Terumo Medical Corporation – FemoSeal Cleanroom Renovation

Precis provided architecture and full mechanical, electrical, plumbing, and fire protection (MEP/FP) engineering services to facilitate interior renovations to provide production space for Terumo Medical Corporation’s FemoSeal^TM vascular closure system. Production operations for this product were being relocated to Elkton, Maryland, from Costa Rica.

The renovations included the addition of an ISO 8 assembly area, an ISO 8 gowning area, and an ISO 8 material airlock, a drying oven and final packaging area, a sterile prep area, siliconization washing, and an analytical lab. The project required strategic re-distribution and re-balancing of existing air-handling systems to maintain production in the adjacent manufacturing suites during construction.

New mechanical systems included a 37,000-CFM custom rooftop dunnage-mounted air-handling unit (AHU) with desiccant wheel dehumidification and associated air distribution to support the low humidity requirement of the manufacturing space, as well as new compressed air drying and heating equipment to support the device assembly process. The siliconization washing space also required a dedicated hazardous exhaust system with lower explosive limit (LEL) monitoring and in-duct sprinkler protection.