Fellow
Aseptic & Sterile Products
CRB Group

Todd Vaughn

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

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

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

 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?

 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?

 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.

 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?

 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.

 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?

 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.

 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.

Articles

Regulatory scrutiny is accelerating adoption of robotics in aseptic manufacturing, shifting expectations toward minimizing human interventions and increasing separation between operators and product. Automation offers major efficiency gains, particularly for environmental monitoring plate changes that currently force line stoppages. Trade-offs include higher capital costs, longer lead times, and substantially more front-end engineering to codify human judgment and manage unplanned interventions. Workforce needs will pivot toward higher technical competency and expanded sterile support roles. The sector is nearing a tipping point where automation becomes standard, challenging legacy lines and smaller manufacturers.

Todd Vaughn and Christa Myers of CRB discuss how robotics are reshaping aseptic pharmaceutical manufacturing, improving efficiency, repeatability, and compliance while demanding new operator skills and capital investment.

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

Todd Vaughn and Christa Myers, CRB, discuss how Robotics are reshaping aseptic pharmaceutical manufacturing, improving efficiency, repeatability, and compliance while demanding new operator skills and capital investment.

rising automation in aseptic manufacturing and growing regulatory focus on sterility.

, Todd Vaughn and Christa Myers, Fellows of Aseptic and Sterile Products at CRB, speak with 

to discuss their panel discussion on the growing role of robotics and automation within the aseptic core of pharmaceutical manufacturing. Their conversation covers where the industry stands today, the opportunities automation presents, and what challenges lie ahead.

Both speakers highlight environmental monitoring, specifically, the automated handling of plates and monitors. As Myers notes, "Every time you stick your hand in a glove to change a plate, which sometimes happens every hour, sometimes happens every two hours, you have to stop your fill line, which means you have to stop production, which means you have to stop manufacturing." Automating this step, she argues, could significantly restore efficiency to fill lines and should have been done years ago.

Beyond environmental monitoring, both emphasize the value of robotics in equipment setup and component handling, citing improved repeatability and reduced reliance on human consistency. However, they are clear that automation doesn't mean fewer people; it means different people with different skills. Operators will need deeper technical knowledge, including mechanical and electronics training, while upstream areas like component prep and sterilization may actually require more staff.

Regulatory expectations are also shifting. As Todd Vaughn states, "Continuous improvement is what's expected now" and operators must be prepared to track trends and demonstrate risk mitigation when regulators come calling. Looking ahead, Vaughn describes the industry as being "right on the edge of novel use to expected use," anticipating that older lines could soon face scrutiny as fully automated systems become the new standard. Vaughn and Myers stress that the industry must also find ways to bring smaller, less-capitalized companies along for this transition, because their contributions to patients remain just as vital.

Videos

Todd Vaughn and Christa Myers discuss how Robotics are reshaping aseptic pharmaceutical manufacturing by improving efficiency, repeatability, and compliance while demanding new operator skills.

At INTERPHEX 2026, Todd Vaughn and Christa Myers of CRB Group discuss rising automation in aseptic manufacturing and growing regulatory focus on sterility.

In part 1 of a multi-part video interview on day one at 

, 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.