GMP Cleanroom Engineering for a Leading Pharmaceutical Manufacturer
Project Challenges
The client requires an oral solid dosage facility compliant with the latest GMP certification standards, featuring Grade B background with Grade A local protection. The environment demands precise control of temperature and humidity (Temperature: 22±1°C, Humidity: 45±5%). Multiple production lines operate simultaneously within the facility; therefore, personnel and material flow paths must be clearly segregated to prevent cross-contamination.
Solutions
Adopts a three-stage filtration system (G4+F9+H14) with constant temperature and humidity air handling units, and installs laminar flow hoods in critical areas. Optimizes duct layout using BIM technology to ensure proper airflow organization. Personnel passages include air showers and changing rooms; material passages feature pass-through windows and buffer rooms. During implementation, construction quality and schedule are strictly controlled. All welding processes use TIG welding to ensure internal pipe cleanliness.
Project Outcomes
The project passed GMP certification on the first attempt, with all metrics exceeding design requirements. Parameters such as cleanroom cleanliness, temperature and humidity, and pressure differentials remained stable and within specifications, earning high praise from the client. After delivery, the client's production efficiency increased by 30%, and the product pass rate rose to over 99.5%.
Project Site
Use Product
- High-efficiency Filter H4
- Medium Efficiency Filter F9
- Initial Filter G4
- HVAC Unit
- Laminar Flow Hood
- Air Shower
- Pass-through window