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CLEANROOM TUTORIAL PROGRAMME

Cleanroom Standards

CLEANROOM CLASSES
ƒ CLASS 1 & 10 These cleanrooms are virtually the exclusive domain of
(ISO Class 3 & 4) the microelectronics industry
ƒ 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
ƒ 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
ƒ 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
ƒ CLASS 100,000 Normally entry level cleanroom classification for use in
(ISO Class 8) Micro and Pharmacare industries

ISO CLEANROOM STANDARDS – (SEP ’05)


ISO Document Title Status

ISO-14644-1 Classification of Air Cleanliness 1999

ISO-14644-2 Specification of Testing for Continued Compliance 2000

ISO-14644-3 Metrology & Test Methods FDIS

ISO-14644-4 Design, Construction & Start Up 2001

ISO-14644-5 Cleanroom Operations 2004

ISO-14644-6 Terminology CD

ISO-14644-7 Seprative Enclosures 2004

ISO-14644-8 Molecular Contamination FDIS

WD-14644-9 Particle Surface Contamination CD

ISO-14698-1 Biocontamination: Control General Principles & Methods 2003

ISO-14698-2 Biocontamination: Evaluation & Interpretation of Data 2004

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ardmac BASIC GUIDE TO CLEANROOM DESIGN
adding value to Cleanroom Construction

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 ISO 5 ISO 6 ISO 7 ISO 8
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
Room Pressure 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 Low Level or Floor Low Level or Floor Low Sidewall 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
Room Height n/a n/a n/a Minimum 3 Minimum 2.75 Minimum 2.25

Comparison of Major Cleanroom Standards


US 209 E 1992 M1.5 M2.5 M3.5 M4.5 M5.5 M6.5
ISO Class 14644-1 1999 3 4 5 6 7 8
EEC GGMP 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 JACA 1989 3 4 5 6 7 N/A

The above is only a guide for cleanroom design


17/11/2004

ISO 14644-1

ISO 14644-1: 1999


Classification of Air Cleanliness

INTRO

• 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

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ISO 14644-1

CLASS Number of Particles per Cubic Meter by Micrometer Size

0.1 um 0.2 um 0.3 um 0.5 um 1 um 5 um

ISO 1 10 2

ISO 2 100 24 10 4

ISO 3 1,000 237 102 35 8

ISO 4 10,000 2,370 1,020 352 83

ISO 5 (Class 100) 100,000 23,700 10,200 3,520 832 29

ISO 6 (Class 1,000) 1,000,000 237,000 102,000 35,200 8,320 293

ISO 7 (Class 10,000) 352,000 83,200 2,930

ISO 8 3,520,000 832,000 29,300

ISO 9 35,200,000 8,320,000 293,000

14644-1 and 209E Equivalents

ISO 144644-1 FS 209E


1 N/A
2 N/A
3 1
4 10
5 100
6 1,000
7 10,000
8 100,000
9 N/A

COMMENTS

• “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

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ISO 14644-1

• “cleanliness class” expressed in terms of an


ISO Class N which represents...
• the max. allowable concentrations (in
particles per m3) for considered sizes of
particles…
• using the formula given in Sect. 3.2

ISO 14644-1

Require 3 items to specify a Cleanroom


Classification to ISO STD 14644-1:
1. ISO Number
2. Particle Size
3. Occupancy

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”

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14644-2

ISO 14644 – 2: 2000


Specifications for testing and
monitoring to prove
continued compliance with
ISO 14644-1

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


Table 1
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

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14644-2 - Testing Schedules
Table 2
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

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 14644-4

ISO 14644-4:2001
Design, Construction, and
Start-up of Cleanroom
Facilities

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ISO 14644-4
Design, Construction & Start-Up
1. Scope
2. Normative References
3. Terms & Definitions
4. Specification of Requirements
5. Planning & Design
6. Construction & Start-
Start-up
7. Testing & Approval
8. Documentation

A1 – INFORMATIVE
Concept of Segregation
Outdoor Environment
Ancillary Areas
Personnel
Cleanrooms
Product
Clean Zones
Raw Materials
Process Core

Waste

Specification of Reqts
Section 4
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

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Planning & Design
Section 5
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

Construction & Start Up


Section 6
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

Testing & Approval


Section 7
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

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Documentation
Section 8
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

Appendices

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

A5.1 Unidirectional Airflow Velocity

UDAF - Filter Grid


#Total UDAF Zone area 8.64m2
Live filter area ~ 83% of total.
Gross area = 8.64 m2
If the Average velocity in zone is 0.45 m/s
Net area = 7.17 m2
#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 EN 1822 for HEPA and ULPA filters.
#EN/ISO 14644-3 will define this important
difference in the section on velocity and volume
measurement.

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A5.1 Unidirectional Airflow Velocity

Filter UDAF - Filter Grid


Face
velocity

System #EN/ISO 14644-3 will define this


velocity at important difference in the section
working on velocity and volume
plane measurement.

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