Cleanroom clothing - why, what and how?

Heidi Tuomi
R3 Nordic symposium
20.5.2014

Contents
People as a source of contamination
Cleanroom clothing
Requirements for cleanroom clothing
Cleanroom apparel
Gowning for the cleanroom

People as a source of contamination

Sources of contamination in a cleanroom

People
Supply air
Room surfaces
Raw materials,
packaging, tools and
equipment
Utilities
Production machinery
Production processes
Adjacent, dirtier areas

People as a source of contamination

Personnel have an important role in the production
process, but they are the greatest contamination
source in a cleanroom and thus can seriously
compromise the product.
80 % of the impurities present in a cleanroom
originate from people.
People are the major source of viable particles
present in a cleanroom.
Everything else in the cleanroom can be sterilized
or disinfected, except people.

People as a source of contamination

skin flakes, microbes, cosmetics particles, hair, textile
fibers, dust
A person sheds the outermost layer of skin epidermis
every 24 hours
10 million particles per day
up to 100 g of dead skin cells per week

As hair regenerates, old hair falls off

The human microbial flora

SKIN scalp
palm
arm
forehead
SALIVA
SNEEZING

1,5 x 106 cfu/cm2

1,0 x 103 cfu/cm2
1,1 x 102 cfu/cm2
2,0 x 105 cfu/cm2
107 - 108 cfu/cm3
104 - 106 cfu

The human microbial flora

The microbes in a human body belong to either the normal
or transient flora
1. Normal flora
Normal flora is the harmless, permanent bacterial
population present in the human body
Normal flora is important for the well-being on a
person
The composition of normal flora varies between
people by age, gender, region and season.

The human microbial flora

2. Transient flora
(mainly on the skin) can contain any microbes
including pathogens
transmits from the environment or from other people
can be removed from the skin by washing and
disinfection
during inflammation the amount of microbes on
skin/mucous membrane can increase thousand fold

The human microbial flora

Microbes are detached from people with skin flakes or
secretions (e.g. saliva)

People as a source of contamination

The number of particles generated from a person
is increased by:
Movement: a person walking generates 10 times
more particles than one sitting down
talking and coughing
smoking; exhalation air contains a great number of
particles
the use of cosmetics = particles applied on the skin

People as a source of contamination

Particles 0,3 m per minute

personal
clothing
sitting

cleanroom
cleanroom
coverall,
coat
boots, hood

448 000

142 000

14 920

standing still

4 450 000

462 000

48 600

rotating the
upper body

2 240 000

390 000

31 700

walking

5 380 000

128 500

157 000

The spreading of contamination

Decreasing the amount contamination from

people
Ways to decrease the amount contamination:
Efficient and correctly worn protective clothing
Slow movements and correct work methods
Good personal hygiene
Training the employees is most important !

Cleanroom clothing

Why use cleanroom clothing?

to protect the cleanroom environment
and products from contamination
secreted by people
to protect the personnel from
hazardous materials or products

Requirements for cleanroom clothing

Cleanroom clothing should
protect the cleanroom environment from contamination
shed no particles
be easy to put on
be comfortable to wear
be dirt repellent and easily cleanable
withstand washing and sterilization
have adequate strength and resistance to break-up
have desirable electrostatic properties

Cleanroom clothing = personal filter

Garments act as filters and retain the particle dispersions
from personnel
The "filtration efficiency" is dependent on the fabric the
garments are made of
Some amount of air escapes from under the garment
unfiltered, via closures and holes in the garment. This can
be reduced by careful design and good construction.

Fabric materials
monofilament polyester

cotton

Fabric types
1.
2.
3.

Woven fabrics
Spun bonded fabrics
Laminated fabrics
(with membrane)

Body garments

Body garments
coat and trousers or coverall (bunny-suit)
simple and straight-lined model
no pockets, belt pleats or tucks
minimum of seams
coverall/coat is sealed with a zipper covered with a
placket (=zipper covering)
secure closures at the wrist, neck and ankle openings;
adjustable (with snaps) or rib knit
garments should be a bit loose (not too large)

Headgear
Hair cover and/or hood
must cover hair completely
the hood should fully cover the head
and reach under the coverall neck
beard cover is worn if required
a cleanroom helmet with a ventilating
fan and exhaust filter for total
containment

Headgear
Facemasks
single use surgical style masks with
earloops or straps
veil-type snapped or sewn into the hood

Goggles
additional barrier
prevents eyebrow hair and eyelashes from falling onto
cleanroom surfaces
provides protection to the eyes

Footwear
Shoe covers
short single use model for lower
classification areas
can be used as first stage protection when
entering the gowning rooms
Boots
the boot should cover the pant leg of the
coverall and reach above the calf
plastic/rubber soles, zipper, straps on the
top hem and for fastening the sole to the
foot/shoe

Gloves
Selection of material depends on the use
knitted/woven gloves may be suitable for
inspection and assembly work
barrier gloves are made of latex, nitrile or vinyl
latex; excellent fit, feel and comfort; allergenic
nitrile; excellent tear and chemical resistance
vinyl; economical, susceptible to tears, breakage
and pinholes

Gloves
Gloves must be powder-free!
The glove should enclose the wrist opening of
the coverall
Undergloves can be worn to enhance comfort
Double gloves can be worn to increase
protection

Clothing in different cleanroom classes

The required filtration efficiency depends on:
the cleanroom class
the product/process (sterile product? aseptic
process?)
It defines the material and model of the clothing

Clothing in different cleanroom classes

Garment systems may include several layers of
garments; by using cleanroom undersuits, the
effectiveness of the cleanroom apparel can be
increased
By combining various types of garments and
accessories a suitable combination for different
cleanroom classes and applications can be found
Clothing manufacturers give recommendations
on which products to use at different cleanroom
classes

Clothing requirements in GMP

Grade D: Hair and, where relevant, beard should be
covered. A general protective suit and appropriate shoes
or overshoes should be worn. Appropriate measures
should be taken to avoid any contamination coming from
outside the clean area.
Grade C: Hair and where relevant beard and moustache
should be covered. A single or two-piece trouser suit,
gathered at the wrists and with high neck and appropriate
shoes or overshoes should be worn. They should shed
virtually no fibres or particulate matter.

Clothing requirements in GMP

Grade A/B: Headgear should totally enclose hair and,
where relevant, beard and moustache; it should be
tucked into the neck of the suit; a face mask should be
worn to prevent the shedding of droplets. Appropriate
sterilized, non-powdered rubber or plastic gloves and
sterilized or disinfected footwear should be worn.
Trouser-legs should be tucked inside the footwear and
garment sleeves into the gloves. The protective clothing
should shed virtually no fibers or particulate matter and
retain particles shed by the body.

ISO 14644-5
Clothing should be made of fabrics that do not shed
particles/contamination
The frequency of clothing change varies according to the
use of the cleanroom
Cleanroom clothing should not leave the controlled area
expect for cleaning or service/repair
Clothing must be stored and transported in a way to
minimize contamination
Clothing should be donned and disrobed in a manner to
minimize the generation and spreading of contamination
Clothing should be regularly inspected to ensure
continued compliance to specifications

IES-RP-C003.3 recommendations

Clothing recommendations

Gowning for the cleanroom

Gowning for the cleanroom

Cleanroom garments are donned prior to entering the
cleanroom
There is no single right practice to put on cleanroom
clothing, but it varies with the clothing used
The best method of changing into cleanroom garments is
the one that minimizes the amount of contamination
getting onto outside of the garments.
A written instruction should be available in the changing
room(s)!

Changing rooms
The number of consecutive changing rooms depends on
the cleanroom class and the gowning procedure.
The changing rooms should act as air-locks
The changing rooms must have a cleanliness
classification high enough not to compromise the
cleanliness of the cleanroom
Personnel entering and exiting the cleanroom should be
separated; either by time interval or in different changing
rooms

Changing rooms
The changing rooms should be divided into
three zones:
1. pre-change zone; for removing clothes
that are not to be worn underneath the
cleanroom garment
2. Changing zone; storing and
donning/taking off cleanroom garments
3. Entrance zone; checking of the
garments and entrance to the cleanroom

Outside the cleanroom

Take a shower, preferably at least 6 hours before
Don clean underwear and socks
Remove jewelry, watches etc.
Don clean working clothes suitable for entry in the prechange area
Put on clean shoes
Don clean hair-cover (and beard cover)

Hand hygiene
An effective scrub-up with soap removes dirt, microbes
transmitted from the environment and a part of the skins
normal flora.
Microbes of the skins normal flora start to multiply fast
after washing hands.
By using disinfectants, the multiplication of bacteria can
be significantly slowed down.
A sterile moisturizer after scrub-up is recommended for
keeping up healthy skin.

Hand hygiene
Instruction for washing hands:
Moisten hands and arms down from the elbows.
Take washing liquid from the dispenser and scrub it in
your hands, with special care taken in between fingers,
nail walls and nails
Scrub hands together for at least 30 seconds.
Rinse hands carefully
Dry hands with a non-linting single use towel.
Close the tap with the towel
Scrub disinfectant on the hands.

Suggested gowning protocol

1.

Remove make-up and jewelry before entering the prechange area.

2.

When entering the cleanroom pre-change area you

should wear clean working clothes, hair cover and
indoor shoes. The cap should cover all hair completely.

Changing room 1
3. Clean shoe soles by stepping on the sticky mat.
4. Take off clothing not to be worn under the cleanroom
garments.
5. Wash hands thoroughly with washing liquid. Dry them
with a paper towel. Disinfect the hands.
6. Move on to the next changing room.

Changing room 2
7. Remove gloves from the packaging and don them.
8. Disinfect the pass-over bench.
9. Select the garments to be worn (2 bags; coverall + boots)
and place them on the bench.
10. Remove face mask from the packaging and tie it on. Do
not touch anything else but the straps and the
nosepiece. Disinfect the gloves.
11. Take the hood from the packaging and don it. Do not
touch anything else but the lower fringe and the straps.
Disinfect the gloves.

Changing room 2
12. Remove the coverall from the packaging and grab it
from the waist, legs and cuffs. Be careful not to touch the
floor or other surfaces with the coverall. Don the coverall.
The outer side of the coverall should not touch your
clothing or skin. Lift the glove cuffs over the coverall cuffs.
Disinfect the gloves.
13. Remove the boots from the packaging put them on
while crossing over the bench at the same time. The
cleanroom boots should not touch the floor on the dirty
side of the bench.

Changing room 2
14. Check the clothing in a mirror for correct wear.
15. Check that the gloves are intact; in case of damage
change a new pair. Disinfect gloves.
16. Enter the cleanroom.

Thank you!