- April 22, 2013
By Bill Lydon, Editor
Representatives of pharmaceutical companies from around the world discussed the value of integrated manufacturing systems. Each participant identified their company's progress and shared first-hand experiences. This is the fourth article from the PAR series.
Pharmaceutical Automation Roundtable (PAR) 2012 - Part 4
By Bill Lydon, Editor
This is the fourth article of a series about the annual Pharmaceutical Automation Roundtable (PAR). I attended the Roundtable in November 2012, hosted by AbbVie, which at the time was part of Abbott in North Chicago, Illinois. Lead automation engineers from pharmaceutical companies all around the world participated. The PAR group members have a wealth of practical knowledge and knowhow to share with other participants, truly learning from each other.
PAR was founded about 15 years ago by Dave Adler and John Krenzke, both with Eli Lilly and Company at the time, as a means of benchmarking and sharing best practices for automation groups among peer pharmaceutical companies. The group specifically does not discuss confidential or proprietary information, cost or price of products, price or other terms of supply contracts, plans to do business or not do business with specific suppliers, contractors, or other companies. This is the most knowledgeable group of pharmaceutical automation professionals gathered in one place discussing automation issues. A range of companies participated including AbbVie, Amgen, Biogen Idec, BMS, Genentech, Genzyme, GSK, Eli Lilly, NNE Pharmaplan, Novo Nordisk, and Pfizer.
Topic: Integrated Manufacturing Systems
The lead presenter made the case for more integrated manufacturing believing they can accelerate product technology transfer time from R&D to manufacturing sites; as well as accelerate product moves between and within manufacturing sites. The S95 (ANSI/ISA-95) standard provides a well-documented, structured framework for implementation and connecting enterprise systems, manufacturing operations management, process control and automation.
The high -level S95 functional framework typically is based on a five-level model:
Level 4 – ERP, Business Planning & Logistics: Schedule Production, Material Use, Delivery, Shipping, and Inventory
Level 3 - MES & LIMS Systems, Manufacturing Operations Management: Work Flow, Recipe Control, WIP, Maintaining Records, and Optimizing
Level 2 – APC & PAT Tools, Discrete, Continuous Batch Control: Monitoring, APC, Supervisory Control, and Automated Controls
Level 1 - PLC & DCS system Infrastructure, Sensing & Controlling the Physical Plant Process
Level 0 - Production Process, Sensors & Field Devices at Physical Plant
Frameworks – Foundation and the Structure
The existence of a common language so systems can communicate efficiently is very important. S88 and S95 provide a functional framework that connects the systems and provides integration with a robust, physical, networked foundation. By logically tying personnel, equipment, automated processes, materials information, quality control together into a database warehouse, manufacturers can save a great deal of time and improve efficiency. The unleashing of manufacturing and process information has more value in a database than buried in documents such as spreadsheets and document files. The goal is to have a resource that provides information that people can easily access and use. A recipe data warehouse aids process understanding.
The presenter posed the question, “Which system should a recipe reside in?” His answer is it should reside in the ERP, MES, and control system. In this context, the recipe = master recipe + product recipe + process recipe. The master recipes reside in the ERP (Bill of Material, Inventory and Production Versions). At production sites, you need MES that receives information from the ERP and couples it with other information including tracking materials through work centers, manual operation tasks, critical product parameters, critical quality attributes, manual process steps, WIP (Work-In-Process), and material handling routings. The MES passes information to the automated control systems that use it and leverage unique production equipment characteristics for desired material transformation via chemical or biological processes from raw materials to finished product or intermediates. A successful integration topology mirrors the desired manufacturing division and site business operating model, providing efficiency and operationally flexibility. Essentially, system topology form follows function.
Lean High Velocity Manufacturing
The goal of lean, high velocity manufacturing requires product, material, and information flow all working in concert. Information flow impacts the efficiency of a responsive manufacturing supply chain. Intelligent manufacturing systems insure optimized, fast, and reliable product and material flow. All three manufacturing site-wide flows acting in concert enable lean, high velocity manufacturing. To achieve this operational goal, manufacturing sites must build a solid foundation (system infrastructure) before building a recipe framework. Ideally, there needs to be a network infrastructure standard and core set of baseline systems (control systems, lab systems, MES, and ERP). These systems should be integrated and networked so that product/process data and business manufacturing information can smoothly “flow”. This coordination requires the development of a common systems application set and convergence strategy. IT should be on this convergence journey since all vertical interfaces need to be well integrated and converged. The presenter emphasized that biopharma is in the business of making drugs, not systems. A key manufacturing competitive advantage is not how well each system works but how well they all work together!
PAR Group Discussion Comments
Individual PAR members from other biopharmaceutical companies injected the following comments on this topic:
“We are way behind and generally do not have site automation master plans. Each site has guidelines of what they are going to implement and tries to stay within them. New facilities typically conform to the corporate guideline. In terms of integrated systems there is currently no clear strategy. We have name brands associated with different functionality but we don’t have the connecting framework. When connections are made it is on a case by case basis. Overall, with integrated manufacturing information and recipes, we are not there. Even when we have the same name brand, automation information integration is different.”
“ERP and MES integration is on a case by case basis. We have created a data staging area for ERP so MES can get information easier than querying ERP. MES is usually “bolted” on top of varying automation systems, creating many problems.”
“We do not have site automation master plans. We recently created one for a site and are planning to do that for our other sites. We have a fairly good overall automation master plan and strategy that does not cover details of integration since we are not far along with this. Discussions with various stakeholders yield varying feedback as far as what they think the priorities are for integration of systems. My observation is everyone has their own pet peeves for what systems they would like to see integrated. For the few that we have done, the integrated systems are pretty close to 100% complete. But we have a lot more sites without integration. We do have a site with integrated ERP and MES that when we studied it had tremendous value. We have not integrated the control system to MES at this point and we are currently trying to determine the best approach.”
“We are bringing information from multiple systems for multi-variant process analysis and optimizations. We are using a troubleshooting tool which is connected to LIMS, historian, ERP, and DCS which provides real-time data. MES and control systems are supported by automation. The business analysis software and ERP are supported by IT.”
“We have a master plan and many sites have a plan focused on a paperless plant initiative. One of our sites is fully integrated with ERP, MES, LIMS, asset management, and DCS. Many of our other sites are not yet fully integrated.
We have roadmaps for each of the sites defining the desired level of integration. We are pretty well integrated. When we implemented ERP, the IT group built a bus structure that allows the ERP system to get information from all the site MES systems because we are not on a common MES system globally. This year the sites are collaborating on building MES template blocks for all the sites that will become a corporate standard. Data from controllers is pushed to a central site historian and we have a commonality of historian types at all sites.”
“We have a corporate plan and common strategy for MES and data warehouse with a single team overseeing the program. Every site is moving at a different pace. The MES and ERP are highly coupled but we only have loose integration with control and automation because the MES we have chosen previously did not have integration capability. Over 80% of sites have MES. We have an aggressive plan to align all sites for data integration.”
“No site automation master plan. We have a global architecture framework plan we are all working towards. Completeness site by site varies all over from 0-100%. Full integration is definitely on the roadmap and we will be integrated based on each site’s business case. Automation is done by the sites but in many cases is outsourced. We have a single multi-year global program to move to an integrated ERP and MES system with integration to automation systems.”
“No automation master plan. Our newest facility is fully integrated but older sites have many islands of automation.We have a data warehouse under the business intelligence initiative started four years ago that is fed with process information.”
“Our new MES was designed by IT with minimal input from operations and automation. The sites that are getting the new MES are not happy because it’s a step backwards in functional capability, compared to their legacy MES systems. But it’s cheaper.”
Other Articles in this PAR Series:
- Part 1 - Management’s View of Automation - Impressions of Automation Performance
- Part 2 - Managements View of Automation - Investment Value
- Part 3 - Management's View of Automation – Focus of Improvements
- Part 5 - Real Time Data Integration and Dashboarding
- Part 6 - System Obsolescence Planning
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