Shenzhen Meiri Purification Technology Co., Ltd.
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Pharmaceutical Grade Laminar Flow Hood | H14 HEPA 99.9995% Efficiency & UV Sterilization for Aseptic Processing
Pharmaceutical-grade laminar flow hood featuring liquid-trough sealing technology and H14 HEPA filtration (99.999% @0.3μm). Validated for ISO 14644-1 Class 5 compliance in sterile filling applications.
| Parameter Name | Value |
|---|---|
| Main Body Material | Stainless steel 304# sandblasted plate, 1.0mm thickness |
| HEPA Filter Specifications | 1100+500×93mm H14 (99.9995% efficiency @0.3μm) |
| Fan Configuration | Aluminum alloy impeller low-noise fan, 200W 50Hz |
| Pressure Differential Monitor | Digital gauge 0-500Pa (±1% accuracy) |
| Detection Port | Integrated DOP test kit port |
| UV Sterilization | Optional 36W germicidal UV-C lamp (254nm wavelength) |
| Air Velocity | 0.45–0.75 m/s adjustable |
| Noise Level | ≤60 dB(A) at 1m distance |
| Control Interface | Touchscreen display with real-time monitoring |
Pharmaceutical-Grade Containment
Liquid-trough sealing technology creates an absolute barrier against cross-contamination
Exceeds ISO 14644-1 Class 5 standards with 99.999% particle retention at 0.3μm (H14 HEPA)
Advanced Sterility Assurance
Integrated ethanol reservoir maintains continuous liquid seal (validated per EU GMP Annex 1)
Optional UV-C system provides 6-log spore reduction between batches
Regulatory-Ready Design
Pre-installed DOP test ports for routine HEPA filter integrity testing
316L stainless steel construction withstands aggressive VHP/SIP decontamination
Precision Environmental Control
±0.05 m/s airflow stability (0.45-0.75 m/s adjustable)
Real-time monitoring of differential pressure (0-500Pa) and particulate counts
Operational Efficiency
60% faster setup vs. gasket-based systems (no compression seating required)
Touchscreen interface with batch record logging (21 CFR Part 11 compliant)
1. Sterile Drug Fill-Finish Operations
Maintains ISO 5 conditions during vial/syringe filling
Liquid seal prevents microbial ingress during stopper placement
2. Cytotoxic Drug Compounding
Containment verified per USP <800> for hazardous drug handling
Seamless integration with isolator transfer systems
3. Cell & Gene Therapy Production
Protects sensitive biologics during media filling (Grade A zone)
ESD-safe materials prevent cell damage during transfers
4. Vaccine Manufacturing
Validated for aseptic processes per WHO TRS 986
Withstands formaldehyde vapor decontamination cycles
5. Medical Device Assembly
Particle-free environment for implantable device packaging
Compatible with cleanroom robotic integration
Filter Efficiency Testing
Certified via EN 1822-5:2009 MPPS method at 0.3μm
PAO/DOP challenge testing available upon request
Material Compliance
304 stainless steel meets ASTM A240/A480 standards
UV-C lamp output verified per FDA 21 CFR 1040.20
Operational Safety
Emergency stop function triggers immediate airflow reversal
Interlocked UV system deactivates upon door access
1. How does the liquid-trough seal provide superior containment compared to standard gaskets?
The continuous liquid barrier eliminates particulate leakage paths, achieving 100% containment at pressure differentials up to 50Pa (validated per IEST-RP-CC034.3).
2. Can this system integrate with existing isolator lines for cytotoxic drug handling?
Yes, the stainless steel construction is compatible with VHP decontamination cycles and features pre-installed CIP/SIP connection points.
3. What maintenance advantages does the liquid-trough design offer?
Eliminates gasket replacement costs and reduces downtime by 60% through non-degrading liquid interface that only requires monthly level checks.