US Laboratory & Cleanroom Design Fundamentals

US Laboratory & Cleanroom Design Fundamentals
Wei Sun, P.E.

Principal, Director of Engineering
Engsysco, Inc.
Ann Arbor, Michigan, USA
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US Laboratory & Cleanroom
Design Fundamentals
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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 Engineering
Engsysco, Inc.
Ann Arbor, Michigan, USA
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Engsysco
www.engsysco.com
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Contents
Lab
Cleanroom
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
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 Definition
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Definition - 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
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Hazard Assessment by safety officers and endusers in:
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Chemical hygiene
Radiation safety
Biological safety
Fire and loss prevention
Process/production/research specifics
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General Standards & Guides

Standards:
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NFPA 45 Fire Protection for Laboratories Using Chemicals

NFPA 99 Health Care Facilities
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OSHA Occupational Exposure to Chemicals in Laboratories
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Guides:
ACGIH 2001 Industrial Ventilation
CDC/NIH 1999 Bio-safety in Microbiological and Biomedical Laboratories
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ASHRAE 2001 Laboratory Design Guide
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Architectural Considerations
Lab Module
Base block of floor planning
Typical Module Size
Width: 10 - 12 ft.
Length: 30 - 36 ft. (or 20 - 24 ft.)
Flexibility
Designed to adapt for modifications
without infrastructure changes
Single
Module
2x
1/3
Module
2/3
Module
Double
Module
Possible Lab Module Subdivision
Basic Elements
Ductwork (supply, exhaust)
Lab piping (gas, water, steam)
Hoods
Conduits
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Fume Hoods - Configurations
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Bench Top
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Walk-in
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Fume Hoods - Types
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Constant Volume Exhaust System

Bypass
Restricted Bypass
Auxiliary
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Open
Closed
Maintain the same exhaust
Open
Closed
Reduce exhaust by 30-60%
Open
Closed
Maintain the same exhaust,

Auxiliary flow at 50% or more
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Fume Hoods -Types

Variable Volume Exhaust System
Restricted Bypass
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Open
Closed
Exhaust varies from 0-50%
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Special Purpose Fume Hoods

Radioisotope:
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
Table
Top
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Up-Draft
Table-Top
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Down-Draft
Table-Top
Canopy
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Customized Hoods
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Bank of floor-mounted
hoods
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Exhaust Systems
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Individual System
Manifold System
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Hood Velocity
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Code Required Face Velocity
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Normal Design Face Velocity: 100 FPM
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Hood Accessories
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Cupsink, Trap and Piping Materials:

Epoxy, Poly, Stainless Steel or Glass
Remote Control
Water Faucet
Velocity Alarm
Remote Control
Gas Outlet
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Cup Sink
S-Trap
Tailpiece
P-Trap
Mixing Faucet, with

Vacuum Breaker
Work Surface Material:

Epoxy, Stainless Steel
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Biological Safety Cabinets

CDC/NIH Standard
Primary Containment for Biohazards:
Selection, Installation and Use of Biological Safety Cabinets
(2000 version)
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Comparison of Biosafety Cabinet (BSC) Characteristics

BSC
Class
Face
Velocity
(fpm)
75
II, A
75
II, B1
II, B2
Applications
Nonvolatile Toxic
Chemicals and
Radio-nuclides
Volatile Toxic
Chemicals and
Radio-nuclides
In at front; exhausted through HEPA to the outside or

into the room through HEPA
YES
YES (1)
70% 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
YES
NO
100
Exhaust cabinet air must pass through a dedicated duct

to the outside through a HEPA filter
YES
YES (minute
amounts (2))
100
No recirculation; total exhaust to the outside through

hard-duct and a HEPA filter
YES
YES (small
amounts)
II, B3
100
Same as II, A, but plenums are under negative pressure

to room; exhaust air is thimble-ducted to the outside
through a HEPA filter
YES
YES (minute
amounts (2))
III
N/A
Supply air inlets and hard-duct exhausted to outside

through two HEPA filters in series
YES
YES (small
amounts)
Airflow Pattern
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Class I
Class II
Type A
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To outside or room thru. HEPA
Positive pressure plenum

70%recirc. thru. HEPA
30% to outside thru. HEPA
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Class II
Type B1
To a dedicated duct to
outside thru. HEPA
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Class II
Type B2
No recirc.; all exhaust
to outside thru. HEPA
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Class II
Type B3
Negative pressure plenum

70% recirc. thru. HEPA
30% to outside thru. HEPA
Class III
Clean Bench
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Glove box. No direct

physical contact
Clean supply from

HEPA-filtered room air
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Examples of Lab Building Configurations
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Examples of Lab Building Configurations
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Lab Airflow Controls
Single Room Pressurization
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Direct Pressure-Differential Control
Differential Flow Tracking Control
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Hybrid Control
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Air Flows and Personnel Flows
among Rooms
Airflow
Between
Rooms
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Personnel Flow
Between
Rooms
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Example of Lab Space Ventilation

Use only with
psychrometric
analysis!!!
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Complex (multi-functional) AHU System (Discharge at 55F

year-around)
Exhaust only
Exhaust w./ heat pipe
Exhaust w./ enthalpy wheel
Dual Return paths
Supply air with possible direct
OA mixing
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Lab Space Exhaust System
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Lower velocity with higher stack,

Or, higher velocity with lower stack
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Bio-safety Containment Labs (BSL)
Summary of Recommended Biosafety Levels for Infectious Agents
BSL
Agents
Safety Equipment
(Primary Barriers)
Practices
Facilities
(Secondary Barriers)
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Not known to consistently

cause disease in healthy
adults
Standard Microbiological
Practices
None required
Associated with human

disease, hazard =
percutaneous injury,
ingestion, mucous
membrane exposure
BSL-1 practice plus:

Limited access
Biohazard warning signs
"Sharps" precautions
Biosafety manual defining any
needed waste decontamination
or medical surveillance policies
Primary barriers = Class I or II

BSL-1 plus:
BSCs or other physical containment Autoclave available
devices used for all manipulations
of agents that cause splashes or
aerosols of infectious materials;
PPEs: laboratory coats; gloves;
face protection as needed
Indigenous or exotic agents BSL-2 practice plus:

with potential for aerosol
Controlled access
transmission; disease may Decontamination of all waste
have serious or lethal
Decontamination of lab clothing
consequences
before laundering
Baseline serum
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 plus:
Physical separation from access
corridors
Self-closing, double-door access
Exhausted air not recirculated
Negative airflow into laboratory
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Dangerous/exotic agents
which pose high risk of lifethreatening disease,
aerosol-transmitted lab
infections; or related agents
with unknown risk of
transmission
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 plus:
Separate building or isolated
zone
Dedicated supply and exhaust,
vacuum, and decon systems
Other requirements outlined in the
text
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BSL-3 practices plus:

Clothing change before entering
Shower on exit
All material decontaminated on
exit from facility
Open bench top sink required
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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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For BSL-3
For BSL-4 (additional)
Architectural/Structural
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
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
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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
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Min. 4 pressure stages

Supply: HEPA filtered
Exhaust: HEPA filtered, no recirculation
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Plumbing Systems
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Gravity flow, all sanitary and fixture drains

to waste de-activation system
No floor drains
Emergency showers
Containment piping
Heat or chemical treatment
Monitoring
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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)
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Pressurized
Suits
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Suit
Change
Room
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Bio-safety Labs (BSL-3/4) Equipment
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BSL-3 Gowning with Respirator
BSL-4 Pressurized Suit
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Airtight Air Lock
Decontamination
Container
Bio-Seal Door
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Access
Door
HEPA
Filtered
Exhaust
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Effluent
Treatment
Glove
Box
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Animal Labs: Bio-safety Levels

Summary of Recommended Biosafety Levels for Activities in Which
Experimentally or Naturally Infected Animals Are Used
ABSL
Agents
Not known to
consistently cause
disease in healthy
human adults.
Practices
Standard animal care and management
practices, including appropriate medical
surveillance programs
Safety Equipment
(Primary Barriers)
As required for normal care of each
species.
Facilities
(Secondary Barriers)
Standard animal facility
No recirculation of exhaust air
Directional air flow recommended
Handwashing sink recommended
Associated with human ABSL-1 practices plus:

disease. Hazard:
Limited access
percutaneous exposure, Biohazard warning signs
ingestion, mucous
Sharps precautions
membrane exposure.
Biosafety manual
Decontamination of all infectious wastes
and of animal cages prior to washing
ABSL-1 equipment plus primary barriers: ABSL-1 facility plus:

containment equipment appropriate for
Autoclave available
animal species; PPES: laboratory coats, Handwashing sink available in the animal
gloves, face and respiratory protection as room.
needed.
Mechanical cage washer used
Indigenous or exotic
agents with potential for
aerosol transmission;
disease may have
serious health effects.
ABSL-2 practices plus:

Controlled access
Decontamination of clothing before
laundering
Cages decontaminated before bedding
removed
Disinfectant foot bath as needed
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
Dangerous/exotic agents
that pose high risk of life
threatening disease;
aerosol transmission, or
related agents with
unknown risk of
transmission.
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
ABSL-3 equipment plus:

ABSL-3 facility plus:
Maximum containment equipment (i.e.,
Separate building or isolated zone
Class III BSC or partial containment
Dedicated supply and exhaust, vacuum
equipment in combination with full body, and decontamination systems
air-supplied positive-pressure personnel Other requirements outlined in the text
suit) used for all procedures and activities
ABSL-2 facility plus:

Physical separation from access corridors
Self-closing, double-door access
Sealed penetrations
Sealed windows
Autoclave available in facility
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Animal Labs
Mech. Floor
Animal Floor
ABSL - 1
Animal Facility
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Animal Labs
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Mech. Floor
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Animal Floor
ABSL - 2
Animal Facility
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Animal Labs
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Mech. Floor
HEPA Floor
Animal Floor
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Waste Floor
ABSL - 3
Animal Facility
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Animal Labs
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Mech. Floor
HEPA Floor
Animal Floor
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Waste Floor
ABSL - 4
Animal Facility
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Animal Labs
Rack
washer
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Tunnel
washer
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Autoclave
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Animal Labs
Cage Stand-alone
Ventilation
Cage Room
Ventilation
System
Cage Room
Ventilation
System
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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
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NSF Standard 49-92 Biohazard cabinetry
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Cleanroom - Introduction
Applications
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Semiconductor
Microelectronic
Pharmaceutical
Biotechnology
Medical Devices
Hospital
Aerospace
Automotive
Miscellaneous
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Cleanroom Definition
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Definition - A specially constructed enclosed

area, its environment has following controlled
parameters:
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Temperature
Humidity
Sound and Vibration
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Common Requirements
Airflow Pattern
Pressurization
Particle Count
Microbial Contamination
Electrostatic Discharge (ESD)
Gaseous Contamination
Process Specific
Special & Unique Requirements
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Standards
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U.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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Classifications
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Air Cleanliness Class Definition Comparison Between

FS 209 and ISO 14644
ISO
FS 209
14644
Class
Class
1
10
100
1000
10,000
100,000
1
2
3
4
5
6
7
8
9
0.2 m
0.1 m
FS 209
ISO 14644
FS 209
ISO 14644
0.3 m
FS 209
ISO 14644
0.5 m
FS 209
1 m
ISO 14644
FS 209
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5.0 m
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
10
2
100
24
10
4
35
1,000
7.5
237
3
102
1
35
8
350
10,000
75
2,370
30
1,020
10
352
83
100,000
750
23,700
300
10,200
100
3,520
832
29
1,000,000
237,000
102,000
1,000
35,200
8,320
7
293
10,000
352,000
83,200
70
2,930
100,000 3,520,000
832,000
700
29,300
35,200,000
8,320,000
293,000
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Classifications
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Old Air Cleanliness Class Definition - FS 209
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100,000,000
10,000,000
PARTICLES PER CUBIC METERS
FS-100,000
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1,000,000
FS-10,000
100,000
FS-100
FS-1,000
10,000
FS-10
1,000
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FS-1
100
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10
1
0.01
0.1
10
PARTICLE SIZE, m
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Classifications
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Current Air Cleanliness Class Definition - ISO 14644
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100,000,000
10,000,000
ISO-9
1,000,000
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ISO-8
100,000
ISO-7
10,000
ISO-6
ISO-4
1,000
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ISO-5
ISO-3
100
ISO-2
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10
ISO-1
1
0.01
0.1
10
PARTICLE SIZE, m
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Classifications
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Classification Comparison Between FS 209 and ISO 14644
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100,000,000
10,000,000
ISO-9
FS-100,000
1,000,000
FS-1,000
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ISO-8
FS-10,000
100,000
FS-100
ISO-7
ISO-5
10,000
FS-10
ISO-6
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ISO-4
1,000
FS-1
ISO-3
100
ISO-2
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10
ISO-1
1
0.01
0.1
10
PARTICLE SIZE, m
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Airborne Particles
Airborne particulates can be:
1.
2.
3.
Particles larger than 100 microns can be seen with

naked eyes.
Next step particles ranging from 0.001 to 100
microns are main interest of contamination for
years.
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 Contamination

Airborne Molecular Contamination (AMC)
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Definition: By draft Standard ISO 14644-8. AMC is:
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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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Classification: 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 (AMC)
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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
Outdoor air
External
Indoor transfer air

between rooms
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.
Makeup air entering

through the air
conditioning systems
Multiple level filtrations
Infiltration through
doors, windows, and
wall penetrations for
pipes, ducts, etc.
Seal wall penetrations,

multiple level
pressurizations &
depressurizations to
obtain proper airflow
directions
Largest source of
internal particles: skin
scales, hair, textile
fibers
Rubbing one item
against another
Spray, painting,
welding, grinding
People
Work surface
shedding
Process
equipment
Internal
Description
Raw and semifinished material

Liquids,
pressurized gases
used in process
Chemicals used
for cleaning
Room
construction
materials
During transport
During preparation,
processing and
packaging
Out-gassing to room
Dust generated from
wall, floor, ceiling,
door, fibrous insulation
Garments, proper
gowning procedures, air
shower before entry
Use cleanroom suitable
or rated furniture
Local filtration and
exhaust
Equipment washing,
cleaning and
sterilization before
entry, use airlock &
pass-through
Local exhaust
Use cleanroom suitable
or rated cleaners
Constructed with
special building
materials
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Particle Dispersion in Relation to

Movement (Example: Personnel)
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___________________________________
___________________________________
___________________________________
Sitting Quietly
Particles shed per min.
= 100,000
Moving
= 1 million
Walking
= 5 million
___________________________________
___________________________________
___________________________________
Microbiological Contamination & Control

Unlike non-viable particles, which cant
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.
Control Methods
Physical:
Heat
Radiation
Filtration
Chemical:
Sterilization
Disinfection
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
Airborne Particle Physical Controls
Filtration
Dilution
Isolation
Utilizing HEPA &

ULPA filters to
remove particles
from supply air
Diluting internally
contaminated air
with clean, filtered
air
Containing or
isolating particle
generations with
barriers
HEPA: 99.97%
(Ef.@0.3m)
ULPA: 99.9997%
(Ef.@0.12m)
Higher air
change
rate, better
dilution.
Process exhaust
Mini-environment
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
Typical Ceiling Filter Coverage

Class
US 209
100,000
10,000
1,000
100
10
1
ISO
9
8
7
6
5
4
3
2
1
Ceiling Filter
Coverage
5% - 15%
5% - 15%
15% - 20%
25% - 40%
35% - 70%
60% - 90%
60% - 100%
80% - 100%
80% - 100%
___________________________________
___________________________________
HEPA
or
ULPA
___________________________________
HEPA
___________________________________
___________________________________
ULPA
___________________________________
___________________________________
Room Airflow Quantity
(Traditional Methodology)
Classification
ISO Class
FS-209 Class
Air Change
Per Hour
Range
700
100,000
5 48
600
10,000
60 90
1,000
150 240
100
240 480
10
300 540
360 540
___________________________________
___________________________________
IEST Recommended (RP-12)

Air Change Rate For Cleanrooms
Air Change Per Hour (ACH)
600
600
540
___________________________________
540
480
500
400
360
300
360
360
240
300
240
200
150
100
360 600
90
48
60
0
0
ISO Cleanliness Class
___________________________________
___________________________________
___________________________________
___________________________________
Airflow Patterns
___________________________________
___________________________________
Non-Unidirectional
(Conventional) Flow
Mixed
Flow
___________________________________
___________________________________
___________________________________
Unidirectional
Flow
Mini-Environment
Flow
___________________________________
___________________________________
Cleanroom Floor Arrangements
Service Area
Ballroom
Office and
Support
Areas
___________________________________
___________________________________
Cleanrooms
Service Area
___________________________________
Service Area
Service Chase
Office and
Support
Areas
Cleanrooms
R
___________________________________
Service Area
Service Area
Mini-Environment
Office and
Support
Areas
___________________________________
Cleanrooms
C
Service Area
___________________________________
___________________________________
___________________________________
Fan Arrangement
___________________________________
Fan Tower
Fan Filter Units
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
Control Airflows Between Rooms

Air Lock
Air Lock
Type
CORRIDOR
AIRFLOW
An intermediate room
between adjacent
areas with different
cleanliness to prevent
airborne cross
contamination
AIRLOCK
++
++
AIRFLOW
AIRFLOW
CLEANROOM
CLEANROOM
+++
CASCADING AIRLOCK
BUBBLE AIRLOCK
CORRIDOR
AIRFLOW
Cascading
Bubble
Sink
Dual Compartment
CORRIDOR
AIRFLOW
AIRLOCK
CORRIDOR
AIRFLOW
AIRLOCK
AIRLOCK
--
AIRLOCK
--
++
AIRFLOW
CLEANROOM
CLEANROOM
AIRFLOW
SINK AIRLOCK
DUAL COMPARTMENT AIRLOCK
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________

Air Lock
Application
Positive or
Negative
Pressure?
Has Fume or Bio
Contamination?
Containment
Needed?
Personal
Protection
Needed?
Type of Cleanroom
Selection
of Airlock
Functionality of Airlock
Positive pressure
Cascading
Prevent cleanroom being Cleanroom: +++

contaminated from dirty
Airlock:
++
corridor air
Corridor:
+
Prevent cleanroom being
contaminated from
surrounding spaces
through cracks
Bubble
Prevent cleanroom being Cleanroom: contaminated from dirty

Airlock:
++
corridor air
Corridor:
+
Prevent cleanroom fume
or bio agent releasing to
corridor
Sink
Prevent cleanroom being Cleanroom: contaminated from dirty

Airlock:
- corridor air
Corridor:
+
Allow cleanroom fume or
bio agent releasing to
airlock. No personal
protective equipment is
needed
Dual
Compartment
Prevent cleanroom being Cleanroom:

contaminated from dirty
Neg. Airlock: - corridor air
Pos. Airlock: ++
Prevent cleanroom fume
or bio agent releasing to Corridor:
No fume or bio agent

No containment
needed
Negative pressure
Has fume or bio
agent contamination
Containment needed
Negative pressure
Has fume or bio
agent contamination
Containment needed
Negative pressure
Has toxic fume or
hazardous bio agent
contamination, or has
potent compound
substances
Containment needed
Personal protection
needed
corridor
Personal protective
equipment (such as
pressurized suit and
respirator) is required
Relative
Pressure
Relationship
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
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 lesscontaminated, 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.
___________________________________
___________________________________
___________________________________
___________________________________

Pressurization
2,000
Single Room Pressurization
Leakage Area
(Sq. in.)
1,700
Room pressurization
Room depressurization
Entering (SA) airflow rate is
lower than leaving (EA +
RA) airflow rate in the
room, room net (offset)
flow is negative.
___________________________________
380
360
340
1,600
320
1,500
Leakage Flowrate (cfm)
Entering (SA) airflow rate is

higher than leaving (EA +
RA) airflow rate in the
room, room net (offset)
flow is positive.
___________________________________
400
1,900
1,800
300
1,400
280
1,300
260
1,200
240
1,100
220
1,000
200
900
180
800
160
700
140
600
120
500
100
400
80
60
300
200
40
100
___________________________________
___________________________________
20
0
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.)
Room Net Flow Rate vs. Pressure Differential
___________________________________
___________________________________
___________________________________

Pressurization
Single Room Pressurization-Problems
Single room control technologies often cause problems
during air balancing:
Adjusting one rooms offset value will impact adjacent
rooms air pressures if they were just balanced earlier.
Design engineer should note that one rooms air gain
could be another rooms air loss through leakages.
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________

Pressurization
Multiple Room (Suite) Pressurization
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
Pharmaceutical Aseptic Suite
___________________________________
___________________________________
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.
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
Typical HVAC Systems
___________________________________
___________________________________
FS209 Class
10,000, 100,000
ISO Class
7, 8
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
FS209 Class
100, 1,000
ISO Class
5, 6
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
FS209 Class
1, 10
ISO Class
3, 4
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
Basic HVAC Flow Diagrams
Configuration-1: Conventional Primary loop
___________________________________
AHU Unit
C
C
OA+RA
FILTER
SA
H
C
OA
Makeup
Air
Efficiency Ea
___________________________________
Co
___________________________________
Efficiency Eb
SA
Supply
Air
HEPA
Space Impurity
Cs
Concentration
Return
Cs
Air
Leakage
Air
___________________________________
RA
Space
Particle Generation
EA
___________________________________
Exhaust
Air
Deposition
D
Cs
Ce
___________________________________
___________________________________
___________________________________
Configuration-2: Primary loop with supply bypass
___________________________________
AHU Unit
SA
C
C
OA+RA
FILTER
SA1
H
C
OA
Makeup
Air
Efficiency Ea
Co
SA2+RA
SA2
___________________________________
Efficiency Eb
___________________________________
Space Impurity
Cs
Concentration
HEPA
SA1
Supply
Air
RA
Space
Return
Cs
Air
Particle Generation
G
Q
Leakage
Air
EA
___________________________________
Exhaust
Air
Deposition
D
Cs
Ce
___________________________________
___________________________________
___________________________________
Configuration-3: Primary loop with dual returns
___________________________________
AHU Unit
C
C
Efficiency Eb
OA+RA1
FILTER
FILTER
SA=OA+RA
H
C
OA
Makeup
Air
Efficiency Ea
RA1
Co
___________________________________
RA2
Efficiency Ec
___________________________________
Space Impurity
Cs
Concentration
HEPA
SA
Supply
Air
RA
Space
Return
Cs
Air
Particle Generation
G
Q
Leakage
Air
EA
___________________________________
Exhaust
Air
Deposition
D
Cs
Ce
___________________________________
___________________________________
___________________________________
Configuration-4: Primary loop plus secondary makeup unit

Primary Fan Unit
OA
Treated
Makeup
Air
C1
Efficiency Eb
C
C
H
C
FILTER
Secondary Makeup Unit

OA+RA
FILTER
SA
Efficiency Ea
OA
___________________________________
Makeup
Air
Co
___________________________________
Efficiency Ec
Space Impurity
Cs
Concentration
HEPA
SA
Supply
Air
RA
Space
Particle Generation
Q
Leakage
Air
Cs
G
Deposition
D
Return
Cs
Air
EA
Exhaust
Air
Ce
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
Configuration-5: Primary loop plus secondary AHU unit with dual returns
Primary Fan Unit
___________________________________
Secondary AHU Unit

C
C
Treated
Makeup
Air
C1
Efficiency Eb
H
C
Efficiency Ea
RA1
Efficiency Ec
OA
FILTER
OA+RA2
OA+RA
FILTER
SA
Makeup
Air
Co
___________________________________
RA2
Space Impurity
Cs
Concentration
HEPA
SA
Supply
Air
Return
Cs
Air
Leakage
Air
___________________________________
RA
Space
Particle Generation
EA
___________________________________
Exhaust
Air
Deposition
D
Cs
Ce
___________________________________
___________________________________
___________________________________
Configuration-6: Primary loop plus secondary AHU unit and tertiary

makeup unit with dual returns
Secondary AHU Unit
FILTER
OA+RA
Tertiary Makeup Unit

OA
H
C
C
C
Treated
Makeup
Air
C1
H
C
Efficiency Ea
OA
Co
RA2
Return
Cs
Air
Leakage
Air
EA
___________________________________
Exhaust
Air
Deposition
D
Cs
___________________________________
___________________________________
RA
Space
Particle Generation
___________________________________
Makeup
Air
Space Impurity
Cs
Concentration
HEPA
SA
C
C
Efficiency Ea
RA1
Efficiency Ec
Supply
Air
OA+RA2
Treated
Makeup
Air
C1
Efficiency Eb
FILTER
Primary Fan Unit

SA
Ce
___________________________________
___________________________________
Process and Building Systems
Building Systems Cleanroom HVAC&R
Cleanroom Process
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
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
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
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
Typical Specified Cleanroom

Components, Devices & Equipment
Air
Sampling
Handhold
Particle
Counter
Air Particle
Sensor
Portable Particle Counter
Fan-Filter Ceiling Module
Bag-in/Bag-out multiple filters

- Against biological, chemical
& radiological materials
___________________________________
___________________________________
HEPA / ULPA Filter
Air
Filtration
___________________________________
___________________________________
___________________________________
Pharmaceutical cGMP
Particle Monitoring & Validation
Microbial Air Sampler &

Agar Media
___________________________________
___________________________________
___________________________________
Typical Specified Cleanroom
Components, Devices & Equipment
___________________________________
___________________________________
Air Valve
Isolator (Glove Box)
Precision
Room
Pressure
Transducer
Soft
Wall
Floor Grate
& Perforated
Panel
Small Mini-Environment
___________________________________
___________________________________
Product
Passthrough
___________________________________
___________________________________
___________________________________
Cleanroom Building Exterior and Interior
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
Cleanrooms in Construction
Building Finished
Exterior
___________________________________
___________________________________
Finished Cleanrooms
___________________________________
___________________________________
Window on
Exterior Wall
Small Class 100,000
Cleanroom
Window on
Interior Wall
Interior Hallway
___________________________________
___________________________________
Class 10,
Raised Floor
Gowning Area,
Raised Floor
Service Hallway
Enclosing Cleanrooms
___________________________________
___________________________________
___________________________________
Cleanroom Utility and Support
___________________________________
___________________________________
Large DI Water
System
___________________________________
AHU Unit for Office/
Administration Areas
Steam-Hot Water
Exchange Unit
(Packaged)
___________________________________
___________________________________
___________________________________
___________________________________
Cleanrooms In Operation
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
Cleanroom Construction Materials

Classification
Wall System
FS Class
FS Class
1
10
ISO Class
ISO Class
1, 2 & 3
4
Aluminum Component
FS Class
100
ISO Class
5
Wall Panel
Honeycomb Aluminum Conductive Finish
Paint
Epoxy
Aluminum Polystyrene Core or

Epoxy Coated Steel Laminated
over Drywall
Epoxy / Latex
Ceiling Grid
2 Aluminum Gel Seal Ceiling System
1 Steel Gasketed
Grid Support
All thread with Strut & Turn buckles
Floor
Raised Floor with Perforated / Grated Access
Air Return
Floor
12 ga wire to grid, 10 ga wire to filter @ Corner of

Grid Intersection Only
Concrete Covered with Epoxy
Solids or Sheet Vinyl
Low Sidewall
Low Sidewall
or Ceiling
___________________________________
FS Class
FS Class
FS Class
1,000
10,000
100,000
ISO Class
ISO Class
ISO Class
6
7
8&9
Aluminum Component or Metal Stud
___________________________________
___________________________________
Vinyl or Epoxy
Coated
Drywall
Latex
___________________________________
___________________________________
___________________________________
___________________________________
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.

utility installation.
Removing local contaminants caused

by installing electricity, gas, water, etc.
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.
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.

early construction.
Cleaning all visible contamination from

ceilings, walls, floors, (filter mountings),
etc. after completion of construction and
installation activities.
Cleaning contractor.
Visual-clean.
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 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.
Vacuum clean; wipe down with
moistened wipers.
Stage 4 Prepare for

air conditioning ductwork
installation.
Wiper-clean.
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
ISO Construction Cleaning Procedures

Stage
Purpose
Responsible party
Method
Standard
Stage 5 Clean before

mounting all air filters
into the system.
Stage 6 Mount the
(HEPA/ULPA) filters into
the air systems
Removing deposited or settled dust, or

both, from ceilings, walls, and floors.
Cleaning contractor.
Wipe down with moistened wipers.
Wiper-clean.
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.
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
Cleanroom Testing
___________________________________
Required Testing (ISO 14644-2)
Schedule of Tests to Demonstrate Continuing Compliance

<= ISO 5
Maximum Time
Interval
6 Months
> ISO 5
12 Months
Air Pressure Difference
All Classes
12 Months
ISO 14644-1 Annex B5
Airflow
All Classes
12 Months
Test Parameter
Particle Count Test
Class
Test Procedure
ISO 14644-1 Annex A
Optional Testing (ISO 14644-2)
Schedule of Additional Optional Tests

Test Parameter
Class
Installed Filter Leakage

Containment Leakage
All Classes
All Classes
Maximum Time
Interval
24 Months
24 Months
Recovery
All Classes
24 Months
Airflow Visualization
All Classes
24 Months
Test Procedure
Reference: NEBB (National Environmental Balancing Bureau)Procedural Standards for Certified Testing of Cleanrooms
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
Cleanroom Construction Cost

Mechanical Construction Cost, conducted by Richard Pavlotsky in 2003
Mech.
Const. Cost
/SQ. FT.
ISO-8
FS-100,000
ISO-7
FS-10,000
ISO-5
FS-100
ISO-3
FS-1
$79-$141
$97-$167
$203-$363
$453-$810
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
Cleanroom Construction Cost
___________________________________
Example: Fab Facility Total Cost, conducted by Norbert Wiegler
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
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?

Engineers design knowledge & experience
Mock-up or scale-down model
CFD validation
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
CFD Applications
___________________________________
Narrower
Cleanroom with
35% FA Floor
Panels
Cleanroom
with 35% FA
Floor Panels
A case study: Examination of flow laminarity of a cleanroom with a

subfab underneath
Cleanroom
with 20% FA
Floor Panels
___________________________________
___________________________________
Floor
Ceiling
FAB
CHASE
SUBFAB
Cleanroom
with 10% FA
Floor Panels
___________________________________
___________________________________
Slab
CFD model geometry
___________________________________
___________________________________
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
Concentration (Number of Particles Per FT3)
1,000,000.0
Internal Particle
Generation Rate:
G = Rate of
impurity
generation unit
floor area,
averaged
throughout the
space
Condition:
100,000.0
OA/SA=5%
6
CO=1x10
EU=95%
EH=99.97%
=1.0
10,000.0
___________________________________
1,000.0
Unit:
3
Particals/FT /Min.
100.0
___________________________________
___________________________________
G=1
10.0
G=10
G=100
G=1000
1.0
G=10000
___________________________________
0.1
0
100
200
300
400
500
600
Supply Air ACH (Air Change Per Hour)
___________________________________
___________________________________
Technology Trend Provide Airflow Rate

Based on Particle Generation Rate
During Operating Phase
___________________________________
___________________________________
Staged Ventilation
ACH Rate
___________________________________
VFD Ventilation
Room Particle Generation Rate G
The goal is to stage the ventilation rate to maintain the same room cleanliness
level through particle sensing during all modes (occupied and unoccupied)
___________________________________
___________________________________
___________________________________
___________________________________
Q&A
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________

US Laboratory & Cleanroom Design Fundamentals

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US Laboratory & Cleanroom Design Fundamentals

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US Laboratory & Cleanroom Design Fundamentals

Wei Sun, P.E.

Wei Sun, P.E.

Definition and classifications

Definition - A specially constructed enclosed

Hazard Assessment by safety officers and endusers in:

General Standards & Guides

NFPA 45 Fire Protection for Laboratories Using Chemicals

OSHA Occupational Exposure to Chemicals in Laboratories

ASHRAE 2001 Laboratory Design Guide

Possible Lab Module Subdivision

Constant Volume Exhaust System

Maintain the same exhaust

Reduce exhaust by 30-60%

Maintain the same exhaust,

Fume Hoods -Types

Exhaust varies from 0-50%

Special Purpose Fume Hoods

Code Required Face Velocity

Cupsink, Trap and Piping Materials:

Mixing Faucet, with

Work Surface Material:

Biological Safety Cabinets

Biological Safety Cabinets

Comparison of Biosafety Cabinet (BSC) Characteristics

In at front; exhausted through HEPA to the outside or

70% recirculated to the cabinet work area through HEPA;

Exhaust cabinet air must pass through a dedicated duct

No recirculation; total exhaust to the outside through

Same as II, A, but plenums are under negative pressure

Supply air inlets and hard-duct exhausted to outside

Biological Safety Cabinets

To outside or room thru. HEPA

Positive pressure plenum

Biological Safety Cabinets

Negative pressure plenum

Glove box. No direct

Clean supply from

Examples of Lab Building Configurations

Examples of Lab Building Configurations

Direct Pressure-Differential Control

Differential Flow Tracking Control

Example of Lab Space Ventilation

Complex (multi-functional) AHU System (Discharge at 55F

Lab Space Exhaust System

Lower velocity with higher stack,

Not known to consistently

Associated with human

BSL-1 practice plus:

Primary barriers = Class I or II

Indigenous or exotic agents BSL-2 practice plus:

Primary barriers = Class I or II

Primary barriers = All procedures

BSL-3 practices plus:

Open bench top sink required

Example: Bio-safety Floor Plan

Example: Bio-safety Floor Plan

For BSL-4 (additional)

Structural Surround (box in box)

Room pressurization, air cascades inward

Min. 4 pressure stages

Bio-safety Labs (BSL-3/4)