無塵室分類標準與法規資訊 - rac.ncut.edu.tw

1 The history1961, Technical Manual , Federal Standard 209, A~E1999, (ISO)ISO 14644-1 NCIT Dr. Wang Lab. Why? m? Why? 90fpm( )NCIT Dr. Wang Lab. Comparison of particle diameterNCIT Dr. Wang Lab. cleanroom and Work Station Requirements, Controlled Environments FS 209 A (1966)209 B (1973)209 C (1987) 209 D (1988)209 E (1992) FS 209 NCIT Dr. Wang Lab. FS 209 DNCIT Dr. Wang Lab. FS 209 E m/m3, 1000 ,M3 NCIT Dr. Wang Lab. FS 209 ENCIT Dr. Wang Lab. ISO 14644-1 (ISO) International Organization for Standardization, ISO 1999,ISO 14644-1 Classification of Air Cleanliness NCIT Dr. Wang Lab. ISO N ISO 9 D m m =DCNnnCNCIT Dr. Wang Lab. ISO ClassNCIT Dr. Wang Lab. FS 209 ISO 14644-1 NCIT Dr. Wang Lab. ISO ClassNCIT Dr. Wang Lab. Occupany state ( ) As built At rest OperationalNCIT Dr.

2 Wang Lab. Ultrafine macroparticles m 5 m M a b ; c a b c NCIT Dr. Wang Lab. Pharmaceutical cleanroom Classification( ) European Union EU, GGMP, 1997 US, FDA, 1981 NCIT Dr. Wang Lab. EU GGMP European Union Guide to Good Manufacturing Practice, EU GGMP 4 Grade (A, B, C, D)NCIT Dr. Wang Lab. EU GGMP ClassificationNCIT Dr. Wang Lab. NCIT Dr. Wang Lab. US FDA (1981) Food and Drug Administration, FDA critical area controlled area NCIT Dr. Wang Lab. critical area controlled area NCIT Dr. Wang Lab. 90ft/min 1cfu/10ft3 NCIT Dr. Wang Lab. Class 100,000 25 cfu /10ft3 20 cfm Dr. Wang Lab. (Information Source) Standard Books Recommended particle Magazine InternetNCIT Dr.

3 Wang Lab. ICCCS International Confederation of Contamination Control Societies, ICCCS SecretariatPostbus 311 3830 A J LeusdenThe :+31 33 43 45 752 Fax:+31 33 43 21 581E-mail:icccs @ Dr. Wang Lab. International cleanroom Standards ISO 14644 14698 FS 209 E EU GGMP US FDANCIT Dr. Wang Lab. ISO 14644 PART 1 Classification of cleanliness PART 2 Specification for testing and monitoring to prove continued compliance with ISO14644-1 ISO 14644-1 NCIT Dr. Wang Lab. PART 3 Metrology and test methods PART 4 Design, construction, and startup PART 5 Operation PART 6 Terms and definitions NCIT Dr. Wang Lab. PART 7 Separative enclosures clean air hoods, gloveboxes, isolator, minienvironments PART 8 Molecular contamination NCIT Dr. Wang Lab. ISO 14698 Cleanrooms and Associated Controlled Environments- Biocontamination Control - PART 1 General principles and methods PART 2 Evaluation and interpretation of biocontamination data NCIT Dr.

4 Wang Lab. Web site ISO, , , FS 209 E , EU GGMP , US FDA , Dr. Wang Lab. Books cleanroom Technology, by Whyte, W. 2001 . Wiley.( , , ) cleanroom Designedited by Whyte, W. 1991 . Wiley. Clean Room Designby Ljungvist, B. and Reinmuller, B. 1997 . Interpharm Press, Buffalo Grove, IL 60089, USA. Introduction to Contamination Control and CleanroomTechnologyby Ramstorp, M. 2000 . Wiley-VCH. Isolator Technologyby Wagner, C. M. and Akers, J. E. 1995 . Interpharm Press, Buffalo Grove, IL 60089, USA. , ,(1997), NCIT Dr. Wang Lab. IEST Institute of Environmental Sciences and Technology Recommended Practices, RPs 940 East Northwest HighwayMount ProspectIllinois, 60056, :+1 708 255 1561 Fax :+1 708 255 1699 Web Dr. Wang Lab. IEST RP IEST-RP-CC001 HEPA and ULPA filters HEPA ULPA HEPA ULPA IEST-RP-CC002 Laminar flow clean-air devices NCIT Dr.

5 Wang Lab. IEST-RP-CC003 Garments required in cleanrooms and controlled environments IEST-RP-CC004 Evaluating wiping materials used in cleanroomsand other controlled environments NCIT Dr. Wang Lab. IEST-RP-CC005 cleanroom gloves and finger cots IEST-RP-CC006 Testing cleanrooms NCIT Dr. Wang Lab. IEST-RP-CC007 Testing ULPA filters ULPA ULPA IEST-RP-CC008 Gas-phase adsorber cell NCIT Dr. Wang Lab. IEST-RP-CC009 Compendium of standards, practices, methods, and similar documents relating to contamination control NCIT Dr. Wang Lab. IEST-RP-CC011 A glossary of terms and definitions relating to contamination control IEST-RP-CC012 Considerations in cleanroom design NCIT Dr.

6 Wang Lab. IEST-RP-CC013 Equipment calibration or validation procedures IEST-RP-CC015 cleanroom production and support equipment NCIT Dr. Wang Lab. IEST-RP-CC016 The rate of deposition of nonvolatile residue in cleanrooms NVR IEST-RP-CC018 cleanroom housekeeping operating and monitoring procedures NCIT Dr. Wang Lab. IEST-RP-CC020 Substrates and forms for documentation in cleanrooms IEST-RP-CC021 Testing HEPA and ULPA filter media HEPA ULPA HEPA ULPA NCIT Dr. Wang Lab. IEST-RP-CC022 Electrostatic charge in cleanroomsand other controlled environments IEST-RP-CC023 Microorganisms in cleanrooms NCIT Dr.

7 Wang Lab. IEST-RP-CC024 Measuring and reporting vibration in microelectronic facilities IEST-RP-CC026 cleanroom operations NCIT Dr. Wang Lab. IEST-RP-CC027 Personnel practices and procedures in clearoom and controlled environments IEST-RP-CC029 Automotive paint spray applications NCIT Dr. Wang Lab. IEST-RP-CC031 Building code reference handbook: a guide to alternative code compliance issues in the semiconductor industry NCIT Dr. Wang Lab. IEST-RP-CC034 HEPA ULPA HEPA and ULPA filter leak tests NCIT Dr. Wang Lab. IEST Guide IEST-G-CC1001 Counting airborne particles for classification and monitoring of cleanroomsand clean zones IEST-G-CC1002 Determination of the concentration of airborne ultrafine particles ISO 14644-1 NCIT Dr.

8 Wang Lab. IEST-G-CC1003 Measurement of airborne macroparticles IEST-G-CC1004 Sequential-sampling plan for use in classification of the particle cleanliness of air in cleanrooms and clean zones ISO 14644-1 NCIT Dr. Wang Lab. International cleanroom Forum( ) ICCCS S2C2 Dr. Wang Lab.