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.

pre-fabricated modular cleanroom

Modular Cleanroom

Application:   ISO Level 7 (Class 10,000)

Size: 20’ x 20’ with 8’ x 10’ Gowning Area

Location: Temecula, California


  • Minimal disruption to active facility
  • Isolate process from dirty warehouse
  • System easily upgraded
  • Walls provide thermal barrier

Details and Scope of Work

We were contacted by our client to help design a system for face shield manufacturing. Due to a high rejection rate from their current process where too many airborne particles were getting into the lens after they left the vacuum oven as they were moved to the curing area.

There were some challenges as the environment needed to maintain stringent temperatures while providing a comfortable work environment for the production staff within the environment.  Careful evaluation of the processing equipment was taken into consideration to ensure proper mechanical elements were provided. read more

medical device cleanroom

Medical Device Modular Cleanroom

Application: ISO 7 ISO 8


  • Medical Device Manufacturer
  • 2 each ISO 7 Cleanrooms with ISO 8 Gown area
  • Separate entry to prevent cross-contamination in each environment
  • Wall mount material pass-thru chambers with interlock
  • Smooth FRP chemical resistant white wall finish


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