The Regulatory and Legislative Situation and Technological Future in Worldwide Contamination Control
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1 The Regulatory and Legislative Situation and Technological Future in Worldwide Contamination Control TUEV SUED Cleancert H. Weißsieker
2 Contamination Control the chain of all technical and operational measures to minimize or avoid the critical influence of contamination on products or personnel.
3 Applications of Contamination Control Microelectronic Micro and Nano Mechanics Optics Glas Fibre Technology Laser Technology Space and Aerospace Multi Media Technology Pharmacy/Biotechnology/ API Food Industries Medical Devices Laboratories Hospitals
4 Dimensions in Contamination Control 1 Micrometer (1/50 of the Thickness of a Hair) Structure Element of µelectronic s < 0,2 /µm (today 0,065!!!) Killer Particle Size ca. 1/6 s Virus Bacteria D ca µm
5 Dimensions in Contamination Control Prions Soruce: Osmonics
6 Tree of Life We The Tree of Life
7 Cleanliness Classes ISO Particle Number Concentration 1/m³ ,01 0, Particle Diameter in µm
8 Cleanroom and associated controlled environments ISO Part 1: Classification of air cleanliness (ISO :1999) ISO Part 2: Specifications for testing and monitoring to prove continued compliance with ISO (ISO :2000) ISO Part 3: Metrology and test methods (Draft Standard ) ISO Part 4: Design, construction and start-up (Draft Standard ) ISO Part 5: Operations (Draft Standard ) ISO Part 6: Terminology (CD) ISO Part 7: Separative enclosures (clean air hoods, gloveboxes isolators, mini-environments) (DIS) ISO Part 8: Airborne molecular contamination (AWI) ISO Biocontamination control - Part 1: General principles (Draft Standard ) ISO Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (Draft Standard ) ISO Biocontamination control - Part 3: Measurement of the efficiency of processes of cleaning and/or disinfection of inert surfaces bearing biocontaminated wet soiling or biofilms (ISO/DIS :1999)
9 VDI 2083 Family Air Cleanliness Class, Part 1 QM: Part 11 Process Equipment, Parts 2, 4, 8 Personal, Part 5, 6 Measurements, Part 3 Surface, Part 4, 8, 9 Process Media, Part 7, 9, 10, 13 Safety & Environmental Protection, Part 12
10 VDI 2083 Part 9 (3. Generation) Surface Cleanliness and Cleanroom Compatibility Emissionsverhalten of sedi - mentierter Partikel Particles luftgetragene Airborne Molecular partikuläre Contaminations Kontaminationen Strömungsverhalten Flow Profiles Parameters der of Reinheitstauglichkeits Cleanroom Compatibility - Prüfung Testing ESD -Eigenschaften Parameters Oberflächenqualität Quality of Surface Einhaltung Compliance ( (inter) -nationaler Richtlinien Regulations und and Standards ( i.e. z.b. GMP, FDA, FDA, ISO) ISO) Weitere Additional Parameter Cleanroom Compatibility vs. Cleanliness Compatibility
11 Airborne Molecular Contamination (AMC) Classification: Values in the Cleanroom Typical MAK Values Acids Crit. Odor Caustic Crit. Odor Condensable Material (VOC) Crit. Odor Dopants Crit. Odor ng/m³ µg/m³ mg/m³ g/m³ Typical AMC Concentrations for µelectronic Applications (ISO )
12 VDI 2083 Outlook, Part 13, 14, 15 Part 13 Purified Water 3. Generation Part 14 Chemical Contamination Part 15 Contamination Control Training... Contamination Control Certified User VDI 2083 (1 5) ISO (1 5) Valid until 2006
13 The Contamination Control World Germany VDI DIN Europe VCCN SRRT CEN BSI AFNOR ASENMCO JACA Asia Pacific IEST ISO ICCCS-Countries International Confederation of Contamination Control Societies USA
14 World Cleanrooms m² - > 2 Mio. Cleanroom Operators ROW 10% USA 30% Asia+SEA 30% Europe without G 20% Germany 10%
15 Cleanrooms for Optics/microstructures 20% Pharma/Biotech 35% Food/Cosmetic 15% µelektronic 30%
16 Certification and Recertification Certification and Documentation for Cleanrooms, Clean Work Benches, Isolators, Enclosures: Cleanliness Classes for - Particles - Micro Organism - AMC (Airborne Molecular Contamination) - Surfaces - Ultrapure Media Filter Integrity and Filter Efficiency of HEPA Filters Environmental Parameters (Temperature, Humidity, Differentiell Pressure Cascade, Sound, Illumination, Air Velocity and Volume, ESD, EMI) Air Flow Visualization and Simulation Air Changes Monitoring, Building Control and Process Control Systems
17 Certification according to VDI 2083 und ISO / ISO and the following Guidelines and Recommendations for the Pharmaceutical Industry: FDA GMP/CFR 21 EU GMP PIC GMP WHO GMP ICH Q7A, 9, etc. USP GAMP (ISPE) FDA CFR 21 Part 11 - CDER DAB + related Papers of ISPE, PIC etc. WHO: World Health Organization PIC: Pharmaceutical International Convention FDA: Food and Drug Administration GMP: Good Manufacturing Practice CFR: Code of Federal Regulation GAMP: Good Automation Manufacturing Practice TC: Technical Comittee USP: United States Pharmacopeia DAB: Deutsches Arzneibuch
18 Pharmaceutical Contamination Control means: Product Protection Product Barrier Product Area Environment/ Operator Area Product Protection Factor =
19 Pharmaceutical Contamination Control means: Protection of Personnel Emission Personnel Protection Factor Immission Product Barrier Product Area Environment/ Operator Area Personnel Protection Factor =
20 Certification Added Value Add Services Performance Service Level Agreements Reduce Cost Customized Engineering Reduce Time Solution Scalability Reliability Reduce Risk Flexibility Security Serviceability
21 Validation according to GxP Regulations GMPGood Manufacturing Practice GCP Good Clinical Practice GLP Good Laboratory Practice GDP Good Distribution Practice GSP Good Storage Practice GEP Good Engineering Practice International Society of Pharmaceutical Engineers
22 Parallel Engineering and Validation/Qualification System Advice Advice Validation Advise Advise Development Project Planning Validation Master Master Plan Plan Risk Risk Analysis // DQ DQ Production Assembly IQ IQ FAT FAT IQ IQ SAT SAT Commissioning OQ OQ Service Training PQ PQ Assisstence Training After-Sales-Service Re-Validation
23 TÜV SÜD Cleancert GmbH Waffenschmidtstraße 4 D Cologne Germany Telefon: Telefax:
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