|
| Brand Name: | SHP |
| Model Number: | Customized |
| MOQ: | 50 square meters |
| Price: | $500.00/square meters 50-499 square meters |
| Payment Terms: | L/C,T/T |
| Supply Ability: | ≥1 set |
According to ISO 14644-1, a cleanroom is "a room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room, and in which other relevant parameters (e.g., temperature, humidity, pressure) are controlled as necessary."
| Application | Pharmaceutical | Lab | Electronics |
| Cleanliness | China class 100 to 100000 | ISO 5 to 8 | EU B to D |
| Scope |
Structure part; Partition and ceiling panel; door and window,epoxy. |
HVAC part; AHU and chiller; Ducting and piping. |
Electrical part; Lamp,switch and socket; Distribution cabinet. |
| Service | Design and production | Construction and test | Validation and training |
| Wall/ceiling panel | Machine-made or Hand-made sandwich board |
| Clean room equipment | Air shower,FFU,Pass box,Laminar flow cabinet,hepa box |
| Cleanliness | Class 100-100000 |
| Purification system | HVAC, or AC conditioner+FFU |
| Floor | PVC anti-static floor or epoxy-based coating |
| Other addessores | stalinite window,LED panel light,Door,Hand wash sink,storage/shoe cabinet etc |
| Service | Design,manufacturing,construction |
Tier 1: Environmental Parameter Control
Function: Establish and maintain baseline physical constants
Air Purity Management: HEPA/ULPA filtration with real-time particulate monitoring
Thermodynamic Stability: Precision HVAC systems maintaining ±0.5°C temperature and ±5% RH humidity control
Pressure Differential Enforcement: Automated pressure cascades (15-30 Pa gradients between zones)
Tier 2: Contaminant Vector Management
Function: Intercept contamination at all transmission pathways
Aerodynamic Contamination Control: Unidirectional airflow at 0.45 m/s ±20% (ISO Class 5)
Surface-Borne Contaminant Mitigation: Non-shedding materials with cleanroom-grade surface finishes
Procedural Contamination Prevention: Gowning protocols with particle shedding limits (<10,000 particles/min for full suit)
Tier 3: Operational Process Control
Function: Standardize all interactions with the controlled environment
Material Flow Engineering: Three-stage airlock systems with interlocked doors
Personnel Contamination Control: Class-specific garment systems with validated donning procedures
Process Isolation: Modular cleanroom designs allowing separation of incompatible operations
Tier 4: Performance Verification Systems
Continuous Monitoring: Networked particle counters with 0.3μm and 0.5μm channels
Validation Protocols: ISO 14644-3 compliant testing (airflow uniformity, recovery testing)
Data Integrity Management: 21 CFR Part 11 compliant data logging and audit trails
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