Medical Device Assembly Cleanroom

Medical Device Assembly Clean Room

Application: ISO Level 7

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

Location: Irvine, California

Medical Device Assembly Cleanroom Benefits

  • Minimal disruption and modification to existing work area
  • Permitting to meet local code
  • Easily relocated or expanded

Details and Scope of the Clean Room Project

Our repeat client came to us needing a cleanroom for assembling catheters. Because they were already familiar with our 4” insulated cleanroom wall system, we discussed details further to meet their needs.

They needed us to work with an onsite general contractor and the property owner to meet local city codes. They also needed us to make minimal modifications to the existing building, as well as utilize an existing HVAC system and its own zone control.

Clean Room Design and Installation

We removed the ceiling in the existing area and installed a cleanroom grade T-bar to maintain the same ceiling height in their lab area. Then we used existing structural members to support their walls. Our U.L. classified raceways provided electrical power for the equipment in the cleanroom.

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

Because of the modular design and our expert installation crew, we got all the cleanroom materials up to the second floor of the facility with very little disruption to the active work area. To learn how we can create a cleanroom for your medical application, see our medical device cleanrooms section or learn about our Dry Room Enclosures.  Contact one of our Cleanroom Specialists for further details or contact our office at 800-959-0878.

Discover More About Our Modular Cleanroom Systems

Cleanrooms by United is a trusted modular cleanroom manufacturer offering a range of flexible solutions. We design and build our modular cleanroom systems in compliance with ISO 16444-1 to meet regulatory requirements. Visit our Clean Room Design Components page for information on all the functional and optional elements that can be added to customize your Cleanroom.  We will work with you on your cleanroom classifcation needs to design and build the right clean room for your industrial application.  We also offer full onsite cleanroom installation services. 

Give us a call at 800-959-0878 for additional assistance or contact us for your modular cleanroom project today.