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Pharma-Grade ISO 5 Certified Laminar Flow Cabinet with Liquid Seal Technology for Sterile Processing
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 working days |
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Detail Information |
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| Custom Made: | Support | ||
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| Highlight: | ISO 5 certified laminar flow cabinet,pharma-grade laminar flow hood,sterile processing laminar flow cabinet |
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Product Description
Pharma-Grade Liquid Seal Laminar Flow Cabinet | ISO 5 Certified Filtration
Aseptic processing laminar flow cabinet featuring patented liquid-trough sealing technology and H14 HEPA filtration. 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 |
| 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
- 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.
Application Scenarios
- Sterile Injectable Manufacturing - Maintains Grade A zone during vial filling/stoppering. Prevents microbial ingress in lyophilizer loading.
- ATMP Production - Protects cell therapies during media transfers. ESD-safe materials for sensitive biologics.
- Vaccine Fill-Finish - Validated for live virus workflows. Withstands formaldehyde fogging decon.
- Implantable Device Packaging - Particle-free environment for Class III devices. Compatible with cleanroom robotics.
Technical Validation
- Filter Efficiency Testing - Certified via EN 1822-5:2009 MPPS method. 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.
Frequently Asked Questions
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).
What documentation supports regulatory submissions?
Includes IQ/OQ templates, material certifications (USP Class VI), and filter test reports per IEST-RP-CC034.3.
Can the system accommodate large component transfers?
Customizable work zones up to 1200mm width maintain ≤0.5% velocity deviation across entire surface.
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