Using Open Control to Optimize WFI

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 vendors—both 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 Rockwell’s 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 platform’s 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, Sanofi’s 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.

The project manager for users’ requirements was involved from start to finish, a point that Landreau says was instrumental to the project’s success. The group used functional analysis tools such as the Delta-Node method, as well as value analysis and a 3-D CAD tool for designing the process.In the meantime, Rockwell designed a training package for all operators and maintenance engineers who would use the new system. This package included training on PLCs, networks (both DeviceNet and Ethernet) and drives, as well as customized training for users and maintenance specialists.Automation proceeded rapidly. In November 2003, nine months after the initial contract was signed, Factory Acceptance Testing (FAT) was completed. Cabling was completed by February 2004, and implementation and commissioning by the end of that year.Now in its fifth month of operation, the automated facility has been a success, Landreau reports. “Before any new process starts, we know that all the pipes and tanks involved have been sterilized,” he says, “and we can ensure that the right raw materials are sent to the right pipes and tanks. In addition, the system provides proof that the process works as required, and can provide the data required to assure regulators, automatically and at any time.”There were some unexpected benefits, too, he says. Operators who were previously in charge of preparing raw materials saw their jobs change for the better. “Now that they no longer had to oversee all cleaning and sterilization processes, they could concentrate on essential KPIs and the core of the business, and produce more to meet increased demand,” says Landreau. In addition, the maintenance team members found that their skills were enhanced, and they became more interested in their jobs, a fact that Landreau traces to the customized training.“We are now completely convinced that ISA S88 methodology helped make this project successful,” says Landreau.