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HEPA boxes play a vital role in ensuring stable, compliant, and high-efficiency air filtration within pharmaceutical cleanrooms. As controlled environments demand strict particulate control to meet GMP and ISO 14644 standards, HEPA boxes provide reliable terminal air purification to maintain the required cleanliness level for critical production processes.

A HEPA box—also known as a terminal HEPA filter unit—is an air distribution device installed at the ceiling level of cleanrooms. It integrates:

• HEPA or ULPA filter
• Air diffusion plenum
• Pressure monitoring port
• Optional damper or flow regulator

Its main function is to deliver highly filtered air into controlled spaces with uniform airflow and stable pressure.

Pharmaceutical environments, especially sterile and aseptic areas, require strict air quality control. HEPA boxes offer several advantages:

HEPA filters (≥99.97% at 0.3 μm) ensure particle removal to meet ISO Class 5–8 cleanliness levels required for:

• Filling lines
• Compounding rooms
• Weighing booths
• Sterilization zones

HEPA boxes can be configured for:

• Laminar airflow for high-risk operations
• Turbulent mixing airflow for general processing areas

This ensures consistent contamination control.

HEPA boxes support compliance with:

• EU GMP Annex 1
• FDA cGMP
• WHO GMP
• ISO 14644

Uniform airflow, stable differential pressure, and proper filtration efficiency are essential for regulatory audits.

HEPA boxes maintain ISO Class 5 conditions around:

• Vial / ampoule filling
• Freeze-dryer loading
• Sterile filtration

They ensure low particulate levels during:

• Weighing and dispensing
• Solution preparation
• Buffer and media mixing

HEPA boxes reduce contamination risk for:

• Sterile packaging
• Blister sealing
• Final product handling

HEPA boxes are widely used in:

• Microbiology labs
• QC labs
• Stability testing areas

They maintain pressure cascades and acoustic comfort while providing clean make-up air.

Air changes per hour (ACH) and airflow distribution must be calculated based on:

• Room size
• Cleanliness grade
• Process requirements

Common options include:

• H13 / H14 HEPA filters
• U15 ULPA filters for high-risk zones

Equipped with test ports or manometers for:

• Filter differential pressure
• Leak detection
• Performance verification

Stainless steel or powder-coated steel housing ensures:

• Corrosion resistance
• Easy surface disinfection

Proper installation allows convenient:

• Filter replacement
• Testing and balancing
• Cleaning

Routine maintenance ensures continued GMP compliance:

• Regular leakage testing (per ISO 14644-3)
• Filter integrity testing
• Airflow velocity measurement
• Differential pressure monitoring

HEPA box servicing must be documented according to facility validation protocols.

HEPA boxes are essential components in pharmaceutical cleanrooms, providing dependable terminal air filtration to maintain ISO-class cleanliness, support GMP compliance, and protect both products and personnel. Whether for aseptic filling, compounding, packaging, or QC labs, properly selected and maintained HEPA boxes are fundamental for contamination control in modern pharmaceutical production.