Outlook for the Future Cleanrooms and Contamination Control Requirements for Pharma and µelectronic
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1 Outlook for the Future Cleanrooms and Contamination Control Requirements for Pharma and µelectronic TUEV SUED Cleancert H. Weißsieker
2 Future of µelectronic Critical Dimension in Semiconductor Technologies C r i t i c a l D i m e n s i o n [ µ m ] Year
3 Future Trends of Pharmaceutical Technologies Drug particle size will shrink from today micrometer to nanometer scales More drugs will be biotech engineered Combination of traditional pharmaceutical and medical device technologies (pens, pumps, inhalers) Medical devices will be stronger based on µelectronics, micro and nano mechanics
4 Contamination Control Continuum and Dynamics Particle Diameter D p in µm Ions Gases Vapors Gas-to-Particle Conversion Evaporation Condensation Condensational Growth Mechanical Coagulation Primary Particle Secondary Particle (Drops, Dendrites, etc.) Chain Aggregate Cluster Mechanical generated air-borne Particle Coagulation Adsorption & Chemisorption Diffusion Rainout & Washout Sedimentation 0,0001 0,001 0,01 0,
5 Cleanliness Classes ISO Particle Number Concentration 1/m³ ISO Outside Air ,01 0, Particle Diameter in µm tomorrow today
6 The µelectronic Production Wheel Process Transport Etch Thin Film (CVD, PVD) CMP Implant Central Fotolithography Support Diffusion
7 Ishikawa or Fishbone Diagram of a Chip Production Material Facilities Process Wafer Bulk Gases Process Gases Ventilation Bulk Chemicals DI Water Control Exhaust/ Lithography Neutralization CMP Ceiling/Wall Floors Support Etch Diffusion Clean CHIP Operator Hygiene Clothing Stepper RTI Oven PVD/ CVD Vapor Water Vacuum Energy PDA Personal Equipment Utilities
8 Reduce Risk The TUEV GSH Fabricator G: Green S: Safe Semiconductor Fabricator H: Healthy with Risk Assessment and Risk Management Environment, Safety & Health Reliability, Availability, Maintainability Serviceability Scalability Flexibility
9 Where SEMI Standards Apply TÜV can be your Partner From I300I-J300 Global Joint Guidance Document, July 15, 1997
10 SEMI Standards and Related Documents Equipment Automation Hardware 125 Equipment Automation Software 95 Facilities 121 Flat panel display 4 Gases 76 Silicon Wafers 82 Lithography 54 Packaging 83 Process Chemicals 80 Safety Guidelines 35 Silicon Materials and Process Control 104 Traceability TOTAL For around half of the Standards TÜV is offering its services!!!
11 Risk Management for a Semiconductor Facility Planning of Measures Hazard & Risk Analysis Cause- Consequence- Analysis Risk Evaluation
12 Comparison Invest Costs against Cost of Ownership Vergleich Invest gegen COW Comparison Investment against Cost of Wafer (COW) , , Blue: Investments Blaue Balken : Investment Invest in $ COW Rote Linie; COW Red: Cost of Wafer 0, , , , , , Fab & AMHS Simulation CIM ( MES H/W+S/W) AMHS sea of lots + conveyor Process Gas Distribution Process Gas Cabinets Process Chemical Supply CMP Slurry Supply DI Water Reclaim Cleanroom Mini-environment (Interface+Robot) Air Exhausts HVAC Control & Safety (MSR) Process Utilities Shell Externals Mechanical & Electrical Services Gewerke
13 Pharmaceutical Production Active Pharmaceutical Ingredients (API) Solid (Dry) Dosage Forms (Tablets, Capsules, etc.) Semi Solid Dosage Forms (Cremes, etc.) Liquid Forms (Vials, Ampules, Sprays)
14 TÜV SÜD Symposium Thailand 2006 Time to Market Critical for Pharmacy
15 Ishikawa or Fishbone Diagram of a Solid Dosage Form Production Material Facilities Process Primary Packing Secondary Packing Operators Personel Hygiene HVAC Bulk Material DDC/Electric Garments Granulator Mill Granulation Ceilings/Walls/ Floors Milling Coater Steam Purified Water Coating Tabletting Disinfection/ Cleaning Process Water Piping Product Personal Equipment Utilities
16 Critical Influences in the GMP Clean Production Contamination Sources in Cleanrooms Process 25% Equipment 25% Facilities 8% Air 7% + Bio-Particles, Radiation, Vibration, ESD Personnel 35%
17 TÜV SÜD Cleancert GmbH Waffenschmidtstraße 4 D Cologne Germany Telefon: Telefax:
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