The process of converting biological agents into pharmaceuticals is one of the most sophisticated and stringent manufacturing processes. Consider: An aspirin molecule contains 21 atoms. A biopharmaceutical molecule could consist of anywhere from 2,000 to 25,000 atoms.
Consistently reproducing these complex compounds from their origin in a bioreactor to their packaging for patients requires both operational precision and strict quality control.
Eli Lilly is one of the top biopharmaceutical developers in the world, Its Lilly-Branchburg plant is primarily dedicated to manufacturing advanced therapies for treating cancer. It also produces biopharmaceuticals that are undergoing clinical trials.
These drugs are processed in two “clean” manufacturing suites, where workers must wear protective suits to avoid contamination. Inside these suites are the human machine interface (HMI) systems that allow operators to see the status of each batch, and ensure the process is running smoothly and consistently.
Assessing the View
The Lilly-Branchburg plant runs 24/7. This around-the-clock schedule offers few opportunities for equipment upgrades, and even the shortest downtime comes at a cost to production.
With the HMIs’ operating system (OS) nearing the end of its life, plant managers took the opportunity to assess how people interacted with the manufacturing process. Feedback from operators, engineers and others who had used the existing HMIs to gain visibility into the production process was consistent – accessing the HMIs required too much time and effort.
“Access to the HMIs was confined to the clean area, resulting in production lulls,” said Mihir Shah, director of automation and electrical engineering at Eli Lilly. “Imagine you’re a manufacturing supervisor checking on the production run. Anytime you’d want to check on production, you’d have to enter the manufacturing suite and put on a protective suit.”
Not only was this time consuming, it also complicated troubleshooting. An issue in the manufacturing suite, for instance, might require an instrument to be recalibrated. An operator had to enter the clean area and identify the issue before knowing who could fix it. In the pharmaceuticals industry, instruments also must be routinely calibrated every six months to verify that parameters on the HMI system are represented on the instrument.
If one of the thick-client computers in one of the suites went down, recovery took anywhere from four to eight hours. Re-establishing a connection with the HMI system required workers to gown up for the production area, apply any required OS patches, check the anti-virus software, and other steps that interrupted normal production.