Insights

Quality to the Core: A Conversation with Jeremy Huotari

Drawing on a proven Quality Management System that has been built over decades to support drugs, biologics, medical devices, and combination products, Lifecore has a strong, 40+ year global quality and regulatory track record.

Quality in pharma manufacturing isn’t just about procedures or training—it is built into the very spaces where work happens. Cleanroom design plays a critical role in protecting both product quality and employee safety. We recently spoke with Jeremy Huotari, Staff Project Manager, whose work sits at the intersection of facility design, manufacturing needs, and regulatory expectations. With more than three decades at Lifecore, Jeremy offers an insider’s view into what it really takes to design, expand, and maintain cleanrooms that support aseptic manufacturing—sometimes while production continues around them.

Can you start by describing your area of responsibility?

I manage cleanroom and equipment projects, with a significant focus on cleanroom design and development. This includes early conceptual layouts, detailed design input, and coordination of capital equipment projects. Much of my work centers on understanding how manufacturing processes function within a cleanroom—integrating people, materials, equipment, and utilities in a way that supports quality, compliance, and reliable operations.

Some people may assume cleanrooms are simply purchased or installed by outside vendors. What role does Lifecore play internally?

It really starts internally. When new clients come on board or capacity needs change, we first work to fully understand the manufacturing process that will take place in the cleanroom. From there, we develop internal user requirements—quality expectations, operational needs, and regulatory considerations—while accounting for the physical space of our existing facility. We also plan beyond immediate needs by considering future growth and how changes may impact ongoing operations. After this internal groundwork is complete, we engage architects and consultants, remaining handson throughout the process to ensure the final design meets operational, quality, and longterm business needs.

How does working with experienced architecture and construction partners support quality?

It makes a huge difference. Our partners understand that design decisions directly impact product quality. They understand why things like sloped surfaces, sealed penetrations, and smooth finishes are essential. Plus, they understand how to work in an environment where cleanrooms are operating all around them since facility updates can occur adjacent to active manufacturing areas. This is where careful planning, a phased approach, and experienced teams really matter.

Smoke studies are something people often find fascinating. How are they used?

Smoke studies allow us to visually confirm that airflow in critical Grade A filling areas behaves as intended. By introducing smoke, we can visually assess airflow behavior—confirming unidirectional or laminar flow and identifying any turbulence or flow disturbances that could allow particles to remain in the critical zone. This provides strong visual evidence that the design effectively directs air to protect the critical zone.

How do operator comfort and safety factor into cleanroom design?

They are incredibly important. Cleanroom operators must work carefully and consistently, often for long periods of time. That means designing for ergonomics, appropriate temperatures, and clear movement paths. A well-designed cleanroom supports the people working in it, which directly supports product quality and operational consistency.

What are the biggest takeaways you would want others to understand about cleanroom design?

Quality is built in long before a product is ever manufactured. Cleanroom design is one of those behind-the-scenes areas where every decision—no matter how small—can have a lasting impact on product quality and patient safety.

Also, a cleanroom isn’t just a room—it’s a system. Everything from airflow to personnel movement and cleaning practices has to work together to protect the product. Over time, you develop a deeper understanding of how small design choices affect daily operations, and those insights really only come from experience.