At Interphex it was all PAT, all day

By Agnes Shanley and Paul Thomas, from sister publication Pharmaceutical Manufacturing

"IF PAT CAN MAKE IT THERE, it can make it anywhere …” well, you get the idea. PAT (Process Analytical Technology) was a big hit at April’s Interphex show at the Jacob Javits center in New York City. From session rooms to the exhibition floor, everyone it seemed was using those three letters to grab a little piece of the show spotlight.

On the exhibition floor, signage advertised PAT for blending, PAT for drying, PAT for tableting, PAT for packaging—anything that’s monitored in real time or has wireless applications got the PAT label.

But what truly qualifies as PAT? That was a question being raised in the sparsely attended sessions and workshops away from the show floor. Nancy Mathis, president of thermal effusivity sensor maker Mathis Instruments, led off one workshop by discussing e-mail correspondence she’d had with FDA. She had posed this question to the Agency: Is measuring temperature on a fluid bed dryer in real time PAT? The Agency had concluded that, no, the measurements in themselves are not PAT unless the operator can leverage those measurements to gain a greater understanding of his or her processes.

Away from the vendor booths, the point that many were driving home is that PAT is less about monitoring pharmaceutical processes than it is about controlling and understanding those processes. Mathis herself is the first to admit, for instance, that her sensors are only a very small piece of what is becoming an extremely grand and complex PAT pie. Process control specialists, including Emerson Process Management, which has launched a new Operational Excellence program, see PAT as a critical tool for improving manufacturing efficiency.

How to make sense of it all? Enter the consultants, who were out in full force at the show, espousing homemade PAT recipes for manufacturing clients. In the Mathis-led session on thermal effusivity as a process analytical technology, Tracy Davis and Normand Dubuc of Invensys Validation Technologies, which now boasts more than 200 PAT consultants worldwide, outlined their firm’s six-stage approach to PAT success.

Davis in particular offered a clear perspective. While all firms should be developing PAT strategies for long-term implementation, Davis noted, starting with just one piece of equipment is a step in the right direction. Collaboration and partnering among solutions providers is also key, he said. Invensys has partnered with Mathis, O’Hara Technologies, and Sentry Equipment Corp. on a device for real-time effusivity monitoring of a FBD. The device is now being tested at Confab, a Canadian contract manufacturer.

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