Robotics in the Aseptic Core: Rising Urgency, Rising Expectations

In part 1 of a multi-part video interview on day one at INTERPHEX 2026, CRB Fellows Todd Vaughn and Christa Myers discuss the expanding role of robotics and automation within aseptic and sterile pharmaceutical manufacturing, as well as what it means for operations and regulatory compliance.

Both experts note that robotics in the aseptic core is not a new phenomenon but that the pace and urgency have shifted considerably. As Myers explains, "This is not the first period of time that robotics have gone into the aseptic core, but we're seeing a lot more information about it right now, and regulatory is dramatically more interested in it now than they have been in the past." The driving force behind this regulatory interest is sterility assurance and, ultimately, patient safety, moving away from traditional fill lines for which personnel worked in close proximity to the product toward greater separation between operators and the final drug product.

Vaughn highlights that while the direction is clear, execution is complex. "It's not going to be straightforward right away, but it's a challenge I think the industry is ready to take on as a whole." Removing human operators from the process requires anticipating every possible failure scenario and engineering automated solutions to handle them, a significant upfront investment in both planning and cost.

Myers adds another layer of complexity: teams must now plan not just for expected interventions, but for unexpected ones, requiring deeper, earlier engagement in the design process. The industry's response has been a strong appetite for data, with manufacturers and design partners building robustness and data collection into facility and line designs from the outset.