As the saying goes, time is money, and in the pharma business, nowhere is that more accurate than when it comes to construction and the commissioning of expanded or new facilities. PhRMA estimates that building a new facility can cost up to $2 billion and take anywhere from 5-10 years. With this in mind, it’s critical that every step in the commissioning and construction process is executed smoothly, efficiently and cost-effectively so that operations are onstream and generating a return on investment as quickly as possible.
Often a significant part of that cost in terms of time and capital comes directly from facility, line and equipment commissioning. Late-stage changes or delays to the facility or equipment design, requirements and configurations must be minimized or ideally, eliminated to reduce the overall cost of facility commissioning.
To solve this, pharma can look to virtual commissioning, an approach that combines traditional and virtual development and testing using digital twins. Unlike physical commissioning, virtual commissioning can commence long before any hardware arrives. This approach enables savings of up to 40% in commission time compared to conventional physical commissioning.
A word on digital twins
A digital twin is a superior virtual representation of a real-world physical entity, system or process that uses data to simulate the behavior of that entity and predict behaviors of the final physical system. Digital twins pair the virtual and physical worlds enabling informed decision-making through historical data analysis, real-time system monitoring, simulations and emulations.
Creating a digital twin requires that every element of the physical engineering system be accurately and virtually replicated. Typically, this involves the definition of mechatronics systems, including motors, actuators and conveyors, connected to a controller, usually a programmable logic controller (PLC). The digital twin includes two aspects: System modeling using CAD and controller code running on physical or emulated controllers.
With the deployment of digital twins across a project, many processes and critical elements are factored into virtual commissioning, leading to a valuable reduction in risk, uncertainty and physical testing time. Engineers can optimize facility design, system design, production line operations, and plant and machinery requirements. They can test and verify the interoperability of materials, services, processes and system elements.
In addition, shop-floor operations can be digitally simulated, drug production monitored and the integration of PLC code with the physical system tested in a virtual environment, enabling different configurations to be explored. Running these ‘what if’ scenarios can identify and analyze anomalies and potential failure modes, enable thorough throughput analysis, and allow improvements to be made before physical testing takes place thus avoiding late-stage capital spend.
Infrastructure-as-code
From an IT/OT convergence angle, virtual commissioning also enables the use of agile concepts to develop processes such as infrastructure-as-code, with the goal being to move toward the automation of code development. The concept is that demand patterns, supply plans, manufacturing networks and anticipated orders will be inputs into the automation infrastructure and code that controls and executes the manufacturing processes in the physical world.
The adoption of these agile concepts will fundamentally change the workflows of OT engineers. Instead of building systems and code from scratch, as was the case with legacy distributed control systems, the process will look a lot more like a software development role, with engineers stepping in after the initial code is developed to adjust based on specific configurations or facility needs.
When it all shakes out
Whether a pharma manufacturer is upscaling an existing facility or planning to construct an entirely new greenfield plant, virtual commissioning using digital twins demonstrably helps realize numerous benefits. Across facility design, production line layouts and equipment specification, digital twins enable decreased physical commissioning times, reduced risk, increased reliability and lower costs throughout the manufacturing operations commissioning process, enabling faster ramp-up to operations and faster time to revenue.
