2025-08-18
I. Definition and Overview
The Embedded Section Ventilation Cabinet (ESVC), also known as a laminar flow containment workstation, is a specialized clean air device designed for processes requiring localized particulate control. As defined by ISO 14644-1:2015 (Cleanrooms and associated controlled environments), it maintains ISO Class 5 (Federal Standard 209E Class 100) or better conditions within its work zone through unidirectional HEPA (High-Efficiency Particulate Air) filtered airflow.
II. Working Principles
1. Airflow Dynamics:
- Vertical laminar flow pattern (0.45 m/s ±20% velocity)
- 30% air recirculation with 70% fresh air make-up
- Dual-stage filtration: Pre-filter (G4 grade) + HEPA (H14 grade)
2. Contamination Control:
- Negative pressure plenum design
- Aerodynamic sealing at section joints
- Vaporized hydrogen peroxide (VHP) compatible surfaces
3. Automation Systems:
- PLC-controlled variable frequency drive (VFD) for fan motor
- Real-time particle monitoring (0.3-5.0 μm)
- Differential pressure alarms (visual/audible)
III. Core Functions
• Cross-contamination prevention (meets USP <800> hazardous drug handling requirements)
• Personnel/product protection (dual containment principle)
• Energy efficiency (30% lower consumption than conventional fume hoods)
• Compliance with:
- EU GMP Annex 1 (2022)
- FDA 21 CFR Part 11 (electronic records)
- NSF/ANSI 49-2022 (biosafety cabinets)
IV. Structural Characteristics
Component | Material Specification | Finish |
---|---|---|
Cabinet body | 304L stainless steel (1.2mm) | Electropolished (Ra ≤0.5μm) |
Work surface | 316L stainless steel (2.0mm) | Mirror finish |
Framework | Aluminum alloy 6063-T5 | Anodized |
View panel | Tempered glass (8mm) | Anti-static coating |
V. Technical Specifications
Parameter | Standard Model | Customized Options |
---|---|---|
Airflow volume | 1000-1500 m³/h | Up to 3000 m³/h |
Power consumption | 0.75 kW | 1.5-3.0 kW |
Noise level | ≤62 dB(A) | ≤55 dB(A) |
Filter efficiency | 99.995% @ 0.3μm | 99.9995% @ 0.1μm |
Work zone dimensions | 1200×600×700 mm | 2400×900×800 mm |
VI. Industry Applications
• Pharmaceutical: Aseptic filling, cytotoxic drug preparation
• Medical Device: Implant manufacturing, sterile packaging
• Biotechnology: Cell culture, PCR workstation
• Electronics: Semiconductor assembly, microelectronics
• Research: Nanomaterial handling, virology studies
VII. Installation Requirements
1. Minimum clearance: 300mm from walls
2. Dedicated electrical circuit: 220V/50Hz or 110V/60Hz
3. Ambient conditions:
- Temperature: 18-26°C
- Humidity: 30-60% RH
- Particulate count: ≤ISO Class 8 background
VIII. Maintenance Protocol
• Daily: Surface disinfection (70% IPA wipe-down)
• Monthly: HEPA filter integrity test (DOP/PAO challenge)
• Quarterly: Airflow velocity calibration
• Annual: Full electrical safety inspection
• Filter replacement: When ΔP reaches 250 Pa (pre-filter) or 500 Pa (HEPA)