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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.
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.
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