how to commission a · pdf filehow to commission a cleanroom presented by: vincent sakraida,...
TRANSCRIPT
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How to Commission a Cleanroom Presented by:
Vincent Sakraida, PE, LEED AP
Sakraida & Associates, LLC
Sakraida &
Associates, LLC
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Seminar Outline
• Introduction
• Design Phase
• Installation Verification
• Operational Verification
• Functional Verification
• Post Occupancy.
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Introduction
Vincent Sakraida, PE, LEED AP
• Bachelor of Mechanical Engineering from Georgia Institute of Technology.
• Licensed Professional Engineer in Colorado and Montana.
• 27 Years Experience in Cleanroom Design, Construction, and Operations.
• Written Articles for Engineered Systems and HPAC Magazines. Cleanroom Articles on Cleanroom Design include Cleanroom Design in Ten Easy Steps and Cleanroom Variable Airflow Design.
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Commissioning
“Commissioning is a systematic process of assuring
that a building performs in accordance with the
design intent and the owner’s operational needs.”
1993 National Conference on Building Commissioning
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Cleanroom Commissioning Plan
The Cleanroom Commissioning Plan will have the Five Commissioning Steps:
• Design Phase
• Installation Verification
• Operational Verification
• Functional Verification
• Post Occupancy.
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Cleanroom Commissioning Plan
Design Phase
• Establish Vision for Facility (How Does Cleanroom Meet Owner’s Needs and Mission?)
• Develop Owner’s Project Requirements (OPR) o Project Goals
(Build Sterile Fill Facility Dedicated to New Drug and Having 10,000 Vials Capacity per Day)
o Design Goals (Design Sterile Fill Facility that Meets Industry Standard of Care, Regulatory Requires, Flexibility, Energy Efficiency, and Client SOPs)
o Measurable Performance Criteria (Vials Filled Per Day, Space Particulate Level, Cleaning Changeover Time Frame)
o Budgets
o Schedules
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Cleanroom Commissioning Plan
Design Phase
• Develop Basis of Design o Weather Data
o Space Performance Requirements (Cleanliness Classification, Unidirectional/Non-Unidirectional Airflow, Air Change Rate, Modular Flow, Temperature, Humidity)
o Applicable Codes (International Building Code, Uniform Building Code, EU)
o Applicable Standards (IEST, ASHRAE, ASTM)
o Applicable Regulations (FDA, EPA)
o Applicable Guidelines (ISPE Sterile Fill Guidelines)
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Cleanroom Commissioning Plan
Design Phase
• Develop Commissioning Plan
• Establish a Project Budget
• Review Design at Meeting Owner’s Project
Requirement, Maintainability, Constructability, and
Commissionability.
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Cleanroom Commissioning Plan
Installation Verification
• Verify Equipment and Material Meet Design Intent.
• Verify and/or Attend Factory Acceptance Testing.
• Verify Equipment and Material Installation Meet Industry Standard of Care.
• Verify Equipment Pre-Start Functions That Meet Manufacturer’s Requirements are Completed.
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Cleanroom Commissioning Plan
Installation Verification
• Verify Equipment and System Start-up Meet
Established Protocols.
• Verify Test and Balance Report.
• Assemble Operation and Maintenance Manuals.
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Commissioning Process
Operational Verification
• Verify Equipment and System Operate Per Design
Intent Sequence of Operation.
• Manage Maintenance Staff Training.
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Cleanroom Commissioning Plan
Operational Verification
The Operational Verification is Performed During Three Different Installation Phases, which are:
• As-Built
• At-Rest
• Operational
Why????
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Cleanroom Commissioning Plan
Operational Verification
As-Built: The Cleanroom Enclosure, Electrical, and Mechanical Systems are Complete but the Cleanroom is Empty. Process Equipment and Workbenches are not Installed.
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Cleanroom Commissioning Plan
Operational Verification
At-Rest: The Cleanroom Enclosure, Electrical, Mechanical, and Process Systems are Installed and Operating with NO Operators.
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Cleanroom Commissioning Plan
Operational Verification
Operational: The Cleanroom Enclosure, Electrical, Mechanical, and Process Systems are Installed and Operating with Operators.
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Cleanroom Commissioning Plan
Operational Verification
The Cleanroom Operational Verification should be separated into its major components, which are:
• Cleanroom Enclosure
• Lighting/Electrical
• Noise
• Process Equipment and Systems
• HEPA Filters
• HVAC Systems
• Vibration
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Commissioning Process Operational Verification
Cleanroom Enclosure
Enclosure Leak Testing to:
• Verify there are No Contamination Entering Cleanroom
• Verify Cleanroom Air Leakage is Not Excessive.
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Commissioning Process Operational Verification
Light/Electrical
• Lighting Foot Candle
Levels
• Lighting Level Uniformity
• Lighting Wave Length
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Commissioning Process Operational Verification
Noise
• Cleanroom Noise Level
• Material: Sound Meter
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Commissioning Process Operational Verification
Process Eqpt
• Exhaust Air Flow
• Cooling Water Flow
• Electrical
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Commissioning Process Operational Verification
HEPA Filters
• HEPA Filter Air Leakage
• Material: Aerosol
Generator and Particle
Counter
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Commissioning Process Operational Verification
HEPA Filters
• HEPA Filter Air Flow
• Material: Airflow Hood
or Anemometer
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Commissioning Process Operational Verification
HEPA Filters
• Air Velocity Testing
• Anemometer
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Commissioning Process Operational Verification
HEPA Filters
• Airflow Parallelism
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Commissioning Process Operational Verification
HVAC System
• Total Supply Air Flow
• Total Return Air Flow
• Space Pressurization
and Stability
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Commissioning Process Operational Verification
HVAC System
•Space Temperature
•Space Humidity
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Commissioning Process Operational Verification
HVAC System
• Space Particulate Level
• Room Recovery
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Commissioning Process Operational Verification
Vibration Testing
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Commissioning Process
Functional Verification
• Verify Equipment and Systems Operate Per Design
Intent Sequence of Operation When Integrated With
All Associated Equipment and Systems.
• Verify Equipment and Systems Fail Per Prescribed
Failure Cascade.
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Commissioning Process
Post Occupancy
• Alternate Season Testing.
• End of Warranty Inspection.
• End of Warranty Occupant Interviews.
• Develop Recommissioning Plan.
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Thank you
Vincent Sakraida, PE, LEED AP
Sakraida & Associates, LLC
Sakraida &
Associates, LLC