Emerson’s Christie Deitz and Bristol-Meyers Squibb’s Joe Maguire are presenting, Electronic Workflow for a Bioreactor, at the 2010 WBF North American Conference this week in Austin. Their abstract:
Automating workflow and eliminating paper batch records can provide many benefits, including reducing deviations, expediting batch review and release, improving real-time inventory management, and utilizing industry and corporate standards. BMS is currently in the commissioning stage of its new state-of-the-art facility in Devens, Massachusetts. BMS’ objective was to create a paperless manufacturing environment. To meet this objective, automation for the facility includes a process control system (PCS) and a manufacturing execution system (MES) system. The project is unique because, to date, it is BMS’ most extensive automation of workflow; that is, the manual instructions that might be traditionally done using paper.
The project team learned some valuable lessons with regard to team organization and approach to testing. They also made some key technical decisions around prompting, phase boundaries and recipe design. This paper will explain many of the lessons learned using the bioreactor area of the project as an example.
Joe described the vision to implement a fully automated, paperless solution that supports release by exception utilizing S95/S88 integrated recipe. The systems included a DeltaV control system, Syncade manufacturing execution software (MES), SAP, SmartLab, and Maximo software for enterprise, lab management, and maintenance planning.
To BMS, release by exception means that all exceptions dealt with in real-time and that the batch release needs to verify all exceptions investigated and signed off. Accomplishing this means the process operations are compliant, more efficient, and more visible.
Joe showed workflows around equipment qualification & facilities, materials verification, batch execution, operations review, QA review, and batch disposition. Moving away from manual, paper-based workflows to electronic workflows removed time and mistakes throughout the workflow.
On lessons learned for such a large project, overall it went smoothly, considering the large scope of manual workflows. The team took a bottom up approach. For future projects, the team would do electronic workflow and traditional automation more integrally in design and project execution.
On future projects, the team would finalize vision and requirements early and bring in plant operations and manufacturing personnel early.