Cleanrooms and HVAC Systems

– Design Fundamentals
Belgrade, Serbia April 28, 2017

Wei Sun, P.E.

ASHRAE
Distinguished Lecturer
Society Technology Transfer Committee Chair (12-13)
“Clean Spaces” Technical Committee (TC9.11) Chair (07-10)
“Healthcare Facilities” Technical Committee (TC9.6) Member
“Laboratory Systems” Technical Committee (TC9.10) Member
IEST (Institute of Environmental Sciences and Technology)
Society President
ISO 14644 Cleanroom Standards
USA Delegate
Engsysco, Inc.
Engsysco President
Ann Arbor, Michigan, USA
Web: www.engsysco.com Email: wsun@engsysco.com
Cleanroom Design Considerations
(Applications)

Semiconductor Medical Devices

Microelectronic Optical Devices
Pharmaceutical Hospital
Biotechnology University Labs
Aerospace Food Processing
Automotive Miscellaneous
 Cleanroom Design Considerations
(Controlled Parameters)

Cleanroom - A special enclosed area, its environment

typically has the following controlled parameters:

Temperature Airflow Pattern

Humidity Room Pressure
Sound and Vibration Particle Contamination
Lighting (Airborne, Surface & Liquid-borne)
etc. Microbial Contamination
(Airborne, Surface & Liquid-borne)
Common Requirements
Electrostatic Discharge
Gaseous Contamination
Process Specifics
Special Requirements
 Cleanroom Standards in US
(Previous US Federal Standard and Current ISO Standards)
U.S. Federal
Airborne particulate cleanliness classes in cleanrooms and clean zones
Standard
(former US standard, canceled in November 2001)
209E

ISO
ISO-14644: Cleanrooms and Associated Controlled Environments
Document

ISO-14644-1 Classification of Air Cleanliness

ISO-14644-2 Cleanroom Testing for Compliance

Methods for Evaluating & Measuring Cleanrooms & Associated Controlled

ISO-14644-3
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

Biocontamination: Methodology for Measuring Efficiency of Cleaning Inert

ISO-14698-3
Surfaces
 These Two Standards Similar?
(Comparison of FS-209E and ISO-14644 in Combined Table)

0.1 µm 0.2 µm 0.3 µm 0.5 µm 1 µm 5.0 µm

ISO
FS 209
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
Class
Class
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 2
2 100 24 10 4
1 3 35 1,000 7.5 237 3 102 1 35 8
10 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 29
1000 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 2,930
100,000 8 100,000 3,520,000 832,000 700 29,300
9 35,200,000 8,320,000 293,000
 These Two
Air Cleanliness Standards
Class Similar?
Definition Comparison
Between FS 209 and ISO 14644
(Comparison of FS-209E and ISO-14644 in Overlapping Chart)
100,000,000

10,000,000
ISO-9

FS-100,000

1,000,000
PARTICLES PER CUBIC METERS

FS-1,000
ISO-8

FS-10,000

100,000 FS-100
ISO-7
ISO-5

10,000 FS-10
ISO-6
ISO-4

1,000 FS-1

ISO-3

100
ISO-2

10
ISO-1

1
0.01 0.1 1 10
PARTICLE SIZE, μm

They are NOT identical, but roughly equivalent under certain classes
and particle sizes.
 ISO 14644 Classification
(Airborne Particle Sizes, Counts and Classifications in 3D Illustration)

Cleanroom Particle Counts Per ISO Classification

100,000,000

10,000,000

1,000,000

100,000
Particle Cou

10,000

1,000

100
nt / m

10

Class 9
3

Class 8
1

Class 7
Class 6
0.1

Class 5
µm 0.2
ss
Class 4
Pa µm 0.3
rtic la
sC
Class 3
le µm 0.5
s
Siz ne
Class 2

µm 1
e(
Ch anli
Class 1

µm 5.0 e
an C l
n µm
el)
 Particle Sources & Control
Sources of Contamination Description Control Methods

Tighter exterior wall

construction, exterior
Infiltration through
zone pressurization,
doors, and cracks at
vestibules at main
windows, and walls
Outdoor air entrances, and seal
space penetrations.
Makeup air entering
External
through the air Multiple level filtrations
conditioning systems
Seal wall penetrations,
Infiltration through multiple level
Indoor transfer air doors, windows, and pressurizations &
between rooms wall penetrations for depressurizations to
pipes, ducts, etc. obtain proper airflow
directions
Largest source of
Garments, proper
internal particles: skin
People gowning procedures, air
scales, hair, textile
shower before entry
fibers
Work surface Rubbing one item Use cleanroom suitable
shedding against another or rated furniture
Process Spray, painting, Local filtration and
equipment welding, grinding exhaust
Equipment washing,
cleaning and
Internal Raw and semi-
During transport sterilization before
finished material
entry, use airlock &
pass-through
Liquids, During preparation,
pressurized gases processing and Local exhaust
used in process packaging
Chemicals used Use cleanroom suitable
Out-gassing to room
for cleaning or rated cleaners
Room Dust generated from Constructed with
construction wall, floor, ceiling, special building
materials door, fibrous insulation materials
 Airborne Particle Physical Controls

Filtration Dilution Isolation

Utilizing HEPA & ULPA Diluting internally Isolating particle
filters to remove contaminated air generations with barriers,
particles from supply with filtered clean air or removing directly from
air major sources

• Higher air change • Process exhaust

• HEPA: >99.97%
(@ 0.3μm MMD) rate, better dilution • Mini-environment
• ULPA: >99.999%
(@ 0.12μm MMD)
Microbiological Contamination & Control

Unlike non-viable particles which can’t Control Methods

reproduce, microorganisms could
reproduce at a rapid rate if nutrition and Physical:
environment are favorable. • Heat
• Radiation
Microorganism can be classified as • Filtration
bacteria, algae, fungi, protozoa and
viruses. Some of these are essential, Chemical:
and harmless, while others are harmful • Sterilization
and dangerous. • Disinfection
ISO 14644 Standard Classifications –
Occupancy States

As Built: Installation is complete with all services

connected and functioning, but with no production
equipment materials and no personnel present.
At Rest: Installation is complete with equipment
installed and operating in a manner agreed between
the customer and supplier, but with no personnel
present.
Operational: Installation is functioning in the
specified manner, with specified number of
personnel present and working in the manner
agreed upon.
 Pharmaceutical Grade
vs. Classification

3
Maximum Permitted Number of Particles Per m (equal to or above )

EU Pharmaceutical Cleanliness Grade

Cleanliness Classification

Grade At Rest In Operation FS 209 ISO

14644
0.5 µm 5.0 µm 0.5 µm 5.0 µm 0.5 µm 5.0 µm
A 3,500 0 3,500 0 100 5 3,520 29

B 3,500 0 350,000 2,000 1,000 6 35,200 293

C 350,000 2,000 3,500,000 20,000 10,000 7 352,000 2,930

D 3,500,000 20,000 Not defined Not defined 100 ,000 8 3,520,000 29,300
 Microbial Contamination Limits
In Operation

Recommended limits for microbial contamination in the

operation state (average values)
Control of Particles and Microbial Sterilized
and Non-sterilized Product

Operation Design
USA FDA EU
Requirements
ISO 8
Particle cleanliness Grade C
(Controlled Area)
Maximum viable
Non-sterilized 2.5/ft3 100/m3
Organisms (cfu)
product or
container 15-20 minute clean-
Room Airflow 20 ACH or higher
up time
Room Pressure 12.5 Pa Positive
ISO 5 in
Grade A in
Particle cleanliness ISO 7 Background Grade B Background
(Critical Area)
Sterilized Maximum viable ISO 5: 0.1/ft
3
A: 1/m3
product or Organisms (cfu) ISO 7: 2.5/ft
3
B: 5/m3
container
Room Airflow 90±20 fpm 0.36 - 0.54 m/s
Room Pressure 12.5 Pa Positive
Typical Ceiling Filter Coverage

Class HEPA
Ceiling Filter
or
Coverage
US 209 ISO ULPA

9 5% - 15%
100,000 8 5% - 15%
10,000 7 15% - 20% HEPA
1,000 6 25% - 40%
100 5 35% - 70%
10 4 60% - 90%
1 3 60% - 100%
ULPA
2 80% - 100%
1 80% - 100%
 Room Airflow Volume/Quantity
(Traditional Approaches: Table Methods)

IEST RP-12.1 (Before 2007)

Classification Air Change

Per Hour (ACH)
ISO Class FS - 209 Class Range
8 100,000 5 – 48
7 10,000 6 0 – 90
6 1,00 0 150 – 240
5 100 240 – 480
4 10 300 – 540
3 1 360 – 540
2 360 – 600
1
 Room Airflow Patterns

Non-Unidirectional Mixed
(Conventional) Flow Flow

Unidirectional Mini-Environment
Flow Flow
 Cleanroom Floor Arrangements

Service Area

Ballroom Office and

Support One Big
Areas Cleanroom

Service Area

Service Area
Shared Return Air
R R R R R Chase (TYP)
Service Chase Office and
Support Multiple Small
Cleanrooms
Areas Cleanrooms
R R R R R

Service Area

Service Area
Mini-Cleanrooms
C C C C
Mini-Environment Office and
Support Cleanrooms Less-clean
Areas C C C C Cleanroom

Service Area
Pressurized Plenum (Fan Tower) Arrangement

Scrubbed Exhaust Air Visitors Corridor

Silencer Waff le Slab Process Corridor

Fan Tow er Maint. Corridor Raised Floor Ceili ng + Filter Stair Case

Pressurized Plenum

Cleanroom

Return Air

Basement

Make-Up Air Cooling Coil Perforated Slab Process Exhaust Submai ns Gas Cabinets
Pump Chemical Supply Systems Process Supply Systems

ITRI
 Fan Filter Units (FFU) Arrangement

Scrubbed Exhaust Air

3.5m

2.2m

3.6m
Stair Case
Cleanroom
9.6m

4.8m
Ret urn Air

4.8m

0. 0m
Basement

Make-Up Air Gas Cabinets Process Suppl y Syst ems Submains Process Supply Submains Scrubber

ITRI
 Particle Migration Control
(Room Pressure Control)

Scennario 1: Room Prerssurized

SA - (EA+RA) = ΔV = ΣQ > 0

Offset
Flow
Total Room Total Room
ΔV
Supply Airflow Exhaust and/or

Supply Airflow
(SA) Return Airflow

Total Room

and/or Return Airflow

Total Room Exhaust
(EA+RA) Total Leakage

(SA)
Airflows
Room ΣQ

(EA+RA)
Positively
+

Pressurized
 Particle Migration Control
(Room Pressure Control)

Scennario 2: Room Non-Prerssurized

SA - (EA+RA) = ΔV = ΣQ = 0

Offset
Flow
Total Room Total Room ΔV = 0

Total Room Exhaust and/or

Supply Airflow Exhaust and/or
(SA) Return Airflow

Supply Airflow

Return Airflow
(EA+RA) Total Leakage

Total Room

(EA+RA)
Airflows

(SA)
Room ΣQ = 0

Non-Pressurized
 Particle Migration Control
(Room Pressure Control)

Scennario 3: Room De-prerssurized

SA - (EA+RA) = ΔV = ΣQ < 0

Offset

Total Room Exhaust and/or Return

Flow
Total Room Total Room ΔV
Supply Airflow Exhaust and/or
(SA) Return Airflow

(EA+RA)
(EA+RA)

Airflow
Total Leakage

Supply Airflow
Room Airflows

Total Room
ΣQ
- Negatively

(SA)
De-pressurized
Why Do Particles Migrate (Exchange) Between
Cleanroom and Adjacent Area(s)? (1)

Particles can migrate through cracks, such as minor leaks on walls,

ceiling, joints, duct/pipe penetrations, etc. and air gap between door
and frame, when a pressure differential exists across the cleanroom
enclosure.
ΔP=0 ΔP>0 ΔP<0
Neutral Pressurized De-Pressurized

Corridor Cleanroom Corridor Cleanroom

Corridor Cleanroom

Pressure differential can force particles to migrate

(in or out) through cracks on cleanroom enclosure.
Why Do Particles Migrate (Exchange) Between
Cleanroom and Adjacent Area(s)? (2)

Particles can also migrate through these cracks when a particle

concentration difference exists across the cleanroom enclosure due
to mass diffusion until an equilibrium is reached.
ΔP=0 ΔP=0 ΔP=0
Neutral Neutral Neutral

Corridor Cleanroom Corridor Cleanroom Corridor Cleanroom

ΔC= One-Class Difference ΔC= Two-Class Difference ΔC= Three-Class Difference

Particle concentration difference can force particles to

migrate (in or out) through cracks on cleanroom
enclosure.
 Particle Net Gain/Loss through Migration

By two forces:

Under pressure difference (air movement by force)

Under particle concentration difference (mass diffusion)

Based on the combination of conditions, these two forces

could work in the same or opposite directions.

What is the combined effect?

The prevailing force determines the particle net gain or

loss through migration into cleanroom.
 Particle Migration Control
(Airlock)

Air Lock AIRFLOW CORRIDOR

+
AIRFLOW CORRIDOR
+
An intermediate room AIRLOCK AIRLOCK

between adjacent ++ ++
areas with different
cleanliness to AIRFLOW CLEANROOM AIRFLOW CLEANROOM

+++ -
minimize particles,
microbial and/or fume CASCADING AIRLOCK BUBBLE AIRLOCK

migrations.
AIRFLOW CORRIDOR AIRFLOW CORRIDOR
+ -
Type AIRLOCK AIRLOCK AIRLOCK
Cascading -- ++ --
Bubble
Sink AIRFLOW CLEANROOM CLEANROOM
AIRFLOW

Dual Compartment - -

SINK AIRLOCK DUAL COMPARTMENT AIRLOCK

 Particle Migration Control
(Airlock Selection)
Type of Cleanroom Selection Functionality of Airlock Relative
of Airlock Pressure
How To Select Relationship

An Airlock?  Positive pressure

 No fume or bio agent
Cascading  Prevent cleanroom being Cleanroom: +++
contaminated from dirty Airlock: ++
corridor air
 No containment Corridor: +
needed  Prevent cleanroom being
contaminated from
Answer questions surrounding spaces
through cracks
below:
 Negative pressure Bubble  Prevent cleanroom being Cleanroom: -
 Has fume or bio contaminated from dirty Airlock: ++
Is the room in agent contamination corridor air
Corridor: +
positive or  Containment needed  Prevent cleanroom fume
or bio agent releasing to
negative pressure? corridor

 Negative pressure Sink  Prevent cleanroom being Cleanroom: -

contaminated from dirty
Has fume or bio  Has fume or bio
agent contamination corridor air
Airlock: --
Corridor: +
contamination?  Containment needed  Allow cleanroom fume or
bio agent releasing to
airlock. No personal
If containment protective equipment is
needed
is needed?  Negative pressure Dual  Prevent cleanroom being Cleanroom: -
Compart- contaminated from dirty Neg. Airlock: - -
 Has toxic fume or
ment corridor air
If personal hazardous bio agent
contamination, or has  Prevent cleanroom fume
Pos. Airlock: ++

protection potent compound or bio agent releasing to Corridor: -

substances corridor
is needed?  Containment needed  Personal protective
 Personal protection equipment (such as
needed pressurized suit and
respirator) is required
 Particle Migration Control
(Pressure Stabilizer)

Pressure Stabilizer
A dynamic control
approach: Use an
pressure-adjustable
automatic relief damper
as a leakage regulator
to maintain a minimum
room pressure when a
door is opened.
Traditional Rules-of-Thumb Design Methods

Flow Percentage Method (Example: VA Hospital Std.)

• Neutral: SA – (RA+EA) = 0
• Positive (+): SA - (RA+EA) = 15% of SA
• Positive (++): SA - (RA+EA) = 30% of SA
• Negative (-): (RA+EA) – SA = 15% of SA
• Negative (- -): (RA+EA) – SA = 30% of SA

Flow Differential Method (Example: CDC Guideline)

• Neutral: SA – (RA+EA) = 0
• Positive : SA - (RA+EA) = Min. 60 L/s (125 CFM)
• Negative : (RA+EA) – SA = Min. 60 L/s (125 CFM)

Problem with these rule-of-thumb approaches: Each room may

have different air-tightness on enclosure, a fixed offset value ΔV
without field adjustment capability could cause problem in
control.
Load Characteristic and Air Loop Selections
(For Energy Conservation and Performance)

Cleanroom often requires higher airflow rate to dilute room

contaminated air in order to lower particle concentration, so its
“airflow rate over cooling load” ratio is typically higher, or
much higher than a normal ratio range for commercial spaces
(CFM/Ton=300-500, or L/s/Ton=150-250).
Mismatch design (higher airflow rate to a relative smaller cooling
load) could cause a cooling coil to have a sensible cooling only
without latent heat removal which may result poor humidity
control inside cleanrooms.
For ISO Class 6 or cleaner cleanrooms, the flow rate/cooling
ratio may be beyond the reach of a single AHU unit can handle to
avoid mismatch, multiple air-handing systems (loops) are often
utilized to ensure performance and save energy.
 HVAC Schematic and Diagram
(Primary Loop Alone Air-Handling System)

For ISO Class 7, 8, 9 (FS-209 Class 10,000, 100,000)

Typical Application:
CFM/Ton ratio: 300-500 (L/s/Ton ratio: 150-250)

AHU Unit

SA OA+RA OA

FILTER
C H
C C
Makeup
Air
Efficiency Ea
Co

Efficiency Eb

Space Impurity
Cs
Concentration
SA RA

HEPA
Space
Supply Return
Air Air Cs
Particle Generation
Q G EA

Leakage Deposition Exhaust

Air D Air
Cs Ce
 HVAC Schematic and Diagram
(Primary-Secondary Loops Air-Handling Systems)

For ISO Class 4, 5, 6, 7 (FS-209 Class 10, 100, 1,000, 10,000)

Typical Application:
CFM/Ton ratio: 800-5,000 (L/s/Ton ratio: 400-2,500)
Primary flow/Secondary flow ratio: 2-10

Primary Fan Unit Secondary Makeup Unit

SA OA+RA OA OA

FILTER

FILTER
C H
C C
Treated Makeup
Makeup Air
Efficiency Eb Efficiency Ea
Air Co
C1

Efficiency Ec

Space Impurity
Cs
Concentration
SA RA

HEPA
Space
Supply Return
Air Air Cs
Particle Generation
Q G EA

Leakage Deposition Exhaust

Air D Air
Cs Ce
 HVAC Schematic and Diagram
(Primary-Secondary-Tertiary Loops Air-Handling Systems)
For ISO Class 1, 2, 3, 4 (FS-209 Class 1, 10)
Typical Application:
CFM/Ton ratio: 2,500-25,000 (L/s/Ton ratio: 1,250-12,500)
Primary flow/Secondary flow ratio: 2-10
Secondary flow/Tertiary flow ratio: 2-5

Primary Fan Unit Secondary AHU Unit Tertiary Makeup Unit

SA OA+RA OA+RA2 OA OA

FILTER

FILTER
C H C H
C C C C
Treated Treated Makeup
Makeup Makeup Air
Efficiency Eb Efficiency Ea Efficiency Ea
Air Air Co
C1 C1

RA1 RA2
Efficiency Ec

Space Impurity
Cs
Concentration
SA RA
HEPA

Space
Supply Return
Air Air Cs
Particle Generation
Q G EA

Leakage Deposition Exhaust

Air D Air
Cs Ce
 Air Handling Configuration Strategies 8
(ISO Class 1, 2, 3, 4, 5, 6, 7)
(FS-209 Class 1, 10, 100, 1,000, 10,000, 100,000)

Configuration-7: Fan-Filter Units For Primary Recirculation

Typical Application:

CFM/Ton ratio: 800-25,000

(L/s/Ton ratio: 400-12,500)
FFU flow/AHU flow ratio: 2-50
Room sensible ratio: high to very high
 Process and Building Systems

Building Systems Cleanroom HVAC&R Cleanroom Process

City water & gas Make-up system Gas detection
services Recirculation system Static control
Cold/hot water Return air system RO and DI waters
distributions Temperature & Process chilled water
Gas distributions humidity controls Chemical gases and
Storm, sanitary & Room pressure storages
vent control Solvent drain and
Fire pump & Airlock collection
automatic Noise and vibration Solvent gas exhaust
sprinkler systems control Process vacuum
Emergency power Hydronic heating
generator Scrubbed exhaust
Comfort chilled water House vacuum
HVAC & Indoor
comfort Cooling tower water Acid drain and waste
Building Particle counting neutralization
management Clean dry air
Instrumentation air &
control
Typical Cleanroom Construction Materials

Classification FS Class FS Class FS Class FS Class FS Class FS Class

1 10 100 1,000 10,000 100,000
ISO Class ISO Class ISO Class ISO Class ISO Class ISO Class
1, 2 & 3 4 5 6 7 8&9
Wall System Aluminum Component Aluminum Component or Metal Stud

Wall Panel Honeycomb Aluminum Conductive Finish Aluminum Polystyrene Core or Vinyl or Epoxy
Epoxy Coated Steel Laminated Coated
over Drywall 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
 Selective Cleanroom Design Ideas (1)

ISO-5 raised-floor large ballroom design Perforated concrete floor allows return air
to meet processing requirements down to sub-floor area below.

Sub-floor area (below cleanroom) houses large Critical process located in a mini-environment
process/utility equipment, ducts and piping. (ISO-5) which is in an ISO-7 large cleanroom
 Selective Cleanroom Design Ideas (2)

Return air floor panels’ arrangement to Shared return air chase could house some
accommodate equipment footprints (ISO-7) process piping and small equipment.

Small pass-through on door allows small items Sliding doors have shorter cycle than swing
transport while minimize door operations. doors to reduce contamination from corridor.
 Selective Cleanroom Design Ideas (3)

CFD analysis of “velocity vector” around a CFD to visualize particle migration from
moving door (second door of an airlock) gowning room to airlock and to cleanroom

Solar panels on roof to supplement Roof storm drains collected for

electricity usage irrigation of landscaping
 Selective Cleanroom Design Ideas (4)

Unidirectional flow inside RAB Mixed flow in Room

Lower concentration inside RAB, higher Higher concentration near face

concentration near person due to recirculation air
By K. Khankari 2013
Selective Cleanroom Renovation Ideas (1)

Before After

Retrofits

Changed from open ballroom to multiple narrower rooms to improve

airstream parallelism.
Used exhaust canopies to remove high-concentration particles generated
from process equipment. Room ACH reduced from 385 to 280.
Selective Cleanroom Renovation Ideas (2)

Before After

Retrofits

Changed from general-purpose chemical lab to ISO Class-3 Nano research

lab in various aspects: Airflow rate, 100% HEPA ceiling with FFUs, tear-
drop lighting, and raised floor, etc.
Selective Cleanroom Renovation Ideas (3)

Before After

Retrofits

ISO-4 cleanroom (358 ACH) converted to ISO-3 cleanroom (400 ACH) with
lighting-integrated ceiling (yellow light area after filtered spectrum).
Replaced “primary-alone” AHU with “primary-secondary” AHU systems,
reduced energy consumption about 65%.
Selective Cleanroom Renovation Ideas (4)

Before After

Retrofits

Retrofitted a 22-ft height shop/storage area into a high-bay ISO-3 cleanroom

for aerodynamic research.
The cleanroom (280 ACH) has 2-ft wide return air chases on both sides, and
3-ft raised floor.