Abstract: This paper describes a case study of a control system design for a batch pharmaceutical process. The ISA standard ISA-88 batch control models and terminology were used as the main guidelines for the implementation. As the ISA-88 is not a guide for how to apply the definitions/structures, etc., one of the main goals of our work was to create a methodology for decomposition of functional requirements in terms of ISA-88 models and structures. This methodology was tested on a real problem, described in the case study. Also presented are some remarks on project methodology and Food and Drug Administration validation.
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