Manufacturing Control Systems – Integration is the key to success for Life Sciences

Inspired by the goals of optimizing performance and providing paperless record keeping, Process Control Systems (PCS) and Manufacturing Execution Systems (MES) have improved manufacturing operations for many pharmaceutical and bio tech companies worldwide. Fueled by the adoption of industry standards and advances in technology, these two systems are providing plants with a high return on investment.

Traditionally, these systems were viewed as separate entities within plants. The MES is widely regarded as an IT system because of its commercial software, servers and applications, and the PCS as an engineering function for its control and alarm monitoring capabilities.

Systems that operate independently of one another, however, are not enough to answer the evolving demands of the life sciences industry. To improve operational performance, plants require a seamless, synchronized system architecture that provides benefits such as common electronic batch records, as well as common exception reporting for automation and production management with resource traceability.

Merging PCS and MES to create a Manufacturing Control System (MCS) is an effective way to achieve these requirements, while generating a streamlined, more consistent operation. It also provides more efficient control of unit operations. For these reasons, MCS is likely to emerge in facilities as the new standard manufacturing solution by the end of the decade.

SEPARATE SYSTEMS UNITE:

PCS as a single solution is designed to improve the productivity and profitability of industrial facilities. Batch management software, a product integrated into most PCS, provides a robust solution for designing, modelling and automating batch processes. Using this solution, manufacturers have improved response time for production orders, as well as efficiency in meeting growing production demands.

MES, meanwhile, has proven effective in managing all steps of the production lifecycle; from specifying the materials to shipping the product. For example, leading MES systems improve manufacturing performance by controlling and tracking all aspects of production, securing predictable quality and providing a complete history for regulatory compliance.

Within the pharmaceutical and biotech industries, MES makes it easier for producers to meet regulatory compliance by managing and recording activities associated with personnel, manufacturing resources and the process itself. Additionally, the MES solution is a direct means to reduce human error during data entry. Users can reduce paperwork, improve overall resource management, and produce fully compliant, paperless production records.

From planning and scheduling to production execution, MES is able to assist production personnel in managing execution decisions. As a result, cycle times are improved, the cost of compliance is reduced and a greater responsiveness is achieved.

MES applications have matured around integrated material management and paperless plant-floor operations, which provide significant production efficiencies and cost savings. Still, personnel often must manually manage vast amounts of information. Users are required to refine production data so operations and quality decisions can be made in a timely manner.

An MCS combines the strengths of the MES for material management, manual work instruction, control and electronic batch records with the abilities of PCS technology to manage automated recipes and control unit procedures. By integrating these core strengths, MCS provides a single environment for manufacturing operations and process automation.

Close integration of the MES and PCS allows life science manufacturers to move beyond simply replicating paper tickets, “paper-on-glass” functionality and leverage all the capabilities the two systems have to offer. These capabilities include material reporting, asset management, laboratory data logging, production dispatching, Electronic Batch Record (EBR) management and electronic work instruction execution and workflows.

HOW IT WORKS:

An MCS provides a platform for managing everything from process orders to lab results to updated inventory and lab requests. Within the unified solution, the MES interfaces with corporate-level systems such as electronic document management and enterprise resource planning applications.

The system delivers orders from the corporate-level systems down to the plant floor, and then automatically dispatches orders based on required recipes, equipment status and availability. Next, the system executes the orders within an integrated system architecture. This eliminates the traditional requirement for operators to check equipment status manually, assign equipment, load recipes and initiate batch execution, which results in fewer errors.

At most plants without an MCS, operators are assigned to manage production resources and report their status. The operator must confirm the status of specified equipment in a paper log or database before a batch can be started.

The MCS solution, however, automates this process since the programmed phase in the PCS controls specific equipment. The phase is designed to automatically request equipment and assets from the MES based on their requirement status. A transaction executed within the MES handles PCS requests for information and the MES automatically allocates resources and performs arbitration should conflicts occur. This allows the automation process to continue without interruption.

Demonstrated through MES/PCS transactions, the benefits of the unified MCS approach are evident. Unit procedural control and phase execution with an MCS is more efficient than in a traditional environment with separate system domains. Transactions between different systems and personnel are seamless; operators see a unified interface, instructions and displays.

IMPROVED TRACKING AND WORKFLOWS:

In plants with disparate MES and PCS systems, the plant operator must pull up a ticket or paper-on-glass in the MES environment to check the status of materials and verify he is adding the prescribed material. He must also acknowledge the material addition is complete and instruct the PCS to complete the execution.

With an MCS, this process is improved by allowing the PCS to interface directly with the MES, which in turn, interfaces with Manufacturing Resource Planning (MRP) as required for inventory updates. During execution of a particular phase, the system reports on the material quality, the quantity that should be added to the batch and other significant details. It then performs system data verification including tracking when the material is introduced into the batch.

When tracking material consumption, the PCS can send a transaction notifying the MES that it is time to automatically or manually consume a particular additive or ingredient. As the automated steps are processed, a procedure becomes available on the operator’s screen with prompts for completing the task.

An MCS automatically presents instructions and workflows on the screen whenever they are needed, no matter the source. Operators are no longer required to coordinate with the MES activities, while staying ahead of PCS execution. This strategy revolutionises the handling of electronic instructions and workflows, eliminates paper procedures and enables a new level of plant production efficiency.

Previous paper-based systems required endless hours of collecting and reviewing paper records, reconciling discrepancies and approving for release. Subsequent designs of disconnected MES and PCS architectures reduced the product release process to a couple of weeks. With the MCS design, it reduces this process to a few hours.

THE END RESULT:

The common goal between manufacturing facilities is improved operational performance. Manufacturers seek shorter product cycle times, faster product changeover, fewer errors and better maintenance scheduling. To achieve these results, a seamless MCS architecture that provides common electronic batch records and production reporting for automation and production management with reliable traceability for materials, equipment and personnel should be installed.

By using an MCS system, pharmaceutical companies ultimately see more consistent operations between plant-level and corporate-level systems. Facility operators realise that in addition to the benefits of improved operational performance, reducing errors and ensuring compliance are critical to getting life-saving drugs to those who need them the most.

Mark Albano, Rajeev Joshi