Nelson Labs Increasing Cleanroom Capacity To Support Increasing Demand For Sterility Assurance Services

Strategic Expansion in Salt Lake City Headquarters Will Meet Stringent EU GMP Annex 1 Requirements

Salt Lake City, UT — Nelson Laboratories, a global leader in microbiological and analytical testing services for the medical device and pharmaceutical industries, today announced the groundbreaking of a major cleanroom expansion project at its global headquarters in Salt Lake City, Utah. 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 to navigate 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.”

For 40 years, Nelson Labs has delivered high-integrity sterility testing solutions to the life sciences sector, combining technical depth with customer-centered service. This expansion not only supports current growth but also enables Nelson Labs to meet future challenges with scalable, regulatory-aligned infrastructure.

Construction is underway, with project completion anticipated in 2026. Cleanroom testing services will remain fully operational throughout the build, and existing capacity is available to support ongoing and new projects without interruption. To schedule sterility assurance testing or explore our full range of services, visit nelsonlabs.com.

About Nelson Labs:

Nelson Labs is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. We serve over 3,000 customers from 12 facilities in the United States, Mexico, Asia and Europe and offer a comprehensive array of over 900 laboratory tests along with the expertise of Regulatory Compliance Associates, a recognized leader in regulatory consulting for the life sciences industry. We support our customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety and quality assurance. We are regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues.