Humidity control solution in pharmaceutical production facilities

This case study explores how we successfully tackled the complex requirements of maintaining optimal environmental conditions in the production facilities of a global pharmaceutical leader.

The situation

Insud Pharma, with over 45 years of experience and a presence in more than 50 countries, operates 18 manufacturing plants worldwide, including several in Spain. The company’s commitment to quality and continuous growth has made it a key player in the pharmaceutical industry, producing active pharmaceutical ingredients (APIs), medications, and biopharmaceutical products. Given the strict regulatory standards enforced by authorities like the FDA and EMA, maintaining precise environmental control in production areas is crucial.

Key points:

• Insud Pharma’s facilities require stringent control of temperature and humidity.
• Production areas include clean rooms and zones where air quality and environmental stability are vital.
• The company needed a reliable partner to ensure these conditions across multiple sites in Spain.

The challenge

The primary challenge was to develop a system that could consistently maintain the required temperature and humidity levels in highly controlled environments, such as clean rooms equipped with HEPA H14 filters. These environments demand:

• Precise air quality control: Ensuring stable temperature and humidity despite high airflow volumes of 11,000 m³/h.
• Pressure management: Overcoming significant pressure drops due to laminar airflow through HEPA filters.
• Energy efficiency: Minimising electricity consumption while maintaining optimal environmental conditions.

Dantherm Group had to design a system that could meet these rigorous demands while also being adaptable to the specific requirements of each production area within the Insud Pharma facilities.

The solution

By leveraging our decades of extensive expertise, we implemented a comprehensive humidity control solution that addressed all of Insud Pharma’s needs. The solution included:

• High-efficiency EC fans: Installed to ensure constant airflow and pressure levels, adjusting automatically to compensate for increased filter resistance as they accumulate particles.
• Steam reactivation technology: Employed to reduce electrical consumption while maintaining humidity control.
• Precision climate control: Air was supplied at 18°C with 3% relative humidity, equating to an absolute humidity of 0.38 g/kg.
• Real-time monitoring: A PLC with Modbus control was integrated into the system, allowing for continuous real-time monitoring and adjustment of all key parameters.

These systems were installed across various production lines in Insud Pharma's Spanish plants, ensuring that the environmental conditions met the stringent requirements necessary for pharmaceutical manufacturing.

Conclusion

Through the strategic partnership with Ecofluidos and the deployment of Dantherm Group’s advanced humidity control systems, Insud Pharma has successfully maintained the high standards required in its production facilities. The solution we supplied not only met the technical challenges but also provided a reliable and energy-efficient system that supports Insud Pharma’s commitment to quality and regulatory compliance.

Key outcomes:

• Consistent environmental control in critical production areas.
• Enhanced energy efficiency through innovative technology.
• Real-time monitoring capabilities for proactive system management.

The success of this project reinforces the trust that leading pharmaceutical companies place in Dantherm Group for maintaining the environmental conditions essential to their operations.