Delivery Time | 7-15 days |
custom made | support |
official website | www.ffu-cleanroom.com |
Brand Name | MRJH |
Model Number | Laminar flow hood |
Certification | ISO 14644,CE,GMP,FDA,UL |
Place of Origin | Guangdong, China |
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Product Specification
Delivery Time | 7-15 days | custom made | support |
official website | www.ffu-cleanroom.com | Brand Name | MRJH |
Model Number | Laminar flow hood | Certification | ISO 14644,CE,GMP,FDA,UL |
Place of Origin | Guangdong, China |
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 |
Precision Contamination Barrier
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.
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
Dynamic airflow adjustment: Maintains 0.45–0.75 m/s laminarity even during door openings (EN 12469:2000 compliant).
DOP test compatibility: Pre-installed ports enable in-situ filter integrity testing per IEST-RP-CC034.3 protocols.
UV-C decontamination cycle: Optional 360° irradiation eliminates 6-log bacterial spores between batches (validated per USP <800>).
Ergonomic Operational Design
Low-noise aluminum fan: Reduces ambient sound levels to 60 dB for operator comfort during extended shifts.
Real-time monitoring display: Tracks differential pressure (0–500Pa), filter load, and UV status via color-coded alerts.
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.
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 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.
Company Details
Business Type:
Manufacturer,Exporter
Year Established:
2012
Total Annual:
1500000-2000000
Employee Number:
100~200
Ecer Certification:
Verified Supplier
Shenzhen Meiri Purification Technology Co. Ltd., known by our brand "MRJH," is a leading manufacturer of cleanroom equipment based in Shenzhen, China. With a spacious facility spanning over 30,000 square meters, we specialize in the research, development, production, sales, and service of profession... Shenzhen Meiri Purification Technology Co. Ltd., known by our brand "MRJH," is a leading manufacturer of cleanroom equipment based in Shenzhen, China. With a spacious facility spanning over 30,000 square meters, we specialize in the research, development, production, sales, and service of profession...
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