For biotech companies who must meet growing demand for smaller volume drugs and more personalized medicines, “flexible manufacturing” is the dominant approach. Thanks to modular design concepts – and advances in mobile and single-use technology – many have transitioned from large, dedicated production plants to agile, multiproduct “facilities of the future.”
But while progress has been impressive, single-use technology has introduced unique challenges – and risk – exacerbated by the industry’s highly regulated environment.
In single-use facilities, modular equipment and totes move continuously – both around the suite and from one suite to another. Operators must complete more diverse tasks, intervene regularly in the process, and react to the compressed batch cycle times intrinsic to limited product runs.
Within this fast-paced environment, what keeps manufacturers up at night are vexing, complex questions:
- How can I ensure the correct equipment is in each suite at the right time?
- Am I efficiently tracking the dozens of totes circulating throughout my facility?
- How do I minimize operator error?
Automation systems are used in a number of ways to improve equipment verification methods and decrease the potential for error. But now new technologies are emerging that promise to reduce the risks inherent to single-use technology even more.
A Dose of Reality
Virtual reality (VR) and augmented reality (AR) can combine with cameras, scanners and tried-and-true control strategies to take risk mitigation to a whole new level. Specifically, VR and AR can improve operator performance and training – and help optimize asset management.
Incidentally, VR can also help uncover human error in facility planning while there is still time to correct it. New technologies can translate building information modeling (BIM) into virtual reality experiences that uncover simple human oversights – like planning a 12-foot skid for a room equipped with a standard 10-foot doorway.
Improving Operational Knowledge
From an operational standpoint, transitioning to single-use technology is no easy task.
Many operators in single-use facilities began their careers in traditional stainless steel installations. Due to the high level of automation in those conventional facilities, operators may not have a clear understanding of the risks single-use technology introduces.
Improving operational knowledge is a critical goal. But training programs often fall short. Standard classroom settings simply cannot replicate real-world production scenarios.
Working hand-in-hand, VR and AR enable personnel to experience the production environment and manufacturing process – long before facility startup. And these technologies simplify equipment interactions once a process is up and running.