As Rockwell Automations life sciences VP, Bob Honor gets to talk shop with some of the industrys leading PAT experts, whose companies desire to make their Rockwell and Allen-Bradley installed bases work with process analytical technologies (PAT). There are challenges in doing this, and the technology is not where it should be yet, says Honor, but most manufacturers would be surprised at what they can do with the control architecture theyve got already.
Pharmaceutical Manufacturings Paul Thomas spoke with Honor at Rockwells recent Automation Fair in St. Louis, and picked his brain about making PAT work with todays automation and control platforms.
P.M.: How well are pharmaceutical manufacturers today really adapting and improving their overall plant automation?
B.H.: Its very slow. The message were trying to convey is for making the business case, for going to senior management with all these good ideas about what automation can do. Thats a difficult task for the typical, say, pharmaceutical manufacturing supervisor. Theyre not used to making this case. But the cost pressures in the industry are so great today that theyve got to do this. Adaptation of automation is spotty. We dont see automation being consistently applied, and that needs to change.
FDA is now encouraging industry to automate and innovate, especially with its promotion of PAT. Of course, you have to overcome 30 years of an adversarial relationship between the Agency and industry. Theres a level of trust that needs to be established. Their main message has been, Work with us, were giving you the opportunity to make changes. The message has not been so much on how to implement PAT, but how to develop better trust between the industry and the Agency.
P.M.: What are your major clients asking of you these days?
B.H.: Theyre coming to us to help them build the infrastructure and openness to allow them to use various tools with their existing control systems. We have a large installed base at a major client's facility, for example, and theyve spent a lot of time with us going over their requirements for PAT, and asking us how we can support them further. They cant afford to throw out all that theyve done, so they have to work on the existing structures. Maybe if theyre building a new plant, they can start from scratch, but thats not the case for most pharmaceutical sites.
Theyre basically asking us for an open architecture that will allow them to integrate tools that theyre developing with their existing control systems.
P.M.: Are you supportive of the idea of such an open architecture?
B.H.: Oh, yes. The whole message behind FactoryTalk [a system which enables different systems to exchange manufacturing data and share common applications] is to give manufacturers the ability to integrate various applications seamlessly. Were a very broad supplier of those applications, but clearly were not going to supply every one of them. As new applications come up and we can provide an infrastructure to allow them to be adopted, we feel thats a competitive advantage for us.
So we do not have any misgivings about open architecture. Now what we do promote is the concept of premier integration. Because we are the manufacturer of both the platforms and the applications that can improve their operation, if a pharmaceutical manufacturer were to use a Rockwell suite to improve operations we can embed and more tightly integrate the applications with the platform. For example, with the latest release of our batch execution package, RS Batch, the interfaces of the control system are now embedded in the actual process architecture because we have the ability to do so. We call that premier integration. We are completely supportive of open connectivity for third parties, but we can provide an additional advantage when using Rockwells solutions.
P.M.: What are the biggest limitations to manufacturers implementing PAT?
B.H.: The analytical tools and the ability to integrate those with their existing control systems. The analysis thats required to look at critical process parameters and adapt processes using those parameters involves complex analytical techniques usually only those that are done off-line. Theyre not really available today as part of an integrated, real-time control system.
So you have a technology gap on the analytical tools, and then secondly, especially when you get into larger molecules, the manufacturing processes are not all that well understood. Technology transfer is important in linking the development processes with manufacturing processes, so that if you were to implement an adaptive control system, you have to have a basic understanding of the model that goes into processing that chemical.
Many of the drugs that are manufactured today have a recipe, and manufacturers prefer not to touch it. They really dont know whats going to happen if they change something. PAT provides a framework for discovering exactly what happens, so theres a lot of discovery work that needs to happen in terms of understanding the physical processes in order to control and predict processes.
P.M.: But do many manufacturers already have the systems in place to begin to implement PAT, and not know it?
B.H.: Yes. They have the data. Because of the regulatory nature of the industry, the industry has been very good about collecting all possible data that might impact a product. What hasnt been done of course is the correlations between that data how do they interact? But the data, whether in historians or archived, is actually in their hands.
Weve actually engaged in a few projects with manufacturers where weve simply looked at their archives of process data, and had some of our researchers and analytical mathematicians look at them, and discovered some process parameters that were actually impacting the variability and quality of a product. We were able to implement a control scheme to monitor a few parameters and get a model to better control a production line.
Its a daunting challenge, and these analytical tools are not yet available in real-time, but the data is there. This is where the investment of making the case to senior management comes in. You need to strategically say, Okay, weve got this high-revenue blockbuster drug product thats where we need to invest time and resources to understand processes. Deciding where to implement controls and PAT thats where supervisors and process engineers can help senior management decide where to allocate resources.
P.M.: For manufacturers that have made that commitment to PAT, where should they be heading in the next few years in terms of control and automation?
B.H.: I think the big investment theyre looking at is the merging of automation and IT. The backbone of infrastructure that allows them to share information across all their systems is really where I see all the key investments being made. We see a lot of activity at the MES layer, and the reason behind it is not just the improvements that you can get from an execution system, but it also provides the framework to implement a future advanced process control system. Now youre getting a common framework across your plant that allows you to share data and effect control in the right area.
Youre building a connection. Instead of having OEM skids of equipment running independently, by putting in an MES you provide the framework for exchanging data and effecting control. We see a lot of investment by the larger pharma companies at the MES layer, because that gives them the framework for using the data and analytical tools to effect control.