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How Airkey Built an ISO 6 Modular Cleanroom for Neutron Generator Manufacturing
2026-07-06
Cell therapy manufacturing requires highly controlled environments to protect sensitive biological materials and maintain consistent production quality.
Airkey designed and manufactured a 178㎡ ISO 7 modular cleanroom for a cell therapy laboratory in the USA. The solution was engineered according to U.S. cGMP, FDA, and USP requirements, integrating pharmaceutical-grade HVAC systems, SS316 stainless steel structures, and customized room layouts.
The modular laboratory provides a reliable environment for advanced pharmaceutical research and cell therapy applications.
| Item | Specification |
|---|---|
| Project | Cell Therapy Lab Modular Cleanroom |
| Location | USA |
| Industry | Pharmaceutical |
| Cleanliness | ISO Class 7 |
| Area | 178㎡ |
| Internal Size | 15300 × 11600 × 2450 mm |
| Series | Light Series |
Cell therapy laboratories require precise environmental control to minimize contamination risks and maintain biosafety.
The cleanroom must provide:
Airkey's modular cleanroom design integrates these requirements into a prefabricated pharmaceutical laboratory solution.
The cleanroom was designed and manufactured according to U.S. cGMP, FDA, and USP requirements.
Factory pre-assembly and testing ensure cleanliness classifications are achieved before delivery, improving project quality control and installation efficiency.
The ISO 7 cell therapy laboratory uses a precision HVAC system designed for pharmaceutical applications.
The system provides accurate control of:
Air passes through primary and intermediate filtration before final purification through terminal H14 HEPA filters.
The cleanroom utilizes an SS316 stainless steel framework.
This material provides:
The structure meets stringent pharmaceutical industry requirements.
Airkey provides customized room layouts and cleanliness classifications based on specific laboratory processes.
This flexibility allows cell therapy facilities to optimize workflows and adapt the cleanroom according to future production requirements.
✓ ISO 7 pharmaceutical modular cleanroom
✓ Designed for cell therapy applications
✓ cGMP, FDA, and USP-oriented design
✓ H14 HEPA filtration system
✓ SS316 stainless steel framework
✓ Fully customized laboratory layout
✓ Factory-prefabricated modular construction
The completed ISO 7 modular cleanroom provides a stable and compliant environment for cell therapy laboratory operations.
Through GMP-oriented engineering, advanced HVAC control, and pharmaceutical-grade materials, Airkey delivered a flexible modular laboratory solution designed for advanced biotechnology applications.
ISO 7 environments provide controlled contamination levels suitable for many pharmaceutical and biotechnology manufacturing processes.
SS316 offers strong corrosion resistance and supports frequent cleaning and sanitization requirements.
Yes. Modular construction allows future layout changes and expansion with minimal disruption.
