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Clinical Trials Biotech Pilot Plant

Challenge

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

Approach

Approach

The 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, fermenters, 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 purified water, steam, chilled glycol, chilled water and biowaste utilities.

Approximately 90% of the I/O utilized bus technology based on FOUNDATION fieldbus and DeviceNet protocols, and a flexible recipe design was implemented to facilitate quick scale-up of product recipes created in the laboratory environment.

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 and review
DeltaV application software design, development and testing
Formal testing for validation
Off-site equipment support for CIP and bioreactor skids
Installation and commissioning support
This large DeltaV control system comprised 6,729 I/O points, 77 process cells, 116 batch units, 54 workstations and 36 controllers

Results

The successful project has allowed the client to produce many different clinical trial biotech products in rapid scale-up from development using this flexible data-rich process platform.