|
| 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 |
A cleanroom is a controlled workspace designed to minimize the introduction, generation, and retention of airborne contaminants, thereby protecting sensitive processes or products from particulate and microbial interference. It achieves this through an integrated system of architecture, HVAC, protocols, and monitoring.
| 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 |
Contaminant Prevention & Elimination
Primary mechanism: Controlled dilution and displacement.
Execution: HEPA/ULPA filtration coupled with laminar (unidirectional) or turbulent (mixed) airflow regimes.
Outcome: Continuous removal and suppression of both viable (microbial) and non-viable (particulate) contamination.
Environmental Process Stabilization
Primary mechanism: Precision regulation of thermodynamic and physical variables.
Execution: Real-time control of temperature, humidity, pressurization, and, when required, vibration and static dissipation.
Outcome: Creation of a predictable, repeatable process foundation, negating ambient environmental drift.
Spatial Containment & Risk Mitigation
Primary mechanism: Differential energy fields (air pressure gradients) and physical segregation.
Execution: Cascading pressure differentials (positive/negative), sealed construction, and dedicated airlocks.
Outcome: Isolation of critical processes, prevention of cross-contamination, and containment of hazardous materials or pathogens.
Protocol-Driven Human-Factor Engineering
Primary mechanism: Standardization and proceduralization of all interactions with the controlled environment.
Execution: Comprehensive gowning systems, material decontamination procedures, behavioral training, and defined workflows for personnel, materials, and waste.
Outcome: Mitigation of the single largest contamination vector: human activity.
Compliance-as-a-Function: Verification & Assurance
Primary mechanism: Data-driven performance validation.
Execution: In-situ particle counting, continuous environmental monitoring (pressure, temp/RH), and rigorous certification against standards (ISO 14644, GMP Annex 1).
Outcome: Objective, documented proof of environmental integrity for regulatory adherence and quality assurance.
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