Clean Room Seminar Fundamental

Clean Room
Fundamentals
A Trane Seminar
© American Standard Inc. 2001 Seminar SYS_P19.PPT

Clean Room Fundamentals
1. Introduction
2. Terminology
3. Contamination sources
4. Standards and classes
5. Design considerations
6. Application considerations
7. Testing
8. Closing thoughts Objective: This Trane seminar
discusses the fundamental design
concepts used in clean rooms.
© 2001 American Standard Inc. 2 Seminar SYS_P19.PPT

Clean Room
Fundamentals
Section 1
Introduction

Introduction
Clean Room Technology
 Started some 40 years ago
 As the manufacturing technology advances,
more clean spaces are needed
 Significant number of clean rooms are
microelectronics related
 Pharmaceutical clean rooms control particles
and viable particles (mostly bacteria growth)
 HVAC challenge is to be low cost

Introduction
The Facts
 Microscopic fabrication, foods, automotive
paint, medical, aerospace, biological, and
other applications require clean and/or germ-
free atmospheres
 Contamination affects health, laboratories,
hospitals, and selected manufacturing
processes
 The best place to control particulates is at the
point of generation

Clean Room
Fundamentals
Section 2
Terminology

Terminology
Use Established Terminology
 Maintain a common language among everyone
in the project
 Very important in written documents
 Mission
 Objective
 Goal
 Specs

Terminology (partial list)
 Aseptic space
 Clean room
 Clean space
 Contamination
 Critical parameter
 Design conditions

Terminology (continued)
 High-efficiency particulate air filter (HEPA)
 a filter with an efficiency in excess of 99.97% of 0.3 micron particles
 Makeup air
 Qualification & Qualification protocol
 ULPA (ultra low penetration air) filter
 Unidirectional flow
 Validation
 Workstation

Clean Room
Fundamentals
Section 3
Contamination
Sources

Contamination Sources
Categories
 External sources
 Outdoor air (makeup air)
 Adjacent spaces (doors, windows, cracks)
 Internal sources
 Personnel (one of most common sources)
 Type of activity
 Manufacturing process equipment
 Products/material
 Cleaning agents
 Processes
 Cross contamination

Examples
 External source — urban areas
 Typically contains 10 million particles (> 0.3 micron)
per cubic foot
 Internal source — people

 A seated or resting person releases 100,000 particles
(> 0.3 micron) per minute
Air pollution refers to particles released outside the building, while

NOTE
contamination refers to inside the building.

Contaminant Classification
 Particulate
 Solid
 Liquid
 Non-particulate
 Gaseous
 Other: ions, radiation, vibration…

Elimination Is Complex
 Thoroughly understand processes to
adequately plan
 Each process has requirements which in turn
define the cleanliness class
 Goal: to control the contamination source

Clean Room
Fundamentals
Section 4
Standards and
Classes

United States
Standards and Classes
 1960 — first clean room concept
(nuclear fusing and firing systems — Sandia Nat. Lab., NM. USA)
 Aviation:gyroscope assembly
 Semiconductors: microchip processing
 HEPA filters
 1966 — first federal standard -> classes

 Current version is Fed-Std-209E (1992)
 ISO Standard 14644-1 is the international

standard for clean rooms
NOTE Fed-Std-209E does not specify air flow velocity — the owner and designer
should do it!
Airborne Particle Concentration Limits
Fed-Std-209E 0.5 micron ISO 0.5 micron
3 3
Class particles/ft particles/m Class particles/m3
1
2 4
1 1 35 3 35
10 10 353 4 352
100 100 3,530 5 3,520
1000 1000 35,300 6 35,200
10,000 10,000 353,000 7 352,000
100,000 100,000 3,530,000 8 3,520,000
9 35,200,000
Cn = N (0.5/D)2.2 where, Cn = concentration limits in particles ft3, N = FS 209 class, and D = particle diameter in micron
Cn = 10N (0.1/D)2.08 where, Cn = concentration limits in particles m3, N = ISO class, and D = particle diameter in micron
SOURCE: ASHRAE 1999
NOTE The concentration limits indicate the maximum number of particulates allowed
for a cleanliness class.
Air Cleanliness Class Limits
Particles per Cubic
Foot
100,000
Class
100,000
10,000
10,000
1,000
1,000
100 100
10
10
1
1
0 0.1 0.2 0.5 1 2 5 10
Particle Size
Source: FED-STD-209E
NOTE The smaller is the class number and the highest is the cleanliness level.

Comparison of Parameters
Cleanliness Number of Filter Average Air Air
Class Particles/ft3 Coverage Velocity Changes
Fed-Std-209E d = 0.5 micron 1 in percentages fpm 2 per hour 3
1 1 > 90 60 – 90 360 – 540

10 10 > 90 50 – 90 300 – 540
100 100 > 85 40 – 80 240 – 480
1,000 1,000 30 – 60 25 – 40 150 – 240
10,000 10,000 10 – 20 10 – 15 60 – 90
100,000 100,000 5 – 10 1– 8 5 – 48
Office 4 (2 – 4 ) 106 — — 3–6
1 Comparisons: human hair: d = 60 – 80 microns

red blood cells: d = 8 microns
2 Relative to total ceiling area

3 Room height = 3 meters (9.84 feet)
4 Consensus practice. (5) 1 m/s = 196.85 fpm

Clean Room
Fundamentals
Section 5
Design
Considerations

Design Considerations
Criteria
 Control the particles within a specified limit
 The manufacturing process within the space
(room’s process) determines the cleanliness
classification
 Design of clean room, should meet specific
requirements (the use and objectives) of the
project

Thermal Load, Air Volumes
 Estimate thermal cooling/heating load like
other spaces, but consider the room’s
manufacturing process
 Set air volumes by:
 Class of cleanliness (refer to Fed-Std-209E)
 Air pattern
 Clean room activity level
NOTES When return air flows through perforated floor, the room’s shape matters.
The greater the class type, the greater the air volumes.

Examples of Clean Room Shapes
Plan View Elevation View
10 m
V = 0, 45 m/s
10 m 0.75 m V = 6 m/s
V = 0, 45 m/s
20 m
0.375 m V = 6 m/s
5m

Example of Single Path Unit
RA
SA
OA

Single Path Psychometrics
93°F DB
OA 75°F WB
72°F
ROOM (R) 50% RH
58.8°F DB
SA 54.8°F WB
76.6°F DB
M 63.8°F WB
LEAVING COIL (L) 54°F DB

53.8°F WB OA
0.98
M
L SA R

Example of Dual Path Unit
Stacked
OA Dehumidification Unit
Outside
(SDU)
(Primary)
Air
M SA
RA
Return
(Secondary)
Air

Dual Path Psychometrics
93°F DB
OA 75°F WB
72°F
ROOM (R) 50% RH
58.8°F DB
SA 54.8°F WB
68°F DB
MIXTURE (M) 58.7°F WB
25.4 Btu/lb
OA
LEAVING COIL (L) 54°F DB
53.8°F WB
0.98
MR
L SA

Example: Class 10,000
example room:
 floor area = 2,545.5 ft2, ceiling height = 10 ft, room volume = 25,455 ft3
 outdoor air = 93°F dry bulb, 75°F wet bulb, 38.3 Btu/lb, sea level elevation
 space set points = 72°F ± 0.5° dry bulb, 50% ± 5% relative humidity
assumptions:
 supply air temperature = 54°F DB (specific volume = 13.7 ft3/lb)
 space sensible load = 234,600 Btu/hr
 space sensible heat ratio (SHR) = 0.98

Example: Calculation Summary
Q = m  cp   T
m = 234,600 / [0.24  (72 - 54)] = 54,300 lb/hr
supply airflow = 54,300  13.7 ft3/lb = 743,986 ft3/hr or 12,400 cfm
air changes/hr (ach) = 746,986 ft3/hr / 25,455 ft3 = 29.2 ach
process requires 40 ach, so new supply airflow is:

 40 ach x 25,455 ft3 = 1,018,200 ft3/h3 = 17,000 cfm = 74,321 lb/hr
outdoor air (OA) required for leakage (cracks/passages):

 m = 2,627 cfm (cracks) + 1,120 cfm (passages) = 3,777 cfm = 16,542 lb/hr

Example: Results
conventional single-path system:
 cooling coil load, QC = m h = 74,321  7.5 / 12,000= 46.4 tons
 reheat load, QRH = m cp  T = 74,321  0.24  4.4 / 3,420 = 25 kW (7.1 tons)
 single-path system: 46.4 + 7.1 = 53.5 tons (equivalent)
alternative dual-path system (precondition outdoor air):

 separate coil preconditions outdoor air, OAL) = 54°F DB, 95% RH, 21.7 Btu/lb
 OA cooling coil load, QOA = m h = 16,542  (38.3 - 21.7) / 12,000 = 22.8 tons
 mixture of OA and R, M = 68°F DB, 58.7°F WB, 25.4 Btu/lb
 supply air condition for 40 ach, SA = 58.8°F DB, 54.8°F WB, 23 Btu/lb
 cooling coil load to cool mixed air from M to SA,
QM = m h = 74,321  (25.4 - 23) / 12,000 = 14.8 tons
 dual-path system: 22.8 + 14.8 = 37.6 tons

Temperature Control
 Provide stable conditions for instruments,
materials and comfort
 Range
 Controla constant temperature
 Accuracy (tolerances: ~1°F; or 0.1 – 0.5°F)
 Comfort conditions
 Use independent humidity and temperature

controls

Humidity Control
 The room’s process determines the required
humidity and tolerance *
 Humidity control is necessary to…
 Prevent condensation and corrosion
 Eliminate static electricity
 Maintain comfort conditions
 RH range should stay between 30 - 50% with
tolerances of ~ 0.5 to 5%
NOTE Use independent humidity and temperature control.

Makeup and Exhaust Air
 Makeup air (MA)
 Affects pressurization, humidity, and cleanliness
 Volume is a function of process exhaust &
pressurization
 Pre-filtered based on contamination level and relative
position to main HEPA filters
 Process exhaust air

 Process exhaust depends on the room’s process
 Exhaust air should be treated before it’s delivered to
the atmosphere

Pressure
 Pressurization
 Causes air to migrate to least clean area
 Differential pressure 0.05 in. wg (~0.01 to ~0.03 in. wg)
 Should be kept as low as possible
 Pressure level results from the balance of…

 Process exhaust
 Makeup air
 Leakage
 Supply and return air volumes

Pressurization Illustration
Airlock with
interlocked doors
Product out
(++) Gown
(++)
Aseptic Core Degown

Class 10,000 (++)
Aseptic Fill
(+++)
(+++)
Auto- Mech Auto- Oven Mech Auto-

clave space clave space clave
Formula preparation Glass wash

Class 100,000 (++) Class 100,000 (++)
(+) Room pressurization level
above zero reference
(+) (+) (+) Unidirectional airflow
(curtained area optional)
Material Personnel Equipment

Filtration and Type of Air Cleaners
 Filtration helps to prevent contamination
 Fibrous media unit
 Viscous impingement filters
 Dry-type extended-surface filters, low- and high-
efficiency air filters (the last)
 High-efficiency particulate air (HEPA)
 Ultra-low penetration air (ULPA)
 Renewable media filters

 Electronic air cleaners
 Combination air cleaners
Filters
Prefilter
Consider need for
Prefilter/Filter Final filter filtration of exhaust air
Return air
?
Outside air H&V coils, Steam Moisture eliminator Space Exhaust fan
washers, etc. humidifier (if required)
SOURCE: ASHRAE 2000

“Ballroom” with Fan Filter Units
Plan View Elevation View
Air handler
Make-up FFUs
air supply
to plenum
Advantage: Easy to
Visitors
corridor
change cleanliness class.

“Comb” with Fan Filter Units
Equipment through partition
Products
entry/exit
Clean area
Support/service area
Maintenance
corridor
Production area Clean
corridor
Maintenance shop/spare parts Dressing rooms Clean

tools
Fan filter units with HEPA filters Exhaust
Treated outside air

(make-up)
Service Return air

Air Pattern
 Objective
 Cleanest air at the critical areas conveyed to less
critical areas
 Large flow at low velocity
 Unidirectional movement (usually downward)
 Air flow patterns

 Unidirectional flow (“laminar”) — air evenly distributed
from one entire surface of the room (ceiling or wall)
at constant velocity
 Single direction, single pass, parallel streamlines

Unidirectional Air Pattern
(classes 1000, 100, 10, 1)
 Vertical
 Total displacement with ceiling HEPA or ULPA filters
(class 100 or better)
 Down-flow with HEPA filters
 Return or exhaust air perforated floor
(not recommended for pharmaceutical clean rooms)
 Horizontal
 Across a section of the room (wall-to-wall)

Air Pattern Unidirectional Air Flow
(classes 1000, 100, 10)
HEPA-filtering
ceiling
 The air volume of the entire room flows at an uniform velocity,

following parallel streamlines
 This “displacement flow” provides a higher cleanliness class
More Air Patterns
 Non-unidirectional (classes 100,000,10,000 & 1,000)
 Eithernon-parallel flow or multiple passes
 Turbulent mixing (dilution) flow, high air change rates,
and ceiling partially covered with HEPA filters
 Mixed configuration
 Non-unidirectional area flow plus unidirectional
module (currently used on pharmaceutical industry)

Air Patterns Illustration
Secondary
air handler
Primary
air handler
Outside
air
99.999%, HEPA or
ULPA filters in ceiling
Return air Return air
Class 10,000 Class 100

non-unidirectional airflow unidirectional airflow

Air Patterns Illustration
Air handler
Outside
air
In-line HEPA or ULPA filter
Return air
Return air
Class 100 Class 10,000

localized airflow non-unidirectional airflow

Optimize Cleanliness Class
 Restrict to class 1, 10, 100 unidirectional
airflow where the product is exposed
 Install partitions to shield “laminar flow” area
 Use class 10,000 or 100,000 turbulent mixing
flow for adjacent areas
The result will be a reduction of

installation and operating costs!

Noise and Vibration
 Establish noise and vibration criteria
 Noise is produced by process equipment and the HVAC
system
 Vibration is a contaminant in microelectronic plants
 Process equipment senses low-frequency vibration (more difficult
to attenuate)
 Sources: rotating machines, fluids in piping, air flowing in duct
system
 Use vane-axial fans (high rpm) instead centrifugal

(low rpm)
 Avoid reciprocating compressors (air or refrigeration)

Energy Savings
 Controlling a clean room requires high energy
 Treatingthe makeup air
 Air movement
 Process exhaust
 Do an energy analysis
 Fans
 Makeup and exhaust air

Air Conditioning Systems
 Future process/equipment changes
 Microelectronic manufacturing functions
 Flexibility
 Proper sizing
 Redundancy
 Process exhaust fans
 Life-cycle economic analysis
 Energy conservation

Clean Room
Fundamentals
Section 6
Application
Considerations

Applications
Microelectronic Plants
 Require class 100 or better due to the size of
their product, circuits
 Goal is less than 1 particle 0.1 micron and larger per
ft3 of air
 Usual design types

 Cleantunnel
 Open bay

Applications — Microelectronic Plants
Clean Tunnel Design
 Modular (~ 8ft to 14ft wide)
 HEPA, ULPA filters, or fan-filter modules
 Advantage
 Reduced filter coverage
 Disadvantages
 Restricts new equipment layouts
 Restricts moving products between equipment

Clean Tunnel Design
Air duct connections

HEPA or ULPA filter
modules in ceiling grid
Work area
Tunnel
wall
Product

Open Bay Design
(up to 100,000 ft2)
 Pressurized plenum or ducted filter modules

 30,000 ft2 or larger sometimes combine tunnel
and open bay
 Advantage
 Flexibility (equipment layout changes)
 Disadvantage
 Larger filtration coverage

Air Flow
 Fed-Std-209E classes 100,10, and 1
 Vertical filters, unidirectional airflow
(w/ HEPA or ULPA filters)
 Pressurize plenum above filters (even pressure
may be a problem)
 Individual ducted filters (higher static loss, higher
maintenance cost due to balancing the system)
 Individual fan-filter units (FFU)
 Return through-the-floor is recommended

Applications
Pharmaceutical Plants
 Distinct from other clean spaces
 Design must consider…
 Room finishes
 HVAC
 Room operations
 Controls
 Process equipment
 Utilities
 All people related to the facility should be
involved in the design phase
 They define the cleanliness class (and necessary
barrier technology or isolators)
NOTE Owner and designer must define the QP as well as drawings, specifications,
critical components, maintenance files, and training.
Applications — Pharmaceutical Plants
Qualification Plan (QP)
 Functional requirement specifications (FRS)
 Critical parameters & acceptance criteria
 Qualification procedure protocols (QPP)
 Installation qualification (IQ) All should be
considered during
 Operational qualification (OQ)
the design process.
 Performance qualification (PQ)
 Standard operating procedures (SOPs)

 Preventive maintenance (PM)
 Operator & maintenance personnel training
 Approval procedure

Documents
 In the USA, FDA inspection is required
 Documents that must be considered
 Code of Federal Regulations 210 and 211
 International Society for Pharmaceutical Engineering
(ISPE) Guides
 National Fire Protection Association (NFPA Std)
 Publications from the Institute of Environmental
Sciences and Technology (IEST)
 Protocols
NOTE FDA stands for Food and Drug Administration.

Good Manufacturing Practice (GMP)
 Proper and repeatable method of producing

sterile products — free from particle and
microbial contaminants
 GMP documents should include test reports
for HEPA filters at operating air velocities
 Efficiency
 Pinhole integrity
 Europe
 Pharmaceutical industry adopted the European Union
Guide to GMP for Medicinal Products in 1992
Clean Room
Fundamentals
Section 7
Testing

Testing
Fundamental Tests
 Cleanliness class
 Air movement
 Room (or zones) conditions
NOTE IEST describes 12 tests for clean rooms.

Testing
Validation Tests
 Tests depend on clean room type
 Unidirectionalflow
 Non-unidirectional flow
 Mixed flow
 Three distinct steps to complete

 Clean room as-built
 Clean room at-rest
 Operational clean room

Clean Room
Fundamentals
Section 8
Closing Thoughts

Closing Thoughts
A Successful Clean Room
 Commitment
 Teamwork (owner, architect, consultant,
contractor)
 Defined responsibility
 Judicious design, simplicity
 Procedures
 Coordination The team members should work
 Testing together for a successful, complete
product — a building that all can
 Documentation be proud of.

Clean Room Fundamentals
References
 ASHRAE
 1981 Symposium: CI-81-5 No.: 3/4 (709-717)
 1986 Transactions No.: SF-86-06 (pages 272-84)
 1987 Symposium: NY-87-13-1 (1279-1287)
 1990 Symposium No.: SL-90-5-1/2/3/4 (609-633)
 1994 Transactions No.: NO-94-18-1/2 (1257-1374)
 1994 Transactions No.: NO-94-28-1/2/3/4 (1629-1651)
 1994 Transactions No.: NO-94-29-1/2 (1655-1675)
 1997 Applications Handbook
 Federal Standard: Fed-Std-209E (September 1992)
 IEST Publications
 Sulzer, Switzerland: Clean Spaces Techniques & Applications
 Brazilian Society of Contamination Control: 1994 Seminar

Clean Room Seminar Fundamental

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Clean Room

© American Standard Inc. 2001 Seminar SYS_P19.PPT

© 2001 American Standard Inc. 2 Seminar SYS_P19.PPT

© American Standard Inc. 2001 Seminar SYS_P19.PPT

© 2001 American Standard Inc. 4 Seminar SYS_P19.PPT

© 2001 American Standard Inc. 5 Seminar SYS_P19.PPT

© American Standard Inc. 2001 Seminar SYS_P19.PPT

© 2001 American Standard Inc. 7 Seminar SYS_P19.PPT

© 2001 American Standard Inc. 8 Seminar SYS_P19.PPT

© 2001 American Standard Inc. 9 Seminar SYS_P19.PPT

© American Standard Inc. 2001 Seminar SYS_P19.PPT

© 2001 American Standard Inc. 11 Seminar SYS_P19.PPT

 Internal source — people

Air pollution refers to particles released outside the building, while

© 2001 American Standard Inc. 12 Seminar SYS_P19.PPT

 Other: ions, radiation, vibration…

© 2001 American Standard Inc. 13 Seminar SYS_P19.PPT

© 2001 American Standard Inc. 14 Seminar SYS_P19.PPT

© American Standard Inc. 2001 Seminar SYS_P19.PPT

 1966 — first federal standard -> classes

 ISO Standard 14644-1 is the international

© 2001 American Standard Inc. 18 Seminar SYS_P19.PPT

1 1 > 90 60 – 90 360 – 540

1 Comparisons: human hair: d = 60 – 80 microns

2 Relative to total ceiling area

© 2001 American Standard Inc. 19 Seminar SYS_P19.PPT

© American Standard Inc. 2001 Seminar SYS_P19.PPT

© 2001 American Standard Inc. 21 Seminar SYS_P19.PPT

© 2001 American Standard Inc. 22 Seminar SYS_P19.PPT

© 2001 American Standard Inc. 23 Seminar SYS_P19.PPT

© 2001 American Standard Inc. 24 Seminar SYS_P19.PPT

LEAVING COIL (L) 54°F DB

© 2001 American Standard Inc. 25 Seminar SYS_P19.PPT

© 2001 American Standard Inc. 26 Seminar SYS_P19.PPT

© 2001 American Standard Inc. 27 Seminar SYS_P19.PPT

© 2001 American Standard Inc. 28 Seminar SYS_P19.PPT

process requires 40 ach, so new supply airflow is:

outdoor air (OA) required for leakage (cracks/passages):

© 2001 American Standard Inc. 29 Seminar SYS_P19.PPT

alternative dual-path system (precondition outdoor air):

© 2001 American Standard Inc. 30 Seminar SYS_P19.PPT

 Use independent humidity and temperature

© 2001 American Standard Inc. 31 Seminar SYS_P19.PPT

NOTE Use independent humidity and temperature control.

© 2001 American Standard Inc. 32 Seminar SYS_P19.PPT

 Process exhaust air

© 2001 American Standard Inc. 33 Seminar SYS_P19.PPT

 Pressure level results from the balance of…

© 2001 American Standard Inc. 34 Seminar SYS_P19.PPT

Aseptic Core Degown

Auto- Mech Auto- Oven Mech Auto-

Formula preparation Glass wash

© 2001 American Standard Inc. 35 Seminar SYS_P19.PPT

 Renewable media filters

SOURCE: ASHRAE 2000

© 2001 American Standard Inc. 37 Seminar SYS_P19.PPT

© 2001 American Standard Inc. 38 Seminar SYS_P19.PPT

Maintenance shop/spare parts Dressing rooms Clean

Treated outside air

Service Return air

© 2001 American Standard Inc. 39 Seminar SYS_P19.PPT

 Air flow patterns

© 2001 American Standard Inc. 40 Seminar SYS_P19.PPT