Airkey partnered with a leading softgel capsule manufacturer to design and build a 485m² turnkey GMP-compliant modular cleanroom in China, providing design, construction and full-process GMP validation.
The facility features a precise ultra-low-humidity control system that maintains 35% ±10% RH, meeting strict pharmaceutical production requirements for hygroscopic softgel shells. The project demonstrates Airkey’s expertise in high-precision environmental control and GMP solutions for complex oral dosage manufacturing.
Project highlights
Scope and classification: 485 m² modular cleanroom, ISO 8 (Class D) throughout.
Purpose: Softgel capsule production with strict temperature and ultra-low humidity control to protect hygroscopic softgel shells and ensure product quality and yield.
Critical rooms (blister, encapsulation, sorting/polishing, printing): 18°C ±3°C, 35% ±10% RH, 25 air changes/hour (ACPH).
Support rooms (airlock, dispensing, gowning, WIP): 22°C ±3°C, 50% ±10% RH, Class D (ISO 8), 25 ACPH.
Key design & technical features
- Custom HVAC system engineered for stable super-low humidity control.
- Modular panel construction for fast, scalable installation and minimal disruption.
- Layout optimised to separate personnel and material flows to reduce cross-contamination.
- Flexible clearances (most areas 2.7 m ceiling; 4 m where large equipment is required).
GMP validation & compliance
- Full DQ/IQ/OQ/PQ validation performed to demonstrate that design, installation, operation and performance meet GMP requirements.
Successful official GMP validation achieved.
Advantages of choosing Airkey
cGMP expertise, precision environmental control (especially humidity), turnkey cleanroom delivery, and proven track record across softgel manufacturing, biopharma and other regulated industries.
Applications
Modular GMP cleanrooms suitable for pharmaceuticals, food, cosmetics, medical devices and biological products.
For more information, please contact www.airkeyx.com