A new pharmaceutical manufacturing facility in North Carolina is setting a high standard for cleanroom performance and air quality. To meet the project’s strict environmental and regulatory demands, Coward Environmental Systems, Inc. (CESI) specified Buffalo Air Handling units, a proven solution known for precision, hygiene, and durability in mission-critical applications.
Building for Precision and Patient Safety
The new facility will produce injectable medications for patients, which means the manufacturing areas must comply with Good Manufacturing Practice (GMP) requirements. These standards ensure that temperature, humidity, and air cleanliness are tightly controlled to prevent contamination.
“This is a new manufacturing facility that’s going to make an injectable product for patients,” explained Greg Munter, PE, Partner and Sales Engineer at CESI. “That means cleanroom environments are essential, with temperature and humidity control, HEPA filtration, and bacterial control all part of the system design.”
Because the production areas include manufacturing spaces that include new manufacturing processes, the HVAC design also called for multiple control zones to maintain consistent conditions throughout the facility.
Specifying Buffalo Air Handling
To meet these complex requirements, CESI partnered with Buffalo Air Handling, a leading U.S. manufacturer of high-performance air handling systems. The all-aluminum construction of the Buffalo Air units was a key factor in the specification, offering durability, lighter weight, and exceptional hygienic properties.
“Buffalo Air supplied all-aluminum units, which are super hygienic,” said Munter. “That’s ideal for cleanroom environments where corrosion resistance and cleanliness are absolutely critical.”
In addition to the material benefits, the design process was guided by prior success overseas. The pharmaceutical company’s parent organization wanted to replicate the performance and functionality of the previous successful pilot project.
“We worked closely with the design team to make sure the units were efficient and modeled after projects that had already been completed overseas,” Munter said. “The parent company was so pleased with the performance of those systems that they wanted to duplicate that success here.”
Engineered for GMP Cleanroom Performance
Each air handling unit was designed to support the facility’s GMP production areas, where medications are manufactured, filled, and packaged under cleanroom conditions. These environments require precise control over air temperature, humidity, and particulate levels, all delivered through Buffalo Air’s advanced engineering.
“The design is all about maintaining a stable, contaminant-free environment,” said Munter. “HEPA filters, humidity regulation, and temperature control all have to work together to meet the GMP requirements.”
Buffalo Air’s units are also designed for easy access and maintenance, minimizing downtime and helping ensure consistent operation. The combination of robust performance and hygienic design made them an ideal choice for the project’s demanding specifications.
Delivering Confidence Through Collaboration
This project reflects CESI’s ongoing commitment to helping clients in highly regulated industries achieve both compliance and performance. By combining Buffalo Air’s proven engineering with CESI’s expert system design and support, the team delivered a solution that balances reliability, energy efficiency, and GMP-level control.
“At CESI, we take pride in working closely with our clients and their design teams to get every detail right,” Munter said. “This project is a great example of how collaboration and proven technology can deliver both regulatory compliance and exceptional performance.”
About Coward Environmental Systems, Inc.
Buffalo Air Handling designs and manufactures custom air handling units for critical environments, specializing in hygienic, energy-efficient systems built from durable materials to meet the demanding standards of pharmaceutical, healthcare, and industrial applications. Coward Environmental is proud to Buffalo Air in select parts of the Mid-Atlantic region. To learn more, contact CESI today.
