Clean Room Behaviour

Cleanroom Operation: Personal Behavior
Presented by Mark Suparat Tang, Ph.D.
May 2006
JENOPTIK Group.
About the Speaker Mark Suparat Tang, Ph.D.

Professional Experience M+W Zander (Thailand) (10/2003 Present)
Operations Manager cGMP Quality Systems Specialist
Alpha Therapeutic / Baxter (1/1998 10/2003)

Senior Principal Scientist and Project Manager for Alpha-1 Anti-trypsin
FDA Technical Issues for Drug Approval and Licensing Yield and Quality Improvement Cleaning Validation and Process Validation
Senior Principal Scientist Research and Development Quality Control Laboratory Manager Quality Assurance Product Release Auditor Quality Assurance Vendor Auditor
Educational Background Ph.D. in Biochemistry and Pharmacology (1997)

University of Pennsylvania School of Medicine Department of Pharmacology
Post-doctoral Research Fellow (1/1997- 12/1997)

California Institute of Technology Department of Chemical Engineering
Thai FDA Presenation on Cleanroom Operation 09.05.06
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JENOPTIK Group.
Presentation Agenda: Staff in the Cleanroom

Definition of Cleanroom Cleanroom Clothing Behaviour in the Cleanroom Designing Workplaces in Accordance with Cleanroom Standards
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JENOPTIK Group.
Cleanroom Technology
Staff in the Cleanroom
1.0 Basics of Cleanroom Technology 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 Definition of Cleanroom Definition of Impurities Particle Sizes and Distribution Sources of Contamination in the Cleanroom Paths of Contamination in the Cleanroom Particle Measuring Technology Factors Influencing Cleanliness Classes of Cleanliness Air Conveyance Systems, Planned Currents
2.0 Cleanroom Clothing 2.1 2.2 2.3 2.4 2.5 Particle Emission from Persons Function of Cleanroom Clothing Evaluation Criteria for Cleanroom Clothing Recommended Cleanroom Clothing Dressing According to Cleanroom Protocol
3.0 Behaviour in the Cleanroom 3.1 3.2 3.3 3.4 3.5 Staff as a Source of Contamination Selection Criteria for Cleanroom Staff Behaviour According to Cleanroom Standards Rules and Guidelines Cleaning the Materials
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Cleanroom Technology
4.0 Designing Workplaces in Accordance with Cleanroom Standards 4.1 Designing Workplaces 4.2 Storage and Transport of Materials 4.3 Airlocks for Materials
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JENOPTIK Group.
Basics of Cleanroom Technology

Definition of Cleanroom Definition of Impurities Particle Sizes and Distribution Sources of Contamination in the Cleanroom Paths of Contamination in the Cleanroom Particle Measuring Technology Factors Influencing Cleanliness Classes of Cleanliness Air Conveyance Systems, Planned Currents
M+W Zander
JENOPTIK Group.
Definition of a Cleanroom
What is a Cleanroom?
Important components of a cleanroom Definition according to ISO 14644 : A cleanroom is an area set apart by a wall or similar partition, whose degree of cleanliness is achieved by purified air ventilation. Cleanroom environment is pressurised to outside area. incoming filtered air ceiling wall +/- 0 balanced pressure floor
++ overpressure
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Definition of Contamination
In cleanroom technology, contaminates are understood to be not only dust particles in the strict sense, but any disturbing effects of a solid, liquid, gaseous, thermal or electromagnetic nature capable of having a negative influence on the course of a process and the quality of a product. The size of particles is defined in microns (abbreviated m) i. e. small in Greek. One micron is a millionth of a meter or a thousandth of a millimeter. As a comparison, one human hair has a diameter of about 60 - 80 microns; all particles from about 5 microns down are present in the air and are therefore called suspended particles.
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Particle Sizes and Distribution

10000
Visible to Naked Eye Heavy Dust Rain Gravity S eparation Sieving
1000
Cloth Filter
Pollen
100
Sinking Dust
Wet Separation
Particle Diameter (m)
10
0,1
Gas Molekule
0,01
Viruses
Electron Microscope
1
Tobaco Smoke Smog
Miner al and Metal Dust
Suspended Matter
Germs
Microscope
Fibre Filter Act. Carbon Filter
Mist
0,001
0,0001
Ash
Types of Particles
Measurement Methods
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Separation
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99,99 99,90
99,00 95,00
Distribution of Particle Sizes in Atmospheric Dust

Concentrat ion(1)
%<P article Diameter
90,00 80,00 70,00 60,00 50,00 40,00 30,00 20,00 10,00 5,00 1,00
Curve 1: Concentration of particles measured with an electron microscope Curve 2: Projected particle surface, calculated Curve 3: Percentage by weight, measured through sedimentation, the broken part of the line was calculated
Surface (2)
0,10 0,01 0,01
Weight (3)
0,1
10
20 m m
Particle Diamet er
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Comparisons of Size in Micro-Range I
Conductor
0,8m
Dust Particle1m
0,8 m
0,8m
m 8 , 0
0,8m
m 8 , 0
Enlargement=10000
Sheet of Paper (Thickness)
Human Hair
1m
80m
60m
Enlargement=1000
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JENOPTIK Group.

Comparisons of Size in Micro-Range II
Smoke particle Slit in Read/Write Head Dust particle Fingerprint Human Hair Aluminium Bearer Plate
Typical Level of Travel of the Read/Write Head 0,5m

20000m
(20Meter)
Magnetic Coating
5m 1m
60m 50m breit
The read/write head travvels at a speed of more than 200 kilometres per hour across the magneticplate, at a distance of less than 0,5m, which is smaller than a diameter of a human hair.
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0,8m
m 8 , 0
60 m 30m 5m

Example of Contamination from Large Particles on Printed Circuits
Enlargement: 100times
60 60
Sugar Cr ystal
Accumula tion of Sticky Particles 10-30 Circuit Paths Hair 60 Diam eter
60 60 60
Cir cuit Paths
Thump- Prin t
25 000
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Sources of Contamination in the Cleanroom
External Impuritities Introduction of contaminated outside air or circulating air * Staff impure process media or raw materials Inadequately cleaned materials, tools etc.
Internal Impurities Staff
Process Production equipment, machines, tools etc. Unsuitable building materials, work materials Mechanical abrasion in the cleanroom
* poor filter quality, not airtight filter seal surfaces, leakage in the ducting system, abrasion in air recirculation equipment and in the ducting system
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each 125
each 1 25
Enlargement: 5 times
Percentage Distribution of the Sources of Contamination
People 30 - 40% Process 20 - 30%
Equipment 20 - 30% Process-Media Air 5 - 10%
5 - 10%
It is important to take the contamination from people into account , which contributes considerable 30% of the total contamination in the cleanroom.
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Emission of Particles by People making various Movements without Cleanroom Clothing
Particle Emission per Minute and Person 100 000 500 000 1 000 000 2 500 000 5 000 000
Type of Activity Standing and sitting without moving Sitting with gentle movement of head, hand or lower arm Sitting with moderate body and foot movement Standing up with full body movement Slow walking - approx 3,5 km/h
7 500 000 10 000 000
Walking at about 6 km/h Walking at about 9 km/h Gymnastics and sports
Germ emission per minute (according to Botzenhart) 1 000 - 13 000 CFU depending on activity
15 - 30 000 000
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Paths of Contamination in the Cleanroom
The Contamination of Processes and Products can occur by:
contact contamination from touching air-borne particles (aerosols) contaminants in the process media (hydrosols)
Contamination can be avoided by:
removing the source of contamination interrupting the transport mechanism for contaminants
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Particle Measurement Technology

Optical Particle Counter Condensation Nucleus Counter
Graphic representation: 1 Air intake; 2 observed volumes; 3 lamp; 4 mirror; 5 sensor chambers; 6 sensor chambers; 7 calibration instrument; 8 photomultiplier. A laser particle counter differs from this instrument mainly in its source of light.
Graphic representation: 1 aerosol intake; 2 alcohol sump; 3 saturation pipe (kept at 35C); 4 Dacron felting; 5 condensation pipe (kept at 10C); 6 image lenses; 7 condenser lenses; 8 lamp; 9 slit (0.1 x 2mm); 10 collector lenses; 11 photodetector; 12 to volume-flow measuring appliance and pump. (Source: TSI inc. St. Paul, USA)
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Air Conveyance Systems, Planned Currents

Measuring Particles in prescribed Cleanroom of Class 100,000 before Refit I
MeasuringPoint No. 0 1 2 3 4 Measuring Location Supply air in helical outlet 2,5 m from center of window-wall 0,5 m from center of window-wall, right corner Lighting device without person Ditto with working person Center of room 1,0 2,0 1,0 2,0 1,1 1,1 1,0 2,0 3,0 Measuring Height in m Particles = 0,5 21.300 19.100 16.900 15.300 12.900 52.000 57.300 36.700 117.100 28.800 0 0 0 0 0 0 0 0 < 0 Particles = 5 1 113 55 17 29 100 1.120 63 110 72 0 0 0 0 0 0 0
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Factors Influencing Cleanliness
Incoming Air cleanliness class air speed air temperature relative humidity ionisation
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Air Current Control type of cleanroom (turbulent, with low turbulence) cleanroom layout arrangement of incoming and outgoing air flows technological environment particle-proof room divisions maintenance of pressure
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Staff rules of behaviour, discipline speed of movement organisation of work activities clothing appropriate for cleanroom regular decontamination of cleanroom clothing entry and exit procedures (airlocks)
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Workplace cleanroom compliant infrastructure ergonomic design arrangement of incoming and outgoing air flows aerodynamics of equipment sources of heat blind-spots in current cleanliness of surfaces cleaning throughout production
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Materials Handling forms of movement logistics of access robot for local manipulation automated conveyer systems
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Process process layout sequence of procedures keeping process media clean (gases, chemicals, DI water, solvents etc.) process equipment, production fittings monitoring procedures inward and outward movement of materials through airlocks
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Cleanliness Classes
Concentration of Particles in the Air
Particle Concentration: - Particles ( _ 0,5m) per m 3 >
.....up to 1.000.000.000 30.000.000 to 60.000.000 10.000.000 to 100.000.000 1.000.000 to 10.000.000 350.000 to 3.500.000 up to 3.500
Measurement Point
Industrial region with SMOG Industrial region Metropolitan area
Rural area after rain

Cleanroom with TMC Class 10.000-100.000 Cleanroom class 100 Cleanroom class 01
up to 3,5
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Cleanliness Classes
Cleanroom Classes
According to ISO 14644
10 Mio 10 8
Particles per ft3 _ dp >

100 Mio
Particles 3 per m _ dp >

10 9
O o do ut
1 Mio
rA ir
10 7
100 000 10 6 10 000

Cla ss C la
Cla ss 10 0/
2.
10 00 00
00
10 5
/M 6. 5
1 000
M
ss 1
00
100
Cla ss 10 /M Cla s s1
3.5
Cl as s1
/M
5.
10 4
5
00 0
/M
10
4 .5
103
/M
1. 5
10 2
Cla s
s0
101
0,5
0,1
0,1 0,2 0,3 1 3 5 10
Particle Diameters in Micrometer (dp)

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Cleanliness Classes
Comparison of Sizes for Class 10 Cleanroom
Class 10 according to ISO 14644 means: Fewer than 350 particles larger than 0,1 microns per cubic foot. Scale enlargement by way of illustration 1 Particle 0,1 microns = 1 pinhead 3 millimetres. Accordingly the relevant volume of air rises to 2,160,000,000 m3 (approx. 2 thousand million m3). This would be the volume of a train from the earth to the moon. Result: A pin in 20 million freight cars You have to look for ONE pin in 20 million freight cars (approx. 360.000 km), to comply to class 10 environment! This would take 200 years, if you need 5 minutes for each freight car. Comparison of Sizes for Class 10 Cleanroom
3 mm
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Air Flow Concepts I
+ -
Unidirectional Flow for Classes 100/10/1/0.1 M3.5-1

The clean air stream is low in turbulence "laminar) in the cleanroom for Classes 00/10/1/0.1, M 3.5 - 1 which results in the sensitive work areas and machines being exposed to minimal contamination.
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Air Flow Concepts II
Air cir culation appliance
Turbulent Dilution Flow

Filter outlet
The clean air in the case of Class 1,000 to 100,000 is fed into the cleanroom as a turbulent flow (swirling) and creates a constant diluting effect, thus cleansing the cleanroom. In this way the required cleanroom level is maintained.
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Air Flow Concepts III

Class 100.000 / M6.5 according to Federal Standard 209D/209E V=0,017 m/s air changed 20 times per hour
ULG AL
Class 10.000 / M5.5 according to Federal Standard 209D/209E V=0,034 m/s air changed 40 times per hour
ULG
AL
ULG
U LG AL
Class 1.000 / M4.5 according to Federal Standard 209D/209E V=0,1 - 0,2 m/s air changed 80 times per hour
Class100, 10, 1, 0.1 / M3.5-1 according to Federal Standard 209D/209E V=0,45 m/s air changed 540 times per hour
AL
*room he ight 3m
ULG = recirculat ion equipment
AL = outside air in feed
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Air Flow Concepts IV
Cleanroom Classes Class 100.000 Class 10.000 Class Class Class Class Class 1.000 100 10 1 turbulent turbulent turbulent laminar laminar laminar
Specific Air Volume 3 2 m /h .m 60 120 240
Specific Size of Recirculation Equipment 1 2x 4x
1620
27 x
0,1 laminar
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Air Flow Concepts V

Example of Cont amination Levels from Persons in a Cleanroom of Class 100,000 (turbulent)
100 000 90 000 80 000 70 000 60 000 6 7 1 2 4 5 3
S afety Zone
Number of particles
50 000 40 000 30 000 20 000 10 000
Underlying Contamination
7.00 1 2 3 4 5 6 7 8.00 9.00 10.00 11.00 12.00 13.00 14.00 15.00 16.00 17.00 18.00 19.00 20.00 7.00 - 8.15 9.00 - 9.15 10.00 - 11.00 12.00 - 13.00 15.00 - 15.15 17.00 - 18.00 19.00 - 20.00
Time
Work begins (flexitime) Coffee break Service work in t he cleanroom Lunch break Afternoon tea Work en ds Cleaners at work
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Air Flow Concepts VI

Measuring Particles in prescribed Cleanroom of Class 100,000 before Refit I
MeasuringPoint No. 0 1 2 3 4 Measuring Location Measuring Height in m Particles = 0,5 21.300 1,0 2,0 1,0 2,0 1,1 1,1 1,0 2,0 3,0 19.100 16.900 15.300 12.900 52.000 57.300 36.700 117.100 28.800 0 0 0 0 0 0 0 0 < 0 Particles = 5 1 113 55 17 29 100 1.120 63 110 72 0 0 0 0 0 0 0
Supply air in helical outlet 2,5 m from center of windowwall 0,5 m from center of windowwall, right corner Lighting device without person Ditto with working person Center of room
0 Class 10 000 not achieved

< Class 100 000 not achieved

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Air Flow Concepts VII

Measuring Particles in prescribed Cleanroom of Class 100,000 before Refit II
MeasuringPoint No. 5 6 7 8 9 Measuring Location Measuring Height in m Particles = 0,5 117.700 186.100 174.400 1,0 2,0 2,0 2,0 284.600 318.500 84.830 206.200
0 Class 10 000 not achieved
Particles = 5 < < < < < 0 < 14 54 106 39 73 109 119 0 0
Waste air to cable conduit 0,5 m from No. 5 below ceiling Brush machine, outlet-side 2 m in front of door to hallway Inspection Inspection with smoking (lunch break)
0 0 0
< Class 100 000 not achieved
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Cleanroom Clothing
Particle Emission from Persons Function of Cleanroom Clothing Evaluation Criteria for Cleanroom Clothing Recommended Cleanroom Clothing Dressing according to Cleanroom Standards
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Particle Emission from Persons

Comparison of Particle Emissions from various Activities of Movement with Cleanroom Clothing or Street Suits
Kind of Movement Particle Emission per s Particle Size > 0,5m Clothing Cleanroom Suit One-Piece Head, Mouth and Nose covered Standing Sitting Head Movement Body Movement Arm Movement Moving Body Moving alnd stretching body Walking slowly Walking fast 300 250 400 500 800 650 1000 2500 4000 100 120 180 250 300 400 600 900 1800 Two-Piece Head covered 1800 1800 2500 4500 5000 9000 10000 17000 24000 5500 10000 15000 50000 50000 35000 50000 50000 90000 Street Suit
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Particle emission from persons

Particle Counts for a Class 10.000 Cleanroom Suit
Exposed body parts, ~10.000 particles Cap, ~320 particles Mouth area, ~500 particles
Cotton/polyester coat, ~10.017 particles
Wiping cloth, ~9.356 particles Approximate number of particles: 50.892/ft3/min. 1 shift = 8 h x 60 min. = 480 mins. 85 persons per shift Normal trousers, socks, shirt, underwear, ~20.000 particles
Shoes, ~500 particles 3 shifts produce = 50.692/ft3/min. x 480 mins. x 85 persons x 3 shifts = 6.205 x 109 particles/ft3/24 h
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Particle emission from persons

Particle Counts determined with Particle Counter: Class 100 Cleanroom Suit
Exposed body parts, ~2.000 particles Cap, ~128 particles Facemask, ~200 particles 100% Polyester-overall, ~1.807 particles
Wiping cloth, ~1.574 particles
Arm-length gloves, ~112 particles
Approximate number of particles: 6.049/28,2l/min. 1 shift = 8 h x 60 min. = 480 mins. 85 persons per shift
Knee-length boots, ~228 particles
3 shifts produce = 6.049/ft3/min. x 480 mins. x 85 persons x 3 shifts = 740.397.600 x particles/ft3/24 h

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Function of Cleanroom Clothing
Particle Barrier functions as a barrier to the particles emitted by the human body as well as fibres and particles from undergarments
Physiological Aspects wearing comfort warmth and dampness emitted from garments
Protection for the Worker resistance to penetration by fluids resistance to chemicals and solvents flame resistance conductivity
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Evaluation Criteria for Cleanroom Clothing
Materials / Fabrics
synthetics or mixed fabrics (polyester, polyamide, cotton, Goretex) fabric made from single-filament threads porosity for particles (densely woven) low emission of own particles resistance to wear when worn or washed flexible strength (softness) non-tearing
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Wearing Comfort
comfortable permeable to heat and dampness well fitting (pump action) collar sealing, sleeve bindings, legs fastenings (zip or Velcro fasteners, buttons, ribbons) seams
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Chemical Resistance resistance to penetration by fluids acids, alkaline solutions solvents colour fastness (wash, friction and light fast) Decontamination wet and chemical cleaning able to be sterilised odours
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Electrostatic Qualities
conductive fibres in the fabric treated with anti-static's
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Recommended Cleanroom Clothing for various Cleanroom Classes
Cleanroom Cleanroom Class Clothing

according to Fed.St. 209E
Special Underwear yes yes recommended no no
Head Covering
Shoes
Gloves
Change Frequency for every entry for every entry daily daily dailyor every 2 days every 2 days
1 10 100 1 000 10 000
overalls overalls overalls overalls overalls
full protective hood full protective hood full protective hood hood beard covering hood or cap beard covering cap
long overboots long overboots long overboots overboots or overshoes overshoes
no powder or lint no powder or lint no powder or lint no powder or lint as required
100 000
white coat
no
overshoes
as required
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Dressing according Cleanroom Protocol I
1
Remove street clothing
2
Remove all additional items such as watches, jewellery, rings, etc.
3
Put on head cover
4
Enter "controlled area"
5
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Temporary gloves
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Dressing according Cleanroom Protocol II
Carefully take out the blister-packed clothes
On the changing bench, take off clogs etc.
and move feet over the clean side
Put on full hood
Put on mask
10
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Take out new (cleaned) overalls

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Dressing according Cleanroom Protocol III
13 11
Pull on overalls without letting them touch the floor
12
On the changing bench, take off clogs etc.
Take special care to put on gloves and overshoes without contamination
14
Pull overshoes up over overalls
15
16
Put on new gloves
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Go to workplace in cleanroom
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Dressing according to Cleanroom Protocol

Cleanroom - Changing Area
~ 13 m
Laundry handover
Benc h Put on cleanroom shoes
Shower
Wardrobe for coats
Outside Area
Emergency Exit
Dressing according to Cleanroom Protocol
Cleanroom Area
WC Air shower Cleanroom clothing Wash basins
Clothes lockers
Overpressure maintained by locking both side s
~6 m
WC
Used clothin g, waste
Clearoom Clothing
C leaning Zone
Street Clothing
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Cleanroom Zone
Cleaning Zone
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Behaviour in the Cleanroom
Staff as a Source of Contamination Selection Criteria for Cleanroom Staff Behaviour according to Cleanroom Standards Rules and Guidelines Cleaning the Materials
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Staff as Source of Contamination

Emission of Particles
1x
5x
10x
25x
* 100.000 Particles (contaminant emissions

= dust skin particles, hair, germs, viruses, smoke etc.) Size: 0,001 micron to;10 microns 1 micron = 1/1.000 mm
50x
*
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100x
150x/300x
*
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Selection Criteria for Cleanroom Staff

Criteria for activities in Cleanroom age body size, weight sensitive vision, hearing, smelling (to recognise hazards) microscope skills precision movements general agility suitability for shift-work discipline team spirit, willingness to co-operate willingness to keep body clean
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Selection Criteria for Cleanroom Staff

Factors limiting Activities in the Cleanroom
skin disorders leading to a greater release of particles or electrolytic contaminates hair diseases (hair loss, heavy dandruff) chronic respiratory illnesses chronic urinary infections metabolic disorders chronic release of bacteria neurological disorders emotional disorders (neuroses, claustrophobia etc.) smoking
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Behavior according to Cleanroom Standards
movements no faster than air flow controlled, not abrupt, movements never taking objects against the air flow protective clothing always sealed
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Behaviour according to Cleanroom Standards

Inappropriate Behaviour
Fast walking causes turbulences due to low pressure points.
Seizing something quickly from above creates turbulences and contamination outbursts.
If installations and appliances are set horizontally to the air current, turbulence is created on the underside.
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Rules and Guidelines

13 "Do's" - Behaviour in the Cleanroom
1. Training All staff working at a Clean Workplace must be trained repeatedly in all aspects which are relevant to the work in question. At the Clean Workplace only the required amount of staff should be present. As far as possible, all monitoring and inspections should be carried out from the outside. If inspectors, service staff or visitors enter the Clean Workplace, the same rules of behaviour apply as for permanent workers in this area. The movement of people between the Clean Workplace and the surrounding areas should be kept to a minimum.
2.
Staff
3.
Checks
4.
Visitors
5.
Moving about
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6. Private items It is not permitted to take food, cigarettes, jewellery and other personal items to the Clean Workplace. Apart from the materials directly needed or the production goods to be processed immediately, no objects or materials may be stored in the vicinity of the Clean Workplace At the Clean Workplace, the staff must move in a controlled and considered manner. Since the emission of particles and germs is related to the workers activity and the type of movement, quick and abrupt movements might cause a strong current and thus are to be avoided at all times. Care must be taken that the prescribed working clothes are worn in the Cleanroom in the correct way at all times.
7.
Materials
8.
Movements
9.
Working clothes
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10. Contacts In order to avoid contaminating the gloves unnecessarily (dust, fats, salt, germs), nothing may be touched at the workplace apart from the appropriate equipment and tools. (Do not fold arms, do not scratch, do not touch door handles or telephone receivers.) Speaking, coughing and sneezing may never take place in the direction of the critical working area. When temporarily not working or merely observing at the Clean Workplace, the staff must move as far away as possible from the critical area. Interventions in the critical work area must take place in such a way that neither the hand nor the arm of the staff comes between the HEPA filter and the object.
11. Communication
12. Jobs
13. Handling
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Put on gloves
Put on protective hood

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Take out new overalls without contamination and pull on without letting them touch the floor
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Pull overshoes up over overalls, put on new gloves and then go to workplace in the cleanroom
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Cleaning the Materials
Manual Cleaning moist / dry cleaning wiping down, brushing solvents according to cleanroom standards lint-free wiping cloths central vacuum cleaner super-clean air pressure ionic air pistol
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Immersion-Bath Cleaning moderately warm immersion baths with / without ultrasonics brushes hot organic solvents such as trichloroethylene, xylene, acetone or substitutes Methane, ethanol, isopropanol DI-water
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Ultrasonic Method 25KHz non-directional sound waves cleaning effect from forces of cavitation Megasonic Method 0.8 - 12 MHz directional sound waves cleaning effect from forces of cavitation
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Cleaning of windows, walls, equipments and transport materials with moist one-way cloth
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Designing Workplaces in accordance with Cleanroom Standards
Designing Workplaces Storage and Transport of Materials Airlocks for Materials
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Designing Workplaces
Design Rules Outflow (double floor) as opposed to in-flow (filter ceiling) Fittings which allow air flow to pass through No blind-spots for current upstream Avoid uncontrolled dead zones Distance of about 10 cm from wall Gap dividing neighboring workplaces about 10 cm Dense flow around heat sources
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Fittings which allow flow to pass through Outflow opposed to inflow No areas for contamination to collect due to non-air flow exposure Dense flow around heat sources
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Flow pattern with lateral outflow through wall
Flow pattern with double floor outflow
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Flow pattern with dividing screen (apron) with lateral outflow through wall
Flow pattern with dividing screen (apron) with double floor outflow
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Storage and Transport of Materials
Materials for Transport and Storage Containers PE - Polyethylene PFA - Polyfluoramide PP - Polypropylene PVC - Polyvenyl Chloride PMMA - Polymethyl Methacrylate AL - Auminium
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Storage open under laminar flow dustproof boxes, containers Handling special tools tweezers, forceps vacuum grips carrier
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Transport dustproof boxes, containers transport cars with integrated super clean air supply
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Airlocks for Materials

to store
take sample internal pallets dust removal,

possible change
of pallets feed belt
external pallets
pallet loading point inward goods

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Cleanroom Validation Procedures

Preliminary Considerations
Purpose of Cleanroom: GMP Requirement All facilities and machinery are correct for the purpose and that they, and the environment in which they are situated, is properly cleaned and appropriately treated. User Requirement Specification (URS) for the Cleanroom 1. User-defined requirements for the Manufacturing Environment to comply with the User-defined Regulatory Requirements. 2. Sufficiently detailed to enable design specifications to be developed. Room Data Sheet 1. Defines the Cleanroom Specifications. 2. All Cleanroom Specifications are reviewed during GMP review. 3. Basis for the Final Acceptance Tests and Specifications for the Cleanroom.
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Cleanroom Validation Procedures

Steps of Validation
1. User Requirement Specification (URS) by User 2. Cleanroom and Facility Design by Cleanroom Engineer 3. Design Qualification (DQ) = Commissioning Procurement 4. Installation Qualification (IQ) = Commissioning Installation and Testing 5. Operation Qualification (OQ) = Commissioning Certification 6. Performance Qualification (PQ) = Compliance to Room Data Sheet 7. Cleaning Validation
** DQ can be covered in normal design reviews
M+W Zander
JENOPTIK Group.
Cleanroom Validation Procedures: Design Qualification

Design Qualification (DQ)
The documented evidence that the Cleanroom Design Objectives concerning GMP and compliance of the project have been properly described in Cleanroom design documentation, and that the Design if Fit for Purpose
Objective:
To Confirm that the Designs fit the User Required Specification Specifications Purchase Orders Vendor Proposal Documents Layouts P&ID/Flowsheets Contractor Strategy / Interfaces Executed in Parallel with During Commissioning Procurement
M+W Zander JENOPTIK Group.
Cleanroom Validation Procedures: Installation Qualification

Installation Qualification (IQ)
The documented verification that all aspects of the Cleanroom that can affect final quality of the Cleanroom environment adhere to approved specifications and are correctly installed.
Objective:
To demonstrate that the item as installed, conforms to the Design Specification (Referring to the Design Specification and User Required Specification) HVAC and other Critical Instruments are still in Calibration Equipment specifications, drawings, operation and maintenance manuals Installation check of Critical Components Critical Component P&ID and Loop Check Testing and Balancing Report HEPA filter Integrity Testing Data Review Executed in Parallel with During Commissioning Installation
M+W Zander
JENOPTIK Group.
Cleanroom Validation Procedures: Operation Qualification

Operation Qualification (OQ)
The documented verification that all aspects of the Cleanroom that can affect the final Cleanroom quality can operate as intended throughout all anticipated ranges.
Objective:
To demonstrate that the Cleanroom can be operated in conformance to the Design Specification (Referring to the Design Specification and User Required Specification) HVAC and other Critical Instruments are still in Calibration Testing of Critical Alarms and Interlocks List of Critical Operating Parameters encompassed by Room Data Sheet Testing for the Specifications detailed in the Room Data Sheet Standard Operation Protocol for HVAC System Controls Cleanroom Operation Protocols for Cleanroom Operations Executed in Parallel with During Commissioning Testing, Balancing, Certification
M+W Zander
JENOPTIK Group.
Cleanroom Validation Procedures: Performance Qualification

Operation Qualification (PQ)
A documented program to demonstrate that the Cleanroom, when operating within the defined parameters, can consistently perform and maintain the Cleanroom conditions.
Objective:
To demonstrate that the Cleanroom can reliably perform in conformance to the Design Specification (Referring to the User Required Specification and Room Data Sheet) Monitoring and Testing for Particulate Levels (Surface and Airborne)
Static (non-viable) Particulate Monitoring (As-built / At rest) Static (viable) Particulate Monitoring (Microbial Monitoring) (As-built / At rest)
Dynamic (non-viable) Particulate Monitoring (Sterile Areas) (In Operation) Dynamic (Viable) Particulate Monitoring (Sterile Areas) (In Operation)
Room Data Sheet is the Cleanroom User Required Specification Executed after Commissioning Certification
M+W Zander
JENOPTIK Group.
Cleanroom Validation Procedures: Additional Considerations

Worst Case Scenarios
Identify critical operating parameters Set operational ranges for each critical parameter Design worst case scenarios to test extremes of ranges min/max temperatures and humidity process equipment operational contamination personnel operational contamination Equipment maintenance schedule
Operational Considerations
Recovery Time Cleaning Procedures Cleaning Validation Re-testing, Re-Certification, and Re-Validation Schedule
M+W Zander
JENOPTIK Group.
About M+W Zander (Thai) Co.

M+W Zander (Thai) is a Consultant Firm Specializing in
Designing Cleanroom Facility, Utility, Building, and Process Equipment and Executing Turnkey Projects for the Pharmaceutical and Microelectronic Industries
M+W Zander (Thai) has developed its own standard operation procedures.
that are in accordance to above listed international standards and that can be adjusted to the clients specific requirements. With Recommendation and Consultancy on scope of the measurements!
M+W Zander (Thai) provides Measurement and Certification services for Cleanroom and HVAC systems.
Following (DIN EN) ISO 14644-1, VDI 2083, IES-RP-CC006.2 or NEBB Following Pharmaceutical and Biological Product GMP Requirements Following the specific process, facility, and client requirements.
M+W Zander
JENOPTIK Group.

Clean Room Behaviour

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Clean Room Behaviour

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Cleanroom Operation: Personal Behavior

Presented by Mark Suparat Tang, Ph.D.

About the Speaker Mark Suparat Tang, Ph.D.

Alpha Therapeutic / Baxter (1/1998 10/2003)

Educational Background Ph.D. in Biochemistry and Pharmacology (1997)

Post-doctoral Research Fellow (1/1997- 12/1997)

Thai FDA Presenation on Cleanroom Operation 09.05.06

Presentation Agenda: Staff in the Cleanroom

Thai FDA Presenation on Cleanroom Operation 09.05.06

Thai FDA Presenation on Cleanroom Operation 09.05.06

Thai FDA Presenation on Cleanroom Operation 09.05.06

Basics of Cleanroom Technology

Thai FDA Presenation on Cleanroom Operation 09.05.06

Thai FDA Presenation on Cleanroom Operation 09.05.06

Particle Sizes and Distribution

Particle Diameter (m)

Miner al and Metal Dust

Fibre Filter Act. Carbon Filter

Thai FDA Presenation on Cleanroom Operation 09.05.06

Particle Sizes and Distribution

Distribution of Particle Sizes in Atmospheric Dust

%<P article Diameter

0,10 0,01 0,01

Thai FDA Presenation on Cleanroom Operation 09.05.06

Particle Sizes and Distribution

Sheet of Paper (Thickness)

Particle Sizes and Distribution

Typical Level of Travel of the Read/Write Head 0,5m

60m 50m breit

Thai FDA Presenation on Cleanroom Operation 09.05.06

Particle Sizes and Distribution

Cir cuit Paths

Thai FDA Presenation on Cleanroom Operation 09.05.06

Sources of Contamination in the Cleanroom

Internal Impurities Staff

Thai FDA Presenation on Cleanroom Operation 09.05.06

Sources of Contamination in the Cleanroom

Percentage Distribution of the Sources of Contamination

People 30 - 40% Process 20 - 30%

Equipment 20 - 30% Process-Media Air 5 - 10%

Thai FDA Presenation on Cleanroom Operation 09.05.06

Sources of Contamination in the Cleanroom

7 500 000 10 000 000

Walking at about 6 km/h Walking at about 9 km/h Gymnastics and sports

Thai FDA Presenation on Cleanroom Operation 09.05.06

Paths of Contamination in the Cleanroom

The Contamination of Processes and Products can occur by:

Contamination can be avoided by:

Thai FDA Presenation on Cleanroom Operation 09.05.06

Particle Measurement Technology

Thai FDA Presenation on Cleanroom Operation 09.05.06

Air Conveyance Systems, Planned Currents

Thai FDA Presenation on Cleanroom Operation 09.05.06

Factors Influencing Cleanliness

Thai FDA Presenation on Cleanroom Operation 09.05.06

Factors Influencing Cleanliness

Thai FDA Presenation on Cleanroom Operation 09.05.06

Factors Influencing Cleanliness

Thai FDA Presenation on Cleanroom Operation 09.05.06

Factors Influencing Cleanliness

Factors Influencing Cleanliness

Thai FDA Presenation on Cleanroom Operation 09.05.06

Factors Influencing Cleanliness

Thai FDA Presenation on Cleanroom Operation 09.05.06