Plug and Play PAT, Anyone?
A common user interface, and “out of the box” software will be essential to driving PAT in the pharmaceutical industry, say Pfizer’s control and IT experts Velumani Pillai and Martin Warman. They’re developing a template for IT requirements and seek input from vendors and other users.
By Velumani Pillai and Martin Warman, Pfizer, Inc.
Widespread adoption of Process Analytical Technologies (PAT) will improve the way that pharmaceutical manufacturers design, monitor and control their processes, and allow them to predict process performance. PAT already enables this understanding. Unfortunately, monitoring, control and predictive capabilities are currently available only as individual components in different systems.
One of the major issues limiting PAT today is the lack of open standards and interfaces between instrumentation and software. Each individual instrument vendor offers its own proprietary software, and, as a result, each PAT installation is unique. While we tolerated this situation when PAT was in its infancy, it has become a major problem, since PAT applications need to operate and acquire data from the process in real-time to monitor, control and optimize processes.
As PAT applications proliferate, so are implementations with custom interfaces, point-to-point interfaces, custom modelers, and data islands. These are no longer acceptable. If PAT applications are to help in multi-factorial analysis, they must interoperate in control and modeling space.
Given this need for an integrated environment, we propose that a Common PAT Software be developed, based on market and public standards. This would be commodity, “off the shelf” software featuring a standard user interface. This interface would be used to:
- set up and run analyzers
- provide a common modeling environment
- serve as a single environment in which to build and configure analyzers
- facilitate the archiving of PAT data in storage systems.
Availability of such software would help end-users reduce validation costs, minimize the deployment time and improve PAT systems’ robustness (see Figure 1 below). A common platform would greatly help ease PAT’s acceptance in the industry by reducing the custom interface code that we have to manage in the future.
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To access a copy of the PowerPoint presentation that Pillai delivered at AutomationXchange, click the Download Now button below.
|Figure 1. A common platform would greatly help ease PAT’s acceptance in the industry by reducing the custom interface code we have to manage in the future, the authors assert.|