Case Study - In the fast-changing world of life sciences manufacturing, operational excellence is a phrase being used liberally by management at all the top performing companies. In a battle being fought on all fronts, their overriding mission is to speed the time to market of their products, while maintaining flexibility in the manufacturing process and helping to reduce costs. One major weapon being used in this war on waste is the convergence of automated manufacturing and enterprise business systems.
"By automating the manufacturing process and providing information flows from the production floor to the boardroom, the life sciences industry can help change the dynamics of its business for the better," Marcel de Grutter of Solvay Pharmaceuticals said. "But despite its revolutionary results, the objective of establishing an Integrated Architecture manufacturing process connected to the Enterprise business systems should be viewed as an evolution. The first step is establishing a mentality in the business to commit to the use of technology as the long-term future of your manufacturing process. Getting the basic foundations of the IT network infrastructure right is essential for delivering the long-term benefits of automation."

The Challenge

de Grutter, automation manager and leader of the Manufacturing Execution System Expert Group has been leading the change to an Integrated Architecture connected to the enterprise business systems at Solvay Pharmaceuticals, the €2.6 billion global pharmaceutical business of the Solvay Group. He believes his extensive experience working in operational and logistics processes has allowed him to appreciate the benefits of integrating the IT and manufacturing systems of a business. "The benefits of automation within an Integrated Architecture are now clear to me," de Grutter said. "Automation brings businesses better consistency, real-time information to make better production and business decisions and a self-learning system to continuously help improve their control and processes. Using automation best practices, companies can achieve a number of objectives, such as:

• standardizing working methods and data;
• centrally recording, storing and archiving data;
• improving traceability of goods, products, manufacturing activities and production line changes;
• using visualization and simulation software to help improve planning and to help minimize the impact of production line changes;
• establishing self-learning and decision-taking workflows to feedback, analyse and improve processes; and
• centralising control over multiple manufacturing sites.

de Grutter recommends analysing each step of the production process and how it could be improved as part of the Integrated Architecture connected to enterprise business systems. The materials, equipment, production methods, environment and people used in the production process can all be assessed allowing the current, intermediate and ideal future positions to be established. For example, at the beginning of a project, manufacturing equipment might be stand alone without any consolidation of data. This means data must be checked or added in real-time to any management system. As a result, the equipment is a little bit cheaper, but there is little or no production data to intelligently manage the manufacturing.
"When a mistake is made in production using this type of system, it would only be picked-up at the end of the manufacturing process, and then the whole batch would have to be destroyed," de Grutter said. At the intermediate stage of automation, the equipment would be more integrated in a user-oriented environment but still not linked to the overall process as part of an Integrated Architecture. There are advantages here as the data can be checked and added to the information systems in real-time, but it is still wholly dependent on user intervention. In the ideal scenario, the equipment is fully automated in a controlled environment, making the link between the different process steps. Data is stored in real-time and that data is used for controlling the process automatically, with less intervention of the operator. For life sciences businesses to make this integrated move, it is important to have a team of cross-functional specialists together to implement the new integrated automation and IT infrastructures.
This in-depth knowledge of the business is critical to providing the processes established are going to be practical for use day-to-day.

Close Cooperation

An important contributing factor here is the close cooperation with the service delivery team of Rockwell Automation. With their long-term experience of implementing solutions, project management and deep knowledge of validation processes within the life sciences industry, Rockwell Automation helped to makes the concept of "integrated automation" a success. On the technology side, de Grutter says the key to success is using open systems technology to integrate the manufacturing and business office networks, whilst keeping the data separate. The data warehouse, enterprise document management system (EDM) and enterprise resource planning (ERP) systems on the office network can be integrated with the core local MES system and the controls systems through to the instruments and equipment. This set-up provides the backbone to deliver true automation benefits. "In the past, enterprise IT and automation were seen as very different worlds," de Grutter said. "People did not see the benefit of connecting the two together. But today, we are beginning to realize that this type of integrated automation provides more knowledge about your production processes and through this knowledge you can optimise the processes with impressive results."
Benefit
Integrated Architecture should be seen as a total concept to drive manufacturing benefits - helping reduce energy usage, cost and waste from the production process. The additional information allows the organisation not only to monitor and check but to alter and improve processes in real-time. Drawing on personal experience, de Grutter explained that using an Integrated Architecture approach changed the methods and processes used at Solvay Pharmaceuticals. For example, implementing complex matrixes for the detailed scheduling of processes where different cleaning times and set-up times were calculated. "At one site, we used to regularly clean the system after every five batches. However, when we looked at the data, it was clear that this was only necessary for wet products but not the dry products. As a result, we can automate the process and help make time and cost savings with minimal impact on quality." de Grutter believes that an Integrated Architecture approach: • forces through standardization and provides tools for improving processes;

• provides better insight into processes and planning;
• helps improve quality and consistency and safety;
• helps decrease training and validation costs;
• helps reduce labor costs;
• can help to improve time to market; and
• helps eliminate waste using real-time control.

Lessons Learned

However, with any success come new issues to be aware of, and de Grutter warns that there are still risks to be managed when moving to an Integrated Architecture connected to enterprise business systems.
"In an automated environment, it is critical to analyze the data carefully from the outset, otherwise errors might not immediately be spotted and this can be costly.
"Also look out for hidden costs, such as maintenance, which are typically 50% on top of the system costs. In addition, make sure that there are clear owners of the different elements of the system and that security helps protect your system from hackers or internal, inadvertent meddlers." But whatever the new challenges of an Integrated Architecture are, de Grutter is convinced that the benefits of automation can be delivered today and continue delivering in the future.
"An Integrated Architecture establishes the foundations that can help a company to grow and with the addition of new technologies and approaches, such as radio frequency identification (RFID) and process analytical technology (PAT), the life sciences industry can continue to reap the benefits of an Integrated Architecture connected to enterprise business systems for many years to come."