Modular Automation for an evolving pharmaceutical industry was one of the themes at the International Society for Pharmaceutical Engineering (ISPE) Europe conference in Lisbon last April. COPA-DATA joined Merck to demonstrate how modular production can unlock efficiency and flexibility in process automation.
Speed and flexibility are in high demand in today’s pharmaceutical industry. The emergence of personalized medicine, including complex technologies like gene therapy has led to the development of more tailored drugs. Frequent and rapid product changeovers have become the norm in pharmaceutical laboratories and along the production line.
One of the notable consequences is a rapidly growing amount of data to process along the development life cycle. These are challenges shared by many of the pharmaceutical organizations that COPA-DATA met at ISPE.
Traditional automation systems lack the scalability and interoperability needed to contend with the challenges of the modern pharmaceutical production line. This is where the modular, process orchestration-led concept based on the Module Type Package (MTP) standard can help. At ISPE, COPA-DATA and the science and technology giant Merck illustrated how this approach to automation can give pharmaceutical organizations the flexibility they need, from proof of process to large-scale production.
Flexibility on all levels
Contract development and manufacturing organizations require greater flexibility than ever on multiple levels. Rapidly switching from one product setup to another is critical, meaning frequent parameter changes. Companies must also scale production volume up and down according to frequently changing market demand.
R&D and innovation are another primary consideration. Transitioning from a small-scale laboratory environment to pilot plants and large-scale production is essential to trialing new products at speed and to bring innovative novel therapies to market.
Manufacturers may also need to move production plants from one location to another due to changing market conditions or proximity to customers or resources. This is where a modular approach to automation comes in.
Modular automation is the answer
Pre-assembled components with standardized interfaces are the building blocks of the modular automation platform COPA-DATA has successfully developed with Merck.
Using this approach, swapping modules becomes quick and easy without requiring specialized technical personnel. Interoperable, vendor-agnostic modules also enable more efficient interaction between R&D and production in pilot plants, accelerating time-to-market by up to 50 per cent.
In a joint presentation, Michelangelo Canzoneri from Merck (in the picture) and Giuseppe Menin from COPA-DATA demonstrated the practical application of modular production in Merck's laboratory environment at ISPE Europe 2024.
MTP in Action
The pioneering modular approach implemented by COPA-DATA in collaboration with Merck is based on the MTP standard developed by the User Association of Automation Technology in Process Industries, known as NAMUR. The standard requires that all the devices within a central control system communicate seamlessly, irrespective of the vendor.
At ISPE, COPA-DATA illustrated how this concept was successfully implemented at one of Merck’s laboratories. This facility features multiple fume hoods fitted with equipment like pumps, stirrers, and dosing modules. Researchers conduct experiments with the different modules requiring frequent reconfigurations according to different product process developments.
The solution implemented by COPA-DATA centers on the zenon software platform. Its Process Orchestration Layer (zenon POL) automatically integrates all instrument functions as MTP modules known as Process Equipment Assembly (PEA). This way, the POL can monitor and control PEA from different vendors. The zenon software offers more than 300 connection options, connecting with virtually any hardware out-of-the-box.
Thanks to this modular setup, all work steps are saved in completed modules that researchers can easily combine into new applications and processes in just a few clicks, and with no programming knowledge required. These modules can then be transferred seamlessly from the laboratory to the production line without the need for reconfigurations.
The MTP-based modular approach also offers another core benefit: paperless operations leading to improved data integrity. Process values, measurements, deviations and execution logs are digitally stored automatically instead of being manually written, minimizing the risk of human errors leading to discrepancies and product recalls.
A future-proof approach to automation
As the pharmaceutical industry continues to evolve driven by new developments in life sciences and medicine, embracing modular automation systems founded upon the MTP standard is critical. This way, manufacturers can unlock the flexibility and efficiency needed to stay competitive and innovative.
Learn how to go modular.