Standards Promote Successful Use of Manufacturing Execution Systems

Manufacturing execution systems (MES) are now considered a proven technology for bio/pharmaceutical manufacturing, and companies are moving forward with more fully implementing MES to accomplish their manufacturing operation-management tasks. The goal is to move beyond merely collecting data for electronic batch records (EBR) and to use MES in a holistic manner, enabling integration with the process automation layer, laboratory information management systems (LIMS), and enterprise resource planning (ERP) systems.

“MES fills the gaps by introducing near real-time data exchange, work instructions, and true integration across all steps of the complex manufacturing process,” explained Gloria Gadea-Lopez, associate director of manufacturing systems at Shire, in a presentation at MES 2013, the 8th Annual Forum on Manufacturing Execution Systems, held in Philadelphia, PA, Aug.13–14, 2013. MES are a crucial link in product lifecycle management (PLM), which is an all-encompassing approach to manage information from product design through manufacturing and beyond to the end-of-life stage, added Gadea-Lopez.

The common terminology brought about by two International Society of Automation (ISA) standards, S88 (for process control) (1) and S95 (for integrating enterprise and control systems) (2), has been crucial for the advancement of MES in PLM. The S88 standard sets out a vision for designing the production process from the first R&D stage all the way to commercial production, said Baha Korkmaz, senior vice-president of operations at Enterprise System Partners, in an MES 2013 presentation. The standard sets out models for activities, procedures/processes, and equipment (i.e., physical model). Modeling the process separately from the equipment provides flexibility because recipes can be developed without equipment constraints, explained Korkmaz. Korkmaz said that process mapping (as defined in S88 and S95) is a crucial part of applying MES early in product development and later in clinical and commercial manufacturing.

Conference participants noted that companies do support this vision of using MES in PLM, but implementing it at the process-development level can be difficult. One challenge is multiple automation and data-collection systems in different manufacturing locations. Another challenge is that, although the technology exists, the necessary application software are only beginning to emerge and are not necessarily ready to go "out of the box" for process development.

MES vendors, several of which displayed their products at the conference, are working on developing such software solutions. Werum, for example, recently introduced a preconfigured package for its PAS-X system that is a standard software product with all major requirements available in prepackaged content modules and GMP-compliant templates, said Marc Puich, senior vice-president of sales and program management, Werum Software & Systems America, in a company newsletter.

Mining MES data
While S88 and 95 standards eased communication between systems and helped users implement MES, the next step is to implement data analytics tools and standards that will ease data transfer and allow greater use of data collected by MES, noted Gadea-Lopez in an interview with Pharmaceutical Technology.

EBR data (e.g., process parameters, material information, and event time stamps) have been buried within MES datastores and not readily available for actionable use, noted Krishna Venkataraman, director of product and technology at POMS, an MES-solutions provider, in a presentation. MES vendors are beginning to develop solutions for extracting data (i.e., data mining) and making it available for various groups (e.g., quality control, engineering, scheduling) to view in the appropriate context and more quickly respond.   

MES have value beyond EBR, pointed out other panelists. MES, for example, can be used for business intelligence (BI) data mining. These data can then be used for activities such as measuring key process indicators (KPIs) and monitoring exceptions in quality control. 

Although MES have already brought operational improvements to pharmaceutical companies, these systems offer even greater potential if used as part of an integrated system that enables comprehensive visualization of process and product data. Vendors are dedicated to developing new tools, and users are working to unlock this potential in their organizations. 

References

1. ISA, ANSI/ISA88.01-1995 Batch Control Models and Terminology (Research Triangle Park, NC, 1995).
2. ISA, ISA95 Manufacturing Enterprise Systems Standards and User Resources, 3rd Edition (Research Triangle Park, NC, 2011).