SN-503: Perspectives on Data Synchronization and Alignment for PAT

This paper addresses the requirements and methods for insuring optimum synchronization and alignment of process data for PAT (Process Analytical Technology). The first part discusses the use of the Proficy RX™ and Symbion RX/DX™ process analytical suites to effect the controlled coordination of data collection from diverse devices and instruments. The second part provides an approach to dealing with data that has already been stored, or processes that are not amenable to controlled coordination of instruments.

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SN-502: Achieving Standardization, Connectivity, and Compliance in Process Analytical Technology

Process analytical technology (PAT) is both an old and a new field of activity. Chemical process analysis (to use the more historical term) has been an active field of endeavor for over 60 years. For example, online infrared (IR) spectroscopy was widely used in the synthetic rubber industry during World War II.1 Within the past few years, however, infrared spectroscopy has seen rapidly growing application in the pharmaceutical industry resulting in the introduction of a number of new requirements.

Wide-scale applications of chemical process analysis in the petrochemical industries often involve the continuous processing of commodities such as gasoline, commodity feedstocks, or polymers. In such applications, a given instrument configuration — and often a given calibration — might be replicated numerous times at various plant locations. And each application generally involves only one type of instrument, most often monitoring a liquid (or at least molten) stream. The requirements of the pharmaceutical industry, however, are often more complex — involving short-run batch processes, samples that often are in powder or tablet form, and a wide range of different products.2 Under such conditions, it is highly desirable for calibrations to be simple and generic.3 At the same time, it is often necessary to integrate the results from disparate measurements in order to form a complete model of a complex process.4 Another factor that distinguishes pharmaceutical process analysis from chemical industry experience is the need for compliance with various industry standards and regulatory requirements in the areas of good automated manufacturing processes (GAMP) and electronic signature integrity (21 CFR, Part 11).

Leading process analysts in the chemical industry have long recognized the need for a standard, flexible software platform capable of controlling diverse instruments while meeting the established needs for on-line process analysis.5 These needs include sample system configuration and control, instrument control, extraction of process variable information from the raw data, real-time trending, system diagnostics, alarming, archiving of data, comprehensive historical data analysis, and remote communication using common protocols. The complex analytical needs of the pharmaceutical industry have made the case for standardization even more compelling while adding new requirements for regulatory compliance and data archiving.

The program outlined in this paper has been aimed at meeting the established requirements for process analysis while providing a standard means for operating a wide range of analytical instruments, the connectivity required for networking, data archiving, and interfacing to other programs, and the safeguards needed for regulatory compliance.

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SN-501: An Introduction to Symbion the Language

The Symbion™ language has been developed to provide a highly efficient, common interface for communicating with, networking, and controlling a wide range of analytical and other instruments. Its syntax is simple to use yet exhaustive, covering all of the significant capabilities required for instrument and sample system control, data analysis, I/O, database storage, and networking.

Benefits

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