Guangzhou Cleanroom Construction Co., Ltd.
1、Definition of Enclosed Structure
An enclosed structure refers to the physical barriers that separate the controlled environment from the external surroundings in cleanroom and purification engineering applications. These structures are designed to maintain specific environmental conditions including temperature, humidity, air pressure, and particulate levels.
2、Key Components
The main components of an enclosed structure in purification engineering include:
| Component | Function | Material |
| Walls | Primary separation barrier | Sandwich panels, steel, glass |
| Ceiling | Air distribution and lighting support | Perforated panels, HEPA filters |
| Floor | Load bearing and cleanability | Epoxy, PVC, raised flooring |
| Doors & Windows | Access while maintaining separation | Air-tight designs with seals |
3、International Standards
Enclosed structures in cleanroom applications must comply with various international standards including:
- ISO 14644-1: Classification of Air Cleanliness
- ISO 14644-4: Design, Construction and Start-up
- EU GMP Annex 1: Manufacture of Sterile Medicinal Products
- FDA Guidance for Industry: Sterile Drug Products
4、Design Considerations
Key design factors for effective enclosed structures include:
- Air tightness to prevent contamination
- Material compatibility with cleaning agents
- Structural integrity under pressure differentials
- Modularity for future expansion
- Integration with HVAC systems
5、Importance in Purification Engineering
As a purification engineering company owner, I emphasize that the enclosed structure is the foundation of any controlled environment system. It directly impacts:
- Energy efficiency of the cleanroom
- Long-term maintenance costs
- Consistency of environmental parameters
- Compliance with regulatory requirements
- Product quality and process reliability