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Clinical Trials Biotech Pilot Plant 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. Ninety percent of the I/O utilized bus technology based on foundation fieldbus and device net protocols, and a flexible recipe design was implemented to facilitate quick scale-up of product recipes created in the laboratory environment.

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Project management
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S88 batch control consulting
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DeltaV batch automation consulting and design
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DeltaV historian consulting, design and implementation
Hierarchal Structure
DeltaV system architecture, i/o and bus design and review
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DeltaV application software design, development and testing
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Formal testing for validation
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Off-site equipment support for CIP and bioreactor skids
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Installation and commissioning support
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This large DeltaV system comprised 6729 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.