Basics of Cleanroom Design, Construction, and Start-up Using ISO 14644-4

Learn the basics of cleanroom design, following the outline of the 2022 update of ISO 14644 Cleanrooms and related controlled environments, Part 4: Design, Construct, and Start-up.  In particular the latest approach to air change based on particle source strength, and the 14644-4 outline of cleanroom criteria to be specified.  The course will include discussion of the differences in cleanroom design based on the industry and use.  Design will focus on 4 key areas; air management, process workflow, utility systems, and structure/architecture/materials. Construction will include recommendations for build clean protocols and stages while start-up provides recommendations for certification and commissioning activities related to cleanroom operations.

Course outline     Who should attend?     Course materials     Instructor    Next date and location

Course outline

  1. Introduction – course objectives, presenter qualifications
  2.  Overview of Cleanrooms (Specify)
    1. Terminology (cleanroom, controlled environments, clean zone, protocol)
    2. Cleanrooms for different applications or “why we build cleanrooms”
      1. Test and Assembly - aeronautics
      2. Biomedical Device
      3. Pharmaceutical & Biomanufacturing
      4. Microelectronics / Semiconductor Fabrication
      5. Metals Free / Geo & Water Testing
    3. The spectrum of cleanrooms (modular/portable to stick-built)
      1. When modular/portable is appropriate
      2. Infrastructure support requirements for temperature and humidity control
      3. When you need more than just “clean air”
    4. ISO 14644 Standard “Cleanrooms and associated controlled environments”
      1. Part 1: Classification of air cleanliness
      2. Part 2: Specifications for Testing
      3. Part 3: Test Methods
      4. Part 4: Design, construction and startup
      5. Key features to specify for the cleanroom in addition to Room Class per ISO 14644
      6. Terminology (particulate, cleanroom class, unidirectional airflow, air changes, face velocity, average room velocity)
    5. Reference Standards and Recommended Practices
      1. IEST (RP) CC012 – Considerations in Cleanroom Design
      2. Cleanroom Certification – “did we do what we set out to do”?
      3. IEST (RP) CC006, Testing Cleanrooms & IEST (RP) CC019 certifier qualifications
  3. Cleanroom Concepts – Air Management (Design)
    1. Terminology (make-up air, exhaust air, recirculating air, HEPA filter, ULPA filter, fan-filter unit (FFU), bay/chase, ballroom, differential pressure)
    2. Initial rough estimates and rules of thumb for primary air systems
      1. Exhaust benchmarking, make-up air, and pressurization
      2. Room volumes and air change calculation
    3. Recirculating air strategies
    4. Bay/chase, ballroom, or hybrid based on process and equipment in the cleanroom
      1. Access Floor
      2. Low Wall Return
      3. Horizontal Flow
    5. Room within a room concept – pressurization
      1. Positive pressurization – particulates
      2. Negative pressure - viables
    6. HVAC concepts:
      1. Temperature and Humidity Control
      2. Makeup and recircs with ducted filters
      3. Makeup and recircs with plenums
      4. Makeup and FFU’s – cooling strategies
      5. FFU’s only – clean air without temperature control
    7. Air Filtration:
      1. HEPA definition, ULPA definition
      2. Specifications for filters
      3. IEST (RP) CC007 Testing ULPA’s, CC036 Testing Fan Filter Units, and CC034 Filter Leak Tests
  4. Cleanroom Concepts – Planning: (Design)
    1. Process Flow and Validation (FDA 21CFR211, cGMP)
      1. Controlled not classified (CNC)
      2. Class D (ISO Class 8)
      3. Class C (ISO Class 7)
      4. Class A/B (ISO Class 5)
    2. Building and fire code requirements
      1. Egress from cleanrooms
      2. Semiconductor cleanrooms:  Fabrication Area, Service Corridor, Control Room, hazardous production materials (HPM)
    3. Equipment move-in/out
    4. Work flow, gowning, protocol management
    5. Vibration and EMI considerations
  5. Cleanroom Concepts – Flexibility – adaptability (Design)
    1. We won’t build it again, how can we modify it while it’s operating?
    2. Cross Section Considerations
      1. The case for increased floor to floor building height
      2. Multi-level cleanroom facilities – fan decks and subfabs
    3. Architectural components
      1. Filters
      2. Ceilings
      3. Partition Systems
      4. Access Floors
      5. Pass throughs, air showers, sliding doors, dumbwaiters
    4. Offgassing – materials selection
  6. Utilities (Design)
    1. Terminology (scrubbed exhaust, PCW, ICW, UPW, house gases, specialty gases, tool power, standby power, UPS, process vacuum, housekeeping vacuum)
    2. Which utilities do we need? –based on processes and techniques in the cleanroom
    3. Flexibility is mandatory
    4. Overhead or underfloor?
      1. Exhaust systems (different types for different cleanroom use)
      2. Piped utilities
        1. Wet (UPW, PCW, ICW, WFI)
        2. Dry (house gases, specialty gases, vacuum systems)
        3. Drains – sanitary, lab waste, treated waste, manual collection
    5. Power systems
      1. Normal power
      2. Standby power
      3. UPS
  7. Cleanroom Construction Fundamentals (Construct)
    1. Terminology (Build Clean, base build, fit-up, hook-up)
    2. “Build Clean”
      1. The role of the cleanroom director
      2. Construction Stages
      3. Protocol levels in construction and key milestones (dried in, blowdown, set filters, certification)
      4. Types of certification – ISO 14644
    3. Deferring design decisions – fit-up and hook-up options for equipment in the cleanroom
    4. Why do cleanrooms cost so much?
      1. Comparative Cost Data
      2. MEP requirements
      3. Build Clean Requirements
      4. “Something new and different”
  8. Start-up and Operation (Operate)
    1. Terminology (certification, validation, as-built, at rest, operational)
    2. The role of commissioning in cleanroom startup
    3. The role of test and balance contractors, certification contractors
      1. Why third party certification is still the best approach
      2. The cost of certification
    4. Turnover – construction protocols to operational protocols
    5. User Training – access control, equipment log-in systems
    6. IEST RP-CC026 Cleanroom Operations & CC027 Personnel Practices
    7. Operating Costs
      1. Energy hogs & Conservation strategies
      2. Consumables
        1. Utilities (gases, UPW, waste treatment, waste collection)
        2. Protocols (gowns, gloves, etc) – re-usable vs once through
    8. Cleanroom cleaning
    9. Operations Staff      
  9. Summary and Discussion

Who should attend?

This course is for anyone involved in the cleanroom construction and design phase including start-ups.

Course materials

  • Copy of PowerPoint presentation in course binder

Continuing Education Units: .6 CEUs


Jack Paul, RA, LEED AP
Vice President, Sr. Professional Associate, HDR Inc.
VIew LinkedIn Profile

With over 37 years of experience planning facilities for manufacturing and research, Jack is a nationally recognized expert in cleanroom design and programming.  He is a licensed architect whose work in cleanroom facilities spans multiple industries including semiconductor, aerospace, biomedical devices, and specialized research and testing cleanrooms for water quality and geochemistry.  When programming facilities, he works closely with the facility users and design engineers to integrate detailed requirements into the building and cleanroom support systems. His portfolio contains projects from around the world, including semiconductor fabs and research buildings, nanotechnology research buildings, and facilities for federally funded research and development centers (FFRDC’s) including national laboratories. A recognized leader in the industry, Jack has been published in Controlled Environments, American Laboratory and several other publications. He also frequently speaks on topics ranging from global trends in designing for science to practical strategies for cleanroom, nanotechnology and core facility design.

Next date and location

May 8, 2023
9:00 a.m. - 4:30 p.m. Central TIme
Intercontinental St. Paul Riverfront*
St. Paul, Minnesota
During ESTECH 2023
Click here to view registration information

*Virtual option also available.