While the advantages of manufacturing execution systems and process control systems are well known to pharmaceutical producers, how can the benefits of both be enjoyed simultaneously? The answer, according to a market leader in automation systems, is to integrate the two entities.

Manufacturing execution systems (MES) and process control systems (PCS) have traditionally been viewed as separate entities within pharmaceutical plants. An MES, with its commercial software, servers and applications, is widely regarded as an IT system. A PCS, by contrast, is seen as the domain of control engineering for its control and alarm monitoring capabilities.

For years, pharmaceutical plants have reaped the benefits of these systems as standalone solutions. But a growing number of plants have discovered that merging them into a manufacturing control system (MCS) provides the tools needed to meet the rigorous demands of today’s life sciences industry. Those demands include:

  • Minimising errors
  • Increasing regulatory compliance
  • Shortening product cycle times
  • Accelerating product changeover
  • Improving maintenance scheduling

Systems that operate independently of one another are not enough to answer these demands. To improve operational performance, plants require a seamless, synchronised 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. An MCS leads to streamlined, more consistent operations and more efficient control of unit operations.

MCS architecture

An MCS combines the strengths of 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.

An MCS provides a platform for handling everything from process orders and 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.

An MCS delivers orders from corporate-level systems down to the plant floor, and then automatically dispatches recipes based on required equipment statuses and availability. It then executes them all 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.

Best of both worlds

A large US biotech company is in the process of installing a Honeywell MCS, which consists of two of the company’s most well-known process industry technologies: Experion Process Knowledge System and POMSnet MES.

On their own, both systems streamline operations while ensuring compliance with federal regulations such as 21 CFR Part 11. But the customer sought to further streamline processing and reporting by merging Experion’s power to give operators a complete view of operations and improve decision-making with POMSnet’s ability to manage and record activities associated with personnel, resources and processes.

Because a product cannot be released without the associated paperwork being reviewed and all exceptions responded to and approved, the resulting enterprise-wide view of data in a single electronic format speeds the release and shortens the cycle time. The MCS therefore leverages the strengths of Experion and POMSnet.

Taking it a step further, the biotech company example illustrates the benefits an MCS can deliver that not even the most robust standalone systems can reach, such as:

  • Recording all equipment and material activities
  • Tracking equipment and material status through tools such as material genealogy and use and maintenance logs
  • Batch release of material and data disposition

Companies have long known that reducing errors and ensuring compliance are critical to speeding life-saving drugs to the market. By offering features such as more efficient scheduling of materials, equipment and resources; automated lot review by exception; reduced cycle time and increased consistency of product variability; pharmaceutical companies will ultimately see more consistent operations and improved cycle times.