Presentation given by Heidi Tuomi in R3 Nordic contamination control society symposium 2014

1. Cleanroom clothing - why, what and how?
Heidi Tuomi
R3 Nordic symposium
20.5.2014

2. Contents
• People as a source of contamination
• Cleanroom clothing
– Requirements for cleanroom clothing
– Cleanroom apparel
• Gowning for the cleanroom

3. People as a source of contamination

4. 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

5. 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.

6. 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

7. The human microbial flora
SKIN scalp 1,5 x 106 cfu/cm2
palm 1,0 x 103 cfu/cm2
arm 1,1 x 102 cfu/cm2
forehead 2,0 x 105 cfu/cm2
SALIVA 107 - 108 cfu/cm3
SNEEZING 104 - 106 cfu

8. 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.

9. 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

10. The human microbial flora
• Microbes are detached from people with skin flakes or
secretions (e.g. saliva)

11. 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

12. People as a source of contamination
Particles  0,3 m per minute
personal clothing
cleanroom coat
cleanroom coverall,
boots, hood
sitting 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

13. The spreading of contamination
Skin particles
Particles from
clothing
underneath
Particles from
surface of
cleanroon clothing
Particles from nose
and mouth
Cleanroom air
Particles inside
cleanroom
garments
Particles inside
facemask
Through neck/wrist/ankle openings
Through fabric pores
Through holes and tears
Venting around the sides of the mask

14. 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 !

15. Cleanroom clothing

16. 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

17. 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

18. 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.

19. Fabric materials
monofilament polyester cotton

20. Fabric types
1. Woven fabrics
2. Spun bonded fabrics
3. Laminated fabrics
(with membrane)

21. Body garments

22. 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)

23. 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

24. 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

25. 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

26. 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

27. 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

28. 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

29. 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

30. 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.

31. 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.

32. 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

33. IES-RP-C003.3 recommendations

34. Clothing recommendations

35. Gowning for the cleanroom

36. 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)!

37. 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

38. 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

39. 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 pre-change
area
• Put on clean shoes
• Don clean hair-cover (and beard cover)

40. 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.

41. 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.

42. Suggested gowning protocol
1. Remove make-up and jewelry before entering the pre-change
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.

43. 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.

44. 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.

45. 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.

46. 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.

47. Thank you!