FABON Pharma

Air Handling Unit (AHU)

200,000.00

Ensure cleanroom integrity and climate control with our high-performance Air Handling Units (AHUs), engineered specifically for pharmaceutical, biotech, and clean manufacturing environments. These systems are essential for maintaining controlled temperature, humidity, and air cleanliness levels to meet stringent GMP and FDA standards.

An Air Handling Unit (AHU) is a vital piece of equipment in pharmaceutical manufacturing plants, used to control and distribute air throughout controlled environments, i.e., cleanrooms. AHUs provide assurance that temperature, humidity, and particulate levels conform to high standards required for product quality as well as regulatory compliance.

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Technical Specifications:

  • Construction Material:
    1. Casing: Stainless steel or galvanized steel with a powder-coated finish to ensure corrosion prevention and ease cleaning.
    2. Insulation: Double-walled panels with polyurethane foam or mineral wool insulation to preserve thermal efficiency and minimize noise.
  • Filtration System:
    1. Pre-Filters: Filter out larger particles to safeguard downstream components.
    2. HEPA Filters: High-Efficiency Particulate Air filters trap at least 99.97% of particles ≥0.3 microns, guaranteeing air cleanliness.
    3. ULPA Filters: Ultra-Low Penetration Air filters offer greater efficiency, trapping 99.999% of particles ≥0.12 microns, utilized in stricter cleanroom classifications.
  • Airflow Configuration:
    1. Laminar Flow: Provides one-way airflow to reduce turbulence and avoid cross-contamination.
    2. Turbulent Flow: Employed in non-critical areas where full laminar flow is not required.
  • Temperature and Humidity Control:
    1. Cooling/Heating Coils: Hold precise temperature setpoints.
    2. Humidifiers/Dehumidifiers: Control humidity levels according to process demands.
  • Fans and Motors:

Variable Frequency Drives (VFDs): Permit accurate fan speed control, optimizing airflow and energy usage.

  • Control Systems:

Building Management Systems (BMS): Coordinate AHU operations for monitoring and control of environmental conditions.

  • Uses:
    1. Environmental Control: Regulate precise temperature and humidity levels required for product stability and process performance.
    2. Air Filtration: Eliminate particulate impurities to meet necessary cleanroom classifications, avoiding product contamination.
    3. Pressure Differentials: Regulate positive or negative pressure zones to manage airflow between zones, avoiding cross-contamination.
    4. Effective design, installation, and maintenance of AHUs are critical to meet Good Manufacturing Practices (GMP) standards and preserve the integrity of pharmaceutical products.

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FAQs

What is an Air Handling Unit (AHU)?
An Air Handling Unit (AHU) is a system designed to condition and circulate air as part of a Heating, Ventilation, and Air Conditioning (HVAC) system. In pharmaceutical environments, AHUs are critical for maintaining cleanroom classifications, temperature, humidity, and pressure differentials.
What is the role of an AHU in pharmaceutical manufacturing?
In pharma facilities, AHUs: Control air cleanliness per ISO/GMP classifications (e.g., ISO 5, 7, 8 or Grade A, B, C, D) Regulate temperature and relative humidity (RH) Maintain differential pressure between classified areas Ensure unidirectional airflow and contamination control
What components are typically included in a pharma AHU?
Pre-filters / Fine filters / HEPA or ULPA filters Heating and cooling coils (steam or chilled water) Humidifiers and dehumidifiers Blowers or fans (usually EC or VFD-controlled) Mixing chambers and dampers Drain pans (SS 304/316) Control panels with BMS connectivity
What filter types are used, and how often are they changed?
Pre-filters (G4 or MERV 8–11): Every 3–6 months Fine filters (F7–F9 or MERV 13–15): Every 6–12 months HEPA filters (H13/H14): Every 12–24 months or per DOP/PAO testing Replacement frequency depends on particle load and pressure drop.
What cleanroom standards must AHUs comply with?
ISO 14644-1 (Cleanroom classifications) EU GMP Annex 1 US FDA cGMP (21 CFR Part 210/211) WHO TRS guidelines ASHRAE and ISPE HVAC guidelines
What materials are used in pharma-grade AHUs?
Casing: Galvanized steel or SS 304 with epoxy coating Internal surfaces: Smooth SS 304 or food-grade aluminum Drain pans: SS 304 or SS 316, slope for drainage Insulation: PUF, PIR, or double-skin panels (thermal break recommended)
Can AHUs be integrated with a Building Management System (BMS)?
Yes, most pharma AHUs include: Sensors for temperature, humidity, and differential pressure PLC or DDC controls BMS/SCADA integration via BACnet or Modbus
How is an AHU validated in pharma environments?
Validation includes: DQ/IQ/OQ/PQ protocols HEPA filter integrity testing (PAO/DOP test) Airflow velocity and unidirectionality checks Temperature & RH mapping Differential pressure mapping
How often should AHUs be maintained?
Visual inspection and filter checks: Monthly HEPA integrity test: Annually Calibration of sensors and BMS controls: Annually Full preventive maintenance: As per SOP, typically quarterly or semi-annually
What are optional features for pharma AHUs?
Air showers or laminar flow units Bag-in/bag-out HEPA filter housing UV-C lamps for microbial control Energy recovery wheels (with GMP design compliance) Automatic damper control for pressurization
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