Medical Device Manufacturing Clean Room Suite | Western Environmental
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Cleanroom Panoramic

MEDICAL DEVICE MANUFACTURING
CLEANROOM SUITE 

PROJECT: ISO 6 & ISO 7 MEDICAL DEVICE MANUFACTURING CLEANROOM SUITE 

 

An example of an ISO 6/ISO 7 cleanroom suite we designed and built for very well-known medical device manufacturer.  The project turned out great and our client was very pleased with the knowledge, professionalism, and expertise our team was able to provide being a “turnkey” design build firm.  

ISO 6 & ISO 7 Project Scope and Design

Project Scope:  

  • An overall footprint of 200’ x 124’ with inside ceiling heights of 10’ and an overall plenum height of 14’ 

  • The total space consisted of (6) cleanroom areas, a corridor, and gowning rooms  

  • The mechanical design included (5) air handling units that were set on the cleanroom’s roof and the condensing units were above on the exterior roof of the host building 

  • Our HVAC operating parameters throughout were: 

  • Set point of 68°F with a tolerance of +/- 3°F 

  • A max of 60% relative humidity 

  • ISO 6 and ISO 7 ISO classifications 

24k sqft Cleanroom ISO 7

Project Design: 

  • Structural steel with a sealed and insulated roof panel system, engineered to maintain a live load of 20 P. S. F.  

  • Wall and roof panels are insulated, and flame/smoke tested to ASTM E84 standards with an FM-4880 class 1 fire rating. (FM approved). 

  • Gasketed cleanroom grid ceiling installed below the roof panel and steel system with HEPA filters throughout the enclosure  

  • We furnished and installed an epoxy floor throughout the space that included clear coat and color chips 

  • An OSHA approved stairway complete with railings was installed for cleanroom roof access  

  • Or Western Environmental custom-built control system was included and monitors in real time: 

  • Room temperature 

  • Room humidity 

  • Room pressure 

  • Fan status  

  • Smoke detector 

  • Cooling coil temperature 

  • Supply air temperature 

  • Overall average temperature 

  • Overall average humidity  

  • System alarms  

  • Also included was fire suppression, airline drops, overhead doors, automatic sliding doors, pass-thru cabinets, and several other design features to make our client’s use of the space as functionable as possible  

  • Once complete, our testing and certification team arrived to test the humidity, pressurizations, lighting levels, air flow, particle counts, and balancing of the rooms. Our testing and certification instrumentation has been calibrated to standards traceable to the National Institute of Standards and Technology (NIST).  A requirement for the ISO 17025 accreditation our firm carries.  We test all our cleanroom projects in accordance with ISO 14644.   

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Check Out Our Design & Build Approach!

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