The Hidden Role of HVAC in Pharmaceutical Contamination Control

When most people think of HVAC systems, they imagine climate control—not pharmaceutical safety. But in facilities where multiple products are manufactured, HVAC systems are critical safeguards against cross-contamination. Airflow doesn’t just carry heat or cooling—it can carry risk.

At Genesis AEC, we specialize in designing HVAC systems that protect product integrity and align with the latest global standards, including WHO Annex 8, PIC/S PI 043-1, and ASHRAE 52.2-2025. These frameworks emphasize the importance of minimizing the risk posed by recirculated or insufficiently treated air.

Engineering Risk Out of the Equation

By analyzing airborne contaminant mass, exposure duration, and filtration efficiency, Genesis quantifies the risk—then design it out. Recent upgrades to ASHRAE 52.2 now evaluate particulate efficiency by PM sizes, allowing for even greater precision.

Even medium-efficiency filters like MERV 13 can offer 800:1 mass reduction, while dual HEPA setups achieve 11-log reduction—nearly eliminating particulate risk entirely.

Filter Efficiency Comparison Table (Adapted from ASHRAE 52.2 Testing)

Filter Type	Typical MERV Rating	Particle Size Range Captured	Approx. Efficiency (%)
Fiberglass Panel	1–4	>10 µm	<20%
Pleated Panel	5–8	3–10 µm	20–70%
Box Filter	9–12	1–3 µm	50–85%
V-Bank Filter	13–16	0.3–1 µm	75–95%
HEPA Filter	17–20+	<0.3 µm	>99.97%

Note: While this table reflects the traditional MERV-based ratings, the ASHRAE 52.2-2025 update introduces PM1, PM2.5, and PM10 size-specific metrics, offering deeper granularity into filtration performance across real-world conditions.

Practical Example

Consider a 100 m³ cleanroom with dual HEPA filters and 20 air changes per hour. Over an 8-hour batch, you may find less than 2 picograms of airborne contaminants. That’s well below critical thresholds—when paired with proper process controls.

Bridging Science and Safety

Larger particles (>10µm) are most likely to settle onto surfaces and create cross-contamination events. That’s why Genesis designs systems with safety margins and applies Computational Fluid Dynamics (CFD)  modeling whenever possible, ensuring that airflow patterns won’t compromise product integrity.

Built for Tomorrow’s Compliance

Genesis’ HVAC strategies reflect updates in the ISPE HVAC Good Practice Guide (2nd Edition, 2024), including:

• Modular air handling
• Adaptive airflow control
• Integrated disinfection systems
• Compatibility with cell and gene and other advanced therapies

Our Commitment

Contamination control starts with quantification. At Genesis, our mission is to help clients design for certainty—not assumptions. Whether you’re modernizing an existing plant or launching a new facility, our cleanroom experts can help future-proof your HVAC systems against regulatory risk.