1Cleanroom StandardsCleanroom 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 whereUAF 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

ISO Document 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)

2BASIC GUIDE TO CLEANROOM DESIGN

EU GMP "A/B" at rest "C" at rest "D" at restClasses ( Fed 209 D ) 1 10 100 1000 10 000 100 000ISO Standard ISO 3 ISO 4 ISO 5 ISO 6 ISO 7 ISO 8Particles per m3 > 0.5 micron 35.3 353 3 530 35 300 353 000 3 530 000Air Changes Per Hour 600 500 500 40 - 120 20 - 40 0 - 20Room Pressure 15 Pa 15 Pa 15 Pa 10 - 15 Pa 10 15 Pa 5 - 10 PaClean 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 wallFilter Location Ceiling Ceiling Ceiling Ceiling Ceiling Ceiling / AHU Return Locations Floor Floor Low Level or Floor Low Level or Floor Low Sidewall SidewallVelocity at clean air inlets (m/s) 0.45 0.45 0.45 0.15 - 0.45 0.15 - 0.45 0.15 - 0.45Velocity at return air (m/s) n/a n/a n/a 0.5- 1 1 - 2.5 2.5Airlock ( required ) Yes Yes Yes Yes Yes NoneArea per occupant ( m2) 40 40 30 20 10 5Equipment in room Minimum Minimum Minimun Minimum 30% Floor 50% FloorRoom Height n/a n/a n/a Minimum 3 Minimum 2.75 Minimum 2.25

Comparison of Major Cleanroom StandardsUS 209 E 1992 M1.5 M2.5 M3.5 M4.5 M5.5 M6.5ISO Class 14644-1 1999 3 4 5 6 7 8EEC GGMP 1989 N/A N/A A & B N/A C DFrance AFNOR 1981 N/A N/A 4000 N/A 400 000 4 000 000Germany VDI 2083 1990 1 2 3 4 5 6Britain BS 5295 1989 N/A N/A E or F G or H J KJapan JACA 1989 3 4 5 6 7 N/A

The above is only a guide for cleanroom design17/11/2004

ardmacadding value to Cleanroom Construction

ISO 14644-1: 1999

Classification of Air Cleanliness

ISO 14644ISO 14644--11

Very Similar to the old Fed Std 209E ISO 14644-1 Direct Outgrowth of 209E ChangesIn Cubic Metres, not Cubic FeetNumber of Cleanliness ClassesNumber of Sample PointsTreatment of Outliers

INTROINTRO

33,520,000 832,000 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 14644ISO 14644--11

N/A9100,000810,00071,0006100510413

N/A2N/A1

FS 209EISO 144644-1

1464414644--1 and 209E Equivalents1 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

COMMENTSCOMMENTS

4 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

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

5ISO 14644 2: 2000Specifications for testing and

monitoring to prove continued compliance with

ISO 14644-1

1464414644--22

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 Interval5 and Cleaner 6 months6 and Less Clean 12 months

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

Table 1

614644-2 - Testing Schedules

Test Parameter Max. Time IntervalAirflow Volume or Velocity*1 12 monthsAir 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 1464414644--4:20014:2001

Design, Construction, and Design, Construction, and

StartStart--upup of Cleanroom of Cleanroom

FacilitiesFacilities

ISO 14644ISO 14644--44

71.1. Scope Scope

2.2. Normative ReferencesNormative References

3. Terms & 3. Terms & DDefinitionsefinitions

4.4. Specification of Requirements Specification of Requirements

5.5. Planning & DesignPlanning & Design

6.6. Construction & StartConstruction & Start--upup

7.7. Testing & ApprovalTesting & Approval

8. 8. DocumentationDocumentation

ISO 14644ISO 14644--44Design, Construction & Start-Up

A1 A1 INFORMATIVEINFORMATIVE

Outdoor Environment

Ancillary AreasCleanrooms

Clean Zones

Process CoreRaw Materials

ProductPersonnel

Waste

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 ReqtsReqtsSection 4

8States that design shall be complete, be approved and integrate all relevant regulations.

Planning Procedure Project PlanEquipment listsOptions & Costs

DesignComplete & documentedMust satisfy all Codes & RegulationsFormally accepted = sign off

Planning & DesignPlanning & DesignSection 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 UpConstruction & Start UpSection 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 & ApprovalTesting & ApprovalSection 7

9Sets 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

DocumentationDocumentationSection 8

Annex A Control and segregation conceptsAnnex B Classification examplesAnnex C Development & ApprovalAnnex D Layout of installationAnnex E Construction and materialsAnnex F Environmental control of cleanroomsAnnex G Control of air cleanlinessAnnex H Additional specification TBABibliography

AppendicesAppendices

#Total UDAF Zone area 8.64m2Live 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.

UDAF UDAF -- Filter GridFilter Grid

Gross area = 8.64 m2Net area = 7.17 m2

A5.1 Unidirectional Airflow VelocityA5.1 Unidirectional Airflow Velocity

10

A5.1 Unidirectional Airflow VelocityA5.1 Unidirectional Airflow Velocity

FilterFace

velocity

Systemvelocity at working plane

UDAF UDAF -- Filter GridFilter Grid

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