Advanced GMP Modular Laboratory Solution for Cell Therapy Applications
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.
Project Overview
| 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 Cleanroom Engineering Requirements
Cell therapy laboratories require precise environmental control to minimize contamination risks and maintain biosafety.
The cleanroom must provide:
- Stable temperature and humidity control
- Reliable pressure management
- High-efficiency air filtration
- Easy cleaning and sanitation
- Flexible laboratory zoning
Airkey's modular cleanroom design integrates these requirements into a prefabricated pharmaceutical laboratory solution.
Airkey Engineering Solution
GMP-Compliant Modular Laboratory Design
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.
Pharmaceutical-Grade HVAC System
The ISO 7 cell therapy laboratory uses a precision HVAC system designed for pharmaceutical applications.
The system provides accurate control of:
- Temperature
- Humidity
- Pressure
Air passes through primary and intermediate filtration before final purification through terminal H14 HEPA filters.
SS316 Corrosion-Resistant Framework
The cleanroom utilizes an SS316 stainless steel framework.
This material provides:
- Excellent corrosion resistance
- Easy cleaning and sanitization
- Reduced contamination risk
The structure meets stringent pharmaceutical industry requirements.
Fully Customized Laboratory Layout
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.
Key Project Features
✓ 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
Project Results
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.
FAQ
Why are ISO 7 cleanrooms used in cell therapy?
ISO 7 environments provide controlled contamination levels suitable for many pharmaceutical and biotechnology manufacturing processes.
Why use SS316 in pharmaceutical cleanrooms?
SS316 offers strong corrosion resistance and supports frequent cleaning and sanitization requirements.
Can modular cell therapy laboratories be expanded?
Yes. Modular construction allows future layout changes and expansion with minimal disruption.
