Editor’s Note: The following blog post summarizes an article that originally appeared in Pharma Manufacturing Magazine (September 19, 2023).
Equipment qualification is an important process in modern-day life sciences manufacturing because it ensures that the equipment used in the production of drugs and other products meets the quality standards and regulations required by the authorities.
When we think of equipment today, we do not picture something basic. Instead, we think of a complex system that is efficient, compact, and compliant but also autonomous and connected (with IIoT, data lakes, smart analytics technologies, and more). The notion of equipment sitting stationary on the shop floor has been replaced by equipment that can change manufacturing dynamics.
The Future of Equipment Qualification
While we see more demand for equipment connected to the internet or within a company’s data servers, we also see an uptick in the workload added to the validation team to deliver the equipment on time. As equipment continues to increase in complexity, qualifying it becomes more complex.
Asking some obvious questions about managing the commissioning and qualification of such systems is crucial. For instance:
- How can we reduce costs and save time during product design?
- How complicated will it be to qualify such equipment?
- How do we simulate the failure mode of the equipment or its computer system?
- How do we tap into the potential of process optimization to reduce variance and predict maintenance issues?
- How do we simulate test conditions without impacting the delivery schedule?
- How do we ensure equipment does not fail during real-time operation?
- Can the system automatically generate data for all predefined tests and manage all iterations that have occurred during system design?
The answers to these questions lie within one of the more recently recognized technologies ― the digital twin.
Digital Twin Technology in Equipment Qualification
A digital twin is a virtual representation of a physical asset, system, or process. It uses real-time data from sensors, advanced analytics, and modeling techniques to create a virtual counterpart of the physical equipment. This digital twin can monitor, analyze, and optimize the equipment's performance; troubleshoot issues; or simulate various scenarios without affecting the actual system.
Several applications of digital twin technology exist for qualification and validation in the pharmaceutical industry, specifically in design and simulation, virtual qualification, process validation, predictive maintenance, regulatory compliance, and training and optimization.
Although this technology is gaining popularity in many sectors, it is still in the early stages of adoption in pharma. By incorporating data and information throughout the lifespan of the equipment, it is possible to exchange it with other digital twin simulators and programs. These connections and interactions make the digital twin a vital decision-making source during the equipment’s lifetime.
The Benefits of Digital Twin
By utilizing digital twin technology for qualification and validation, pharma manufacturers can reap many benefits, including:
- Real-time monitoring: Digital twin technology allows pharma companies to continuously monitor equipment during validation. This real-time monitoring enables them to detect deviations and anomalies, ensuring prompt corrective actions and reducing the risk of manufacturing defects.
- Enhanced data analytics: The pharmaceutical industry can gain deeper insights into equipment behavior and performance by integrating various data streams into the digital twin model. Data analytics help identify patterns, predict potential failures, and optimize equipment settings for improved efficiency and reliability.
- Cost and time savings: Traditional equipment validation processes involve considerable time and expenses. Digital twin technology reduces the timeline for creating physical prototypes, accelerates the validation timeline, and minimizes the need for costly trial-and-error approaches.
- Risk reduction: Pharma companies must adhere to strict regulatory requirements. Digital twin technology can help lower risks by ensuring that equipment complies with the necessary regulations and guidelines from the outset.
- Process simulation: Digital twin enables the simulation of different operational scenarios without interrupting actual production. This capability allows manufacturers to assess how equipment responds to varying conditions, helping to optimize processes and avoid potential downtime.
- Predictive maintenance: By continuously monitoring equipment performance, digital twin technology can predict when maintenance is required, reducing the chances of unexpected breakdowns and unplanned production interruptions.
Digital twin technology offers significant advantages for equipment validation in the pharmaceutical industry. By providing real-time monitoring, enhanced data analytics, and the ability to simulate different scenarios, it streamlines the validation process, reduces costs, and improves the overall reliability of pharmaceutical manufacturing equipment.
As the technology continues to evolve, its adoption is expected to become more widespread, transforming how pharmaceutical companies validate their equipment and ensuring they remain at the forefront of compliance and quality standards.
Read the full Pharma Manufacturing article to learn how digital twin technology can streamline and enhance your equipment validation processes.