Nelson Laboratories, a global provider of microbiological and analytical testing services for the medical device and pharmaceutical sectors, has started a major cleanroom expansion project at its headquarters in Salt Lake City, Utah, US.
The development will double the company’s current ISO-classified cleanroom capacity in response to increasing demand for sterility assurance services and the evolving requirements of international regulatory frameworks.
Construction of the expanded cleanroom space is now underway and is scheduled for completion in 2026.
Nelson Labs has confirmed that sterility testing services will remain fully operational throughout the build, with existing capacity in place to support ongoing and new client projects without disruption.
The development will double the company’s current ISO-classified cleanroom capacity
The expanded facilities are being specifically designed to comply with the rigorous expectations of EU GMP Annex 1, which governs the manufacture of sterile medicinal products in the European Union and has recently undergone significant revision.
The project will incorporate enhanced contamination control measures, including a new isolator suite, zoned HEPA filtration to mitigate contamination risks, and upgraded laminar airflow systems capable of supporting more complex and varied sample configurations.
Zachary Anderson, Senior Director of Salt Lake City Laboratory Operations at Nelson Labs, commented: “Our new cleanroom is designed to meet the rigorous standards of EU GMP Annex 1, which emphasise tight engineering controls, aseptic technique, and robust quality systems. This expansion is a direct response to our customers’ needs and ensures our ability to support their sterility testing programmes now and in the future.”
The expansion will also focus on improving testing efficiency and turnaround times, enabling pharmaceutical and medical device manufacturers to manage increasingly complex global supply chains.
The expanded facilities are being specifically designed to comply with the rigorous expectations of EU GMP Annex 1
The development represents a strategic investment in scalable, regulatory-aligned infrastructure, positioning the company to address future market challenges.
Founded over 40 years ago, Nelson Labs offers sterility, microbiology, and analytical laboratory services to customers worldwide.
The company’s headquarters in Salt Lake City serves as its primary operational hub and centre of technical expertise.
