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Cleanroom Standards PDF
Cleanroom Standards PDF
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)
ardmac
adding value to Cleanroom Construction
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
17/11/2004
ISO 14644-1
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
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
*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
ISO 14644-4
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
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
#EN/ISO 14644-3 will define this important difference in the section on velocity and volume measurement.
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