Strukturen, Funktionalitäten und Engineering der Leittechnik im regulierten Bereich Hartmut Hensel Hochschule Harz, Wernigerode Korrespondenz: Prof. Dr.-Ing. Hartmut Hensel, Hochschule Harz, Fachbereich Automatisierung und Informatik, Friedrichstr. 57- 59, 38855 Wernigerode (Germany), e-mail: hhensel@hs-harz.de Structures, Functionalities and Engineering of Process Control Systems for Regulated Industries At first the paper describes basic models and various structures of process control systems for the application fields of the manufacturing and process automation. Then the networking of the control systems among each other and the integration of control systems into the company-wide computer network (ERP) are drawn. The considerable increase of computing and storage capacities, the development of new technologies in the software area and the simpler inter-connectability of computer systems led and lead to an architectural and structural change of the process control systems. These structures are outlined in the paper. In the second part of the paper the classical, structured engineering approach for process control systems and its extensions for the regulated indus-tries are discussed. The methods are described in detail in the VDI / VDE guideline 3517 „Validation of Process Control Systems“ and in the GAMP Good Practice Guide „Validation of Process Control Systems“, and be introduced in this paper in their essential features. Key words GAMP-Gute-Praxis-Leitfaden • Leittechnik, Engineering, Funktionalität, Strukturen • Process Analytical Technology (PAT) • VDI/VDE-Richtlinie 3517 |
|
pharmind 2006, Nr. 3, Seite 340