Shenzhen Meiri Purification Technology Co., Ltd.
| 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
Pharmaceutical-grade laminar flow hood featuring liquid-trough sealing technology and H14 HEPA filtration (99.999% @0.3μm). Validated for ISO 14644-1 Class 5 compliance in sterile filling applications.
| 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 |
Pharmaceutical-Grade Containment
Liquid-trough sealing technology creates an absolute barrier against cross-contamination
Exceeds ISO 14644-1 Class 5 standards with 99.999% particle retention at 0.3μm (H14 HEPA)
Advanced Sterility Assurance
Integrated ethanol reservoir maintains continuous liquid seal (validated per EU GMP Annex 1)
Optional UV-C system provides 6-log spore reduction between batches
Regulatory-Ready Design
Pre-installed DOP test ports for routine HEPA filter integrity testing
316L stainless steel construction withstands aggressive VHP/SIP decontamination
Precision Environmental Control
±0.05 m/s airflow stability (0.45-0.75 m/s adjustable)
Real-time monitoring of differential pressure (0-500Pa) and particulate counts
Operational Efficiency
60% faster setup vs. gasket-based systems (no compression seating required)
Touchscreen interface with batch record logging (21 CFR Part 11 compliant)
1. Sterile Drug Fill-Finish Operations
Maintains ISO 5 conditions during vial/syringe filling
Liquid seal prevents microbial ingress during stopper placement
2. Cytotoxic Drug Compounding
Containment verified per USP <800> for hazardous drug handling
Seamless integration with isolator transfer systems
3. Cell & Gene Therapy Production
Protects sensitive biologics during media filling (Grade A zone)
ESD-safe materials prevent cell damage during transfers
4. Vaccine Manufacturing
Validated for aseptic processes per WHO TRS 986
Withstands formaldehyde vapor decontamination cycles
5. Medical Device Assembly
Particle-free environment for implantable device packaging
Compatible with cleanroom robotic integration
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 liquid-trough seal provide superior containment compared to standard gaskets?
The continuous liquid barrier eliminates particulate leakage paths, achieving 100% containment at pressure differentials up to 50Pa (validated per IEST-RP-CC034.3).
2. Can this system integrate with existing isolator lines for cytotoxic drug handling?
Yes, the stainless steel construction is compatible with VHP decontamination cycles and features pre-installed CIP/SIP connection points.
3. What maintenance advantages does the liquid-trough design offer?
Eliminates gasket replacement costs and reduces downtime by 60% through non-degrading liquid interface that only requires monthly level checks.
Company Details
Business Type:
Manufacturer,Exporter
Year Established:
2012
Total Annual:
15000000-20000000
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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