A Unified Solution for the Life Sciences Industry

y Carey Clements?Senior Marketing Manager?Honeywell??
Today, life sciences companies are faced with many challenges–managing risk, lowering costs, improving efficiency and speeding new products to market, all while maintaining high quality and regulatory compliance standards. Fueled by the goals of optimizing performance and providing paperless recordkeeping, Process Control Systems (PCS) and Manufacturing Execution Systems (MES) have improved manufacturing operations for pharmaceutical and biotech companies across the world. With the increased adoption of industry standards and technology advancements, these two systems have had an extraordinary impact on the industry today.

By tradition, these systems were viewed as separate bodies within plants. Only recently have the lines between these systems begun to blur. The MES functions as an IT solution that supports the primary production processes in a production plant, while the knowledge-based PCS works as an engineering function for its control and alarm monitoring capabilities.?Unfortunately, systems that operate independently of one another are not enough to answer the ever-increasing demands of the life sciences industry. To improve operational performance, plants require a seamless, synchronized system architecture that provides benefits such as electronic batch records, as well as common exception reporting for automation and production management with resource traceability.

By integrating PCS and MES to create a new hybrid solution – the Manufacturing Control System (MCS), manufacturers can achieve these requirements, while maintaining efficient, streamlined operations with fewer errors, greater consistency and increased compliance with FDA regulations. The MCS also provides more efficient management of unit operations. As a result, MCS is likely to surface in facilities as the new benchmark manufacturing solution by the end of the decade.

Systems Unite

Companies are now recognizing the benefits of managing plant-level and corporate-level systems as part of a single, unified enterprise architecture. As a single solution, PCS is designed to improve the productivity and profitability of industrial facilities. Batch management software, a product integrated into most PCS, functions to collect useful data and information and determine what to do with it. By utilizing this solution, manufacturers can achieve faster response to production orders and schedule changes, flexible processing to support new product introduction, and increased throughput to meet expanding production demands.

MES, on the other hand, has proven valuable in managing all steps of the production lifecycle; from materials receipt to product shipment. For example, POMSnet MES, the industry-leading MES system from Honeywell Process Solutions, improves manufacturing performance by controlling and tracking all aspects of production, enforcing Good Manufacturing Practices (GMP) and providing a complete history for regulatory compliance.

From the processes of 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, traditional “paper-on-glass” systems do not collect, organize or manage production in a way that is useful in aiding management decisions. Users are required to refine production data so operations and quality decisions can be made in a timely manner.

An MCS – such as the Honeywell’s widely recognized process industry solutions Experion Process Knowledge System and POMSnet MES – 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 formulas and control unit processes. The combination of these core strengths enables MCS to provide a single environment for manufacturing operations and process automation.

The fusion of the MES and PCS allows life science manufacturers to move beyond “paper-on-glass” functionality and leverage all the diverse 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.

Understanding the Process

An MCS provides a platform for managing everything from process orders to lab results to updated inventory and lab requests. The system’s distributed design utilizes the strengths of MES for material management and plant floor applications while simultaneously incorporating the latest advancements in PCS technology.

The process begins by delivering orders from the corporate-level systems down to the plant floor, and then automatically dispatches formulas based on necessary equipment statuses and availability. Then, the system executes the orders within an integrated system architecture. This eliminates the traditional need for operators to check equipment status manually, assign equipment, load formulas and initiate batch execution, thus resulting in fewer errors.

At plants that do not have an MCS, operators are assigned to manage production resources and report on their statuses. 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 because the programmed phase in the PCS controls what equipment is needed. Therefore, the phase automatically requests equipment and assets from the MES based on their required 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 disruption.

Through the exchange of 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.

MCS as an Operator

In plants with incongruent 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 then must acknowledge the material addition is complete and instruct the PCS to complete the execution.

With an MCS there is no middle man, instead, PCS to work 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 use, the PCS can send a transaction notifying the MES that it is time to automatically or manually consume a particular additive or ingredient. Once the steps are processed, a procedure is determined and available on the operator’s screen with steps 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 tasked with coordinating MES activities, while staying ahead of PCS executions. This strategy revolutionizes the handling of electronic instructions and workflows, eliminates paper procedures and enables a new level of plant production efficiency.

Improved Performance

The common goal amongst 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, an open 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 have the means to drive efficient production, enforce best practices and maintain proper records. Facility operators realize that in addition to the benefits of improved operational performance, they can also achieve the agility needed to stay ahead of the competition and respond quickly to changing customer requirements.