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Ventana de paso de sala limpia
Creado 07.08
Cleanroom Pass-Through Window
GMP-Compliant Material Transfer Solution
1. Product Overview
The cleanroom pass-through window is designed for material transfer between controlled environments, complying with EU GMP Annex 1 (2022) requirements for material transfer. CE certified and meets ISO 14644-1 Class 5-8 standards.
2. Key Features
- Airtight Isolation:
- Self-Cleaning:
- UV Sterilization:
- Pressure Monitoring:
3. Technical Specifications
Parameter | Standard | UV Version | Laminar Flow |
Material | 304 Stainless Steel (1.2mm thickness) |
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Cleanliness Class | ISO Class 5 |
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Air Velocity | 0.3-0.6m/s | 0.3-0.6m/s | 0.45±0.1m/s |
Sterilization Time | N/A | 0-999s adjustable | 0-999s adjustable |
Power Supply | AC220V±10%, 50Hz |
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4. Operation Protocol
Standard Operating Procedure:
- Ensure both doors are closed with proper pressure differential
- Load materials and close outer door to activate purification cycle
- Wait until green indicator lights (typically 30-120 seconds)
- Open inner door to retrieve materials and close immediately
Maintenance Requirements:
- Daily: Inspect door gaskets
- Monthly: HEPA filter pressure check (initial ΔP≤50Pa)
- Quarterly: Air velocity test (±15% tolerance)
- Annually: Third-party integrity testing
5. FAQs
- GMP requirements for pass-through windows?
- CE certification process details?
- How to validate cleanliness performance?
- HEPA filter replacement criteria?
- Required periodic tests?
Contacto
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