Medical Device Assembly Room

Medical Device Assembly Cleanroom

Application: ISO Level 7

Size: 16’ x 16’ with 4’ x 8’ Gowning Area

Location: Irvine, California


  • Minimal disruption
  • Permitting to meet local code
  • Easily relocated or expanded

Details and Scope of Work

Our repeat client came to us with a need for a cleanroom for assembling catheters. There requirement was to work in conjunction with an onsite general contractor and the property owner to ensure a local city codes were met and  minimal modifications to the existing building were needed.

As the customer was familiar with our 4” insulated cleanroom wall system from a prior project we discussed specific details further to meet their needs.

This cleanroom needed to utilize an existing HVAC system and its own zone control. The ceiling in the existing area was removed and a cleanroom grade t-bar was installed to maintain the same ceiling height in their lab area. The walls are supported by existing structural members and our U.L. classified raceways provided electrical power for the equipment in the cleanroom.

The cleanroom features custom height wall panels with interior FRP finish. A 24” x 24” wall mount pass through chamber located in the gown area allows sample materials to be passed from the ISO –7 clean area without disturbing the environment.

Thanks to the modular design and our expert installation crew, we were able to get all the cleanroom materials up to the 2nd floor of the facility with very little disruption to an active work area.

See our medical device cleanrooms section or contact one of our Cleanroom Specialists for further details or contact our office at 800-959.0878.

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