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Pharma-Grade Liquid Seal Laminar Flow Cabinet | ISO 5 Certified | H14 HEPA 99.999% Filtration
Product Details:
| Place of Origin: | Guangdong, China |
| Brand Name: | MRJH |
| Certification: | ISO 14644,CE,GMP,FDA,UL |
| Model Number: | Laminar flow hood |
Payment & Shipping Terms:
| Minimum Order Quantity: | 1 |
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| Price: | Contact Us |
| Delivery Time: | 7-15 days |
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Detail Information |
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| Custom Made: | Support | Official Website: | Www.ffu-cleanroom.com |
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Product Description
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 |
Product Features
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Absolute Containment Technology
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Continuous ethanol liquid trough creates hermetic seal (no gasket degradation)
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Maintains ISO 5 conditions during dynamic operations
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Regulatory-Compliant Design
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Pre-validated per EU GMP Annex 1 & FDA 21 CFR 210/211
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Integrated DOP test ports for filter integrity verification
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Smart Monitoring System
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Real-time differential pressure tracking (0-500Pa)
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Touchscreen with alarm thresholds for critical parameters
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Decontamination Ready
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316L stainless steel withstands VHP/SIP cycles
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Optional UV-C system (40mJ/cm² dose)
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Ergonomic Operation
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55dB noise level for communication clarity
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Glove-compatible control interface
Application Scenarios
1. Sterile Injectable Manufacturing
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Maintains Grade A zone during vial filling/stoppering
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Prevents microbial ingress in lyophilizer loading
2. ATMP Production
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Protects cell therapies during media transfers
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ESD-safe materials for sensitive biologics
3. Oncology Drug Handling
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Containment verified per USP <800>
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Liquid seal contains cytotoxic particulates
4. Vaccine Fill-Finish
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Validated for live virus workflows
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Withstands formaldehyde fogging decon
5. Implantable Device Packaging
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Particle-free environment for Class III devices
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Compatible with cleanroom robotics
Technical Validation
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Filter Efficiency Testing
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Certified via EN 1822-5:2009 MPPS method at 0.3μm
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PAO/DOP challenge testing available upon request
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Material Compliance
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304 stainless steel meets ASTM A240/A480 standards
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UV-C lamp output verified per FDA 21 CFR 1040.20
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Operational Safety
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Emergency stop function triggers immediate airflow reversal
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Interlocked UV system deactivates upon door access
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FAQs
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.