Three years ago, managers of Sanofi-Aventis facility in Ambares, France decided to optimize Water-for-Injection (WFI) operations. Their goals were clear: to ensure long-term compliance with U.S. and European aseptic processing regulations, and to track and control the process according to 21 CFR Part 11. System security was essential, says project manager Serge Landreau.There was just one catch. Demand for their product was growing, so they needed a solution that would scale up quickly and easily.Sensing that distributed open control would answer their needs, Landreau and his colleagues evaluated a number of different process control systems from U.S., European and Japanese vendorsboth distributed control and programmable logic controllers. Ultimately, they decided to use Allen-Bradley ControlLogix Programmable Logic Control with Rockwell Systems RSView Supervisory Edition (SE), a scaleable human machine interface (HMI) system for supervisory-level monitoring and control.Sanofi-Aventis was impressed by Rockwells knowledge of pharmaceutical process constraints and its team approach, Landreau says. But the software itself also promised to simplify automation of the process.RSView SE is set up so that it can continue to monitor processes and track quality data even during critical phases, and even if the main HMI server should go down. The platforms electronic signature function features double e-signatures, ensuring redundancy, access control and change management at the operator level, says Rockwell project manager Andre Dalmasso.Rapid installationOnce it had identified the software solution, Sanofis first step was to create a cross-disciplinary task force at the site to oversee the automation and software installation, including:
- an overall project manager
- a project manager focused on users requirements
- representatives from engineering and quality departments
- an engineering service group from the vendor
- an independent consultant specializing in modular automation.