Q&A: Christa Myers and Todd Vaughn Discuss Robotics in Aseptic Manufacturing

At INTERPHEX 2026, PharmTech connected with Todd Vaughn, fellow, Aseptic & Sterile Products, and Christa Myers, senior fellow, Aseptic and Sterile Products, both at CRB Group, to discuss the growing role of robotics and automation in sterile pharmaceutical manufacturing and what it means for the industry's future.

Watch the 2-part video interview with Vaughn and Meyers:
Part 1: Robotics in the Aseptic Core: Rising Urgency, Rising Expectations

Part 2: Todd Vaughn and Christa Myers on What Robotics Mean for Pharma Manufacturing

PT: Why Is Robotics in the Aseptic Core Such a Hot Topic?

Vaughn: Robotics in aseptic manufacturing isn't new; equipment using robotics has existed for the last 10 to 15 years in this part of our industry. What's changed is the regulatory posture. Regulators are dramatically more interested in it now than they have been in the past, and they're pushing the industry to move further away from personnel manipulations associated with the process: How do we minimize human interaction all the way back from traditional fill lines, to now having greater separation between operators and the final patient?

Myers: And it's a fantastic opportunity. One area I'm particularly excited about is environmental monitoring—the handling of plates and monitors inside the aseptic environment. That should have been the first thing we automated. We could have done it 20 years ago. Every time an operator sticks a hand in a glove to change a plate, you have to stop the fill line, which means stopping production entirely. Robotic replacement is going to drive meaningful efficiency back into the line.

What Trade-offs Does the Industry Need to Prepare for?

Vaughn: The upfront work becomes significantly more challenging. When you remove personnel from the process, you have to identify every single thing that could possibly go wrong and figure out how to replicate what an engineer or operator would do across an entire batch operation. You're essentially encoding human judgment into automated systems, and that's not a small task.

Myers: We've always been able to plan for interventions. Now we have to plan for unplanned interventions. It means thinking much deeper about your process and doing that work much earlier in the design phase. On top of that, the price tags on these fill lines are going up, and so are the lead times. Robustness has to be built in from the very beginning.

How Does this Shift Affect the Workforce?

Myers: The operator knowledge base is likely to change significantly. In some cases, operators may actually need a greater understanding of operations than before. And the shift isn't limited to the aseptic core. We're going to need more people in component prep, parts prep, and sterile operations to facilitate cleaning and sterilization of rapid transfer ports and other components feeding into automated fill lines. There's a real workforce shift coming, and companies need to get ahead of it.

Vaughn: Regulatory expectations are evolving too. The days of a site being grandfathered in are over. Continuous improvement is what's expected now. Operators and administration staff need to be tracking trends, and when regulators show up, you need to know your data and know where your highest risks are and how you're mitigating them.

Where Does the Industry Stand on the Adoption Curve?

Myers: We're right on the edge between novel use and expected use. The first fully automated lines are coming off manufacturing floors now and will be installed at operating companies soon. That's going to drive more regulatory commentary, and as those next-generation lines follow, probably a year behind, regulatory expectations will shift again. Lines that are 10 or 15 years old could become suspect, much like what happened during the transition from restricted access barrier systems to isolators.

Vaughn: One concern I have is for smaller companies. Larger organizations have the capital to push these designs forward, but smaller manufacturers are going to face real challenges keeping up. Our industry needs to figure out how to bring those companies along by finding solutions that are well-funded and accessible. Those companies are just as valuable to patients, and in many cases they're the seed that larger companies eventually acquire. We can't leave them behind.