Inconsistent sterility testing results can introduce risk to product release and regulatory review.
Nelson Labs’ purpose-built cleanroom suite was designed to provide consistent, reliable results so you can move forward with confidence.
The cleanroom was designed to align with Annex 1 to support high-quality testing and efficient throughput for consistent release timelines. With optimized layouts, expanded hood capacity, and next generation equipment, the layout and infrastructure enable testing to scale without compromising quality.
Unidirectional flow for personnel and materials, restricted access, touchless wave-to-open doors, and passthroughs support controlled movement through the cleanroom and preserve the integrity of the testing environment.
Two independent cleanroom wings allow maintenance or requalification to occur without shutting down operations, helping you maintain testing timelines and avoid unnecessary delays year-round.
Continuous monitoring, integrated viewing windows, enhanced recordings, and an audit-friendly design support real-time oversight and provide the documentation needed for investigations and regulatory review.
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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