At the Emerson Global Users Exchange in Anaheim California last week, BMS was awarded the Innovation award for most innovative application of Emerson technologies at its new facility in Devens, Massachusetts, which received FDA approval for manufacturing earlier this year. The plant will manufacture the rheumatoid arthritis treatment, Orencia, a biologic.
Plans for the facility began five years ago, but, in fact the groundwork was laid even earlier by Paul McKenzie and R&D and manufacturing teams in Ireland and the U.S., which piloted S-88 and S-95.
The facility represents a living embodiment of ISA-95 and 88 standards, explained Saroj Patnaik, head of Emerson’s Life Sciences business. “In the mid-1990s to 2000’s a lot of people in ISA wondered if anyone would actually use S-95 in its entirety. In this plant, all levels came together, from Level 0 on up to instruments, devices, control and ERP,” he said.
BMS representatives Chris Stevens, Associate Director of Manufacturing (and a member of one of the original Pharmaceutical Manufacturing Teams of the Year) and manufacturing executive Dave Gleeson shared details on the plant’s startup. Joining them was former colleague, Heather Schwalje, who now works for Emerson. (Read her recent article on Continuous Process Verification here.
The decision was made to move to a paperless plant, in order to remove “the hidden factory,” Stevens explained.
The facility, which is recipe-driven and designed around ISA88 and ISA95 standards, uses Emerson Process Management’s Syncade operations management software and DeltaV digital automation system for paperless manufacturing. This system is integrated with both enterprise and plant-level systems including SAP, LIMS, scheduling and computerized maintenance management systems, as well OSI PI historians and off-line instruments. Process analytical technology (PAT) is used at the facility.
Emerson Process Management President Steve Sonnenberg said that the life sciences industry “stretches and challenges us.”