic, step-by-step methodology for managing the scientific analysis, control and integration while improving development time, increasing manufacturing efficiencies, and simplifying the regulatory documentation. We fully expect it to speed up our development time while improving efficiency and facilitating compliance.  This solution which uses state-of-the art technology gives us a leading edge on the competition,” said Confab Senior Vice President Richard Fecteau (www.confab.ca), who is also hosting demonstrations of the technology for other companies.

Both Invensys and Mathis envision that their process analytical technology collaboration will extend to automation of other processes and other production equipment.