The International Forum on Process Analytical Chemistry (IFPAC/2004), held January 12-15 in Washington, D.C., featured a strong emphasis on applications of process analytical technology (PAT) in the pharmaceutical manufacturing environment. Roughly half of the conference attendees had a pharmaceutical focus, with total attendance growing from 176 in 1998 to more than 350 this year.
For the IFPAC meeting, PAT is narrowly construed to mean on-stream, real-time composition monitoring. This is only one of four principal components of the FDA's PAT initiative, which also places tools for multivariate data acquisition and analysis; process and endpoint monitoring and control; and continuous improvement and knowledge management under the PAT umbrella.
Monitoring and control of blending and drying operations with on-stream near infrared (NIR) analysis data was a frequently cited application. Laurie St. Pierre Berry, PAT specialist at Pfizer's Groton, Conn., plant described her company's use of NIR as well as infrared (IR) and reduction-oxidation techniques.
"New PAT strategies are being implemented into API [active pharmaceutical ingredient] facilities for controlling and monitoring of process chemical reactions and hydrogenations," she said. "Reactions no longer need to be interrupted for sampling. Reaction profiles provide several advantages including knowledge of reaction rates, endpoint determinations and impurity formation due to over reaction." Other PAT papers were presented by Amgen, Merck, Abbott and Novartis, among other pharmaceuticals manufacturers. For more information, visit
http://www.ifpac.com
