ISO 7 Cleanroom

In order to meet customer demand to deliver a FDA regulated device to assist with lung-related functions, BKM was retained by Breethe to construct an ISO 7 clean space for the manufacturing of the bio-medical device.

The new 900 square foot clean room was supplied by a roof-mounted institutional grade air handling unit to maintain stringent temperature and relative humidity controls with 50 air changes per hour to terminal HEPA filter modules in the ceiling. An exhaust system serves a hood and other exhaust ports to remove particulate during manufacturing. Controls allow for the outdoor air quantity to be reduced during non-business hours as an energy savings measure. Compressed air piping was provided to operate with designated equipment in the clean room. The electrical distribution system was modified to support the new air handling unit, equipment loads and sealed lighting fixtures.