The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
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Benefits of Our New Cleanroom

EU GMP Annex 1 Alignment

With an optimized layout and state-of-the-art equipment, the cleanroom aligns with Annex 1 to support reliable testing outcomes.

Robust Contamination Control

Unidirectional flow for personnel and materials, restricted access, touchless entry, and strategic passthroughs help ensure aseptic processes.

Operational Continuity

Two independent cleanroom wings with expanded testing capacity allow maintenance or requalification to occur without shutting down operations, helping customers avoid unnecessary delays and maintain testing timelines year-round.

Visibility and Oversight

An audit-friendly design, integrated viewing windows, continuous monitoring, and enhanced recording capabilities enable rigorous investigations and quality audits.

Get a glimpse into our new cleanroom.

Two laboratory workers in full protective hazmat suits looking at a tablet in a cleanroom hallway

Expert Support Behind Every Test

Infrastructure alone isn’t enough to ensure reliable outcomes. Nelson Labs combines this purpose-built environment with experienced microbiologists, established quality systems, and cross-functional expertise. If your team is scaling production, addressing Annex 1 expectations, or preparing for regulatory review, Nelson Labs is ready to support you.

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Resources

Learn more about sterility testing.
Podcast

The Value in Partnering for Sterility Testing

Sterility testing is a critical part of demonstrating medical device safety, but navigating testing requirements, regulatory expectations, and product-specific challenges can be complex. In this episode of MPO's Medtech Matters...

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On-Demand Webinars

Advancing Microbial-Contamination Detection Through Rapid Sterility Testing

Increasing industry and product demand for expedited product release reinforces the need to embrace rapid sterility technologies. Nelson Labs is pleased to introduce the implementation of the Celsis® Advance II...

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On-Demand Webinars

Designing an End-to-End Sterility Assurance Program

Sterility assurance for a pharmaceutical product is critical, and includes many aspects outside of the actual sterilization cycle or aseptic process. There is some recent movement in the health care...

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