Introduction: The "Invisible Weight" of Cleanrooms

In pharmaceutical manufacturing facilities, cleanroom-related energy consumption—primarily HVAC systems—can account for more than half, and in some cases 50-70%, of the total facility energy usage.

Strict 24-hour environmental control (room pressure, temperature, humidity, cleanliness) is a mandate of GMP (Good Manufacturing Practice), but it also represents a massive operating cost. The mindset that "cost is inevitable for quality" has long been dominant, but with decarbonization goals and soaring energy prices, that premise is crumbling.

Optimization via Risk-Based Approach

Reviewing excessive air change rates and safety margins through a "Risk-Based Approach" is recommended, based on ICH Q9 (Quality Risk Management) principles.

• Reducing air change rates during non-operational hours (Night Setback)
• Dynamic control of air change rates based on particle monitoring data
• Reducing excessive outside air intake and promoting recirculation

Key Points for Implementation

To implement energy-saving measures while maintaining a validated state through proper Change Control, close collaboration between the Engineering and Quality Assurance (QA) departments is essential. By scientifically proving no impact on quality based on data, it is possible to balance cost and quality.