GMP Liquid-Trough Sealed Laminar Flow Hood | H14 HEPA 99.999% Efficiency | ISO 5 Certified

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.

Key Product Features

1. 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)

2. 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

3. Regulatory-Ready Design

   • Pre-installed DOP test ports for routine HEPA filter integrity testing

   • 316L stainless steel construction withstands aggressive VHP/SIP decontamination

4. 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

5. Operational Efficiency

   • 60% faster setup vs. gasket-based systems (no compression seating required)

   • Touchscreen interface with batch record logging (21 CFR Part 11 compliant)

Application Scenarios

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

Technical Validation

1. Filter Efficiency Testing

   • Certified via EN 1822-5:2009 MPPS method at 0.3μm

   • PAO/DOP challenge testing available upon request

2. Material Compliance

   • 304 stainless steel meets ASTM A240/A480 standards

   • UV-C lamp output verified per FDA 21 CFR 1040.20

3. Operational Safety

   • Emergency stop function triggers immediate airflow reversal

   • Interlocked UV system deactivates upon door access

FAQs

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.

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 professional cleanroom solutions.

At MRJH, we offer a wide range of high-quality products to meet your purification needs. Our product lineup includes Fan Filter Units, Pass Boxes, Air Showers, Cargo Showers, laminar flow hoods, HEPA Box, HEPA Filter , Clean Room Filters , steel doors, and various other clean room equipment. We take pride in our ability to provide OEM/ODM/customized services to tailor our products to your specific requirements.

Since our establishment in 2012, we have been committed to delivering exceptional air filters, air purification equipment, and cleanroom solutions. Our state-of-the-art production facilities are equipped with advanced AMADA CNC punching machines, CNC bending machines, shearing machines, and large laser machines. These cutting-edge technologies enable us to maintain stringent quality control and ensure the precision and reliability of our products.

At MRJH, we prioritize customer satisfaction and strive to provide solutions that meet international standards. Our friendly and professional team is dedicated to delivering outstanding service and support throughout the entire process. We are proud to serve clients globally and look forward to partnering with you to create a cleaner and safer environment.

Please feel free to contact us for any inquiries or further information.