Download - Clean Room Behaviour
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JENOPTIK Group.
Cleanroom Operation: Personal BehaviorCleanroom Operation: Personal Behavior
May 2006
Presented by Mark Suparat Tang, Ph.D.
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
About the Speaker – Mark Suparat Tang, Ph.D.Professional Experience
M+W Zander (Thailand) (10/2003 – Present)Operations ManagercGMP 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 DevelopmentQuality Control Laboratory ManagerQuality Assurance Product Release AuditorQuality Assurance Vendor Auditor
Educational BackgroundPh.D. in Biochemistry and Pharmacology (1997)
University of Pennsylvania School of Medicine Department of PharmacologyPost-doctoral Research Fellow (1/1997- 12/1997)
California Institute of Technology Department of Chemical Engineering
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Definition of Cleanroom
Cleanroom Clothing
Behaviour in the Cleanroom
Designing Workplaces in Accordance with Cleanroom Standards
Presentation Agenda: Staff in the Cleanroom
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Cleanroom Technology
Staff in the Cleanroom
1.0 Basics of Cleanroom Technology
1.1 Definition of Cleanroom1.2 Definition of Impurities1.3 Particle Sizes and Distribution1.4 Sources of Contamination in the Cleanroom1.5 Paths of Contamination in the Cleanroom1.6 Particle Measuring Technology1.7 Factors Influencing Cleanliness1.8 Classes of Cleanliness1.9 Air Conveyance Systems, Planned Currents
2.0 Cleanroom Clothing
2.1 Particle Emission from Persons2.2 Function of Cleanroom Clothing2.3 Evaluation Criteria for Cleanroom Clothing2.4 Recommended Cleanroom Clothing2.5 Dressing According to Cleanroom Protocol
3.0 Behaviour in the Cleanroom
3.1 Staff as a Source of Contamination3.2 Selection Criteria for Cleanroom Staff3.3 Behaviour According to Cleanroom Standards3.4 Rules and Guidelines3.5 Cleaning the Materials
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Cleanroom Technology
4.0 Designing Workplaces in Accordance with Cleanroom Standards
4.1 Designing Workplaces4.2 Storage and Transport of Materials4.3 Airlocks for Materials
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 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
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Definition of a Cleanroom
What is a Cleanroom?
Important components of a cleanroomDefinition according to ISO 14644 :
A cleanroom is an area set apart by a wall or similar partition, whose degree of cleanliness is achieved bypurified air ventilation. Cleanroom environment is pressurisedto outside area.
incomingfiltered air
ceiling
wall
+/- 0balanced pressure
floor
+ +overpressure
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
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 µm) 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 thereforecalled suspended particles.
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Particle Sizes and Distribution
Siev
ing
Act.
Car
bon
Filte
r
Gra
vity
Sep
arat
ion
Clot
h Fi
lter
Wet
Sep
arat
ion
Fibr
e Fi
lter
Mic
rosc
ope
Elec
tron
Mic
rosc
ope
Visi
ble
to N
aked
Eye
Toba
co S
mok
eAs
h
Ger
ms
Mis
tSm
og
Gas
Mol
ekul
eMin
eral
and
Met
al D
ust
Susp
ende
d M
atte
r
Viru
ses
Sink
ing
Dus
tH
eavy
Dus
t
Polle
n
Types of Particles SeparationMeasurementMethods
0,0001
0,001
0,01
0,1
10000
10
100
Parti
cle
Diam
eter
(m
)µ
1
1000
Rai
n
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Particle Sizes and Distribution
0,010,01 0,1 10 20 mm1
0,10
1,00
5,00
10,00
20,0030,0040,0050,0060,0070,00
80,0090,00
95,00
99,00
99,90
99,99
Concentrat ion(1)
%<
Parti
cle
Diam
eter
Weight (3)
Surface (2)
Particle Diameter
Distribution of Particle Sizes in Atmospheric Dust
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 brokenpart of the line was calculated
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Particle Sizes and Distribution
0,8µm
0,8µm
0,8µm
Comparisons of Size in Micro-Range I
0,8µ
m
0,8µ
m
1µm 80µm 60µm
Enlargement=10000
Enlargement=1000
0,8µ
m
0,8µ
m
0,8µ
m
Dust Particle 1µmConductor
Human HairSheet of Paper (Thickness)
1µm
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Particle Sizes and Distribution
60µm
60µm
30µm30µm
5µm
1µm
5µm
Typical Level of Travel of the Read/Write Head 0,5µm
20000µm
(20Meter)
Magnetic Coating
Smoke particleDust particle
Slit in Read/Write HeadFingerprint
Human Hair
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 0,5µm, which is smaller than a diameter of a human hair.
Aluminium Bearer Plate
Comparisons of Size in Micro-Range II
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Particle Sizes and Distribution
Example of Contamination from Large Particles on Printed CircuitsEnlargement: 100times
Enlargement: 5 times
Sugar Crystal
Thump- Print
Circuit Paths
Circuit Paths
Accumulation of Sticky Particles 10-30µ
Hair 60µ Diam eter
25 000µ
60µ
each
125
µea
ch 1
25µ
60µ
60µ
60µ
60µ
25 000µ
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
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.
* poor filter quality, not airtight filter seal surfaces, leakage in the ducting system, abrasion in air recirculation equipment and in the ducting system
Internal Impurities
Staff
Process
Production equipment, machines, tools etc.
Unsuitable building materials, work materials
Mechanical abrasion in the cleanroom
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Sources of Contamination in the Cleanroom
It is important to take the contamination from people into account , which contributes considerable 30% of the total contamination in the cleanroom.
Percentage Distribution of the Sources of Contamination
People
30 - 40%
Process
20 - 30%
Equipment
20 - 30%Process-Media
5 - 10%Air
5 - 10%
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Sources of Contamination in the Cleanroom
Standing and sitting without moving
Sitting with gentle movement of head, hand or lower arm
Sitting with moderate body andfoot movement
Standing up with full body movement
Slow walking - approx 3,5 km/h
Walking at about 6 km/h
Walking at about 9 km/h
Gymnastics and sports
Type of ActivityParticle Emission perMinute and Person
100 000
500 000
1 000 000
2 500 000
5 000 000
7 500 000
10 000 000
15 - 30 000 000
Emission of Particles by Peoplemaking various Movementswithout Cleanroom Clothing
Germ emission per minute (according to Botzenhart)1 000 - 13 000 CFU depending on activity
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Paths of Contamination in the Cleanroom
contact contamination from touching
air-borne particles (aerosols)
contaminants in the process media (hydrosols)
removing the source of contamination
interrupting the transport mechanism for contaminants
The Contamination of Processes and Products can occur by:
Contamination can be avoided by:
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
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 35°C); 4 Dacron® felting; 5 condensation pipe (kept at 10°C); 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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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Air Conveyance Systems, Planned Currents
Measuring Particles in prescribed Cleanroom of Class 100,000 before Refit I
Measuring-Point 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
Measuring Height in m
1,02,0
1,02,0
1,11,1
1,02,03,0
Particles= 0,5µ
21.300
19.10016.900
15.30012.900
52.00057.300
36.700117.10028.800
0
00
00
00
0<0
Particles= 5µ
1
11355
1729
1001.120
6311072
00
00
000
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Factors Influencing Cleanliness
Incoming Air
cleanliness class
air speed
air temperature
relative humidity
ionisation
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Factors Influencing Cleanliness
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
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Factors Influencing Cleanliness
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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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Factors Influencing Cleanliness
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
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Factors Influencing Cleanliness
Materials Handling
forms of movement
logistics of access
robot for local manipulation
automated conveyer systems
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Factors Influencing Cleanliness
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
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Cleanliness Classes
Cleanroom with TMC Class 10.000-100.000
Industrial region
Cleanroom class 100
Industrial region with SMOG
Metropolitan area
Measurement Point
10.000.000 to 100.000.000
up to 3.500
.....up to 1.000.000.000
350.000 to 3.500.000
30.000.000 to 60.000.000
Particle Concentration:- Particles ( _> 0,5µm) per m 3
Concentration of Particles in the Air
Rural area after rain 1.000.000 to 10.000.000
Cleanroom class 01 up to 3,5
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Cleanliness Classes
per ft >_ dp3
Particle Diameters in Micrometer (dp)
Class 1 000/M 4.5
Class 100/M 3.5Class 10/M 2.5Class 1/M 1.5
Class 0
Cla ss 100 000/M 6.5
0,1 0,2 0,3 0,5 1 3 5 10
100 Mio
10 Mio
1 Mio
100 000
10 000
1 000
100
10
1
0,1
109
108
107
106
105
104
103
102
101
Particles Particles
Class 10 000/M 5.5
Outdoor Air
per m >_ dp3
Cleanroom ClassesAccording to ISO 14644
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
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 ofa train from the earth to the moon.
Result: A pin in 20 millionfreight 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 m
m
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Air Flow Concepts I
Unidirectional Flowfor 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 thesensitive work areas and machines beingexposed to minimal contamination.
+-
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Air Flow Concepts II
Turbulent Dilution Flow
The clean air in the case of Class 1,000 to 100,000is 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.
Air cir culation appliance
Filter outlet
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Air Flow Concepts III
ULG
ULGULG
AL
ALULGAL
AL
*room he ight 3m ULG = recirculat ion equipment AL = outside air in feed
Class 100.000 / M6.5 according toFederal Standard 209D/209E V=0,017 m/sair changed 20 times per hour
Class 10.000 / M5.5 according toFederal Standard 209D/209E V=0,034 m/sair changed 40 times per hour
Class 1.000 / M4.5 according to Federal Standard 209D/209E V=0,1 - 0,2 m/sair changed 80 times per hour
Class100, 10, 1, 0.1 / M3.5-1 according toFederal Standard 209D/209E V=0,45 m/sair changed 540 times per hour
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Air Flow Concepts IV
60
120
240
1620
1
2 x
4 x
27 x
Class 100.000 turbulent
10.000 turbulent
1.000 turbulent
100 laminar
10 laminar
1 laminar
0,1 laminar
Class
Class
Class
Class
Class
Class
Specific Air Volumem /h .m3 2
Cleanroom Classes Specific Size of Recir-culation Equipment
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Air Flow Concepts V
10 000
7.00 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
20 000
30 000
40 000
50 000
60 000
70 000
80 000
90 000
100 000
7.00 - 8.159.00 - 9.1510.00 - 11.0012.00 - 13.0015.00 - 15.1517.00 - 18.0019.00 - 20.00
1 2
3
4 5
6
7
Example of Contamination Levels from Persons in a Cleanroom of Class 100,000 (turbulent)
1 Work begins (flexitime)2 Coffee break3 Service work in t he cleanroom4 Lunch break5 Afternoon tea6 Work en ds7 Cleaners at work
Safety Zone
Time
Num
ber o
f par
ticles
Underlying Contamination
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Air Flow Concepts VI
Measuring-Point 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 personDitto with working person
Center of room
Measuring Height in m
1,02,0
1,02,0
1,11,1
1,02,03,0
Particles= 0,5µ
21.300
19.10016.900
15.30012.900
52.00057.300
36.700117.10028.800
0
00
00
00
0<0
Particles= 5µ
1
11355
1729
1001.120
6311072
00
00
000
Measuring Particles in prescribed Cleanroom of Class 100,000 before Refit I
0 Class 10 000 not achieved < Class 100 000 not achieved
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Air Flow Concepts VII
Measuring-Point No.
5
6
7
8
9
Measuring Location
Waste air to cable conduit
0,5 m from No. 5 belowceiling
Brush machine, outlet-side
2 m in front of door to hallway
InspectionInspection with smoking(lunch break)
MeasuringHeight in m
1,02,0
2,02,0
Particles= 0,5µ
117.700
186.100
174.400
284.600318.500
84.830206.200
<
<
<
<<
0<
Particles= 5µ
14
54
106
3973
109119
0
0
0
00
Measuring Particles in prescribed Cleanroom of Class 100,000 before Refit II
0 Class 10 000 not achieved < Class 100 000 not achieved
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
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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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Particle Emission from Persons
300 100 55001000015000
5000050000
50000
50000
90000
35000
1800
1800
2500
45005000
9000
10000
17000
24000
120180
250300
400
600
900
1800
250400
500800
650
1000
2500
4000
Particle Emission per sParticle Size > 0,5µm
ClothingCleanroom Suit
One-Piece
Head, Mouth andNose covered Head covered
Street SuitTwo-Piece
Kind of Movement
Standing
SittingHead Movement
Arm Movement
Walking slowlyWalking fast
Moving Body
Moving alndstretching body
Body Movement
Comparison of ParticleEmissions from various Activities of Movement with Cleanroom Clothingor Street Suits
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Particle emission from persons
Particle Counts for a Class 10.000 Cleanroom Suit
Exposed body parts,~10.000 particles
Wiping cloth,~9.356 particles
Cap, ~320 particlesMouth area, ~500 particles
Normal trousers, socks, shirt,underwear, ~20.000 particles
Cotton/polyester coat,~10.017 particles
Approximate number of particles: 50.892/ft3/min.1 shift = 8 h x 60 min. = 480 mins.85 persons per shift
3 shifts produce = 50.692/ft3/min. x 480 mins. x 85 persons x 3 shifts = 6.205 x 109 particles/ft3/24 h
Shoes, ~500 particles
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Particle emission from persons
Exposed body parts,~2.000 particles
Wiping cloth,~1.574 particles
Cap, ~128 particlesFacemask, ~200 particles
100% Polyester-overall,~1.807 particles
Arm-length gloves,~112 particles
Knee-length boots,~228 particles
Approximate number of particles: 6.049/28,2l/min.1 shift = 8 h x 60 min. = 480 mins.85 persons per shift
3 shifts produce = 6.049/ft3/min. x 480 mins. x 85 persons x 3 shifts = 740.397.600 x particles/ft3/24 h
Particle Counts determined with Particle Counter: Class 100 Cleanroom Suit
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Function of Cleanroom Clothing
Particle Barrier
functions as a barrier to the particles emitted by the human bodyas 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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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
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
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Evaluation Criteria for Cleanroom Clothing
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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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Evaluation Criteria for Cleanroom Clothing
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
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Evaluation Criteria for Cleanroom Clothing
Electrostatic Qualities
conductive fibres in the fabric
treated with anti-static's
23
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Recommended Cleanroom Clothing for various Cleanroom Classes
1
10
100
1 000
10 000
100 000
CleanroomClass accordingto Fed.St. 209E
Cleanroom Clothing
SpecialUnderwear
Head Covering Shoes Gloves ChangeFrequency
overalls
overalls
overalls
overalls
overalls
white coat
yes
recommended
no
no
no
yes
full protective hood
cap
full protective hood
full protective hood
hoodbeard covering
hood or capbeard covering
long overboots
overshoes
long overboots
long overboots
overboots or
overshoes
overshoes
no powder or lint
as required
no powder or lint
no powder or lint
no powder or lint
as required
for every entry
daily
orevery 2 days
every 2 days
for every entry
daily
daily
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Dressing according Cleanroom Protocol I
Remove street clothing Remove all additional items suchas watches, jewellery, rings, etc.
Put on head cover
Enter "controlled
area" Temporary gloves
1 2 3
4
5
24
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Dressing according Cleanroom Protocol II
6 Carefully take out the blister-packed clothes
On the changing bench, take off clogs etc.
7 and move feet over the clean side
Put on full hood8 Put on mask 9 Take out new (cleaned) overalls
10
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Dressing according Cleanroom Protocol III
11 Pull on overalls without letting them touch the floor
On the changing bench, take off clogs etc.
12
Take special care to put on gloves and overshoes without contamination
Pull overshoes up over overalls
14 Put on new gloves15Go to workplace in cleanroom
16
13
25
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Dressing according to Cleanroom Protocol
~ 6 m~ 13 m
Cleanroom - Changing Area
Overpressure m
aintainedby locking both side
s
Wardrobe for coats
Clothes lockers
Shower
WC
WC
Used clothin g,wasteEmergency Exit
Put oncleanroom shoes
Wash basins
Laundryhandover
Cleanroom clothing
Cleanroom
Area
Outside A
rea
Airshower
Street ClothingC leaning ZoneClearoom Clothing
Bench
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Dressing according to Cleanroom Protocol
2 31
Cleanroom Zone Cleaning Zone
26
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
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
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Staff as Source of Contamination
100.000 Particles(contaminant emissions
= dustskin particles,hair,germs,viruses,smoke etc.)
Size: 0,001 micron to;1 micron = 1/1.000 mm
10 microns
*1x
50x
5x 10x
100x
25x
150x/300x
Emission of Particles
**
*
*
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
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
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
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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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
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
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Behaviour according to Cleanroom Standards
Inappropriate Behaviour
Fast walking causes turbulencesdue to low pressure points.
If installations and appliances are set horizontally to the air current, turbu-lence is created on the underside.
Seizing something quickly fromabove creates turbulences andcontamination outbursts.
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Rules and Guidelines
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 Work-place, 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.
1. Training
2. Staff
3. Checks
4. Visitors
5. Moving about
13 "Do's" - Behaviour in the Cleanroom
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Rules and Guidelines
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.
6. Private items
7. Materials
8. Movements
9. Working clothes
13 "Do's" - Behaviour in the Cleanroom
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Rules and Guidelines
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.
10. Contacts
11. Communication
12. Jobs
13. Handling
13 "Do's" - Behaviour in the Cleanroom
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Behaviour according to Cleanroom Standards
Put on gloves Put on protective hood
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Behaviour according to Cleanroom Standards
Take out new overalls without contamination and pull on without letting them touch the floor
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Behaviour according to Cleanroom Standards
Pull overshoes up over overalls, put on new gloves and then go to workplace in the cleanroom
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
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
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Cleaning the Materials
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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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Cleaning the Materials
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
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Cleaning the Materials
Cleaning of windows, walls, equipments and transport materials with moist one-way cloth
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Designing Workplaces in accordance with Cleanroom Standards
Designing Workplaces
Storage and Transport of Materials
Airlocks for Materials
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
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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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Designing Workplaces
Fittings which allow flow to pass through
Outflow opposed to inflow
No areas for contamination to collectdue to non-air flow exposure
Dense flow around heat sources
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Designing Workplaces
Flow pattern with lateral outflow through wall Flow pattern with double floor outflow
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Designing Workplaces
Flow pattern with dividing screen (apron) with lateral outflow through wall
Flow pattern with dividing screen (apron) with double floor outflow
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
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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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Storage and Transport of Materials
Storage
open under laminar flow
dustproof boxes, containers
Handling
special tools
tweezers, forceps
vacuum grips
carrier
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Storage and Transport of Materials
Transport
dustproof boxes, containers
transport cars with integrated super clean air supply
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Airlocks for Materials
internal pallets
external pallets
take sample
dust removal,possible changeof pallets
feed belt
pallet loading point
to store
inward goods
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Cleanroom Validation ProceduresPreliminary Considerations
Purpose of Cleanroom: GMP RequirementAll 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 Cleanroom1. 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 Sheet1. 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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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Cleanroom Validation Procedures
Steps of Validation1. User Requirement Specification (URS) by User2. Cleanroom and Facility Design by Cleanroom Engineer3. Design Qualification (DQ) = Commissioning – Procurement4. Installation Qualification (IQ) = Commissioning – Installation and Testing5. Operation Qualification (OQ) = Commissioning – Certification6. Performance Qualification (PQ) = Compliance to Room Data Sheet7. Cleaning Validation
** DQ can be covered in normal design reviews
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 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
SpecificationsPurchase OrdersVendor Proposal DocumentsLayoutsP&ID/FlowsheetsContractor Strategy / Interfaces
Executed in Parallel with During Commissioning – Procurement
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 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 CalibrationEquipment specifications, drawings, operation and maintenance manuals Installation check of Critical ComponentsCritical Component P&ID and Loop CheckTesting and Balancing ReportHEPA filter Integrity Testing Data Review
Executed in Parallel with During Commissioning – Installation
© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 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 CalibrationTesting of Critical Alarms and Interlocks List of Critical Operating Parameters encompassed by Room Data SheetTesting for the Specifications detailed in the Room Data SheetStandard Operation Protocol for HVAC System ControlsCleanroom Operation Protocols for Cleanroom Operations
Executed in Parallel with During Commissioning – Testing, Balancing, Certification
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 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 Cleanroomconditions.
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 ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 JENOPTIK Group.
Cleanroom Validation Procedures: Additional Considerations
Worst Case ScenariosIdentify critical operating parametersSet operational ranges for each critical parameterDesign worst case scenarios to test extremes of ranges
min/max temperatures and humidityprocess equipment operational contaminationpersonnel operational contaminationEquipment maintenance schedule
Operational ConsiderationsRecovery TimeCleaning ProceduresCleaning ValidationRe-testing, Re-Certification, and Re-Validation Schedule
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© M+W ZanderThai FDA Presenation on Cleanroom Operation 09.05.06 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 client’s 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.