Medical Equipment & Operating Room Cleanroom Solutions
创建于06.27
Medical Equipment & Operating Room Cleanroom Solutions
Precision Environments for Healthcare
Modern medical facilities require cleanrooms that meet stringent standards for:
- Implant manufacturing
- Surgical suites
- Pharmaceutical compounding
- Diagnostic equipment
Key Design Requirements
1. Operating Room Specifications
Parameter | Standard | Our Solution |
Airflow | ≥0.25 m/s laminar | 0.30 m/s ±5% controlled flow |
Particles (0.5μm) | ≤3,520/m³ (Class 5) | ≤1,000/m³ typical performance |
Pressure Differential | +2.5 Pa minimum | +5 Pa maintained |
2. Medical Device Manufacturing
- Material compatibility
- ESD protection 10⁶-10⁹ ohm
- Cleanability 50mm
Regulatory Compliance
All designs comply with:
- FDA 21 CFR Part 820 (Quality System Regulation)
- ISO 13485:2016 (Medical Devices)
- EU MDR 2017/745 (Medical Device Regulation)
Case Example: Orthopedic Implant Facility
- Challenge
- Solution
- Unidirectional airflow with 400 ACH
- Pass-through decontamination chambers
- Result
Implementation Process
- Risk assessment
- Design validation
- Certification
Maintenance Requirements
- Daily
- Monthly
- Annual
Contact
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