9. Cleanroom Testing
Purposes for initial test:
• Fulfill the design
– working correctly and achieving the contamination
– establish the initial performance of the room to
compare the results of routine check or contamination
problem in the future.
• Training the staff: (most important)
– initial testing is to familiarize and train the staff.
– Only opportunity to understand how their cleanroom
works and learn the methods used to test.
– been built/ going to hand over/ reopen
• Tested standards
– ISO 14644-1.
– to regularly check the room at the time
intervals set by ISO 14644-2
Principles of Cleanroom Testing
– Turbulently: dilute--air volume (supply and extract)
– Unidirectional: remove –air velocity
• Direction (flow direction):
– from clean area less-clean areas to minimise the
movement of contaminated air.
– the air will not add significantly to the contamination
within the room
• Distribution inside cleanroom
– the air movement has no areas with high
concentrations of contamination.
• Air supply and extract quantities
– turbulently ventilated cleanrooms the air
supply and extract volumes
– unidirectional airflow air velocity.
• Air movement control between areas:
– The pressure differences between areas are
– The air direction through doorways, hatches,
etc. is from clean to less-clean.
• Filter installation leak test
– a damaged filter
– between the filter and its housing or
– any other part of the filter installation.
• Containment leak testing
– Contamination is not entering the cleanroom
through its construction materials.
• Air movement control within the room
– turbulently ventilated : check that there are no
areas within the room with insufficient air
– unidirectional airflow : check that the air
velocity and direction throughout the room is
that specified in the design.
• Airborne particles and microbial
– final measurements of the concentration of
particles and micro-organisms
• Additional tests
– relative humidity
– heating and cooling capabilities of the room
– sound levels
– lighting levels
– vibration levels.
• Guides provided by
– the American Society Heating Refrigeration
and Airconditioning Engineers (ASHRAE) in
the USA, and
– the Chartered Institute of Building Services
Engineers (CIBSE) in the UK.
Testing in Relation to Room Type
and Occupation State
• The type of tests to be carried out in a
cleanroom depends on whether the room
is unidirectional, turbulent or mixed airflow:
– ‘as-built’ ---in the empty room,
– ‘at rest’ --- the room fitted with machinery but
no personnel present or
– ‘fully operational’---these occupancy states
are discussed more fully in Section 3.4 of this
Re-testing to Demonstrate
• The cleanroom
Monitoring of Cleanrooms
• Use risk assessment to decide what monitoring
tests should be done and how often. The
variables that are most likely to be monitored
– air pressure difference
• This might be necessary in high quality cleanrooms such as
ISO Class 4, and better.
– airborne particle count
• This might be necessary in high quality cleanrooms such as
ISO Class 4, and better.
– where appropriate, microbiological counts.
10. Measurement of Air
Quantities and Pressure
• A cleanroom must have sufficient clean air
supplied to dilute and remove the airborne
contamination generated within the room.
• Air Cleanliness:
– Turbulently ventilated cleanroom
• air supply; the more air supplied in a given time, the cleaner
– unidirectional cleanroom
• air supply velocity
– Initial testing of the design
– Regular intervals check
– Hoods: air supply
– Anemometers: air
• Turbulently ventilated
– measured within the
Measuring air quantities from
within a cleanroom
• Air air filter (no diffuser) anemometer at the
filter face average velocity air volume
– Difficulty: the non-uniformity of the air velocity
• Air air diffusers unevenness of air
velocities incorrect air volume
• Hood: air supply volume average velocity
measured at the exit of the hood air volume
• Anemometers: away from the filter of
about 30cm (12 inches)
• Vane Anemometer
– Principle: Air supply turning a vane
– Accuracy: velocity is less than about 0.2 m/s
(40 ft/min), the mechanical friction affects the
turning of the vane
• Principle: Air passing
through the head of
cooling effect the
air velocity: Fig.10.3 :
a bead thermistor (有
• Low velocities can be
measured with this
type of apparatus
Differential Pressure Tests
• The units:
– Pascals, inch water gauge are used (12Pa =
0.05 inch water gauge).
• Pressure difference: 10 or 15 Pa between
– 15 Pa is commonly used between a
cleanroom and an unclassified room,
– 10 Pa between two cleanrooms.
• Large openings:
– problems can occur when trying to achieve a
pressure difference between areas connected
by large openings, such as a supply tunnel.
To achieve the suggested pressure drop :
• Very large air quantities through the tunnel
• To accept a lower pressure difference
Apparatus for measuring
– range of pressure
difference of 0-60 Pa
(0-0.25 inch water)
– inclined manometer;
• works by pressure
pushing a liquid up an
– small pressure
changes in the inclined
tube up to a pressure
of about 60 Pa.
– After that pressure, the
tube moves round to
the vertical measuring
can be in the 100 to
500 Pa range.
Methods of checking pressure
• pressure differences between areas
– adjusting the pressure differences :
• extract be reduced to increase the pressure, and increased to
• If manometers are not permanently installed, a tube from
a pressure gauge is passed under the door, or through
an open by-pass grille or damper into the adjacent area.
• In some ventilation systems, the pressures within rooms
are measured with respect to one reference point. When
this type of system is being checked, the pressure
difference across a doorway can be calculated by
subtracting the two readings of the adjoining spaces.
11. Air Movement Control
Between and Within
• To show that a cleanroom is working
correctly, it is necessary to demonstrate
that no contamination infiltrates into the
cleanroom from dirtier adjacent areas.
• Cleanroom Containment Leak Testing
– Airborne contamination: doors and hatches,
holes and cracks in the walls, ceilings and
other parts of the cleanroom fabric
Contamination can be pushed into
the cleanroom at
• ceiling-to-wall interface
• filter and lighting housings-to-ceiling interfaces
• ceiling-to-column interface
• the cladding of the ceiling support pillars
• Service plenums and the entry of services into
the cleanroom: electrical sockets and switches,
and other types of services providers.
Particularly difficult to foresee and control in a
negatively pressurized containment room.
Methods of checking infiltration
• Smoke test (dust test)
– flow direction: open door, or through the
cracks around a closed door, cracks at the
walls, ceiling, floor and filter housings, service
ducts or conduits.
– where the containment originates from may
be unknown, and it is often difficult to find the
places to release test smoke.
Containment leak testing
– handing it over to the user
– major reconstruction work has been carried
– ISO 14644-2 lists the ‘containment leak’ test
as an ‘optional’ test and suggest a re-testing
interval of two years
Air Movement Control within a
• sufficient air movement
– dilute, or remove airborne contamination prevent a build-up of
• turbulently ventilated cleanroom:
– good mixing, critical areas: where the product is exposed to the
risk of contamination
• unidirectional flow cleanroom
– critical areas should be supplied with air coming directly from
the high efficiency filters. However, problems may be
encountered because of:
• heat rising from the machinery and disrupting the airflow
• obstructions preventing the supply air getting to the critical area
• obstructions, or the machinery shape, turning the unidirectional flow
into turbulent flow
• contamination being entrained into the clean air.
Air movement visualization
• Objective: sufficient clean air gets to the critical
areas qualitative methods
– smoke or particle streams
• Streamers (threads or tapes):
– high surface-area-to-weight ratio, ex. recording tapes
– A horizontal flow: 0.5 m/s (100 ft/min) streamer 45°
to the horizontal
• about 1m/s (200 ft/min) almost horizontal.
smoke or particle streams
–Water vapour :
from solid C02
(dry ice) or by
putter and smoke tube':
• Titanium tetrachloride
acid corrodes some
surfaces harmful to
sensitive machinery or
harm the operator's
Air Movement in turbulently
• working well: quickly dispersed
• not working well Areas: not disperse
quickly contamination build up
improved by adjusting the air supply
diffuser blades, removing an obstruction,
moving a machine.
Air Movement in unidirectional flow
• air moves in lines
– Still picture
Air velocity and Direction
• A permanent record: velocity and direction
Recovery Test Method
• A quantitative approach
• A burst of test particles introduced into
the area to be tested mixed with their
surroundingsthe airborne particle count
should be measured,
• A useful endpoint is one-hundredth of the
original concentration, and the time taken
to reach there can be used as an index of
Filter Installation Leak
• Manufacturer's factory and packed OK
• Unpacked and fitted into the filter housings
• Leakage problems
• Testing : artificial test aerosol
Leakage areas in a HEPA filter
A - filter paper-to-case cement area C- gasket
D - frame joints. B - filter paper (often at the paper fold)
Gasket leaks from filters Gasket and casing leaks from
inserted down from ceiling filter inserted up from cleanroom
Figure 12.4 Filter-housing gel seal method
Artificial Smoke and Particle Test
• Cold-generated oils
– Di-octyl phthalate (DOP)鄰苯二甲酸二辛酯
• oily liquid, potentially toxic effects, no longer used
– Di-octylsebacate (DOS)葵二酸二辛酯
– poly alpha olefin (PAO)聚烯茎油
Cold-generated oil Test
air Laskin nozzle Air+
(high pressure) oil particle
Air pump oil
Hot generated smokes
Hot oil smoke generator
• chemical products harmful to filter
• 使用Polystyrene Latex Spheres (PLSs)
聚苯乙烯乳膠球(0.1 ~ 1mm)
Apparatus for Measuring Smoke
– 28 1/min (1 ft3/min) of
– particles refract the light
– electrical signal
– concentration: between
0.0001 μg/1 and 100 μg/1.
• Single particle
– sample a volume of
air and this is
collected in a set time
Methods of Testing Filters and
• Scanning methods
– a probe with a photometer, or single particle
– Scan speed : not more than 5cm/s
– leaks : media, filter case, its housing
– The most common leaks:
• around the periphery of the filter
• the casing-to-housing seal,
• the casing joints
Repair of leaks
• Filter media leak
– at the fold of the paper
– repaired on site with
Airborne Particle Counts
• air supply volume,
• pressure differences,
• air movement within and between
• filter integrity
• airborne particle concentration
• Particle counter : both counts
• Photometer : mass of particles
principle of Particle Counter
Airborne particle counter:
flow rate: 28 1/min (1 ft3/min) of air
size range: regular 0.3 μm or 0.5 μm
high-sensitivity: 0.1 μm but with a smaller air
Continuous Monitoring Apparatus
for Airborne Particles
Sequential monitoring system
Simultaneous monitoring system
best but most expensive
Particle Counting in Different
• Occupancy state: as built, at rest,
• cleanroom contractor: 'as built'
• ‘rule of thumb: ‘as built’ room will be
about one class of cleanliness cleaner
than when ‘operational’.
Measurement of Particle
Concentrations (ISO 14644-1)
• Principles: The number of sampling
locations must reflect the size of the room
and its cleanliness.
• The methods: (a) number of sampling
locations and (b) the minimum air volume
Sample locations and number
(ISO standard 14644-1)
• Minimum number of locations:
– Where NL rounded up to a whole
– A is the area of the cleanroom,
or clean air controlled space, in
• evenly distributed and height
Airborne sampling volume
• Minimum volume at each location: the air
volume should be large enough to count
20 particles of the largest particle size
• V= 20/C x 1000
– where V is the minimum single sample
volume per location, expressed in litres.
– C is the class limit (number of particles/m3)
• One or more samples : at each location
• The volume sampled at each location: at
least two liters
• The minimum sample time : at least one
Acceptance criteria( ISO 14644-
• the average particle concentration at each of
the particle measuring locations falls below
the class limit
• when the total number of locations sampled is
less than 10, the calculated 95% Upper
Confidence Limit (UCL) of the particle
concentrations is below the class limit.
• 4m x 5m size. ISO Class 3 in the 'as built'
condition at a particle size of >= 0.1 μm.
• Number of locations
– A= 4m x 5m. N = √4x5 = 4.475
– The minimum number of locations is 5
• Minimum air sampling volume
– V= 20/C x 1000
– C: ISO Class 3 room is 1000/m3.
– ∴Minimum volume = 20/1000 x 1000= 20 litres
• particle counter flow rate of 28.3 liter/min,
i.e. 20liter, time = 42 s
• ISO 14644-1 requires a minimum sample time
of 1 minute
• 1 minute
• first part of the ISO requirement is
• As less than nine samples were taken
95% UCL does not exceeded the class
Calculation of 95%UCL
• the 'means of averages': M
M = (580+612+706+530+553)/5 = 596
• Standard deviation (s.d).
(Xi M ) 2
• Standard deviation s.d.=69 s.d i 1
• 95﹪UCL = M+[UCL factor x (s.d/√n)]
• As number of locations is 5, the t-factor is 2.1.
• ∴ 95﹪ UCL for particles > 0.1 μm = 596 + [ 2.1 x
69/√5 ]= 661<1000
• The cleanroom is therefore within the
required class limit.
• The way to avoid any 95% UCL problems
is to always test more than nine points in
Ch.14 Microbial Counts
• People are normally the only source of
micro-organisms in a cleanroom
• as built/ at rest little value
• Operational: micro-organisms are
continually dispersed from people in the
Microbial Sampling of the Air
• Volumetric air sampler
• Settle plate sampling
Volumetric' air samplers
• a given volume of air is sampled; also
known as 'active' sampling.
• impact micro-organisms onto agar
• remove micro-organisms by membrane
• Agar: jelly-type material with nutrients
added to support microbial growth.
• Micro-organisms landing
temperature, time colony (millimetres
Settle plate sampling
• where micro-organisms are deposited,
mainly by gravity, onto an agar plate.
• Impaction onto agar:
– inertial impaction
– centrifugal forces.
• Time and Temperature to grow
• Bacteria : 48 hours at 30° C to 35° C;
• Fungi: 72 hours at 20° C to 25° C
Inertial impaction samplers
• Flow rate: 30 to 180 litres/min (1 ft3/min to 6
ft3/min) of air
• Air Inertial impactors slit or hole
Centrifugal air samplers
• Air rotating vane centrifugal force agar
• The impaction surface is in the form of a
plastic strip with rectangular recesses into
which agar is dispensed
• A membrane filter is mounted in a
holder vacuum draw air microbe-
carrying will be filtered out by membrane
The membrane placed an agar plate
• A membrane filter with a grid printed on
the surface will assist in counting the
Membrane holder with filter
Microbial Deposition onto Surfaces
• Indirect measurementvolumetric
• direct method settle plate sampling
Settle plate sampling
• micro-organisms skin particles 10 to
30μm by gravity onto surfaces at an
average rate of about 1 cm/s
• Settle plate sampling: Petri dishes
(diameter:90mm) containing agar medium
opened and exposed time (4~5
hours) particles to deposit Petri dishes
Calculation of the likely airborne
Contaminat ion rate
Settle plate count
area of product
area of petri dish
time product exposed
time settle plates exposed
Microbial Surface Sampling
• contact sampling
Contact surface sampling
• surface (flat) RODAC
Detection and Counting)
dishes Fig 14.5 are
usedThe agar is rolled
over the cleanroom
organisms stick to the
agar incubated time
and temperature micro-
organisms grow &
• uneven surfaces: bud
swab rubbed surface
and then rubbed over
an agar plate.
Copan Swab Rinse Kits
• Personnel are the primary source of micro-
organisms in a cleanroom.
• The methods commonly used are:
– Finger dabs.
– The person's fingers tips, or their gloved hand, is pressed or wiped
on an agar plate and the number of micro-organisms ascertained.
– Contact plates or strips.
– The person's garments are sampled by pressing the plate or strip
onto their clothing. This is best done as they come out of the
– Body box.
– If a person wearing normal indoor clothing exercises within a body
box their dispersion rate of airborne micro-organisms can be
Operating a Cleanroom:
• considering the sources and routes of
contamination within a cleanroom and how
to control these.
• assessing risk during manufacturing: such
as Fault Tree Analysis (FTA) and Failure
Mode and Effect Analysis (FMEA).
(Electrical and mechanical systems)
Hazard Analysis and Critical
Control Point (HACCP) system.
• HACCP has a seven-step approach:
– Identify the sources of contamination in the
– Assess the importance of these sources
– Identify methods that can be used to control these
– Determine valid sampling methods to monitor
either the hazards, or their control methods, or
– Establish a monitoring schedule with 'alert' and
– Establish a monitoring schedule with 'alert' and
– Verify that the contamination control system is
working effectively by reviewing the product rejection
rate, sampling results and control methods and,
where appropriate, modifying them.
– Establish and maintain appropriate documentation.
– Train the staff.
Identification of Sources and
Routes of Contamination
• Sources of contamination
– dirty areas adjacent to the cleanroom;
– unfiltered air supply;
– room air;
– machines, as they work;
– raw materials;
Airborne and contact routes of
– The two main routes of transfer are airborne
– Airbone: particles are small; fibres, chips or
cuttings fall directly on to the product.
– Contact: machines, containers, packaging,
raw materials, gloves, clothes, etc.
Construction of a risk diagram
• Risk diagram: possible sources of
contamination; their main routes of
transfer; methods of controlling this
• Figure 15.1 is an example of a risk
diagram; the manufacturing process has
Sources and routes of particle and microbial contamination in a
cleanroom along with preventative measures
Sources and routes of control associated with process machinery.
Assessment of the Importance of
• Possible sources of contamination routes of
transmission risk assessment
• Risk factors:
– risk factor A: the amount of contamination on, or in,
the source that is available for transfer
– risk factor B: the ease by which the contamination is
dispersed or transferred
– risk factor C: the proximity of the source to the critical
point where the product is exposed
– risk factor D: how easily the contamination can pass
through the control method
Risk factors for assessing hazards
• Risk rating = A x B x C
• Low: a risk rating of
less than 4
• Medium: between 4
• High: higher than 12
Identification of Methods to Control
• Identify the contamination hazards their
degree of risk assessed methods
available to control them.
• Figures 15.1 and 15.2 show methods that can be used to
control the routes of spread of contamination. These are:
– HEPA or ULPA air filters supply air
– Airborne contamination from areas outside the cleanroom air
moves from the cleanroom outward
– The contamination from the floors, walls and ceiling cleaning
– People’s mouth, hair, clothing and skin Cleanroom garments
– Contamination from machines design of the machine, the use
of exhaust air systems to draw the contamination away.
Cleaning dirt on the machine.
– Raw materials, containers and packaging made from
materials that do not generate contamination; manufactured in
an environment have minimal concentrations of contamination;
correctly wrapped to ensure that they are not contaminated
Sampling Methods to Monitor
Hazards and Control Methods
– collection efficiency of sampling instruments;
– calibration of the instruments;
– determination that the hazard is of sufficient
importance to need to be monitored;
– determination that the sampling method used
is the best available for directly measuring the
hazard, or its control method.
Establishing a Monitoring Schedule
with Alert and Action Levels
• 'alert' and 'action' conditions; 'warning' and
• The 'alert' level should be set to indicate that the
contamination concentrations are higher than
might be expected, but are still under control.
• The 'action' level should be set such that when it
is exceeded there should be an investigation.
• Analysing the monitoring results and setting
'alert' and 'action' levels is quite a complicated
subject if a statistical approach is used.
Knowledge of statistical techniques, especially
the use of trend analysis.
Verification and Reappraisal of the
• The method is correctly implemented
rejection rate of the product; measurement of the
particle, or microbial, levels in samples of the
final product. We can now reassess the
– the relative importance of the hazards
– the necessity and the methods for controlling the
– the effectiveness of the control methods
– the correctness of the monitoring schedule
– whether the 'action' and 'alert' levels should be
lowered or raised.
• An effective contamination control system will
• (1) the methods described in the preceding
steps of this chapter,
• (2) the monitoring procedures, and
• (3) results from the monitoring.
• Regular reports should be issued of an analysis
of the monitoring results and any deviations from
the expected results.
• They first arrive at the cleanroom
• Train at regular intervals throughout their
16. Cleanroom Disciplines
• source of contamination
– particles and fibres
People Allowed into Cleanrooms
– produce 1,000,000 particles >= 0.5 mm
– several thousand microbe-carrying particles
• Suggestions contain criteria that can discriminate
against some personnel
– Skin conditions: skin cells, dermatitis, sunburn or bad
– Respiratory conditions: coughing, sneezing
• allergic conditions, which cause sneezing, itching, scratching,
or a running nose
• allergic to materials used in the cleanroom, (a) garments
(polyester) (b) plastic or latex gloves, (c) chemicals: acids,
solvents, cleaning agents and disinfectants, and (d) products
manufactured in the room, e.g. antibiotics and hormones.
Personal Items Not Allowed into
• General rule: nothing should be allowed
into the cleanroom that is not required for
production within the room.
• food, drink, sweets and chewing gum
• cans or bottles, smoking materials
• radios, CD players, Walkmans, cell phones,
• newspapers, magazines, books and paper
• pencils and erasers
• wallets, purses and other similar items.
Disciplines within the Cleanroom
• Within a cleanroom: rules-of-conduct:
written procedures; 'does and don'ts'
posted in the change or production area
• Air transfer:
– come in and out through change areas: buffer
zone; not use emergency exit
– Doors: not be left open; not be opened or
closed quickly: open inwards into the
• No Silly behaviour: The generation of
contamination is proportional to activity.
– motionless: 100,000 particles >=0.5 μm/min
– head, arms and body moving: 1,000,000 particles >= 0.5
– walking: 5,000,000 particles >= 0.5 μm/min
• position themselves correctly
• not lean over the product;
• working in unidirectional air: not between
the product and the source of the clean
air, i.e. the air filter.
• 'No-touch' techniques should be devised:
from gloved hand onto the product.
• Oil and skin particles would contaminate
the wafer with catastrophic results.
• not support material against their body
• No personal handkerchiefs
• Washing, or disinfection when required, of
gloves during use should be considered.
• The movement of materials between the
inside and outside of a cleanroom should
• Waste material: collected frequently into
easily identified containers and removed
frequently from the cleanroom.
Maintenance and Service
• Enter a cleanroom with permission.
• Maintenance be trained cleanroom
techniques, or closely supervised when they are
within the cleanroom.
• Wear the same cleanroom clothing as
• Technicians should ensure they remove dirty
boiler suits, etc. and wash their hands before
changing into cleanroom clothing.
• Tools cleaned and sterilized; stored for sole used
within the cleanroom; Tool’s materials not corrode.
Only the tools or instruments needed within the room
should be selected, decontaminated, and put into a
cleanroom compatible bag or container.
• instructions or drawings can be photocopied onto
cleanroom paper, or laminated within plastic sheets, or
placed in sealed plastic bags.
• Particle generating operations such as drilling holes, or
repairing ceilings and floors should be isolated from the
rest of the area. A localized extract or vacuum can also
be used to remove any dust generated.
17. Entry and Exit of
• Skin and clothing: millions of particles and
thousands of microbe-carrying particles
• Features of cleanroom clothing:
– not break up and lint: disperse the minimum
of fibres and particles
– filter: against particles dispersed from the
person's skin and their clothing.
• The type of cleanroom clothing
– contamination control is very important: a
coverall, hood, facemask, knee-length boots
– contamination is not as important: less
enveloping clothing such as a smock, cap and
Prior to Arriving at the Cleanroom
• Frequency of bathe or shower:
• remove the natural skin oils;
• dispersion of skin and skin bacteria;
• dry skin may wish to use a skin lotion
• What clothing is best worn below cleanroom garments?
• Artificial fibres: polyester are better than those made from wool and
• Close-woven fabrics: more effective in filtering and controlling the
particles and microbe-carrying particles
• Cosmetics, hair spray, nail varnish removed rings,
watches and valuables removed and stored
Changing into Cleanroom
• The best method of changing into
cleanroom garments is one that minimises
contamination getting onto the outside of
• The design of clothing change areas is
divided into zones:
– Pre-change zone
– Changing zone
– Cleanroom entrance zone.
Approaching the pre-change zone
• blow nose, go to the
• shoe cleaner
– Sticky cleanroom mats
or flooring: two general
• street or factory clothes removed
• Watches and rings removed. Items such as cigarettes and
lighters, wallets and other valuables should be securely stored.
• Remove cosmetics and apply a suitable skin moisturizer (no
chemicals used in the formulation cause contamination
problems in the product being manufactured)
• Put on a pair of disposable footwear coverings, or change into
dedicated cleanroom shoes.
• wash the hands, dry them and apply a suitable hand lotion.
• Cross over from the pre-entry area into the change zone.
• The garments to be worn are
• A facemask and hood (or cap) is
• Temporary gloves known as
'donning gloves' are sometimes
• The coverall (or gown) should be
removed from its packaging and
unfolded without touching the floor.
Cleanroom entrance zone
• rossover bench: allows
(overshoes or overboots)
to be correctly put on.
• Protective goggle can be
put on. These are used
not only for safety
reasons but to prevent
eyelashes and eyebrow
hair falling onto the
• The garments should be checked in a full-length
mirror to see that they are worn correctly.
• If donning gloves have been used they can be
dispensed with now. They can, however, be kept
on and a pair of clean working gloves put on top.
Two pairs of gloves can be used as a precaution
against punctures, although sensitivity of touch
• Low particle (and if required, sterile)
working gloves should now be put on. In
some cleanrooms this task is left until the
personnel is within the production
Exit Changing Procedures
• When leaving a cleanroom, personnel will either
• discard all their garments and on reentry use a new
set of garments (this is normally only employed in an
aseptic pharmaceutical cleanroom)
• discard their disposable items, such as masks and
gloves, but reuse their coverall, smock, etc. on re-
– clothing rolled up; footwear pigeon holes;
– The hood (or cap) can be attached to the outside of the
coverall (or gown) hung up, preferably in a cabinet.
– Garment bags can be used.
Materials used in a cleanroom
• For manufacturing
• Packaging for the product
• Process machinery and equipment
• Tools used for the maintenance,
calibration or repair of equipment and
• Clothing for personnel, such as suits,
gloves and masks;
– Materials for cleaning, such as wipers and
– Disposable items such as writing materials,
labels and swabs.
Materials used in a cleanroom for
• pharmaceutical manufacturing:
containers and ingredients
• microelectronics industry: silicon wafers
and process chemicals;
Contamination on materials can be:
– electrostatic charge
– molecular outgassing.
– abrasives or powders;
– aerosol-producing cans or bottles;
– items made from wood, rubber, paper,
leather, wool, cotton and other naturally
occurring materials that break up easily;
– items made from mild steel, or other materials
that rust, corrode or oxidise;
– items that cause problems when machined or
processed, e.g. they may smoke or break up;
– paper not manufactured for use in
– pencils and erasers;
– paper correcting fluid;
– personal items listed in Section 16.2 should
not be brought in by cleanroom personnel;
– disposable items such as swabs, tapes and
labels that are not cleanroom compatible.
Transfer of Items and Small Pieces
of Equipment through an Airlock
– Transfer area with a
• door (uncontrolled area)
opened and the person
enters The package
should be placed on the
'wrapped receiving' or
'dirtier' part of the pass-
• The wrapping is then
cleaned and removed
• The outer packaging
is now removed and
deposited into a
The item is then be
placed on the
'wrapping removed' or
'clean' part of the
• The person leave. The
airlock may be left for a
few minutes to allow the
airborne contamination to
come down to a
personnel now enter the
cleanroom and pick up
items that have been left
Entry of Machinery
– Machines, and other heavy and large bulky
items of equipment, are occasionally taken in
or out of a cleanroom.
– The best solution to the movement of bulky
items is to design the materials airlock to be
large enough to allow the entry and exit of
every piece of machine to be brought in or out
of the room.
19. Cleanroom Clothing
• Contamination source: people clothing
• Cleanroom clothing: originated from
• Function: reducing inert particles and
Sources and Routes of Inert
• More activity more particles disperse
Dispersion is dependent on the clothing
worn, but can be in the range of 106 to 107
per minute for particles >= 0.5 μm, i.e. up
to 1010 per day.
• People may disperse particles from:
• Skin; clothing they wear under cleanroom
garments; cleanroom clothing
• mouth and nose.
Sources of particles and
mechanisms of release
• Skin: People shed approximately 109 skin cells
per day. Skin cells are approximately 33μm x 44
• Skin cells:
– released onto clothing and laundered away;
– others are washed away in the bathtub or shower.
– a large number are dispersed into the air.
Sources and routes of particles and microbe containing particles from people
Skin surface showing skin cells and beads of sweat
Clothing under cleanroom
• natural fabrics: such as a cotton shirt,
cotton jeans and woollen jerseylarge
quantities of particles. natural materials
have fibres that are both short and break
• synthetic fabric: the particle challenge can
be reduced by 90% or more.
Cotton fabric photographed through a microscope. Magnification about 100 times
• synthetic plastic materials: such as
polyester or nylon.
Routes of transfer of particles
• Pores: between 80μm and 100μm The
particles generated from the skin and the inner
clothing therefore pass through easily.
• Personnel move: particles be pumped out of
closures at the neck, ankles, wrists and zips.
Secure closures tight
• tears or holes, particles can easily pass through.
Microcolony of bacteria on surface of skin
Routes of microbial dispersion
• The routes of transfer the same as with inert
• the pores in the fabric
• poor closures at the neck, sleeves and ankles
• damage to the fabric, i.e. tears and holes.
• expelled from the mouth: speaking, coughing and sneezing.
• When males wear ordinary indoor clothing, the
average rate being closer to 200 per minute.
Females will generally disperse less.
Types of Cleanroom Clothing
• Clothing designs
– The most effective type:
• completely envelopes a person;
• be made from a fabric that has effective filtration properties
• have secure closures at the wrist, neck and ankle.
– The choice of clothing will depend on what is being
produced in the cleanroom. A poorer standard of
cleanroom may use a cap, zip-up coat (smock) and
• In a higher standard
of cleanroom a one-
piece zip-up coverall,
and a hood that tucks
under the neck of the
garment will be typical
• The most popular type of clothing is
made from woven synthetic fabrics.
• Non-woven fabrics, such as Tyvek, are
used as single, or limited reuse,
garments. They are popular for visitors
and are used by builders when
constructing the room. They are also
popular in pharmaceutical
manufacturing facilities in the USA.
Membrane barrier fabrics, such as
GoreTex, which use a breathable
membrane sandwiched onto, or
between, synthetic woven fabrics, are
very efficient; they are expensive, and
hence are used in the higher standard
• To prevent the raw edges
• To minimise shedding, the zippers,
fasteners and shoe soles should not chip,
break up or corrode.
• Choice of garments
– IEST Recommended Practice RP-CC-003.2.
R = recommended NR == not recommended
AS = application specific (NR*) = not recommended in nonunidirectional flow
Table 19.2 Garment systems for aseptic cleanrooms (IEST RP CC-003.2)
Processing of Cleanroom
Garments and Change Frequency
– to be reused cleanroom laundry antistatic
treatment and disinfection or sterilisation
• Frequency of change
• semiconductor industry ( the highest specification),
changed once or twice a week.
• fresh garments are put on every time personnel
move into an aseptic pharmaceutical production
Body box: a, metronome; b, bacterial and particle sampler
Comparison of clothing made
from different fabrics
• Bacterial dispersion (counts/min) in
relation to fabrics
Particle dispersion rate per minute
in relation to fabric
20. Cleanroom Masks and
Dispersion from the month
• sneezing, coughing and talking; these droplets
contain salts and bacteria.
• Saliva particles and droplets : about 1 to
2000μm; 95% of them lie being between 2 and
100μm, with an average size of about 50μm;
bacteria in saliva is normally over 107 bacteria
• A 100μm particle will drop 1 metre in about 3
seconds, but a 10μm particle takes about 5
• Drying time: Particles of water 1000μm in
diameter will take about 3 minutes to
evaporate, a 200μm particle will take 7
seconds, a 100μm particle about 1.6
seconds and a 50 μm particle about 0.4
• Efficiencies of over 95% for particles
expelled from the mouth are usually
obtained by most masks. A loss in
efficiency is caused by particles passing
round the side of the mask, and much of
this is due to small particles (reported to
be < 3μm in the dry state).
Number of inert and microbe-carrying
particles emitted by a person
Particles emitted when
pronouncing the letter `f’
• surgical-style with
straps and loops:
• Consideration: pressure drop across the mask
fabric; masks high filtration efficiency against
small particles give a high-pressure drop
across the mask that causes the generated
particles to be forced round the outside of the
mask. 'veil' or 'yashmak' type, one of these
types being exposed to show its shape in Figure
20.4. The normal way it is worn is shown in
Powered exhaust headgear
• These provide a barrier to
from the head, as well as
the mouth. The exhaust
from the helmet and face-
shield is provided with a
filtered exhaust system
so that contamination
does not escape into the
cleanroom. An example is
shown in Figure 20.6.
• Hand contamination and gloves
– There are two types of gloves associated with
• Knitted or woven gloves are used for lower
classes, i.e. ISO Class 7 (Class 10,000) and
poorer areas, as well as undergloves. The knit or
weave should be tight and a number of loose
• Barrier gloves, which have a continuous thin
membrane covering the whole hand are used in
the majority of cleanrooms.
• Cleanroom gloves are not usually manufactured in a
cleanroom; they therefore require cleaning before being
• Gloves may be required in some cleanrooms to prevent
dangerous chemicals, usually acids or solvents,
attacking the operator's hands.
• Some operator's skin is allergic to the materials that
gloves are made from.
• Other glove properties: chemical resistance and
compatibility, electrostatic discharge properties, surface
ion contribution when wet, contact transfer, barrier
integrity, permeability to liquids, heat resistance and
Glove manufacturing process
• Gloves are generally manufactured by dipping a 'former'
(porcelain or stainless steel), shape of a hand, molten
or liquid glove material removed from the molten or
liquid material a layer of material stripped by release
agent Release agents are a problem in cleanrooms
Release agents kept to a minimum.
• When stripped from the formers, latex gloves are 'sticky'.
To correct this, latex gloves are washed in a chlorine
bath. The free chlorine combines chemically with the
latex chemical bonds and lead to a 'case-hardening' of
the surface of the glove, which prevents them sticking to
each other. This washing also helps to clean to the
Types of gloves
• Polyvinyl chloride (PVC) gloves
• Latex Gloves
• Other Polymer Gloves
Polyvinyl chloride (PVC) gloves
• These plastic gloves are also known as vinyl
gloves and are popular in electronic cleanrooms;
can not sterilised, not used in bioclean rooms.
• They are available in normal and long-sleeve
length. Consideration should be made of the fact
that plasticisers make up almost 50% of a vinyl
glove. Plasdcisers come from the same group of
chemicals used to test the integrity of air filters,
i.e. phthalates, antistatic properties, outgassing
• This is the type used by surgeons, and the 'particle-free' type is now
used in cleanrooms. Latex gloves can be produced 'powder-free',
and those gloves that are washed further by use of filtered,
deionised water are often used in ISO Class 4 (Class 10) or ISO
Class 3 (Class 1) cleanrooms.
• They have good chemical resistance, giving protection against most
weak acids and bases, and alcohols, as well as having a fairly good
resistance against aldehydes and ketones.
• They are slightly more expensive to buy than the PVC type, but
cheaper than any other polymer. They can be sterilised. Because of
their elasticity, the glove can securely incorporate the cuff of a
garment under the sleeve.
Other Polymer Gloves
• Polythene gloves
– are used in cleanrooms and have the advantage of being free of oils and additives, as well
as resistant to puncturing. They are not resistant to aliphatic solvents. The main drawback of
this glove type is that they are constructed from float sheets and the seams are welded.
Manual dexterity is reduced with these gloves.
• Neoprene and nitrile gloves
– are chemically similar to latex gloves, but have the advantage of having a better resistance to
solvents than latex gloves. They are slightly more expensive than latex.
• Polyurethane gloves
– are strong, very thin, quite inflexible, and expensive. They may be manufactured with
microporous material for better comfort, or with carbon in the formulation which makes them
• PVA gloves
– are resistant to strong acids and solvents, but not water in which they are soluble. They are
• Gore-Tex gloves
– have welded seams and are hypoallergenic. They are breathable because of their porous
membrane. They are expensive.
21. Cleaning a Cleanroom
Why a Cleanroom Must be
– cleanroom clothing, over 100,000 particles >= 0.5 μm and over
10,000 particles >= 5.0μm.
– Machines also disperse millions of particles.
• Microbe-carrying particles: People can also disperse
hundreds, or thousands, of microbe-carrying particles
per minute. Because these micro-organisms are carried
on skin cells, or fragments of skin cells, their average
equivalent diameter is between 10 μm and 20 μm.
• Transfer: Cleanrooms surfaces get dirty be transferred
by personnel touching a cleanroom surface and then the
Cleaning Methods and the Physics
of Cleaning Surfaces
• Forces hold particles to cleanroom
– The main force : the London-van der WaaP’s
force, this being an inter-molecular force.
– Electrostatic forces can also attract particles
to a surface.
– A third force can arise after wet cleaning.
Particles that are left behind will dry on the
surface, and may adhere to it
• The methods that are generally used for
cleaning a cleanroom, are:
– Vacuuming (wet or dry): immersing the particle in a
liquid, as occurs in wet pick-up vacuuming
– Wet wiping (mopping or damp wiping): an aqueous-
based detergent is used then the London-van der
WaaFs force and electrostatic forces can be reduced
or eliminated. The particle can then be pushed or
drawn off from a surface by wiping, mopping or
– Picking-up with a tacky roller.
• Dry vacuuming :
– depends on a jet of air moving towards the vacuum
nozzle and overcoming the adhesion forces of
particles to the surface
– Figure 21.1 : efficiency of dry vacuuming against
different sizes of sand particles on a glass surface.
• Wet vacuum: Water and solvents have much
higher viscosity than air, so that the drag forces
exerted by liquids on a surface particle are very
Efficiency of dry vacuuming
• Wet -wiping
– Wet wiping, with wipers or mops, can
efficiently clean cleanroom surfaces. The
liquid used allows some of the particle-to-
surface bonds to be broken and particles to
• Tacky rollers
– The particle removal efficiency of 'tacky'
rollers is dependent on the strength of the
adhesive force of the roller's surface.
• dry brush should never be used to sweep
a cleanroom. they can produce over 50
million particles >= 0.5 μm per minute.
• String mops are not much better, as they
can produce almost 20 million particles >=
0.5 μm per minute.
• Dry vacuuming: popular method
– relatively inexpensive
– no cleaning liquids are needed
– Note: unfiltered exhaust-air must not pass into
the cleanroom. This is achieved by using
either an external central-vacuum source, or
providing a portable vacuum's exhaust air with
a HEPA or ULPA filter.
• Wet vacuum or 'pick-up' system: is more
efficient than dry vacuum
– more efficient than a mopping method,
– less liquid left to dry on the floor
– floor will also dry quicker.
– Wet pick-up systems are used on
conventionally ventilated cleanroom floors,
but may not be suitable for the pass-though
type of floor used in the vertical unidirectional
• Mopping systems
– mops for cleanroom:
• materials that do not
easily break up: PVA or
foam, or a fabric such as
• The compatibility of the
material to sterilization,
disinfectants and solvents
should be checked
• Buckets should be made
from plastic or stainless
Two and three bucket systems
How to use a three-bucket mopping system
– Purpose: wipe surfaces and remove contamination; to
wipe contamination from products produced; used dry
to mop-up liquids that may have been spilled.
• Sorbency is an important property of wipers. Wipers are often
used to mop up a spillage and other similar tasks.
• wiper's sorbency: both its capacity (the amount
of liquid it can sorb) and its rate (how fast it can
• Tacky rollers
– Tacky rollers are
similar in size and
shape to paint rollers
used in the home, but
they have a tacky
material around the
outside of the roller.
An example of a tacky
roller is shown in