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Clean production
in an industrial environment


    Anton de Jong, Anton Duisterwinkel
1
                                   2011-03-11
                                   Themadag Schoon Produceren




CONTENTS

1. Introduction
2. Systematic approach of assessing risks
3. Contamination control
   - Prevention
   - Cleaning
   - Detection and Qualification
2
                                    2011-03-11
                                    Themadag Schoon Produceren




Why bother?

 Cleanliness becomes more important for the High Tech industry, e.g.
  Semiconductor (ASML, ASMI, supply chains)
  Analytical instruments, mass flow controllers of Bronkhorst; FEI
  Automotive (Nedcar, etc.)
  Medical
  Space (ESA, NASA)
  Solar
  Lighting (OLED’s), electronics

 Important:
  How to produce cleanly in a cost effective way
  How to check the quality of products



Essential: keep the balance between costs of risks and the
costs that control of the risks will bring
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                                          Themadag Schoon Produceren




Clean production of high tech products




Product                 Company          cleaniliness                               Remark
                                         particles organic             outgassing
                                                    cont.              vacuum
Analytical flowmeters   Bronkhorst       yes        yes                no           oxygen safety
(EUV) Lithography       ASML             yes        yes                yes          optical performance
Electron Microscopy     FEI              yes        yes                yes          opitcal performance
Space instruments       TNO Space, ESA   yes        yes                yes          optical performance
Solar cell prodution    OTB,…..          yes        yes                no/yes       yield, lifetime
OLED, OPV               Holst            yes        yes                no/yes       yield, lifetime
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                                    2011-03-11
                                    Themadag Schoon Produceren




Contaminants: what and where from?

 Films
     Oil, grease (production), Food, Biofilms
 Molecular
     Water (condensate), Hydrocarbons (air), NH3, silicones (production)
 Particles
     Organic particles (pollen, micro-organisms, hairs, fibers, …, > 1 µm)
     Metallic particles (due to production, abrasion, ageing, > 1 µm)
     Oxidic: Sand, dirt, asbestos (environment, glass treatment, abrasion)
     Soot/smoke, salt, (NH4)2SO4 (condensation: < 1 µm)




             Object surface
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                                    Themadag Schoon Produceren




Cleanliness: does it exist?
Example 1:   Oxygen application;
                   maximum concentration organic material (< 66 mg C/m2)


Example 2:   Clean surface in food industry, allowed number of colony’s?
                   2.5 CFU/cm2, or 25000 per square meter!


Example 3:   Clean assembly: ISO Class 4, allowed number of particles?
                   10000/m3 (of 0.1 µm or larger);
                   352/m3 (of 0.5 µm or larger)



             ‘Dirty’, but fit for purpose !
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                                2011-03-11
                                Themadag Schoon Produceren




What is clean?

    Clean is dirty …
    to the extent that functionality is not hindered.

Rule 1   ‘Clean must defined’
         - Typically: no gross (visual) contamination
         - Definitions on particles (size, number) and molecules
Rule 2   Testing method must be defined
         - who and when determined
         - exact description of method
Rule 3   Responsibility, liability must be defined
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                                   2011-03-11
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CONTENTS

1. Introduction
2. Systematic approach of assessing risks
3. Contamination control
   - Prevention
   - Cleaning
   - Detection and Qualification
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                                 2011-03-11
                                 Themadag Schoon Produceren




Systematic approach for contamination control:
                                                    Example:



1. Products and production scheme
                                                                                                                                Supplier: D                                      Supplier: B
                                                                                                                                T = ..                                           T = ..
                                                        Product : example complex assy
                                                                                                                                   002                                               002
                                                                                                                                   lfeedthrough                                      Gas hoses          Supplier: A
                                                                                                                                   s
                                                                                                                                                                                                        T = ..


                                                                        001                          003 t=..    004, t=..         t=..            005 t=..       004, t=..          t=..           005 t=..          008 t=..
                                                                                        002          Milling     Intermediate      Transport to    Melt in
                                                                        Material for     QD1:                                                                     Intermediate       Transport to   Weld gas          Intermediate
                                                                                        fQ                                         Louwers
                                                                        backplate        Mat. Cer.               Wet clean                         electrical     Wet clean          A              hoses to          Wet clean
                                                      Supplier: A                                                                                  feedthroughs                                     backplate
                                                      T = ..
                                                                        001                          003 t=..    004, t=..         007 t=..
                                                                        Material for    002          Milling     Intermediate      Store
                                                                                         QD1:
                                                                        cooler body     fQ                       Wet clean
                                                                                         Mat. Cer.                                                028 t=..                       008 t=..                                            t=..
                                                                                                                                                  Weld water        002          Intermediate                                        Transport to
                                                                                                                                                  hoses to          Press        Wet clean                                           T
                                                      Supplier: B       023                                      026, t=..         027 t=..
                                                                                        024                                                       cooler body
                                                                        Water Hose       QD1:                    Intermediate      Store
                                                      T = ..                            fQ
                                                                                         Mat. Cer.               Wet clean


                                                                        029
                                                                       041                                       032, t=..
                                                                                                                044, t=..          033 t=..
                                                                        Filament
                                                                       Vac. Bolts        QD1:
                                                                                        030
                                                                                       042
                                                                                         QD1:                    Intermediate
                                                                                                                Intermediate       Store
                                                                                        fQ
                                                                                       fQMat. Cer.               Wet clean
                                                                                        Mat. Cer.               Wet clean
                                                      Supplier: C
                                                      T = ..
                                                                       035                                      038, t=..         039 t=..
                                                                       Screws          036
                                                                                        QD1:                    Intermediate      Store
                                                                                       fQ                       Wet clean
                                                                                        Mat. Cer.




2. Assessment of the risks (FMEA)




3. Solving of the most important risks
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What kind of product?

 Simple mono part


 Simple assembly wet cleanable


 Assembly not wet cleanable


 Complex assembly sensitive not wet cleanable and sensitive to heat
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Step 1: Product /production analyses



Goal: Define the how “dirty/clean” the (end)product may be in the
   different production steps.


1. Describe the product and production steps
2. Describe the requirements to the end product and the intermediate
   steps
3. Define where contamination is critical for the next step in the
   process
4. Define the contamination sources in the process
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                                                                                   2011-03-11
                                                                                   Themadag Schoon Produceren




Strategy for the control of a production process
       Example:
                                                                                      Supplier: D                                      Supplier: B
                                                                                      T = ..                                           T = ..
           Product : example complex assy
                                                                                         002                                               002
                                                                                         lfeedthrough                                      Gas hoses          Supplier: A
                                                                                         s
                                                                                                                                                              T = ..


                           001                          003 t=..    004, t=..            t=..            005 t=..       004, t=..          t=..           005 t=..          008 t=..
                           Material for    002          Milling     Intermediate         Transport to    Melt in
                                            QD1:                                                                        Intermediate       Transport to   Weld gas          Intermediate
                                           fQ                                                B
                                                                                         Louwers
                           backplate        Mat. Cer.               Wet clean                            electrical     Wet clean          A              hoses to          Wet clean
         Supplier: A                                                                                     feedthroughs                                     backplate
         T = ..
                           001                          003 t=..    004, t=..            007 t=..
                           Material for    002          Milling     Intermediate         Store
                                            QD1:
                           cooler body     fQ                       Wet clean
                                            Mat. Cer.                                                   028 t=..                       008 t=..                                            t=..
                                                                                                        Weld water        002          Intermediate                                        Transport to
                                                                                                        hoses to          Press        Wet clean                                           T
         Supplier: B       023                                      026, t=..            027 t=..
                                           024                                                          cooler body
                           Water Hose       QD1:                    Intermediate         Store
         T = ..                            fQ                       Wet clean
                                            Mat. Cer.


                           029
                          041                                       032, t=..
                                                                   044, t=..            033 t=..
                           Filament
                          Vac. Bolts        QD1:
                                           030
                                          042
                                            QD1:                    Intermediate
                                                                   Intermediate         Store
                                           fQ
                                          fQMat. Cer.               Wet clean
                                           Mat. Cer.               Wet clean
         Supplier: C
         T = ..
                          035                                      038, t=..            039 t=..
                          Screws          036
                                           QD1:                    Intermediate         Store
                                          fQ                       Wet clean
                                           Mat. Cer.




• Choice and sequence of the production steps
• Detail for the production steps
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                                           2011-03-11
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Failure Mode Effect Analysis


Step 2: Make a list of all failure modes



1.   Severity                  How big is the negative effect
     (Higher score if it is more severe)


2.   Occurrence                 How often does is happen
     (Higher score with increasing frequency)


3.   Detection/prevention        How difficult is it to detect the failure
     (Higher score if it is more difficult to detect)
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                                                 2011-03-11
                                                 Themadag Schoon Produceren




FMEA (2)


 FMEA score   Ernst                              Voorkomen             Detectie
  1      1    geen                               nooit                 zeker
              minimale gevolgen voor product                           zeer
  2           (alleen kritische klanten)         vrijwel nooit         waarschijnlijk
         2    minimale gevolgen voor product
  3           (50 % van klanten)                 laag                  waarschijnlijk
  4           gemiddelde gevolgen voor product   af en toe             boven gemiddeld
         3                                       met
  5           grote gevolgen voor product        tussenposen           gemiddeld
              kleine schade aan
  6           productieapparatuur                regelmatig            laag
  7      4    schade aan productieapparatuur     erg regelmatig        erg laag
              grote schade aan
  8           productieapparatuur                vaak                  onwaarschijnlijk
         5                                                             zeer
  9           wettelijke normen                  erg vaak              onwaarschijnlijk
  10          mensveiligheid                     extreem vaak          niet mogelijk
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FMEA (3)


 Calculate the “Risk Priority Number” for each failure mode
                       RPN = effect x occurrence x Detection
 Sort on RPN


Example:
   Failure mode                            severity        occurance          detection RPN
   failure in cleaning unit                           10                  3            8    240
   failure in contamination verification               8                  2            9    144
   delivery of dirty tubing                            3                  2            9     54
   fingerprints on product                             2                  4            3     24
   FM4
   FM5
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                                   2011-03-11
                                   Themadag Schoon Produceren




CONTENTS

1. Introduction
2. Systematic approach of assessing risks
3. Contamination control
   - Prevention
   - Cleaning
   - Detection and Qualification
16
                                   2011-03-11
                                   Themadag Schoon Produceren




Solving the risks: Contamination control

Is a systematic effort to control contamination to such a level that it
 does not disrupt functionality of a process or product by


 Prevention
     Clean design           some major principles
     Clean environment      this afternoon
     Clean assembly         this lecture
 Cleaning
     Overview               details this afternoon
 Detection and Inspection
     Detection (lab)        NOT
     Inspection (fab)       this lecture
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Contamination control: Prevention

1. Design rules

   Source control
     Clean in (checked!); filtering; easy to clean oils etcetera

   Design of instruments and processes
     Accessibility; flow away from critical surfaces; hanging


   Materials selection and development
     (electro)polished materials; controlled contacts; non-stick coating


   Optimization of process conditions
     Add chemicals that remove dirt; prevent hot spots
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                                     2011-03-11
                                     Themadag Schoon Produceren




Contamination control: Prevention

2. Clean environment


   Separate from normal production area
   Closed room where only qualified personnel can enter
   Cleanroom necessary for very critical parts only
   For packaging of critical parts: clean bench or flow bench
   Hang overcoats and gloves near the entrance door.
   Place extra gloves boxes near baths and clean bench.
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                                     2011-03-11
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Contamination control: Prevention

3. Clean assembly


   Control the cleanliness of incoming materials and parts:
    Clean raw materials like bar, rod and profiles
    before processing
    Plastics will have oily residues, silicones and
    plasticizers on the surface from manufacturing
    All third party components must be qualified,
    even if they are claimed to be ‘clean’
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Contamination control: Prevention

3. Clean assembly


   Manufacturing of components by machining:
    Do not use oil based cutting fluids or use vegetable oils
    Use separate tools for manufacturing especially cleaned for vacuum
    All surfaces must be machined
    Last machining step preferably dry or with ethanol or IPA as cutting fluid
    prevents burial of cutting fluid in surface
      Clean the parts in the same run
      Beware of explosion risk and human safety!
    After machining immediately blow off with nitrogen or dry, pressurized, oil
    free air for removal of excessive cutting fluid.
    Wipe parts with lint free cloth soaked with ethanol or IPA
    Store under clean conditions for future cleaning
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Contamination control: Prevention

3. Clean assembly


   Clean Handling of clean parts
    Handling of objects only by qualified personnel
    Always wear overcoat and clean gloves (powder free!)
    Limit touching of the part to a minimum.
    After contact with contaminated objects put new gloves on.
    Do not hesitate to change your gloves if you suspect they got
    contaminated, it can save you a lot of work!
    Make sure extra gloves are available
    Put clean objects in a clean bench on aluminium foil
    Use a flow bench to briefly store clean objects in
    Package clean objects ASAP
    Do not cough or sneeze above (clean) objects
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Contamination control: Cleaning

1. Strategy: Step by step cleaning

   Preclean
     Removes film, visible dirt, gross contamination
     Can be manual, industrial dish washer is preferred

   Particle removal
     Removes particles and droplets to required level
     Often involves wet cleaning, ultrasonic
     Rinsing is critical.

   Molecular cleaning
     Removes last molecules,
     Drives off absorbed contaminants
     Preferably done shortly before use
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                                    2011-03-11
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Contamination control: Cleaning

1. Strategy: Cleaning strategy per material

   Metals can tolerate most cleaning methods
     Alkaline detergents can etch or stain aluminium


   Glasses are vulnerable for micro-cracking caused by
   ultrasonic agitation or etching by surfactants

   Plastics are sensitive to solvents and might change
   their properties (tacky surface or swelling)

   Ceramics are often porous and can contain large
   amounts of water: baking after cleaning necessary!
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Contamination control: Cleaning

2. Cleaning methods: precleaning
to remove visible dirt and oily residues, prevent clogging

   Wiping
   + standard, no investment;     - no control, labour intensive

   Solvent and vapour degreasing
   + good for high volume         - environment, k€

   Industrial dish washer
   + well controlled              - (k€)

   Ultrasonics
   + standard, well controlled    - k€, needs supervision
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                  Contamination control: Cleaning

                  2. Cleaning methods: particle removal
                  to remove all particles larger than a specified size
                          Ultrasonics usually good
                          New methods for submicrometer particles
                           Megasonics; CO2-snow; Nano-spray


            1,0E-04

            1,0E-05                                                                  Small                =   hard to remove
            1,0E-06
                          capillary                                                  Binding force is smaller BUT
Force [N]




            1,0E-07
                                                                                     • Removal force = even smaller
                 VanderWaals
            1,0E-08
                                                                                     • Particles hide in roughness
            1,0E-09
                                    electrostatic              gravity               • Boundary layer
            1,0E-10
                   0,01       0,1            1            10           100       1000
                                      Particle diameter [micrometer]
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Contamination control: Cleaning

3. Cleaning methods: molecular cleaning
To remove molecules to specified outgassing rate or coverage

   Baking in/of vacuum system
   + standard, proven;        - high T, low P

   Plasma
   + relatively cool; quick   - low P, crevices

   Solvent and vapour degreasing
   + good for high volume     - environment, k€

   UV-ozon (optical components)
   + low T, 1 bar, quick      - line of sight, O3
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Contamination control: Cleaning

4. After cleaning: packaging

   Package a part as soon as is has reached room temperature
   Always check if components are clean
   Pack the objects in a clean bench or a flow bench
   Touch the clean objects only with clean, non-powdered gloves
   Seal the package and mark it with ‘clean parts’.
   Package in layers
     Aluminium foil (clean, getter, but may smear)
     Plastic bags (clean, easy, may outgas)
     Casing or box for physical protection during shipping
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Contamination control: Inspection

1. Pragmatic monitoring methods: non contact

   Direct inspection
    Compare to clean surface
    Use strong and stable lighting and a binocular
    Also inspect at grazing incidence
   Black light (purpose built UV-source)
    Will show up fluorescent contaminants
    Use protective glasses, aim at surface only
    Darken the room
   Fluorescence
    Will show up fluorescent contaminants, e.g. oils
    Need to scan the surface
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                                      2011-03-11
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Contamination control: Inspection

2. Pragmatic monitoring methods: contacting methods for particles

   Wiping (white glove, white towel)
     Wipe form clean to dirty
     Compare to non-used glove or towel
     Use strong and stable lighting, fiber optics
   Tape test
     Press transparent tape on object
     Carefully remove and place on white paper
     Compare tape to white paper
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Contamination control: Inspection

3. Pragmatic monitoring methods: contacting methods for greasiness
    Water break test (ASTM Method F 22-26)
     Observes hydrophobic contaminants only
     Breathing or atomizing is better alternative
     Use contact angle measurements for qualification
   Atomizer test
     Gently spray deionized water over the surface
     Observe whether droplets are deposited uniformly
     Non-uniform spots due to hydrophobic contaminants
   Contact angle measurements
     Sessile drop technique is preferred. Use DI-water
     Semi-automized equipment is available (10-20 k€)
     Sensitive to less than monolayer contamination
   Water drop test
     Place drop of 0.2 ml DI-water on surface.
     Determine surface area (diameter) after standard time
     Smaller = more hydrophobic = dirtier
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Contamination control: Inspection

4. Strategy for qualification of parts and assemblies

1. Set clear requirements with client
     Type of contaminant (gross, particle, grease, …)
     Method for measurement (suitable for type of contaminant)
     Maximum acceptable value (that can be determined by that method)
2. Develop clean production method (= handling, cleaning, packaging)
     Test with selected method
     Optimize production process; document this
     Train and coach the staff (this is an ongoing activity)
3. Ensure clean supply line                                        Parts             Assemblies
     Qualify your suppliers on quality control,      Non-          Random sampling   Random sampling
     validated procedures, staff training and        critical      practical test    functional test
     coaching, supply chain, facilities
                                                     Critical      All pieces        All assemblies
4. Perform regular tests                                           practical test    functional test
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Conclusion

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Clean production in an industrial environment

  • 1. Clean production in an industrial environment Anton de Jong, Anton Duisterwinkel
  • 2. 1 2011-03-11 Themadag Schoon Produceren CONTENTS 1. Introduction 2. Systematic approach of assessing risks 3. Contamination control - Prevention - Cleaning - Detection and Qualification
  • 3. 2 2011-03-11 Themadag Schoon Produceren Why bother? Cleanliness becomes more important for the High Tech industry, e.g. Semiconductor (ASML, ASMI, supply chains) Analytical instruments, mass flow controllers of Bronkhorst; FEI Automotive (Nedcar, etc.) Medical Space (ESA, NASA) Solar Lighting (OLED’s), electronics Important: How to produce cleanly in a cost effective way How to check the quality of products Essential: keep the balance between costs of risks and the costs that control of the risks will bring
  • 4. 3 2011-03-11 Themadag Schoon Produceren Clean production of high tech products Product Company cleaniliness Remark particles organic outgassing cont. vacuum Analytical flowmeters Bronkhorst yes yes no oxygen safety (EUV) Lithography ASML yes yes yes optical performance Electron Microscopy FEI yes yes yes opitcal performance Space instruments TNO Space, ESA yes yes yes optical performance Solar cell prodution OTB,….. yes yes no/yes yield, lifetime OLED, OPV Holst yes yes no/yes yield, lifetime
  • 5. 4 2011-03-11 Themadag Schoon Produceren Contaminants: what and where from? Films Oil, grease (production), Food, Biofilms Molecular Water (condensate), Hydrocarbons (air), NH3, silicones (production) Particles Organic particles (pollen, micro-organisms, hairs, fibers, …, > 1 µm) Metallic particles (due to production, abrasion, ageing, > 1 µm) Oxidic: Sand, dirt, asbestos (environment, glass treatment, abrasion) Soot/smoke, salt, (NH4)2SO4 (condensation: < 1 µm) Object surface
  • 6. 5 2011-03-11 Themadag Schoon Produceren Cleanliness: does it exist? Example 1: Oxygen application; maximum concentration organic material (< 66 mg C/m2) Example 2: Clean surface in food industry, allowed number of colony’s? 2.5 CFU/cm2, or 25000 per square meter! Example 3: Clean assembly: ISO Class 4, allowed number of particles? 10000/m3 (of 0.1 µm or larger); 352/m3 (of 0.5 µm or larger) ‘Dirty’, but fit for purpose !
  • 7. 6 2011-03-11 Themadag Schoon Produceren What is clean? Clean is dirty … to the extent that functionality is not hindered. Rule 1 ‘Clean must defined’ - Typically: no gross (visual) contamination - Definitions on particles (size, number) and molecules Rule 2 Testing method must be defined - who and when determined - exact description of method Rule 3 Responsibility, liability must be defined
  • 8. 7 2011-03-11 Themadag Schoon Produceren CONTENTS 1. Introduction 2. Systematic approach of assessing risks 3. Contamination control - Prevention - Cleaning - Detection and Qualification
  • 9. 8 2011-03-11 Themadag Schoon Produceren Systematic approach for contamination control: Example: 1. Products and production scheme Supplier: D Supplier: B T = .. T = .. Product : example complex assy 002 002 lfeedthrough Gas hoses Supplier: A s T = .. 001 003 t=.. 004, t=.. t=.. 005 t=.. 004, t=.. t=.. 005 t=.. 008 t=.. 002 Milling Intermediate Transport to Melt in Material for QD1: Intermediate Transport to Weld gas Intermediate fQ Louwers backplate Mat. Cer. Wet clean electrical Wet clean A hoses to Wet clean Supplier: A feedthroughs backplate T = .. 001 003 t=.. 004, t=.. 007 t=.. Material for 002 Milling Intermediate Store QD1: cooler body fQ Wet clean Mat. Cer. 028 t=.. 008 t=.. t=.. Weld water 002 Intermediate Transport to hoses to Press Wet clean T Supplier: B 023 026, t=.. 027 t=.. 024 cooler body Water Hose QD1: Intermediate Store T = .. fQ Mat. Cer. Wet clean 029 041 032, t=.. 044, t=.. 033 t=.. Filament Vac. Bolts QD1: 030 042 QD1: Intermediate Intermediate Store fQ fQMat. Cer. Wet clean Mat. Cer. Wet clean Supplier: C T = .. 035 038, t=.. 039 t=.. Screws 036 QD1: Intermediate Store fQ Wet clean Mat. Cer. 2. Assessment of the risks (FMEA) 3. Solving of the most important risks
  • 10. 9 2011-03-11 Themadag Schoon Produceren What kind of product? Simple mono part Simple assembly wet cleanable Assembly not wet cleanable Complex assembly sensitive not wet cleanable and sensitive to heat
  • 11. 10 2011-03-11 Themadag Schoon Produceren Step 1: Product /production analyses Goal: Define the how “dirty/clean” the (end)product may be in the different production steps. 1. Describe the product and production steps 2. Describe the requirements to the end product and the intermediate steps 3. Define where contamination is critical for the next step in the process 4. Define the contamination sources in the process
  • 12. 11 2011-03-11 Themadag Schoon Produceren Strategy for the control of a production process Example: Supplier: D Supplier: B T = .. T = .. Product : example complex assy 002 002 lfeedthrough Gas hoses Supplier: A s T = .. 001 003 t=.. 004, t=.. t=.. 005 t=.. 004, t=.. t=.. 005 t=.. 008 t=.. Material for 002 Milling Intermediate Transport to Melt in QD1: Intermediate Transport to Weld gas Intermediate fQ B Louwers backplate Mat. Cer. Wet clean electrical Wet clean A hoses to Wet clean Supplier: A feedthroughs backplate T = .. 001 003 t=.. 004, t=.. 007 t=.. Material for 002 Milling Intermediate Store QD1: cooler body fQ Wet clean Mat. Cer. 028 t=.. 008 t=.. t=.. Weld water 002 Intermediate Transport to hoses to Press Wet clean T Supplier: B 023 026, t=.. 027 t=.. 024 cooler body Water Hose QD1: Intermediate Store T = .. fQ Wet clean Mat. Cer. 029 041 032, t=.. 044, t=.. 033 t=.. Filament Vac. Bolts QD1: 030 042 QD1: Intermediate Intermediate Store fQ fQMat. Cer. Wet clean Mat. Cer. Wet clean Supplier: C T = .. 035 038, t=.. 039 t=.. Screws 036 QD1: Intermediate Store fQ Wet clean Mat. Cer. • Choice and sequence of the production steps • Detail for the production steps
  • 13. 12 2011-03-11 Themadag Schoon Produceren Failure Mode Effect Analysis Step 2: Make a list of all failure modes 1. Severity How big is the negative effect (Higher score if it is more severe) 2. Occurrence How often does is happen (Higher score with increasing frequency) 3. Detection/prevention How difficult is it to detect the failure (Higher score if it is more difficult to detect)
  • 14. 13 2011-03-11 Themadag Schoon Produceren FMEA (2) FMEA score Ernst Voorkomen Detectie 1 1 geen nooit zeker minimale gevolgen voor product zeer 2 (alleen kritische klanten) vrijwel nooit waarschijnlijk 2 minimale gevolgen voor product 3 (50 % van klanten) laag waarschijnlijk 4 gemiddelde gevolgen voor product af en toe boven gemiddeld 3 met 5 grote gevolgen voor product tussenposen gemiddeld kleine schade aan 6 productieapparatuur regelmatig laag 7 4 schade aan productieapparatuur erg regelmatig erg laag grote schade aan 8 productieapparatuur vaak onwaarschijnlijk 5 zeer 9 wettelijke normen erg vaak onwaarschijnlijk 10 mensveiligheid extreem vaak niet mogelijk
  • 15. 14 2011-03-11 Themadag Schoon Produceren FMEA (3) Calculate the “Risk Priority Number” for each failure mode RPN = effect x occurrence x Detection Sort on RPN Example: Failure mode severity occurance detection RPN failure in cleaning unit 10 3 8 240 failure in contamination verification 8 2 9 144 delivery of dirty tubing 3 2 9 54 fingerprints on product 2 4 3 24 FM4 FM5
  • 16. 15 2011-03-11 Themadag Schoon Produceren CONTENTS 1. Introduction 2. Systematic approach of assessing risks 3. Contamination control - Prevention - Cleaning - Detection and Qualification
  • 17. 16 2011-03-11 Themadag Schoon Produceren Solving the risks: Contamination control Is a systematic effort to control contamination to such a level that it does not disrupt functionality of a process or product by Prevention Clean design some major principles Clean environment this afternoon Clean assembly this lecture Cleaning Overview details this afternoon Detection and Inspection Detection (lab) NOT Inspection (fab) this lecture
  • 18. 17 2011-03-11 Themadag Schoon Produceren Contamination control: Prevention 1. Design rules Source control Clean in (checked!); filtering; easy to clean oils etcetera Design of instruments and processes Accessibility; flow away from critical surfaces; hanging Materials selection and development (electro)polished materials; controlled contacts; non-stick coating Optimization of process conditions Add chemicals that remove dirt; prevent hot spots
  • 19. 18 2011-03-11 Themadag Schoon Produceren Contamination control: Prevention 2. Clean environment Separate from normal production area Closed room where only qualified personnel can enter Cleanroom necessary for very critical parts only For packaging of critical parts: clean bench or flow bench Hang overcoats and gloves near the entrance door. Place extra gloves boxes near baths and clean bench.
  • 20. 19 2011-03-11 Themadag Schoon Produceren Contamination control: Prevention 3. Clean assembly Control the cleanliness of incoming materials and parts: Clean raw materials like bar, rod and profiles before processing Plastics will have oily residues, silicones and plasticizers on the surface from manufacturing All third party components must be qualified, even if they are claimed to be ‘clean’
  • 21. 20 2011-03-11 Themadag Schoon Produceren Contamination control: Prevention 3. Clean assembly Manufacturing of components by machining: Do not use oil based cutting fluids or use vegetable oils Use separate tools for manufacturing especially cleaned for vacuum All surfaces must be machined Last machining step preferably dry or with ethanol or IPA as cutting fluid prevents burial of cutting fluid in surface Clean the parts in the same run Beware of explosion risk and human safety! After machining immediately blow off with nitrogen or dry, pressurized, oil free air for removal of excessive cutting fluid. Wipe parts with lint free cloth soaked with ethanol or IPA Store under clean conditions for future cleaning
  • 22. 21 2011-03-11 Themadag Schoon Produceren Contamination control: Prevention 3. Clean assembly Clean Handling of clean parts Handling of objects only by qualified personnel Always wear overcoat and clean gloves (powder free!) Limit touching of the part to a minimum. After contact with contaminated objects put new gloves on. Do not hesitate to change your gloves if you suspect they got contaminated, it can save you a lot of work! Make sure extra gloves are available Put clean objects in a clean bench on aluminium foil Use a flow bench to briefly store clean objects in Package clean objects ASAP Do not cough or sneeze above (clean) objects
  • 23. 22 2011-03-11 Themadag Schoon Produceren Contamination control: Cleaning 1. Strategy: Step by step cleaning Preclean Removes film, visible dirt, gross contamination Can be manual, industrial dish washer is preferred Particle removal Removes particles and droplets to required level Often involves wet cleaning, ultrasonic Rinsing is critical. Molecular cleaning Removes last molecules, Drives off absorbed contaminants Preferably done shortly before use
  • 24. 23 2011-03-11 Themadag Schoon Produceren Contamination control: Cleaning 1. Strategy: Cleaning strategy per material Metals can tolerate most cleaning methods Alkaline detergents can etch or stain aluminium Glasses are vulnerable for micro-cracking caused by ultrasonic agitation or etching by surfactants Plastics are sensitive to solvents and might change their properties (tacky surface or swelling) Ceramics are often porous and can contain large amounts of water: baking after cleaning necessary!
  • 25. 24 2011-03-11 Themadag Schoon Produceren Contamination control: Cleaning 2. Cleaning methods: precleaning to remove visible dirt and oily residues, prevent clogging Wiping + standard, no investment; - no control, labour intensive Solvent and vapour degreasing + good for high volume - environment, k€ Industrial dish washer + well controlled - (k€) Ultrasonics + standard, well controlled - k€, needs supervision
  • 26. 25 2011-03-11 Themadag Schoon Produceren Contamination control: Cleaning 2. Cleaning methods: particle removal to remove all particles larger than a specified size Ultrasonics usually good New methods for submicrometer particles Megasonics; CO2-snow; Nano-spray 1,0E-04 1,0E-05 Small = hard to remove 1,0E-06 capillary Binding force is smaller BUT Force [N] 1,0E-07 • Removal force = even smaller VanderWaals 1,0E-08 • Particles hide in roughness 1,0E-09 electrostatic gravity • Boundary layer 1,0E-10 0,01 0,1 1 10 100 1000 Particle diameter [micrometer]
  • 27. 26 2011-03-11 Themadag Schoon Produceren Contamination control: Cleaning 3. Cleaning methods: molecular cleaning To remove molecules to specified outgassing rate or coverage Baking in/of vacuum system + standard, proven; - high T, low P Plasma + relatively cool; quick - low P, crevices Solvent and vapour degreasing + good for high volume - environment, k€ UV-ozon (optical components) + low T, 1 bar, quick - line of sight, O3
  • 28. 27 2011-03-11 Themadag Schoon Produceren Contamination control: Cleaning 4. After cleaning: packaging Package a part as soon as is has reached room temperature Always check if components are clean Pack the objects in a clean bench or a flow bench Touch the clean objects only with clean, non-powdered gloves Seal the package and mark it with ‘clean parts’. Package in layers Aluminium foil (clean, getter, but may smear) Plastic bags (clean, easy, may outgas) Casing or box for physical protection during shipping
  • 29. 28 2011-03-11 Themadag Schoon Produceren Contamination control: Inspection 1. Pragmatic monitoring methods: non contact Direct inspection Compare to clean surface Use strong and stable lighting and a binocular Also inspect at grazing incidence Black light (purpose built UV-source) Will show up fluorescent contaminants Use protective glasses, aim at surface only Darken the room Fluorescence Will show up fluorescent contaminants, e.g. oils Need to scan the surface
  • 30. 29 2011-03-11 Themadag Schoon Produceren Contamination control: Inspection 2. Pragmatic monitoring methods: contacting methods for particles Wiping (white glove, white towel) Wipe form clean to dirty Compare to non-used glove or towel Use strong and stable lighting, fiber optics Tape test Press transparent tape on object Carefully remove and place on white paper Compare tape to white paper
  • 31. 30 2011-03-11 Themadag Schoon Produceren Contamination control: Inspection 3. Pragmatic monitoring methods: contacting methods for greasiness Water break test (ASTM Method F 22-26) Observes hydrophobic contaminants only Breathing or atomizing is better alternative Use contact angle measurements for qualification Atomizer test Gently spray deionized water over the surface Observe whether droplets are deposited uniformly Non-uniform spots due to hydrophobic contaminants Contact angle measurements Sessile drop technique is preferred. Use DI-water Semi-automized equipment is available (10-20 k€) Sensitive to less than monolayer contamination Water drop test Place drop of 0.2 ml DI-water on surface. Determine surface area (diameter) after standard time Smaller = more hydrophobic = dirtier
  • 32. 31 2011-03-11 Themadag Schoon Produceren Contamination control: Inspection 4. Strategy for qualification of parts and assemblies 1. Set clear requirements with client Type of contaminant (gross, particle, grease, …) Method for measurement (suitable for type of contaminant) Maximum acceptable value (that can be determined by that method) 2. Develop clean production method (= handling, cleaning, packaging) Test with selected method Optimize production process; document this Train and coach the staff (this is an ongoing activity) 3. Ensure clean supply line Parts Assemblies Qualify your suppliers on quality control, Non- Random sampling Random sampling validated procedures, staff training and critical practical test functional test coaching, supply chain, facilities Critical All pieces All assemblies 4. Perform regular tests practical test functional test
  • 33. 32 2011-03-11 Themadag Schoon Produceren Conclusion