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“Commissioning is a systematic process of assuring that a CLEAN ROOM performs in accordance with the design intent and the owner’s operational needs.”
The Cleanroom Commissioning Plan will have
the Five Commissioning Steps Below:
• Design Phase
• Installation Verification
• Operational Verification
• Functional Verification
• Post Occupancy.
Design Phase
Establish Vision for Facility & Utility
(How Does Cleanroom Meet Owner’s Needs and Mission?)
Develop User Requirement Specifications (URS)
Project Goals
(To meet ISO 14644 clean room standard / GMP/PIC/Meet Local Code requirement etc.)
Design Goals
(Design Space Management, Sterile Fill Facility that Meets Industry Standard of Care, Authority Regulatory Requires, Flexibility For Future Expansion, Energy Efficiency, and meet Client SOPs etc.)
Measurable Performance Criteria
(Space Particulate Level, Daily Record Clean Room Temperature & Relative Humidity,
Cleaning, Changeover Time Frame).
Budgets?
Schedules / Timeframe?
Develop Basis of Design
Space Performance Requirements
(Cleanliness Classification, Unidirectional/Non-Unidirectional Airflow, Air Change Rate, Modular Flow, Temperature, Relative Humidity, User Friendly Space Management etc.)
Applicable Codes
(International Building Code, Uniform Building Code, Local Authority Code BCA/ SCDF /HSA etc.)
Applicable Standards
(NEBB, ASHRAE, ASTM etc.)
Applicable Regulations
(Owner In-house Rules and Regulations etc.)
Applicable Guidelines
(Specialist Installer Guidelines etc.)
Develop Commissioning Plan
Establish a Project Budget
Review Design at Meeting with Owner’s Project
Requirement, Maintainability, Sustainability,
Constructability, and Commission ability.
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.
• Verify Equipment and System Start-up Meet Established Protocols.
• Verify Test and Balance Report.
• Assemble Operation and Maintenance Manuals.
Operational Verification
• Verify Equipment and System Operate Per Design Intent Sequence of Operation.
• Manage Maintenance Staff Training.
The Operational Verification is Performed During Three Different Installation Phases, which are:
• As-Built
• At-Rest
• Operational
As-Built:
The Cleanroom Enclosure, Mechanical and Electrical, Systems are Complete but the Cleanroom is Empty. Process Equipment, Furniture and Workbenches are not Installed.
At-Rest:
The Cleanroom Enclosure, Mechanical, Electrical, and Process Systems are Installed and Operating with NO Operators.
Operational:
The Cleanroom Enclosure, Mechanical, Electrical, and Process Systems are Installed and Operating with Operators.
The Cleanroom Operational Verification should be
separated into its major components, which are:
• Cleanroom Enclosure (Partition, Ceiling, Floor etc.)
• ACMV / HVAC Systems
• HEPA Filters
• Noise
• Lighting / Electrical
• Space Particulate Level
• Process Equipment and Systems
• Vibration (if require)
Cleanroom Enclosure
Enclosure Leak Testing to:
• Verify there are No Contamination Entering to Cleanroom
• Verify Cleanroom Air Leakage is Not Excessive.
HEPA Filters
• HEPA Filter Air Flow Check
• Equipment / Tools : Airflow Hood or Anemometer to Check Air Velocity
ACMV / HVAC System
• Total Supply Air Flow
• Total Return Air Flow
• Space Pressurization and Stability
ACMV / HVAC System
•Space Temperature
•Space Humidity
HEPA Filter Air Leakage Checks
• Material: Aerosol Generator and Particle Counter
Airflow Parallelism Check
Airflow Visualization Test (Smoke test)
Noise
Noise
• Cleanroom Noise Level
• Equipment Tools To Measure: Sound Meter
Light / Electrical
• Lighting Foot Candle Levels
• Lighting Level Uniformity
• Lighting Wave Length
Space Particulate Level
(Equipment / Tools: Particle Counter)
• Room Recovery
Operational Verification (if require)
Process Eqpt
• Exhaust Air Flow
• Cooling Water / Gases Flow etc.
• Electrical
Operational Verification (if require)
Vibration Testing
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.
Post Occupancy
• Alternate Season Testing (During DLP).
• End of Warranty Inspection (During Final Inspections Service).
• End of Warranty Occupant Interviews (During Hand Over to Building Facility Dept) .
• Develop Recommissioning Plan (During Plan Maintenance).
GMPc Clean Room Information
Good Manufacture Practice "current" for Medicinal Products
Local Authority Compliances (Singapore)
HSA-Health Sciences Authority
PICs- Pharmaceutical Inspection Co-operation Scheme
General Documentation Procudure
User Requirement Specifications (URS)
Good Engineering Practice (GEP)
Design Qualification (DQ)
Installation Qualification (IQ)
Operation Qualification (OQ)
Performance Qualification (PQ)
Terminology
Active Pharmacy Ingredient (API)
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