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75 human interface in cleanrooms
as disinfectants, unless used with emollients like glycerol, tend to dissolve
the skin oils and aggravate shedding. Austin and others have carried
out extensive studies on this phenomenon and their results are
summarised here.
The different organisms present on the skin may be classified as transient
organisms (microorganisms which are deposited on and contaminate
the skin but do not multiply there), temporary residents (viable
contaminants that multiply on the skin and persist for short periods)
and resident organisms (microorganisms which colonise the deeper
crevices of the skin and hair follicles - 20% of skin bacteria are situated
deep within the skin, covered and protected by lipids and superficial
cornified epithelium, and are most inaccessible). The numbers and types
of bacteria on the skin differ considerably according to the body site
where they are found, or the sampling technique that may be employed.
In addition, individual variation in numbers is vast. This variation can
depend upon skin pH, fatty acids, age, condition, and the temperature
and humidity of the skin and environment. Some people may spread
bacteria more easily than others. Although the number of bacteria on
the skin of the hand is comparatively low, there is still a wide variation
from person to person. It is known that some individuals have
consistently high bacterial counts on their finger tips, while others have
Activity Particles > 0.3F
emitted
per minute*
Viable
contaminants
generated
per minute*
Standing or sitting without movement 100,000 750
Light head, hand & forearm movement 500,000 1,000
Moderate body and arm movement 1,000,000 1,500
Changing positions - sitting to standing 2,500,000 2,500
Slow walking 5,000,000 4,000
Moderate walking 7,500,000 8,000
Fast walking 10,000,000 15,000
Climbing stairs 10,000,000 15,000
Calisthenics $ 15,000,000 30,000
Coughing $ 15,000,000 $ 30,000
Sneezing (excluding large droplets) $ 30,000,000 $ 50,000
Austins Index of contaminants shed by personnel
* These figures refer not to contaminant density but to gross contaminant rate
Table 1: Austins contamination index
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76 cleanroom operators manual
very low counts regardless of the method of hand washing or disinfectant
employed. Swabs are increasingly being taken from parts of the body
other than the conventional glove/finger prints. One organisation takes
swab samples from soles of operators' feet, abdomen, forearm and
forehead.
While it is generally agreed that the removal or killing of the transient
and temporarily resident flora is sufficient to prevent their transfer to
the product, any removal of resident flora is deemed a valuable additional
safeguard.
The body has glands all over, each producing its own substance. Oils,
sweat, saline, saliva, and wax are some of the substances so produced
that have the potential to contaminate the environment. We are familiar
with the oil stains that accompany our finger prints; each time we blink
we splash saline; when we open our mouths we spray droplets of saliva;
the sweat we generate passes through our clothes to a greater or lesser
extent, depending on the permeability of the fabric, by capillary action;
Site
Aerobic flora Anaerobic flora
Females Males
Forehead 2075 1225 8000 13500
Sternum 2125 165 50000 3500
Subclavicular area 350 130 18500 2275
Centre back 450 155 67500 7500
Shoulder 128 48 1025 1075
Deltoid area 118 65 57 127
Forearm 250 35 9 13
Palm 98 155 33 85
Lower axilla 500 92 14 12
Lumbar area 300 33 178 142
Periumblical area 850 175 55 80
Thigh upper front 325 140 9 35
Thigh lower front 350 67 14 16
Thigh back 325 82 4 5
Shin 190 77 7 8
Calf 173 20 2 5
Dorsum of foot 80 122 3 10
Sole 22750 675 10 4
Males
Human Bioprofile
Table 2: Human bioprofile
Females
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77 human interface in cleanrooms
on evaporation of sweat the residual salts remain deposited on our skin
cells. Chlorides of sodium and potassium are routinely found on
analysing the contaminants in clean rooms.
Hair becomes statically charged on combing, and attracts dust. Oiled
hair retains the dust better than dry hair. Dry hair is brittle and breaks
easily. Hair also produces a protein called keratanin, which is released
into the environment.
Studies indicate that a man on an average breathes 16,000 quarts of air
per day, which converts to approximately 20 kg/day! And this aerosol is
exhaled from a distance as close as 20 to 40 cms from the sensitive work
piece. Inhalation disturbs the air pattern around the work area; exhalation
carries a mixture of gases, vapour, liquid droplets, mucous and, of course,
microorganisms. In particular, the exhaled air is rich with dust and
other allergens that the lung is anxious to be rid of, and such contaminants
are often thrown out with unusual force. Extreme examples are coughs
and sneezes.
Smokers breathe out more contaminants than nonsmokers, even several
hours after they have last smoked. Drinking water after smoking helps
slightly reduce the number exhaled.
Cuts, abrasions, wounds, rashes, allergies and boils; and topical
medicaments, dressings and plasters further aggravate the problem.
Other conditions requiring care and vigil are discharges from eyes, ears,
and nose; coughs, colds and sneezes; and, of course, menstrual periods.
Figure 2: Smokers exhalation
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78 cleanroom operators manual
Data published in Ljungqvist and Reinmullers Ventilation and Airborne
Contamination Cleanrooms indicates that the total population of aerobic
bacteria on human skin is typically greater than 1.2 million/m
2
in the
head and neck region of both male and female subjects. The numbers of
organisms present on the hands and arms is typically in the range of
0.9-3 million/m
2
on healthy subjects. The numbers of viable anaerobes
are many times higher and consist primarily of Proprionibacterium
acnes.
A number of studies have been done on the release of total particulate by
humans in cleanroom clothing.
In the same publication referenced above, a study conducted by Takasago
Thermal Engineering found that a fully gowned person sitting in a
cleanroom would release about 15,000 particles per minute. A walking
individual, according to this study, releases roughly 157,000 total
particulates per minute.
In a study published by Reinmdller in 2001, it was reported that the
typical ratio between total particles > 0.5 and viable aerobic organisms
recovered is in the range of 600-7000 to 1.
Studies done on personnel clothed in new full coverage clean room gowns
found that these people release 600-1300 total particulates per hour in
the >0.5 size range and that among these were as many as 40 CFU of
viable aerobic organisms. These data are generally consistent with the
findings published by Dr William Whyte.
Reinmullers data also showed that as the gowns aged and were subjected
to washing and re-sterilization, both the number of total particulate and
the level of microbial contamination increased.
Not surprisingly, these studies indicate that there is also a correlation
between the amount of physical activity undertaken by personnel and
their strength as a source of contamination, or put another way the amount
of contamination they contribute to their surrounding environment.
Reinmuller also reported microbial contamination is strongly associated
with particulate, in the 0.5 size class. It has been widely assumed that
microorganisms in aseptic processing areas are associated with
particulate in the 5-10 size range.
If we consider from the work of Whyte, Reinmuller and others that it is
reasonable to consider that a typical, properly gowned cleanroom worker
will contribute 10-100 CFU of viable aerobic organisms to the
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79 human interface in cleanrooms
environment per hour it is obvious that, given the high air exchange
and hence dilution rates used in todays cleanrooms that the total
recovered microbial concentration should be very low.
However, these data also clearly indicate that even our best cleanrooms
do not under any circumstance approach sterility.
In fact, it could be argued that they can only attain asepsis if we are
fortunate enough to have facilities staffed only by personnel who do not
release pathogens.
Body temperature is maintained at 37
0
C; but the skin temperature varies
from head to toe as can be demonstrated by thermographic techniques.
The average of these values is usually around 33
0
C. Since the cleanroom
is designed to operate within the range 22 - 24
0
C, the body surface is at
an average of about 10
0
C above its surroundings. This thermal gradient
triggers convective currents rising from floor level to above the head.
These currents disturb the airflow pattern in the room.
These are some of the intrinsic contaminants ushered in with every
human being who enters the cleanroom. Once we understand the body
and its danger zones, it is easier to devise ways and means to contain
the damage they can cause.
extrinsic contaminants
Not only do people produce contaminants, but they also serve as unwitting
carriers of contaminants that are extrinsic to them. Starting from the
water they wash with; the soaps they use; the towels and napkins; the
Figure 3: Convective air currents surround body
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80 cleanroom operators manual
undergarments and street clothes; the cosmetics and makeup; jewellery
and personal effects - all these make their contributions to the
contaminant load carried by the individual. Analysis of the contaminants
found in clean rooms show compounds of zinc and magnesium and talc,
all originating from the talcum powders used by both men and women.
The dust and grit on the streets, the grime and soot in the air; the jostling
in crowds while they commute to work covers them all over with potential
contaminants. And since people are mobile, they carry these contaminants
with them wherever they go, leaving a trail along their path and place
in jeopardy whatever they handle or touch. Movement also causes
disturbance in the airflow field, and depending on how they move, they
cause turbulence and eddies in their wake of varying severity. The greater
the number of people in a room, the higher the contaminant level, and
greater the risk of product contamination.
Now that we know about the human microenvironment, and how humans
can be vectors of contaminants, we can devise ways and means to control,
if not altogether stop contamination from occurring.
The first regulation begins with ascertaining the bare minimum number
of people the cleanroom requires and setting the limit on the head count
in the room on this basis and declaring the area out of bounds for others.
In addition to restricting the entry into the cleanroom, there should be
further restrictions for accessing critical environments within the
cleanroom itself.
m
a
n
u
a
l
4. Ezee, or Genteel
5. Antistatic agent, Optical whitener, Fabric
softener (Carboxymethyl cellulose 5% v/v)
6. Class M6.5 (100,000) or better
1. Hyglo, Teepol, Clinitol, or CCl
4
2. Savlon, Dettol/Iteol, Hydrogen peroxide or
Peracetic acid
3. Perchloroethylene, Trichloroethylene or
Mineral turpentine