Shenzhen Meiri Purification Technology Co., Ltd.
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Pharma-Grade Liquid Seal Laminar Flow Cabinet | ISO 5 Certified | H14 HEPA 99.999% Filtration
Aseptic processing laminar flow cabinet featuring patented liquid-trough sealing technology and H14 HEPA filtration (99.999% @0.3μm). Validated for ISO 14644 Class 5 compliance.
| 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 |
Absolute Containment Technology
Continuous ethanol liquid trough creates hermetic seal (no gasket degradation)
Maintains ISO 5 conditions during dynamic operations
Regulatory-Compliant Design
Pre-validated per EU GMP Annex 1 & FDA 21 CFR 210/211
Integrated DOP test ports for filter integrity verification
Smart Monitoring System
Real-time differential pressure tracking (0-500Pa)
Touchscreen with alarm thresholds for critical parameters
Decontamination Ready
316L stainless steel withstands VHP/SIP cycles
Optional UV-C system (40mJ/cm² dose)
Ergonomic Operation
55dB noise level for communication clarity
Glove-compatible control interface
1. Sterile Injectable Manufacturing
Maintains Grade A zone during vial filling/stoppering
Prevents microbial ingress in lyophilizer loading
2. ATMP Production
Protects cell therapies during media transfers
ESD-safe materials for sensitive biologics
3. Oncology Drug Handling
Containment verified per USP <800>
Liquid seal contains cytotoxic particulates
4. Vaccine Fill-Finish
Validated for live virus workflows
Withstands formaldehyde fogging decon
5. Implantable Device Packaging
Particle-free environment for Class III devices
Compatible with cleanroom robotics
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 liquid sealing outperform traditional gaskets in sterile processing?
The ethanol barrier eliminates compression fatigue and microbial harborage points, providing consistent containment through 10,000+ cycles (validated per ISO 14644-3).
2. What documentation supports regulatory submissions?
Includes IQ/OQ templates, material certifications (USP Class VI), and filter test reports per IEST-RP-CC034.3.
3. Can the system accommodate large component transfers?
Customizable work zones up to 1200mm width maintain ≤0.5% velocity deviation across entire surface.