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US Laboratory & Cleanroom Design Fundamentals Wei Sun, P.E.
Principal, Director of Engineering Engsysco, Inc.
Ann Arbor, Michigan, USA
US Laboratory & Cleanroom Design Fundamentals
Engsysco
Presented by
Wei Sun, P.E.ASHRAE
“Clean Spaces” Technical Committee (TC9.11) Chairman“Healthcare Facilities” Technical Committee (TC9.6) Member“Laboratory Systems” Technical Committee (TC9.10) Member
Principal, Director of EngineeringEngsysco, Inc.
Ann Arbor, Michigan, USAwww.engsysco.com
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Contents
Lab• Lab definition• Standards and guidelines• Architectural layout &
considerations• Hazard assessment• Fume hoods - type and
configuration• Biological safety cabinets (BSC)
and classification• Bio-safety containment labs (BSL)
and classification• Animal bio-safety labs (ABSL)
and classification• Ventilation and exhaust• Lab pressurization control
Cleanroom• Definition and classifications• Standards• Nonviable, viable particles
(microbiological) and airborne molecular contamination (AMC)
• Airflow quantity and pattern and floor arrangement
• Airlock and pressurization• HVAC, plumbing, fire protection, and
process systems• Common devices and equipment• Architectural construction materials,
cleaning procedures, testing standards and construction cost
• CFD application
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Lab - Introduction
Applications
• Chemical• Biological• Animal• Physical
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Laboratory DefinitionDefinition - A specially constructed enclosed area, its environment has following controlled parameters:
• Temperature• Humidity• Sound and Vibration
Common Requirements
• Airflow Pattern• Pressurization• Microbial Contamination • Chemical Fume Contamination• Process Specific
Special & Unique Requirements
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Hazard Assessment
Hazard Assessment by safety officers and end-users in:
• Chemical hygiene• Radiation safety• Biological safety• Fire and loss prevention• Process/production/research specifics
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General Standards & GuidesStandards:
NFPA 45 – Fire Protection for Laboratories Using Chemicals
NFPA 99 – Health Care Facilities
OSHA – Occupational Exposure to Chemicals in Laboratories
Guides:
ACGIH 2001 – Industrial Ventilation
CDC/NIH 1999 – Bio-safety in Microbiological and Biomedical Laboratories
ASHRAE 2001 – Laboratory Design Guide
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Architectural ConsiderationsLab ModuleBase block of floor planning
Typical Module SizeWidth: 10 - 12 ft. Length: 30 - 36 ft. (or 20 - 24 ft.)
FlexibilityDesigned to adapt for modifications without infrastructure changes
Basic ElementsDuctwork (supply, exhaust)Lab piping (gas, water, steam)HoodsConduits
1/3 Module
Single Module
2/3 Module
DoubleModule
Possible Lab Module Subdivision
x x x x
x
2 x
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Fume Hoods - Configurations
Bench Top
Walk-in
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Fume Hoods - TypesConstant Volume Exhaust System
Open Closed Open Closed
Bypass Restricted Bypass Auxiliary
Reduce exhaust by 30-60%Maintain the same exhaust
Open Closed
Maintain the same exhaust,Auxiliary flow at 50% or more
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Fume Hoods -TypesVariable Volume Exhaust System
Open Closed
Restricted Bypass
Exhaust varies from 0-50%
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Special Purpose Fume HoodsRadioisotope:• One-piece stainless steel interior and work surface with
integral cupsink, all corners coved, welded and grounded.• Filter system required
Perchloric Acid:• Designed to minimize possibility of fire and explosion• One-piece, stainless steel interior and dished work
surface, with all joints coved, welded and grounded. • Collection and disposal of wash-down waters
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Small Hoods
TableTop
Canopy
Up-DraftTable-Top
Down-DraftTable-Top
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Customized Hoods
Bank of floor-mounted hoods
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Exhaust Systems
Individual System Manifold System
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Hood VelocityCode Required Face Velocity
Normal Design Face Velocity: 100 FPM
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Hood Accessories
Mixing Faucet, withVacuum Breaker
Remote ControlWater Faucet
Velocity Alarm
Cupsink, Trap and Piping Materials:Epoxy, Poly, Stainless Steel or Glass
S-Trap
P-Trap
Cup Sink
Tailpiece
Remote ControlGas Outlet
Work Surface Material:Epoxy, Stainless Steel
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Biological Safety CabinetsCDC/NIH Standard
Primary Containment for Biohazards:Selection, Installation and Use of Biological Safety Cabinets
(2000 version)
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Biological Safety CabinetsComparison of Biosafety Cabinet (BSC) Characteristics
YES (small amounts)YESSupply air inlets and hard-duct exhausted to outside
through two HEPA filters in seriesN/AIII
YES (minute amounts (2))YES
Same as II, A, but plenums are under negative pressure to room; exhaust air is thimble-ducted to the outside through a HEPA filter
100II, B3
YES (small amounts)YESNo recirculation; total exhaust to the outside through
hard-duct and a HEPA filter100II, B2
YES (minute amounts (2))YESExhaust cabinet air must pass through a dedicated duct
to the outside through a HEPA filter100II, B1
NOYES70% recirculated to the cabinet work area through HEPA; 30% balance can be exhausted through HEPA back into the room or to the outside through a thimble unit
75II, A
YES (1)YESIn at front; exhausted through HEPA to the outside or into the room through HEPA 75I
Volatile ToxicChemicals andRadio-nuclides
Nonvolatile ToxicChemicals andRadio-nuclides
Applications
Airflow PatternFace
Velocity(fpm)
BSCClass
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Biological Safety Cabinets
Positive pressure plenum70%recirc. thru. HEPA30% to outside thru. HEPA
To outside or room thru. HEPA
Class IIType AClass IIType AClass IClass I
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Biological Safety Cabinets
To a dedicated duct to outside thru. HEPA
Class IIType B1Class IIType B1
No recirc.; all exhaust to outside thru. HEPA
Class IIType B2Class IIType B2
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Biological Safety Cabinets
Negative pressure plenum 70% recirc. thru. HEPA30% to outside thru. HEPA
Clean supply from HEPA-filtered room air
Glove box. No direct physical contact
Class IIType B3Class IIType B3
Class IIIClass III Clean Bench Clean Bench
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Examples of Lab Building Configurations
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Examples of Lab Building Configurations
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Lab Airflow ControlsSingle Room Pressurization
Direct Pressure-Differential Control Differential Flow Tracking Control
Hybrid Control
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Air Flows and Personnel Flows among Rooms
AirflowBetweenRooms
Personnel FlowBetweenRooms
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Example of Lab Space Ventilation
Complex (multi-functional) AHU System (Discharge at 55°F year-around)
• Exhaust only• Exhaust w./ heat pipe• Exhaust w./ enthalpy wheel
• Dual Return paths
• Supply air with possible directOA mixing
Use only with psychrometric analysis!!!
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Lab Space Exhaust System
Lower velocity with higher stack,Or, higher velocity with lower stack
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Bio-safety Containment Labs (BSL)
BSL-3 plus:•Separate building or isolated zoneDedicated supply and exhaust, vacuum, and decon systemsOther requirements outlined in the text
Primary barriers = All procedures conducted in Class III BSCs or Class I or II BSCs in combination with full-body, air-supplied, positive pressure personnel suit
BSL-3 practices plus:Clothing change before enteringShower on exitAll material decontaminated on exit from facility
Dangerous/exotic agents which pose high risk of life-threatening disease, aerosol-transmitted lab infections; or related agents with unknown risk of transmission
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BSL-2 plus:Physical separation from access corridorsSelf-closing, double-door accessExhausted air not recirculatedNegative airflow into laboratory
Primary barriers = Class I or II BCSs or other physical containment devices used for all open manipulations of agents; PPEs: protective lab clothing; gloves; respiratory protection as needed
BSL-2 practice plus:Controlled accessDecontamination of all wasteDecontamination of lab clothing before launderingBaseline serum
Indigenous or exotic agents with potential for aerosol transmission; disease may have serious or lethal consequences
3
BSL-1 plus:Autoclave available
Primary barriers = Class I or II BSCs or other physical containment devices used for all manipulations of agents that cause splashes or aerosols of infectious materials; PPEs: laboratory coats; gloves; face protection as needed
BSL-1 practice plus:Limited accessBiohazard warning signs"Sharps" precautionsBiosafety manual defining any needed waste decontamination or medical surveillance policies
Associated with human disease, hazard = percutaneous injury, ingestion, mucous membrane exposure
2
Open bench top sink requiredNone requiredStandard Microbiological Practices
Not known to consistently cause disease in healthy adults
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Facilities (Secondary Barriers)
Safety Equipment(Primary Barriers)PracticesAgentsBSL
Summary of Recommended Biosafety Levels for Infectious Agents
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Bio-safety Labs (BSL-3/4)Primary Barriers- Safety Equipment
Hoods• Fume• Laminar • Containment
BSL-3• BSC cabinets type II & III• Protective clothing
BSL-4• BSC cabinets type III
(Isolator/Glove Box)• Protective clothing &
biohazard suits
Secondary Barriers - Facilities
Access Control• Trap, card keys
Gowning & Entry• Primary gowning – Plant clothes, foot and hair covers• Secondary gowning - Gloves, respirators, self contained suits
De-Gowning & Egress• Transition zone• Decontamination (BSL-4)• Outer germent removal
Material/Equipment Access• Air locks• Pass throughs
Event Response• Spill containment Control and Clean-up• Fire
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Example: Bio-safety Floor Plan(BSL-3)
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Example: Bio-safety Floor Plan(BSL-4)
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Bio-safety Labs (BSL-3/4)For BSL-3
Architectural/Structural
• Structure to Structure• 2 Layers of Gypsum Board Both Taped• All Penetrations Framed or Sleeved• Openings Foam Sealed & Caulked• Doors: Compression Seals Minimum Gap
HVAC Systems
• Room pressurization, air cascades inward• Min. 3 pressure stages• Supply: 95% eff. filtered• Exhaust: Allow recirculation, exhaust to
be HEPA filtered• Standby Power & Redundancy• Status Monitoring & Alarm
For BSL-4 (additional)
Architectural/Structural
• Structural Surround (box in box)• Reinforced Concrete - Slow Cured• Hard surfaces, washable/chemical
resistant• All Penetrations with Embedded Sleeves• Openings Foam Packed, Caulked & Filled• Doors: Captured Inflatable Seals – Air Tight
HVAC Systems
• Min. 4 pressure stages • Supply: HEPA filtered• Exhaust: HEPA filtered, no recirculation
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Bio-safety Labs (BSL-3/4)Plumbing Systems
• Gravity flow, all sanitary and fixture drains to waste de-activation system
• No floor drains• Emergency showers• Containment piping• Heat or chemical treatment• Monitoring
Fire Protection
• Hazard classification• Self closing heads• Run-off containment decontamination• Low water content foam or ”dry” systems
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Bio-safety Labs (BSL-4)Pressurized Suits
Suit Change Room
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Bio-safety Labs (BSL-3/4) Equipment
BSL-3 Gowning with Respirator BSL-4 Pressurized Suit
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Bio-safety Labs (BSL-3/4) Equipment
DecontaminationContainerAirtight Air Lock Bio-Seal Door
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Bio-safety Labs (BSL-3/4) Equipment
AccessDoor
HEPAFilteredExhaust
EffluentTreatment
GloveBox
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Animal Labs: Bio-safety Levels
ABSL-3 facility plus: Separate building or isolated zone Dedicated supply and exhaust, vacuum and decontamination systems Other requirements outlined in the text
ABSL-3 equipment plus: Maximum containment equipment (i.e., Class III BSC or partial containment equipment in combination with full body, air-supplied positive-pressure personnel suit) used for all procedures and activities
ABSL-3 practices plus: Entrance through change room where personal clothing is removed and laboratory clothing is put on; shower on exiting All wastes are decontaminated before removal from the facility
Dangerous/exotic agents that pose high risk of life threatening disease; aerosol transmission, or related agents with unknown risk of transmission.
4
ABSL-2 facility plus: Physical separation from access corridors Self-closing, double-door access Sealed penetrations Sealed windows Autoclave available in facility
ABSL-2 equipment plus: Containment equipment for housing animals and cage dumping activities Class I or II BSCs available for manipulative procedures (inoculation, necropsy) that may create infectious aerosols. PPEs: appropriate respiratory protection
ABSL-2 practices plus: Controlled access Decontamination of clothing before laundering Cages decontaminated before bedding removed Disinfectant foot bath as needed
Indigenous or exotic agents with potential for aerosol transmission; disease may have serious health effects.3
ABSL-1 facility plus: Autoclave available Handwashing sink available in the animal room. Mechanical cage washer used
ABSL-1 equipment plus primary barriers: containment equipment appropriate for animal species; PPES: laboratory coats, gloves, face and respiratory protection as needed.
ABSL-1 practices plus: Limited access Biohazard warning signs Sharps precautions Biosafety manual Decontamination of all infectious wastes and of animal cages prior to washing
Associated with human disease. Hazard: percutaneous exposure, ingestion, mucous membrane exposure.
2
Standard animal facility No recirculation of exhaust air Directional air flow recommended Handwashing sink recommended
As required for normal care of each species.
Standard animal care and management practices, including appropriate medical surveillance programs
Not known to consistently cause disease in healthy human adults.
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Facilities (Secondary Barriers)
Safety Equipment (Primary Barriers)PracticesAgentsABSL
Summary of Recommended Biosafety Levels for Activities in Which Experimentally or Naturally Infected Animals Are Used
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Animal Labs
ABSL - 1 Animal Facility
Mech. Floor
Animal Floor
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Animal Labs
ABSL - 2 Animal Facility
Mech. Floor
Animal Floor
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Animal Labs
ABSL - 3 Animal Facility
Mech. Floor
Animal FloorHEPA Floor
Waste Floor
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Animal Labs
Mech. Floor
Animal FloorHEPA Floor
Waste Floor
ABSL - 4 Animal Facility
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Animal Labs
Rack washer
Autoclave
Tunnel washer
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Animal LabsCage Stand-aloneVentilation
Cage Room VentilationSystem
Cage Room VentilationSystem
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Bio-safety Guidelines and Standards
Biological Safety Guidelines and Standards
CDC/NIH - Biosafety in Microbiological and Biomedical Laboratories
USDA Agricultural Research Service (ARS) - Facility Design Standards
Animal & Plant Health Inspection Service (APHIS) - Quarantine Facility Guidelines
WHO - Laboratory Safety Guidelines
NFPA Standard 45 – Fire protection for laboratories using chemicals
NIH – Research laboratory design policy and guidelines
NIH – Vivarium design policy and guidelines
NSF Standard 49-92 – Biohazard cabinetry
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Cleanroom - Introduction
Applications
• Semiconductor• Microelectronic• Pharmaceutical• Biotechnology• Medical Devices• Hospital• Aerospace• Automotive• Miscellaneous
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Cleanroom DefinitionDefinition - A specially constructed enclosed area, its environment has following controlled parameters:
• Temperature• Humidity• Sound and Vibration
Common Requirements
• Airflow Pattern• Pressurization• Particle Count• Microbial Contamination • Electrostatic Discharge (ESD)• Gaseous Contamination• Process Specific
Special & Unique Requirements
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StandardsU.S. Federal Standard 209E
Airborne particulate cleanliness classes in cleanrooms and clean zones (former US standard, canceled in November 2001)
ISO Document ISO-14644: Cleanrooms and Associated Controlled Environments
ISO-14644-1 Classification of Air Cleanliness
ISO-14644-2 Cleanroom Testing for Compliance
ISO-14644-3 Methods for Evaluating & Measuring Cleanrooms & Associated Controlled Environments
ISO-14644-4 Cleanroom Design & Construction
ISO-14644-5 Cleanroom Operations
ISO-14644-6 Terms, Definitions & Units
ISO-14644-7 Enhanced Clean Devices
ISO-14644-8 Molecular Contamination
ISO-14698-1 Biocontamination: Control General Principles
ISO-14698-2 Biocontamination: Evaluation & Interpretation of Data
ISO-14698-3 Biocontamination: Methodology for Measuring Efficiency of Cleaning Inert Surfaces
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ClassificationsAir Cleanliness Class Definition Comparison Between FS 209 and ISO 14644
FS 209 ISO 14644 FS 209 ISO 14644 FS 209 ISO 14644 FS 209 ISO 14644 FS 209 ISO 14644 FS 209 ISO 14644
Particles/ft3 Particles/m3 Particles/ft3 Particles/m3 Particles/ft3 Particles/m3 Particles/ft3 Particles/m3 Particles/ft3 Particles/m3 Particles/ft3 Particles/m3
1 10 22 100 24 10 4
1 3 35 1,000 7.5 237 3 102 1 35 810 4 350 10,000 75 2,370 30 1,020 10 352 83
100 5 100,000 750 23,700 300 10,200 100 3,520 832 291000 6 1,000,000 237,000 102,000 1,000 35,200 8,320 7 293
10,000 7 10,000 352,000 83,200 70 2,930100,000 8 100,000 3,520,000 832,000 700 29,300
9 35,200,000 8,320,000 293,000
0.1 µm 0.5 µm 5.0 µm0.3 µm 1 µmFS 209 Class
ISO 14644 Class
0.2 µm
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ClassificationsOld Air Cleanliness Class Definition - FS 209
1
10
100
1,000
10,000
100,000
1,000,000
10,000,000
100,000,000
0.01 0.1 1 10
PARTICLE SIZE, μm
PAR
TIC
LES
PER
CU
BIC
MET
ERS
FS-1
FS-100,000
FS-10,000
FS-1,000
FS-100
FS-10
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ClassificationsCurrent Air Cleanliness Class Definition - ISO 14644
1
10
100
1,000
10,000
100,000
1,000,000
10,000,000
100,000,000
0.01 0.1 1 10
PARTICLE SIZE, μm
PAR
TIC
LES
PER
CU
BIC
MET
ERS
ISO-1
ISO-2
ISO-3
ISO-6
ISO-9
ISO-8
ISO-7
ISO-5
ISO-4
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ClassificationsClassification Comparison Between FS 209 and ISO 14644
1
10
100
1,000
10,000
100,000
1,000,000
10,000,000
100,000,000
0.01 0.1 1 10
PARTICLE SIZE, μm
PAR
TIC
LES
PER
CU
BIC
MET
ERS
ISO-1
ISO-2
ISO-5
ISO-4
ISO-3
ISO-6
ISO-9
ISO-8
ISO-7
FS-1
FS-100,000
FS-10,000
FS-1,000
FS-100
FS-10
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Airborne Particles
Airborne particulates can be:
1. Particles larger than 100 microns can be seen with naked eyes.
2. Next step particles ranging from 0.001 to 100 microns are main interest of contamination for years.
3. Atoms and molecules used to be considered too small as industrial contamination, but not any more after introduction of molecular contamination.
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Airborne Molecular ContaminationAirborne Molecular Contamination (AMC)
Definition: By draft Standard ISO 14644-8. AMC is:• Molecular (non-particulate) species • Gaseous or vapor state (non-solid)• May be harmful to product, process, or equipment• Concentrations between 100 to 10-12 g/m3
Categories: Semiconductor Equipment and Materials International (SEMI) Standard F21-95 defined AMC into four categories:
• Acids (A)• Bases (B)• Condensables (C)• Dopants (D)
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Airborne Molecular ContaminationClassification: The classification number is determined by the maximum allowable concentration of a category expressed in parts per trillion molar.
Format: MX-xxxx,X - represents the first letter of the contaminant category (A, B, C, or D)xxxx - represents the magnitude for the concentration allowed For instance, MA-100 : Max. concentration of all acids < 100 ppt molar
Surface Deposition: AMC can occur in a reversible (physically deposit on surface) or irreversible (once it contacts, it remains on the surface, often chemically reactive) manner.
Gas Phase Filtration: Apply gas-phase filtration in both make-up and recirculation air units. This filtration lets a gas compound be attracted to the solid surface and then is chemically bound or changed. Activated carbon is the most commonly used absorption material.
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Airborne Molecular Contamination
Airborne Molecular Contamination (AMC)
Equipment: Real-time monitoring of longer-term AMC mass deposition trends and rates are available.
Design Reference: IEST-RP-CC035: “Design Considerations for Airborne Molecular Contamination Filtration Systems in Cleanrooms”
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Particle Sources & Control Sources of Contamination
Description Control Methods
Infiltration through doors, and cracks at windows, and walls
Tighter exterior wall construction, exterior zone pressurization, vestibules at main entrances, and seal space penetrations.
Outdoor air
Makeup air entering through the air conditioning systems
Multiple level filtrations External
Indoor transfer air between rooms
Infiltration through doors, windows, and wall penetrations for pipes, ducts, etc.
Seal wall penetrations, multiple level pressurizations & depressurizations to obtain proper airflow directions
People
Largest source of internal particles: skin scales, hair, textile fibers
Garments, proper gowning procedures, air shower before entry
Work surface shedding
Rubbing one item against another
Use cleanroom suitable or rated furniture
Process equipment
Spray, painting, welding, grinding
Local filtration and exhaust
Raw and semi-finished material During transport
Equipment washing, cleaning and sterilization before entry, use airlock & pass-through
Liquids, pressurized gases used in process
During preparation, processing and packaging
Local exhaust
Chemicals used for cleaning Out-gassing to room Use cleanroom suitable
or rated cleaners
Internal
Room construction materials
Dust generated from wall, floor, ceiling, door, fibrous insulation
Constructed with special building materials
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Particle Dispersion in Relation to Movement (Example: Personnel)
Sitting QuietlyParticles shed per min.= 100,000
MovingParticles shed per min.= 1 million
WalkingParticles shed per min.= 5 million
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Microbiological Contamination & Control
Control Methods
Physical:
• Heat• Radiation• Filtration
Chemical:
• Sterilization• Disinfection
• Unlike non-viable particles, which can’t reproduce, microorganisms could reproduce at a rapid speed if nutrition and environment are favorable.
• Microorganism can be classified as bacteria, algae, fungi, protozoa and viruses. Some of these are essential, useful and harmless, while others are harmful and dangerous.
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Airborne Particle Physical Controls
Containing or isolating particle generations with barriers
• Process exhaust• Mini-environment
IsolationDiluting internally contaminated air with clean, filtered air
• Higher airchangerate, betterdilution.
DilutionUtilizing HEPA & ULPA filters to remove particles from supply air
• HEPA: 99.97%([email protected]μm)
• ULPA: 99.9997%([email protected]μm)
Filtration
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Typical Ceiling Filter Coverage
Class
US 209 ISO
Ceiling Filter Coverage
HEPA or
ULPA
9 5% - 15% 100,000 8 5% - 15% 10,000 7 15% - 20% 1,000 6 25% - 40% 100 5 35% - 70%
HEPA
10 4 60% - 90% 1 3 60% - 100%
2 80% - 100% 1 80% - 100%
ULPA
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Room Airflow Quantity(Traditional Methodology)
Classification
ISO Class FS-209 Class
Air Change Per Hour
Range 8 100,000 5 – 48 7 10,000 60 – 90 6 1,000 150 – 240 5 100 240 – 480 4 10 300 – 540 3 1 360 – 540 2 360 – 600 1
IEST Recommended (RP-12) Air Change Rate For Cleanrooms
5
150
240
300
360360360
4890
240
480
540540
600600
600
100
200
300
400
500
600
700
0 1 2 3 4 5 6 7 8 9
ISO Cleanliness Class
Air
Chan
ge P
er H
our (
AC
H)
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Airflow Patterns
Non-Unidirectional(Conventional) Flow
UnidirectionalFlow
Mixed Flow
Mini-EnvironmentFlow
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Cleanroom Floor Arrangements
Ballroom Office and Support
AreasCleanrooms
Service Area
Service Area
Mini-Environment
Service Chase
Office and Support
AreasCleanrooms
Service Area
Service Area
CCCC
C CCC
Office and Support
AreasCleanrooms
Service Area
Service Area
RRRRR
RRRRR
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Fan Arrangement
Fan TowerFan Filter Units
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Control Airflows Between Rooms Air Lock
CLEANROOM
AIRLOCK
+CORRIDOR
++
+++
AIRFLOW
CASCADING AIRLOCK
AIRFLOW CLEANROOM
AIRLOCK
+CORRIDOR
++
-
AIRFLOW
BUBBLE AIRLOCK
AIRFLOW
CLEANROOM
AIRLOCK
+CORRIDOR
- -
-
AIRFLOW
SINK AIRLOCK
AIRFLOW CLEANROOM
AIRLOCK
-CORRIDOR
++
-
AIRFLOW
AIRFLOW
- -AIRLOCK
DUAL COMPARTMENT AIRLOCK
Air LockAn intermediate room between adjacent areas with different cleanliness to prevent airborne cross contamination
Type• Cascading• Bubble• Sink• Dual Compartment
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Control Airflows Between Rooms Air Lock
Type of Cleanroom Selection of Airlock
Functionality of Airlock Relative Pressure Relationship
• Positive pressure • No fume or bio agent • No containment
needed
Cascading • Prevent cleanroom being contaminated from dirty corridor air
• Prevent cleanroom being contaminated from surrounding spaces through cracks
Cleanroom: +++ Airlock: ++ Corridor: +
• Negative pressure • Has fume or bio
agent contamination • Containment needed
Bubble • Prevent cleanroom being contaminated from dirty corridor air
• Prevent cleanroom fume or bio agent releasing to corridor
Cleanroom: - Airlock: ++ Corridor: +
• Negative pressure • Has fume or bio
agent contamination • Containment needed
Sink • Prevent cleanroom being contaminated from dirty corridor air
• Allow cleanroom fume or bio agent releasing to airlock. No personal protective equipment is needed
Cleanroom: - Airlock: - - Corridor: +
• Negative pressure • Has toxic fume or
hazardous bio agent contamination, or has potent compound substances
• Containment needed • Personal protection
needed
Dual Compart-ment
• Prevent cleanroom being contaminated from dirty corridor air
• Prevent cleanroom fume or bio agent releasing to corridor
• Personal protective equipment (such as pressurized suit and respirator) is required
Cleanroom: - Neg. Airlock: - - Pos. Airlock: ++ Corridor: -
Application• Positive or
Negative Pressure?
• Has Fume or BioContamination?
• ContainmentNeeded?
• Personal ProtectionNeeded?
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Control Airflows Between Rooms Pressurization
• Air should always flows from high pressure to low pressure area. Normally the desired flow path should be from the area of cleanest, to less-clean, to less-contaminated, and then to dirty areas.
• Pressurization is defined as a technique that air pressure differences are created mechanically between rooms to introduce intentional air movement paths through room leakage openings. These openings could be either designated, such as doorways, or undesignated, such as air gaps around doorframes or other cracks.
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Control Airflows Between Rooms Pressurization
0100
200300
400500
600700
800900
1,000
1,1001,200
1,3001,400
1,500
1,6001,700
1,8001,900
2,000
0 0.005 0.01 0.015 0.02 0.025 0.03 0.035 0.04 0.045 0.05 0.055 0.06 0.065 0.07 0.075 0.08
Pressure Differential Between Rooms (in.)
Leak
age
Flow
rate
(cfm
)
• Room pressurizationEntering (SA) airflow rate is higher than leaving (EA + RA) airflow rate in the room, room net (offset) flow is positive.
• Room depressurizationEntering (SA) airflow rate is lower than leaving (EA + RA) airflow rate in the room, room net (offset) flow is negative.
Single Room Pressurization 400Leakage Area(Sq. in.)
380360340320
300280
260
240
220200
180
160140
120100
80
60
40
20
Room Net Flow Rate vs. Pressure Differential
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Control Airflows Between Rooms Pressurization
Single Room Pressurization-Problems
Single room control technologies often cause problemsduring air balancing:
• Adjusting one room’s offset value will impact adjacent rooms’ air pressures if they were just balanced earlier.
• Design engineer should note that one room’s air gain could be another room’s air loss through leakages.
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Control Airflows Between RoomsPressurization
Multiple Room (Suite) Pressurization
Pharmaceutical – Aseptic Suite
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Control Airflows Between Rooms Pressurization
Multiple Room (Suite) Pressurization ─New Adaptive Control Technology
• Better control strategy is to control all rooms’ pressures as an optimized system, instead to control room pressures independently.
• The three “single room control methods” are either to “ignore”, “assume” or “manually fix in field” the offset value.
• New Adaptive Control is more suitable for suite pressurization. It controls the offset value accordingly through an “offset reset equation” which is based on an “identified” relationship in order to achieve optimized airflows (supply, return or exhaust) and the desired pressure in the rooms. It is a principal-based, auto-tuning control scheme.
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Typical HVAC Systems
FS209 Class10,000, 100,000
ISO Class7, 8
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Typical HVAC Systems
FS209 Class100, 1,000
ISO Class5, 6
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Typical HVAC Systems
FS209 Class1, 10
ISO Class3, 4
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Basic HVAC Flow DiagramsConfiguration-1: Conventional Primary loop
RA
EA
SA
Q
OAOA+RASA
Space Impurity Concentration
ExhaustAir
LeakageAir
Particle Generation
Deposition
Cs
Space
D
G
Efficiency Ea
SupplyAir
ReturnAir
MakeupAirCo
CeCs
Cs
HC
FILT
ERCC
AHU Unit
HEP
A
Efficiency Eb
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Basic HVAC Flow DiagramsConfiguration-2: Primary loop with supply bypass
RA
EA
SA1
Q
OAOA+RASA
Space Impurity Concentration
ExhaustAir
LeakageAir
Particle Generation
Deposition
Cs
Space
D
G
Efficiency Ea
ReturnAir
MakeupAirCo
CeCs
Cs
HC
FILT
ERCC
AHU Unit
SA1
SA2 SA2+RA
SupplyAir
HEP
A
Efficiency Eb
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Basic HVAC Flow DiagramsConfiguration-3: Primary loop with dual returns
RA
EA
SA
Q
OAOA+RA1
Space Impurity Concentration
ExhaustAir
LeakageAir
Particle Generation
Deposition
Cs
Space
D
G
Efficiency Ea
ReturnAir
MakeupAirCo
CeCs
Cs
HC
FILT
ERCC
AHU UnitSA=OA+RA
RA2
FILT
ER
Efficiency EbRA1
SupplyAir
HEP
A
Efficiency Ec
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Basic HVAC Flow Diagrams
Configuration-4: Primary loop plus secondary makeup unit
RA
EAQ
OAOA+RASA
Space Impurity Concentration
ExhaustAir
LeakageAir
Particle Generation
Deposition
Cs
Space
D
G
Efficiency Eb
ReturnAir
Treated MakeupAirC1
CeCs
Cs
FILT
ER
Primary Fan Unit
HC
FILT
ERCC
Secondary Makeup Unit
OA
MakeupAirCo
SA
SupplyAir
HEP
A
Efficiency Ea
Efficiency Ec
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Basic HVAC Flow DiagramsConfiguration-5: Primary loop plus secondary AHU unit with dual returns
RA
EAQ
OA+RA2OA+RASA
Space Impurity Concentration
ExhaustAir
LeakageAir
Particle Generation
Deposition
Cs
Space
D
G
Efficiency Eb
ReturnAir
Treated MakeupAirC1
CeCs
Cs
FILT
ER
Primary Fan Unit
HC
FILT
ERCC
Secondary AHU Unit
OA
MakeupAirCo
SA
SupplyAir
HEP
A
Efficiency Ea
Efficiency EcRA2RA1
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Basic HVAC Flow DiagramsConfiguration-6: Primary loop plus secondary AHU unit and tertiary
makeup unit with dual returns
RA
EAQ
OA+RA2OA+RASA
Space Impurity Concentration
ExhaustAir
LeakageAir
Particle Generation
Deposition
Cs
Space
D
G
Efficiency Eb
ReturnAir
Treated MakeupAirC1
CeCs
Cs
FILT
ER
Primary Fan Unit
HC
CC
Secondary AHU Unit
OA
SA
SupplyAir
HEP
A
Efficiency Ea
Efficiency EcRA2RA1
HC
FILT
ERCC
Tertiary Makeup Unit
OA
MakeupAirCo
Efficiency EaTreated MakeupAirC1
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Process and Building Systems
Building Systems
• City water & gas services
• Cold/hot water distributions
• Gas distributions• Storm, sanitary &
vent • Fire pump &
automatic sprinkler systems
• Emergency power generator
• HVAC & Indoor comfort
• Building management
Cleanroom HVAC&R
• Make-up system• Recirculation system• Return air system• Temperature &
humidity controls• Room pressure control• Noise and vibration
control• Hydronic heating• Comfort chilled water• Cooling tower water• Particle counting
Cleanroom Process
• Gas detection• Static control• RO and DI waters• Process chilled water• Chemical gases and storages• Solvent drain and collection• Solvent gas exhaust• Process vacuum• Scrubbed exhaust• House vacuum• Acid drain and waste
neutralization• Clean dry air • Instrumentation air & control
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Typical Specified Cleanroom Components, Devices & Equipment
Fan-Filter Ceiling Module
HEPA / ULPA Filter
Bag-in/Bag-out multiple filters- Against biological, chemical & radiological materials
Air Filtration
Handhold Particle Counter
Pharmaceutical cGMPParticle Monitoring & Validation
Microbial Air Sampler &Agar Media
Portable Particle CounterAir Particle Sensor
Air Sampling
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Typical Specified Cleanroom Components, Devices & Equipment
Air Valve
Precision Room Pressure Transducer
Floor Grate & Perforated Panel
Isolator (Glove Box) Small Mini-Environment
Product Pass-through
Soft Wall
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Cleanroom Building Exterior and Interior
Building Finished Exterior
Cleanrooms in Construction
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Finished Cleanrooms
Window on Exterior Wall
Window on Interior Wall
Service Hallway Enclosing Cleanrooms
Class 10, Raised Floor
Gowning Area, Raised Floor
Interior HallwaySmall Class 100,000 Cleanroom
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Cleanroom Utility and Support
Large DI Water System
Steam-Hot Water Exchange Unit (Packaged)
AHU Unit for Office/ Administration Areas
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Cleanrooms In Operation
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Cleanroom Construction MaterialsFS Class 1
FS Class 10
FS Class 100
FS Class 1,000
FS Class 10,000
FS Class 100,000
Classification
ISO Class 1, 2 & 3
ISO Class 4
ISO Class 5
ISO Class 6
ISO Class 7
ISO Class 8 & 9
Wall System Aluminum Component
Aluminum Component or Metal Stud
Wall Panel Honeycomb Aluminum Conductive Finish Aluminum Polystyrene Core or Epoxy Coated Steel Laminated over Drywall
Vinyl or Epoxy Coated Drywall
Paint Epoxy
Epoxy / Latex Latex
Ceiling Grid 2” Aluminum Gel Seal Ceiling System
1½” Steel Gasketed
Grid Support All thread with Strut & Turn buckles
12 ga wire to grid, 10 ga wire to filter @ Corner of Grid Intersection Only
Floor Raised Floor with Perforated / Grated Access
Concrete Covered with Epoxy Solids or Sheet Vinyl
Air Return Floor Low Sidewall Low Sidewall or Ceiling
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ISO Construction Cleaning Procedures
Stage Purpose Responsible party Method Standard Stage 1 — Clean during demolition or preliminary construction such as framing for wall installation.
Preventing unnecessary dust concentration in places that will be difficult to reach during later construction.
Contractor. If the construction contractor has no relevant experience in cleanroom cleaning, it is advisable to hire a professional cleaning contractor specializing in cleanroom cleaning.
Vacuum clean upon completion. Visual-clean.
Stage 2 — Clean during utility installation.
Removing local contaminants caused by installing electricity, gas, water, etc.
Installation engineer. Vacuum clean; wipe-down piping and fixtures with moistened wipers upon completion. The use of vacuum cleaning and/or other cleaning materials is necessary.
Visual-clean.
Stage 3 — Clean during early construction.
Cleaning all visible contamination from ceilings, walls, floors, (filter mountings), etc. after completion of construction and installation activities.
Cleaning contractor. Vacuum clean; wipe-down piping and fixtures with moistened wipers. Application of protective floor sealants is generally a particle generating activity. If this is necessary, it should be applied at this time.
Visual-clean.
Stage 4 — Prepare for air conditioning ductwork installation.
Cleaning any dust from ductwork sections before installing using a vacuum cleaner and wipers. Meanwhile, a positive pressure should be introduced to the cleanroom.
Installation engineer and cleaning contractor.
Vacuum clean; wipe down with moistened wipers.
Wiper-clean.
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ISO Construction Cleaning Procedures
Stage Purpose Responsible party Method Standard Stage 5 — Clean before mounting all air filters into the system.
Removing deposited or settled dust, or both, from ceilings, walls, and floors.
Cleaning contractor. Wipe down with moistened wipers. Wiper-clean.
Stage 6 — Mount the (HEPA/ULPA) filters into the air systems
Removing possible contamination caused by the mounting operation.
Cleanroom HVAC filter engineer/ technician.
Clean all surface edges on all sides.
Wiper-clean.
Stage 7 — Adjust the air conditioning equipment.
Removing suspended dust from the airflow and creating overpressure installation, including the filters.
Cleanroom HVAC filter engineer/ technician.
Air conditioning air flushing operation.
Wiper-clean.
Stage 8 — Upgrade the room into prescribed classification.
Removing all deposited and clinging dust from every surface (in order: ceilings, walls, equipment, floors).
A professional cleanroom cleaning by personnel specially instructed on regulations, routing and behaviour.
Wipe down with moistened wipers. Wiper-clean.
Stage 9 — Approve installation.
Verifying the cleanroom to the prescribed design specifications. Customer acceptance.
Installation engineer and certification engineer.
Monitor airborne and surface particles, air velocities, temperature and humidity.
Wiper-clean. Results should conform to agreed design criteria.
Stage 10 — Clean daily and periodically
Maintaining the cleanroom in long-term compliance with designed classification. Microbiological cleaning and testing begins in biocleanrooms.
Cleanroom manager/cleaning contractor.
Listed in F.1 to F.8. A tailor-made cleaning programme for the cleanroom, accounting for the specific demands of the production process and the customer. Routine testing of critical operation parameters.
NOTE 1 During Stages 4 to 10, all high-efficiency and ultra-high-purity components, such as filters, ducts, etc., should arrive on site protected by plastic or foil covers on both ends. Covers should only be removed when ready for use. NOTE 2 During Stages 6 to 10, all activities should be done wearing prescribed cleanroom clothing.
Stage Purpose Responsible party Method Standard Stage 5 — Clean before mounting all air filters into the system.
Removing deposited or settled dust, or both, from ceilings, walls, and floors.
Cleaning contractor. Wipe down with moistened wipers. Wiper-clean.
Stage 6 — Mount the (HEPA/ULPA) filters into the air systems
Removing possible contamination caused by the mounting operation.
Cleanroom HVAC filter engineer/ technician.
Clean all surface edges on all sides.
Wiper-clean.
Stage 7 — Adjust the air conditioning equipment.
Removing suspended dust from the airflow and creating overpressure installation, including the filters.
Cleanroom HVAC filter engineer/ technician.
Air conditioning air flushing operation.
Wiper-clean.
Stage 8 — Upgrade the room into prescribed classification.
Removing all deposited and clinging dust from every surface (in order: ceilings, walls, equipment, floors).
A professional cleanroom cleaning by personnel specially instructed on regulations, routing and behaviour.
Wipe down with moistened wipers. Wiper-clean.
Stage 9 — Approve installation.
Verifying the cleanroom to the prescribed design specifications. Customer acceptance.
Installation engineer and certification engineer.
Monitor airborne and surface particles, air velocities, temperature and humidity.
Wiper-clean. Results should conform to agreed design criteria.
Stage 10 — Clean daily and periodically
Maintaining the cleanroom in long-term compliance with designed classification. Microbiological cleaning and testing begins in biocleanrooms.
Cleanroom manager/cleaning contractor.
Listed in F.1 to F.8. A tailor-made cleaning programme for the cleanroom, accounting for the specific demands of the production process and the customer. Routine testing of critical operation parameters.
NOTE 1 During Stages 4 to 10, all high-efficiency and ultra-high-purity components, such as filters, ducts, etc., should arrive on site protected by plastic or foil covers on both ends. Covers should only be removed when ready for use. NOTE 2 During Stages 6 to 10, all activities should be done wearing prescribed cleanroom clothing.
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Cleanroom TestingRequired Testing (ISO 14644-2)
ISO 14644-1 Annex B412 MonthsAll ClassesAirflowISO 14644-1 Annex B512 MonthsAll ClassesAir Pressure Difference
12 Months> ISO 5ISO 14644-1 Annex A
6 Months<= ISO 5Particle Count Test
Test ProcedureMaximum Time IntervalClassTest Parameter
Schedule of Tests to Demonstrate Continuing Compliance
Optional Testing (ISO 14644-2)
ISO 14644-3 Annex B724 MonthsAll ClassesAirflow Visualization
ISO 14644-3 Annex B1324 MonthsAll ClassesRecoveryISO 14644-3 Annex B424 MonthsAll ClassesContainment LeakageISO 14644-3 Annex B624 MonthsAll ClassesInstalled Filter Leakage
Test ProcedureMaximum Time IntervalClassTest Parameter
Schedule of Additional Optional Tests
Reference: NEBB (National Environmental Balancing Bureau)-“Procedural Standards for Certified Testing of Cleanrooms”
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Cleanroom Construction Cost
Mechanical Construction Cost, conducted by Richard Pavlotsky in 2003
$453-$810$203-$363$97-$167$79-$141Mech. Const. Cost /SQ. FT.
ISO-3FS-1
ISO-5FS-100
ISO-7FS-10,000
ISO-8FS-100,000
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Cleanroom Construction CostExample: Fab Facility Total Cost, conducted by Norbert Wiegler
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Cleanroom Design Problems & Validation
Common Design Problems• Poor laminarity• Fail to pressurize to specified pressure levels• Local stagnation near point of service• Ineffective chemical vapor exhaust• Too high noise• Temperature & humidity variations above specifications
How to Ensure Quality During Design Phase?• Engineer’s design knowledge & experience• Mock-up or scale-down model• CFD validation
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CFD Applications
A case study: Examination of flow laminarity of a cleanroom with a subfab underneath
CFD model geometry
FloorCeiling
Slab
FAB
SUBFAB CHASE
Cleanroom with 35% FA Floor Panels
Narrower Cleanroom with 35% FA Floor Panels
Cleanroom with 20% FA Floor Panels
Cleanroom with 10% FA Floor Panels
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Technology Trend – Determination of Airflow Rate Based on Particle Generation Rate
During Design Phase
Room Particle Concentration versus Air Change Rate (Steady State)
- Effect of Internal Particle Generation Rate
0.1
1.0
10.0
100.0
1,000.0
10,000.0
100,000.0
1,000,000.0
0 100 200 300 400 500 600
Supply Air ACH (Air Change Per Hour)
Con
cent
ratio
n (N
umbe
r of P
artic
les
Per F
T3 )
G=1
G=10
G=100
G=1000
G=10000
Condition:
OA/SA=5%CO=1x106
EU=95%EH=99.97%η =1.0
Internal Particle Generation Rate:G = Rate of impurity generation unit floor area, averaged throughout the space
Unit: Particals/FT3/Min.
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Technology Trend – Provide Airflow Rate Based on Particle Generation Rate
During Operating Phase
ACH
Rat
e
Room Particle Generation Rate G
VFD Ventilation
Staged Ventilation
The goal is to stage the ventilation rate to maintain the same room cleanliness level through particle sensing during all modes (occupied and unoccupied)
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Q & A
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