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The Impact of Cleanroom Behavior on Contamination Control

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 Wissenschaft und Technik
Technik

The Impact of Cleanroom Behavior

on Contamination Control
Koos Agricola
International Confederation of Contamination Control Societies, Woerden, Netherlands

Cleanrooms are used to prevent unwanted contamination of uct surface, the severity should be de-

Zur Verwendung mit freundlicher Genehmigung des Verlages / For use with permission of the publisher
products. People are the major source of particles and a fraction of termined. The contamination control
these particles carry micro-organisms. Cleanroom behavior con- solution should limit (control) the
chance of the unwanted contamina-
sists of 2 aspects: First, the various procedures that are in place to
tion to be transferred onto the critical
minimize the impact of people and second, the correct behavior of product surface.
personnel that are executing these procedures. There are 2 contamination mech-
Contamination control starts with a risk assessment followed by a anisms: First, the transfer of particles
design of the contamination control solutions. After the contami- from the air or the deposition of par-
nation control solutions are established the effectiveness of the ticles and second the transfer of par-
ticles by contact with an unclean sur-
contamination control solutions during operation should be
face or medium. Contact surfaces
demonstrated by a monitoring program. will be contaminated by both mech-
In this paper, both aspects of cleanroom behavior will be addresses. anisms. In the end, the particle de-
position rate in the critical environ-
In tr o d u ct io n (mini environments) are used to ex- ment is the major factor that should
ecute the manufacturing process or be controlled.
A cleanroom with a proper clean- an intermediate solution with sepa- Particle deposition is caused by
room installation reaches in the “at rative devices – like glove boxes – is particles in the air that cannot be re-
rest” occupancy state an airborne applied. moved by the ventilation system.
particle concentration that is deter- To control the impact of people, These particles come into the air by
mined by the design and construc- procedures for permission, gowning, the introduction of unclean air and by
tion of this installation. The particle entering, cleaning, working, transfer- the transfer of particles from surfaces
deposition rate of macroparticles ring goods and leaving the clean- into the air. The transfer of particles
(> 5 mm) will be zero. As soon as room are set up. Personnel should from surfaces arises from unclean
people come into the cleanroom, be trained regularly and motivated surfaces and from particle generating
the particle concentration in the air to execute these procedures in a surfaces. Surfaces generate particle by
increases and deposition of particles proper way. In this paper both as- wear, friction, shredding and aging.
will occur. pects will be addressed. In contamination control, the
In a cleanroom, people are neces- deposition rate of particles is consid-
sary in order to perform complicated R i s k of P r o d u c t ered. The result of particle deposition
operations that cannot be done by C o nt a m i n a t i on is sometimes called particle fall out.
machines in an economical way. The relation between the particle
People can make decisions based The first step of a risk assessment is to deposition rate and the number NDc
on their observations and acquired determine what could be harmful for of unwanted deposited critical par-
measurement data and adapt their a product (or patient) during the ticles ≥ Dcmm onto a critical product
operations accordingly. process steps that are required to surface Ac at a specific location is
The impact of human conta- reach the goal of the executed process given by:
mination and contamination by steps. The way to perform this type of NDc = RDc.Ac.T
human activities should be limited analysis is described in [1, 2]. The re- where RDc is the particle depos-
by developing and implementing sult will be a list of critical locations at ition rate of particles ≥ Dcmm during
proper operational procedures. In which the contamination of particles exposure time T. T is in fact the time
some cases, it is not possible to of a specific nature and/or size should during the “operational occupancy
reach the required cleanliness level not be transferred onto a critical state” since there is no particle de-
and then machines (robots) in sep- product surface. For each type of con- position of macroparticles in the “at
arate cleanrooms or clean zones tamination and at each critical prod- rest” state.

Pharm. Ind. 79, Nr. 1, 112–116 (2017)

112 Agricola • Impact of Cleanroom Behavior © ECV • Editio Cantor Verlag, Aulendorf (Germany)
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 Wissenschaft und Technik
Technik
Contamination by contact transfer
will not be quantified here, but it
should be clear that all potential con-
tact surfaces like tools, product hold-
ers, benches, hand, packaging etc. will
be contaminated by particle deposi-
tion after cleaning and/or unpacking.
Particle deposition rate R is ex-
pressed in the number of particles
per area per time (number/m2/s),
see also [3–5].
The particle deposition rate de-
pends on the local air cleanliness
(concentration C of particles per m3)
and the particle deposition velocity u:
R = C.u
The particle deposition rate will
cause a change of surface cleanliness
by an increase of the concentration
ΔCs of particles per m2 during expo-
sure:
R = ΔCs.T
The particle deposition rate is de-
termined by the activity of people
and the total number of macropar-
ticles in a cleanroom. Particles
> 20 mm can only be removed by
cleaning. If there is no proper regular
cleanroom cleaning, the total num-
ber of particles on surfaces will in-
crease. Therefore, in combination
with the activity by people, the par-
ticle deposition rate will increase.
C o n tam i n ati on b y H u ma n s
A person sheds almost one billion
particles per day. This is not a con-
tinuous process but a collection of
events depending on the activity of
a person. Most of these particles will
be kept inside the clothing. In a
cleanroom, a person wears special
cleanroom garments that act as a
simple filter (sieve with variable
holes). The transmission of particles
through these garments depends on
the occlusivity of these garments and
the quality of the fabric.
The generation of particles by a
person in a cleanroom depends on
the efficiency of the barrier function,
but also on the amount of particles
carried on the outside of the garment.
The number of particles on the out-
side depends on the changing fre-
114 Agricola • Impact of Cleanroom Behavior
quency, changing procedure and
cleanliness of the changing room1).
The cleanliness of the changing
room depends on the number of peo-
ple with street clothes in the changing
room and the cleaning program of the
changing room. The logistics are also
important. If a person takes the clean-
room garment off, many particles will
be distributed into the air. If another
person puts a clean garment on at the
same time, many particles from the
person leaving the cleanroom will
come onto the person that is prepar-
ing to enter the cleanroom. Further-
more, the number of changing stages
in the changing room will affect the
amount of cross contamination. If
people wear cleanroom undergar-
ments first, the particle load of these
garments is much lower. Additionally,
the use of special changing gloves will
reduce the particle impact. By the use
of undergarments, the cross contam-
ination and the transfer through the
cleanroom garments will both be de-
creased.
A rough estimate of the impact by
people dressed for a cleanroom can
be made by using a simplified empir-
ical relation made by the author:
ND = N1 / (P.D2)
where ND is the emission of par-
ticles ≥ Dmm by a person per second
(D ≥ 1 mm). It is assumed that the
particle emission of a walking person
in street clothes is about 100,000 par-
ticles ≥ 1 mm per second. P is the
garment performance factor of the
garments used. P is about 4 for a
cleanroom smock with head and
shoe covers, 20 for a coverall and
100 for complete cleanroom gar-
ments including undergarments2).
In case there is no protection P = 1/D.
1) In some cleanrooms an air shower is used to
reduce the number of particles on the outside
of the garments. The effectiveness is deter-
mined by the design of the air flow, the initial
contamination on the garments and the resi-
dence time of the person. There are no data
available of the impact of air showers on the
particle deposition rate.
2) As an example, this relation leads to the
emission of 200 particles ≥ 5 mm per second
when wearing a coverall with P = 20 and an
emission of 8 particles ≥ 25 mm per second.
It should be clear that the impact
of personnel can be decreased by se-
lecting the entering procedure, the
garment performance factor and
the layout of the changing room.
The result is strongly influenced by
the number of people since the shed-
ding and cross contamination is pro-
portional to the number of people.
The better result will be more expen-
sive. Therefore, a compromise is
Zur Verwendung mit freundlicher Genehmigung des Verlages / For use with permission of the publisher
made in practice. This compromise
depends on the accepted particle
deposition rate and airborne concen-
tration of particles. In micro-bio-
logical applications with strict envi-
ronmental requirements, often the
better entrance procedures are ap-
plied. In technical applications, pro-
cedures are balanced with the num-
ber of accepted rejects. However, the
knowledge to understand the rela-
tion between contamination control
solutions and performances is not al-
ways available or present [6, 7].
C o n t a m i n a t i o n by H u m a n
Activities
Human activities in a cleanroom
cause contamination in many ways.
The particle generation has been de-
scribed above. The disturbance of air
flows by people will cause the local
re-entering of particles from unclean
surfaces. Particles are transferred
from and to surfaces when contact
is made by touching these surfaces.
Movements of people will cause the
re-entering of particles from their
own garments and body surfaces.
When the air supply in a small cleanroom of
80 m3 with one person is 480 m3/hr (6 air
changes per hour), the airborne concentration
N5 will be 3,600*200/480 = 1,500 particles
≥ 5 mm per m3, which is within an air cleanli-
ness level of ISO 7 in operation. If the supply
air is increased to 3,600 m3/hr, N5 will become
200/m3 which is within ISO 6 (ISO 14644-1).
Most particles ≥ 25 mm will be deposited on
surrounding surfaces. Say the surrounding
surface area is 36 m2 then the particle depo-
sition rate R25 for particles ≥ 25 mm will be
8*3,600/36 = 1.000 particles ≥ 25mm per m2 per
hour. During 6 h of operation the average
surface cleanliness will change from SCP 4
(after cleaning) to log10 (10,000 + 6*1,000*25) =
SCP 5.2 (ISO 14644-9).
Pharm. Ind. 79, Nr. 1, 112–116 (2017)
© ECV • Editio Cantor Verlag, Aulendorf (Germany)
Furthermore, people transport par-
ticles throughout the cleanroom by
moving around and by ejecting par-
ticles by footsteps. When moving
slowly, this impact will be lower.
People must be aware of the crit-
ical locations and moments in the
manufacturing processes and their
own impact on contamination. This
awareness should help to avoid wrong
behavior in the neighborhood of the
critical product and tool surfaces.
C o n t a m i n a t i o n Co n t r o l
S o l ut i o n s
The basics of the contamination con-
trol solutions are the control of the
introduction of particles into the
critical zone, the removal of airborne
particles with a cleanroom installa-
tion and the removal of the deposited
macroparticles from all surfaces by
frequent cleaning.
The cleanroom installation is de-
signed in such a way that the concen-
tration of particles up to 5 mm re-
mains within the cleanroom class
limits for 95 % of the time at all loca-
tions during operation. Since people
are the main source of airborne par-
ticles, the number of people and the
selected garment type etc. should be
known in order to make a dedicated
design. For the classification of air
cleanliness levels, ISO 14644-1:2015
[8] can be used.
The cleaning program should be
designed in such a way that the con-
centration of particles on all surfaces
should stay within a specified surface
cleanliness limit. The surface cleanli-
ness levels are described in ISO
14644-9:2012 [9]. The surface clean-
liness specification for critical surfa-
ces like those of tools could be
stricter than that for floors.
The particle deposition rate is in-
fluenced by the way the cleanroom is
used. It can be controlled by describ-
ing various operational procedures. A
high particle deposition rate leads to a
higher concentration of particles on
surfaces. Unclean surfaces in combi-
nation with human activity lead to
higher particle deposition rates. In or-
der to control the particle deposition
rate, the introduction of macropart-
icles should be limited and the clean-
ing program should be keeping the
surface cleanliness within proper lim-
its. The VCCN Guideline 9:2013 could
be used to express levels of the par-
ticle deposition rate [10–12].
In a given cleanroom the opera-
tional procedures will determine the
particle deposition rate level and
therefore influence the risk of un-
wanted product contamination. The
particle deposition rate can be con-
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Sterilisation
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www.wzb-reinraum.de
trolled by designing procedures that
limit the introduction of particles
and the total surface cleanliness by
Zur Verwendung mit freundlicher Genehmigung des Verlages / For use with permission of the publisher
cleaning. Various procedures could
be optimized by establishing the rela-
tion with the particle deposition rate.
This will require more research. Clean-
room procedures should be made for:
. The entry into the cleanroom
. The use of garment and the
changing of garments
. Bringing of goods into the clean-
room
. Cleaning procedures
. Cleanroom behavior
. Working procedures
. The exiting of the cleanroom
When these procedures are made
during the design phase, the layout
of the clean facility can be optimized
for the execution of the procedures.
D e m o n s t r a t i n g Co n t r o l
When the cleanroom installation and
the operational procedures are es-
tablished it is important to monitor
the relevant cleanliness attributes to
demonstrate control. The air cleanli-
ness can be monitored with particle
counters. They give information on
the cleanroom installation and the
emission of particles up to 5 mm.
The surface cleanliness could also
be measured at critical locations. As-
 Wissenschaft und Technik
Technik
suming the cleaning procedures are
sufficiently effective, it is sensible to
measure this just before cleaning.
This will show whether the cleaning
frequency is too high or too low.
To demonstrate the execution of
the operational procedures, the par-
ticle deposition rate should be moni-
tored at critical locations. This can be
done with witness plates with known
surface cleanliness and measured sur-
face cleanliness after sufficient expo-
sure. In situ (and real time) particle
deposition monitors could be used as
an alternative [12–14].
In case the monitored particle
deposition rate level is too high, ei-
ther the execution of the operational
procedures or the procedures them-
selves should be improved. To deter-
mine which operational aspects
should be improved, further analysis
of particle deposition rate data
should be executed. The most impor-
tant information is given by the mo-
ments of particle deposition and the
size distribution of the deposited
particles. This distribution can be
compared with the theoretical par-
ticle size distribution that belongs
to the required particle deposition
rate level. For example, the particles
≥ 100 mm are relatively high when
compared to this distribution. Then
the cleaning of cleanroom and equip-
ment surfaces should be improved. If
the number of particles between 30
and 100 mm are relatively high, the
impact of people should be reduced
by improving the entrance and asso-
ciated procedures.
Monitoring data will demonstrate
the need for improvement of the ex-
ecution of operational procedures or
the improvement of the operational
procedures.
A c h i e v i n g R e q u i r e d H u ma n
Behavior
Adequate operational procedures
should be in place in order to control
the impact of cleanroom behavior of
people on contamination control.
These procedures should be such
that when everybody applies them
116 Agricola • Impact of Cleanroom Behavior
View publication stats
in the right manner the air cleanli-
ness and particle deposition rate
levels stay within the set limits.
To achieve the right execution of
these procedures, regular training of
anybody who enters the cleanroom
is required. Furthermore, people
should be motivated to follow these
procedures. Motivation is part of a
company’s culture and should re-
ceive continuous attention. When
procedures differ a lot from the nat-
ural behavior of people, the quality of
the execution will slip. Therefore,
good execution should be rewarded
and wrong execution should be cor-
rected. The regular refreshing of the
execution instructions should pre-
vent slipping. Especially anybody in
a managerial position should be
aware of giving the right example.
Therefore management, that occa-
sionally will enter the cleanroom,
should also be trained regularly. Dis-
play of real-time particle deposition
will create awareness.
C on c l us i o n
When writing this article, the author
realized he was describing the ideal
situation. In practice, improvisation
and common sense are required to
achieve proper results. The world of
contamination control needs much
more related data to be able to de-
sign and realize proper dedicated so-
lution.
Many cleanrooms are overde-
signed and too much air is circulating
through the cleanroom, whereas the
operations could be much more effec-
tive. This will cost a lot of energy. The
impact of the operations is only par-
tially visible when monitoring with
particle counters only. A particle dep-
osition monitoring system will help to
collect data that can be used in risk
evaluation. Moreover, the system can
also show the impact of changes in
the operational procedures. In clean-
room for micro-biological purposes,
particle deposition rates will be pro-
portional to settle plate data and will
therefore also be useful to monitor
the operational quality.
n LITERATURE
[1] Agricola K (2015). Product Oriented
Contamination Control (POCC). Clean
Air and Containment Review 24, p. 10–17.
[2] Agricola K and Oostendorp C (2007). Stra-
tegic Battle against Particles (in Dutch),
VCCN.
[3] Whyte W, Agricola K and Derks M (2015).
Airborne Particle Deposition in Clean-
rooms: Deposition Mechanisms. Clean Air
and Containment Review, Issue 24, p. 4–9.
[4] Whyte W, Agricola K and Derks M (2016).
Airborne Particle Deposition in Clean-
rooms: Relationship Between Deposition
Rate and Airborne Concentration. Clean Air
Zur Verwendung mit freundlicher Genehmigung des Verlages / For use with permission of the publisher
and Containment Review, Issue 25, p. 4–10.
[5] Whyte W, Agricola K and Derks M (2016).
Airborne Particle Deposition in Cleanrooms:
Calculation of Product Contamination and
Required Cleanroom Class. Clean Air and
Containment Review, Issue 26, p. 4–10.
[6] Agricola K (2012). Determination of Op-
erational Quality of Cleanroom by Par-
ticle Deposition Monitoring. ICCCS Sym-
posium 2012, Zürich.
[7] Agricola K. and Van Duijn CJ (2012). Impact
of Cleanroom Personnel on Cleanliness (in
Dutch). VCCN magazine 25 (1), p. 11–14.
[8] ISO 14644-1:2015. Cleanrooms and Asso-
ciated Controlled Environments. Part 1:
Classification of Air Cleanliness by Par-
ticle Concentration. International Or-
ganization for Standardization, Geneva,
Switzerland, 2015.
[9] ISO 14644-9:2012. Cleanrooms and Asso-
ciated Controlled Environments. Part 9:
Classification of Surface Cleanliness by
Particle Concentration. International Or-
ganization for Standardization, Geneva,
Switzerland, 2012.
[10] VCCN Guideline 9. Particle Deposition in
Cleanrooms and Associated Controlled
Environments. Vereniging Contamina-
tion Control Nederland, Woerden, The
Netherlands, 2014.
[11] Agricola, K. Particle Deposition Monitor-
ing – The Missing Link in Contamination
Control. 45th R3Nordic symposium, Naan-
tali, VIT Technology, 168, p. 143–153, 2014.
[12] Agricola K. Proposal for the Classification
of Particle Deposition. ICCCS Symposium
2014, Seoul, 2014.
[13] Agricola K. Practical Experiences in Par-
ticle Deposition Monitoring. ICCCS Sym-
posium 2014, Seoul, 2014 and Clean Air and
Containment Review, Issue 21, p. 4–8, 2015.
[14] Agricola K. Real-time Particle Deposition
Monitoring of Operational Cleanroom
Quality, Journal of the IEST, V.59.1,
p. 1–13, 2016.
Correspondence:
Koos Agricola
International Confederation of Contam-
ination Control Societies
VCCN
Korenmolenlaan 4
3447 GG Woerden (Netherlands)
e-mail:
Koos.Agricola@TechnologyofSense.com
Pharm. Ind. 79, Nr. 1, 112–116 (2017)
© ECV • Editio Cantor Verlag, Aulendorf (Germany)