We partnered with Cleanroom Construction Associates, Hodess Cleanroom Construction and Gamewell Mechanical to deliver a turn-key Design-Build 60,000 square foot pharmaceutical cleanroom facility for a leading pharmaceutical company. The project involved creating Grade A (ISO Class 5) and Grade B (ISO Class 7) cleanroom environments compliant with FDA cGMP and EU GMP Annex 1 requirements.
The facility required maintaining tight environmental controls (±0.5°C temperature and ±3% RH) while accommodating large heat loads from process equipment.
Our solution incorporated precision air handling units with proportional-integral-derivative (PID) control algorithms and rapid response cooling coils to maintain stability during equipment heat load fluctuations.
The facility was built inside an existing two story shell building. All our mechanical systems had to be supported independently from the original building structure. Our design included custom pipe racks that were prefabricated off site and shipped in sections to the facility. Coordinated shipping splits for custom air handling units to fit down narrow service corridors. The AHU installation was closely coordinate with the prefabricated pipe rack installation. All utilities were installed successfully and without issue.
Leading Biotech Company
60,000 sq ft
June 2022
"Essential Engineering delivered a facility that exceeded our expectations. Their attention to detail in cleanroom design and validation was instrumental in our successful FDA inspection."
John Smith
Director of Facilities, Client Company
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