Pharmaceutical Grade Laminar Flow Hood | H14 HEPA 99.9995% Efficiency & UV Sterilization for Aseptic Processing

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.

Product Features

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.

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

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 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.

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.