The Challenge: The owner was designing/constructing a new multi-purpose/multi-product Vaccine facility and required the specification, development, installation, commissioning, and qualification of a Process Control System and Building Management System that would be suitable for a wide range of equipment sizes and process unit operations. The solution to this challenge required a PCS that would have a high degree of flexibility and ease of operation for Development operations and a rigorous DCS formula controlled operation for Manufacturing Operations. The development and deployment of this system was further complicated by the owner’s lack of staff to adequately man the Automation portion of the project.
The Solution: The principals’ in CHT had previously supplied this customer with innovative Automation Engineering and Process Solutions on numerous Development scale projects. CHT has also worked for this customer as Owner’s Representative for numerous other major projects. Consequently, CHT was selected as the Owner’s Representative and was contracted to manage the Automation Engineering functions for this $150 million project with responsibilities for overall performance, schedule, and budget. CHT staff joined the project team near the end of the PID development stage and worked with the customer’s to identify and document operational requirements.CHT built on this knowledge base to develop User Requirement and Functional Specifications. After selecting and bringing the System Integrator onboard, the concept of a multi-purpose easily operated process controls began to emerge from a concept into a system specification.
Ultimately, the team developed and deployed a unique process control system that has selectable modes of operation. In the Development Mode, the scientist or operator is presented with multiple menu type graphical screens that present questions with pull down responses for the specific types of unit operations that will be conducted, the specific equipment that will be used, and all other variable process information. All information is recorded into a Part 11 compliant set of historians and presented in the End of Run Report.
The control system code is especially complicated both because of the variety of choices for unit operations such as Media, Buffer, Fermentation, Centrifugation, Ultrafiltration, and Chromatography as well as the many different methods of operation for each type of multipurpose equipment. For example, depth filtration operations could be selected for product capture, contaminant capture, or charcoal filtration.
The Result: The customer ended up with an easy to use, highly flexible, process control system that works well in either Development or Manufacturing operational mode. All operations at either scale are conducted in full batch control by the DCS process control system. The procurement and engineering integration of the controls were completed within the initial budget.
Almost immediately, the system proved its flexibility and value since during the later stages of commissioning several new serotypes were introduced that required significant process changes and final development during initial operations. The Development Mode operation was leveraged to a large extent to successfully and very quickly make the modifications required to operate the new processes.