Nelson Laboratories has broken ground on an expansion project at its Salt Lake City headquarters that will double its cleanroom capacity and support growing demand for sterility assurance testing.

Designed to align with stringent EU GMP Annex 1 requirements, 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 and the project is expected to be completed 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.

Nelson Labs is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. The company serves more than 3,000 customers from 12 facilities in the United States, Mexico, Asia, and Europe, and offers over 900 laboratory tests as well as the expertise of Regulatory Compliance Associates. Nelson Labs supports customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety and quality assurance.