Cleanroom Standards CLEANROOM TUTORIAL PROGRAMME CLEANROOM CLASSES ISO CLEANROOM STANDARDS (SEP 05)

Transcription

1 CLEANROOM TUTORIAL PROGRAMME Cleanroom Standards CLEANROOM CLASSES 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 ISO CLEANROOM STANDARDS (SEP 05) ISO Document ISO ISO ISO ISO ISO ISO ISO ISO 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 Status FDIS CD 2004 FDIS WD Particle Surface Contamination CD ISO ISO Biocontamination: Control General Principles & Methods Biocontamination: Evaluation & Interpretation of Data

2 ardmac adding value to Cleanroom Construction BASIC GUIDE TO CLEANROOM DESIGN EU GMP "A/B" at rest "C" at rest "D" at rest Classes ( Fed 209 D ) ISO Standard ISO 3 ISO 4 ISO 5 ISO 6 ISO 7 ISO 8 Particles per m3 > 0.5 micron Air Changes Per Hour Room Pressure 15 Pa 15 Pa 15 Pa Pa Pa 5-10 Pa Clean air inlets Cover as % of ceiling area 100% 100% 90% % % 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) Velocity at return air (m/s) n/a n/a n/a Airlock ( required ) Yes Yes Yes Yes Yes None Area per occupant ( m2) 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 EEC GGMP 1989 N/A N/A A & B N/A C D France AFNOR 1981 N/A N/A 4000 N/A Germany VDI Britain BS N/A N/A E or F G or H J K Japan JACA N/A The above is only a guide for cleanroom design 17/11/2004 ISO ISO : 1999 Classification of Air Cleanliness INTRO Very Similar to the old Fed Std 209E ISO Direct Outgrowth of 209E Changes In Cubic Metres, not Cubic Feet Number of Cleanliness Classes Number of Sample Points Treatment of Outliers 2

3 ISO 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 ISO ISO 3 1, ISO 4 10,000 2,370 1, ISO 5 (Class 100) 100,000 23,700 10,200 3, ISO 6 (Class 1,000) 1,000, , ,000 35,200 8, ISO 7 (Class 10,000) 352,000 83,200 2,930 ISO 8 3,520, ,000 29,300 ISO 9 35,200,000 8,320, , and 209E Equivalents ISO FS 209E N/A N/A ,000 10, ,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 3

4 ISO 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 Require 3 items to specify a Cleanroom Classification to ISO STD : 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 4

5 ISO : 2000 Specifications for testing and monitoring to prove continued compliance with ISO 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 5

6 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 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 :2001 4:2001 Design, Construction, and Start-up of Cleanroom Facilities 6

7 ISO Design, Construction & Start-Up 1. Scope 2. Normative References 3. Terms & Definitions 4. Specification of Requirements 5. Planning & Design 6. Construction & Start-up 7. Testing & Approval 8. Documentation A1 INFORMATIVE Concept of Segregation Outdoor Environment Ancillary Areas Cleanrooms Clean Zones Raw Materials Process Core Waste Personnel Product 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 7

8 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 8

9 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 Gross area = 8.64 m 2 Net area = 7.17 m 2 #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 EN 1822 for HEPA and ULPA filters. #EN/ISO will define this important difference in the section on velocity and volume measurement. 9

10 A5.1 Unidirectional Airflow Velocity Filter Face velocity UDAF - Filter Grid System velocity at working plane #EN/ISO will define this important difference in the section on velocity and volume measurement. 10