CLEANROOM TUTORIAL PROGRAMME

Cleanroom Standards

CLEANROOM CLASSES

CLASS 1 & 10
(ISO Class 3 & 4)

These cleanrooms are virtually the exclusive domain of the microelectronics industry ntil the microelectronics industry demanded finer line widths, this was the highest cleanliness level and is now widely used in many fields of technology Used less frequently, but has been a cleanliness classification in the US; it is a mixed class where UAF workstations are in close proximity Probably the most used cleanliness level. Is very frequently used as a base cleanroom cleanliness level together with localised clean areas of Class 100 within the cleanroom itself for Pharmacare & Micro Normally entry level cleanroom classification for use in Micro and Pharmacare industries

CLASS 100
(ISO Class 5)

CLASS 1,000
(ISO Class 6)

CLASS 10,000
(ISO Class 7)

CLASS 100,000
(ISO Class 8)

ISO CLEANROOM STANDARDS (SEP 05)

ISO Document ISO-14644-1 ISO-14644-2 ISO-14644-3 ISO-14644-4 ISO-14644-5 ISO-14644-6 ISO-14644-7 ISO-14644-8 WD-14644-9 ISO-14698-1 ISO-14698-2 Title Classification of Air Cleanliness Specification of Testing for Continued Compliance Metrology & Test Methods Design, Construction & Start Up Cleanroom Operations Terminology Seprative Enclosures Molecular Contamination Particle Surface Contamination Biocontamination: Control General Principles & Methods Biocontamination: Evaluation & Interpretation of Data Status 1999 2000 FDIS 2001 2004 CD 2004 FDIS CD 2003 2004

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adding value to Cleanroom Construction

BASIC GUIDE TO CLEANROOM DESIGN

1 ISO 3 35.3 600 15 Pa 100% Ceiling Ceiling Floor 0.45 n/a Yes 40 Minimum n/a 10 ISO 4 353 500 15 Pa 100% Ceiling Ceiling Floor 0.45 n/a Yes 40 Minimum n/a EU GMP "A/B" at rest "C" at rest 100 1000 10 000 ISO 5 ISO 6 ISO 7 3 530 35 300 353 000 500 40 - 120 20 - 40 15 Pa 10 - 15 Pa 10 15 Pa 90% 20 - 50 % 10 - 20 % Ceiling Ceiling Ceiling Ceiling Ceiling Ceiling Low Level or Floor Low Level or Floor Low Sidewall 0.45 0.15 - 0.45 0.15 - 0.45 n/a 0.5- 1 1 - 2.5 Yes Yes Yes 30 20 10 Minimun Minimum 30% Floor n/a Minimum 3 Minimum 2.75 "D" at rest 100 000 ISO 8 3 530 000 0 - 20 5 - 10 Pa 5 - 10 % Ceiling / High wall Ceiling / AHU Sidewall 0.15 - 0.45 2.5 None 5 50% Floor Minimum 2.25

Classes ( Fed 209 D ) ISO Standard Particles per m3 > 0.5 micron Air Changes Per Hour Room Pressure Clean air inlets Cover as % of ceiling area Clean air inlets Locations Filter Location Return Locations Velocity at clean air inlets (m/s) Velocity at return air (m/s) Airlock ( required ) Area per occupant ( m2) Equipment in room Room Height Comparison of Major Cleanroom Standards US 209 E 1992 ISO Class 14644-1 1999 EEC GGMP 1989 France AFNOR 1981 Germany VDI 2083 1990 Britain BS 5295 1989 Japan JACA 1989 The above is only a guide for cleanroom design

M1.5 3 N/A N/A 1 N/A 3

M2.5 4 N/A N/A 2 N/A 4

M3.5 5 A&B 4000 3 E or F 5

M4.5 6 N/A N/A 4 G or H 6

M5.5 7 C 400 000 5 J 7

M6.5 8 D 4 000 000 6 K N/A

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

ISO 14644-1
CLASS
Number of Particles per Cubic Meter by Micrometer Size 0.1 um ISO 1 ISO 2 ISO 3 ISO 4 ISO 5 (Class 100) ISO 6 (Class 1,000) ISO 7 (Class 10,000) ISO 8 ISO 9 10 100 1,000 10,000 100,000 1,000,000 0.2 um 2 24 237 2,370 23,700 237,000 10 102 1,020 10,200 102,000 3,520 35,200 352,000 3,520,000 35,200,000 4 35 352 8 83 832 8,320 83,200 832,000 8,320,000 29 293 2,930 29,300 293,000 0.3 um 0.5 um 1 um 5 um

14644-1 and 209E Equivalents

ISO 144644-1 1 2 3 4 5 6 7 8 9 FS 209E N/A N/A 1 10 100 1,000 10,000 100,000 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

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 At Rest
...installation is complete with all services connected and functioning but with no production equipment, materials of personnel present installation is complete with equipment installed and operating in a manner agreed upon by the customer and supplier, but with no personnel present installation is functioning in the specified manner, with the specified number of personnel present and working in the manner agreed upon

Operational

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: 12 months: 24 months: Avg. Avg. Avg. < 183 Max < 190 Days < 366 Max < 400 Days < 731 Max < 800 Days

Testing Particle Conc Limits

Table 1

ISO Class 5 and Cleaner

Max. Time Interval 6 months

6 and Less Clean 12 months

Normally performed in operational state May be performed in At Rest state

14644-2 - Testing Schedules

Table 2
Test Parameter Airflow Volume or Velocity*1 Air Pressure Difference*2 Max. Time Interval 12 months 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 Airflow Visualization Recovery Containment Leakage Class All All All Max. Time Interval 24 Months 24 Months 24 Months 24 Months

Installed Filter Leakage All

Note: NOT Recommended for Microelectronics

ISO 14644-4

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

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

A1 INFORMATIVE
Concept of Segregation
Outdoor Environment Ancillary Areas Cleanrooms Clean Zones

Personnel Product

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

Planning & Design

Section 5
Planning Procedure Project Plan Equipment lists Options & Costs Design Complete & documented Must satisfy all Codes & Regulations Formally accepted = sign off
States that design shall be complete, be approved and integrate all relevant regulations.

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

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 Annex B Annex C Annex D Annex E Annex F Control and segregation concepts Classification examples Development & Approval Layout of installation Construction and materials Environmental control of cleanrooms

Annex G Control of air cleanliness Annex H Additional specification TBA Bibliography

A5.1 Unidirectional Airflow Velocity

UDAF - Filter Grid
Gross area = 8.64 m2 Net area = 7.17 m2 #Total UDAF Zone area 8.64m2 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 EN 1822 for HEPA and ULPA filters. #EN/ISO 14644-3 will define this important difference in the section on velocity and volume measurement.

A5.1 Unidirectional Airflow Velocity

Filter Face velocity
System velocity at working plane UDAF - Filter Grid

#EN/ISO 14644-3 will define this important difference in the section on velocity and volume measurement.

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