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Pharmaceutical Cleanroom Solutions
Created on 07.31
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.
Frequently Asked Questions (FAQ)
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