Garment

management
for controlled
environments:
an introduction

the micronclean organisation

cleanroom garments

testing

content

contamination control

garment management systems

typical cleanroom laundry function

5
6

getting started

the micronclean organisation

Micronclean International was established in the 1980s to meet the growing need for professional cleanroom
clothing management services. Now Micronclean is present throughout the world and has a portfolio of customers in
diverse industrial and service organisations.
The organisation operates to the highest standards of professionalism, working
within the very latest international codes of practice. It is recognised as an
innovator, having contributed significantly to modern cleanroom garment
design and management techniques.
All Micronclean centres operate from modern premises and with
a workforce committed to a right first time philosophy.
Objectives and philosophy
We aim to be the best! We are prepared to meet the
ever increasing technical demands on fabrics, clothing style
production and the disciplines required within our processing plants.
Only by being the best do we expect to command the respect and
future business from our customers.
The International dimension
Micronclean has but one standard - the highest possible quality.
Our procedures are common to all processing plants and our policy of
closed loop garment management is designed to ensure efficient
tracking and optimised asset management irrespective of geographical
location. One policy, one standard!
Communication with customers
All Micronclean companies have a commitment to communicate with their
customers. The results for garment performance and the processing are both communicated.
We help you with the training of your personnel. We keep you informed on international standards
and developments and we help you to find any specific information you might need. Micronclean is putting a lot of effort
into the continuous improvement of our communications by using technology (e.g. the internet).
Global guarantee
When you are served by a Micronclean company, you have the assurance of dealing with a quality global cleanroom
solution partner.
Uninterrupted service
Every Micronclean company has a fully detailed contingency plan with another Micronclean plant to ensure your
cleanroom garment needs are always met.
Leading edge technology
Micronclean companies undergo a formal technology audit every six months. Then, against a peer group of advanced
cleanroom operations from around the globe, quality of output, equipment capabilities and quality systems are analysed,
compared and refined.
Research and development
Micronclean International has permanent R&D projects. These projects include all elements of the cleanroom services
we offer, be it specific decontamination processes for a certain industry, garment and fabric development. We have our own
testing facilities and co-operate with specialised research laboratories where needed. Most of the time we include some of
our customers in our R&D projects to combine our know-how with practical experience.
Cleanroom solution partner
All twenty-plus Micronclean companies around the globe share informaton. They are truly partnering with customers
to find solutions for all their cleanroom needs. Micronclean International has unparalleled depth to call upon to help find
those optimal solutions. We have resources around the globe, with experience in every cleanroom application, classification
and service aspect. Micronclean companies lead the industry and can rapidly bring the experience and knowledge to help
solve your toughest problem.

Garment management for controlled environments: an introduction

the micronclean organisation

Low cost provider
Micronclean companies benchmark all leading indicators of efficiency and performance on a continuous basis.
Copy exactly
Micronclean International understands international customers need for identical cleanroom processes across multiple
locations. We are uniquely positioned to accommodate copy exactly requirements. We speak a common language
around the globe and have a support team charged with facilitating cross-site communication. We operate
international working groups and an aggressive schedule of cross training and visitation programmes.
International standards
Micronclean International has representatives at the standards bodies which impact your business
and quality requirements.
Micronclean International has the manpower and international reach to stay abreast of
developments communicating them promptly around the globe. Micronclean companies meet all
recognised standards.
Market coverage
Principle areas of operation include: Microelectronics - Pharmaceuticals - Opticals - Biotechnology Telecommunications - Aerospace & Defence - Medical devices - Static Sensitive Areas - Hospital Pharmacies - Cosmetics - Food
Processing - ...

With this brochure Micronclean International provides you a basic knowledge of contamination control and garment
management for cleanrooms. We will be pleased to assist with any information you might request.

Garment management for controlled environments: an introduction

the micronclean organisation

Micronclean International
Headquarters:
Micronclean International
Diedenweg 94
6717 KV Ede
the Netherlands
phone: +31 318 622 484
fax: +31 318 630 444
info@micronclean-international.com
www.micronclean.com
Members Europe:
AUSTRIA
Micronclean Austria
Wozabal Sterilgut-Systeme
Atterseestrae 97
4860 Lenzing
phone: +43 7672 913 0
fax: +43 7672 913 85
www.wozabal.com
BELGIUM
Micronclean Belgium
Scaldis St.Martin
36, rue de la Hurtrie
7600 Peruwelz
phone: +32 69 77 16 25
fax: +32 69 77 57 70
www.micronclean.com
DENMARK
Micronclean Denmark
Berendsen Textil Service
Vlundsvej 12
4300 Holbk
phone: +45 59 43 22 22
fax: +45 59 43 53 72
www.berendsen.com
FRANCE
Micronclean France
Initial Services Textiles
Parc dactivits de Villejust
6, rue Lionel Terray
91971 Courtaboeuf
phone: +33 1 69 31 76 80
fax: +33 1 69 31 76 89
www.initial-btb.fr
GERMANY
Micronclean Germany
Bilger-Schwenk
Stollweg 6
72760 Reutlingen
phone: +49 7121 3121 57
fax: +49 7121 3121 21
www.micronclean.de
HOLLAND
Micronclean Holland
Micronclean
Koopman Heeresweg 10
8701 PR Bolsward
phone: +31 515 578 990
fax: +31 515 578 981
www.micronclean.nl

IRELAND
Micronclean Ireland
Micron Clean (Ireland)
Spiddal Industrial Estate
Spiddal, Co. Galway
phone: +353 91 553 066
fax: +353 91 553 068
www.micronclean.ie

USA
Micronclean ICS USA
American Cleanroom Garments
P.O. Box 82269
Portland, OR 97282-0269
phone: +1 503 233 5445
fax: +1 503 235 0509
www.intlcleanroom.com

ITALY
Micronclean ICS Italy
Linen Supply Italiana
Via Cesare da Sesto 15
20123 Milano MI
phone: +39 02 89 40 05 23
fax: +39 02 89 40 14 93
www.intlcleanroom.com

Micronclean ICS USA

American Cleanroom Garments
971 Northpoint Boulevard
Waukegan, IL 60085-8214
phone: +1 847 473 1200
fax: +1 847 473 4595
www.intlcleanroom.com

SWEDEN
Micronclean Sweden
Berendsen Textil Service
Rttarvgen 4
611 35 Nykping
phone: +46 155 20 96 00
fax: +43 155 28 49 40
www.berendsen.com

Micronclean ICS USA

American Cleanroom Garments
Servitex Cleanroom Services
3 Yadkin Street
Durham, NC 27703
phone: +1 919 957 9800
fax: +1 919 957 0403
www.intlcleanroom.com
Members Australia:

Micronclean Sweden
Berendsen Textil Service
Axel Danielssons vg 195
215 92 Malm
phone: +46 40 36 80 00
fax: +46 40 36 80 60
www.berendsen.com
UNITED KINGDOM
Micronclean Newbury
Micronclean
C1 Faraday Road
Newbury, Berkshire
RG14 2AD
phone: +44 1635 37901
fax: +44 1635 31528
www.micronclean-newbury.co.uk

Micronclean ICS Australia

Clean Room Products
1 Carlotta Street
Artamon NSW 2064
Sydney
phone: +61 2 9439 3622
fax: +61 2 9437 4351
www.intcleanroom.com

Micronclean Skegness
Micronclean
Roman Bank
Skegness, Lincolnshire
PE25 1SQ
phone: +44 1754 767377
fax: +44 1754 610344
www.micronclean.co.uk
Members America:
BRAZIL
Micronclean ICS Brazil
ALSCO Toalheiro Brasil
Rua Conde de It, 875
04741-001 So Paulo
phone: +55 11 5523 8722
fax: +55 11 5523 6961
www.intlcleanroom.com

Garment management for controlled environments: an introduction

contamination control
Contamination control is a key element in the concept of the zero defect philosophy employed
by an increasing number of modern production and service organisations.
Few productive entities escape the need for close attention to contamination control. Gone are
the days when cleanroom concepts were confined to leading edge space and biological
developments. The cleanroom philosophy can now be found in production environments as
diverse as vehicle finishing and food processing where all important added value factors are
reliant on quality and performance.
1.1. The nature of contamination
Contamination can be considered as anything which has an effect on the quality or performance of something being
created. Contaminates can take the form of particulate, biopollutants, chemical cross-contamination or electrical charges
(ESD), which individually or collectively can have a deleterious effect on product or process performance.
That such contaminates can be of infinitesimally small or of surprisingly large proportion - as small as 0,1 micrometers in the case
of particulate or as high as 0,1 Amp in ESD terms - makes the task all the more challenging. Furthermore, no
single element can be considered in isolation. The integrity of any process is only as strong as its weakest link, be that in the
operating environment, the logistics including style, composition and comfort of clothing or in the inherent disciplines which
must be maintained throughout the cycle.
By working within a controlled area like a cleanroom, some pollutants can be filtered out, others eliminated by
improvements in the production environment. Airborne particles - skin, fibres, bacteria - pose the greatest challenge.

1.2.

Different contaminants

Whilst there are many different potential contaminants, these four pose the
greatest threat:
fig. 01
1.2.1.

Dust

In this context this can be considered as skin shed by operatives or

particulate matter brought into the production area from outside either by
operatives or through poorly filtered purging air. (fig. 01)

1.2.2.

Bacteria

In the broadest sense this embraces not only particulate and

chemical pollutants likely to affect the quality of production but also the
health of operators. Thus production chemicals and incoming air must
be strictly controlled. This is mainly a problem for pharmaceutical and
food processing industries. (fig. 02)

fig. 02

Garment management for controlled environments: an introduction

contamination control
1.2.3. Chemicals
Potential cross-contamination from process-to-process or from bodies, garments or equipment entering the controlled
environment.
1.2.4. Electrical charge
Static electricity is a contaminant causing possible problems in all areas of cleanroom activity. Polyester cleanroom
garments produce static electrical charge as fabric is in contact with fabric or with garments worn under the cleanroom
garments. Electrical charges of many thousands of volts may be present on the garments during use. The charge may be
discharged at any time to the cleanroom structure, articles or products in the cleanroom. Discharges of static electricity may
cause problems in the following ways:
- Microelectronics: the discharge of static electricity may damage sensitive products such as microchips and disc drives.
Discharges of static electricity occur so rapidly that current flow for a short duration may be high
enough to damage products. Damage may weaken components causing premature failure.
- Pharmaceuticals: these cleanrooms are not normally associated with products that are damaged by electrostatic
discharge, however many pharmaceutical cleanrooms require protection:
- Protection against explosion caused by spark discharges
- Protection against damage to sensitive microelectronic measuring equipment
- Protection against attraction or repulsion of micro-organisms by electrically charged cleanroom
garment fabrics.

1.3. Cleanrooms
The history of cleanrooms starts during World War II. Indeed during the assembly of the first atomic weapons, it was
found that some of the problems were related to dust. The idea of the HEPA (High Efficiency Particulate Air Filter) was
introduced in an air-conditioned environment.
A next step in the development of cleanroom techniques was the space race. Dust particles caused
problems in the liquid oxygen release valves in the rockets. This introduced a research
programme to develop precision component assembly methods. This programme led to
the laminar flow cleanroom.
Microelectronics and the pharmaceutical industries started using cleanrooms in the
60s and 70s. Since the 80s other industries became interested in the
advantages of cleanrooms for their critical production processes. Now we find
cleanrooms in such diverse industries as: opticals; biotechnology; telecommunications; aerospace & defence; medical devices; static sensitive areas;
hospital pharmacies; cosmetics; food processing; ... Cleanroom concepts also
found their way into the modern operating theatres.
A cleanroom is an enclosed space served by HEPA filtered air at positive
pressure. In view of the major threat to the clean environment posed by
humans, the area should preferably be unpopulated by operators - obviously not
always possible.
Modern cleanrooms are extremely efficient in reducing contamination but there are
no standard solutions. Each industry and location has its own priorities. To a microelectronics specialist the problem of static electricity is probably as critical as particulate
contamination; to a micro-biological company the attendant risk might well come from the danger
from toxins or explosion. Each project must be the subject of individual risk assessment.
Logically, the current trend is towards compact, localised cleanrooms or compartmentalised workstations for essential clean
working rather than large volume coverage. This approach is most flexible, controllable and economical.
Whilst much has been achieved in the design of production benches and equipment, such elements now contribute about
half the pollution, the balance being from incoming air, gases, chemicals and people.

Garment management for controlled environments: an introduction

contamination control
1.4. Basic cleanroom concepts
Modern cleanrooms fall into two principal categories:
- Unidirectional cleanrooms (fig. 03).
The airflow in this type of cleanroom is often vertical. The air flows downwards through HEPA or ULPA (Ultra Low
Penetration Air) filters located in the ceiling and is extracted through perforated flooring or grilles mounted in the walls at
floor level. Airflow in unidirectional cleanrooms may also be horizontal when the air flows through a full wall of filters and is
extracted through returns in the opposite wall. Horizontal airflow is used in applications where operations with stringent
SA
cleanliness requirements take place close to the wall of filters and operations with decreasing cleanliness requirements take
place downstream (meaning further away from the filter wall).

RA

- Non-unidirectional cleanrooms (fig. 04).

In this type of cleanrooms the air flows from HEPA or ULPA filters located in various positions and is returned through
opposite locations. Filters may be distributed at equal intervals throughout the cleanroom or grouped over critical areas.
Because of the distribution of the filters and returns, the airflow may be turbulent in nature.
Horizontal

In several cleanrooms a combination of both types can be found.

fig. 03

SA

SA

RA

Horizontal
RA

RA
Vertical
RA

fig. 04

Turbulent

SA

SA

RA

RA

Displacement

RA

SA

Displacement

Vertical

Garment management for controlled environments: an introduction

contamination control
The classification of the cleanroom environment is determined by the number of particles of a given size in a cube of
air at any moment. Fig. 05 illustrates the established standard classifications for controlled environments. These form part
of internationally accepted working practices detailed elsewhere in this publication.

Class limits (particles/m3)

ISO 14644-1

Fed Std. 209E

0,1 m

0,2 m

0,3 m

0,5 m

ISO Class 1

101=

10

ISO Class 2

102=

100

24

10

1 m

5 m

ISO Class 3

Class 1

103=

1.000

237

102

35

ISO Class 4

Class 10

104=

10.000

2.370

1.020

352

83

ISO Class 5

Class 100

105= 100.000

23.700

10.200

3.520

832

29

ISO Class 6

Class 1.000

106=1.000.000

237.000

102.000

35.200

8.320

293

ISO Class 7

Class 10.000

352.000

83.200

2.930

ISO Class 8

Class 100.000

3.520.000

832.000

29.300

35.200.000

8.320.000

293.000

ISO Class 9
fig. 05: Airborne particulate cleanliness classes

Garment management for controlled environments: an introduction

contamination control
1.5. Cleanroom standards
The construction and operation of cleanrooms is subject to a number of international standards and recommended
practices.
The first standard on cleanrooms was the American Federal Standard 209, which has been revised several times. The role of
this Federal Standard will be taken over by the international standard ISO 14644.
For the operation of cleanrooms several standards and recommended practices have been developed by standardisation
bodies such as ISO and CEN or controlled environment organisations such as IEST, FDA, ... In most cases these organisations
are related to a specific industry, e.g. HACCP for the food processing industry, GMP for the pharmaceuticals, ...

1.6. The human element

Between 40 % and 80 % of contamination can be traced to human operatives working in cleanrooms.
The threat posed by human intrusion into cleanrooms is obvious - each of us sheds our outer layer of skin approximately every
week in the form of loose particles (about 4/5 micrometers) or groups of cells typically 25/30 micrometers or larger. Abrasion
can grind these into a fine powder, using convection to issue these particles - some of which contain chemical or bio residues
- into the atmosphere.
Fig. 06 shows the particulate shed by humans during a range of activities.
Sex, age, temperature differentials and patterns of activity all have a bearing on the rate of issue, as do contaminants
from clothing, cosmetics and personal hygiene.

15.000.000
30.000.000

1.000.000

100.000
2.500.000

500.000
10.000.000
fig. 06

5.000.000

Garment management for controlled environments: an introduction

10

contamination control
1.7. Use of specialist clothing
The human body creates its own micro-environment of potentially damaging particulate contamination (fig. 07). Since
humans are essential to production situations, damage limitation through the use of purpose-designed cleanroom
clothing has proved to be the most practical solution to the problem.
The use of specialist clothing is now commonplace. To be effective it must:
- form a particulate barrier for the human micro-environment
- allow freedom of movement and be comfortable
- address any specialist requirement, e.g. static dissipation
- avoid being a significant particulate contributor itself
Details of parameters for garments including
those for the head, torso and feet are included in
section 2 of this publication.

fig. 07

Garment management for controlled environments: an introduction

11

cleanroom garments
2.1. Garment materials
As mentioned in the previous section, people are one of the greatest contaminants in a controlled
environment. Therefore we need specialised garments to protect the environment and the workplace from the human
contaminant.
Cleanroom garments are unique as they must meet specific protection criteria. This involves special materials, particular
construction and individual styling. They must be comfortable, easy to apply and practical in use.
Inevitably the result is a compromise between wearability and optimum barrier efficiency. The overriding function is
containment of particulate matter. The contaminant should be retained within the garment and not released into the
surrounding atmosphere. Of course the garment itself should not create any contaminants.
In some cases additional requirements for protection are needed depending on the actual use of the garments and the
situation in the cleanroom. These requirements can include ESD characteristics, protection against flames or chemicals, ...
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)

The fabrics must:

be low shedding
permit the body to breathe whilst trapping particles within the garment
be flexible enough for comfortable wearing
withstand repeated cleaning / sterilisation cycles
meet any specific requirements like control of static
meet the opacity requirements
look and feel as good as possible
be cost-effective

There are 3 broad categories of fabric used in the construction of cleanroom garments.
These include:
- woven fabrics
- laminated or membrane fabrics
- disposable or limited life materials

2.1.1. Woven fabrics

First of all there is the choice of the fibre material. Since the garments
should not shed particles, it is obvious that the fibres need to be continuous.
This excludes all natural fibres since all of these have a limited length
(e.g. cotton fibres have an average length of 30 mm). Polyester still has the
best characteristics for use in cleanroom conditions (see further in this section).
Fig. 08 shows a cotton fabric - fig. 09 is a polyester cleanroom fabric.
Woven or re-usable fabrics are the most commonly used fabrics in cleanroom
environments. As the name implies, they are woven on sophisticated looms from
yarns of continuous filaments of polyester. The thickness of the yarn and filaments is
important (the finer the yarn the tighter the weave can be made and the
better the filtration), but also pattern and tightness of the weave is
important to reduce the pore size to a minimum. The use of
continuous filament polyester means that there are few loose ends
from which particles may be shed.

fig. 08

fig. 09

Garment management for controlled environments: an introduction

12

cleanroom garments
The weave is critical to the trade-off between desired filtration and
comfort. The yarn must be closely and consistently woven to provide a consistent
fabric pore size ... too small a pore size will cause wearer discomfort through
inability of the fabric to breathe and emit vapour; too large and the garment
becomes an ineffective filter.
Plain weave (fig.10) produces a tighter fabric and good results under test but
tight bending of the yarns can lead eventually to damage
and particulate flaking.
Twill weaves (fig.11) produce less stressing and
show superior results in body box testing
which simulates normal use.
Calendered woven fabrics are another option
in which the fabric surface is flattened after
weaving under (heated) rollers to produce a
shiny finish. This can, however, affect the
breathing characteristics and is subject to
pore re-opening after prolonged use.

fig. 10

fig. 11
2.1.2. Laminated fabrics
Laminated fabrics, favoured for some high grade microelectronic
environments, are produced by bonding together 2 or more layers (often a
combination of woven and non-woven fabrics) (fig. 12). Particle retention and
vapour permeability are achieved by incorporating a membrane that will give
the filtration required. The lamination is a critical process in the production
of these materials.
To work efficiently garments from these materials require optimum sealing at
all openings, making production relatively expensive.

fig. 12

2.1.3. Disposable or limited use fabrics

The most common of these non-woven fabrics are from spun bonded olefin and polypropylene. Comprising a densely
interlinked matt of fibres, these can provide good results for a limited period.
Garments from such materials need to be processed and decontaminated before use in the cleanroom.
Disposable or limited use garments are mainly used in those environments where protection of the wearer against
potentially hazardous products are required. A typical example is an environment where toxic chemicals are used. Other
applications for these garments are situations where the process would ruin re-usable garments, such as working with certain
inks, or where the wearer is on a one-off visit to the cleanroom.
Widespread use is seldom cost-effective but in low frequency applications where a managed cleaning cycle is unwarranted or
where there is a casual requirement for units off-the-shelf, the disposal concept may prove perfectly viable.

Garment management for controlled environments: an introduction

13

cleanroom garments
2.1.4. Coping with Electro-Static Discharge
Almost all modern cleanroom fabrics have a grid of conductive yarns woven into the fabric. These yarns
contain carbon or other electrically conductive material so that the fabric becomes
electrically conductive. The conductive yarns may have the conductive
material exposed, partially encapsulated or totally encapsulated in a non
conductive polyester (fig. 13).
It was thought that garments manufactured from such
fabric would discharge to earth if connected to a grounding
point in the work area. The methods commonly used are by a wrist
strap or by use of an electrically conductive floor and electrically
conductive soled footwear. Garments manufactured by traditional
methods prove difficult to electrically connect to ground and this
approach, at best, reduces electrostatic charge from several thousand
volts to several hundred volts. In the past this degree of control was
adequate and still is in some applications, but as products have become
sensitive to voltages as low as 25 volts, more effective control is required. In these cases the
design and construction of the garment will require special attention.

fig. 13

2.2. Garments
2.2.1. Design and construction
For the design and construction of the garments the same basic requirements as the fabrics apply. Indeed, a
performing fabric does not necessarily mean that the garments made up in this fabric will meet the requirements for use in
controlled environments.
A garment produced purely for maximum protection would be made out of one piece of material, without seams and
covering the whole body. Clearly this is impractical, if only because of personal size and shape differences. Normally the
design will, nevertheless, feature the minimum of seams and closures, no pockets, belt pleats or tucks and be configured to
reduce abrasion against skin and any under clothing.
Seams must be constructed in such a way that they do not allow air flow through them and thus keep the particles inside the
garment. They must also encapsulate the raw edges of the material. Raw edges should be prepared (e.g. heat sealed or
encapsulated) to prevent fibres fraying.
Since the performance of the garment equals the performance of the weakest part, all materials used in the garment (sewing
thread, zips, studs, knitted material for cuffs, ...) must meet the basic requirements individually. This means that e.g. the
sewing thread must also be a polyester filament yarn or the zip must resist repeated sterilisation cycles.
The design of the garment system must be such that air currents generated by the natural movements of the wearer and
trapped by tightly woven fabrics do not pass readily through garment closures. This means that particular attention needs to
be paid to fitting around the face of hoods, garment closures and fitting at neck, wrists and ankles. The better fitting and
more flexible the garment, the less this 'pumping' action and air compression. This means careful selection of materials,
careful styling and the availability of a suitable range of size options.
To combat static dissipation the garment construction may require adding conductive tapes to the seams, earthing studs
and/or specific sole material and cuffing for full effectiveness.
Garment systems may include several layers of garments, depending on the extent of the control required. Generally more
layers mean more protection. Choosing the right inner layer can also improve the comfort of the wearer and thus lead to
improved working conditions.
Most cleanroom garments are unisex, produced in a wide range of sizes and with possible options to suit most male and
female requirements off-the-shelf. This reflects the need for cost-effectiveness whilst offering the choice required to ensure
suitability for purpose.

Garment management for controlled environments: an introduction

14

cleanroom garments
2.2.2. Areas of protection
Garments are designed to provide protection for the head, body, hands and feet.

2.2.2.1. Head
Options include open face hoods, pullover hoods, peaked hats, berets, face masks, hairnets, goggles, helmets and a
variety of specialist protection items. In some environments full head covering with external supply of air is required.
In general the more you cover and the more layers you use, the higher the level of protection. Items which only partially cover
hair give only limited protection and are apt to be misworn. (fig. 14, 15, 16)

fig. 14

fig. 15

fig. 16

2.2.2.2. Body
A wide variety of undergarments, secondary and tertiary layer garments are available to meet the infinite variety of
cleanroom applications.
Coveralls (anything up to ISO class 3 conditions - fig. 17) are the most popular top layer and are normally essential where a
high degree of protection is required. These are normally front entry and sealed with a zip from crutch to neck. Other options
include centre zip coats (fig. 18) and trouser/jacket combinations (ISO class 7 or less strict).
Undergarments can either be one-piece or a top and trouser set. (fig. 19)

fig. 17

Garment management for controlled environments: an introduction

fig. 18

fig. 19

15

cleanroom garments
2.2.2.3. Hands
The choice of gloves involves decisions about tactile sensitivity, nature of use and cost. The majority are disposable but
several types of re-usable barrier gloves are available - used mainly in microelectronics production environments. (fig. 20, 21)
Inner gloves made of knitted re-usable materials may improve the comfort for the wearer.
Oversleeves, which cover the forearm and wrist, may also be worn to give added protection.

fig. 20

fig. 21

2.2.2.4. Legs and feet

Coveralls are used in combination with dedicated captive footwear to provide the protection required in high
classification cleanrooms.
Where the demands are more relaxed and outdoor clothing is worn in the cleanroom, shoes will normally be covered by
overshoes which can be either disposable or re-usable. In such cases staff should be required to ensure that items of
general clothing are clean and not liable to produce fibre contamination. Alternatively, an undergarment suit or disposable
cleanroom socks can be worn to achieve adequate leg covering and protection.
Boots and overshoes are available with a variety of soles and fastenings to meet pharmaceutical, (micro-)electronic and other
special needs. Some examples are shown in fig. 22 and 23.

fig. 22

fig. 23

2.3. Garment selection

In establishing a system for garment selection one must consider the broader aspect of cleanroom use: suitability of
fabric, garment style, layers, the nature of the tasks involved, costs and any regulatory or specific customer requirement.
The classification of the cleanroom will inevitably be the major factor in determining the degree of personnel protection
required and thus the fundamental choice of garments. Factors which also need to be addressed include the provision of
changing facilities, operating procedures and the garment management system. These are covered in Section 3 of this
publication.

Garment management for controlled environments: an introduction

16

cleanroom garments
2.3.1. Choosing a fabric
Technical specification is clearly important in fabric selection (see section 2.1.) but so are these practical factors:
- Continuity of supply for both initial and subsequent batches for garment replacement.
- Repeatability: successive batches must conform to specification.
- Wearer comfort - essential for optimum productivity. Not just theoretical performance but embracing the feel right
factor, opacity, air and vapour permeability, fit, style, ... factors which sometimes only wearer trials will confirm.
- Special factors including the need for sterilisation (often gamma irradiation or steam sterilisation). Polyester is the
only fabric which will withstand repeated gamma irradiation and even this involves fibre breaks and loss of
integrity under intense treatment.
- Cost of the material.
The aim must be to match a fabric to the combined needs of the end use, be they for unclassified or the highest grade
cleanroom. Investing unnecessarily in a high specification material for a low grade project merely wastes money. On the other
hand to under-specify can have potentially disastrous consequences. Suppliers will readily assist with the selection.

2.3.2. Choosing a style

The wearer issue system - either disposable products or re-usable pool stock will influence the choice of garment.
Disposables equate to limited life items like gloves, masks and certain caps and overshoes. These are usually the subject of
bulk supplies in one or a limited range of sizes for distribution at the point of use.
When re-usable garments are provided the options are to issue each wearer with an individual and identified set or to
provide a pooled range of sizes and for each wearer to select a set of garments as required.
The latter policy has cost advantages since the number of items issued as part of an efficient garment management regime is
less in a pool programme. It also provides a stock of garments for casual users, avoiding the need for disposable garments
for visitors.
The policy should allow for the need to isolate the garments or specify different fabrics for staff whose tasks create staining
contaminants which could spread through the garment stock.
In any pool system care should be taken to relate choices of style and size to the existing and any intended balance of
male/female wearers and to the range of tasks.
Fig. 24 gives some indications for the type of garments in function of the classification of the controlled environment.

ISO class
3
4
5

body
coverall
coverall
coverall

coverall or coat

head
full hood + mask
full hood + mask
full hood
mask as required
hood or snood

7
8

coverall or coat
coat

hat or cap
hat or cap

feet
long overboots
long overboots
long overboots

hands
powder & lint free
powder & lint free
powder & lint free

overboots or
overshoes
overshoes
overshoes

powder & lint free

as required
as required
fig. 24

Garment management for controlled environments: an introduction

17

garment management systems

The principle aim of any garment management system must be to ensure that every person
working in the controlled environment has access to appropriate clothing on a continuous basis,
taking into account the three basic elements:
- In-use phase
- In-transit phase (to and from laundry)
- In-laundry phase
The cleanroom user's quality commitments are dependent on the consistent availability of such
supplies. Thus the entire project team must essentially aim towards a zero tolerance quality
programme. In practice professional suppliers work within the ISO 9002 standard or its equivalent.
3.1. Cost parameters
Whilst each set of cleanroom requirements is unique to individual sites there are certain basic elements which have to
be considered in any cost projection:
-

the capital cost for garment purchase

capital cost of plant if opting for in-house laundry
capital cost of stockholding
projected duration of the programme
staff cost, including any management element
operating costs if opting for own laundry (including distribution, stock handling, maintenance and repair)
garment processing cost in case the laundry cycle is contracted out
rental cost in case the garments are rented from a service company

3.2. Supply options and quantities

Fig. 25 illustrates a typical service cycle. This assumes that cleaning will be undertaken by an outside specialist laundry.
Two fundamental decisions are to be made:
- to buy or to rent the garments
- to dedicate garments to each person or install a pool stock

3.2.1. To buy or rent?

However you evaluate the two options the costs invariably come out much the same. Those who buy outright
can claim control over the asset but take on the responsibility of the day-to-day management and running costs of the
processing operation. They will also have to finance the stock of garments and make sure there are at all times new
garments available. In return, they save on the profit element required by any external garment management facility.
Sufficient to say that there is a significant movement towards the use of external specialists handling the entire supply /
handling / cleaning cycle. The investment in plant and manpower, the commitment required and the technology involved in
achieving the ever higher demands of performance (focus on core business) has much to do with this trend!
Those opting for the renting service, where garment purchase cost, identification, replacement and refurbishing costs are
covered by a periodical (mostly weekly) rental charge, will certainly benefit from greater all-round support, particularly in areas
of programme development.
In a full garment management service, the supplier will undertake 100% of the garment life cycle, including programme
development, supply, collection, cleaning and delivery. Under this programme the garments will effectively be leased to the
customer under a contract spanning several years.

Garment management for controlled environments: an introduction

18

garment management systems

fig. 25

fig. 26

3.2.2. To dedicate or use a pool stock

The decision of whether to commit a set of garments to a
specified individual or have staff draw from a pool stock, has to be a
pragmatic one based on the circumstances. By far the majority of
those who employ external contractors choose pool stock
programmes with all the benefits of readily available replacement
garments in the event of loss or damage and the significantly reduced
garment quantities.
Fig 26 illustrates how the volume of garments required to support a
weekly service cycle (most programmes are based on a weekly
projection) can amount to a significant investment. Enough garments
have to be in circulation to allow the user company to have at least a
weeks stock of clean garments on site.
The number of garments required will also depend on the frequency
of changes made by the wearers. Recommendations for usage
according to cleanroom classification are covered by the IEST
Recommended Practice CC003 (varies from one change a week for
ISO class 8 and 9 to a change at each entry in ISO class 3 or cleaner).

CHANGE
FREQUENCY
BASED ON
WEEKLY
CYCLE

IN-USE

TRANSIT

LAUNDRY

1 x PER WEEK
STOCK = 3 SETS

2 x PER WEEK
STOCK = 5 SETS

DAILY =
5 x PER WEEK
STOCK = 11 SETS

4 x PER DAY =
20 x PER WEEK
STOCK = 44 SETS

To this must be added a quantity in transit (influenced by the number

of deliveries per week) and a quantity equal to a weeks usage at any
time being processed in the laundry.
The implications of dedicating specific sets of garments to individual operatives are clear to see. The pool stock, by
comparison, allows reductions based on experience of true usage and a much more flexible operating cycle, particularly at the
point of distribution where handling and storage can be critical.

Garment management for controlled environments: an introduction

19

garment management systems

3.2.3. Wearer measurement and supply programmes
Whether purchasing or hiring, dedicating or pooling, the supplier needs to know the size mix and the nature of the
garments he is to issue.
The best way to obtain the size mix is by using sets of garments covering the full range of options, allowing wearers the chance
to try a complete set (under- and outer-garments where applicable). It is by no means certain that the wearer of a medium
hood will also require a medium coverall or medium overboot. It is important for the wearer not only to put on the set of
garments, but also make the movements he is likely to make during his activities in the controlled environment to make sure
he gets the best and most comfortable fit.
Normally suppliers will readily provide such fitting sets. The assessment of each wearers requirements should be agreed by
both parties at the end of the measurement session.
Supply quantities will be a function of:
-

the number of staff to be equipped

the changing frequency
the process turnaround time
any required buffer stock for replacements or visitors

3.3. Garment issue

Traceability requirements dictate that, prior to the issue of any
garment, each should be identified detailing size, style, issue date and any other
relevant information.
Increasingly this is being achieved by
using a bar code or chip as illustrated in fig. 27.
In addition to providing proof of receipt and issue this coding will form
the basis of a stock management programme which will
monitor the garment's history. Events such as repairs, replacements
and judgements about the continued suitability-for-purpose of each
garment will take place within the agreement between
supplier and customer.
Since a similar system makes it possible to know exactly which items
are dedicated to a certain batch in the laundry production, all relative information on the decontamination cycles (monitoring of the
wash and dry process, cleanroom monitoring at the laundry, results of
batch testing) can be traced for each individual garment. This will be
essential in the quality management system of both the garment supplier
and the customer.
The information obtained will be used to improve the garment management
for the customer. Indeed accurate information on e.g. the actual changes,
number of garments available at any given time, real life-time of the
garments, over or under usage of garments for certain individuals or
departments will lead to better understanding of the situation and thus to
better management of the garment issuing.

fig. 27

Information technology makes it possible to have this information available in

the most convenient form for the customer. Even on-line access at any moment
is possible through the internet.

Garment management for controlled environments: an introduction

20

garment management systems

3.4. On-site procedures
Whilst the design and layout of cleanroom preparation areas are site-specific, the principles of employing progressive
areas from the discarding of outdoor clothing, through robing to the air shower prior to entry into the cleanroom are well
established.
Staff training in robing procedures is essential for the effectiveness of the garment system. These procedures may differ in
function of the class of the controlled area and the garments in use. In most cases the following steps will be included in
these procedures:
-

remove all jewellery and store in lockers provided

remove all cosmetics
remove shoes, stow in lockers and apply any specialist cleanroom footwear
apply any specified initial hair covering (e.g. a hairnet)
clean face and hands using soap and water, thoroughly scrubbing to remove all soiling, paying particular attention to
fingernails
- fit disposable robing gloves to avoid cross-contamination during robing
- put the headwear on first, making sure hair is tucked in and out of sight. Smooth the shoulder cape and do up any
fastenings.
- fit face mask
- draw the garment from its store, remove any packing and fit the garment as directed, ensuring no contact with floor or walls
- ensure any headwear elements are tucked well inside the garment and close fastenings (zip, neck studs, ankle and wrist
fixings).
- collect and fit cleanroom overboots as directed, ensuring that items do not touch contaminated surfaces. Fix securely
without leaving any draping ties.
- change from robing to cleanroom gloves as directed, then move to the production area
Exit from the cleanroom using the reverse procedure, employing receptacles provided specifically for clothing that will be worn
again or for garments to be decontaminated, depending on the change cycle.

Garment management for controlled environments: an introduction

21

typical cleanroom laundry function

The basic functions of the laundry can be seen from fig. 25. Essentially there are four basic functions:
-

stock control
handling of incoming and outgoing garments
cleaning and decontamination
quality control

4.1. Issue and identification of stock

One of the primary reasons for choosing to use a contract cleanroom laundry is the anticipated
thoroughness of stock handling and control. In today's laundry, every garment is positively identified and the subject of closed
loop control which enables full tracking and service history feedback.
There are no standard breakdowns of content but a coding system might include:
-

company name of the customer

size
operative's code and name
departmental location
garment number and issue date
user cleanroom reference
garment type, fabric and colour
locker number

Information which might be recorded with each scan could include the following which gradually builds up a vital history for
each item:
-

current location
current process date
condition of garment
repairs undertaken

Before the garments are issued, the laundry will organise the necessary fitting sessions to obtain the sizes required.
In some cases the application of logo's may be required by the customer. This logo may be a way to identify the wearer as a
visitor or somebody with specific skills (e.g. training in first aid) or it may be used to enhance the corporate identity. In any
case, the material and the application method must be compatible with the controlled environment.

4.2. Pre- and post-processing operations

Cleanroom laundering remains a personal service. Each garment is manually inspected upon arrival and set aside, if
necessary, for repair or special attention.
Repairs will be done according to standards set by the laundry and appropriate for cleanroom garments. In most cases the
type and number of repairs acceptable for the customer are part of the service contract. The specially trained laundry
personnel uses original materials for the repairs, where possible.
Production batches are made based on the capacity of the washing machines, the type of garment and on the process
needed to clean the garments. By linking the garments to the batch number, all relative process information is available both
during and after the process.
In-process quality control also ensures each garment is manually inspected after cleaning and prior to despatch.
The garment identification makes it possible to check the number of garments received and despatched to the customer,
ensuring the customer receives the same quantity sent in.

Garment management for controlled environments: an introduction

22

typical cleanroom laundry function

4.3. Cleaning and decontamination

4.3.1. General principles

A typical cleanroom laundry will have a controlled environment similar to the class where the garments to be cleaned
are used (fig. 28). The barrier washing machines are built into the walls and are loaded outside the controlled room and
unloaded inside the cleanroom. Also the dryers are built into the walls and are only accessible from within the cleanroom.
Tables are put in the cleanroom for controlling and folding the garments. Once the garments are packed, they leave the
cleanroom for further sorting and preparation for despatching (fig. 29).
Great care is given to the cleaning of the controlled room and the equipment. Every possible measure is taken to avoid
cross-contamination. In certain cases it will be necessary to empty the cleanroom completely before starting the process for
the next customer.

fig. 28

DRYING
TEST
EQUIPMENT

load

WASHING
MACHINE

unload
FOLDING

PACKING

PASS
OUT

AIR SHOWER
CHANGING
ROOM

fig. 29

Garment management for controlled environments: an introduction

23

typical cleanroom laundry function

Washing
fig. 30

The soiled garments are subject to a wet wash providing a physical and
chemical action to remove pollutants. The detergents involved are designed
to remove soil and retain it in suspension prior to being dumped to waste.
Different processes are possible depending on the type of garment, the use
of the garments, the size of the machines etc. Some examples are
described further in this chapter. All parameters (e.g. temperature, pH,
chemicals, ...) are available and will automatically control the washing
process. Monitoring is essential for the quality control.
According to the type of article, the weight of the load and the machine
the dosage of the chemicals is fully automated and controlled. The latter
means when chemicals are dispensed, there is a check on the amounts
dispensed and the same occurs when entering the washing machine.
Defects are registered by the machine and result in adjustments.
The water used for the cleaning cycle must of course be
treated before use, in order to prevent contamination of the
garments. A flow diagram of a typical water treatment plant
(fig. 31) in a laundry is shown in fig. 32.

fig. 31

Flow Diagram of Water Treatment Plant

Mains
Water

Carbon
Filter

Water
Softener

Ultra
Filtration

Point of Use Washing Machines

U.F. Storage
Tanks
Reverse
Osmosis

- Ultra Filtration:
- Reverse Osmosis:
- Electronic DI Unit:
- U.V. Light:
- Polisher:

Filters water down to sub micron level

Removes bacteria, salt, rust and fine suspended
matter and filters water down to 0,2 m
Takes positive ions from water
Kills bacteria
Keeps water pure

Electronic
DI Unit

DI Tank
Washing
Machines

U.V.
Light

Polisher

fig. 32

Garment management for controlled environments: an introduction

24

typical cleanroom laundry function

Following this cleaning cycle great care must be taken to ensure the garments are not re-contaminated. The garments are
rinsed several times to remove all detergents. The temperature of the rinsing water is gradually lowered to prevent thermal
shock. Depending on the process, chemicals can be added in the last rinse cycle for specific finishes.
Decontamination
Particles are physically removed from the surface of the cleaned garment in
a tumble drying sequence (fig. 33). The air used in the dryers is filtered
according to the cleanliness desired (mostly HEPA filters are used).
After the garments have dried and cooled (the cooling must be
gradual to avoid wrinkling or creasing of the fabric), particles are
liberated into the tumbler plenum and removed in the exhaust air.

fig. 33

Packing
Once cleaning and decontamination have been completed each garment must
be packed and heat sealed in clean non-particulating bags for issue to
the wearer (fig. 34). This activity must be undertaken under
the same cleanroom conditions as the previous process
steps.
If sterile garments are required a subsequent
sterilisation must be undertaken once the
garment has been packed. This may need
specific packaging material.

4.3.2. Specific processes

fig. 34

Some examples of specific processes are

described in this part. In consultation with the laundry specialist a customer specific process can be developed.

4.3.2.1. The pharma process

The high demands of the pharmaceutical industry for sterile garments on the one hand and on the other hand the
knowledge that repeated sterilisation cycles decreases the life-time of the garments drastically, have led to the development
of the pharma process by the Micronclean organisation. With this process it is possible to produce disinfected garments that
can be used in aseptic production environments without conventional sterilisation.
The pharma process involves aseptic cleanliness throughout the entire wash / decontaminate / dry / packing cycle using
barrier techniques, optimum control of washing water and truly clean surfaces in all areas. Before the application of the
pharma process the cleanroom and all equipment is cleaned and monitored. Only if the necessary level of aseptic cleanliness
is achieved can the process start. Monitoring of the environment requires constant microbiological checks. Staff training is
even more critical.
Choosing the suitable chemicals and their dosage was a crucial part in the development of the process. And even with years
of experience with the process, research and development effort is made in research and development to improve the process
and the monitoring of it. The rewards, however, justify the effort since results indicate that the life-time of such garments can
be doubled using the pharma process.

Garment management for controlled environments: an introduction

25

typical cleanroom laundry function

4.3.2.2. E.S.D. process
Increasingly electronics based companies are demanding higher garment cleaning standards to combat E.S.D.
behaviour. To maintain the performance of the garments produced for this industry the call is for ISO class 7 laundry facilities.
The process includes specialised finishes of the garments as well as specific equipment and training for the personnel. Only
the most professional suppliers are able to meet such demands.
Garments designated for the microelectronics industry where ISO class 3 or 4 are common may be treated with the same
specific finishes as mentioned above but adding the most demanding care for particle cleanliness.

4.3.2.3. Food process

The food industry is more and more aware of the necessity of particle clean garments. Looking clean is no longer
acceptable. Working in controlled environment with the appropriate garments can lead to a significantly longer shelf life for
the food processed. This is essential for a growing industry.
Micronclean developed specific processes for garments designated to ISO class 7 or 8 environments. Since the concern of the
food industry is similar to the pharmaceutical industry, the pharma process is the basis for the treatment of the food garments.
The levels of cleanliness both for particulate and microbiological contamination are adapted to the specific needs of the industry.

4.4. Garment delivery and collection

Most cleanroom laundries use their own transport to ensure the essential control over a facility which is more critical
than it might at first appear. Efficiency in this area means that garments are issued accurately to the wearer and retrieved in
good time ready for processing. Any urgent amendments to schedules can be accommodated without undue cost and
without unnecessary upheaval. It also provides a vital direct point of contact between customer and supplier.
An inadequate or inappropriate system will rapidly cause garment shortages and eventually disrupt customer production.
The system employed will depend on several factors:
-

pool stock or identified wearer

change frequency
storage between use
distribution method
available space

If a wearer-identified system has been selected then it will be necessary to distribute each garment set to each individual (to
allocated lockers or shelves, or by staff collecting their garments from a central distribution point).
Garments issued to a pool stock system require bins or shelves allocated by size for "picking" by staff.
Change on entry systems produce discarded items at a central soiled collection point. Any scheme involving re-use requires
a storage facility (as simple as named hanging pegs or more elaborate like laminar flow garment storage cabinets) and a more
disciplined system of handover.
Available space, number of wearers, size of the site and scattered production all make their contribution to programming and
costing. Suppliers will provide as much or as little help as you need to develop the best programme.

Garment management for controlled environments: an introduction

26

testing
The regime selected for each cleanroom will form an integral part of the whole contamination
control and must, therefore, be incorporated into the QA and validation procedures.
This requirement extends not only to the area in which the garments are used, but also to the
processing controls and environment of the cleanroom laundry.
These are the minimum checks and systems that will be required:
- Registration to and effective operation of a recognised quality management system - normally
ISO 9002.
- Particulate, airflow and pressure validation of the cleanroom by an independent organisation to
show conformance to specified and recognised standards e.g. ISO 14644-1.
- Routine environment monitoring of the cleanroom for microbiological contamination to show
compliance to a standard e.g. ISO 14698.
- Additional microbiological monitoring of the bioburden on cleaned garments, of critical water
systems and other relevant areas.
- Maintenance of batch records to show that critical processing parameters have been met e.g.
for thermal disinfection.
- Tests on processed garments to show that particle decontamination has been achieved to a
stated standard e.g. ASTM F51-68.
- Tests on processed garments to show that static dissipation is functioning to a stated standard.
- Supply of accurate and traceable conformance paperwork e.g. for gamma irradiated garments.
5.1. Fabric testing
In order to assess the suitability of different fabrics for different applications, it is necessary to test a range of
characteristics both of the fabric and the garments made from it. It is also important to do several tests on new fabrics and
on washed materials to determine the evolution of the characteristics throughout the life-time of the garments. Most of the
tests require specialised equipment and will therefore be used mainly for research and development purposes.
Tests on fabrics may include:

5.1.1. Pore size

Test principle: the fabric is wetted with a suitable fluid of known surface tension. Air pressure is applied across the
fabric. By studying the fabric and measuring the air pressure required to overcome the surface tension of the fluid, the
bubble-point may be ascertained. This air pressure measure is then used to determine the relative pore size of the fabric. The
test is fully described in BS 3321.
The smaller the pore size, the greater the particle retention and therefore the better the filtration. The ability to transmit air
and water is inversely proportional, so a balance has to be found. Ideal for filtration would be a fabric with pore size 0, but
such fabrics will not allow the fabric to breathe and will thus be extremely uncomfortable.
For a highly effective woven monofilament polyester fabric the pore diameter will typically be 20 m or less.

Garment management for controlled environments: an introduction

27

testing
5.1.2. Comfort factors
Factors such as weight, pore size, weave will influence the wearer comfort of the fabrics used in controlled
environments. Different textile laboratories are doing a lot of research on methods for measuring comfort in one single
objective test. So far no single test has proven to be applicable. The following tests give a good indication:
Water vapour permeability:
A test to determine the rate at which water vapour passes through the fabric, measured in grams per square meter per hour,
gives an indication of the comfort level of the fabric. The lower the water vapour permeability, the lower the comfort.
25 g/m2/h is a typical result for a high grade barrier fabric.
Air permeability:
This test establishes the litres of air per square meter per second at 0.98 mbar pressure differential. The higher the result, the
better the comfort, but also the worse the filter efficiency. A typical result for a woven barrier fabric would be about 45 l/m2/sec.

5.1.3. Particle holdout efficiency

Test principle: The test fabric is challenged with an air stream containing a known contamination (number and size of
the particles). By comparing this particle count with those of the air that passed through the fabric, the particle holdout
efficiency is calculated in a percentage for a given particle size. The counts can be repeated at different given time intervals
(e.g. after 5, 15, 30 and 60 minutes).
The higher the holdout percentage, the better the filtration efficiency of the fabric. A woven high grade barrier fabric should
give results higher than 80% for particles > 0,3 m. The bigger the particles, the better the holdout efficiency should be.

5.1.4. Particle generation

This test examines the number of particles generated by the fabric whilst undergoing a standard flexing under mild
abrasion. Results of this test give an indication of the linting of the material. The lower the figure, the better the fabric is
suited for use in cleanrooms. For a monofilament polyester woven fabric the result would be typically less than 75 particles > 5 m.

5.2. Garment system testing

As mentioned in section 2, the fabric is an important element in the garment, but other factors also influence the
efficiency of the garment to be used in a controlled environment. Therefore test methods to evaluate the garment system
need to be developed.
To test wearer comfort, so far the only way is to set up a real life trial to compare different possibilities. The selection of the
test persons and the way the evaluation by these persons is reported are essential to the success of the test, as are other
factors that will influence the results. A good test programme will give an indication of the most comfortable garment system tested
at the same time. Results from one test are not to be compared with results from another test, since too many variables are involved.
Body box
In order to test the particle control efficiency of garment systems, a simulation test was
developed, the body box. The full set of cleanroom garments under test is worn by a tester who
stands in a cabinet which is fed from the top with filtered air (fig. 35). The tester moves in a standard way in time to a metronome. Air is continuously drawn from the base of the box
cabinet and the number of liberated particles counted. This is therefore the most realistic dynamic
measure of the garment in actual use.
By using the same wearer and experimental conditions, it is possible to directly compare the
filtration efficiency of different garment systems. Once again this test gives a comparison and not
absolute figures.
fig. 35

Garment management for controlled environments: an introduction

28

testing
5.3. Particle counting (monitoring)
American Standards ASTM F51-68 and Fed. Std. 209 have provided the basis for analysis of the cleanliness of a
controlled environment, but the recently introduced ISO 14644 part 1 and 2 have the benefits of being compiled against
modern production procedures. The former standard specifies the procedures for verifying a given cleanroom classification,
the latter the testing and monitoring required to prove continued compliance. In the same series a number of standards
dealing with design, cleanroom operations and many more are in preparation (see fig. 06).
Monitoring the cleanroom in which the decontamination process takes place is essential for the quality control of the
laundry.
But there is also a need to measure the efficiency of the decontamination process. ASTM F51-68 was the first test on
decontaminated garments. The disadvantage of this test is that the particles are counted on a relatively small surface of the
garment and visually by means of a microscope.
Over the past years the Helmke Drum test has become the most applied test method to batch check the decontamination
process (fig.37). Garments to be tested are placed in a rotating drum and tumbled to release particulate matter. The air from
the drum passes an automatic particle counter to determine the amount of particles per size range. IEST developed a
classification chart for Helmke results in its Recommended Practice IEST-RP-CC003 (see fig. 36). This is based on the average
surface of the fabric in the tested garments (size M is used as reference). The numbers of particles are 0,5 m or larger.

Category
I

II

III

Garment tested
1 coat
1 coverall
3 hoods
1 coat
1 coverall
3 hoods
1 coat
1 coverall
3 hoods

Particles counted
< 1.000
< 1.200
< 450
1.000 10.000
1.200 12.000
450 4.500
10.000 100.000
12.000 120.000
4.500 45.000

fig. 36

fig. 37

Different organisations over the world (including Micronclean) are working on the improvement of the test method
(e.g. repeatability, number of tests to do per batch).
It has to be remarked that this method gives an indication of the number of particles released by the garments. A Helmke
Drum result gives no indication of the particle holdout efficiency of the garments tested. It could be possible to obtain good
Helmke results with a garment offering no filtration efficiency.

5.4. Microbiological controls

Many medical and pharmaceutical cleanrooms demand nothing short of sterile garments. Historically this has been
achieved by autoclaving, irradiation (gamma or beta) or ETO (ethylene oxide). Autoclaving and irradiation are destructive to
modern fabrics through thermal shock or fibre breakdown.
The pharma process developed by Micronclean offers a solution for most applications. By aseptic cleanliness throughout the
entire process using barrier techniques, it is possible to deliver sterile garments.
In order to assure the quality it is necessary to monitor the bioburden in all steps of the process. Before, during and after the
process all relevant surfaces (e.g. folding tables, fingertips of operators) are checked with dipslides. Since there are, at the
moment, no internationally accepted standards to check the bioburden on garments, the test method and level of
acceptance is part of the agreement between the laundry and the customer. Extensive research is actually being done by
Micronclean to develop practical test methods to ensure the quality of its processes.

Garment management for controlled environments: an introduction

29

testing
5.5. Static electricity
Static electricity is a contaminant causing possible problems in all areas of cleanroom activity. Polyester garments
produce static electrical charge as fabric makes contact with fabric or with garments worn under the cleanroom garments.
Electrical charges of many thousands of volts may be present on the garments during use. The charge may be discharged at
any time to the cleanroom structure or materials in the cleanroom.
Different tests are used in this field, all covering a part of the phenomenon. It is important to test not only new garments,
but also garments after a number of washes.
Surface resistivity:
Measures the resistivity on the surface of the material. This test was initially developed for materials having the same
composition at any place on the surface. This is not the case for cleanroom fabrics with a grid structure of conductive yarns.
Another problem for this test is the use of encapsulated conductors in the conductive yarns, since in this type of fabric the
conductivity is not at it strongest on the surface. Generally results between 7.5 x 10 E5 and 1 x 10 E12 ohm are accepted.
Static decay test:
The garment is charged to 1.000 volts. The time is measured to discharge the garment to 50 volts after connecting the
garment to a grounding point. Less than 2 seconds is accepted in most cases.
For some applications, 50 volts is too much. Indeed some products have become sensitive to voltages as low as 25 volts. In
reality the behaviour of the garment will be influenced by such factors as the method of grounding, the fabrics worn under
the cleanroom garment, the conductivity of the flooring, etc. These are not taken into account in this test method.
Testing electrostatic voltage on the body:
A person wears the test garment seated on a plastic covered chair. A probe connects an electrostatic voltmeter to the hand.
The wearer then moves to create an electrostatic charge. The next step is for the wearer to stand. At the moment the chair
and the garment separate, an electrostatic charge may be recorded.
With this principle you can test garments in different ways (garment connected to earth or not, feet on insulated plate or not
and any combination). If the test person is grounded at the wrist, body voltages generated decay rapidly, however the
residual charge on the garment is typically 50 to 300 volts for standard cleanroom garments. With specific designed
garments the decay is faster (less than 0,2 seconds) and the residual charge is reduced to below measurable levels.

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getting started
This publication illustrates that a cleanroom garment management programme covers substantially
more than garment cleaning and that any relationship is likely to involve a long term partnership
(most contracts are based on a 3 year minimum period).
Since the involvement is significant, it makes sense to consider all aspects before committing to
a specific supplier. The process must begin with an assessment of the needs of the user. These
needs have to be translated to specifications and become a part of the agreement with the
supplier.
A number of matters to be considered are listed here:
6.1. Garments specifications
-

Materials to be used:
particle barrier required in function of classification of the controlled environment
need for sterilisation
ESD requirements
specific risks such as flame, chemicals, ...

Garment system:
styles involved, again in function of the classification (coverall, hood, boot, coat, ...)
multiple layers or not
compatibility of the garment system with other equipment (e.g. gloves, safety shoes, earthing straps, ...)
choice of colour for the garments (taking into account opacity)
need for differentiation of personnel (using different colours, logos, ...)
garments as part of the corporate identity programme

Issue programme:
number of changes (daily, weekly, ...)
estimate for garments for visitors
garments dedicated to a person or pool stock
dressing procedures
sizes available
possibility to obtain customised sizes from supplier
evolution of the number of wearers (stable number or variable)

6.2. Decontamination specifications

-

type of contamination of the soiled garments

type of process: microelectronics, pharmaceutical, food, ESD, ...
need for a customer specific process
sterilisation and if yes what process (autoclave, irradiation, ETO)
number of changes per week
specific requirements for folding and packaging

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getting started
6.3. Service specifications
-

number of deliveries per week

delivery schedule (e.g. 1 place at the customers plant or delivery in each department)
distribution system of the garments, taking into account the choice of pool stock or designated garments
buffer stock of new garments
identification of the garments including barcode or chip
training of the personnel (e.g. dressing procedures)
fitting of sizes
tests of new garments
garment repairs: who and what is acceptable
replacement of used garments
adjustments to garments (e.g. shortening of trousers)
information on the garment programme available from supplier
research and development possibilities
involvement in standardisation
contingency plan in case of break down

6.4. Monitoring specifications

-

ISO 9000 or similar QA system

test methods applied by the supplier in function of the decontamination process
performance levels for the different tests
validation of the processes
traceability
effectiveness of the corrective action plan in case of a problem
reports on quality (at each delivery or only when requested)

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appendix: bibliography
ISO standards:
ISO 14644: cleanrooms and associated controlled environments
Part 1: classification of air cleanliness
Part 2: specification for the testing and monitoring to prove continued compliance with ISO 14611-1
Part 3: metrology and test methods
Part 4: design, construction and start-up
Part 5: cleanroom operations
Part 6: terms and definitions
Part 7: enhanced clean devices
Part 8: molecular contamination
ISO 14698: cleanrooms and associated controlled environments biocontamination control
Part 1: general principles
Part 2: evaluation and interpretation of biocontamination data
Part 3: methodology for measuring the efficiency of processes of cleaning and (or) disinfection of inert surfaces bearing
biocontamination wet soiling or biofilms
The IEST (Institute of Environmental Sciences and Technology) publishes a number of recommended practices (RP) and
reference documents (RD) for controlled environments. On the matter of garment management, the following are specifically
of interest:
IEST-RP-CC003: garment system considerations for cleanrooms and other controlled environments
IEST-RD-CC009: compendium of standards, practices, methods and similar documents relating to contamination control
IEST-RD-CC011: a glossary of terms and definitions relating to contamination control
IEST-RP-CC022: electrostatic charge in cleanrooms and other controlled environments

Information on ISO standards is available on: www.iso.ch. For more information on the IEST documents and other standards:
www.iest.org

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