GMP Compliant Air Handling Unit Custom Air Handling Systems For Cleanrooms

GMP Compliant Air Handling Unit with HEPA Filtration for Cleanrooms

Product Overview

Our custom-engineered Air Handling Unit (AHU) is the heart of your GMP cleanroom, delivering precisely conditioned, triple-filtered air 24/7. Designed to meet the strictest particulate and microbial limits, it integrates primary, secondary, and terminal HEPA H14 filtration with dew-point control and full redundancy. This unit guarantees a stable Grade A through D environment while optimizing energy via heat recovery. Every AHU is factory-tested under ISO 14644-3 protocols, and delivered with a comprehensive validation package that shortens your OQ timeline significantly.

Cause

Poorly designed HVAC is the root cause of 60% of cleanroom failures cited in FDA 483 observations. Inconsistent temperature and humidity destable protein-based drugs; dead zones let particles accumulate; and energy waste is enormous—a single 10,000 CMH AHU operating 24/7 can incur six-figure annual energy bills. Additionally, cross-contamination risk soars when exhaust air is not handled correctly. If your AHU cannot prove sustained recovery times after door openings or cannot maintain precise 45%±5% RH for powder handling, your batch integrity is compromised and regulatory action is almost certain.

Solution

We engineer each GMP AHU specifically for your cleanroom layout and climatic conditions. The supply path forces air through pre-filter (G4), bag filter (F8), cooling coil, heating coil, steam humidifier, then the supply fan, and finally passes through multiple HEPA terminal filters in the ceiling. For Grade A/B zones, we design turbulent or laminar flow as required. Our direct drive EC plug fans reduce electrical consumption by up to 30%. An integrated Run-around coil or enthalpy wheel recovers energy without cross-contamination. The control system uses hot-wire anemometer arrays to maintain ±10% of set air volume, compensating for filter loading automatically.

Specifications

Application

• Central air supply for tablet compression (D-grade)

• Laminar flow for aseptic filling lines (A/B)

• Downflow booths for potent compound handling

• Hospital isolation rooms (negative pressure)

• Cell therapy cleanroom suites with B/C grade

• Medical device ISO 7 cleanroom conditioning

How It Works

Return air (mixed with fresh, pre-treated outdoor air at a 60/40 ratio) enters the AHU. Sensors measure particle concentration, temperature, and humidity. The controller modulates chilled water valves and steam to meet the dew point. The air then moves through the supply duct to terminal HEPA filters in the ceiling grid. Inside the cleanroom, air displacement pushes particles out via low-wall returns. A 15 Pa positive cascade ensures that hallway air never infiltrates into the process core. If a sudden pressure drop is detected, the BMS closes fire dampers and boosts the supply fan to stabilize.

How To Choose

Start with your required cleanliness class and room volume to calculate ACPH (Air Changes Per Hour): Grade B needs ≥50 ACPH, Grade C ≥25, Grade D ≥15. Determine if you need constant volume or variable air volume. Specify the required temperature (e.g., 20±1°C) and RH (e.g., 45±5%). If handling volatile solvents, request an ATEX-rated exhaust. Finally, decide on redundancy: N+1 fans prevent total shutdown during maintenance. Send us your facility’s URS and we’ll simulate dynamic loads in our CFD tool to size the unit precisely.

FAQ

Q1: How often should HEPA filters be replaced in a GMP AHU?

A: With proper pre-filtration, HEPA terminal filters typically last 3–5 years. We recommend annual in-situ DOP/PAO integrity testing and replacement when the differential pressure exceeds 2x initial clean reading.

Q2: Can the AHU handle nighttime setback?

A: Yes. We program a low-energy mode that maintains the essential pressure cascade and reduces ACPH, significantly cutting energy costs while protecting the cleanroom.

Q3: Is the control system 21 CFR Part 11 compliant?

A: Our based BMS provides user-level security, electronic signatures, and unalterable audit trails, fully supporting 21 CFR Part 11 compliance.

Q4: What happens if a fan fails during production?

A: N+1 configuration is standard for critical suites. The standby EC plug fan starts instantly, and the BMS sends an alarm to maintenance; no loss of pressurization occurs.