Making use of pharma's hidden data
Gero Lustig, global business manager, pharma and life sciences ABB, explains why tapping into the hidden data of a manufacturing plant might not be as difficult as perceived, if the latest manufacturing operations management (MOM) solutions are deployed correctly.
After reaching the patent cliff, many pharmaceutical and biotech companies are now turning their attention towards improving their overall competitiveness. Today there is an increased focus on bringing products to market quicker while maintaining profitability in a regulated environment.
Achieving these goals is helped with the arrival of smart sensors and digital control systems. These devices give access to an abundance of data. The challenge facing manufacturers is a lack of know-how for converting this data into usable information. This creates a scenario of data richness/ information poverty. What is often missing is the ability to connect the data in a manageable way, without the need to maintain individual interfaces. This is the art of digitalisation.
Many solutions for the pharma and biotech industries are not fully integrated, requiring high efforts in engineering and synchronisation of data between the manufacturing execution system (MES) and distributed control system (DCS). Especially in GMP productions this has as a crucial influence on time to market, quality and profitability.
The key to unlocking this hidden potential in a factory is to ensure that the interface between enterprise, manufacturing execution and control systems is a standardised solution - one that conforms to ANSI/ISA-95 or ISA-95 standard. A very promising approach is a message-based interface which provides a powerful way to build an ecosystem, as opposed to point-to-point techniques. A message-based communications system sends and receives instructions and data such as quality, setpoint and consumption between the MES and the production equipment and is open to include other equipment and components in a digital ecosystem.
Distributed control system (DCS)
A distributed control system (DCS) enables compliance with the FDA’s 21CFR Part 11 through electronic batch recording, dual signature access, verification and audit trails, as well as certification, modelling and calibration tool integration. These solutions meet both GxP and non-GxP requirements. A DCS provides a consistent method for accessing enterprise-wide data and for interacting with multiple applications from any connected workstation in the plant or office. Powerful information management software collects, stores, retrieves and presents historical, process and business data to enhance the usefulness of data from all operations.
Manufacturing Operations Management (MOM)
A Manufacturing Operations Management (MOM) is a comprehensive, scalable and modular software suite maximising visibility, knowledge and control throughout the complete manufacturing domain and thus includes the elements of the Manufacturing Execution System (MES). It is the natural extension and complement to the real-time DCS. By turning large amounts of industrial data into actionable information, the MOM software helps daily operations improve, by ensuring subsequent shifts run more efficiently than the last.
MOM directly supports stakeholders working in the plant and business side of a company, by collecting, storing, combining and translating data from business, control and monitoring systems into meaningful, actionable information. Such users work with the overall plant operations in the areas of data analysis, reporting, production planning/execution, quality and asset management.
Summary
Few digital systems in manufacturing industry are fully integrated. Companies, suppliers and customers are not closely linked and departments such as engineering, production and service are not always communicating with each other effectively. Yet the need for agile manufacturing where production can be adapted to meet specific customer demands, can only be achieved if everyone is talking the same digital language. MOM brings end-to-end visibility to an entire production process. As such it affords the various plant stakeholders effective decision-making and reliable lean production execution through fully integrated operations.