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Batch control system project for a pharmaceutical plant.

Roman Holý1, Jaroslav Pozivil

  • 1Department of Computing and Control Engineering, Faculty of Chemical Engineering, Prague Institute of Chemical Technology, Praha, Czech Republic.

ISA Transactions
|June 20, 2002
PubMed
Summary

This study presents a methodology for designing control systems in pharmaceutical batch processes using ISA standard S88.01. The developed approach facilitates requirement decomposition for enhanced batch control system implementation.

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Area of Science:

  • Chemical Engineering
  • Automation and Control Systems
  • Pharmaceutical Manufacturing

Background:

  • Batch control systems are critical in pharmaceutical manufacturing.
  • Existing standards like ISA S88.01 provide models and terminology but lack detailed application guidance.
  • Designing effective control systems requires a structured approach to functional requirement decomposition.

Purpose of the Study:

  • To develop and present a methodology for decomposing functional requirements based on ISA S88.01 models and structures.
  • To validate this methodology through a case study of a batch pharmaceutical process.
  • To provide insights into project methodology and Food and Drug Administration validation within this context.

Main Methods:

  • Utilized ISA S88.01 batch control models and terminology as foundational guidelines.

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  • Developed a novel methodology for functional requirement decomposition tailored to S88 structures.
  • Applied the methodology to a real-world batch pharmaceutical process case study.

    • Main Results:

    • Successfully demonstrated a practical application of the S88 standard through a case study.
    • The proposed methodology effectively guided the decomposition of functional requirements for control system design.
    • The case study provided valuable insights into the implementation of S88 in pharmaceutical batch control.

    Conclusions:

    • The developed methodology offers a structured approach to control system design in pharmaceutical batch processes.
    • Adherence to ISA S88.01, supported by a clear decomposition methodology, enhances process control and facilitates validation.
    • This work contributes to the practical implementation of batch control standards in the pharmaceutical industry.