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Pharmaceutical Grade Laminar Flow Hood | H14 HEPA 99.9995% Efficiency & UV Sterilization for Aseptic 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 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
Pharmaceutical Grade Laminar Flow Hood | H14 HEPA 99.9995% Efficiency & UV Sterilization for Aseptic Processing
Engineered for precision contamination control in sterile processing environments. Compliant with ISO 14644-1 Class 5 and EU GMP Annex 1 requirements for critical applications in pharmaceutical filling lines and biotechnology cleanrooms.
| 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
Precision Contamination Barrier
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304 stainless steel construction: Resists chemical disinfectants (ethanol/IPA/hydrogen peroxide) with Ra ≤0.5μm surface finish, reducing particle retention by 80% vs standard finishes.
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H14 HEPA filtration: Exceeds ISO 29463-1 Class H14 standards, capturing 99.9995% of 0.3μm particulates critical for aseptic filling operations.
Advanced Process Control
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Dynamic airflow adjustment: Maintains 0.45–0.75 m/s laminarity even during door openings (EN 12469:2000 compliant).
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DOP test compatibility: Pre-installed ports enable in-situ filter integrity testing per IEST-RP-CC034.3 protocols.
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UV-C decontamination cycle: Optional 360° irradiation eliminates 6-log bacterial spores between batches (validated per USP <800>).
Ergonomic Operational Design
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Low-noise aluminum fan: Reduces ambient sound levels to 60 dB for operator comfort during extended shifts.
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Real-time monitoring display: Tracks differential pressure (0–500Pa), filter load, and UV status via color-coded alerts.
Application Scenarios
Biologic Drug Fill-Finish
Maintains ISO Class 5 conditions during vial filling, with H14 filtration preventing 0.3μm particle ingress in lyophilizer loading zones.
Cell Culture Workstations
Optional UV cycle eliminates mycoplasma contamination between cell line transfers in BSL-2 laboratories.
Microelectronics Wafer Handling
ESD-safe stainless steel body prevents static discharge during photoresist coating processes (SEMI F47 compliant).
Veterinary Vaccine Production
Seamless integration with isolator systems for live virus handling, featuring airlock-compatible pressure stability.
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 the 0.45-0.75 m/s adjustable airflow prevent turbulence in critical zones?
The aerodynamically optimized aluminum impeller maintains laminar flow (EN 12469 certified) even during material transfers, reducing eddy currents by 62% compared to standard fans.
2. Can the UV system be retrofitted to existing units for regulatory compliance?
Yes, the modular UV-C assembly (254nm wavelength) installs without tools and includes validation documentation for FDA/EMA audits.
3. What makes the 304 stainless steel construction suitable for peroxide vapor decontamination?
The sandblasted finish (Ra ≤0.5μm) resists pitting from VHP cycles, with welded seams eliminating contamination traps per EU GMP Annex 1.