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Pharmaceutical Cleanroom Solutions

Created on 2025.07.31
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 require online sterilization (dry heat/moist heat).
  • Equipment design: Surfaces in contact with pharmaceuticals utilize 316L stainless steel, with welded and polished Ra ≤0.8μm, ensuring no dead corners.
Lean Operation Strategies
  • Real-time monitoring: Online particle counters (recording every 30 minutes), continuous temperature and humidity tracking, with automatic alarms for exceeding standards.
  • Energy-saving solutions: Implement variable frequency air handling units + heat recovery devices, and reduce frequency during non-production periods (achieving energy savings ≥25%).
  • Maintenance plan: Annual HEPA filter leak detection, quarterly verification of air conditioning systems, and weekly full-item testing of process water.
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)
1. Do Food Processing Facilities Need Cleanrooms?
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3. In-depth Analysis of the Specifications of High-Efficiency Air Supply Outlets and Their Corresponding Air Volumes
4. Global Cleanroom Cooperation Proposal
5. Unlocking the Outstanding Mysteries of the FFU Test Bench
6. Calculation Method of Cooling Capacity in Clean Room
7. The Selection of Air Conditioning Control Systems for Cleanrooms
8. Convenient Food Factory Pass Windows: Strengthening Food Safety Barriers and Significantly Boosting Production Efficiency with a Core Solution
9. What is an Air Shower? Understand How It Purifies Air in One Article
10. Common Issues and Solutions for Food Factory Changing Rooms
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