Rockwell Automation offers integrated control solutions that can be used in any manufacturing process. Integrated architecture with Allen-Bradley and Rockwell Software products at its core, is able to manage overall control functions. A recent installation of Rockwell Software for a large pharmaceutical company demonstrates the advantages of having an integrated solution.
Pharmaceutical manufacturers must keep up with rigorous and constantly modified compliance regulations for pharmaceutical testing and manufacturing in order to guarantee high-quality products. In anticipation of the US Federal Drug Administration (FDA) requirements, Rockwell Automation worked with sanofi-aventis to implement a control and visualisation solution to help it achieve FDA 21 CFR Part 11 compliance regulations and improve its tracking process.
sanofi-aventis is a leading pharmaceutical group in Europe and third-largest worldwide. Each year, the Ambarès sanofi-aventis plant, produces approximately 5,2 billion tablets, 600 million capsules and 30 million ampoules of injectable solution. Tracking production status and cost-effectively meeting regulatory requirements in the countries where sanofi-aventis manufactures and sells its products is no small feat.
In one of its production lines, the Ambarès plant manufactures injectable liquid. After the liquid is created, the mixture is stirred and poured manually into tanks, according to recipe specifications. The final solution is then stored in ampoules to preserve the product before it is shipped. The tanks are cleaned and prepped for the next batch after each operation.
With a disconnected and manually intensive process, sanofi-aventis' managers aimed to improve existing processing methods to reduce risk associated with human error and increase efficiencies. As a starting point, managers investigated ways of improving aseptic process, focusing on clean in place (CIP) and sterilise in place (SIP) processes and by implementing new water-for-injection loops (WFI). WFI purifies water by distillation, rendering it sterile to prevent microbiological contamination. Specifically, the company sought to achieve compliance with US and European pharmaceutical regulations for the next five years - specifically, tracking and controlling the WFI process according to 21 CFR Part 11 specifications.
To meet its compliance goals, sanofi-aventis evaluated various control system platforms, including distributed control systems (DCS), programmable logic controllers (PLCs) and other automation solutions from vendors in the US, Europe and Japan.
Company managers met with Rockwell Automation representatives and decided that a distributed, open control system would best meet their needs. "Representatives from Rockwell Automation demonstrated in-depth knowledge on more than just automation," says Serge Landreau, project manager, sanofi-aventis. "They really understood the constraints associated with the pharmaceutical manufacturing process and were willing to work with us to find the right solution."
The working relationship between sanofi-aventis and Rockwell Automation began in February 2003 and continued over the next 18 months to achieve sanofi-aventis' goals. Based on a full analysis of the current manufacturing process, the team installed an Integrated Architecture from Rockwell Automation, with two Allen-Bradley ControlLogix controllers at its centre. Rockwell Software RSView Supervisory Edition HMI software and Allen-Bradley PanelView HMI terminals were also incorporated. RSView SE was chosen for two specific features: redundancy and access control of specific functions via the electronic signature feature in a Windows domain control environment. The redundancy function is divided into the HMI server and the data server.
sanofi-aventis uses the redundant HMI server for continuous process monitoring. Even if the time for each process does not last long, there is a specific critical time where they cannot stop. In the event of main HMI server failure, the operator can still monitor the process without any disruption. It is also crucial for the company to trace data for regulation and quality purposes, which is why the RSView SE data server was set up in a redundant mode to prevent any data loss. The overall system is secure for monitoring, regulation and quality issues. The switchover in this application is less than one second.
The electronic signature will discriminate against some users for specific actions, such as modifying the setup of key parameters for quality, cleaning and sterilisation operations. Linked to the company domain controller, individual usernames and passwords come from the IT department. With the previous system, all 20 sanofi-aventis employees had access to the manufacturing process via the HMI system in place. With the current system, only four employees, out of the 20 who have access to the process via the seven RSView SE clients, have access to both the cleaning and sterilisations functions via the electronic signature, and two have authorisation to counter these actions. This helps ensure that only authorised personnel can make changes to recipes for improved safety and security of the products.
With an integrated control solution from Rockwell Automation, sanofi-aventis engineers can now confirm that all pipes and tanks are sterilised before a new process starts. Because the process is completely automated, they can also ensure that the right raw materials go into the right pipes and tanks, at the right time.
In addition to the immense process enhancements, the company also improved the productivity of its employees, by eliminating non-valuable tasks traditionally performed manually, such as cleaning and sterilisation. This allowed employees to concentrate on core aspects of the business. Rockwell Automation also designed a training package for all sanofi-aventis operators and maintenance engineers using the new system. The package included training on ControlLogix, networks and drives, as well as customised training for users and maintenance specialists. The customised training sessions helped improve the skill level of the maintenance team.
sanofi-aventis improved process quality and security by employing the system's electronic double signatures that help protect product integrity and streamline changes. It streamlined planning efforts and more cost-effectively allocated resources and the total availability of monitoring and data collection during all manufacturing phases helps with 21 CFR Part 11 compliance and ensures traceability and realtime information.
"This was the first time we built an automatic injection compounding process and upgraded our water-for-injection process to meet 21 CFR Part 11 regulations using automation solutions," says Landreau. "We are now convinced that the customised automation support we received from Rockwell Automation helped make this project successful."
For more information contact Rudolf van Wyk, Rockwell Automation, 011 654 9700, [email protected], www.ra.rockwell.com
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