Save the Date! Vision. Innovation. Expertise. 27. + 28. 10. 2015 Frankfurt am Main
Internationale Fachmesse und Kongress für Reinraumtechnologie. Innovativ & interdisziplinnär – Reinraumlösungen für alle Branchen. Mehr Informationen und Impressionen unter www.cleanzone.messefrankfurt.com
Dear Cleanroom Magazin Readers,
3
Magazin“. After the first release of the magazine three years ago, it was time to re-design the magazine regarding both its content and appearance. The goal was to present a clean look and feel for a clean industry. We are striving to present more than just a cosmetic change. The magazine should not only become optically more attractive but also to become more target-group oriented, more user-valued, more structured and much more interesting. Our relaunch is the result of a scientific analysis, more exactly from three analyses. We commissioned media scientists to compile for us a market analysis, a competition analysis and a target group analysis. This was a very time consuming process which was addressed to by the media consulting and market research agency comstrat. The owner and director of the agency, Professor Jasper Friedrich, a communcations and media scientist at the Leipzig University and his partner, the journalist Christoph Heinemann presented the results to us during three ardulously long sessions. Their suggestions and recommendations occasionally led to quite conFrank Duvernell »This is a question from our
troversial discussions, however the melting pot of facts, opinions, gut feelings
target group analysis: Which topics are for
and arguements ultimately crystallized and our new magazine structure final-
you as our readers relevant, interesting and
ly emerged.
captivating? The answer was not at all sur-
5%
prising. The desired topics should be neutral
abstract
and up-to-date from experienced and industry-expert sources. Further results from the questionaire can be found below in the info-
22%
19%
graphics.«
22%
Statements of respondents:
Text only
technically
54%
46%
modern
32%
lifestyle
1.
Reports
1. How would you like the design of this magazine? 2. Which magazine style would fit?
Articles
2.
In a nutshell, here are the most important results of the analyses. We have separated the German and English versions of the contents and have laid them out on opposing pages. Perhaps this has become apparent to you on the basis of the double title page. Due to the separation of the German and English versions, we have been able to change from the former two-column layout (left-German; right-English) to a three-column layout which has opened up very diverse design and format possibilities. The contents of the magazine have been partitioned into a current news section, a journalistic section, a technical section and a service section. Our very thorough spring cleaning activities have now been brought full circle. I wish you all good reading!
Frank Duvernell Editor
2/2015
EDITORIAL
Today you are holding in your hands the newly designed issue of “Cleanroom
4
Contents 02/2015 08 08
08
Title Story: Beautiful Nature – Dangerous Contamination Cleanroom operators are especially challenged to protect their products from contamination risks coming from the outside environment.
LIFE & BUSINESS CONTENTS
News from the World of Cleanrooms
06
Market News in Brief
An Overview of What is happening in the Market • New Research Center in Villach The Pharmaceutical Industry Drives Swiss Exports • Record Year for Braun Melsungen AG • An Ebola Vaccine This Year? • Semiconductor World Market in US Hands • SEMICON brings Founders and Investors Together • Europe’s Micro-Technology Industry Invests
.................................................. 16 16
Hospital Germs: Let’s put an End to Infections In Europe, 3.2 million people are infected with dangerous pathogens every year. By systematically using cleanroom technologies, a large percentage of these infections and resulting deaths could be prevented.
..................................................
22
Nano-Biomedicine Personalizes Healing
Nano-systems could guide medical active agents directly to seat of a disease where they could be specifically released. The door to personalized medicine seems to have opened.
16
.................................................. 28 Behind the Scenes: On the Road with… Philippe Trösch, Sales Engineer at Novasina AG.
.................................................. 30 30
OLEDs: The Future of Light Organic light emitting diodes could revolutionize display and lighting technologies. Their particular properties open fascinating possibilities for totally new kinds of products.
2/2015
5 36
Portrait: Armando Rastelli
30
Professor Armando Rastelli directs the Institute for Semiconductor and Solid State Body Physics in Linz, Austria. The Institute’s cleanrooms play a key role in research in Austria.
SCIENCE & TECHNOLOGY
Solutions in the World of Cleanrooms
40
Technologies in Brief
50
New Materials for Nano-Systems • Quicker Transfer from Laboratory to Production • A Computer the Size of a Grain of Rice • Nano-Medicine Protects Nerves • New Cleaning Procedure for Therapeutics Cleanroom Suitable Servo Presses • Humanoid Laboratory Robots
.................................................. 42 Efficiency in the Cleanroom: This is how it’s done. Operating a cleanroom can mean high costs. Considerable reductions in these costs are possible through simple modifications.
.................................................. 46
Up and Coming Staff: Students found a GMP School
Laws and regulations regarding the production of pharmaceutical products, cosmetics and food products seldom belong to a study curriculum. Therefore students from three German universities on their own initiative founded a GMP School.
.................................................. 49
What do you do there?
Stefan Grilec, cleanroom production assembler
SERVICE
Events, Awards, Regular Rubrics
50 50
Laws and Regulations: Standards are money saving tips The norms and guidelines for cleanroom operations are more than just an annoying obligation. They also contain a lot of advice on how to reduce operating costs.
................................................
................................................
52 Innovation: Wanted – Candidates for the Cleanroom Award 2015
55
Until August 31, 2015, ideas and projects in the direction of innovation, sustainability and energy efficiency in cleanrooms can be submitted to the ReinraumAkademie (Cleanroom Academy).
................................................ 53
Cleanroom Award: Now is the time to submit projects.
Referring to the Cleanroom Award, it doesn’t matter whether simply an idea or a market-ready product is presented. Please send in your applications now for any and all projects!
................................................ 54
The Winners: Previous Cleanroom Award Winners
Award-worthy: Those were Nominees from previous years
The Cleanroom Award has been presented since 2012. Who has been counted among the finalists since this time?
................................................ 56 Interview: Egon Buchta
How the Cleanroom Award candidates are selected is explained by Jury member Egon Buchta, Managing Director of Ingenieurbüro & Reinraumservice Egon Buchta GmbH (Engineering Office and Cleanroom Service Egon Buchta GmbH).
................................................ 58
Events
60
Imprint
................................................ ................................................
Every year, the visitors of the Cleanzone Trade Fair select the innovation of the year from among the f ive f inalists.
2/2015
6
Life&Business
LIFE & BUSINESS | CURRENT NEWS
Market news in brief
New Research Center in Villach
the chemical-pharmaceutical indus-
meeting on March 27th in Melsun-
try increased their exports. Exports
gen, Germany. The company found-
in these industries rose about five
ed in 1839 as a pharmacy, is today
Excellence Cluster | With ASSIC, the
percent to 85.3 billion Franks as re-
present in 61 countries and has
Austrian Smart Systems Integration
ported by the Swiss Federal Customs
50,000 employees.
Research Center, a new excellence
Administration. Thereby the chem-
cluster was recently authorized in
ical-pharmaceutical industry ac-
Villach, Austria. This location will be
counted for 60% of last year’s growth
expanded as one of the leading Euro-
in exports. This sector’s share of total
pean regions for the research in mi-
exports increased by 41%.
co-electronics and systems integration. ASSIC has received the COMET status from an international expert
New Record for Braun Melsungen
Ebola Vaccine Coming in This Year? Research Success | Scientists at the Institute for Tropical Medicine in Tübingen, Germany have carried out promising work in finding an effective Ebola vaccine.138 volunteers
jury, a status which is allotted for up to eight years. The COMET program
Jump in Profits | The company B.
in Gabon, Kenya, Germany and Swit-
(Competence Centers for Excellent
Braun Melsungen AG celebrated
zerland have taken part in this in-
Technologies) supports the cooper-
their 175 year anniversary with re-
ternational study. The active agent
ation between science and industry
cord numbers in revenues and earn-
rVSV-ZEBOV-GP, a ten-year old but
as well as the set-up of common re-
ings. This German medical tech-
still unlicensed agent from Canada,
search competencies and their eval-
nology manufacturer increased its
was used in the study. The tests have
uation. Thanks to this sponsorship,
revenues in 2014 by five percent to
shown that this agent is tolerated
numerous intelligent components
by the test subjects and forms anti-
and systems will be able to find their
bodies against Ebola. The research-
way into the lives of many people
ers hope that the vaccine will be li-
who bear the hallmark of the new
censed sometime this year. In the
excellence center whether it be in
current Ebola outbreak in West Afri-
automobiles, mobile telephones, in
ca according to world health organi-
medical technology, entertainment
zations, 25,000 people have been in-
technology or in household devices.
Pharmaceutical Industry Pushes Swiss Exports
Production of infusion devices: Reduction of sprue in the prevention of waste.
fected by this life-threatening virus and more than 10,000 of these people have died from the disease.
€5.43 million (previous year: €5.17 million). The company’s net income
Record Year | Switzerland exported
increased by 0.3% to €316.3 million
more goods last year than ever be-
(previous year: €315.5 million). “The
fore. With export goods valued at
B. Braun finds itself in a good and
208.3 billion Swiss Franks, 2014 ex-
stable economic condition.” says
ceeded the previous record from
company Chairman Heinz-Wal-
A new agent against Ebola could soon be
2008 by two billion Franks. Above all,
ter Große at the company’s annual
approved as a vaccine.
2/2015
Micro-Technology Industry is Investing Again
7
Automotive engineering Consumer Goods
The most important target markets of the European micro-technology industry
Please indicate your main target market.
Electronics industry Industrial automation Sensor, measuring and control technology Mechanical and plant engineering Medical / Health Optical industry Research & Development Semiconductor industry
between 2013 and 2015. Graph: IVAM Research
Semiconductor World Market in US Hands
Founders Meet Investors
Study | At the semiconductor con-
SEMICON Europe | At the semicon-
IVAM Association for Micro-Tech-
gress and trade fair “SEMICON Eu-
ductor congress-trade fair, „SEMICON
nology, about a third of the indus-
rope” to be held from October 6th to
Europe“ taking place from October
try’s companies invested more
October 8th, 2015 in Dresden, Ger-
6th to October 8th, 2015 in Dresden,
money in 2014 than in the previ-
many, 60 young high-tech compa-
Germany, 60 young high-tech com-
ous year. This shows that the in-
nies will get the chance to present
panies will receive the chance to
dustry is much more willing to in-
their ideas to investors. As the in-
present their ideas to investors. The
vest than in previous years and also
dustry association SEMI has an-
industry association SEMI has an-
more than the average of the Euro-
nounced, these presentations will
nounced that this strategy of bring-
pean economy. Micro-Technology
activate more venture capital so that
ing young companies into contact
companies want to keep up this
start-up companies from the key in-
with investors will loosen up more
trend in 2015 and invest more in
dustries of micro and nano-technol-
venture capital so that these innova-
R&D and in company growth. 36%
ogies, information and communi-
tive start-ups in the key industries
of the industry’s companies plan
cation technologies, environmental
of micro and nano-technologies, in-
to invest more than in 2014. Target
formation and communication tech-
markets for the micro-technology
nologies, environmental and energy
industry are the markets for med-
technologies, automobile manufac-
ical technology and in the medi-
ture, material science, mechanical
cal products market. More than
engineering, machine and facility
half of the European companies
construction as well as medical tech-
deliver to these markets. These
nology and life sciences will be able
markets are the target markets for
to successfully grow into established
about a fourth of all companies.
nated by US corporations. Photo: popov48
companies. Start-up companies Eu-
The automobile industry has al-
rope-wide can send in their applica-
so become more important dur-
and energy technologies, automo-
tions to take part in Europe’s largest
ing the last two years. Automo-
bile manufacture, material science,
semiconductor trade fair. Applica-
bile technology is at this time the
machine and facility construction
tions must be in by May 31st, 2015.
target market for about 11% of all
technology industry has started to invest again. According to the data collection of the international
The global semiconductor industry is domi-
as well as medical technology and life sciences will be able to grow into successful companies. Start-up companies European-wide are able
Micro-Technology Industry is Investing Again
micro-technology companies. In 2013, only about 4% of all companies were active in this market.
to apply for participation in Europe’s biggest semiconductor trade fair.
Optimism | The European micro-
2/2015
Sneezing girl standing in front of a tree in bloom. Photo: fotolia, Tatyana Gladskih
LIFE & BUSINESS | TITLE STORY
8
2/2015
9
Beautiful Nature – Dangerous Contamination
Pollen and Humidity present Challenges in Cleanrooms 2/2015
10
Beautiful Nature – Dangerous Contamination
LIFE & BUSINESS | TITLE STORY
Pollen and Humidity present Challenges in Cleanrooms
In the springtime, pollen and fertilizer dust contaminate the air. Likewise, germ growth explodes due to rising temperatures and humidity. Cleanroom operators are especially challenged to protect their products from the higher risk of contamination coming from outside.
els of pressure loss and their high operating efficiency. The third stage consists of a HEPA filter which corresponding to the class of cleanroom removes to the greatest possible extent all remaining particulate con-
The winter has come and gone, the
ry out regular maintenance so that
days are becoming longer and the
the facility stays clean.” emphasizes
temperatures are rising. At last!
Spehl. He knows of a situation in a
“If we look at the airborne particles
With the onset of spring, people
laboratory located in a forested area
in relation to their size, in a figura-
feel inside the stirrings of fresh
whose operator experienced a nasty
tive sense we are dealing with a mix
vitality and energy. Nature is also
surprise after the installation of new
of rubber balls, watermelons, ap-
blooming and this means: grasses,
filters during the conifer blooming
ples, blueberries, and poppy seeds.”
herbs, flowers and trees are send-
period. “The filters had to deal with a
says the filter expert Frank Spehl.
ing out myriads of pollen into the
really sticky pollen dust. Because the
“The rubber balls and watermelons
mild spring air. Farmers begin their
pollen was milky-white, it was dif-
get caught in the first stage filters.
work in the fields loading the air
ficult to see on the new filters. The
The apples, comparable to the pol-
with additional fertilizer dust, liq-
result was that the filters became
len, as well as the blueberries are
uid manure particles and herbicide
clogged like they had been treated
filtered out in the second stage. In
aerosols. “Everything that a person
with a spray-glue which couldn’t be
the third stage, the Hepa-filter, at the
is able to smell are chains of mole-
determined at first glance. This sit-
most only a couple of poppy seeds
cules which also hide risks for the
uation, however, remained unde-
will pass through depending on the
cleanroom.” says Frank Spehl, Sales
tected in the cleanroom.” reports the
filter classification.”
Manager for AAF Lufttechnik GmbH
AAF filter expert.
(AAF Air-Equipment GmbH) in Germany and Switzerland. The company located in Oberhausen, Germany is specialized in air filtering systems.
Three Stage Filter Concept
tamination.
Time to Change the Air Filter As pollen, when the facility has been
Essentially, Frank Spehl reassures us, modern air filtering equipment
In order to keep pollen out of the
built correctly, never even make it to
is so good that neither pollen nor
cleanroom, a three-stage filtering
the Hepa-filters, let alone into the
other such particulate matter is able
concept is recommended. High-
cleanroom, there is no difference
to enter a cleanroom. The first and
grade pocket filters made from syn-
when comparing the operation of
second levels of filtering normal-
thetics are recommended in the first
an ISO cleanroom and a GMP clean-
ly filter out all pollen and fine par-
stage. These have a high capacity
room. The ISO norm (International
ticulate matter from the air. “How-
for filtering out dust and withstand
Organization for Standardization)
ever you have to consider foremost
high levels of moisture. Compact fil-
puts down firmly the maximally
the condition of the equipment in
ters should be used in the second
allowed particle concentration in
the cleanroom, the correct working
stage because of their large filtering
a cleanroom which is relevant for
behavior of employees and to car-
surface areas, the resulting low lev-
the semiconductor industry. GMP
2/2015
11
Birch tree aments spreading pollen. Photo: fotolia, Ingo Bartussek
guidelines (Good Manufacturing Practice) provide for the quality as-
Accelerated Germ Growth
surance in cleanrooms in which
pendence of the Relative Humidity”). In German latitudes, summer temperatures bring on high levels of
particle free and germ free environ-
Other challenging times of year for
humidity ( see the graph: “Moisture
ments are critical for example in the
cleanrooms are in spring and sum-
Content in the Air”). Rising tempera-
production of pharmaceutical prod-
mer when temperatures rise and
tures enable air to take on more wa-
ucts, food products and cosmetics.
the corresponding increase in hu-
ter, thus increasing the lifespan of
When considering a filter change,
midity. Both conditions drive up
airborne germs. The large amount
it makes no sense to carry out a fil-
the growth of germs. As with peo-
of airborne particles in summer air
ter change immediately before the
ple, most germs are at their best in
becomes an advantage for germs.
pollen season begins. It is much bet-
warm temperatures. Germs multi-
Pollen and dust act as germ-shut-
ter to keep using the present filters
ply much more rapidly in summer
tles and lead to a rapid distribution
until the peak of the pollen season
than in winter.
of micro-organisms in the air. On-
and then to change them out in ear-
ly after a thunderstorm does the air
ly summer. The next maintenance
Micro-organisms because of the lack
become de-contaminated and the
should occur in November to pro-
of nutrients don’t find in air the best
germs flushed out of the air to be
vide the cleanroom facility with
living conditions and die off rapid-
deposited on the ground.
fresh filters to work over the win-
ly. However when the air humidi-
ter and to be ready for the follow-
ty increases, their chances for sur-
ing spring and the beginning of the
vival increase dramatically (see the
pollen season.
graph: “Survival of Germs in De-
Advises changing the filters after the pollen season. Frank Spehl, Sales Manager for Germany/Switzerland at AAF Lufttechnik GmbH. Photo: René Dreyer, Cleanroom Media
»Everything that a person can smell is a molecule chain which can also hide risks for a cleanroom.« Frank Spehl, AAF-Lufttechnik GmbH (AAF Air Equipment GmbH)
2/2015
12
Dec
Jan
Feb
Mar
Apr
May
June
July
Aug
Sept
Oct
Nov
hazel alder poplar willow ash-tree hornbeam birch beech oak pine grasses Plantain
LIFE & BUSINESS | TITLE STORY
rye stinging nettle mugwort ragweed main blossoming
pre- and post-blossoming
possible occurrence
SOURCE: Pollen season calendar: the peak of the pollen season is approximately from April to July. Source: DAK/ German Pollen Information Service Foundation.
Cleanroom or Germ-Room
The reason for the susceptibility of
rector of MCRT Micro CleanRoom
the room-air equipment is the so-
Technology GmbH. The company
called dew point. This is the tem-
located in Heuchelheim, Germany
Especially susceptible to germs set-
perature threshold under which the
is a leading supplier of customer
tling down in spring and summer
moisture in the air condenses out
tailored cleanroom solutions. The
are the room-air technical systems.
(see the graph: “Dew Points at a Rel-
problem of outside temperature and
These are the systems responsible
ative Humidity of 80%”). An air tem-
room humidity pertain to nearly
for the desired conditions of the air,
perature of 25° Celsius and 80% rel-
every domain of cleanroom technol-
for example the temperature, the
ative humidity has a dew point of
ogy, in which medicines, pharma-
moisture content and the air qual-
21° Celsius. If this 25° Celsius warm
ceutical products, micro-structures
ity. This equipment works to bring
summer air is cooled down to 20°
and nano-structures are produced
about the desired air exchange and
Celsius, the moisture in the air will
emphasizes Machmüller. “It should
provides the cleanroom with condi-
condense onto cool surfaces and
never be forgotten that a person who
tioned and cooled air.
subassemblies. Everyone has experi-
sweats presents a major source of
enced such effects for example when
contamination for the process and
the mirror in the bathroom fogs up
the entire cleanroom, a source much
while showering. If the condensed
greater than what normally occurs.”
water makes contact with margin-
Conversely, dry conditions in pro-
al contamination in a cleanroom,
duction areas can cause the destruc-
a micro-milieu is formed which of-
tion of products due to electrostat-
fers ideal conditions for germs to
ic charges.
Warns against inadequate air de-humidification in cleanrooms: Andreas Machmüller, Managing Director of MCRT Micro CleanRoom Technology GmbH. Photo: Archiv.
multiply. “The cooling and de-moisturizing of air is a very difficult task especially
Wet Filters and Dripping Ceilings
in facilities whose temperature and
2/2015
humidity must be held within strict
Andreas Machmüller’s experience
tolerance ranges, independent of the
tells him that the norms as defined
conditions of the outside air.” says
and interpreted for cleanroom air
Andreas Machmüller, Managing Di-
conditioning systems, at 32° Celsi-
13 us with 40% air humidity are no
drops, like a wet sponge being
crannies, uneven surfaces and edg-
longer suitable. The example of
wrung out, can be used for this
es, dead zones where air is trapped
correctly installed and adjusted air
purpose. The moist summer air
can harbor particles and germs
conditioning systems failing in ICE
can also be directed over a cooling
which have fallen out of the air
trains have shown this clearly. “Ac-
battery where the water is cooled
stream and become deposited on
cording to my estimates, there is an
down below the dew point and
exposed surfaces. Therefore, when
urgent need to raise these values.”
condenses out. The de-humidifi-
planning a cleanroom facility, con-
says the MCRT Managing Direc-
cation of warm air can well cause
sideration should be given to hav-
tor. New information has brought
higher operating costs. However if
ing as few nooks and crannies in
out that cooling water lines sweat
costs want to be brought down, the
the canal system as possible. Also
when surface temperatures reach
danger than exists that germs are
important to consider is the com-
18° Celsius. This water then distrib-
able to favorably develop and be-
pliance to maintenance schedules
utes itself into the circulating air
come distributed throughout the
and the cleaning/sanitation work
in the cleanroom which is abso-
entire cleanroom via the air con-
before the beginning of summer.
lutely detrimental or in the worst
ditioning system. Incidentally, the
case comes onto process-relevant
topic of air conditioning will be on
An additional risk analysis is rec-
surfaces which can lead to serious
the agenda at this year’s Cleanzone.
ommended for the summer peri-
damage. This problem can be rec-
This International Trade Fair for
od. Especially important to con-
ognized in wet particle filters and
Cleanroom Technology will take
sider air flow behaviors in the
dripping ceilings. “Therefore I rec-
place from October 27th to October
cleanroom and to identify the ar-
ommend the ‘wet’ outside air fil-
28th, 2015 in Frankfurt am Main,
eas with minimal air movement
ters to be set at 34° Celsius to 35°
Germany.
as in these areas the risk is high-
Celsius with 40% relative air hu-
er that airborne germs cannot be
midity.” says Andreas Machmüller.
adequately transported out of the
Air de-humidification in clean-
Air-Flow-TechnicalDead-Spaces
rooms is essential in spring and
cleanroom. Possible condensation zones should be localized as these marginal colder surface areas can
summer. High performance com-
Further sources of contamination
lead to the deposition of moisture
pressors which compress the air
can be found in windy, complex ca-
and create ideal conditions for
until the moisture falls out as
nal systems. In all those nooks and
germ growth.
Pollen. Photo: fotolia, haemengine
2/2015
14
LIFE & BUSINESS | TITLE STORY
Half-life Graph 1: Survival of Germs in Dependence of the Relative Humidity | When the air humidity increases from 15% to 85%, germs survive considerably longer, here portrayed with Staphylococcus aureus, Escherichia coli and Enterococcus faecialis. • Half life: time period in which half of the germs die. • r.F.: an abbreviation for relative Feuchte (humidity), this means the relative percentage of the maximal possible absorption of water in the air. Reference: Böhm et al.: Abfall Wirtschaft (Waste Economy) The latest from research and practice. M.I.C. BAEZA- Publisher Witzenhaus, 1998.
Train Correct Cleanroom Entry Procedures It is naturally important to thoroughly monitor the largest gateways for the entry of particles
When the air humidity increases from 15% to 85%, germs survive considerably longer.
and germs. Included here are the air outlets and inlets, filters and above all the personnel and ma-
prevented says Frank Duvernell,
This applies to the entry of materials
terial air locks. The entry of peo-
Managing Director of profi-con
as well. A tool box that a tradesman
ple and material through the air
GmbH Contamination Control
used previously on a construction
locks provide for pollen, germs
in Leipzig, Germany. Since 1985,
site and now wants to bring inside
and particles great opportunities
the company has been work-
a cleanroom must be beforehand
to be dragged into the cleanroom.
ing in the business of cleaning
thoroughly cleaned square millim-
In order to minimize this con-
dust-free and sterile cleanrooms
eter by square millimeter. This can
tamination, there exist definite
as well as giving seminars and
take up a lot of time when the clean-
dressing procedures. It should be
workshops to cleanroom per-
ing is done correctly. “The motiva-
planned that one person enters
sonnel. “The discipline and daily
tion of the personnel also plays a
several air lock areas and with the
routines of employees can lead
big role in this respect.” says Frank
lowest demands as much outside
from time to time to significant
Duvernell. To avoid the time and ef-
clothing as possible be taken off
discrepancies.” comments Frank
fort and the risk of contamination,
and to pick up and put on the cor-
Duvernell, an expert in correct
Frank Duvernell advises to store
rect clothing for each particular
cleanroom working procedures.
tools in the cleanroom which can
air lock entry phase.
“Therefore it is important that
be cleaned by the appropriate pro-
employees’ awareness be raised
fessionals. If the bringing in of cer-
Despite exactly described pro-
by targeted training dealing with
tain tools cannot be circumvented,
cedures, the accidental entry of
the risks involved with pollen,
the air lock entry procedure must
contamination can never be fully
particles and germs.”
be exactly described and the person-
2/2015
15 Water absorption in g / m3
Air temperature in °C
Relative humidity 80% Water content (g/m3)
Dew point (°C)
Air temperature in °C Graph 2: Moisture Content in the Air
Graph 3: Dew Points at a Relative Humidity of 80%
The higher the temperature rises, the more water the air can absorb.
The cooling of air with 80% relative humidity leads to condensation of
Saturation is achieved when humidity reaches 100%.
water at the dew point.
nel trained in this procedure. Only
Cleanroom operators who take the
calmly. Airborne pollen, humidity
in this way can the maximal reduc-
advice of experts to heart can face
and germs won’t be able to get foot-
tion of contamination be achieved.
the warmer times of year more
holds in their cleanrooms.
Cleanroom Expert Days: »Cleanroom Design« On May 5th and May 6th, the ReinraumAkademie (Cleanroom Academy) in Leipzig will be hold-
The event will take place in: Cleanroom Experience Competence Center
ing the Cleanroom Expert Days. The topic of the
Rosa-Luxemburg-Straße 12-14
event will deal with “Cleanroom Design”. The
04103 Leipzig
spectrum of expert presentations and discus-
Germany
sions range from the demands and requirements in the design of cleanrooms, optimal airlock concepts, air ventilation concepts, cleanroom monitoring concepts, clothing designs, safety issues
Information regarding registration can be found at: Email: luisa.guenther@reinraum-akademie.de Internet: www.cl-ex.com (under “Expert Days”)
and the aspects of modern cleanroom design.
2/2015
16 Instrument table: Differential Flow Ventilation prevents that germs from surrounding areas find their way into open wounds or onto instrument
LIFE AND BUSINESS | HOSPITAL GERMS
tables. Photo: WavebreakmediaMicro.
2/2015
What is being done about Hospital Germs?
In Europe’s clinics and hospitals 3.2 million people are infected every year with dangerous pathogens.
Hospital germs cause the death of up to 40,000 people a year in Germany alone. This data comes from the German Association for Hospital Hygiene. As there is no central notification procedure available, the number of deaths is bound to increase. A consistent application of cleanroom technologies could prevent a large part of these infections. It is quick, aggressive and has in the
80,000 Patients Daily
meantime taken the lives of twelve
plete with antibiotics prescriptions the following results were obtained: the pathogens caused lung inflammation in 19.4% of all infected patients; 19% of all patients acquired urinary tract infections; in nearly 20% of the cases, surgical wounds became infected. According to the study, the intensive-care station car-
people. Its name: Acinetobacter bau-
Outbreaks of multi-resistant path-
ries the highest risk of germ infec-
manii. The scene of the crime: The
ogens, as in the Kiel University
tion. The European average for all
University Hospital Schleswig-Hol-
Hospital, happen regularly in hos-
patients who became infected by
stein in Kiel, Germany. This feared
pitals round the world. Alone in Eu-
hospital germs lies at 19.5%. In most
hospital pathogen has been running
rope, 3.2 million people are infected
cases, airways and blood vessels be-
rampant here since December, 2014.
every year with hospital germs. This
came infected.
baumanii had already infected oth-
Clostridium difficile counts as one of the main
Staphylococcus aureus is known as the most
er patients. The outbreak seemingly
pathogens in hospitals which can in serious
frequent cause of hospital infections. Photo:
cases of diarrhea bring about death. Photo:
HZI/Rhode.
Normally the pathogen lives in water and in soil. It succeeded in infiltrating the University Clinic by tagging a ride along with a patient who had been transferred from areas around the Mediterranean Sea to Kiel on December 11, 2014. By the time this patient died, Acinetobacter
was under control at the beginning of 2015, however a second wave of in-
HZI/Rhode
fections broke out and this time no
frightening statistic was the result of
The ECDC study shows that the
one has any idea where the patho-
a study done by the European Centre
intestinal bacterium Escherichia
gen originated from. The nasty thing
for Disease Prevention and Control
about the pathogen is: It spreads it-
(ECDC) in Solna, Sweden. 80,000 pa-
self through the air and also by con-
tients are treated against infections
tact-infection. That the pathogen is
daily in Europe’s hospitals, patients
invisible is only one problem, the
who before coming into the hospital
other is that it is resistant against
had not been infected, only acquir-
several antibiotic groups – it doesn’t
ing the infection afterwards.
go down easily.
1000 hospitals from all EU countries including Norway and Island took part in the study. According to the analysis of 231,000 patient files com-
ECDC Director Marc Sprenger pleads for a multi-dimensional prevention and control program for the avoidance of hospital infections. Photo: ECDC.
2/2015
17
LIFE AND BUSINESS | HOSPITAL GERMS
18
Medical instruments. Photo: werbefoto-burger.ch.
tal infections could be prevented
Association Vice-President Pro-
by a mix of sustainable and mul-
fessor Julia Seifert. According to
ti-dimensional prevention and
the opinion of the Association
control programs.”
there are many reasons for the increase of multi-resistant germs:
Stronger Laws are demanded
the increasing use of antibiotics in animal feed; contaminated imported meat; the transfer of pathogens by farmers, veterinarians
The Professional Association of
and tourists. Additional reasons
German Surgeons are going one
are too lax hygiene requirements
step further and demanding
and the lax handling of antibiot-
stronger laws. In order to get a
ics in other countries.
handle on the problem, the new infection-protection law doesn’t
Georg Baum, Chief Managing
fulfill the present demands.
Director of the German Hospital
Measures must be taken when
Federation (DKG) wants to set the
the pathogen first emerges and
lever on hospitals. “As the case in
not just when the germ appears
Kiel has shown, despite consist-
in the hospital. “The pathogens
ently keeping to hygiene require-
Coli (E.Coli) is the most frequently
rarely originate in the hospital
ments and measures, the risk of
found hospital germ. The second
but rather get dragged in.” says
pathogen-transmission cannot be
Julia Seifert, Vice-President of the German Surgical Association observes that pathogens seldom originate in hospitals but are brought in from outside. Photo: Jenny Sieboldt.
most frequent is Methicillin-resistant Staphylococcus aureus (MRSA). This pathogen causes between 20% and 40% of all hospital infections in Germany; in Romania, Italy and Portugal, this is more than 60%. The Director of ECDC, Marc Sprenger from the Netherlands warns those people in charge: “A major part of hospi-
2/2015
“The battle against resistant germs requires us to act consequently on all levels.” Hermann Gröhe, German Federal Health Minister
19
Operation: Open wounds are gateways for germs. Photo: WavebreakMediaMicro
of the Hospital”. “Every hospital should possess at least one cleanroom: the OP.” says Gernod Dittel. Cleanroom technologies allow for the needed microbiological air purity to be established.
Cleanroom Concepts for the OP There are three principal concepts for OP cleanrooms: turbuGeorg Baum, Chief Executive of the German
Gernod Dittel, Chairman of the German
lence-free displacement air flows,
Hospital Association, is demanding concen-
Cleanroom Institute, criticizes that many
trated cooperation among all involved parties
OP’s do not correspond to modern techno-
turbulent mixed ventilation and
regarding infection prophylaxis. Photo: DKG.
logical standards. Photo: Stefan Noack.
laminar ventilation. In all three procedures, purified air would continually be supplied. The dif-
ruled out.” What is necessary is a
Professor Gernod Dittel is pleading
ference: Wh ile t h e t urb ulen t
concentrated collaboration of all
for these investments. The Chair-
mixed air flow thins out the con-
involved parties. Indeed now for
man of the German Cleanroom In-
centration of airborne particles,
years, hospitals have set the high-
stitute and Managing Director of
the turbulence-free displacement
est priorities on infection-proph-
Dittel Engineering criticizes that
air flow and laminar ventilation
ylaxis however there is much
the major part of operating theat-
systems effectuate a displacement
room for improvement. “Bet-
ers in Germany, don’t meet today’s
of the particles – the displacement
ter infection-prevention would
technical standards. Many OP’s
air flow system from above and
be possible when all parties in-
are over 30 years old. Dittel from
the laminar ventilation system
volved would systematically con-
Kochel am See in Bavaria, Germa-
from below.
tribute.” says Baum. Along with
ny is convinced that the number of
these measures, investments in
infections can be reduced when it
The turbulence-free displacement
structural and sanitary facilities
starts to become cleaner and more
air flow system is especially suitable
are necessary.
sanitary in the “Heart Chambers
for operating theaters. The patient
2/2015
20 and the OP team are bathed in sterile, purified air from ceiling outlets which then is able to escape via corner outlets. This method as well as the laminar flow method prevents particles and germs coming from external areas from entering open wounds or from settling on surface areas inside the OP. These procedures can become very
LIFE AND BUSINESS | HOSPITAL GERMS
expensive when planning for an entire OP, therefore it is recom-
Sterilization equipment. Photo: werbefoto-burger.ch.
mended to partition the OP into sectors of varying grades of cleanliness. Differential flow ventilation systems work very well in achiev-
Inferior Protective Clothing
ing this effect. These systems gen-
A, the highest of all sterile cleanroom classes. This was shown by tests done by the Lucerne Univer-
erate a faster air flow rate inside the
Despite these preventive meas-
core areas of the OP than in the rest
ures, the danger from infections
of the room. Therefore the highest
through airborne hospital germs
Hospitals generally contain their
grade of air purity is created in this
cannot be disregarded. The differ-
own pharmacies in addition to
core area where it is needed and
ential flow ventilation system does
their OP’s. Cleanroom solutions can
contamination from other areas of
indeed protect the core areas from
also help here regarding the neces-
outside contamination, howev-
sary cleanliness. Isolators for exam-
er a serious source of contamina-
ple or safety and laminar flow work
tion is found within this displace-
benches make possible the aseptic
ment-flow core, this being the OP
preparation of active ingredients.
team itself. The wearing of protec-
Protected with the rubber sleeves
tive clothing is absolutely compul-
and gloves of an isolator, employees
sory in order to protect the patient.
are able to safely handle the mate-
“The requirements in this case are
rials inside the isolated cabinet of
not especially strict.” criticizes Ger-
the isolator. A laminar flow system
nod Dittel. “In other cleanrooms,
assures the required air purity. The
Researcher using a scanning electron microscope. Hospital germs can be seen on the monitors. Photo: Jan-Peter Kasper, FSU.
sity of Applied Science.
for example in the pharmaceuti-
isolated areas inside the isolator
the room is reliably prevented from
cal industry, significantly stricter
are afterwards cleaned and steri-
penetrating the core.
clothing requirements and airlock
lized with hydrogen peroxide.
entering/exiting procedures are However, hospital operators should
practiced.” It would be unthinkable
Universal and consistent project
be mindful that the movements of
to enter a cleanroom wearing street
planning is decisive for rendering
the OP staff as well as the heat com-
shoes. Doctors and OP assistants
harmless the hospital germs. Indi-
ing from lamps and other devic-
are in no way completely covered
vidual measures help only mini-
es cause the displaced air to swirl
up in an OP theater. The clothing
mally as all sub-systems of a hos-
about. In order to safeguard that the
consists of aprons, sterile gloves,
pital are complexly interconnected.
displacement effect is maintained,
head and mouth coverings as well
“The modification of an OP is in it-
the appropriate service provider
as normal shoes and socks. If the
self insufficient in making a hos-
should examine beforehand which
personnel wore total-body overalls
pital virologically and bacteriologi-
kind of air flow and speed are re-
with breathing-exhaust systems as
cally safe.” says Gernod Dittel. What
quired to compensate for these in-
well as sterile boots, the number of
use is a sterile OP when subsequent
terference factors.
micro-organisms per cubic meter
germs find their way to patients
air would be drastically reduced,
from the hospital’s kitchen or from
namely to the level of GMP-class
visiting family and friends? It also
2/2015
21 happens that newly-built departments have to be re-built even before their initial startup because of hygienic deficiencies. For example, when the tiles in a new OP are set with normal cement, this would be equivalent to the ultimate micro-biological disaster. Therefore a hospital has to be seen as a complex of interacting departments, not just as individual parts of a whole. An inter-disciplinary approach is necessary.
The Health Minister acts
Autoclave in a medical laboratory. Photo: Lyosha Nazarenko.
turing Practice). These manufac-
industries, hospitals have little ex-
turing guidelines assure the qual-
perience with GMP. If the guide-
ity of production practices and
lines were consistently applied,
A sharp weapon in the battle
environments in the production of
many hospital infections could be
against hospital germs are the
pharmaceutical products. In com-
avoided. Alone the fact that hospi-
GMP guidelines (Good Manufac-
parison to many hygiene-critical
tal pharmacies are less strictly audited than external pharmacies, allows hospital pharmacies to fall
Multi-resistant Hospital Germs
into negligence. Hermann Gröhe has in the mean-
What are multi-resistant germs?
time started to act. “The battle
These are disease pathogens which become resistant due to a fre-
against resistant germs requires
quent or an incorrect antibiotic application. As some pathogens de-
us to act consequently on all lev-
velop a resistance to several classes of antibiotics, they are named
els.” he said after the 12th fatality
multi-resistant germs.
in the Kiel University Hospital, laying out a ten point plan. He is de-
Why are multi-resistant germs so dangerous?
manding from hospitals to strictly
Germs which have developed resistance to antibiotics do not allow
hold to existing hygiene require-
themselves to be killed with drugs. Their transmission is carried out
ments as well as more strict mon-
by means of direct contact, by contact with objects and by air.
itoring from health officials. In addition, he wants to tighten re-
Which germs more often occur?
porting obligations so that patho-
MRSA-, VRE- and EBSL pathogens cause most cases of death. The
gens will be reported at their first
abbreviations stand for Methicillin-resistant Staphylococcus au-
appearance and not after an out-
reus, Vancomycin-resistant Enterococcen and Beta-Lactamase
break in a hospital. This will pro-
producing Entero-bacteria.
vide health officials valuable time. Gröhe says that the incidence in
Who is in danger of infection?
Kiel has to become the occasion
Hospital germs are especially dangerous for older people and those
to try out procedures whereby pa-
who have weak immune systems as well as patients in intensive care
tients be tested for certain danger-
wards. Patients who have been put into rooms with many other pa-
ous germs before a planned hospi-
tients in tight quarters are endangered. Deficient hospital hygiene al-
tal visit. His ordinance proposal is
so raises the risks of infection.
already in the interdepartmental coordination phase. It should become effective this coming summer.
2/2015
22
Diving with a Submarine to a Cancer Cell
Through the integration of nano-technologies in bio-medical applications active agents are able to be applied directly to the seat of the disease thus enabling their active ingredients to react more effectively. The nano-systems are able to recognize the beginning stages of a disease even before the first symptoms appear. The door to personalized medicine has seemingly been opened.
and supply chains beginning with the development of nano-materials and up to the development of entire clinics. The occasion for this consolidation was the revelation that nano-technology has only been successfully deployed in bio-medical
In the future, when doctors want
tut für Elektronische Bauelemente
applications when material scien-
to diagnose a disease they won’t
und Schaltungen der Universität
tists and engineers, chemists, biol-
first look into the mouth, rather
Ulm), explains: “With semi-con-
ogists and physicists work togeth-
they will dive into the cells. Tiny
ducting nano-structures, the accu-
er with pharmacists, clinics and
sensor systems in the nano-meter
mulation of just a few molecules
industrial companies. The found-
range will soon make this possible.
on the surface is enough to signif-
ing of this platform now has pro-
These sensor systems use mini-
icantly change the conductivity of
vided the framework for all those
mally invasive procedures and like
the structure.” Consequently, dis-
involved to establish contact and
a needle penetrate the walls of liv-
ease-specific bio-markers are able
exchange their experience and
ing cells and then proceed to carry
to be detected early on. Research-
knowledge.
out various bio-chemical tests. The
ers are also able to look at the pro-
beginning stages of a disease are
cesses happening inside a cell with
The German Federal Ministry for
thereby recognized early on even
the help of the nano-sensors. Steff-
Education and Research supports
before the patient has perceived
en Strehle together with other sci-
the application of nano-technol-
the first symptoms.
entists have been able to intracel-
ogy in pharmaceutical and med-
lularly record the ‘heart beat’ of a
ical technologies with numerous
Researchers in southwest German
single heart muscle cell. “Nano-sys-
affirmative action measures in the
Ulm have been working for a while
tems possess interesting and diverse
research of materials and health.
on such nano-submarines. These
application potentials.” says Strehle.
Especially promising is the deploy-
submarines consist of small semi-
Unfortunately, these nano-system
ment of a so-called nano-scaled,
conducting nano-structures which
procedures are not so often prac-
operational transporter. This
are able to examine diverse process-
ticed in the laboratory.
transporter has been designed to
Foto: fotolia
LIFE AND BUSINESS | NANO BIOMEDICINE
Nano Biomedicine is helping to recognize diseases earlier and to react with targeted therapies.
ing inside a cell without appreciably
efficiently transport active ingre-
disturbing the complex interactions
dients over biological barriers to
going on inside the cell. This could make working with probes dispen-
Nano Medicine Platform Founded
their target locations. Researchers have been working on the development of the corresponding carrier
sable as such probes strongly impair the bio-chemical processes in-
In order to change this situation,
systems. Macro-molecules such as
side a cell.
a German Nano Medicine Plat-
lipids, biopolymers, hydrogels and
form was founded on March 4, 2015
other molecules are being used. It
Steffen Strehle, a researcher at the
in Frankfurt am Main. The goal
is fascinating how many additional
Institute of Electron Devices and Cir-
of this platform is to establish re-
functions in these carrier systems
cuits at the University of Ulm (Insti-
search-based, overlapping concepts
permit themselves to be integrat-
2/2015
Photos: fotolia, beawolf
23
Nano-robots will in the future be able to transport medical active ingredients, destroy cancer cells and carry out gene therapies on cells.
ed. For example, the active ingredi-
Nano-particles are suitable as trans-
their target locations via the skin,
ents can be activated using magnet-
port receptacles against the mul-
the intestines or the blood circula-
ic fields or pH values or the active
titude of diseases such as tumors,
tion, for example to locations inside
ingredients can be enriched at the
inflammations, skin diseases and
the brain, in the digestive tract or
target location.
Alzheimer. They can be brought to
into the other various organs. Na-
2/2015
LIFE AND BUSINESS | NANO BIOMEDICINE
Photo: fotolia, beawolf
24
no-particles are also predestined
number are around 150 products
the body’s immune systems so that
to be used as transport receptacles
which are currently in the clinical
they can be successfully transport-
for DNA in cells, for example in
testing phase.
ed to their target locations.
gene therapies. Applications which have been
Strong Growth Market
established for some time now are processes which provide for th e i m p ro v e d ab sorp ti o n and
The market for nano-technological
bio-availability of active ingredi-
medical products is booming. The
ents. Included here are the process-
worldwide turnover with current
es of capsulation with liposome
products according to the progno-
and polymers, the enlargement of
sis of the market research compa-
the active ingredients surface ar-
ny BCC, from a value of $43 million
ea by grinding and emulsification
in 2011, will more than double this
processes and the chemical bind-
amount by the year 2016. The num-
ing of polyethylene glycol to pro-
ber of nano-medical products on
tein agents. Concerning the chem-
the world market is estimated to
ical binding process, chain-like
be more than 100, a third of these
structures are hung onto the ac-
products coming from the phar-
tive agents which envelope them
maceutical industry. Adding to this
thus offering protection against
Nano-silver being focused on in the battle against antibiotics-resistant germs: Professor Manfred Köller, Head of the Department of Surgery, University Hospital in Bochum.
Commercial Nano-Products Commercial nano-products in the medical technology industry in-
“Nano-particulate silver provides new perspectives.” Professor Manfred Köller
clude above all products in in-vitro and in-vivo diagnostics, in bone replacement materials and in nano-laminated implants. The nano-laminated example is being focused on by the occupational
2/2015
Photo: fotolia, beawolf
25
Cancer Cells Targeted
insurance association University
medical practitioners to look for al-
Clinic Bergmannsheil in west-Ger-
ternatives. “In this instance, nano
man Bochum. Researchers and sci-
silver particulate offers itself as a
A further very promising applica-
entists from the area of surgical
new perspective.” emphasizes Pro-
tion of nano-biomedicine is to the
research are working with nano
fessor Köller. Applications include
recognition of cancer cells in their
silver-particulate. “The antimicro-
for example the coating of cathe-
early stages. Physicians at the Jo-
bial effect of silver has been known
ters, sterile packaging, OP devic-
hannes Gutenberg University in
for some time but the triumph of
es and machines and prostheses.
Mainz are doing research on a pro-
antibiotics has let the application
The advantage of nanoparticles is
cess which combines nano-technol-
of silver in the medical field to be-
in their tiny size, their diminutive-
ogy with principles from hard disk
come nearly forgotten.” says Pro-
ness. Their surface area is much
technology using innovative new ap-
fessor Manfred Köller, Director
larger than that of an single, larg-
proaches. This approach will be able
of the University Surgical Clinic.
er-sized body containing the same
to detect free roaming tumor cells
Many micro-organisms, especially
amount of silver. The enlarged sur-
in human blood circulation. “ This
the so-called Hospital Germ or Bug,
face area is able to continually re-
approach suggests that in the body
have become in the meantime re-
lease silver which better inhibits
free roaming tumor cells are indeed
sistant to antibiotics, thus forcing
the growth of micro-organisms.
an early warning signal for cancer
Swiss Medtech Expo 2015 The Swiss Medtech Expo in Lucerne, Switzerland is known as the meeting point for companies in the medical technology industry. It takes place from September 15th to September 16th, 2015. System suppliers and service providers as well as research and education institutes will be presenting their products market overview on topics such as passive implants, diagnostics, new materials, surfaces, micro and nano-technologies, robotics and electromechanical devices.
2/2015
Foto: fotolia
and services at the trade fair. Visitors from companies operating cleanrooms will receive here a current
LIFE AND BUSINESS | NANO BIOMEDICINE
26 or for the reoccurrence of the dis-
by researchers at the Institute for
nano-particles causes the refract-
ease after a tumor therapy has tak-
Physics at the Karl-Franzens Uni-
ed light passing through the bound
en place.” says Project Manager Pro-
versity in Graz, Austria. The goal is
proteins to change which by using
fessor Roland Stauber.
to develop highly sensitive bio-sen-
the corresponding measuring meth-
sors which will be able to detect a
ods allows a diagnosis in the very
The detection of such tumor cells is
heart attack quickly and assured-
early stages of the disease.
especially meaningful for the prog-
ly. Certain proteins play a particu-
nosis as well as the diagnosis of the
lar role as bio-markers. Their occur-
The scientific foundation for this
disease. The Mainz researchers to-
rence in the blood is an indicator of
approach has been laid. The steps
gether with partners from indus-
the disease and makes early diagno-
toward practical applications are
try and science are working toward
sis possible.
now being taken. Professor Joachim
determining the concentration of
Krenn, Director of the Nano-Optic
these infrequent cells in the blood
Group is already thinking ahead to
by using magnetic detection with
corresponding optical nano-sen-
a hard disk head. The Scientific
sors: “We have learned over the last
Chairman of the University Medi-
years how to produce and to charac-
cal Board, Professor Reinhard Urban
terize nano-particles. Their applica-
explains: “ Timely recognition as it
tion in sensor technology is the next
has always been, remains the deci-
logical step.”
sive criterion in the battle against cancer.” The approach of this joint project is colossally innovative and promises a new dimension in future
Research being done on nano-sensors for the early recognition of heart attacks: Professor Joachim Krenn, University Graz.
therapy concepts.
Nano Sensors Against Heart Attacks
These kinds of innovative medical products are playing an increasing role in the fields of therapy and diagnostics. The pre-requisites for
The basis of an early recognition
flawless functionality are to protect
consists of specially designed gold
the production of such products
nano-particles which are produced
from contaminant particles and
at the university and which pos-
microbes. Cleanroom technology
sess particular optical characteris-
provides these production environ-
Nano-biomedicine could soon reach
tics. These nano-particles are coated
ments. Without completely sterile
a break-through in the early recog-
with a molecular layer which binds
and clean research and production
nition of a heart attack. Very prom-
itself to the sought-after proteins.
facilities, nano-biomedicine would
ising work in this field is being done
The spectral composition of the
be impossible.
A clean room arises from the mind www.cleanroom-academy.com ACADEMY – Training courses, seminars, coaching CLEANROOM EXPERTS DAYS – conferences KNOWLEDGE BASE – Trends and Innovations COMPETENCE CENTER – Cleanroom knowledge at your fingertips
2/2015
27
Helfen steht jedem gut. Jette Joop, Designerin und DRK-Botschafterin
Eines f端r alle ...
DRK.de 2/2015
28
On the road with...
LIFE & BUSINESS | ON THE ROAD
Philippe Trösch, Novasina AG
Philippe Trösch is Sales Engineer at Novasina AG. This Swiss company develops and produces solutions for the measurement, visualization and evaluation of climate parameters such as air humidity and differential pressure. Philippe Trösch’s task is to design for customers the optimal measurement and control technical solutions out of the various and diverse possibilities.
work. However in practice, the automobile is my preferred means for travelling as I am able to take with me all the necessary equipment and materials required for the road trip, not to forget that the travel routes can be flexibly planned. In-
How often are you on the road?
deed, I would have nothing against tomers via the telephone or email
having a chauffeur, or at least a ve-
and to do the required documen-
hicle with a coffee machine.
tation work. Every week, I am two to three days on site at the customers’ premises and I consult with them on finding
What is your favorite mode of transportation?
What is important to think about when planning a trip? That I haven’t forgotten anything.
the most ideal solutions for their individual requirements. The week
Actually this would be by plane or
This not only includes any docu-
also includes the necessary office
by train. These modes of transpor-
ments, offers, devices or machines,
time to maintain contact with cus-
tation allow me while travelling to
but also a fresh change of cloth-
2/2015
29 ing in those cases I inadvertently
While driving I concentrate on the
spill coffee or other colorful sub-
traffic and prepare myself men-
stances on my shirt. Everything
tally for the next customer visit.
else just falls into place. An addi-
After arriving in my hotel room,
tional bonus is a charming, quiet
I unwind best by going jogging or
hotel which isn’t at that moment
walking.
being invaded by a Techno Convention or other similar event.
What should never be missing while on the road?
What is your most successful way to unwind? By doing sport or by walking through a beautiful, old, historical
Besides the business documenta-
city and finding a charming café to
tion and products I should always
enjoy a glass of this or that, these
have my water cooker with me. I
are ways I can relax. Simply sitting
really love preparing a cup of tea
on a park bench and staring out
or coffee in my hotel room in the
into a beautiful landscape is also
evening. A business traveller tends
an enjoyable, relaxing experience.
to drink too little or too much of the wrong things. Moreover I am able to wind down in the evening with a
What destinations do you favor and why?
warm drink and a good book.
What kind of music do you enjoy listening to?
I like small cities and towns with an historical charm for example Wangen an der Aare, where a person is able to meet interesting peo-
I mostly listen to that which is
ple from the cleanroom industry.
playing on the car radio, from the
It is also mind-boggling just how
howlers of the 1980’s to the current
many enchanting 300-person val-
catchy songs. Sometimes my mood
leys exist in Switzerland, in which
after a business visit determines
high-tech startups or small compa-
my choice of music. When I want
nies with world reputations are lo-
to free up my head and at the same
cated. Privately, my favorite coun-
time hurtle down the highway I lis-
try is South Korea. Earlier, I was
ten to hard rock.
often there on business and I grew
Which countries and regions are most often on your list of destinations? I am often in Switzerland and in Ger-
to admire the South Korean people.
What would be the first thing you would do if you had the unlimited power to do so?
many. In Germany my territory ranges from Bavaria up to Frankfurt am
I would open the hearts of people
Main. A frequent destination is the
to accept the new and different and
cluster in Basel, Switzerland. This
to accept change. I would also see
cluster consists of pharmaceutical
to it that people would put down
companies and suppliers.
their computers and take up real
Are you able to wind down when you are on the road?
QUALIFIZIERUNG QUALIFIZIERUNG WARTUNG WARTUNG STRÖMUNGSSTRÖMUNGSVISUALISIERUNG VISUALISIERUNG MONITORING MONITORING MESSTECHNIK MESSTECHNIK KALIBRIERUNG KALIBRIERUNG SERVICE SERVICE BERATUNG BERATUNG SCHULUNG SCHULUNG
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conversations and enjoy the simple things in life for example a face full of springtime sunshine.
2/2015
30
Light Newly Invented
LIFE & BUSINESS | OLEDS
OLEDs could revolutionize Display and Light Technology
Organic light-emitting diodes are extremely thin, have very strong contrast properties and are extremely energy efficient. These properties open fascinating possibilities for fully new kinds of products. That the visionary applications for this technology mean a stronger need for cleanroom technology, only a few people are aware of this.
no polarization filters and no background lighting. Every sub-pixel is its own little lamp.” explains Manfred Weigand, Global OLED Lighting Marketing Director at Merck KGaA in Darmstadt, Germany. A further asset of OLEDs is that they
The world has never seen such
an additional touch display arch-
are able to be put onto flexible sub-
an instrument panel. Instead of a
es out from the middle console to-
strates enabling displays to be bent.
speedometer and tachometer, this
wards the driver. OLED technology
“This opens to manufacturers total-
automobile cockpit is equipped with
has made possible this unbelievable
ly new possibilities in product de-
new kinds of displays – from the
arching procedure.
sign.” says Weigand.
steering wheel to the passenger-side door. Audi presented this innovation in November, 2014 at the Los Ange-
Amazing Properties
Imaginable is a kind of smart packaging on which marketers could put their film and text advertisements
les Motor Show in their spectacular, attention-getting prologue Au-
OLED stands for “organic light-emit-
getting the attention of every pass-
di Avant.
ting diode”. The diode is a light emit-
ing customer. In the joint project
ting component made from organ-
“cyFLEX”, promoted by the German
The instrument panel has been de-
ic semiconductor material which is
Federal Office for Education and Re-
signed using touch pads installed
able to be produced in thin layers.
search, the Karlsruher Institute for
over the entire width of the display
In contrast to liquid crystal displays
Technology KIT and the German Cy-
area. The driver is able to control the
(LCDs), OLEDs provide brilliant color
nora GmbH are working on materi-
lights and assistant systems from
qualities, razor-sharp contrast and a
als which are suitable for printing
the steering wheel. To the right of
thousand time faster reaction time
or coating with organic light diodes.
the steering wheel, a widescreen
whereby the image can be refreshed
Printed OLEDs make possible the
display has been installed which
with a simple tap of the finger. Or-
production of luminous signposting
the passenger is able to operate to
ganic light diodes give off their light
or billboards. This project will run
control the multi-media system for
diffusely and without any glare over
until the Autumn of 2015 and could
example to make music selections
the entire surface which is in con-
revolutionize product marketing.
or to enter the travel route. With a
trast to other conventional light
swipe of the finger, the passenger
sources. Further advantages of the
simply sends to the driver the nav-
OLED are its wider angle of view, the
igation information or music play
paper-thin construction and its low
list which the driver can now see
energy consumption.
A Revolution in Light and Product Design Lighting technology is experienc-
on his steering wheel display. If this virtual instrument panel is not spec-
OLEDs are pre-destined to be used
ing the same situation. Illumi-
tacular enough, Audi has installed
in portable devices such as mobile
nated wallpapers are among the
in its digital cockpit still another
telephones and notebook comput-
visionary ideas of experts, wall-
highlight: After starting the motor,
ers. “OLEDs need no liquid crystals,
papers which with the flick of a
2/2015
Photos: Audi AG
31
The instrument panel and other displays of Audi Avant prologue consist of large touch displays, some of which are made of organic light emitting diodes.
switch would be transformed in-
OLED lighting the “next big thing”,
approach. Such colour-variable or-
to a television display. Illuminat-
that is, as soon as prices fall.
ganic light diodes could be used
ing large surfaces is made possible
in the large laminated glass pan-
with OLEDs because their mole-
Researchers are working on
els which are installed in trains as
cules are distributed over a broad
large-surface OLED modules in
baggage racks. These racks could
area and no cooling is needed as
the joint project LOIGB. The first
then be used to provide lighting
with LCDs. However, large-surface
results were presented in March,
as well. “The application possibili-
applications are still foundering
2015 at the International Trade Fair
ties for the results so far achieved
because of costs. Every implemen-
for Printed Electronics in Munich,
are exceptionally diverse.” explains
tation depending on the applica-
Germany, including colour-var-
Project Manager Jan Hesse exuber-
tion, OLED light is 10 to 100 times
iable OLED modules which pro-
antly. “Alongside the application in
more expensive than convention-
duce white blended light. The col-
general-purpose lighting, for ex-
al technologies. Nevertheless mar-
ours red, green and blue have to
ample in windows, convertible-el-
ket observers see in large-surface
be separately actuated with this
ements and wallpapers, colour-var-
2/2015
LIFE & BUSINESS | OLEDS
32
Future Lighting Trends: OLED backlight demonstrator. Photo: Osram.
iable OLEDs are suitable for use in
flexible OLED displays installed on
are taking giant steps in conquer-
automobiles and rail vehicles as in-
the interior side of the doors. The
ing the display market. The market
terior lighting – especially as am-
occupants of the vehicle are able
research institute DisplaySearch
bient or accent lighting.” The aer-
to have a look at media contents
predicts that in 2019 the worldwide
onautics industry has also shown
or keep an eye on the autopilot.
market volume alone for OLED dis-
perspective interest in this technol-
When a passenger reaches for the
plays will amount to more than €30
ogy as ambient lighting in airplane
display, virtual controls appear by
million. This market should grow
cabins.
means of eye-tracking and sensors.
yearly by 35%.
New Perspectives in Vehicle Manufacture
Any surface whether it be a window, wall, mirror or lampshade, could serve in the future as a source of light. Manufacturers are already in-
Automobile producers are flirting
tensely working on such future pos-
with the OLED possibilities ena-
sibilities. The South Korean com-
bling them to come up with brand
pany LG Chem Ltd announced in
new design concepts. Audi has al-
Autumn, 2014 a new OLED illumi-
ready presented the innovative
nated display panel which has an
cockpit in its prologue showcase
operating lifetime of 40,000 hours
car Avant. The thin-film organic
at an efficiency of 100 lumens per
light diode could be produced in-
watt (light bulbs: 16 to 20 lumens per
to any desired form to be used as
watt). This is a new efficiency record
Because of the high costs, organ-
blinkers or rear lights and simply
and makes OLEDs competitive with
ic light diodes are pre-destined
glued onto the car’s body. The di-
other technological solutions such
for use in small-surface devic-
odes could be also used as inte-
as florescent lamps and LEDs.
es such as smart phones, tablet
rior lighting or as informational displays. Mercedes Benz demonstrated the latter application in January, 2015 at the Consumer Elec-
Round Things | The Samsung Galaxy S6 Edge has the world’s first double-sided OLED display. Photo: Samsung.
computers, PC monitors and flat
Breakthrough in the Display Market
tronics Show CES in Las Vegas, Ne-
screens in which energy saving, contrast-rich OLED displays can be implemented. Amoung the pioneers in this market is the compa-
vada. The futuristic research ve-
Besides the room lighting mar-
ny LG. This South Korean compa-
hicle, the F-015 is equipped with
ket, organic light emitting diodes
ny has brought attention to itself
2/2015
33 The functionality of OLEDs
Cathode Conductive layers
Electricity doesn’t flow through OLEDs through a wire as with
Light emitting layers
light bulbs, but rather through several organic layers. There
Conductive layers
and light emitting layers. The layers are imbedded between two
are conducting layers for the transport of the charged particles
Anode
large-area electrodes, the cathode and the anode. Graph: HYPER-
Glass / Foil
LINK „http://www.cl-ex.com“www.cl-ex.com. Light
with its curved television which
tron Beam and Plasma Technology
to have a look at virtual informa-
fills the complete field of vision of
FEP in Dresden, Germany have won
tion coming from the internet. A
the viewers sitting in front of it. In
the Innovation Award for eye-con-
camera function senses the move-
the meantime prototypes have ap-
trolled data glasses. These glasses
ment of the eyes so that he can con-
peared which allow the viewers to
are equipped with two mini-dis-
trol the information shown with
modify the curvature of the display
plays in place of the normal lens.
his eyes. For example, by looking
with the push of a button. Nokia
The displays are made with organ-
at the arrow key the pages of an in-
and the Japanese company Semi-
ic light diodes. The glasses enable
struction manual can be turned.
conductor Energy Laboratory Co.,
the user to simultaneously see nor-
System designer Rigo Herold who
Ltd. (SEL) have gone a step further.
mally through the lens as well as
has been centrally involved in the
Their jointly developed OLED displays are not only curved but are
New OLED high-performance modules from Philips. Photo: Philips
also able to be folded while showing videos. According to Nokia, the displays are able to withstand undamaged up to 100,000 folding instances. Samsung has also discovered the flexible OLEDS. On March 1st, 2015, on the opening day of the Mobile World Congress in Barcelona, Spain, the new top-of-therange smart phone Galaxy S6 Edge was presented. The phone’s special feature is a display which is curved over the phone’s edges. The curved edges serve as additional informational displays. Over the next two years, Samsung plans to invest an estimated €3.3 billion in the manufacture of organic displays.
German Researchers are leading the Way German researchers are leading the way internationally in the development of OLED technology. Researchers at the Fraunhofer Institute for Organic Electronics, Elec-
2/2015
34 The Year of Light
ny knows which challenges have to be dealt with in cleanroom-production of organic light emitting di-
UNO has proclaimed 2015 as the “International
odes. “OLEDs are highly sensitive
Year of Light and light-based Technologies”.
to oxegen and moisture. They have
Light impulses make up the backbone of
to be perfectly encapsulated to pre-
the internet, improve medical procedures,
vent corrosion at the cathode and to
make possible wireless communication and
protect the sensitive OLED layers.”
reduce the emission of greenhouse gases
How dense the encapsulation has
through the use of photovoltaic and energy
to be is explained by Weigand us-
efficient OLED light.
ing the example of a football field
LIFE & BUSINESS | OLEDS
In 2015, many days coincide with important dates out of the science of optics. 400 years ago, French engineers developed the first prototype of a solar energy driven machine. 200 years later, Fresnel published his first work on the wave theory of light. In 1865, Maxwell put down the fundamentals of the science of electricity with his theory of classical electro-dynamics. In 1915, Einstein presented his universal theory of relativity. In 1965, Penzias and Wilson discovered evidence for the Big Bang theory with cosmic microwave background radiation.
which has been fully covered by a tarp. If it rains permanently for a complete month, the tarp should let through at the most one single drop of water. Bringing this example to the production of OLEDs, this means less than a single visible defect on a television screen. A further challenge is the cost of series production. The hopes here
development of the glasses proud-
study’s participants see the high
rest on the latest inkjet technol-
ly said: “The Innovation Award
production costs as being the big-
ogy. This established technology
shows that in addition to Google,
gest danger for success in the mar-
could replace the expensive evap-
data eye glasses are intensively be-
ket. Further critical factors are the
oration of the OLED layers. “We
ing researched in Germany and
technical drawbacks in mass pro-
are convinced that by printing
that our glasses with their touch-
duction such as the scalability of
the OLEDs, the costs for large sur-
less eye control function possess a
production, the immaturity of the
face area applications will be sig-
sensational, very unique character-
printing processes and the high
nificantly reduced.” says Manfred
istic.” Applications for the eye glass-
rate of rejections. According to the
Weigand. His opinion does not per-
es could come about in the surgical
study, the risks are dependent on
tain to the question of if OLEDs will
wards, in the automobile industry,
the application of the display, as the
achieve this breakthrough at all,
in aeronautics and airplane manu-
complexity and costs of production
but rather simply when.
facturer, in the maintenance indus-
rise disproportionately to the size
try and also in commercial diving,
of the display. “If solutions cannot
“These are exciting times for or-
in fact, in those places where the
be found for the current technical
ganic electronics.” states Professor
user has to have both hands free
obstacles, cost-efficient mass pro-
Ching W. Tang. The Chinese/Amer-
while simultaneously needing ac-
duction will not be feasible.” fears
ican chemist at the University of
cess to an instruction manual.
Thomas Krug, Managing Partner of
Rochester in the USA is known as
WTS Consulting.
the father of organic solar cells and
OLED Technology – Its Risks and Opportunities
other optoelectronic components, OLED expert Manfred Weigand of
one being the organic light diode.
Merck KGaA in Darmstadt, Germa-
When asked his opinion on the future of his invention, Tang prog-
Alongside all the enthusiasm for
noses: “OLEDs used as lighting will
the many new possibilities – OLED
first appear in automobiles, then
technology is facing some econom-
will capture the home and apart-
ic and technical challenges. In the
ment market.”
latest study done by Munich WTS Consulting GmbH concerning the OLED display market, 76% of the
2/2015
Flexible OLED, manufactured with sheet-tosheet processing. Photo: Fraunhofer FEP
35 What is the difference between LED and OLED? Material: LED (light emitting diode) are made out of inorganic light emitting semiconductor components. OLED (organic light emitting diode) consist of organic semiconductor layers. Properties: LEDs radiate dot-like. They are therefore predestined for applications which require directed light for example shop, street and stage lighting. LEDs have a long burning time and are able to utilize their advantages in eff iciency in places where lights are on the whole day. OLEDs radiate on entire surfaces. They emit a pleasant white, non-glare, diffuse light which makes possible new decorative applications. As OLEDs are f lexible, they will be able in the future to transform any object into a light source. Longevity: LEDs have a long lifetime. When they are operated under the right conditions (operating voltage and temperature), they are able to emit light for over 100,000 hours. In contrast to conventional light bulbs, LEDs don’t go bad suddenly, but rather lose their brightness slowly over time. OLEDs have generally a lifetime of 10,000 hours. The Lumiblade OLEDs developed by Philips have reached operating times of over 30,000 hours with 70% of their intensity still available. In contrast, a conventional light bulb lasts for approximately 1000 hours.
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2/2015
36
The Art of Nano-Structuring
LIFE & BUSINESS | PORTRAIT
Unique basic research in Linz
Professor Armando Rastelli is the Director of the Institute for Semiconductors and Solid State Physics at the Johannes Kepler University in Linz. The cleanrooms of this institution play a key role in Austria in the fields of education, training and fundamental research.
arduous. Unceremoniously he grabs the piece of paper and reads the text once again. Yes, this is correct he says. He lies the sheet of paper back down on the table for me, takes a swallow from his coffee and looks at
Somehow the aura of professorship
the institute is considered the lead-
me observantly through his glasses. I
seems to be missing when meet-
ing research institution in Austria
ask him what exactly does the writ-
ing him for the first time. He could
in the fields of nano-structures and
ing on the sheet of paper mean, and
be almost be taken as a student. He
semiconductor materials. “What we
he explains: “We want to use the new
comes across unbelievably younger
do here is quite unique.” says the In-
semiconductor-nano-structures as
than his 41 years. His behaviour al-
stitute Director.
sources of light and with the help of approaches from the field of quan-
“What we do here is quite unique.” Professor Armando Rastelli, Johannes Kepler University, Linz, Austria.
tum mechanics make possible the creation of a new kind of computer.” When future light particles instead of electrons whizz along through conductors , data communications will become faster, more secure and energy-saving. Up until now there
so makes him younger: personable,
Pioneering Research
unpretentious, approachable. There
have never existed such light sources. In this respect, the Linz researchers are leading the way in the depo-
is no trace of any kind of authori-
The research which Rastelli togeth-
tative bearing. Upon meeting him
er with his team does may sound
for an interview, the German infor-
rather cryptical, however is in fact
mal “Du” nearly popped out with-
quite spectacular. These scientists
out thinking.
are working on: “Proceeding To-
sition of semiconductor structures.
German as an Independent Study
wards the Production of New Kinds However the first impression is de-
of Semiconductor Nano-Structures
Before Rastelli moved to Austria
ceiving. Professor Armando Rastel-
for the Control of Their Optical and
three years ago, his career had al-
li’s life story instills absolute respect.
Electronic Properties as well as the
ready led him through the coun-
He studied and graduated with a
Examination of the Thermo-Elec-
tries of Switzerland, Italy, Finland
PhD, has worked in five European
tronic Properties of Semiconduc-
and Germany. Besides the physical
countries as a scientist and today
tor-Thin-Films”. I am quoting this
phenomena, he was also able to ob-
manages 50 employees. Rastelli is
from the source. Rastelli who is sit-
serve and study the differences in
the Director of the Institute for Sem-
ting across from me, bends over the
European mentalities. He was born
iconductors and Solid State Physics
table, takes a look at the printout and
Armando Rastelli in Fermo, Italy as
at the Johannes Kepler University in
tries to read the text which for him
the son of an architect and a house-
Linz, Austria. With its cleanrooms,
is upside down. This is obviously too
wife. After his physics studies in
2/2015
37
Professor Armando Rastelli: The Italian physicist is the Director of the Institute for Semiconductor and Solid State Physics at the Johannes Kepler University in Linz, Austria.
Camerino and Bologna, he did re-
mulated questions, I learned very
group leader at the Max-Plank-Insti-
search in semiconductor physics in
quickly how to express myself more
tute for Solid State Research in Stutt-
Pavia. An opportunity and offer to
distinctly and well-structured.”
gart. “My professor from Zurich had
move on to the Swiss Federal Insti-
Despite such small introductory dif-
sent a recommendation for me to
tute of Technology in Zurich, Swit-
ficulties, the young Italian stayed
the institute and they agreed to take
zerland came up which the young
in Zurich for a year and a half in-
me.” Rastelli also accepted the of-
researcher immediately accepted al-
stead of the planned four months.
fer and never suspected that besides
though he couldn’t speak one word
He found in Zurich all the mate-
gaining experience in growing sem-
of German. “I taught myself German
rial dealing with silicon-germani-
iconductor structures, he would also
in the evening with books and cas-
um-nano-structures he needed for
win the heart of a woman. Today he
settes.” he says grinning. “Initially
his doctorate dissertation. During
and his wife are parents of twin sis-
this helped me very little in Zurich.”
this time he was also in Finland at
ters, both of course seven years old.
Swiss-German is actually quite dif-
the Optoelectronic Research Center
ferent from German.
at the TU in Tampere, Finland for three months and for four months
The Swiss Apprenticeship
Swabia and Saxony
in Como, Italy at the Laboratory for Nano-Structure-Epitaxy and Sili-
In 2007, once again moving boxes
con-Spintronics. Lastly the initial-
had to be packed. “My Stuttgart su-
ly distant Swiss even helped him to
pervisor received an offer as a pro-
“Moving to Switzerland was a big ad-
move on and further his profession-
fessor and he asked me if I would
justment for me.” says Rastelli. He
al career.
like to join him.” explains Rastelli.
had to somewhat tame his loose, Ital-
As the offer was for a permanent
ian small-talk mentality. “After not
The next career step after his grad-
position, he jumped at the chance
receiving any answers to my very
uation with his PhD in Pavia in 2003,
and became Department Manag-
verbose and obviously aimlessly for-
took him to Germany. He became the
er at the Leibniz Institute for Sol-
2/2015
LIFE & BUSINESS | PORTRAIT
38
Professor Armando Rastelli was born in Fermo, Italy. Today he lives in Linz, Austria, and is the father of twin sisters.
id State Bodies and Material Re-
dren. He is doing research on new
fulfill their internships in the clean-
search. I asked him how he found
semiconductor elements based
rooms which prove to be for most
living among the Swiss, the Swabi-
on gallium-arsenide for applica-
candidates advantageous when lat-
ans and the Saxons. He didn’t have
tions in quantum-optics and quan-
er seeking a job.
to think long about this: “The Ger-
tum-communications. Privately he
man attitude towards the Italians
loves cycling, hardrock and metal
is more positive than that of the
music, family hiking trips and as-
Swiss.” he answered. The Saxons
tronomy. He has been able to get his
are more relaxed than the Swabi-
daughters enthusiastic with the last
“In Austria, cleanroom facilities for
ans. “Working with the Swabians
item, astronomy. Speaking of wom-
training and education are only
means to always ‘Get it done!’, ‘Get
en and science, he is endeavoring to
found here in Linz and in Vienna.”
it done!’ and ‘Get it done!’, which
get more female trainees and ap-
emphasizes Professor Rastelli. He
also characterizes and influences
prentices to work in cleanrooms.
himself comes into a cleanroom at
the research work. The people in
The events “Women and Technolo-
the most once a week. He observes
Dresden are more easy-going and
gy” and “Girl’s Day”, enable the par-
the cleanroom employees while
friendlier.” Rastelli finishes off his
ticipants to experience a guided
they do their jobs, over-the-shoulder
coffee. He is on his way to attend
tour through the cleanrooms and
so to speak. “Because of the teach-
a student’s defense of a doctorate’s
carry out experiments for exam-
ing operations I rarely have time to
dissertation.
ple, how to expose a wafer. The en-
try out something myself.” Howev-
thusiasm is always grandiose. The
er, this situation will be changing
complicated dressing procedures
in the near future. The Linz Insti-
are even found to be fun. “The high-
tute for Semiconductor and Solid
light is always the air shower.” re-
State Body Physics will be getting
Women in the Cleanroom
Looking Forward to 2016
ports Rastelli. Furthermore there is
a new facility for the production
As I take a brief look at my notes,
the event “Dream Profession – Tech-
of nano-structures on the basis of
the Austrian-of-choice leans over
nology” organized for both genders,
gallium-arsenide materials in 2016.
with his elbows on the table and
also with guided cleanroom tours
Professor Rastelli has firmly taken
reads along with me. He has been
and explanations and illustrations.
on the intention of going back into
living in Linz since 2012 togeth-
Besides all this, Master and Bache-
the cleanroom and getting back in-
er with his Swabian wife and chil-
lor candidates are able to partially
to research. | Text: Frank Baecke
2/2015
39
DO YOU SPEAK CLEANROOMS?
ional Issue t a n r e t In l ia c Spe ition ACHEMA Ed s 20.000 Copie
© NEJRON PHOTO | Fotolia
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2/2015
40
Science & Technology Technologies in Brief
SCIENCE & TECHNOLOGY | NEWS IN BRIEF
03
Nano-Systems Materials
ica Research ISC in Würzburg, Ger-
It sends the measurements or photos
many, has made available a pilot
to a receiver. As this micro-computer
plant in which the producer will
has no keyboard or monitor, it is pro-
Fiber-Crystals | In the thin film lab-
be able to test and ensure material
grammed using light waves. Accord-
oratories of the Max Planck Institute
and process parameters before the
ing to the researchers, the “Michigan
for Intelligent Systems in Stuttgart,
transfer to their own production fa-
Micro Mote” can be deployed in the
Germany, fiber crystals are being
cilities. The coating plant is able to
“Internet of Things” as well as inside
produced which suitable for pro-
work with differing substrates, coat-
a human body. The development of
ducing the smallest yet possible ro-
ing materials and application pro-
this computer took ten years and
bots. The crystals are produced in
cedures. This opens to producers
the researchers claim that it is now
the form of “Nano-Hairs” by vaporizing metals in a vacuum. These crys-
ready for series production.
02
tals are characterized by having a completely defect-free structure and
Human-like Laboratory Robots
therefore extremely durable. Their structure maintains its form over
ACHEMA | The robot manufacturer
time even under mechanical loads.
Yaskawa will present at the ACHEMA
The crystals suit themselves as the
trade fair from June 15th to June 19th,
ideal material for producing intelli-
2015 in Frankfurt am Main, Germa-
gent systems in a nano-format. They
ny, two robot models for deployment
need little energy and bounce back
in the chemical and process indus-
to their original form after being
completely new development pos-
tries, in laboratories, in the field of
mechanically stressed.
sibilities in the field of coating tech-
analysis as well as in pharmaceuti-
01
nologies. The roll to roll facility oper-
cal, packaging and logistics technol-
ates inside a Class ISO 8 cleanroom.
ogies. The robot Motoman MH3BM
This ensures high quality and trou-
meets the highest hygienic stand-
ble free coating.
ards and can be used for the devel-
Computer in Rice Grain Format
Quicker Transfer from the Lab to Production
ample in the preparation of samples and for pharmaceutical doses appli-
Miniaturization | The smallest, pos-
Fig. 01: “Nano-Hairs”: Fiber crystals which are
sible functioning computer in the
produced in a vacuum are extremely durable un-
world has a size of only a cubic milli-
der mechanical stress. Photo: Dr. Gunther Richter
meter. This computer was produced
Fig. 02: The roll to roll facility operates inside a
by researchers at the University of Coating | With functionalized sur-
Michigan and given the name “Mich-
faces companies are able to enhance
igan Micro Mote”. This micro-mini is
their products and increase net val-
able to measure pressure and tem-
ue. The Fraunhofer Institute for Sil-
perature as well as take photographs.
2/2015
opment of new medications, for ex-
Class ISO 8 cleanroom. Photo: K. Dobberke für Fraunhofer ISC Fig. 03: At the ACHEMA trade fair, the robot manufacturer Yaskawa will present a human-like robot doing complex laboratory tasks in a live demo-cell. Photo: Yaskawa
41 cations. Its approval for cleanroom
press. The manufacturer’s joining
class ISO5 makes it possible to be
modules are used in the production
used for assembly, handling and
of heart pace makers and in the func-
packaging tasks in laboratories or
tional testing of syringes and inha-
in the production facilities of many
lators. The units can be delivered as
industries.
modules for integration in existing facilities or as precision work places.
The robot CSDA10F will also be pre-
As a precision work place, the unit is
sented. This robot has been devel-
suitable for the precise joining and
oped to meet the high hygienic
crimping of individual parts or com-
cation were too quickly broken down
standards required in laboratories
ponent groups and possesses an inte-
inside the body and eliminated. Al-
and is predestined to be used in
grated quality control function. Also
so, the barriers between the blood
bio-medical synthesis and in chem-
available are sealed units suitable for
circulation and the brain could not
ical analysis.
applications in cleanrooms.
be penetrated. These problems have
Cleanroom Suitable Servo Press
Nano-Medicine Protects Nerves
Photo: psdesign1
been solved by the researchers with the help of nano-particles which are coupled with the active agent Adenosin which acts on the receptors of the
Trade Fair Innovation | The Berlin
Research Success | Scientists at the
nervous system. This combination of
company PROMESS Society for As-
University Hacettepe in Ankara, Tur-
ingredients slows down the break-
sembly and Testing Systems mbH
key have developed a nano-medi-
down of the medication through the
presented at the end of April at
cine which improves the treatment
body’s metabolic processes, improves
the Medtec Trade Fair 2015 in Stutt-
of medical situations such as bone
the blood-brain-barrier penetration
gart, Germany, a selection of their
marrow injuries and strokes. Up un-
and raises the effect of the medi-
high-precision servo presses, among
til now, after medication was given to
cation on the neurons. Side effects
these a newly developed cleanroom
a patient the molecules of the medi-
were not observed.
ZĞŝŶƌĂƵŵƚĞdžƟ ůŝĞŶ ŝŵ DŝĞƚƐLJƐƚĞŵ WƌŽĮ Ɵ ĞƌĞŶ ^ŝĞ ŐůĞŝĐŚ ŵĞŚƌĨĂĐŚ͗ ͻ DĂƘŐĞƐĐŚŶĞŝĚĞƌƚĞ ĞŬůĞŝĚƵŶŐƐŬŽŶnjĞƉƚĞ ƵŶĚ ZĞŝŶŝŐƵŶŐƐƐLJƐƚĞŵĞ ͻ dƌĂŶƐƉĂƌĞŶƚĞ ŝŶnjĞůƚĞŝůďĞǁĞŐƵŶŐĞŶ ͻ >ƺĐŬĞŶůŽƐĞ ŽŬƵŵĞŶƚĂƟ ŽŶ ͻ ďƐĐŚćƚnjďĂƌĞ <ŽƐƚĞŶ ͻ WƌŽĨĞƐƐŝŽŶĞůůĞ ƵŶĚ ŬŽŵƉĞƚĞŶƚĞ ĞƌĂƚƵŶŐ ^ƉƌĞĐŚĞŶ ^ŝĞ ƵŶƐ ĂŶ͕ ĨŽƌĚĞƌŶ ^ŝĞ ƵŶƐ ŚĞƌĂƵƐ͊ Tel: 09841 – 40140850 E-Mail: info@decontam.de Internet: www.decontam.de
2/2015
42
Lest the Cleanroom Become a Cost Driver
SCIENCE & TECHNOLOGY | EFFICIENC Y IN THE CLEANROOM
Marked energy and cost savings can often be achieved with slight changes and modifications.
The operation of clean production environments demands substantial expenditures for technical equipment and professional cleaning procedures. Furthermore the running costs for expendables such as gloves, towels and clothing must be added in. These costs and expenditures can be reduced by implementing targeted optimization. A broad spectrum of possible solutions already exists.
ing envelope (cladding; façade) using a high degree of circulating air, by dehumidifying using direct vaporization, by re-heating using available hot exhaust gases, by heating and cooling using heat pumps and by utilizing a reduced operation mode after production has stopped.
When the controller’s face becomes
this book the economic, technical
contorted after taking a look at the
and organizational expectations of
If the cleanroom has already been
energy bill, it won’t take long be-
the contracting authority concern-
built and equipped, the running
fore the call for cost reductions be-
ing the planned facility are deter-
costs for the operation, maintenance,
comes very loud. Unfortunately the
mined and recorded. “In the spec-
training and support can often be
creation and maintenance of cer-
ification handbook, we find often
significantly reduced by adjusting
tain cleanroom classes demand a
only what the contracting authori-
particular determinant factors. “Do
substantial amount of energy in
ty wants to achieve with the facility,
I really have to maintain a 50 plus/
the form of warmth, cold and elec-
not what the energy planning should
minus 5% air humidity and there-
tricity. However there is a lot which
look like.” says Steffen Röhm point-
with expend a great deal of ener-
can be done to counter these energy demands. Experts warn, though, of taking blind action. “Energy saving measures should never generate costs which in 30 years no longer make financial sense.” warns Steffen Röhm. He is the project manager in the Competence Center Engineering of Pharmasery GmbH & Co. KG in Hessian Marburg.
Energy Planning has to be Part of the Requirements Specification Book
“The purchase of cleanroom materials based on price alone can become very expensive when working with cleanroom equipment.“ Carsten Moschner, Managing Director dastex ing out this frequent shortcoming.
gy over the course of a year to hu-
For those who are designing a new
midify and de-humidify the air, or
cleanroom, they had better incorpo-
is it enough to keep cleanroom staff
rate into their requirements speci-
comfortable by holding the humidi-
For those who begin their clean-
fication books the energy planning,
ty within the range of 35 to 65%, tak-
rooms on the drawing board they
respectively the energy-efficient op-
ing there are no pre-existing product
can indicate measures for the reduc-
eration of the facility. The technical
requirements, thus saving energy by
tion of energy costs in their require-
possibilities exist for example by de-
not having to constantly regulate the
ments specification handbooks as in
signing an energy-optimized build-
humidity?” asks the qualification en-
2/2015
43 Comparison air cleanliness classes Vergleich derof Luft-Reinheitsklassen according to the particle concentration nach der Partikelkonzentration ISO 14644-1
GMP
US Fed Std 209E*
ISO Klasse Class 11 ISO Klasse Class 22 ISO Klasse Class 33
1 ISO Class 44 ISO Klasse
10 ISO Class 55 ISO Klasse
A/B 100 ISO Class 66 ISO Klasse
1 000 ISO Class 77 ISO Klasse
C 10 000 ISO Class 88 ISO Klasse
D 100 000 ISO Class 99 ISO Klasse
0,1 10 100 1 000 1 240 10 000 12 400 100 000 1 000 000 -
0,2 2 24 237 265 2 370 2 650 23 700 26 500 237 000 -
*particulate limits (μm/m3) Partikelgrenzwerte (µm/m3) 0,3 0,5 10 4 102 35 106 35,3 1 020 352 1 060 353 10 200 3 520 3 520 10 600 3 530 102 000 35 200 35 300 352 000 352 000 353 000 3 520 000 3 520 000 3 520 000 35 200 000
1 8 83 832 8 320 83 200 12 461 832 000 124 610 8 320 000
5 29 20/29 293 247 2 930 2 900 2 470 29 300 29 000 24 700 293 000
**Der TheUS-Federal-Standard US Federal Standard209E 209E has been replaced by der the ISO ISO14644-1 14644-1abgelöst in 2001 und and ist is no longer valid. wurde im Jahr 2001 von nicht mehr gültig.
gineer Steffen Röhm. Further pro-
were manufactured with a rough
replacing the filters but the opera-
cess-related energy saving possibili-
pre-filter followed by a finer filter
tor is able to influence the ‘when’.
ties include the adjustment of canal
medium. Today we have available a
It makes much more sense to pur-
pressure and room temperature, the
newly developed nano-wave struc-
chase expensive but good filters with
effective determination of the actual
tured filter. “These materials nearly
a longer service life. These expensive
necessary cleanroom classes and siz-
double the filtering capacity while
filters don’t have to be replaced so of-
es as well as the reduction of air flow
cutting pressure losses in half.” ex-
ten and money is saved.”
rates to reasonable levels.
plains Frank Spehl. In other words:
More Efficiency with Modern Filters
the new synthetic air filter medium
Further cost-reducing tips are of-
offers a much higher filtering capac-
fered by Jürgen Blattner, the own-
ity while significantly raising ener-
er of BSR Engineering Offices in
gy use efficiency. The positive side
Baden-Württemberg Oberhaus-
effect: the process assurance and sus-
en-Rheinhausen. He is specialized in
Filters have a major influence on
tainability increases and therefore
the qualification and the monitoring
operating costs.”The crux of the
the quality of the products produced
of cleanrooms. This learned process
problem is: A large filtering capac-
in the cleanroom goes up.
technician points out that nowhere
ity demands high energy expendi-
is it stipulated how often the air in a
tures“, says Frank Spehl, Sales Man-
Even the best filters have to eventu-
cleanroom has to be exchanged. “It
ager of AAF Lufttechnik GmbH (AAF
ally be replaced. This is an expen-
makes a distinct difference whether
Air Technology GmbH) in North
sive task for cleanroom operators as
two or ten people are working in the
Rhine-Westphalian Oberhausen.
opening the ceiling means not on-
room.” explains Blattner. He recom-
“The energy requirements of filters
ly stopping the production but also
mends to operators to have the par-
need to be reduced – at this point
causing substantial contamination
ticle concentration in the cleanroom
we faced a dilemma.” New devel-
in the cleanroom. Frank Spehl com-
measured over the course of an en-
opments in the technology brought
ments, “Every operator will have to
tire working day. The level of parti-
forth the solution. In the past, filters
face one day the cost and work of
cle concentration then becomes vis-
2/2015
44 ible as the working day begins and
Jürgen Blattner explains: “Don’t wait
equipment - more exactly said: it isn’t
how this level increases with the en-
until 90% of the service life of a fil-
the cost factor alone but the cost-uti-
tering of personnel and material, how
ter has been expended before replac-
lization relationship which should
the level over time goes back down,
ing it. At some point, a new filter will
be examined. “It brings you nothing
how it comes back up after the break-
be cheaper than the energy expendi-
when the consumable goods are on-
fast break, decreases toward midday
tures caused by the performance loss
ly purchased for reasons of lower
and so on. The operator who knows
of an old filter.”
prices which as a consequence bring on higher costs in production.” says
havior is able to optimally adapt the
When changes in a facility are
Carsten Moschner. He ist he Manag-
air exchange rates to the processes.
planned, the operator has to assure
ing Director of dastex Reinraumzube-
“In this way we are able to reduce the
that the facility will still meet quali-
hör GmbH & Co. KG (dastex Clean-
air exchange rates for customers by
fied standards and norms. Numerous
room Supplies GmbH & Co. KG) in
around 20%.” comments Jürgen Blat-
norms, guidelines and ordinances de-
Muggensturm near The Black For-
tner on the value of this procedure.
scribe the necessity and procedures
est (Schwarzwald) Other examples of
regarding the re-qualification of a
such opportunity costs are the pur-
facility, however it is not mentioned
chase of low quality clothing arti-
how often a re-qualification should
cles which have to be prematurely
take place. Dr. Lothar Gail, consultant
replaced or unsuitable towels which
and expert for cleanroom and sterile
cause even more work because of
When designing and constructing
technology recommends to cleanroom
their limited cleaning capabilities.
cleanrooms, operators should keep
operators to take the dependability of
The situation can become really ex-
in mind not to oversize such rooms.
their processes as the benchmark for
pensive when the ‚Tight is Right‘ at-
The more equipment which comes
product quality. Helpful in this mat-
titude in purchasing consumable
into a cleanroom, the higher the costs
ter is to scrutinize the measurement
materials leads to product damage.
of maintenance and support will be.
procedures and values. “When these
Carsten Moschner is well aware of
There is always more to take into con-
values are appropriate, I can decide if
such cases. A company in the sem-
sideration than what first impressions
a re-evaluation in 24 months is suffi-
iconductor industry was saving a
offer. Regular maintenance has to take
cient or if I should examine the values
five figure sum of money per year
place not only for the process ma-
every six months.” explains Dr. Gail.
in the purchase of lower quality ni-
Less Technology, Lower Maintenance Costs
chines in the cleanroom but also for
trile gloves but suffered a significant-
the electrical, ventilation, heating and
ly higher loss because of damage to
cooling systems, the facilities for technical gases, water treatment and air pressure, the MSR equipment (process
‘Tight is Not Right‘ Regarding Consumable Materials
measuring and control technology)
wafers due to corrosion caused by the inferior gloves. In a company in the optic industry a very unsuitable cleanroom towel led to the total de-
and the systems for GMP monitoring.
Cleanroom operators should be scru-
struction of the optical surface of a
Also to be taken into consideration is
tinizing their costs for consumable
very expensive object without even
the scheduling of maintenance and
materials such as gloves, clothing,
coming into contact with this object.
repair as this has economic relevance.
towels, swabs and cleaning tools and „The purchase of cleanroom products and supplies on the basis of their low price can when dealing with cleanroom technology become very expensive.” warns Carsten Moschner. “I can only tell you: Save on costs yes, but keep it in relation.“ Concerning gloves Photos: Cleanroom Media
SCIENCE & TECHNOLOGY | EFFICIENC Y IN THE CLEANROOM
his typical particle concentration be-
2/2015
for example, keep in mind the glove’s
Stainless steel products like this cleaning trolley are predestined for the cleanroom. The smooth surfaces can be cleaned particularly well, also stainless steel can be sterilized.
45 tearing strength, its seal tightness and its resistance against chemicals when making a purchasing decision and not only on the best price. “When I tear every second glove while putting it on, Photos: Cleanroom Media
I save absolutely nothing.“ says Moschner. A similar case applies in the selection of towels. “When you want to wipe off your fingerprint from the surface of your mobile phone with a cellulose tissue, then you will need quite a long time to do this. However by using a microfibre cloth, this can be done quite quickly.“ emphasizes Moschner, speaking on the optimization poten-
Easy to clean furniture also ensures efficient operation of the clean room.
tial. If an operator first takes into con-
used for all cleaning carts and devic-
sults. This phenomenon exempli-
sideration what he is dealing with, for
es because this material is able to be
fies itself in sticky hospital floors.
example the cleaning of plexi-glass
sterilized. Manual systems should be
or stainless steel surfaces, or if he has
made with open drains and round-
Pfennig has solved the too-wet-too-
to remove oils, fats, loose particles or
ed edges because these devices are
dry problem with the development of
chemical compounds, he can be un-
easier to access and clean. Connec-
a closed system in which the mop au-
erring in his decision to choose tow-
tions to machines and other devices
tomatically is soaked with the same
els with the highest efficiency.
should either be tight and without
amount of the disinfecting solution.
gaps or removable in order to avoid
This makes a reproducible quality in
the accumulation of particles and
manual cleaning possible. All cus-
micro-organisms. Micro-organisms
tomers who disparagingly say it is on-
deposit themselves on uneven weld-
ly a matter of cleaning up, Dietmar
Dietmar Pfennig can sing songs
ing seams and in hairline cracks. One
Pfennig counters: “Cleaning and dis-
when considering a purchaser’s in-
hairline crack of only three millim-
infecting influence production in a
fluence. „In the consideration of
eters in length and three one-hun-
cleanroom as much as an air circu-
cleanroom cleaning, by purchasing
dredth millimeters in depth, offers
lation system. The system is at one
unsuitable, untested, non-certified
room for 100,000 micro-organisms.
point designed and then is put into
Efficient Cleaning
equipment, this can lead to finding
operation – assuming the appropri-
something in the cleanroom which
Besides the choice of cleanroom
ate maintenance has been planned.
you really don’t want to find there.”
optimized products, cleaning pro-
Cleaning and disinfecting are indi-
says the Managing Director of Pfen-
cedures also have a distinct influ-
vidual procedures and are performed
nig Reinigungstechnik GmbH (Pfen-
ence on the efficient operation of a
by people. This is why reproducible
nig Cleaning Equipment GmbH) in
cleanroom. “The problem is: People
quality is so important.“
Durach located in southern Germa-
understandably never work in ex-
ny. Cotton fibre mops for example
actly the same ways, therefore pro-
In order to operate a cleanroom ef-
are able to release up to 100,000 times
cedures are not reproducible. A mop
ficiently, it takes much more than
more particles because cotton is not
for example after soaking can be ei-
keeping an eye on energy and con-
a continuous fibre but rather a short
ther too dry or too wet.” says Diet-
sumable material costs. There are
fibre. This example alone shows the
mar Pfennig. If the mop is too dry,
immense potentials and opportuni-
potential for efficiency in the use
germs are in seventh heaven. “The
ties for improving efficiency and sav-
of optimized systems. Mops should
water which is brought onto the
ing costs by optimizing the processes.
be made from textile fibres which
floor is like a tramway with which
Moreover, with wisely planned pro-
are able to withstand the mechan-
the disinfection medium is brought
cessing practices, not only can ex-
ical wear and tear of cleaning pro-
to the germs.” explains Pfennig. A
penditures and cost-intensive invest-
cedures and the thermal conditions
break in the film of water means
ments be reduced, but also employee
of the autoclave and still be able to
therefore no disinfection. If the mop
safety, the products and the environ-
clean well. Stainless steel should be
is too wet, a build-up of deposits re-
ment will benefit.
2/2015
46
Students found a GMP school
SCIENCE & TECHNOLOGY | GMP SPRING SCHOOL
Graduates organize on their own initiative, GxP courses and lectures.
On their own initiative, students from three German universities have together launched a GMP Spring School, in order to take one small but important step to further their studies, this step being to become more aware of the laws and regulations governing the production of pharmaceutical products, cosmetics and food products.
ufacturing Practice (GMP) and in Good Distribution Practice GDP), in short, about everything concerning “GxP” in a compact form. These courses which took place in Halle, were so successful that further courses were considered. The
Many well-educated graduates
itiative for Natural Sciences e.V.)
results: The students founded a
who have studied natural sciences
of the Martin Luther University
company under civil law (GbR) and
find out after beginning their pro-
in Halle, the project entitled “GMP
have thus created the framework
fessional careers that their knowl-
for Students”.
for the successful continuation of
edge about the laws governing the life science industry is lacking. As this type of information is seldom
the project.
GxP Compact
taught at colleges and universi-
This success was not long in the waiting. 150 people notified their
ties, students from Halle, Leipzig
In this one-week course, students
interest in taking part in the next
and Dresden have launched an ex-
in their final semesters and those
event in Dresden. This course took
emplary initiative of their own.
people just beginning their careers,
place from March 9th to March
They have brought into life with
were instructed in the regulatory
13th, 2015, in the Dresden Center
support from the Studentischen
environment in Good Laborato-
for Regenerative Therapy. The or-
Förderinitiative der Naturwissen-
ry Practice (GLP), in Good Clini-
ganizers with their zeal and com-
schaften e.V. (Student Funding In-
cal Practice (GCP), in Good Man-
mitment were able to bring in very competent speakers and representatives from regional life science companies.
Win-Win Situation for the Region With their idea, “GMP for Students”, the organizers found the industry representatives very open to their initiative. Most initial inquiries were answered very favorably. Why were these students so successful The GMP Spring School initiated by three German university students was directed at students and doctoral candidates doing studies in life sciences. Foto: Philip Franke
2/2015
47
Müsliboard mit 48 Portionsbechern (à 85g Bio-Müsli) Folgebestellung zum Vorzugspreis Lieferrhythmus wählbar, keine Mindestlaufzeit
DE-ÖKO-037 EU-/ Nicht-EULandwirtschaft
2/2015
SCIENCE & TECHNOLOGY | GMP SPRING SCHOOL
48
with their idea? It was simply because the concept based itself on a
Practical Transfer of Knowledge
win-win situation at regional lev-
GMP applies to Cleanrooms as well The organizers of the “GMP for Students” also incorporated additional
els. On the one hand, the students’
As many of the “GMP for Stu-
programs into this event. Speakers
concerns on closing the gaps in
dents” event’s industry represent-
and lecturers from the industries
their knowledge about the laws
atives are employed in the field
of logistics and cleanroom man-
and regulations were covered by
of GMP, they could present this
agement had also been invited. The
local professionals and experts
topic in very practical and realis-
representative from a worldwide
and on the other hand, company
tic terms. Speakers and lecturers
logistics provider spoke about the
representatives were brought into
coming from research institutions
possibilities and the risks of safe
contact with potential future em-
doing experimental and pre-clini-
transport (against imitation prod-
ployees out of the very enthusias-
cal work emphasized how impor-
ucts) of pharmaceutical products
tic group of course participants. In
tant it is that the development of
and analysis samples. The course
fact, ample time for this network-
innovative, diagnostic and thera-
was rounded out with an overview
ing was planned into the event.
peutic concepts follows regulatory
of GMP requirements seen from the
The representatives who were in-
framework conditions. When the
perspective of governmental offi-
vited were given the time to in-
requirements which are laid down
cials.
troduce their companies. Further-
by the Good Laboratory Practice
more, human resource employees
(GLP) and the Good Clinical Prac-
The participants of “GMP for Stu-
from these companies were invit-
tice (GCP) are underestimated, the
dents” received a certificate upon
ed to lay out their respective com-
risks that an innovative project will
completion of the course which can
pany’s application procedures.
end in disaster run high.
only be advantageous when applying for a job. The next course is already in the planning stages and will take place in July, 2015 in Halle. Information about the course can be found at www.gmp-kurs.de. Text: Dr. Rüdiger Laub Above: The not-so-simple procedure of putting on a cleanroom suit could also be experienced. Photo: Eleni Patelakis Left: A full lecture hall: The interest of the students and the motivation to expand their knowledge of GMP regulations was exceptional. Photo: Eleni Patelakis
2/2015
What do you do there, Stefan Grilec?
49
“My name is Stefan Grilec. I have
I assemble disposable high-puri-
drawings, the pharmaceutical con-
been working at Tecno Plast In-
ty tube systems in cleanrooms for
nections are built in and fastened.
dustrietechnik GmbH in Düssel-
use in the pharmaceutical indus-
Finally the tube systems are multi-
dorf, Germany, since March 2012
try. These tube systems are indi-
ply-packed and labeled. The infor-
as a Production Technician. My
vidually designed according to cus-
mation on the labels assure that any
tasks include the production of
tomers’ specifications, meaning
particular lot and its product alloca-
Single-Use-Systems in clean and
that there is no limit to their size
tion can be traced. When a customer
sterile rooms as well as the qual-
and form. During production, the
so desires, the products will be gam-
ity control of parts and reference
tubes are cut to their desired length.
ma-sterilized.
samples from suppliers.
In compliance with the technical
To protect the tube systems from contamination, a conscientious and clean-working approach is required. This means that during the entire production time inside the cleanroom, not only protective clothing must be worn but also regular cleaning and disinfection of work surfaces must be carried out following exact guidelines and specifications. Working inside a cleanroom demands a very high degree of self-responsibility and self-reliance with respect to the clean and appropriate manufacture of the products. I provide completed systems with their first layer of outer packaging..
Stefan Grilec is a Cleanroom Production Technician at TECNO PLAST Industrietechnik GmbH (TECNO PLAST Industrial Technology GmbH), a company which customizes and finishes tube systems for the pharmaceutical and chemical industries associated with cleanroom production.
2/2015
SCIENCE & TECHNOLOGY | WHAT DO YOU DO THERE
A Short Personal Profile from the Cleanroom Industry
50
Regulations – Bothersome Obligations or Valuable Pointers
SERVICE | REGULATIONS
Many Suggestions on Increasing Efficiency can be found in Official Norms and Guidelines Compliance to all requirements for the operation of cleanrooms cause higher operating costs. However there are possibilities to reduce these costs without violating the regulations.
here is that these requirements only depict representative energy consumption cost factors. Current studies give evidence that the turbulence-free dis-
Even Goethe groaned: “If a man were
er of the International Confederation of
placement flow can be held at 0.2 me-
to study each and every law, he would
Contamination Control Society (ICCCS)
ters per second. “The value of 0.45 indi-
have absolutely no time to break
and is active in the VDI (Association of
cates nothing.” states Dr. Lothar Gail.
them.” Concerning this grievance, to-
German Engineers) as a member of the
“Achieving and holding to a certain air
day’s cleanroom operators can certainly
VDI Cleanroom Committee and is also
speed is not the decisive factor but rath-
agree with Goethe. If an operator wants
active in the International Cleanroom
er the sustainability of a unidirection-
to keep with all the regulatory demands
Standardization Board. Taking from his
al displacement flow.” Just how strong
on the design, construction and the op-
experience as a consultant, Dr. Gail in-
these flows should be depend on the
eration of cleanrooms he is faced with
dicates: “As a rule, the possibilities for
individual application. Current regu-
an enormous challenge. This is only
improving efficiency have not been ex-
lations forego a standard specification.
one side of the coin, the other side be-
hausted.”
ing able to pull out the implications
Barrier technologies also offer possibil-
for one’s own facility in regards to the
This begins with the air speed in clean-
ities for cost optimization in cleanroom
numerous norms, regulations, policies
rooms which is designed to keep air-
operations which help to decrease the
and guidelines, and then to implement
borne contamination away from the
energy consumption for the treatment
these specifications so that the oper-
product. The standard specification in-
and transport of the enormous volumes
ating costs remain within budgetary
dicates a speed of 0.45 meters per sec-
of air. This is made possible by keeping
constraints.
ond plus/minus 20%. US researchers
process surface areas as small as possi-
determined these specifications long
ble in the various critical stages of pro-
“Cleanroom regulations contain diverse
ago in the 1960’s and then like a prayer
cessing. Recommendations concerning
suggestions on how a cleanroom lets it-
wheel repeated these specifications
this matter are obtained from the VDI
self be operated efficiently.” emphasizes
long enough until they established
guideline 2083, page 4.2 (Energy Efficien-
Dr. Lothar Gail. Dr. Gail is the co-found-
themselves as the norms. The problem
cy). This guideline describes the clean-
Cleanroom Technology Start Ups At Cleanzone 2015, the International Trade Fair for Cleanroom Technology to be held in Frankfurt am Main, Germany, from October 27th to 28th, 2015, visitors will have the opportunity to attend discussions on the topic of “Starting Up in the Cleanroom Technology Industry”. Industry experts will be leading discussions on topics such as how suppliers can successfully enter the market and which norms and requirements should not be underestimated. Cleanroom technology users will be able to learn how they can find qualified suppliers and suitably qualified employees. The presentation “Starting Up in the Cleanroom Technology Industry” will take place on October 28th, 2015, in the Cleanzone Plaza.
2/2015
51 Important Cleanroom Regulations ISO 14644
GMP Directive
VDI 2083 Cleanroom Technology
The EN ISO 14644 is an internation-
The EU-GMP-Directive for Human
This series of guidelines set the re-
al norm for the production in clean-
and Animal Pharmaceutical Products
quirements for the cleanliness of
rooms and adjoining areas. This norm
contains the guidelines for quality as-
room air, for work areas (surface ar-
replaces the US Federal Standard
surance in the production of phar-
eas, machines, tools), for the process
209E. This ISO norm sets and deter-
maceutical products, cosmetics, food
medium (gases, fluids, chemicals) and
mines cleanroom classes.
products and animal feed.
for the personnel who work in the various cleanroom industry sectors.
room-specific energy saving potentials.
be permanently maintained which is
The advantage of going into a set-
Cleanroom operators are advised to car-
very cost-intensive. Dr. Lothar Gail has
back operation mode according to
ry out processes with the highest clean-
some important advice concerning this
VDI 2083, 4.2 is explained by Dr. Lo-
liness requirements in separate areas,
matter: “The pressure difference spec-
thar Gail by using a case study of a
the reason being that when the critical
ification refers only to production en-
company equipped with a laboratory,
processes are separated from outside
vironments and not to air lock areas.
with galenics operations, with clini-
environments the surfaces with very
Energy consumption can be reduced
cal material preparation and pack-
high air-cleanliness requirements as
in the production areas.” Cleanroom
aging and facilities for keeping live
well as the rate of air exchange can be
experts advise to design pressure dif-
animals. The question facing man-
reduced. Besides offering reductions
ferences as cost and quality factors and
agement was if going into setback
in energy consumption, this procedure
to do this from the outset of a project. “
operation would be financially ben-
provides an additional advantage: “The
It is worth thinking about which pres-
eficial. Two alternatives were pro-
smaller a processing surface is, the bet-
sure-cascade really is needed.” For ex-
posed: the first, a minimal operation-
ter the quality of the product because
ample, in order to isolate two rooms
al change with significant savings
contamination, especially from per-
separated by a door or window, 5 Pas-
and the second, a large operational
sonnel becomes easier to avoid.” says
cal would be more than actually need-
change for maximum possible sav-
Dr. Lothar Gail.
ed, 1 or 0.5 Pascal would be sufficient.
ings. The first alternative encom-
VDI guideline 2083, page 4.2 (Energy
passed the setting back of humidifi-
Efficiency) contains a further savings
cation of the laboratory, the galenics
possibility, namely the reduced opera-
operations and the material prepara-
tion or setback operation for the times
tion facility from 43% to 35%, and for
when production does not take place.
the animal keeping areas from 48%
According to the guideline, the setback
to 35%. The savings amounted to 35%.
operation can, “…in times of a produc-
The second alternative encompassed
Dr. Lothar Gail is an outstanding expert for
tion stop or pause, considerable ener-
a general setback of humidification
Cleanrooms and aseptic technologies, Phar-
gy can be saved with the ventilation
for the laboratory, the galenics oper-
systems and with the processing ma-
ations, the material preparation fa-
maceutical Technology, Particle Measurement and pure media.
chines.” Nevertheless the compliance
cility and the animal keeping area
Further possibilities for reducing costs
to predetermined limit values has to
of 35%. The savings reached with this
can be found within the topic of pres-
be ensured. It is important to note that
alternative amounted to 55%.
sure differences. According to ISO
all personnel must have left the pro-
Norm 14644-4 (Planning, Construction,
duction area before the setback opera-
This case study impressively shows
and Initial Start-up of Cleanrooms and
tion is initiated and to have a produc-
that by following norms, regula-
Cleanroom-Associated Areas), pressure
tion-stop time plan after the cleaning
tions, guidelines and policies, it is
differences between adjoining clean-
work has been completed. The switch
possible to implement cost optimiz-
room areas should range between 5
from full production to setback oper-
ing procedures in the operation of
and 20 Pascal. As the individual areas
ation should take place automatically
cleanrooms. These norms and regu-
cannot be hermetically separated from
and be coordinated with the surveil-
lations serve to be much more than
each other, the pressure-cascade has to
lance of access areas.
just annoying requirements.
2/2015
SERVICE | CLEANROOM AWARD 2015
52
Foto: Francis Rembarz
2/2015
Apply Now for the Cleanroom Award 2015 The Cleanroom Innovation of the Year will be chosen at the trade fair Cleanzone.
The ReinraumAkademie (Cleanroom Academy) is calling once again for applications from companies and research institutions involved in the cleanroom industry for the Cleanroom Award 2015. The five best innovations will be presented at the Cleanzone trade fair which will take place from October 27th to October 28th, 2015 in Frankfurt am Main, Germany. The winner, chosen by Cleanzone’s attendees, will be awarded €3000.00. Have you ever – perhaps only for testing purposes – tried an allout full braking maneuver with your car, simply to get the feeling how your car would react? Probably not. You are not alone in this instance. Many people have never attempted how quickly they can bring their car to a full stop when they really step hard on the brakes. Many do not trust themselves to do perform such an act, or the strength and determina-
fast the failing braking power and thereby possibly rescuing
To Improve Awareness in the Industry
the driver’s life. The injustice in this matter is that the driv-
Companies in the cleanroom indus-
er credits the automobile man-
try have as a rule the same situation
ufacturer for his rescue who has
as described above. Although many
manufactured such a marvelous
products used in our daily lives
vehicle. The supplier who actual-
would not have the desired quality
ly produced the sensor and de-
or functionality when not produced
serves the glory remains un-
in cleanrooms, the companies in the
known.
cleanroom technology industry are hardly noticed or appreciated.
Applying for the Cleanroom Award 2015 What is allowed to be submitted? Sought are ideas and innovations which involve the topic of sustainability and energy efficiency. The submissions should bring to the cleanroom industry advances in technology, energy benefits and advantages in competitiveness. It doesn’t matter if the concept has already been put into practice or if it exists only as a sketch in a notebook. All interesting ideas can be submitted – scribbles on a piece of paper on up to a finished product. Until when can applications be submitted? The deadline for submission is August 31st, 2015. Participants can be companies, institutions, scientific facilities and individual developers. Where are applications to be sent? Please send applications for the
tion to do so is missing.
Cleanroom Award 2015 to the following address:
Therefore some resourceful au-
ReinraumAkademie GmbH
tomobile suppliers have developed tiny sensors which recognize the moment the brakes are applied and whether the driver wants to do a full stop, or more exactly said, has to brake hard.
Code Word “Cleanroom Award” Rosa-Luxemburg-Str. 12-14 04103 Leipzig Tel.: +49 341 98989 302 E-Mail: info@reinraum-akademie.de Internet: www.reinraum-akademie.de
The sensor recognizes lightning
2/2015
53
54 Previous winners of the Cleanroom Awards (left to right): the Dutch company Technology of Sense (Apmon, 2012), the Portuguese Laborial SA (Blue Touch, 2013), the German Initial Textil Service GmbH & Co.KG (CleanVision cleanroom suit, 2014). Photos on this page: René Dreyer and Stefan Noack, Cleanroom Media;
SERVICE | CLEANROOM AWARD 2015
Sandra Gätke, Messe Frankfurt Exhibition GmbH
In order to change this situation the Re-
been bringing into the public eye since
the cleanroom industry. Every year out
inraum Akademie brought into life the
2012 the best and most innovative ide-
of a variety of entries the five best ide-
Cleanroom Award. This distinction has
as, products and services coming out of
as are selected by a jury and effective-
These are the previous Cleanroom Award winners
BLAUTOUCH: Cleanroom Award 2013 | The Portuguese company Laborial S.A. won the Cleanroom Award 2013 for their
APMON: Cleanroom Award 2012 |
project Blautouch. Blautouch is
The Dutch company Technology of
a laboratory table with an inter-
Sense won the very first Cleanroom
active surface which was devel-
Award in 2012 with the project AP-
oped in compliance with the GMP
MON. APMON stands for Ad-
Guidelines for Cleanrooms. The
CleanVision Cleanroom-Suit:
vanced Particle Deposition Monitor
interactive Touchsystem has been
Cleanroom Award 2014 | Clean-
and refers to a measuring device
built under a glass surface and
zone’s visitors chose the Ger-
which above all monitors the parti-
man company Initial Textil Ser-
cles in a room which could fall on-
vice GmbH as the winner of the
to a product. A computer assesses
Cleanroom Award 2014 for their
the data which the APMON device
innovative product Cleanvision
is sending out, shows permanently
Cleanroom-Suit. The one piece
the current levels of contamination
suit has an integrated hood and
on a product’s surface area and
a replaceable visor. Thanks to
sounds an alarm when a thresh-
its construction, the suit is near-
old value has been exceeded. This
ly completely closed which pre-
makes possible a significant reduc-
destines the suit for deployment
tion in the number of faulty or de-
makes it possible to use a com-
in sterile environments. The zip is
fective products.
puter which actually is located
located on the inside of the suit’s
outside of the cleanroom. There-
leg instead of on the breast which
fore any possible contamination
allows the user to completely op-
sources coming from a work sta-
erate the zip from the left side re-
tion have been ruled out. The
ducing the risk of outside con-
smooth glass surface is easy to
tamination while dressing. The
clean and disinfect. Blautouch is
integrated visor makes the wear-
a solution for aseptic facilities.
ing of safety glasses unnecessary.
2/2015
55
ly presented to the media and the at-
idea for the cleanroom industry is de-
publicity for our company.” The result
tendees to the Cleanzone Trade Fair in
cided by Cleanzone’s attendees by bal-
is that numerous inquiries have been
Frankfurt am Main, Germany. In 2015,
lot. The award ceremony takes place
received regarding his new product.
Cleanzone – the International Trade
on the second day of the fair, award-
Applications for the Cleanroom Award
Fair and Congress for the Cleanroom
ing to the winner €3000.00 in prize
can be submitted by companies, sci-
Industry will be taking place from Oc-
money and extensive press coverage.
entific institutions and individual
tober 27th to October 28th.
Jan Gerbrands, Managing Director of
developers. What are sought, are in-
Technology of Sense B.V. in the Neth-
novations, concepts and ideas for im-
erlands won the very first Cleanroom
proving sustainability and energy effi-
Award in 2012. This award has helped
ciency. The deadline for submission is
to put his company on the map. “A
August 31st, 2015 (see box).
Cleanroom Award Increases Awareness
great deal of attention and coverage is Which of the five nominated ideas is
given to us by industry professionals.”
selected as the best, most pioneering
says Gerbrands. “This is a lot of free
The Nominees from Previous Years
tem for the calibration of particle
cy and minimizing CO2 emissions
counters. |
with cleanroom climate control sys-
TU Graz: University Course of Stud-
tems utilizing a power-heating-cool-
Every year at Cleanzone, five can-
ies in Cleanroom Technology. |
ing-coupling technique.
didates are presented for the Clean-
AAF-Lufttechnik GmbH: A new gen-
room Award who had been chosen
eration of filter equipment. |
Finalists in 2014:
by a jury out of the variety of ap-
Colandis GmbH: A project for bring-
Schiller Automatisierungstechnik:
plicants. From these five finalists,
ing art into the cleanroom.
Ceiling conveyor system for facto-
Cleanzone’s visitors select the win-
ry automation |
ner for the innovation of the year.
Finalists in 2013:
Topas GmbH: Innovative fog gener-
The winners from previous years
Berner International GmbH: The new
ator for visualizing air flows. |
are found in the box “These are the
generation of safety work-benches. |
W.O.M. World of Medicine GmbH:
previous winners of the Cleanroom
Albany Door Systems GmbH: Rap-
A cleanroom production facility
Award“. Here are the other candi-
id Roll® Clean – The first certified
with diverse production areas un-
dates who were nominated and
cleanroom gate. |
der one roof. |
made it into the final round.
CO2Nexus Inc.: Tersus™ Liquid CO2
AAF International: Sterilization
Cleanroom Laundry Solution. |
circuit with hot air for the phar-
Finalists in 2012:
Curasan AG: Innovative cleanroom
maceutical industry.
Palas GmbH: Referenz Aerosol Sys-
concept: Maximizing energy efficien-
2/2015
56
“Jury work changes one’s point of view“
SERVICE | CLEANROOM AWARD 2015
Egon Buchta reports about the responsibilities of the Cleanroom Award Jury.
Cleanroom Magazine: Mr. Buchta, as
and cutting edge ideas in terms of in-
ions concerning the same projects. As
a member of the Cleanroom Award
novation, sustainability and efficien-
a consequence, a different vantage
Jury, your job is to select together
cy. The applications have to be signif-
point is often acquired.
with the other jury members, who
icant and meaningful. Only then are
incidentally come from all sectors
the jurors able to get comprehensive
Cleanroom Magazine: Who was your
of the cleanroom industry, five can-
pictures of the projects and to hand
favorite in the initial screening and
didates who will be allowed to pres-
in well-founded votes.
pre-selection process 2014?
does the screening and pre-selection
Cleanroom Magazine: With nearly 30
Buchta: I saw CleanVision’s clean-
process work?
applications, each juror certainly has
room suit as being far ahead of the
his or her favorite. How does the jury
other entries and indeed Cleanzone’s
come to a common decision?
attendees voted this company as the
ent their projects at Cleanzone. How
Buchta: This is almost similar to the election of the pope. The jury meets
winner of the Innovation Award 2014.
in closed chambers and discusses the
Buchta: We have to look for an over-
As the trade fair’s attendees choose
projects which have been submitted.
all majority. When one or two fa-
the winner, the atmosphere remains
Then the jury keeps voting as long as
vorites coincide with several jurors,
quite suspenseful for the members
it takes to find the five finalists.
then we can quickly choose the first
of the jury right up to the end of the
finalists. With further candidates
election process.
Cleanroom Magazine: According to
the list of criteria has to be consult-
which criteria are the Award candi-
ed and the arguments of the other
Cleanroom Magazine: Mr. Buchta, we
dates selected?
jurors have to be weighed up. This is
are looking forward to Cleanroom
what is fascinating about jury duty:
Award’s candidates 2015. Thank you
the differing points of view and opin-
very much for the interview.
Buchta: The jury looks for pioneering
About the Person Egon Buchta is the Managing Director of Ingenieurbüro & Reinraumservice Egon Buchta GmbH (Engineering Office and Cleanroom Service Egon Buchta GmbH) in Wannweil, Germany, located near Stuttgart, Germany. The company is specialized in qualifying and maintaining cleanrooms and cleanroom technical devices and machines as well as entire cleanroom facilities. Egon Buchta is a regular consultant and contributor on topics concerning cleanroom service technicians, safety work benches and the transfer of knowledge at the Chamber of Commerce and Industry in the region of Niederrhein. In addition to these duties, he holds the position of Chairman for the Association of Cytostatics Work Benches DIN 12980 of the Laboratory Instruments and Laboratory Equipment Standards Committee of the German Federal Standards Institute. | Egon Buchta, Photo René Dreyer
2/2015
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14.-16.07.2015 SEMICON West San Francisco (USA)
Trade Fairs and Congresses
Kiel
06.-08.10.2015 Biotechnica Hannover (Germany) SERVICE | EVENTS
Schwerin
Hamburg
Germany
Bremen
Hannover
Berlin Potsdam Magdeburg
30.09.-03.10.2015 EXPOPHARM Düsseldorf (Germany)
Leipzig Düsseldorf
10.-14.10.2015 Anuga Köln (Germany)
Erfurt
Dresden
Köln
15.-19.06.2015 ACHEMA Frankfurt am Main (Germany)
Frankfurt am Main
Wiesbaden Mainz
Nürnberg
Saarbrücken
27.-28.10.2015 Cleanzone Frankfurt am Main (Germany)
Stuttgart
15.-16.09.2015 Swiss Medtech Expo Luzern (Switzerland)
München
Konstanz
Basel Aarau Delèmont Solothurn
Zürich
St. Gallen
Wangen
Neuenburg
Luzern Freiburg
Bern Chur
Lausanne
Genf
Switzerland
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Attraktives Reiseziel für Technologen Popular destination for technologists
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Gestaltungsmöglichkeiten von Reinräumen Cleanroom design ideas
An industrial sector gets new impulses
1/2013
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Erster Innovationspreis für die Reinraumbranche First special award in the cleanroom industry
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Blühende Natur Gefährliche Kontamination
Jan Gerbrands Motivation und Leidenschaft Motivation and Passion
Cleanroom Award –
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So nehmen Pollen und Luftfeuchtigkeit Einfluss auf Ihre Produktion
Regularien Lästige Pflicht oder geldwerte Tipps? OLEDs Die Lichtrevolution aus dem Reinraum Krankenhauskeime Wie Raumtechnologien Infektionen verhindern
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Imprint CLEANROOM MAGAZIN is edited and published by the Cleanroom Media GmbH Rosa-Luxemburg-Straße 12-14 04103 Leipzig Germany Internet www.cleanroom-media.com Executive board Frank Duvernell Director Cleanroom Media Maja Franke Tel. +49 341 98989 404 maja.franke@cleanroom-media.com
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Editor in Chief Frank Baecke Tel. +49 341 98989 405 frank.baecke@cleanroom-media.com Translation Bill Hillman Contributors Frank Baecke Prof. Gernod Dittel Frank Duvernell Maja Franke Dr. Rüdiger Laub Knut Neubauer Advertisements Maja Franke Tel. +49 341 98989 404 maja.franke@cleanroom-media.com
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