Virtual Twin Validation In Drug Manufacturing

In the highly regulated pharmaceutical industry, validating that new machinery will operate as planned, and in strict compliance with regulations established to protect human health, is vital to delivering positive, predictable outcomes for patients. This was precisely the challenge faced when a major pharmaceutical company needed to commission a new machine to automatically fill syringes with precise amounts of medicine under precise manufacturing conditions.

The challenge was especially great because the tests had to account for the drug formulation process, fast filling, and robotized control stations, all installed in atmosphere-controlled areas. Ideally, therefore, the control system needed to be debugged and tested for the full variety of expected process operations before the machines were delivered and installed, to minimize disruption to existing operations.

Conducting the tests and calibration via virtual twins proved to be the answer, allowing all tests to be conducted and validated as the machine was being manufactured.

Beginning with the machine manufacturer’s documentation, Dassault Systèmes (3DS) created virtual twins of the machine and modeled its physical behavior. Simulations were created for pressures, temperatures and humidity inside the machine, and then to test the control systems’ ability to adjust its operation. Other factors simulated by the virtual twin included piping, hydraulic and electrical systems, handling, robotic and control systems.

The virtual environment, with the virtual machine in place, was then connected to the factory’s programmable logic controllers (PLCs, a common type of manufacturing computer) and supervisory control and data acquisition (SCADA) network, which would control the machine.

In this way, the pharmaceutical company was able to use the virtual twins to run formal qualification tests on the machine virtually. Virtual commissioning and testing also allowed the pharmaceutical company’s automation and operations team members to verify that production would run correctly in different scenarios. Everything learned during the process also gave the teams valuable experience in operating and controlling the machine, accelerating their readiness for production.

By eliminating issues before installation, 3DS estimates that virtual commissioning reduced the time needed to bring the machine into operation by two-thirds of what is typical for such complex, high-precision equipment.