Pharmaceutical Cleanroom Solutions

Unique Requirements and Standards​

• Strict classification: Divided into Grade A/B/C/D according to GMP. Grade A (ISO 5) is used for sterile preparation filling, while Grade D (ISO 8) is suitable for non-sterile API production.​

• Multi-parameter control: Temperature 18-26℃, humidity 45-65%, unidirectional airflow velocity in Grade A areas 0.36-0.54m/s, pressure differential gradient ≥10Pa.​

• Compliance requirements: Must meet WHO GMP, FDA cGMP and China GMP. Regular environmental monitoring (viable airborne particles, settleable bacteria, surface microorganisms) is required.​

Core Solutions​

Air Purification System​

• Filtration system: Three-stage filtration of primary (G4) + medium (F8) + high efficiency (H14) filters. Grade A areas adopt 100% fresh air with full exhaust.​

• Airflow organization: Grade A areas are fully covered with HEPA filters. Grade B areas use non-unidirectional airflow with air change rate ≥20 times/hour.​

• Disinfection system: Integrated VHP (vaporized hydrogen peroxide) sterilization, with qualified biological indicator challenge (spore kill rate ≥6 log).​

Contamination Prevention Measures​

• Personnel management: Dedicated gowning process (first change → second change → air lock). Grade A areas require sterile coveralls + breathing masks.​

• Material control: Raw materials enter through sterile pass-through boxes. Primary packaging materials need online sterilization (dry heat/moist heat).​

• Equipment design: Surfaces in contact with pharmaceuticals use 316L stainless steel, with welded and polished Ra ≤0.8μm, no dead corners.​

Lean Operation Strategies​

• Real-time monitoring: Online particle counters (recording every 30 minutes), continuous temperature and humidity tracking, automatic alarm for exceeding standards.​

• Energy-saving solutions: Adopt variable frequency air handling units + heat recovery devices, and reduce frequency during non-production periods (energy saving ≥25%).​

• Maintenance plan: HEPA filter leak detection annually, quarterly verification of air conditioning systems, full-item testing of process water weekly.​

Future Trends​

• Modular construction: Prefabricated cleanroom components, installation cycle shortened by 40%, meeting flexible production needs.​

• Digital upgrading: Environmental data traceability based on MES system, AI predicts filter lifespan.​

• Green certification: Use low-carbon materials, reuse wastewater/waste gas after reaching standards, reduce environmental load.​

Pharmaceutical cleanrooms need to balance sterility assurance and production efficiency. Through strict hierarchical management, advanced purification technology and intelligent operation, they provide a core barrier for pharmaceutical quality.​