The manufacturing of solid dosage forms—including tablets, capsules, and granules—demands rigorous contamination control to ensure product safety, efficacy, and regulatory compliance. Airkey, a premier modular cleanroom manufacturer in China, proudly announces the successful factory completion and testing of a turnkey ISO 8 cleanroom for a US-based pharmaceutical client specialising in solid dosage manufacturing.
Dedicated processing rooms for cross-contamination prevention
The cleanroom is strategically divided into three independent processing rooms, each dedicated to a specific stage of solid dosage manufacturing. This separation is critical for cross-contamination prevention in pharmaceutical production.
1. Granulation, milling & blending room
Purpose: initial processing where active pharmaceutical ingredients (APIs) and excipients are combined, granulated, milled and blended to achieve uniform particle size and content uniformity.
Critical parameters: humidity control is essential here, as moisture content directly affects granule flowability and tablet compression characteristics.
Separation: isolated from downstream processes to prevent cross-contamination between raw materials and finished dosage forms.
2. Tabletting room
Purpose: compression of granules or powder blends into uniform tablets using rotary tablet presses.
Critical parameters: temperature and humidity stability ensure consistent tablet hardness, weight uniformity and dissolution performance.
Separation: dedicated environment prevents cross-contamination from granulation or encapsulation activities.
3. Encapsulation room
Purpose: filling of powders, granules or liquids into hard gelatin or vegetarian capsules using automatic capsule filling machines.
Critical parameters: humidity control is particularly critical here, as gelatin capsules are hygroscopic and can become brittle or sticky outside the specified range.
Separation: independent room ensures no cross-contamination with tabletting or granulation operations.
HVAC system with pre-fabricated ducting
To maintain the required stable temperature and humidity of 20–24°C and 45–50% RH, the cleanroom is equipped with a purpose-designed HVAC system, including chiller, AHU, air ducts and water pipes.
Understanding that on-site ductwork fabrication can be time-consuming and prone to errors, Airkey implemented an innovative approach. Air duct sections are pre-fabricated in our factory to precise dimensions, reducing on-site assembly time. All connection adaptors like duct collars are manufactured and fitted in advance, ensuring perfect fit and airtight seals during installation.
Flush-mounted air return panels for energy efficiency
Recirculation design: return air is channelled back to the HVAC system for reconditioning and recirculation, rather than being exhausted.
Energy savings: by recirculating conditioned air, the system significantly reduces the energy required for heating, cooling and humidification.
Space optimisation: flush mounting eliminates protruding return columns, maximising usable floor space for equipment and personnel movement.
Seamless cleanability: smooth, flush surfaces are easy to clean and do not trap particles.
Intelligent control system for real-time monitoring
Air speed & volume regulation: operators can adjust air supply volume to meet specific process requirements. The system maintains required air changes per hour (ACPH) for ISO 8 classification and allows reduced airflow during non-production periods to save energy.
Temperature and humidity monitoring & control: continuous monitoring with automatic adjustment to maintain setpoints and alarm notification if values deviate.
Factory pre-assembly & testing: guaranteed performance
Before shipment to the United States, the complete modular cleanroom was assembled in Airkey's facility and subjected to rigorous factory acceptance testing (FAT).
This project demonstrates Airkey's capability to deliver high-quality, pre-validated cleanroom solutions for US pharmaceutical manufacturers producing solid dosage forms.
Whether for granulation, tabletting, encapsulation, or other oral solid dosage (OSD) processes, Airkey's modular cleanroom systems provide:
- Regulatory compliance (cGMP, ISO 14644-1)
- Cross-contamination prevention (separate processing rooms)
- Precise environmental control (20–24°C / 45–50% RH)
- Energy-efficient operation (recirculating air returns)
- Quick installation (pre-fabricated components)
- Intelligent monitoring (real-time control and monitoring)
