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A short Introduction to Cleanliness Technology:

Meeting the future Challenges

Udo Gommel1, Guido Kreck1

[email protected], [email protected]

1
Fraunhofer Institute for Manufacturing Engineering and Automation IPA, Stuttgart, Germany

Abstract

For semiconductor components, the demand to improve performance and velocity as well as energy
consumption is met through miniaturization. The continuing trend to miniaturize semiconductor structures
can be observed since several decades and requires, among other things, sophisticated cleanliness
technology. Cleanliness technology in this context is to be understood as the chain of all activities taken to
control and reduce all contamination harmful to the product. Because of the very challenging particulate and
outgassing contamination levels, semiconductor industry still claims technological and economic leadership
in terms of cleanliness technology. But no longer only semiconductor industry is relying on cleanliness
technology as the following case studies graphically demonstrate:

In life science industries, mainly microbiological contamination is controlled to prevent users and patients
from severe health issues caused by poor hygiene or cleanliness of the highly effective pharmaceuticals or
very innovative medical devices.

Space exploration combines nowadays the challenging cleanliness requirements of semiconductor and
pharmaceutical industry to be in compliance with the planetary protection program, the guiding principle to
preserve planetary and terrestrial conditions for future generations.

And even automotive industry discovered the benefit of cleanliness technology almost ten years ago:
Metallic micro sized particles (>50µm) were identified as critical contamination because they can cause
malfunctions in fluidic and electronic vehicle systems such as antiblocking systems.

By having a closer look on these three case studies, the increasing importance and on-going diversification
of cleanliness technology can be shown and also the challenging future requirements of cleanliness
technology over the next few years can be derived.

Key words: Cleanliness Technology, Cleanroom Technology, Contamination Control, Medical Devices,
Pharmaceuticals, Semiconductors, Space Exploration, Flight Hardware, Automotive.

resulted in the awareness that there is critical

1. Introduction
"invisible" contamination and that such
contaminants must be controlled. At the very
The knowledge about cleanliness is very old and
beginning, this principle was mainly applied to
dates back to ancient times when medicines first
protect human health and safety. But soon, starting
recognized the importance of microbiological
at the first half of the last century, this knowledge
cleanliness, in this context often called “hygiene”.
was also transferred to the production of
The first scientific cleanliness technology
contamination sensitive products, components and
approaches in modern times were also made by
systems, e.g. integrated circuits, flat panel displays,
medicines like Semmelweis and Lister. Their
hard disk drives, PV modules, pharmaceuticals,
proposed disinfection methods established in
medical devices, automotive turbochargers - and so
hospitals and operating rooms reduced the infection
on and so forth. This list of examples could be
and mortality rate of patients dramatically. The
continued almost ad infinitum and demonstrates the
acknowledgement of their work in sciences finally
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daily increasing and highly diversified application Depending on the branch of industry and process
fields of cleanliness technology. In this concerned, different forms of contamination have a
understanding, cleanliness technology means the damaging influence on the product. An industrial
chain of all activities taken to control and reduce survey carried out by Fraunhofer IPA in 2003
contamination harmful to the product as well as confirmed that the greatest problem in clean
human health (Gail et al 2012). manufacturing continues to be submicrometer-sized
particles, followed by molecular contamination
(outgassing), electrostatic discharge phenomena
(ESD) and microbiological contamination (Gommel
2006).

To reduce the contamination to a non-critical,

tolerable level, cleanroom technology as one very
powerful instrument of cleanliness technology was
developed, mainly to remove biotic and abiotic
particles from the production environment by a
constant air filtering, air exchange and
aircirculation.

Because of the very challenging contamination

levels, semiconductor industry still claims
technological and economic leadership in terms of
classical cleanliness technology. But no longer only
semiconductor industry is relying on this
technology (Figure 1). The following three case
studies out of different industry branches
demonstrate the increasing importance, on-going
diversification and future challenges of cleanliness
technology.

2. Life-Science Applications

2.1 Short Market Analysis

“We are finally entering an exciting time in

medicine where we have the technology to custom-
tailor treatment and preventive protocols just as
we’d custom-tailor a suit or designer gown to one’s
individual body.” (Agus 2011)
This quotation originates from the 2011 published
book “The End of Illness” written by David Agus,
oncologist and attending doctor of Steve Jobs. It
testifies the trend that medicine owes new therapy
options mostly life science innovations, e.g. tailored
cytostatics, i.e. drugs to inhibit cell division, for
highly efficient cancer therapies. In consideration of
the approx. 7 million people who died of cancer in
2010 worldwide (Mukherjee 2010), an outlook that
gives hope and that justifies also the economic
importance of the life science branches. A closer
look on medical technology confirms this: In 2005,
Figure 1. Overview of markets (incl. exemplarily only this industry branch generated a turnover of
shown products) relying on cleanliness technology. approx. 190 billion EUR, mainly spread between
Image Source: Fraunhofer IPA and Shutterstock
the world market leaders U.S.A. (~40%), Japan
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(~10%) and Germany (~10%). Also the growth Therefore, also the cleanliness of medical devices,
prognosis is very promising: A steady growth of like medical machines, reusable surgical
approx. 3-4% p.a. over the next five years is instruments, implants and artificial hip joints,
forecasted (Deutsche Bank Research 2008). This is moves more and more into the public focus.
due to the fact that, in conjunction with the
demographic change, people in the industrial The following facts and figures also make the
countries will have an increased life expectancy hygiene and cleanliness issues of medical devices
over the coming decades. Therefore the demand for very clear:
pharmaceuticals and medical products is expected to Increasing number of nosocomial infections in
rise in order to maintain the quality of life. These hospitals: only in Germany approx. 500,000
developments make the prediction of Gerard infections per year, 10,000 of them (equates to
Kleisterlee, the former CEO of Royal Philips 2%) lethal (BMG 2011).
Electronics, the world's third largest manufacturer Recall campaigns initiated by the FDA: 243
of medical devices, comprehensible: “Medical recalls in the years 2001 to 2011, 64 of them
technology is the growth market of the future”. (equates to 26%) because of cleanliness issues,
upward trend in the last years (FDA 2012).
2.2 Specific Contamination Control Aspects
Although the knowledge that cleanliness is
The trend in medical technology is currently important for medical devices is available since
towards innovative, long-lasting, high-quality many decades and written down in numerous
products with the aim of optimising patient benefits national and international guidelines (e.g. the
and keeping physical and psychological stress as European Union legal framework for medical
well as costs as low as possible. In view of the devices consists of the three directives 90/385/EEC,
extremely high and continually growing demands 93/42/EEC and 98/79/EC and defines basically four
placed on medical devices, the industry needs a high risk classes for medical devices, ranging from low
innovation potential. This is partially reflected by risk to high risk), there are still problems caused by
the fact that German medical technology companies poor hygiene or cleanliness. The hygiene and
achieve over 50% of their turnover with products cleanliness of medical devices has meanwhile also
that are less than two years old (BMBF 2005). an economic dimension: Due to rejection reactions
and inflammations, e.g. of implants, post treatment
To be competitive in the life science markets, high costs arise, in Germany estimated 7 billion EUR per
quality products are required to protect the human year (Kramme 2007).
health and safety of patients and operating
personnel (medicines, nurses, etc.). Because very However, the cleanliness validation, i.e. the
often the products are in direct contact with human inspection of the cleanliness state of products,
tissue, the infection risks caused by microorganisms instruments or other surfaces in the medical device
have to be considered carefully (Figure 2). environment lags behind. Methods for cleaning or
sterilization are validated using only qualitative
approaches like visual inspection. Quality assurance
is often limited to the compliance with standardized
processes, not on inline inspections to directly
monitor the cleanliness or sterility.

2.3 Suitable Cleanliness Validation

At this point it is worth thinking outside the box. In

particular, new measuring techniques provide new
approaches for conducting quantitatively cleanliness
validations of the most critical contaminants, i.e.
particles (abiotic and biotic) and
thin-film contamination (e.g. organics like
lubricants from process tools, finger prints, etc.)
Figure 2. Example of a 3 x 3 mm implanted artificial even on complex shaped products (direct or indirect,
retina chip implanted in a human eye. Source: Retina Figure 3).
Implant AG, Tübingen.
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Contamination: Detection & Analysis

especially for extra-terrestrial space missions, e.g.
for the search of life missions. According to this
direct indirect policy, neither may terrestrial life forms, i.e.
directly on the product surface after extraction of particles microorganisms such as bacteria and spores,
contaminate outer space, nor may the earth be
qualitative semi-quantitative quantitative contaminated by unknown life forms from sample
return missions. All this is done to minimize
What?
What?
influences on evolution as well as to avoid falsified
What? How many results and misinterpretations on search for
How many?
(partially)?
missions. Thus, space flight combines the very
challenging contamination control requirements of
Type: Type:
• biotic • biotic/abiotic semiconductor industry (particles, molecular
• abiotic • organic/anorganic contamination, ESD) and pharmaceutical industry
• organic • etc.
• anorganic Quantity: (microbiological contamination).
• etc. • number
• concentration
To guarantee the specified cleanliness levels of the
Figure 3. Approaches to detect contamination on flight hardware, cleaning processes are necessary.
surfaces for the quantitative validation of the This in turn means to choose suitable ultraprecision
cleanliness state. cleaning technologies as well as suitable concepts to
avoid a recontamination of the cleaned flight
3. Space Flight hardware during the assembly and integration
phase. Sophisticated concepts to take this all into
3.1 Short Market Analysis consideration are being developed currently.

At first glance, space industry seems to be a niche. 3.3 Validation of Cleaning Technologies
But at second glance, the global space revenue from
government and private activities reached in 2008 So far, there is less validated knowledge about the
more than 257 billion USD (Space Foundation quantitative efficacies of cleaning technologies
2008). But actually, this isn’t really surprising if available. Thus, in the first place, a suitable
you have a closer look. A lot of technological space validation concept of cleaning technologies is
flight achievements are unnoticed but an required. Main problem of such a concept is to
indispensable part of modern life. Navigation avoid crosscontamination from the environment and
systems, telecommunications, as well as weather the operator. Hence, all validation steps have to be
and climate forecasts are inconceivable without performed in an AMC (“airborne molecular
satellites in space. And the numerous interplanetary contamination”) controlled ISO Class 1 cleanroom
space missions, for example the exploration of according to ISO 14644 by skilled cleanroom
Mars, can influence the quality of life here on earth operators. The main test principle is to contaminate
in many positive, yet unforeseeable ways: representative test samples in a defined way and to
generation of new scientific knowledge, exploration determine the contamination quantitatively before
of new habitats or exploitation of natural resources and after the cleaning process. This can be done
are only a few facets of such visions. using the following measuring and analysing
techniques:
3.2 Specific Contamination Control Aspects To detect particles on surfaces, scanning electron
microscopes (SEM) can be used which can count
“Failure is not an option” is not only a slogan for particles automated on a surface due to the
space flight. To fulfil the very challenging material contrast down to nanometre sizes.
requirements in regard of durability, reliability and To detect organic molecular contamination, a gas
performance of satellites and spacecrafts under chromatograph combined with a mass
extremely stressful conditions in space, nothing less spectrometer (TD-GC/MS) can be used.
than the best available cleanliness technology is All measuring and analysing techniques have to be
good enough to be on the safe side. of course installed in the mentioned controlled clean
environment.
In addition to improving performance and
reliability, internationally ratified "Planetary CO2 snow cleaning is a very promising
Protection" requirements have to be considered, ultraprecision cleaning technology for space
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applications because it can remove particulate and trucks were on the road (OICA 2012). Only
(biotic and abiotic) and molecular (organic) these figures show the impact of this industry
contamination at the same time very effectively. branch, even if it is known as a very cyclic industry.
With the described approach, it could be proven that But automotive industry has also a reputation of
CO2 snow cleaning is a suitable ultraprecision being one of the biggest polluter: particulate matter
cleaning technology for space flight because it emission and climate change due to CO2 emission
fulfils the high requirements of the planetary are only two key aspects in this connotation. In
protection policy (Figure 4). Also other cleaning consequence, a very high innovation potential of the
technologies can be validated with this approach to automotive companies is needed to survive in this
make the cleaning efficacies of different cleaning internationalized market.
technologies comparable for the first time. Of
course, such concepts can be also transferred to Therefore, to reduce gas consumption in
validate the efficacies of cleaning technologies conjunction with CO2 emission and also to increase
relevant for other branches like semiconductor, safety, new materials (e.g. carbon fibres laminates
pharmaceutical or medical device industry. used for light construction), new techniques (e.g.
efficient common rail direct injection engines or
electric motors) and sophisticated vehicle systems
(e.g. electronic stability programs or antiblocking
systems) have to be developed and implemented. To
support these developments, many governments
have provided research funds. For example the
E-Mobility activities of the German government are
targeted on the goal of one million electric vehicles
on the road until the year 2020 (situation in 2011:
Figure 4. CO2 snow cleaning as ultraprecission approx. 4,500 registered electric vehicles and
cleaning technology (left) used in the precision approx. 50,000 registered hybrid vehicles,
cleaning cleanroom at ESTEC (right). Automobil Industrie 2012).
3.4 Clean Assembly Environment
4.2 Specific Contamination Control Aspects
The cleaning procedures for the flight hardware
require a clean environment fulfilling the same
requirements as described for cleaning technology
validation to avoid any critical crosscontamination
during the assembly and integration, i.e. an AMC
controlled ISO Class 1 cleanroom. All operators
have to be specially and regularly trained. And also
sophisticated material and personnel flows have to
be designed. Such a cleanliness technology was Figure 5. Damaged connection rod (left) and
cylinder (right). Failure reason was a continuous
newly installed at the European Space Research and
gas injection caused by a micrometre sized particle.
Technology Centre (ESTEC) in Noordwijk,
Netherlands. The dissemination of the knowledge During the last ten years, the following quality
about contamination control for space applications problems could be observed: residual particulate
is guaranteed by the ESA initiative “European contamination, mainly metallic particles >50µm,
Cooperation for Space Standardization (ECSS)” that caused various functional impairments, e.g. in many
makes the knowledge available to public in fluid circuits found in automobiles (fuel systems,
manifold product quality and management brake circuits, lubricating and hydraulics systems,
standards. cooling and air-conditioning systems, air intakes or
exhaust systems and further treatment, etc.) as well
as in mechanical and electronic units. Even very
4. Automotive Industry
small amounts can cause severe problems
(Figure 5).
4.1 Short Market Analysis
Sources for critical particles are mainly production,
In the year 2011, worldwide almost 60 million
handling and assembly processes. But even if you
automobiles were produced and nearly 1 billion cars
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use sophisticated cleanroom concepts for production 5. Conclusions

and assembly or cleaning steps at critical process
points, the risk of particulate contamination can’t be The semiconductor industry is still the classical and
completely eliminated. Thus, in any case, all most driving force for further developments in
relevant system components are generally cleaned cleanliness technology, especially in cleanroom
after manufacture and the level of cleanliness technology. But the three case studies out of the life
needed for them to function must be specified and science, space flight and automotive industry
inspected. demonstrated that no longer only this classical
semiconductor branch is relying on the use of
4.3 Cleanliness Inspection (VDA Volume 19) cleanliness technology: Almost daily new markets
are discovering the advantages of a certain
The VDA 19 (2004) guideline describes the cleanliness level on the product quality and
conditions for applying inspection methods for reliability. By transferring the already established
determining the particulate contamination state of cleanliness technology to other industry branches,
components, carried out in the following three steps synergy potentials may be used and in consequence,
(all steps have to be performed in a sufficient clean the diversification of cleanliness technology leads to
environment): an evolution of already established cleanliness
extraction of particles (e.g. rinsing) methods and concepts. Thus, cleanliness technology
filtration keeps being a fascinating, fast growing market in
analysis (e.g. automated particle counting using future.
light microscopes or scanning electron
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