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.​

Pharmaceutical Cleanrooms & GMP Basics Questions
1.What is a Pharmaceutical Clean Room?
2.What is a Clean Area in the Pharmaceutical Industry?
3.What is a Clean Room in GMP?
4.What is a Clean Room in a Pharmacy?
Cleanroom Standards & Classifications
5.What are the Cleanroom Standards for Pharmaceuticals?
6.What is the FDA cGMP for Pharmaceuticals?
Cleanroom Equipment & Applications
7.What is a Downflow Booth in the Pharmaceutical Industry?
8.What is the Role of Clean Room Panels in the Pharmaceutical Industry?
Importance of Cleanrooms in Pharma
9.Why are Clean Rooms Important in the Pharmaceutical Industry?
GMP & cGMP in Pharmaceuticals
10.What is GMP and cGMP in Pharma?
For further inquiries, please consult the sales team.