ANYL 276 |
| Steve Hammond, Process Analytical Support, Pfizer, Ramsgate Road, Sandwich, United Kingdom and Martin Warman, IPC 597, Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom. |
| Pfizer Global Manufacturing have a desire to move to "Right First Time" performance. An essential part of achieving this status of almost zero defects, is process understanding and control of "Critical to Quality Attributes." Process Analytical Technologies are an essential tool for achieving these desires. Process Analytical Technology (PAT) is the use of at-line or on-line sensors to effect timely measurement and control of a process. Often this will is described as real time measurement at process critical control points (PCCP's). Many technologies are used, UV, Mid-IR, Raman and recently acoustic and imaging systems. However more than seventy percent of applications involve Near Infrared spectroscopy (NIR), because of the ease of sample interfacing, and the development of the optic systems by the telecommunication industry. This presentation will provide examples of the use of these PAT to improve the control and understanding of some important steps in the production of pharmaceutical products. From the monitoring of reactions, crystallisation of API's, through to the formulation steps of blending, granulation, and compression. Specific examples will be given describing the insertion of on-line sensors into API production vessels, secondary production blenders, granulators and dryers. The development of an on-line system that can be interfaced to a press to analyse tablet cores will be discussed. The regulatory implications of these technologies will be reviewed in the light of the FDA initiative on PAT. The author is a member of the FDA's sub-committee for PAT, and will provide some information on the sub-committees activities.
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Process Analytical Chemistry
8:30 AM-11:55 AM, Thursday, March 27, 2003 Convention Center -- Room 384, Oral
Division of Analytical Chemistry |