1

Cleanroom Standards Cleanroom Standards

CLEANROOM TUTORIAL PROGRAMME
CLASS 1 & 10 These cleanrooms are virtually the exclusive domain of
(ISO Class 3 & 4) the microelectronics industry
CLASS 100 ntil the microelectronics industry demanded finer
(ISO Class 5) line widths, this was the highest cleanliness level
and is now widely used in many fields of technology
CLASS 1,000 Used less frequently, but has been a cleanliness
(ISO Class 6) classification in the US; it is a mixed class where
UAF workstations are in close proximity
CLASS 10,000 Probably the most used cleanliness level. Is very
(ISO Class 7) frequently used as a base cleanroom cleanliness
level together with localised clean areas of Class
100 within the cleanroom itself for Pharmacare & Micro
CLASS 100,000 Normally entry level cleanroom classification for use in
(ISO Class 8) Micro and Pharmacare industries
CLEANROOM CLASSES
WD-14644-9 Particle Surface Contamination CD
ISODocument Title
ISO-14644-1 Classification of Air Cleanliness
ISO-14644-2 Specification of Testing for Continued Compliance
ISO-14644-3 Metrology & Test Methods
ISO-14644-4 Design, Construction & Start Up
ISO-14644-5 Cleanroom Operations
ISO-14644-6 Terminology
ISO-14644-7 Seprative Enclosures
ISO-14644-8 Molecular Contamination
ISO-14698-1 Biocontamination: Control General Principles & Methods
ISO-14698-2 Biocontamination: Evaluation & Interpretation of Data
Status
1999
2000
FDIS
2001
2004
CD
2004
FDIS
2003
2004
ISO CLEANROOM STANDARDS (SEP 05)
2
BASIC GUIDE TO CLEANROOM DESIGN
EU GMP "A/B" at rest "C" at rest "D" at rest
Classes ( Fed 209 D) 1 10 100 1000 10 000 100 000
ISO Standard ISO 3 ISO 4 ISO5 ISO 6 ISO 7 ISO8
Particles per m3 > 0.5 micron 35.3 353 3 530 35 300 353 000 3 530 000
Air Changes Per Hour 600 500 500 40 - 120 20 - 40 0 - 20
RoomPressure 15 Pa 15 Pa 15 Pa 10 - 15 Pa 10 15 Pa 5 - 10 Pa
Clean air inlets Cover as %of ceiling area 100% 100% 90% 20 - 50 % 10 - 20 % 5 - 10 %
Clean air inlets Locations Ceiling Ceiling Ceiling Ceiling Ceiling Ceiling / High wall
Filter Location Ceiling Ceiling Ceiling Ceiling Ceiling Ceiling / AHU
Return Locations Floor Floor LowLevel or Floor LowLevel or Floor LowSidewall Sidewall
Velocity at clean air inlets (m/s) 0.45 0.45 0.45 0.15 - 0.45 0.15 - 0.45 0.15 - 0.45
Velocity at return air (m/s) n/a n/a n/a 0.5- 1 1 - 2.5 2.5
Airlock ( required ) Yes Yes Yes Yes Yes None
Area per occupant ( m2) 40 40 30 20 10 5
Equipment in room Minimum Minimum Minimun Minimum 30%Floor 50%Floor
RoomHeight n/a n/a n/a Minimum3 Minimum2.75 Minimum2.25
Comparison of Major CleanroomStandards
US 209 E 1992 M1.5 M2.5 M3.5 M4.5 M5.5 M6.5
ISOClass 14644-1 1999 3 4 5 6 7 8
EECGGMP 1989 N/A N/A A & B N/A C D
France AFNOR 1981 N/A N/A 4000 N/A 400 000 4 000 000
Germany VDI 2083 1990 1 2 3 4 5 6
Britain BS 5295 1989 N/A N/A E or F G or H J K
Japan JACA1989 3 4 5 6 7 N/A
The above is only a guide for cleanroomdesign
17/11/2004
ardmac
adding value to CleanroomConstruction
ISO 14644-1: 1999
Classification of Air Cleanliness
ISO 14644 ISO 14644- -1 1
Very Similar to the old Fed Std 209E
ISO 14644-1 Direct Outgrowth of 209E
Changes
In Cubic Metres, not Cubic Feet
Number of Cleanliness Classes
Number of Sample Points
Treatment of Outliers
INTRO INTRO
3
3,520,000 832,000 29,300
ISO 9 35,200,000 8,320,000 293,000
ISO 8
35,200 8,320 293
ISO 7 (Class 10,000) 352,000 83,200 2,930
ISO 6 (Class 1,000) 1,000,000 237,000 102,000
352 83
ISO 5 (Class 100) 100,000 23,700 10,200 3,520 832 29
ISO 4 10,000 2,370 1,020
4
ISO 3 1,000 237 102 35 8
ISO 2 100 24 10
0.5 um 1 um 5 um
ISO 1 10 2
0.1 um 0.2 um 0.3 um
CLASS Number of Particles per Cubic Meter by Micrometer Size
ISO 14644 ISO 14644- -1 1
N/A 9
100,000 8
10,000 7
1,000 6
100 5
10 4
1 3
N/A 2
N/A 1
FS 209E ISO 144644-1
14644 14644- -1 and 209E Equivalents 1 and 209E Equivalents
cleanroom definition
define level of suspended particles in cleanroom
air
define clean space airborne particulate
cleanliness classes
provide statistically based methodology for
testing and certification of cleanrooms
COMMENTS COMMENTS
4
cleanliness class expressed in terms of an
ISO Class N which represents...
the max. allowable concentrations (in
particles per m
3
) for considered sizes of
particles
using the formula given in Sect. 3.2
ISO 14644-1
1. ISO Number
2. Particle Size
3. Occupancy
ISO 14644-1
Require 3 items to specify a Cleanroom
Classification to ISO STD 14644-1:
OCCUPANCY STATES
As Built
...installation is complete with all services connected and
functioning but with no production equipment, materials of
personnel present
At Rest
installation is complete with equipment installed and
operating in a manner agreed upon by the customer and
supplier, but with no personnel present
Operational
installation is functioning in the specified manner, with
the specified number of personnel present and working in
the manner agreed upon
5
ISO 14644 2: 2000
Specifications for testing and
monitoring to prove
continued compliance with
ISO 14644-1
14644 14644- -2 2
14644-2 Definitions
Monitoring Frequency
Continuous
Updating Constantly
Frequent
Updating at Specified Intervals Not Exceeding 60 Minutes
During Operation
Intervals:
6 months: Avg. < 183 Max < 190 Days
12 months: Avg. < 366 Max < 400 Days
24 months: Avg. < 731 Max < 800 Days
Testing Particle Conc Limits
ISO Class Max. Time Interval
5 and Cleaner 6 months
6 and Less Clean 12 months
Normally performed in operational state
May be performed in At Rest state
Table 1
6
14644-2 - Testing Schedules
Test Parameter Max. Time Interval
Airflow Volume or Velocity*1 12 months
Air Pressure Difference*2 12 months
*1 Determined by either velocity or volume measurement
*2 Test will not apply to clean zones which are not totally
enclosed.
Note: Tests may be performed in operational or
at- rest condition
Table 2
14644-2 Annex A - Optional Tests
Test Parameter Class Max. Time Interval
Installed Filter Leakage All 24 Months
Airflow Visualization All 24 Months
Recovery All 24 Months
Containment Leakage All 24 Months
Note: NOT Recommended for Microelectronics
ISO ISO 14644 14644- -4:2001 4:2001
Design, Construction, and Design, Construction, and
Start Start- -up up of Cleanroom of Cleanroom
Facilities Facilities
ISO 14644 ISO 14644- -4 4
7
1. 1. Scope Scope
2. 2. Normative References Normative References
3. Terms & 3. Terms & D Definitions efinitions
4. 4. Specification of Requirements Specification of Requirements
5. 5. Planning & Design Planning & Design
6. 6. Construction & Start Construction & Start- -up up
7. 7. Testing & Approval Testing & Approval
8. 8. Documentation Documentation
ISO 14644 ISO 14644- -4 4
Design, Construction & Start-Up
A1 A1 INFORMATIVE INFORMATIVE
Outdoor Environment
Ancillary Areas
Cleanrooms
Clean Zones
Process Core
Raw Mat er i al s
Pr oduc t
Per sonnel
Wast e
Concept of Segregation
Defines things that must be considered:-
Reference no. of standard
Use of the space or device
Choice of Design Concept
Class of space
Other environment parameters
- Material flow
- Occupancy state
- Layout and critical dimensions
- Equipment
- Maintenance
- Responsibilities
- External influences
Specification of Specification of Reqts Reqts
Section 4
8
States that design shall be complete, be approved and
integrate all relevant regulations.
Planning Procedure
Project Plan
Equipment lists
Options & Costs
Design
Complete & documented
Must satisfy all Codes & Regulations
Formally accepted = sign off
Planning & Design Planning & Design
Section 5
States that construction shall comply with the approved
design, shall be accurate, shall be undertaken in an
appropriate way.
In accordance with drgs & Specs
Clean construction protocol
Cleaning methods shall be defined
Carry out full functional tests before use for
operational activity
Training the operational personnel part of the start-up
responsibility
Construction & Start Up Construction & Start Up
Section 6
States that organised tests shall be carried out.
Carry out an agreed series of inspections and tests
Construction approval
Demonstrate that the installation complies with the
design
Functional approval
Demonstrate compliance during AS BUILT or AT
REST states
Operational approval
Demonstrate Full operational performance
Testing & Approval Testing & Approval
Section 7
9
Sets out the main things that shall be well
documented.
Record of the Installation
URS, Drgs, test records, spares list
Operational Instructions
Performance Monitoring Instructions
Maintenance Instructions
Maintenance Record
Training record
Documentation Documentation
Section 8
Annex A Control and segregation concepts
Annex B Classification examples
Annex C Development & Approval
Annex D Layout of installation
Annex E Construction and materials
Annex F Environmental control of cleanrooms
Annex G Control of air cleanliness
Annex H Additional specification TBA
Bibliography
Appendices Appendices
#Total UDAF Zone area 8.64m
2
Live filter area ~ 83%of total.
If the Average velocity in zone is 0.45 m/s
#Then, the required velocity
through filter media is 0.55 m/s.
#This is critical for choosing the correct filters
because filter efficiency is velocity dependent. See
also EN1822 for HEPAand ULPAfilters.
#EN/ISO14644-3 will define this important
difference in the section on velocity and volume
measurement.
UDAF UDAF - - Fi l t er Gr i d Fi l t er Gr i d
Gross area = 8.64 m
2
Net area = 7.17 m
2
A5.1 Unidirectional Airflow Velocity A5.1 Unidirectional Airflow Velocity
10
A5.1 Unidirectional Airflow Velocity A5.1 Unidirectional Airflow Velocity
Filter
Face
velocity
System
velocity at
working
plane
UDAF UDAF - - Filter Grid Filter Grid
#EN/ISO14644-3 will define this
important difference in the section
on velocity and volume
measurement.