For their new facility, a major biotech company required a state-of-the-art automation system to control the GMP process. As with most Bio/Pharm facilities the facility licensing schedule was mission critical for the company. The scale-up bio-processing facility consisting of two cell culture trains, a purification suite, and supporting clean utilities. The automation project included P&ID development support, complete automation design documentation, system network design, controller programming, HMI development and batch configuration as well as instrument and automation commissioning with IQ and OQ support.
With a project already over budget and behind schedule, this pharmaceutical firm engaged Brillig Systems to provide project management to guide the recovery of this mission critical software project. Beyond the budget and schedule issues, quality problems had caused rejection of the initial software releases from the software provider.
Fast Track Upgrade
Faced with an escalating demand for their product, this global pharmaceutical company needed to upgrade its production facility. Fifty percent of the equipment and the attendant automation systems were to be upgraded or replaced. Regulatory commitments meant that the plant shutdown required for the upgrade had to start within 15 months of the project’s inception. This very aggressive schedule required a fast-track project.
Additionally there were limited internal resources available to this large upgrade project. Involvement of many different groups would be required, including multiple client departments, multiple third-party integrators, and an engineering and construction company.
New Process Commissioning
A new company had discovered a new method to produce ethanol from the material in a recycling plant. During their first years, they proved in a lab environment the functionality of their innovative process and were in the middle of building their first scale facility. Most of the company personnel were new to the company and new to the process. Fifty percent of the operation personnel were just out of school. Brillig was engaged to support the commissioning and start-up of the ethanol production plant.