Air Handling Units (AHUs)
Purpose-built AHUs for GMP-compliant pharmaceutical manufacturing, cleanroom, and biotechnology environments – engineered to meet WHO GMP, USFDA, EU GMP Annex 1, and ISO 14644 standards.
Key Features
- Multi-stage HEPA filtration with hygienic, particulate-resistant enclosure
- Heating, cooling, and humidity control for classified manufacturing areas
- Pressure cascade configuration across GMP production zones
- Controlled recirculation ratios with fresh air and exhaust management
- Heat recovery options for energy-efficient facility operation
- Available in range of capacities – sized to your cleanroom classification and air change rate requirements
Compliance & Validation
- Supports IQ/OQ/PQ qualification protocols
- Compatible with WHO GMP, USFDA, EU GMP Annex 1, ISO 14644
- Full documentation package available for regulatory audits
Applications
- Pharmaceutical manufacturing (OSD, Injectables, Biologics)
- GMP cleanrooms — ISO Class 5 to 8
- Biotechnology and vaccine production facilities
- Laboratory and quality control environments
Frequently Asked Questions
A pharmaceutical air handling unit (AHU) conditions and distributes filtered air throughout GMP cleanrooms and controlled manufacturing areas. It controls temperature, relative humidity, pressure differentials, air change rates, and airborne particulate levels — maintaining cleanroom classifications from ISO 5 to ISO 8 (Grade A to D) as required by WHO GMP, EU GMP Annex 1, and USFDA.
A GMP pharmaceutical AHU comprises pre-filters, intermediate bag filters, and terminal HEPA filters; heating and cooling coils; a humidifier; supply and return fans; a mixing box for fresh air and recirculated air; dampers; and automated controls linked to building management systems. All internal surfaces use hygienic, smooth, cleanable materials to prevent particulate shedding and microbial
Pharmaceutical AHU capacity is sized based on the cleanroom's required air change rate (ACH) for its ISO or GMP grade, room volume, heat load from equipment and personnel, humidity gain or loss, and fresh air requirements. Grade A/B areas demand much higher airflow — up to 600 ACH — than Grade C/D support areas, driving AHU size and fan selection significantly.
Pharmaceutical AHUs serving Grade C and D (ISO 7–8) areas require H13 terminal HEPA filters with 99.97% efficiency at 0.3 µm. Grade A and B (ISO 5–6) areas require H14 HEPA filters at 99.99% efficiency. All HEPA filters must be integrity-tested using DOP or PAO aerosol challenge during IQ/OQ qualification and at defined re-certification intervals per EU GMP Annex 1.
AHU zoning assigns dedicated air handling units to specific cleanroom zones or production suites — preventing cross-contamination between different products, potency categories, or classification grades. Separate AHUs for OSD, injectables, oncology, and microbiology areas ensure each zone maintains independent pressure cascades, temperature setpoints, and contamination control without shared airflow paths between incompatible manufacturing areas.
A recirculating AHU returns a portion of exhaust air through HEPA filtration and re-supplies it to the cleanroom — improving energy efficiency and suitable for most OSD and support areas. A 100% fresh air (once-through) AHU exhausts all air without recirculation — required for highly potent APIs, cytotoxics, oncology suites, and areas with chemical or biological hazards where recirculation poses cross-contamination risk.
Pharmaceutical AHU qualification follows three stages: IQ (Installation Qualification) verifies the unit is installed as specified with correct utilities and documentation; OQ (Operational Qualification) confirms controls, alarms, HEPA integrity, and environmental parameters operate within defined ranges; PQ (Performance Qualification) demonstrates sustained cleanroom classification, pressure differentials, temperature, humidity, and particle counts under simulated production conditions.
A GMP-compliant pharmaceutical AHU uses smooth, crevice-free stainless steel or powder-coated panels to prevent particulate accumulation; hygienic internal drain trays and coil design to prevent microbial growth; gasketed, leak-free construction to avoid unfiltered air bypass; and validated controls with continuous monitoring outputs compatible with building management and environmental monitoring systems required by EU GMP Annex 1 and WHO GMP.
Yes, all our products are designed and sourced to meet international regulatory standards, including GMP, USFDA, EU-GMP, WHO, and other relevant compliance requirements.
Absolutely. Our solutions are engineered for seamless integration with existing systems, ensuring minimal disruption and optimal performance within your current setup.
Yes, our team offers technical consultation to help you choose the most suitable product based on your process requirements, facility design, and compliance needs.
Yes, all our products are aligned with our turnkey execution approach, ensuring compatibility with overall facility design, engineering, and operational requirements.
Yes, we provide customised solutions tailored to your process, capacity, and regulatory requirements to ensure optimal performance and efficiency.
Our products are used across pharmaceutical manufacturing, biotechnology, nutraceuticals, research laboratories, and regulated healthcare environments.
We follow strict quality standards and work with trusted technologies and manufacturing processes to ensure consistent performance, durability, and compliance.
Yes, we offer ongoing technical support to ensure smooth operation, performance optimisation, and long-term reliability of all supplied systems and components.
