Clean Room Renovation

Project Detail:

Cost $25,000,000

Size 20,000 SF

Markets:

HEAPY designed the mechanical, electrical, controls, and security systems for a confidential client in Santa Ana, CA. The facility produces medical devices and equipment, and the project scope consisted of three ISO 8 cGMP/FDA validated environment cleanrooms and 18,000 SF of gown room space.

INNOVATION & SCHEDULE ADHERENCE

The project schedule was fast-tracked. HEAPY created pre-purchase equipment packages for fan filter units, cleanroom wall and ceiling systems, air handling units, condensing units, and desiccant dryer units to mitigate the impact of long lead times for equipment, allowing the project to stay on schedule and hit critical path milestones.

PRECISE TEMPERATURE & HUMIDITY CONTROL

Two of the cleanrooms required 72+/-2F and 50 +/- 5RH control, while one the rooms required 72+/-2F and 20%RH maximum control. Careful consideration to room pressurization cascade and vapor barrier for each space was required to ensure proper compliance to cGMP. As part of the design, HEAPY designed and coordinated the cGMP validated monitoring system for temperature, humidity, pressure, and particulate count, allowing for live, online trending and monitoring.


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