Abstract
The fundamentals of retrofitting for automatic control apply to all process industries, as well as the pharmaceutical industry. The retrofit of pharmaceutical unit operations, however, requires that the fundamentals revolve around the validation objectives. These fundamentals are implemented by a “project team,” consisting of engineering, validation, production, and maintenance personnel. The project team can minimize a project cycle by emphasizing a “total system” approach to control design, i. e., relating process design to control design, as well as performing the necessary "background work" before specifying hardware/software requirements. The background work consists of defining the control objectives, specifying the I/O list, and designing a robust sequencer algorithm. The sequencer design is divided into logic consisting of initiation, error/fault handling, control, operator override and termination sections. Finally, the retrofit start-up is optimized by emphasing testing procedures and thorough documentation, in light of the validation objectives.
- Received July 23, 1985.
- Accepted September 26, 1985.
- Copyright © Parenteral Drug Association. All rights reserved.
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