Clinical Trials Fermentation Pilot Plant

Industry

Pharmaceutical

Business Issue

Customer needed to build a new automated flexible batch manufacturing facility to produce pharmaceutical products for use in stage 3 clinical trials.  The purpose of the facility is to scale-up and manufacture on-spec products from the recipes created in a laboratory environment, in the shortest time possible.

Project Summary

This project included engineering services and products for control of a fully automated, flexible, batch manufacturing process using biotech equipment and its associated utilities.  Process areas contained equipment for Media Preparation, Bioreactors, Fermentors, Product Harvest and Purification.  The batch control included full automation of CIP and SIP systems, closely integrated with production control to maximize equipment availability. Continuous control was provided for the utilities: Purified Water, Steam, Chilled Glycol, Chilled Water and Biowaste.  Ninety percent of the I/O utilized bus technology based on Foundation Fieldbus and Device Net protocols.

Scope Responsibility

Cornerstone Controls was responsible for the following areas:

  • Project Management
  • S88 Batch Control Consulting.
  • DeltaV Batch Automation Consulting and Design.
  • DeltaV Historian Consulting, Design and Implementation.
  • DeltaV System Architecture, I/O and Bus Design & Review.
  • DeltaV Application Software Design, Development and Testing.
  • Formal Testing for validation.
  • Off-site Equipment FAT support for CIP and Bioreactor skids.
  • Installation and Commissioning Support.
  • This large DeltaV system was comprised of 6729 I/O points, 77 process cells, 116 Batch units, 54 workstations and 36 controllers.

Results

A flexible recipe design was implemented to facilitate quick scale-up of product recipes created in the laboratory environment.