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.