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Reading: Nelson Labs Doubles Sterility Testing Capacity with Major Cleanroom Expansion
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Global Regulations

Nelson Labs Doubles Sterility Testing Capacity with Major Cleanroom Expansion

Last updated: June 17, 2025 3:20 am
Published: 9 months ago
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The strategic expansion in the Salt Lake City Headquarters will meet stringent EU GMP Annex 1 requirements.

Nelson Laboratories announced the groundbreaking of a major cleanroom expansion project at its global headquarters in Salt Lake City, UT. The expansion will double the lab’s existing ISO-classified cleanroom capacity, supporting growing demand for sterility assurance testing and reinforcing Nelson Labs’ role as a trusted partner to pharmaceutical and medical device manufacturers navigating evolving global regulations.

Designed to align with the stringent requirements of EU GMP Annex 1, the new space reflects Nelson Labs’ continued emphasis on contamination control, rigorous environmental controls, and disciplined facility oversight. Key enhancements include a new isolator suite, zoned HEPA filtration to reduce contamination risk, and upgraded laminar airflow systems to accommodate larger and more complex sample configurations. The expansion also prioritizes testing efficiency and accelerated turnaround times to support manufacturers in navigating increasingly complex supply chains.

“Our new cleanroom is designed to meet the rigorous standards of EU GMP Annex 1, which emphasize tight engineering controls, aseptic technique, and robust quality systems,” said Zachary Anderson, Senior Director of Salt Lake City Laboratory Operations at Nelson Labs. “This expansion is a direct response to our customers’ needs and ensures our ability to support their sterility testing programs now and in the future.”

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