CLEANROOM MAGAZINE
01
winter 2016
Life & Science Information for Cleanroom Technology
Approaching the Dimension 3D printing is opening new perspectives for cleanrooms
Outlook 2016
Experts estimate future prospects in the cleanroom industry
Talent Development
How employees become cleanroom operatives
Laws & Regulations
Newest revisions of ISO 14644-1 and ISO 14644-2
Internationale Fachmesse und Kongress f端r Reinraumtechnologie International trade fair and congress for cleanroom technology Vision. Innovation. Expertise. 8. + 9. 11. 2016 Frankfurt am Main
Save the Date!
3
Dear Readers, What challenges are facing the cleanroom industry in 2016? We queried Netherlands and Switzerland (see page 16). Among the answers, a few topics were especially conspicuous because they were more frequently mentioned than others. Besides standardization, automation and Track and Trace, these topics were particularly dominant: finding and qualifying cleanroom employees as well as the establishment of new standards. This is why we are emphasizing in this issue how you can develop new or existing employees into qualified cleanroom operatives (see page 28). Furthermore you will learn about which changes for your production are applicable under the newly revised DIN EN ISO 14644-1 and -2 in our column “Laws and Regulations” (see page 50). In your own opinion, Frank Duvernell: “We didn’t want to only know
do the cleanroom
which topics are relevant to you in a professional
technology users
cleanroom journal. We also asked if cleanroom
consitute as a
technology users and operators see themselves
seperate industry?
forming their own industry. The findings were conclusive: 47 percent answered with a yes. This was ten percent more than just one year ago.”
Of course, we focus the CLEANROOM MAGAZINE on the needs of our readers with this topic and all others which are presented in this issue. We re-launched the magazine one year ago with the support from media scientists. The re-launch was based on market, competition and target group analyses. All this resulted in besides a new layout, a restructuring of the contents. In order to find out how successful the re-launch was, we asked visitors and exhibitors at the last Cleanzone Trade Fair which topics in a professional journal for cleanroom technology are expected. The answers showed us that our mix of stories and articles correspond very well with current cleanroom issues, however we see potentials for making the magazine even better. Exploiting these potentials will be our biggest challenge in 2016 and we are looking forward to tackling these challenges. I wish you all the best in the coming year and enjoyable reading.
Frank Duvernell Editor
Editorial | CLEANROOM MAGAZINE 1/2016
EDITORIAL
and interviewed cleanroom professionals from Germany, Austria, the
4
CONTENTS 01/2016
08
.................................................. 08 Title Story: 3D Printing
INHALT
Three dimensional printed objects – everything from a tool, a work piece, even a part of the body – could soon be revolutionizing our lives. 3D printing will also open new perspectives for cleanrooms.
..................................................
LIFE & BUSINESS Current News from the World of Cleanrooms
06 What’s Happening in the Market Consumables for cleanrooms will become clearly, cleanly indicated • Semi-conductor investments decrease • German economy lags behind in respect to digitalization • Toyota invests in artificial intelligence • World not prepared for a new Ebola epidemic • Significance of Swiss pharmaceutical industry bigger than previously thought.
..................................................... 16 Experts’ Forecasts 2016 Title theme: 3D-Printing
28
Cleanroom professionals from Germany, Austria, the Netherlands and Switzerland speak about the challenges facing the industry in 2016.
.................................................. 20 Controversy: Pharmaceutical Manufacturers place Profit before Innovation
The pharmaceutical industry is more closely observing their profits and not the needs of patients, criticizes the Techniker Krankenkasse (Technician Medical Health Insurance Company). The pharmaceutical product manufacturers are rejecting this allegation as unfounded. We questioned both sides regarding this issue.
................................................ Talent development: From employee to a cleanroom operative
CLEANROOM MAGAZINE 1/2016 | Contents
5 42
24 Portrait: Andreas Rauschenbach How a certified mechatronics technician who always had wanted to build and create things, suddenly became the person in charge of the cleanroom.
................................................ 28 Aptitude Development: From
Semiconductors: New materials, new applications
54
Employee to Cleanroom Operative
The best cleanroom equipment is useless if the personnel are not trained in proper cleanroom behaviors and techniques. Such training courses have to regularly be repeated and the employee learning curve examined.
................................................ 32 Insights: On the Road with… Steffen Röhm, Project Leader at Pharmaserv GmbH & Co KG in Marburg, Germany.
................................................
SCIENCE & TECHNOLOGY Solutions for the World of Cleanrooms
34 Technology in Brief Researchers develop a new kind of data storage • Smarter wound bandages for nerve fibers • Giant molecules block entrance of the Ebola virus into the body • Head OP’s: Robot-worm munches around corners • Stem cell cultivation on algae skeletons • The smallest amounts of fluid exactly measured to the nano-liter • Electronic automobiles: batteries with a brain
Clean area, with a record number of vistors and exhibitors
42 Semi-conductors:
New Materials, New Applications
The digitization of the economy and everyday life is requiring more powerful semi-conductors. The next generation will be based on new materials. Therefore demands on cleanrooms will also be increasing.
.............................................
SERVICE
Events, Awards, Regular Columns
.................................................. 46 36 Containments:
Higher Process Safety Demands New medical agents are often in small dosages highly reactive. Therefore containments have to not only reliably protect the product but also employees. How to achieve process safety.
.............................................
Ergonomics and Fitness: Well-being in the Cleanroom
Sitting for long periods of time in front of a microscope or a safety work bench puts one-sided physical demands on the body. By implementing simple but effective measures, cleanroom personnel remain healthy.
and Exhibitor Records
The company InfraSolution AG won the Cleanroom Award with its RobotScanFlex. The new Creative Prize experienced its inauguration. Its first winner is Med-El in Innsbruck, Austria.
................................................ 57 Professional Literature:
References for the Cleanroom Industry
• Containment Handbook • Good Transport Practices in the Pharmaceutical Industry
................................................ 58 Trade Fairs and Events
................................................ 60 Imprint
................................................
41 What do you do there…?
50 Laws and Regulations: The new ISO 14644-1 and ISO 14644-2
Petra Hagel, Manager of Occupational Health Management at Vetter PharmaFertigung GmbH & Co. KG (Vetter Pharma-Manufacture GmbH & Co. KG).
The most important international cleanroom technology norms are being revised. What changes pertain to the production in cleanrooms.
.............................................
54 Cleanzone with Visitor
................................................ Contents | CLEANROOM MAGAZINE 1/2016
6
life&Business
LIFE & BUSINESS
What’s Happening in the Market
Cleanroom consumables clearly and cleanly identified Standardization | The industry association “Cleanroom Suitable Consumables” (CSC) is working on laying the foundation for a uniform
the quality of their products. The
a possible 100 points. This is reported
CSC held a meeting in December
in the “Monitoring Report Wirtschaft
regarding this issue. Its long term
Digital 2015” published by the Federal
goal is an ISO standard.
Economics Ministry. By 2020, a cautious
Semi-conductor investments are decreasing
increase to 56 points is expected. The report examined eleven core industries and arranged these into five categories: from strongly above-
cleanroom consumables cleanliness standard. This would encompass
Prognosis | Worldwide investments
average to strongly below-average.
clothing, gloves, cleaning towels,
in semi-conductors are supposed to
The results: Digitized strongly above-
packaging materials and much more.
decrease in 2016 by 3.3 percent to $61.7
average is only the IKT economy.
Up until now there have been no
billion. This prognosis comes from the
Applicable as digitally above-
consistent, uniform requirements
market research company Gartner.
average are information-intense
specifying how manufacturers in
The analysts are looking to 2017 for
service providers, financial services
regards to cleanroom suitability
renewed growth in the industry and
providers and insurance companies.
should test and appropriately
As digitally average are companies
label their products. Such a set of
in trade and commerce. Digitally
regulations is badly needed in the
below-average are those companies
industry. A survey carried out by the
in transport, logistics, machine
Fraunhofer IFA indicated that users
engineering and construction,
are demanding more comparability.
chemicals and pharmaceuticals.
Manufacturers and suppliers also
Digitally strongly below-average are
need this data as evidence for
businesses in health care, automobile Microchip. Photo: Jürgen Lösel
this growth will be vigorous at 5.5 percent to $65.2 billion. In 2018, the industry will grow by 6.6 percent ($69.4
production and other, miscellaneous production companies.
Toyota invests in artificial intelligence
billion) and in 2019 will grow by 5.1 percent ($73 billion). Expenditures for
A future industry | Toyota wants to
semi-conductor products are regarded
invest a billion dollars in the founding
as an indicator for the expected sales
of a subsidiary with the name Toyota
of electronic products.
Research Institute. This subsidiary
German economy lags behind regarding digitalization
will be concerned with artificial intelligence in two areas: self-driving automobiles and household robots. The Toyota Research Institute will
Monitoring Report | The degree
start operations in January, 2016.
ent guidelines for cleanroom consumables cleanliness
of digitalization of the German
The investment will be distributed
specifications. Photo: Rainer Bez
economy has reached only 49 out of
over five years. According to Toyota,
The industry association CSC wants to establish consist-
CLEANROOM MAGAZINE 1/2016 | Life&Business – What’s Happening in the Market
7 Toyota investing heavily: in a car that drives accidentfree, regardless of the driver‘s own capabilites. In addition, research aims for robots to aid and support the elderly in and around the home. Photo: Fotolia, jim
artificial intelligence has the potential
dangerous diseases. The rest of the
supported by an Instituts Bakbasel
to create a whole new industry. The
countries are lacking laboratories
study. The reason for the upward
automobile corporation wants to
for the early and timely diagnosis of
correction is the inclusion of the
develop for the long term a vehicle
infections as well as the necessary
research and development data in
which independently of the driver’s
treatment possibilities especially
the calculation of the GVA due to the
ability will never cause an accident.
hospitals with quarantine wards.
change-over to the European system
Additionally, the researchers are
Without such facilities, infections
looking to develop robots to help eld-
could very quickly spread. In Africa,
erly people with household chores.
20 countries lie within the range of
World not prepared for a new Ebola epidemic
free-roaming animals which are capable of transmitting the Ebola virus. WHO reports that more than 28,000 people fell ill to Ebola and 11,000
Early warning system lacking |
died from the virus in the countries
According to the estimates of the
Guinea, Liberia and Sierra Leone
World Health Organization (WHO)
where the Ebola epidemic has only
the world is not properly prepared
recently been declared as ended.
for a new Ebola outbreak. Only
Significance of the Swiss pharmaceutical industry is bigger than thought
The gross value added (GVA) of the Swiss pharmaceutical industry amounted to one-third more than previously estimated. Photo: I-vista/pixelio.de
for national economic accounts. It should be born in mind that 100 Swiss franks of net-value-added in the pharmaceutical industry
Electronic microscopic picture of the Ebola virus. Photo: Cynthia Goldsmith, CDC
Market Study | The gross value added,
effectuates a further 80 Swiss
the GVA, of the Swiss pharmaceutical
franks for suppliers. This means the
industry in 2014 amounted to over 25
contribution of the pharmaceutical
billion Swiss franks, nearly a third
industry amounts to just under 45
a third of the 194 WHO member
higher than previously assumed. The
billion Swiss franks respectively
countries have an early warning
industry association Interpharma
seven percent of the gross domestic
system for the recognition of
recently reported this information
product (GDP).
Life&Business – What’s Happening in the Market | CLEANROOM MAGAZINE 1/2016
8
Printing the World
Photo: Cleanroom Media
LIFE & BUSINESS
3D printers enable the production of many useful things, such as the printing of micro-structures in cleanrooms and implants in OP’s.
CLEANROOM MAGAZINE 1/2016
9
Complex geometry: finished part from a 3D printer. Photo: 3D Laserdruck
The 3D printer could soon revolutionize many domains of our life. Its areas of application include regenerative medicine, household goods, high-tech products and many more. The 3D printer poses no threat to cleanrooms, rather it will open new perspectives to this industry.
CLEANROOM MAGAZINE 1/2016
10 At the latest when the US law student Cody Wilson presented his selfmade pistol, the topic of 3D printing had become the talk of the town and the reputation of this technology with a very promising future was for the time being ruined. Wilson produced out of plastic 15 out of the 16 parts necessary for his pistol with a 3D printer. For the sixteenth part he used an ordinary nail which acted as the firing pin. The shocked
LIFE & BUSINESS
media invoked the idea as evidence for the 3D printer’s unpredictability and monstrosity.
Printing your own weapon? The media not so easily frightened approached the 3D printer from the perspective as a device for hobbyists and do-it-yourselfers. What home-use products were not
3D printer, respectively laser-melting: The actual printing area in which the part is created is hidden behind the door
able to be produced by a 3D printer:
upper left. Photo: 3D Laserdruck
Plates and cups, protective covers and cases for smart phones or
Some of the processes which today
important requirement for the
even plastic ducks for the bathtub
have been consolidated together
current hype in 3D printing was the
were imaginable. Everybody could
under the term 3D printer have
expiration of the American patent.
become a designer. That this
existed for nearly 30 years. Science
This enabled numerous companies
prospect was supported by many
and industry have known for some
and start-ups to further develop and
people was supported by a survey
time: The 3D printer is above all a
improve the 3D printer as well as to
conducted by the research institute
technology which solves problems.
offer models to every interested user
Emnid: 69 percent of Germans
Several utopians see in the 3D
for a few hundred Euros.”
could imagine buying a 3D printer
printer a solution for the issue
and anyway, two percent of those
of world hunger and initiatives
In the meantime, data banks have
surveyed already owned one.
already exist which are working
been compiled listing objects and
on the production of noodles and
products which make complex
meat using 3D printers.
designs using CAD programs
The technology is available with no restrictions
unnecessary. Materials used for printing have also been further developed and improved. “There are available now all imaginable
No fireworks, no magic: Laser-melting in a powder-bed. Photo: Fraunhofer IFAM
CLEANROOM MAGAZINE 1/2016 | 3D-Print
That the 3D printer is making
materials: plastics, metals, glass
its way from the laboratory into
and ceramics” reports Godlinski.
living rooms and student flats, as
According to the prognosis of
in the case of Cody Wilson, there
the market research company
are a number of reasons for this.
Gartner, the number of 3D printers
Dirk Godlinski, Project Leader for
delivered will double yearly and by
Functional Printing at the Bremer
the year 2019, this number will lie
Fraunhofer Institute for Production
in the range of 5.6 million devices.
Technology and Applied Material
According to Gartner, the 3D printer
Research (IFAM) explains: “An
market will keep on developing out
11 of its niche into a worldwide market
amount to a mere 20 micrometers.
This revolutionary technique used
for consumers and companies.
However, there is more: A further
directly on location offers time-
highlight of this research project
wise advantages: The Mainz doctors
is the successful cultivation of
are able to plan a re-construction
fat tissues in a new kind of bio-
operation within four days by using
reactor. The combination of these
their newly acquired 3D printer. Up
Apart from the hype and all the
fat tissues with a skin model allows
until now, such procedures were
publicity regarding its possible
the production of a complete skin
done in cooperation with external
applications: What is the current
model with a thickness of up to 12
companies and could take up to
status of the 3D printer and what
millimeters.
weeks.
question, it is worthwhile to take
Researchers are hoping that the
Scientifically interesting is the 3D
a look at several current projects
principle of blood flow by using
printer technology additionally
going on in science and industry.
artificial blood vessels could in the
developed for the field of regen-
3D Printer Hype: What can it really do?
can it really do? In answer to this
future enable the production of entire
erative medicine. The central
The EU research project “ArtiVasc 3D”
organs. However the application
research question reads as follows:
is located at the Fraunhofer Institute
possibilities of the skin models are
How are tissues and cells integrated
for Laser Technology (ILT) in Aachen,
diverse: They promise quick help with
with materials and surfaces foreign
Germany. Researchers are working
skin injuries over large surface areas
to the body? The poor adherence of
on reproducing lower layers of
or they could serve as substitutes,
human skin. The reproduction of
replacing live test animals in the
upper layers has long been possible.
pharmaceutical industry.
These layers are very thin and don’t have to be supplied with blood. The
True to Original Patient Models
layers underneath, the subcutis, have to absolutely be supplied with
The Hospital for Mouth, Jaw and
blood and are interspersed with
Face Surgery (MKG) at the Medical
blood vessels, as without a blood
University Mainz in Germany, has
supply, no life.
revolutionized its métier with 3D printing. For example, with jaw re-
The scientists at the Fraunhofer ILT
construction, a piece of the fibula is
have developed a new procedure
removed in order to close the gap in
to produce artificial blood vessels
the jawbone. The 3D printer is able
which are biologically compatible,
to produce an exact model of the jaw
porous and branched, therefore
and the fibula. Subsequently, the
“An important requirement for the current hype in 3D printing was the expiration of the American patent.” Dirk Godlinski, Fraunhofer IFAM
To print first. This is now possible. Photo: 3D-Laserdruck
implants as well as the body’s own defensive reactions could strongly influence a treatment’s success such as with artificial joints, heart pace makers, blood vessel prostheses or artificial teeth. Material research is therefore an important pillar in the research at MKG. Professor Bilal Al-Nawas explains: “The 3D printer
enabling a uniform and consistent
surgeon is then able to play through
enables us to plan re-construction
blood supply. This procedure is
the operation in advance, taking
operations for our patients within
based on 3D printing: The structures
into account all details and possible
a relatively short period of time
are mathematically simulated and
complications. This enables him to
and provides a link to other groups
then built layer for layer from a
plan the operation specifically for each
working intensively to develop
synthetic polymer in a 3D printer.
patient and to carry out the operation
innovative materials for implants
The individual layer-thicknesses
according to this individualized plan.
and re-construction operations.”
3D-Print | CLEANROOM MAGAZINE 1/2016
LIFE & BUSINESS
12 Besides the printing processes
immediately fully operational, for
replaced: “Our company produces
which are being driven towards
example as sensors for measuring
3D laser building components in
ever smaller resolutions, the second
forces. Alexander Kaya, Managing
a clean room environment which
fundamental problem of 3D printing
Director of Nanoss: “More than 250
is able to create reproducible
is: How do the printing materials –
complex process steps involving
climatic conditions in order to
the filaments, powders and metals
cleanroom equipment, from the
keep the production environment
– allow themselves to be produced
initial idea to the finished circuitry
stable for the highly sensitive
and processed so that the desired
have been required to roll out
metal-laser-melting equipment.”
properties are obtained at high
sophisticated micro-components
The processing powder demands
levels of dependability? Regarding
such as sensors with a guaranteed
constant temperature and air
medicine, printed structures
quality and quantities.” In contrast
humidity conditions.
have to be as bio-compatible as
to this is the Nanoss procedure “a
possible. In engineering, printed
revolutionary one-step procedure
Sven Skerbis gets the clean room
metal structures should have the
which makes it possible to completely
know-how from his company’s own
same rigidity and density as those
bypass the numerous, complex
“Family”: 3D Laserdruck belongs to
parts produced using conventional
cleanroom processes such as masking
the consortium of the ap-systems
casting procedures.
techniques” emphasizes Kaya.
GmbH, a Reutling cleanroom
Will ‘cleaner’ 3D printing make cleanrooms redundant?
turnkey supplier. Martin Hirlinger, Can the 3D printer make cleanrooms
the Managing Director of ap-
dispensable? Sven Skerbis who is
systems works next door to Sven
responsible for technical sales at
Skerbis and explains that the
With an example of a third app-
3D Laserdruck GbR in Reutlingen,
activities in the direction of 3D
lication, the meaning of 3D printers
Germany, doesn’t think so. The
printing have been expanded since
for the cleanroom industry comes
company is a specialist in the
the technology emerged a few years
to a head: The company Nanoss
field of metal-laser-melting and
ago. “The 3D printer is our youngest
GmbH in Darmstadt, Germany, a
produces for its customers’ diverse
child” says Hirlinger.
producer of micro-components
metal parts and components in a
such as sensors, is touting a new
3D printer.
3D printer-based product with the idea that it could make the complex and expensive traditional
Cleanrooms will always remain necessary
The Challenge of Series Production Sven Skerbis and Martin Hirlinger see their challenges with laser-
manufacturing processes of semiconductors and silicon as well as
In a dialogue with Skerbis, he
melting while the industry faces
cleanrooms themselves dispensable.
admits that in specific cases such as
the challenge of crossing over to
with the sensor manufacturer, this
mass production. This is the step
Nanoss is three-dimensionally
is certainly conceivable. However,
which the 3D printer still has to
printing micro-components onto
he can’t imagine for his company
take. Injection molding machines
arbitrary substrates. They are
that the cleanroom could ever be
produced in high volumes are
Seit 12 Jahren Kompetenz für generative Technologien
14. – 16. Juni 2016, Messe Erfurt • Fachmesse und Kongress
Rapid.Tech
• Anwendertagung „Neue Technologien“
International Trade Show & Conference for Additive Manufacturing
• Fachforen Wissenschaft, Medizintechnik, Luftfahrt und Werkzeuge
www.rapidtech.de
CLEANROOM MAGAZINE 1/2016 | 3D-Print
Titelmotiv: Bremspedal, EOS/Materialise Foto: Andreas Stedtler
13 still considerably faster and more
(see interview on the future of 3D
another question which end users
efficient than a 3D printer. As of
printing on page 14)
concerning their preferences have
yet. “Because of continued process optimization, 3D productivity continues to increase. In medical
Problem Solutions for a better Life
technology and in the aerospace
to ask. In industry and in science, 3D printers are without a doubt tools with
industry, we are currently seeing
The news about producing weapons
great potentials, tools which solve
breakthroughs in small and
with 3D printers comes up again
problems on a small scale and on a
medium-size series production
and again since the time of Cody
large scale improve all our lives.
when complex geometries are
Wilson. However very few of
requested” observes Sven Skerbis.
the plastics used were actually
Author: Piet Felber
suitable for a plastic – weapon 3D printer manufacturers and
– imitation. In contrast, the list
cleanroom builders have a
of hopeful inventions which 3D
common nut to crack: How can
printing makes possible has in the
the 3D printer be better integrated
meantime become nearly endless:
into cleanroom processes even
Clothing without seams and waste
when under the demands of
material, less costly prostheses,
series production? For cleanroom
even automobiles produced in a 3D
builders and service providers this
printer are less today utopia than
question poses far-reaching fields
concrete developmental goals. If
of activities. Dirk Godlinski from
plates and cups produced in 3D
the Fraunhofer IFAM confirms.
printers are really necessary is
Complex geometry: finished part from a 3D printer. Photo: 3D Laserdruck
How 3D printing works Under the terminology 3D printer, several production processes have been combined with which objects, assembly parts and tissues can be produced in diverse ways. More correctly, these processes should be designated as generative, respectively additive production processes. The oldest of these processes come from the 1980’s. Three fundamental types of processes should be differentiated: Stereolithographic respectively Liquid Material Procedure: With this procedure, a liquid plastic is selected and hardened layer for layer by using a laser. With some of these procedures, the created part is dipped again and again into the material whereby the next layer is put on. Other procedures use a large roller on which the part is created. These rollers can be turned inside a material bath: Finished parts can be removed from the roller outside of the material
bath while inside the fluid a new part can be created on the roller. Powder-based Beam Fusion: The most established beam fusion procedure is selective lasermelting. The processing material is at first applied in powder form in a thin layer onto a base plate. The material is selectively melted with a laser beam and forms a hard layer after solidification. Further layers are applied and hardened until the part is finished.
Freeform Procedure: These are the processes which can be most closely compared with 2D printing processes: With “Fused Deposition Modeling” a solid filament (plastic, wax or wire) is fused using a hot nozzle and then applied onto a base plate. The object is built up layer for layer on this base plate without being supported by a material bath or bed of powder. Supporting structures may also have to be printed depending on the kind of object. These structures are then removed after the printing process has been completed.
3D-Print | CLEANROOM MAGAZINE 1/2016
14
“Printing processes mustn’t become mere particle accelerators.“
LIFE & BUSINESS
Dirk Godlinski, Project Leader Functional Printing at the Bremer Fraunhofer IFAM in consideration of the future of 3D printing. Cleanroom Magazin: Promises
advances in 3D printing with high-
implants which have to be processed
are being made which indicate
performance materials concurrent
under clean, sterile conditions, or in
that advances in 3D printing are
with improved reproducibility
laser facilities which process with
significant, especially in the areas
there are enormous cost-saving
flammable or very fine, toxic metal
of medicine, the life sciences and
possibilities, when quantities are
powders. There are producers which
sensor technology. What does 3D
low and with respect to lightweight
are now attempting to appropriately
printing still have to ‘learn’?
construction and function-integra-
encapsulate their printers. In these
tion, in the aeronautic and space
cases, cooperation between printer
Dirk Godlinski: These areas of
industries, for example in the con-
manufacturers and cleanroom or
application are in fact the most
struction of satellites.
glove-box professionals would be
important. 3D printers are to date
rational. With the integration of
operated as ‘stand alone’ devices. A
Cleanroom Magazin: How has the
3D printers in production processes
qualitative break through would be
opinion arisen that 3D printing in
with cleanrooms, such as in the
for many experts the linking of 3D
some areas of application make
micro-electronics industry, it would
technologies with other industrial
cleanrooms redundant? Couldn’t
be important to consider the issue
production processes such as ‘pick and
it more be thought that synergies
of compatibility. The printing
place’. With such 3D hybrid processes,
would come about?
process should never become a
it would not only be possible to set
particle accelerator and in view of
up components geometrically but
its cleanroom suitability perhaps
also to simultaneously integrate the
be modified. In powder-based
electronics, connectors and so on.
processes, the risks are significant.
At the end, the final product would Cleanroom Magazin: Are there
emerge.
application areas in which 3D Cleanroom Magazin: In which other
printers will have to be deployed in
areas could there exist application
clean environments?
possibilities? Dirk Godlinski: A current issue is the Dirk Godlinski: Further application
deployment of 3D printers in the
possibilities exist in the lighting
production of satellites and rocket
industry where low volume
components which is to take place
production often takes place. The
in clean environments in order to
conventional products could be
Dirk Godlinski is the Project Leader for Functional Prin-
minimize sources of error when put
replaced with functional LED
ting at the Bremer Fraunhofer Institute for Production
into operation in outer space. The
lighting products consisting of frames, housings and lamps
Technology and Applied Materials Research (IFAM). Photo: Fraunhofer IFAM
next step would be the deployment under the conditions of outer space:
constructed, integrated and when
Dirk Godlinski: Some 3D printers
Aboard the International Space Sta-
as the case may be outfitted with
have to be encapsulated due their
tion ISS, a 3D printer has been in op-
additional sensors all with 3D hybrid
environments, for example printers
eration since 2014 for the production
printing processes. Because of
for biological materials, tissues and
of parts using synthetic materials.
CLEANROOM MAGAZINE 1/2016 | 3D-Print
15
6–8 March • Nice, France
ISS EUROPE 2016 Transforming Markets • New Applications • New Opportunities A new age is dawning in the micro/nano-electronics industry as the use of ever more complex and capable chips is complemented by a developing demand for smart systems to fuel, the Internet of Everything. These market changes are driving a new era of industry value chains – extending beyond the
traditional semiconductor companies to the full ecosystem. This is being accompanied by a massive influx of new applications intended to meet societal needs with cost efficient electronic solutions, enabling intelligent mobility, future cities, smart power, health – to name but a few.
Speaker Outline:
Laith Altimime SEMI Europe
Cor Claeys imec
Christophe Frey ARM
Asit Goel NXP Semiconductors
Rob Hartman ASML
Dan Hutcheson VLSIresearch
Haruyoshi Kumura Nissan Global Foundation
Klaus-Dieter Lang Fraunhofer IZM
Philippe Magarshack STMicroelectronics
Bill McClean ICInsight
Denny McGuirk SEMI
Arunjai Mittal Infineon Technologies
Khalil Rouhana European Commission – DG Connect
An Steegen imec
Rutger Wijburg GLOBALFOUNDRIES
Sponsored by:
3D-DruckCLEANROOM | MAGAZINE 1/2016
Register now at:
www.semi.org /ISSEurope
16
Experts‘ Forecast 2016
LIFE & BUSINESS
What Challenges are waiting for the Cleanroom Industry.
The CLEANROOM MAGAZINE interviewed cleanroom professionals in Germany, Austria, the Netherlands and Switzerland as to what topics and trends will influence and characterize the cleanroom industry in 2016.
could lead to needing new levels
Frans Saurwalt President of the International Cleanroom Society ICCCS, Leusden, the Netherlands
strumentation is able to count both
cleanroom behavior and more
separately. Up until now, for each,
thorough cleanroom cleaning.
of standardization and changes to our scales and indexes. Additionally, we will require more disciplined
individual microbial contamination measurement, an individual breeding substrate was needed which had to be incubated for days on end. To-
Michael Müller Managing Director vali.sys gmbH, Wetzikon, Switzerland
I see two formidable challenges for
day, a new process using lasers and
the cleanroom industy. For the first,
optical detectors immediately recog-
From my standpoint, the biggest
we arguably need new norms for the
nize all metabolisms at one go. New
challenge for the cleanroom industry
growing presence of germs, for the
devices, whose development was su-
lies in the assured acquisition
second we need to pay stronger at-
pervised by the Dutch Cleanroom So-
of professional, qualified future
tention to the cleanliness of the air
ciety ICCCS, available for the meas-
employees. Several colleges and
and surface areas.
urement of particles on surface areas
universities have already taken on
are much more exact than previous
the task of developing new study
devices.
programs, however these programs
The reason for this is founded on the new measurement technology
have yet to be implemented into their
available to the industry. Newly de-
The result is: We are suddenly ob-
curriculums. We here in Switzerland
veloped devices count not only parti-
serving that there is much more
are markedly noticing that there are
cles without differentiating between
contamination in cleanrooms
next to no trained, qualified cleanroom
germs and dust particles the new in-
than previously assumed. This
personnel available. In order to cover our company’s needs, we hire people with technical backgrounds and train them in-house. An important issue in 2016 will be the continued development of sensor technology. The trend to obtain even more information from devices will continue to prevail. Many sensor manufacturers have been working in this direction for some time. The goal is to develop into industrial technology the mainstream technology such as is prevalent in mobile telephones. A mobile
Frans Saurwalt
CLEANROOM MAGAZINE 1/2016 | Experts‘ Forecast 2016
telephone is able to intuitively serve
17 expansion for which we will need trained, qualified employees. From my point of view, the issues of energy-thematic, renewable energies and energy efficiency in cleanrooms will increasingly become more important in 2016. Additional trends will be the growing importance of health and ergonomics in work places. We want to keep our employees for as long as possible, as healthy as possible and for this a lot can be done in and around a cleanroom. Belonging to this aspect is Michael Müller
the factor of color and its positive ef-
Markus M. Schröder
fects which has up to now been largethe needs of any user. When this
ly underestimated.
legislative act in August, 2015, the
becomes successful in industrial
i m pl e m e n t a t i o n o f m ea s u r e s
technology and when the division
It is also important that companies
protecting against falsification,
between mobile communication
don’t get bogged down with regulations,
EU Directive 2011/62/EU is coming
devices and industrial technology
rather to find their own ways on this
closer. From then on time will be
is surmounted, the gains for users
‘Highway of Norms’. In this respect,
running, as until the official start in
would be substantial in view of data
seminars, trade fairs, conferencing
2019, the serialization of medications
and Apps inter-exchanges.
and exchanges of experience will
available only on prescription will
Christian Dragosits Group Leader MED-EL Medical Electronics, Innsbruck, Austria will be the continued training and
“Track-and trace will challenge companies in the pharmaceutical industry.”
schooling of our employees and to re-
Christian Dragosits, Group Leader MED-EL
The major challenge for us in 2016
main at up to date levels of knowledge and know-how. We have 200 people employed in our cleanroom and are
help. We have been supporting several
be binding in the EU. This means
currently in the planning stages for
colleagues who have had their problems
that companies will at first have
seeing the forest through the trees with
to initiate the serialization of
help and advice. Reciprocally, we are
individual packages. Pilot projects
also profiting with this support as we
have already been started in larger
are faced with questions which we
companies however many middle-
ourselves would never have asked.
sized companies don’t believe they have to start thinking about this
Christian Dragosits
Markus M. Schröder Managing Consultant, AVANTALION Consulting Germany GmbH, Berlin, Germany
issue. This is a false conclusion, as
From my standpoint, the topics of
but also the SOP’s and internal
Track and Trace will challenge
procedures in nearly every de-
pharmaceutical companies in
partment. Realistically, I see the
the coming year. With the release
implementation time frame as
of the first draft of the delegated
being at least one to two years.
to be able to trace every single box or bottle, not only the machines and IT systems have to be adapted to the new IT-supported processes,
Experts‘ Forecast 2016 | CLEANROOM MAGAZINE 1/2016
18 Gerhard Winter Professor Faculty Life Science, Albstadt-Sigmaringen University, Germany The classification of cleanroom cleanliness classes from ISO 9 to ISO 1 will not be sufficient in the future,
LIFE & BUSINESS
as technological developments are
longer will people be sent into clean-
all sensor indicators registered and
rooms, rather the production must
determined correct. Nothing in
and will be carried out by robots.
the future will be undetected or to go unnoticed as the indicator will
Andreas Fiebich Product and Project Manager, Division Pharma, Niotronic GmbH, Gratz, Austria
remain red and the cleanroom is protected against contamination.
Joachim Ludwig Founder and Managing Director COLANDIS GmbH, Kahla, Germany
encroaching into the nano-meter
I believe that the further and
range. This is making possible the
continued automation of cleanroom
production of completely new prod-
technology belongs to the most
ucts for example medications which
important developments in 2016.
The trend toward mini-environments
are absorbed by rubbing them in-
These developments include status
and isolators will continue in 2016.
to the skin thus eliminating many
signals and indications which will
The need exists in semi-conductor
side effects.
incorporate visualization technology, voice systems which will give employees acoustic instructions as well as authorization via RFID chips which will be able to specifically support and help employees inside air locks. The entering of cleanrooms by actuating the emergency stop button will no longer be possible in the future as the personnel will be guided by modern measurement, sensor and automation technology which will help to rule out errors. Decisions will become as easy to make as possible for production employees for example via red and
Joachim Ludwig
green indicator lights. Therefore employees will carry out their
backend processes in which the
activities or enter a cleanroom
integrated circuits are isolated. Also
Our particle safety limits, however
only when all required sensors are
with injection molding processes
end for the cleanest cleanliness class
active, alarm systems are activated,
where clean air from ceiling vents
Gerhard Winter
ISO 1 at the value of 0.1 micrometer.
is barely able to reach the hot
Particles of this size will soon be-
machines, such developments are
come too big for production in clean-
economically reasonable in view of
rooms, as the topic of miniaturiza-
the operating costs as it makes more
tion will continue to advance. This
sense to put the essential processes in
trend has not only significant effects
clean environments than to put the
on cleanroom technology but also on
machines inside a large cleanroom.
measurement technology, cleaning
Within the word cleanroom, the
procedures and much more. There-
word room is included which makes
fore companies which produce in
many people to think on length,
clean environments will be facing
width and height instead of on the
brand-new challenges. This will con-
process. Consultation is necessary in
cern especially pharmaceutical pro-
these cases.
ducers and the semi-conductor inA further development can be seen
dustry. In practice, this all means in plain language: In the future, no
Andreas Fiebich
CLEANROOM MAGAZINE 1/2016 | Experts‘ Forecast 2016
in the advancement of controlled
19 environments into more and more
employees very difficult. Therefore it
industrial subsectors and sub-
is high time for the set up of academic
divisions, areas which today are
degrees and apprenticeships by the
hardly imaginable. The same applies
Chambers of Commerce and Industry
for new markets such as South
as well as by the various associations
America. In Brazil, a semi-conductor
and syndicates. What we need is
production facility is being built in
something like the universally
which many cleanroom peripheries
deployable cleanroom engineer or
are being set up. In the Arabian
the mechatronic technician for
world, new technologies are being
cleanroom technology.
developed for the time after the oil runs out and in Iran which can soon
The second challenge is standard-
count on the end of the sanctions,
ization. The cleanroom industry
there is a huge backlog for hospital
finds itself only in the early stages.
and high-tech technology.
Everyone is cooking his own brew. For example, when we clean parts
Ludwig Költzsch
Ludwig Költzsch Founder MKF GmbH, Lederhose, Germany
require clean production conditions
customer says: Do it according to
are coming in from all sides. Take
our procedures, otherwise you won’t
for example the automotive industry
receive the order although we are able
The acquisition of employees and
whose very strict requirements are
to guarantee the same result using
standardization are for me the major
forcing more and more suppliers to
our own procedures. It is difficult to
challenges. The cleanroom industry
produce in cleanrooms. This is leading
adapt to every individual customer
will experience a further boost in 2016
to a shortage in employee potentials
instead of keeping to one standard
because new industrial sectors which
and is making the acquisition of new
fulfilling the same results.
PT16_175x125_CLEANROOM_MAGAZIN_C4_PHARMA.indd 1
for the automotive industry, the
14.12.15 13:40
Experts‘ Forecast 2016 | CLEANROOM MAGAZINE 1/2016
20
Profit versus innovation
Follows the return of the pharmaceutical industry, rather than the needs of the patient? An expert dispute.
LIFE & BUSINESS
An industry in sectors with high profits is increasingly active and neglected diseases unprofitable. The pharmaceutical industry rejects the accusation as unfounded. We have 2 contrasting views on this topic. PRO: Prof. Dr. Gerd Glaeske,
of striving for returns instead of
co-editor of Innovation Reports
medical progress, in other words innovation would find no place
Cleanroom Magazin: According
where it was needed. Are the lives
Innovation Report 2015, the
of patients at risk?
Techniker Krankenkasse, the pharmaceutical industry developed
Gerd Glaeske: That strive
over the needs of the patient. What
pharmaceutical companies make
is the basis your thesis?
in any sector, is not to criticize. There are privately owned
Prof. Dr. Gerd Glaeske is co-editor of the Innovation Report
Gerd Glaeske: The Innovation
businesses that have obligations to
Report has always pointed out that
their shareholders, pension funds
the research of the pharmaceutical
or owners. The problem lies in the
industry is necessary. Because in
fact, that they will always try to
many disease effected areas new
make high profits with drugs that
or existing drugs are lacking.
shows no medical progress. The
2015, the Techniker Krankenkasse. The pharmacologist studied one of the most famous health scientists in Germany. Glaeske was from 2003 until 2009 Member of the Advisory Council
“Research costs are not really transparent” Prof. Dr. Gerd Glaeske
on the Assessment of Developments in Healthcare. Since 1999, professor of medicinal, Glaeske applied research at the Center for Social Policy at the University of Bremen and is the head of the research unit “drug counseling and drug information”. Since 2007 he is Co-Director of the Department of Health Economics, Health Policy and Health Services Research. His research areas are the transparency, quality and efficiency of the drug market.
PRO
Currently, there is an increase in
welfare of the patient may then be
rare diseases, new antibiotics and
at risk. When with economically
antidepressants. Nevertheless,
oriented studies new drug offered
among the new drugs especially
as a therapeutic advance and
expensive supplments, special
prescribed widely. The examples
preparations are needing to be
of rheumatic agent Vioxx, the
applied in cronological diseases
cholesterol-lowering drug Lipobay
or multiple sclerosis, while in
or the appetite inhibitor Acomplia
the treatment of infections in
should teach us not to speak rashly
hospitals in Germany rises every
of therapeutic progress - all of
year up to 15,000 people, and these
these funds had to be taken off
people usually end up losing
the market as sometimes fatal
there life, due to a lack of effective
incidents did occur.
antiviral drugs. Cleanroom Magazin: The report
CLEANROOM MAGAZINE 1/2016 | Controversy
Cleanroom Magazin: The pharma-
criticizes the fact that new cancer
ceutical companies are accused
drugs have a degree of innovation
21 but the medical benefits often bear
equation “Money for Value”, and
no reasonable relation to the price.
“Value for Money” with appropriate
Why is this so and through which
numbers.
pipelines of many companies, you can be sure, this will be like this also in the future.
health policy incentives this could potentially be changed?
Cleanroom Magazin: In your opinion, is the criticism justified,
Gerd Glaeske: With many new
that the pharmaceutical industry
oncology medicine, prices are
follows the return and not the
growing much faster than the
needs of the patient?
Cleanroom Magazin: The pharmaceutical companies are accused of striving for returns instead of medical progress, and innovation would find no place where it was needed. I ask again is
“Innovations has been repeatedly approved” Stefan Oelrich
the lives of patients at risk?
therapeutic benefit. We note that
Gerd Glaeske: Yes, and we urgently
there is an additional survival time
need to talk about priorities in
of 20 to 40 days up to a few months
research and about the value
in the majority of newly marketed
and benefits new drugs have to
agents. The cost of these treatments
have. We need to have absolutely
are however at 50,000 euros and
no doubt about what research
more. There should exist more
activities the pharmaceutical
contracts for cost containment
industry is undertaking. But
risk of companies: If the funds do
not all new medicines are also
not deliver what they promise,
innovative in terms of their added
the costs between insurers and
therapeutic value over existing
manufacturers should be divided.
Stefan Oelrich is since 2011 the
medicines. This shows the AMNOG
Managing Director of Sanofi-
In addition, the funds should
process (Pharmaceutical Market
Aventis Germany GmbH. The French
be more cost-effective and more
Restructuring Act), which shows the
umbrella company Sanofi-Aventis
frequent, as longer they are applied.
opinions of the Institute for Quality
is one of the largest pharmaceutical
and Efficiency in Health Care and Cleanroom Magazin: Let’s go back to
companies worldwide. From 1989-
demonstrates our Innovation
2011 Oelrich worked at Bayer inter
the accusation for profit. Have high
Report.
alia, in South America and in Paris
prices for new drugs not justified
at the head of Bayer HealthCare.
by the fact, that the industry needs to refinance their research and investment costs? Gerd Glaeske: I could answer that question much better if the research costs would be really transparent. But it is not just about the research costs, it is also about the purchase price of innovative
CONTRA: Stefan Oelrich, CEO Sanofi-Aventis Germany GmbH Cleanroom Magazin: According Innovation Report 2015 the pharmaceutical industry is developing over the needs of the patient. What do you say to this argument?
drugs for other companies. And sometimes the whole biocompanie is bought equal. Research has
Stefan Oelrich: It is unfortunate that the Innovation Report
clearly changed: innovations were
repeats this assertion. The
bought, not developed. That is why
truth is that real innovations
it has become difficult to talk about reasonable prices and backed the
2003 went Oelrich to the US where he marketed as vice president of marketing the Bayer portfolio. From 2007 he also initiated in the USA as Senior Vice President the Women’s Healthcare business. Since 2013 Oelrich is member of the Association’s Research-Based Pharmaceutical Companies (VFA). In June 2015 Oelrich also took over the position as spokesman of the cluster from the health industry Berlin-Brandenburg.
CONTRA
have been approved during the current year. If you look at the
Controversy | CLEANROOM MAGAZINE 1/2016
LIFE & BUSINESS
22 Stefan Oelrich: The welfare of the
today, who are either tumor-
consistentlyfollow the return or
patient is always at the center of
free or could extend their lives,
in other words profit, and not the
our actions.
significantly are doing that.
needs of the patient?
Without the patient’s well-being,
there is no additional benefit
Cleanroom Magazin: Let’s go
Stefan Oelrich: That a company
in the German reimbursement
back to the accusation for profit.
would like to achieve a return on
system.
Have high prices for new drugs
its economic activity, is a driving
justified the fact, that the industry
force of the market economy. This
Cleanroom Magazin: The report
needs to refinance their research
combined with the patient’s well-
criticizes the fact, for example,
and investment costs?
being, is not a contradiction. A
that when new cancer drugs of
prescription drug that passes by
the degree of innovation and the
Stefan Oelrich: I do not understand
the needs of the patient, receives
medical benefits often bear no
this point. The cost of drugs
in Germany no added value and
reasonable relation to the price.
have remained stable over the
thus in consequence a price
Why is this so, and through which
last five years in Germany and
that can not be higher than the
health policy incentives is there a
therefore makes it possible to
current economical comparison
need for change?
compensate for the rising costs
of hospitals and doctors. Higher
Stefan Oelrich: The research
costs for innovations were able to
into cancer has made enormous
be compensated for by low-cost
progress over the past decade.
generics.
Here a mixed viewed discussion
takes place. What matters, is that
Cleanroom Magazin: This is the
many patients who live through
bottom line: Is the criticism of the
the innovative drugs in oncology
pharmaceutical industry that you
therapy. Author: Gero Hassink
Reinraumtextilien im Mietsystem Profitieren Sie gleich mehrfach: • Maßgeschneiderte Bekleidungskonzepte und Reinigungssysteme • Transparente Einzelteilbewegungen • Lückenlose Dokumentation • Abschätzbare Kosten • Professionelle und kompetente Beratung Sprechen Sie uns an, fordern Sie uns heraus! Tel: 09841 – 40140850 E-Mail: info@decontam.de Internet: www.decontam.de
CLEANROOM MAGAZINE 1/2016 | Controversy
23
PROGRESS THROUGH WISDOM.
K A E P S Issue s WLE e g n u o CLEANROOMS!
© Kovalenko Inna | Fotolia
5 e: February 0 n li d a e D l a ri Edito h 01 eadline: Marc D g in is rt e v d A
Know-how and News – for R&D and Industry. ◾ ◾ ◾ ◾
The leading trade publication in German speaking Europe for Operators and Users Volume 18, 2016 – 5 issues per annum 14,000 qualified readers (IVW)
Cleanroom technology
–
Sterile technology –
Hygiene
–
Production
CLEANROOM MAGAZINE 1/2016
24
How a Virgin found himself in the cleanroom
Photo: Cleanroom Media
LIFE & BUSINESS
Andreas Rauschenbach manages the mkf GmbH cleanroom.
Actually he always wanted to create, to build something, therefore he became a mechatronics technician. However instead of building clever and ingenious machines, Andreas Rauschenbach takes care of particle counters, air humidity, job orders and assignments. What went wrong? Nothing at all! He was merely asked one day if he wanted to be the person responsible for the cleanroom and he said yes. How a simple, harmless question
ing and construction. However,
a 260 person community in the
can sometimes change into a life’s
what he didn’t know was: He was
federal state of Thuringia. Although
journey. It happened five years ago.
supposed to build these machines
Lederhose’s coat of arms does
“Rauschi, do you trust yourself to
inside a cleanroom. “That was my
indeed bear a pair of lederhosen,
do this?” the Production Manag-
first contact with this topic” re-
the town’s name has really nothing
er wanted to know. Andreas Raus-
counts the 30 year old.
to do with clothing. The name
chenbach didn’t need much time to
goes back to the Slavic name of
think about it. He was supposed to
Out of this “first contact” has in
Ludoraz. Today in Lederhose a
be building machines. No problem,
the meantime become his main
stone’s throw from the Autobahn
he was after all a qualified mecha-
job. Andreas Rauschenbach is the
A9, the company mfk GmbH with
tronics technician with experience
man responsible for the mkf GmbH
its 85 employees builds customer-
in specialized machine engineer-
cleanroom in Lederhose, Germany,
specific automation solutions. Since
CLEANROOM MAGAZINE 1/2016 | Portrait
25 2008, in addition to building high-
figure, the green polo shirt and the
and footlets. The cleanliness val-
tech assemblies and devices under
grey cargo trousers – the company’s
ues were nonetheless within lim-
cleanroom conditions, the company
working-clothes colors – emphasize
its” says Rauschenbach und sounds
provides services such as cleaning
this impression. However when
a little surprised himself at this. To-
and packaging inside cleanrooms.
speaking to him, it becomes obvious
day he can never imagine working
that no greenhorn is standing
under those conditions. In those
in front of you. Rauschenbach’s
days, however, there had been no
Concerning the latter, there was a customer who started the ball rolling. He had request a solution which was only possible to achieve inside a cleanroom. The company’s management decided to push forward into this new field of business and has never regretted this decision. Today, the products
“In the beginning, cleanroom employees wore only a gown, bonnet, gloves and footlets” Andreas Rauschenbach, mkf GmbH
coming out of the cleanroom are responsible for a large part of the yearly revenues. No one thought
entrance is that of an experienced,
one responsible for the cleanroom.
that this would be possible five years
mature, calm and articulate person
In 2010, as he entered the world of
ago. “We started really in a small
and he really understands his
cleanrooms, his production man-
way with very few square meters of
trade: His cleanroom competence
ager merely “gave a short introduc-
cleanroom space – virtually in a flow
gleams in every sentence whether
tion and initiation” and “roughly
box” says Rauschenbach jokingly.
the topic is about permanent versus
explained” the work to be done. “In
Because of his black beard, his
removable floor mats, or ultra-sound
this way, I slipped into the world of
teeth appear especially white when
cleaning with ultra-pure water,
cleanrooms” recounts Rauschen-
he laughs. Also, with his beard, he
FFU-alternating intervals, the re-
bach. “Whereby I continued to do
doesn’t come across to be only 30
ordering of gloves or calculation of
what I was trained to do when I
years old.
isopropyl mixing ratios.
was needed and when there wasn’t
Based on his appearance alone, this
This cleanroom know-how was
This training included: Mecha-
son of an industrial management
not always available at mkf GmbH.
tronics technician with specializa-
assistant and an electrician born in
“At the beginning, workers in the
tions in special machine construc-
1985 in Gera, Germany could still be
cleanroom were only wearing a
tion and welding. Rauschenbach
doing his apprenticeship. His slender
white work coat, a hood, gloves
learned his profession between the
much to do inside the cleanroom.”
EasyMop GMP
®
Reliable cleaning and disinfecting of pharmaceutical cleanrooms
Pfennig Reinigungstechnik GmbH · Heubachstr. 1 · 87471 Durach · ✆ +49 (0) 8 31 / 5 61 22 - 0 · www.pps-pfennig.de
Portrait | CLEANROOM MAGAZINE 1/2016
26 2002 and 2006 at a Bavarian compa-
He trusted himself indeed and af-
A new cleanroom became necessary
ny near Ansbach. In this respect, he
ter working hours he started to re-
in 2012 and in 2013 a brand-new
differed from the rest of his family.
search this topic cleanroom and
cleanroom, cleanliness class ISO 6,
His father, his mother and his old-
learned about the requirements
nearly 90 square meters in size with
er sister all learned and now work
in cleanroom production environ-
an additional 15 square meters of
for the Deutsche Telecom. “I had
ments. He promptly determined:
material and personnel air locks
absolutely no interest to work for
“We have the wrong cleaning tow-
went into operation. Along with the
Telekom. I wanted more to create,
els!” These were not doubly-sealed
decision to build a new cleanroom
to build something.” It would take
thereby tearing and shredding eas-
was the decision to keep Andreas
two years after finishing his ap-
ily. “I addressed this issue and ex-
Rauschenbach active in both the
prenticeship before homesickness
plained to management what we
cleanroom and outside in the
and the 330 kilometer commute
really needed and showed the dif-
normal production areas. “You’ve
every weekend pulled Rauschen-
ferences between the products” says
already taken care of so much, don’t
bach from Bavaria back to his roots.
Rauschenbach. Although the new
you want to become the person
towels were more expensive, his
responsible for the cleanroom?”
Following his return to Thuringia
supervisors reacted with open ears.
asked his Production Manager.
in 2008, the young professional
Such stories are very encouraging.
Rauschi was indeed confident
started looking for a new employer.
enough in himself to say yes.
He turned down an offer to work
After taking care of the towel issue,
for a company which wanted to
he arranged that the PU gloves be
Since that time, everything has
hire him for maintenance and
exchanged for the better-suited
turned out differently. “It’s not any
repair activities. “I didn’t want to
nitrile gloves, he brought in overalls
more about working occasionally
repair things, I wanted to create
instead of lab coats, he organized
in the cleanroom, it’s about keeping
them” reiterates Rauschenbach. He
swabs for the cleaning of drilled
the cleanroom up and running”
then took a job at mkf in Lederhose
holes, he brought in adhesive
says the young man clearly aware
w h e r e h e n o t o n l y ‘c r e a t e d’
mats for the areas in front of and
of his responsibilities. This means
specialized machines but also was
behind the gray zones, he procured
instructing and monitoring the
able to assemble and disassemble
mouth protection and beard
cleanroom employees, organizing
them at customers’ sites. In 2010, the
nets. Presumably these peu à peu
orders and workflows, dealing
memorable moment came when he
improvements would have gone
with particle counters, filters, air
was challenged to set up a machine
on and on if it were not for the fact
humidity, to monitor temperatures,
inside a cleanroom for the first
that the cleanroom had become too
to write job and test instructions,
time in his life: “Rauschi, do you
small for the growing number of
to monitor and check material
trust yourself to do this?”
orders.
brought in through the air lock, to
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
CLEANROOM MAGAZINE 1/2016 | Portrait
27 organize maintenance schedules,
in the next work hall, still packed in
b i o g r a p h i e s ab o u t p e o p l e i n
to re-order disposable materials,
plastic and wooden boxes and this all
sports and is a fan of the DTM and
to check assemblies to be delivered
has to be organized and managed, to
Formula 1. When the latter takes
with UV lamps and much more. The
be “created”.
place at the Hockenheimring in
lists of things to do includes even to
Germany, he will “absolutely” be
sign holiday applications. As the
Andreas Rauschenbach is a frequent
present. He even takes his tent and
cleanroom Master, Rauschenbach is
visitor to the ReinraumAkademie
camps overnight for the DTM at
constantly peppered with a myriad of questions as he makes his way through the production areas. In order for the cleanroom employees to reach him easily, he carries with him a cordless telephone, as well as a small notebook. “I write down everything which people ask me as I’m walking along, otherwise I’ll forget the half of it.”
“I have already taken our quality manager there, because there is nothing worse than being enterprise blindsighted.” Andreas Rauschenbach, mkf GmbH
Does all this have anything to do with “creating”? “Not really!” admits
(Cleanroom Academy) in Leipzig
the Lausitzring. Considering that
Rauschenbach frankly. “Nevertheless,
because of his cleanroom knowledge.
his favorite food is fast food, steaks
the work is quite motivating.” He
“I have even taken along our Quality
and noodles, it is a wonder that he
has the opportunity on five or ten
Manager as there is nothing worse
stays so slim. Perhaps the reason
days a month to assemble and build
than to suffer from tunnel vision.”
is, besides playing a lot of football,
something inside the cleanroom,
In the meantime, Rauschenbach
the fact that he doesn’t like to drink
but he would also like to implement
has become so knowledgeable in his
Germany’s traditional favorite: “I
many of his own ideas, for example
trade that in 2015 he held his first
don’t drink beer.” Oops! If that isn’t
to build a Handyclean device with
seminar.
a curiosity: The person in charge
which employees would be able to
of a cleanroom who despises of all
degrease their gloves under a fine
Privately, this freshly-married
things a product which is governed
spray. Another idea would be to
man is very interested in sports.
by the German Reinheitsgebot
replace the adhesive mats with a
He was a boxer earlier and won
(German Purity Law)!
permanent mat system. Besides all
championships in Thuringia and
this, the next cleanroom is standing
German-wide. He enjoys reading
Author: Frank Baecke
100% quality 100% service 100% know-how 100% confidence www.profi-con.com Professional cleanroom cleaning Life Science and Microtechnology
Training around Cleanroom cleaning and behavior
Portrait | CLEANROOM MAGAZINE 1/2016
28
How employees become cleanroom operatives
SCIENCE & TECHNOLOGY
The best cleanroom equipment is useless unless the personnel knows what they are doing.
For those companies which don’t want to suffer quality losses in production cleanrooms, they have to regularly train their personnel. In-house seminars and workshops when correctly organized are also able to assure quality in production processes.
employees how to move around in a cleanroom! Instruct your employees to keep their work places clean!” This is easier said than done. How
This expert’s advice was outstand-
tion which is then distributed by
does one communicate to his
ing but in practice, pointless. “When
personnel moving around. Many
employees that the environmental
you want to keep your cleanrooms
particles can also be carrying mi-
conditions, process safety and product
clean, then refrain from sending
crobes” explained Agricola which
quality are decisively influenced
any people into them” advised Koos
describes operators’ age-old prob-
by correct or incorrect working
Agricola as a participant in the
lem. Even worse: when disrobing
behaviors. Furthermore, how does one
congress held at the International
in the air lock, these particles are
communicate this information so that
Cleanroom Trade Fair in Frankfurt
dispersed into the air, which before
in 14 days time it won’t be forgotten?
am Main in October, 2016. The Gen-
had been held back from an em-
eral Secretary of the International
ployee’s clothing, but during break
An excellent possibility is to have
Confederation of Contamination
times settle down onto the disrobed
this information mediated and em-
Control Societies (ICCCS) recom-
clothing and after the break are
ployees qualified and certified by
mended to an astonished audience
carried back into the cleanroom by
professional training centers, such
to send robots into cleanrooms in-
the employee. “There are five times
as the ReinraumAkademie (Clean-
stead of humans.
more particles on clothing than in
room Academy). For those compa-
the air” says Agricola. In order to
nies which would rather train their
Of course this comment was made
keep the cleanroom as clean as pos-
employees in-house, Claudia Pachl,
tongue in cheek, nevertheless it has
sible, Agricola gave his audience
Partner of Avantalion Consulting
a serious background. “The skin,
three pieces of sound advice: “Nev-
Switzerland AG in Luzern, Switzer-
the breath, the employees’ cloth-
er send more people into a clean-
land recommends for these compa-
ing – all of this causes contamina-
room than necessary! Teach your
nies to use standardized procedures
Regular training leads to qualified staff. ‚The cleanroom academy auditorium during an event on the topic staff‘. Photo: Cleanroom Media.
CLEANROOM MAGAZINE 1/2016 | How employees become cleanroom operatives
29
Koos Agricola at the cleanzone 2015. Photo: Cleanroom Media.
in the contents of their courses. Top-
certain behaviors are not followed.
With all these training activities,
ics for the seminars and workshops
Additionally, Ms. Pachl advised to
cleanroom operators should con-
could include hygiene, cleanroom
review how successful the training
stantly have in the back of their
working behaviors, production pro-
has been immediately following the
minds the idea that successful
cesses and so on, always keeping in
event as well as to monitor the effect
employee qualification is never a
mind to carry out the courses at the
of the newly learned information
permanent situation. Claudia Pachl
same level of quality. It is decisive
in practice. In order to assure the
urges “You must always be asking the
however for training courses to be
optimal transfer of knowledge,
question: How long can I consider a
successful that management places
it is helpful to document such
cleanroom employee qualified?”
a high value on employee qualifica-
proceedings in well-structured
tion and instruction. Thereby will
and easily understandable ways.
Many companies would gladly
the participants also find the train-
Only when the newly learned
share these concerns. When com-
ing worthwhile and not just an an-
information and its relationship to
pared to the problem of even find-
noying obligation.
working practices are internalized
ing qualified employees, training
by employees can the effects of
qualified employees becomes an
Besides the standardized procedures
such seminars and workshops be
issue of luxury. The demand for
and internal value of the seminars
sustainably successful. It is useful
professionals in the cleanroom
and workshops, the factor of regu-
to set minimum criteria in order
technology sector has increased
lar, repetitive training is also impor-
to review the success of employees’
enormously in the last years. The
tant to take into account. “You can
qualifications. This could be
industry is demanding specialized
bombard your employees with two
look like the following: The first
training and study courses which
hours of new information but how
qualification follows the successful
will prepare those participants spe-
much of this information will stick?
passing of three consecutive courses
cifically for cleanroom conditions
It is much better to repeat courses
on different days; re-qualification
and requirements. However, up to
at regular intervals” says Claudia
follows the successful passing of
now there are no recognized and
Pachl. To keep employees’ interest
further courses within a defined
certified professions in the fields of
peaked, the trainers should pres-
period of time. Further criteria might
cleanroom technology and too few
ent the topic using vivid and easi-
be added due to stricter demands
academic professionals and grad-
ly remembered techniques as well
and requirements, for example, “the
uates. Therefore many companies
as portraying why the topic is im-
successful partici-pation at MediaFill
are dealing with this crisis autodi-
portant and the consequences when
which deals with aseptic filling”.
dactically.
How employees become cleanroom operatives | CLEANROOM MAGAZINE 1/2016
30 However this will not be enough in
these activities exist” explains Jür-
The curriculum for this trade in-
the future emphasizes Frank Du-
gen Tausch. This is why it is criti-
cludes the topics of planning, mate-
vernell, Managing Director of the
cal that real and recognized profes-
rials management, automation and
ReinraumAkademie (Cleanroom
sions be created and publicized. In
production equipment” says Chris-
Academy). “The working world
order to raise the attractiveness of
tian Dragosits, Group Leader Main-
of cleanrooms has become in the
such professions, these should be
tenance and Environmental Con-
meantime commonplace, but that
comprehensively created and devel-
trol in the manufacture of implants.
of professional training hasn’t yet adapted itself to this situation. Just as the companies involved in warehousing, logistics and forwarding
SCIENCE & TECHNOLOGY
have fused together over the last 20 years into a single logistics industry, so too must the companies involved in cleanroom technology develop into a single industry. In order to acquire employees, the many new pro-
“You must always be asking the question: How long can I consider a cleanroom employee qualified?” Claudia Pachl, Avantalion Consulting Switzerland AG
fessional fields have to be brought to the attention of the general public.” oped, the various professional fields
“We thoroughly train our Process
The personnel recruiter Jürgen
overlapping each other, thus mak-
Technicians inside and around
Tausch, proprietor of Jürgen Tausch
ing it easier for employees to switch
cleanrooms, thus they become at
Personnel Service and Associate of
companies and for companies to ac-
the end technical All-Rounders.”
Höfer and Tausch GmbH in Dres-
quire professionals who have grad-
However, even Dragosits would very
den, Germany sees in this situation
uated with the same or comparable
much like to see specific academic
an obligation of the Chambers of
degrees and who could be trained
training meant for the cleanroom
Trade and Crafts. These chambers
for their required tasks with lower
industry. “There are many providers
have to illustrate the many clean-
expenditures and effort.
of cleanroom seminars and work-
room professions and effectively
shops but no occupational profile.
make the general public aware of
Using this approach, MED-EL Elec-
Diplomas are up until now ‘only’
these opportunities. “Our biggest
tro-medical Devices Ges.m.b.H. in
a participation certificate even if
problem today is that we are sup-
Innsbruck, Austria, has successful-
these certificates suggest otherwise.
posed to be motivating people for
ly generated a part of its cleanroom
My opinion is why not designate the
the activities inside a cleanroom
staffing. “In Austria, there exists the
subject matter under other names,
while most people aren’t even aware
profession of Process Technician.
such as Filter Technology, Measure-
Training at the competence center at the cleanroom academy Leipzig, next to the training cleanroom. Photo: Cleanroom Media.
CLEANROOM MAGAZINE 1/2016 | How employees become cleanroom operatives
31 ment Technology, Climate Technol-
rectly on a company’s own premises.
ence and of course to build up rela-
ogy and Building Technology which
The seminars, workshops and coach-
tionships with other companies, to
would provide a fitting job descrip-
ings are pre-destined for providers
form partnerships and other net-
tion and occupational profile, perhaps consolidated under the desig-
because of time and personnel limi-
“Our biggest problem is that we should be motivating people for the activities taking place inside cleanrooms while most people are not even aware these activities exist.”
tations, many external training pro-
Jürgen Tausch, Proprieter of Jürgen Tausch Personnel Service
nation of ‘Cleanroom Technology’” Until the situation comes to this point, companies have to rely on their own strategies regarding the development of talent and future employees. For those companies with no in-house training program
viders are available to help out. The ReinraumAkademie (Cleanroom Academy) in Leipzig, Germany and
and users of cleanroom technology
working structures. All this enables
the CleanroomAcademy in Wan-
and equipment but also for service
companies to move themselves in-
gen an der Aare, Switzerland offer
providers in cleanroom planning
to the position of fulfilling the high
year-round courses, seminars and
and design or for cleanroom clean-
demands of clean production with-
workshops covering many diverse
ing companies. Participants receive
out having to follow the advice of
topics. The spectrum goes from Re-
first-hand knowledge and informa-
Koos Agricola (“If you want to keep
inraum-Expertentagen (Cleanroom
tion directly out of the practice. Also
your cleanrooms clean, don’t send
Expert Days) to two-day seminars,
participants are able to speak with
any people inside them”).
coachings and workshops as well
the people presenting the topics, are
as courses and seminars offered di-
able to exchange ideas and experi-
Author: Frank Baecke
Ihr Partner für validierte Systeme! Kompetente, faire und zuverlässige Beratung und Ausführung rund um Monitoring-Systeme und industrielle Automatisationen.
innovativ – kompetent – kundenspezifisch vali.sys gmbh hofstrasse 94 ch-8620 wetzikon telefon: fax: e-mail: internet:
+41 43 495 92 50 +41 43 495 92 60 info@valisys.ch www.valisys.ch
How employees become cleanroom operatives | CLEANROOM MAGAZINE 1/2016
32
On the Road with …
Photos: Cleanroom Media.
SERVICE
Steffen Röhm
Steffen Röhm is a project leader at the Competence Center Engineering in the department of Equipment and Maintenance at the company Pharmaserv GmbH & Co KG in Marburg, Germany. He looks after customers in the area of cleanroom technology regarding various topics but focusing on the qualification of cleanroom technical equipment and facilities. How often are you on the road? On
What is important to you when on
a notebook computer in order to be
the average, about two to three days
a business trip? When travelling by
reachable. These devices have become
a week, according to the particular
car, I like and prefer to drive when the
indispensable in the working world.
projects, sometimes an entire week.
streets and highways are free of traffic.
Business trips take place primarily in
Therefore I try to plan my trips during
What kind of music do you enjoy lis-
Germany.
off-peak travel times. Besides traffic-
tening to? Radio stations with a broad
free highways, I very much value
spectrum of Rock and Pop from re-
punctuality.
cent decades.
the car because I often have to take
What should never be missing on a
Which countries and regions are
with me various documents and
business trip? When travelling by car,
most often on your list of destina-
documentation as well as measuring
of course a good radio station. Other-
tions? For business, Germany has
instruments.
wise, a mobile telephone, a tablet and
been the destination in recent years.
What is your favorite means of transportation? In most cases, I use
CLEANROOM MAGAZINE 1/2016 | On the Road with …
33
Privately, northern Germany and
have in my luggage. At the moment,
What would be the first thing you
northern Europe are appealing.
I am reading Wolfgang Niedeckens
would change if you had the un-
autobiography “Zugabe. Die Geschichte
restricted possibility to do so? The
Are you able to relax when you are
einer Rückkehr” (Encore. The Story of
question is difficult to answer. There are
travelling on business? Yes and no,
a Comeback).
so many topics such as environmental
it always depends on what I have to do.
protection, the wasting of resources, Which travel destinations do you
wars and so on which affect and
favor and why? On business, I enjoy
concern us all. For me personally, it
How do you best unwind after a
travelling to Berlin and to Switzerland.
would be important that each of us
working day? I am best able to unwind
Privately, my absolute favorites are
think a little more on others and not
with a good book which I always
Finland, Sweden and Switzerland.
so much on ourselves.
Your partner for critical environment solutions •
Full service solutions for cleanrooms and critical environments
•
Highly skilled specialists and high level of flexibility to turn your needs into a custom-made supply concept
•
Supply chain excellence to provide 100% security of supply and JIT-deliveries
•
Comprehensive portfolio of premium-products and services
•
Global network of suppliers and partners
VWR International | basan - the cleanroom division of VWR | info.basan@eu.vwr.com | vwr.com/basan
On the Road with … | CLEANROOM MAGAZINE 1/2016
34
Science & Technology
SCIENCE & TECHNOLOGY
Technolgy Briefs
Researchers develop a new kind of information storage device
Smarter wound dressing for nerve fibers
Ion Conductor | Scientists of the
Nano-membranes | Researchers at
University Kiel and University Bochum
the Leibniz Institute Dresden and
have developed an information storage
the TU Chemnitz are working on
device with uses ions to store data.
ultra-thin membranes which roll up
Common storage devices are based
by themselves into micro and nano-
on electrons which when current is
tubes. Such tubes provide medical
induced are displaced. As computers
technology enormous innovation
in use today need more time to
potentials. Equipped with integrated
move data than to do calculations,
electronics these tubes could serve as
researchers have wanted to get away
wound dressings for defect or healing
from charged-based storage to that
nerve bundles. The possibility to
based on electrical resistance. Such
open and close the sleeves by outside
A rolled up membrane used as a sleeve for nerve cells made of electronic components. Graphic: IFW Dresden
regarding physiological processes such as the healing of wounds.
Giant molecule blocks Ebola virus from entering the body Medical Research | A giant molecule developed by researchers of the University Madrid could soon provide effective protection from the Ebola virus. The molecule blocks the decisive docking site on cell’s surface and blocks the Ebola virus from entering the cell. In cell cultures it has already been shown to prevent infection. Should results in tests with live animals confirm this, Inspection of memory cells in the cleanroom of the Kiel Technical College. Photo: AG Nanoelectronic
the procedure could enable a way to produce an anti-viral medium
a component has emerged from the
influences makes their application
against Ebola. The custom-made
Kiel and Bochum laboratories. When
in the regeneration, monitoring
giant molecule which researchers
current is induced, ions are moved
and stimulation of nerves very
have created consists of fullerene,
between two electrodes in a solid state
attractive. Furthermore these smart
hollow carbon spheres which are
ion conductor. A further advantage:
nano-membranes can serve as
coated with appendages made of
Such structured cells can be reduced
antennas for implants which would
sugar. The latter protects a cell’s
to atomic sizes.
be able to transmit information
docking site from the Ebola virus.
CLEANROOM MAGAZINE 1/2016 | Science & Technology – Technolgy Briefs
35 Head OP: Robot worm grinds its way around corners
integrated with existing laboratory equipment and running processes. With this device’s help, processes in
Medical technology | In order to
pharmaceutical, chemical, life sciences,
reach a tumor inside the inner
bio-technolgy, nano-technology as well
ear, doctors in most cases have to
as medical technology can become
remove a part of the temporal bone.
more easily automated. In comparison
In the future, a five millimeter tunnel through the bones which
to conventional pipette technology, Dual-flow nozzle apparatus for the production of algina-
the PipeJet-Tip-Technology is able
a new mini-robot has ground will
te globules. Photo: Fraunhofer IBMT
be enough. Unique here is: The
medicines. As the researchers
robot curves around blood vessels
have found out, the alginate acts
and nerves. This OP device was
as a particularly efficient source of
developed by Fraunhofer researchers
nutrition for the reproduction of
in Mannheim together with several
stem cells. British pharmaceutical
universities. The robot, thanks to its
companies have currently validated
Micro-controller | Stuttgart Fraunhofer
accordion-like construction is able
this process in their laboratories.
researchers have developed a battery
to creep forward like a worm. Its
Further trials are to be done by
for electronic automobiles, which is
direction is controlled by hydraulic
European partners in 2016. The goal
considerably more cost effective than
lines and pumps operated from the
is to produce with this process stable
present batteries and this over its
OP. This maneuverability makes it
pluripotent stem cells.
entire life cycle. If one of the over one
possible for the first time minimalinvasive operations of inner ear tumors. The innovation is supposed
Exactly dosing fluids in the smallest amounts
Robots could be used in the operating room in the future. Photo: Fotolia
Stem cell cultivation on algae skeletons
amounts of fluid.
Electro-auto: Batteries with brains
hundred battery cells becomes defect, this can be modular-like exchanged. Up until now, the entire battery had to be replaced. The exchanging of
to be ready for series production in two years.
to dispense 100 to 1000 times smaller
Micro-dosage systems |BioFluidix
single cells has been made possible
GmbH in Freiburg has won the STEP
as each cell is controlled by its own
Award 2015 in the category “Process”
integrated micro-controller. Therefore
with their pipette technology. The
each cell recognizes its own condition.
STEP Award distinguishes innovative
If a cell is empty, it simply disconnects
companies in Germany, Austria
itself from the other cells and directs
and Switzerland. BioFluidix won
the flow of current past itself. The
the award for their PipeJet-Tip-
car doesn’t have to stop dead. The
Technology which allows micro-
researchers have already developed
drop dosing. The BioFluidix pipette
a prototype. In the next phase, the
tips are compatible with common
researchers want to miniaturize the
pipettes and pipette equipment. The
electronics in the cells.
technology is therefore, able to be easily
Bio-technology | On the exoskeleton of algae, the gel-like alginate, Fraunhofer researchers in Sulzbach are cultivating pluripotent stem cells. These have the potential to transform into random body cells for example into inner organ cells. The pharmaceutical industry requires such stem cells in large amounts for the testing of new Micro-controllers extend the driving range of electronic cars. Photo: estations
Science & Technology – Technolgy Briefs | CLEANROOM MAGAZINE 1/2016
36
Are you of sound mind?
Foto: Fotolia.
SCIENCE & TECHNOLOGY
Containments have to be able to protect not only the product but also employees.
New medical agents are of ten even in small dosages very potent. The processing of these agents is putting higher demands on safety in laboratories and pharmaceutical production facilities. Containments have to provide the highest levels of tightness while at the same time providing straightforward material flows and maintenance. A technological balancing act.
CLEANROOM MAGAZINE 1/2016
37 Trends in the development of containments are clearly going in the direction: Preferably more protection as too little. The reason: Often the active agents of new medications are highly potent even in small amounts. This is making the planning, the production and operation of pharmaceutical facilities a considerable challenge. Production facilities have to fulfill complex toxicological requirements and ensure the lowest possible threshold values in work environments. In March, 2015, new and expanded EUGMP regulations and guidelines regarding process safety procedures became effective. In order to make it easier for laboratory operators and pharmaceutical manufacturers to get an overview of the technologies, processes and regulations involved, the work group ‘Containment’ of the ISPE D/A/CH (International Society for Pharmaceutical Engineering – Germany, Austria, Switzerland) has worked for five years putting
The safety of process is important in the clean room. Photo: Fotolia.
together the widely scattered
in November, 2015. This publication
environment from contamination
knowledge into a single resource.
provides for the first time in one
from the substances being processed.
“Our goal was to compile an all-
volume, practice relevant support
The terminology containments does
encompassing handbook dealing
in the planning, construction and
not only speak about closed systems,
with highly active substances.
renovation of manufacturing
but all the measures involved which
Until now, nothing like this has
facilities.
limit the spread of highly potent substances.
“A well-chosen primary containment enables reductions in cost with the secondary containment.”
Containment can be differentiated into primary and secondary containment. Primary containment encompasses all measures which prevent the spread of substances out of the production facility, for example housings, isolators, continuous line systems, suction conveying systems and exhaust sys-
been available.” says Richard Denk,
Under the term, containment,
tems. Secondary containment are
Sales Manager Containment of the
various concepts and technologies are
those measures which collect and
company Skan AG in Allschwil,
to be understood, which safeguard
reduce those substances which es-
Switzerland. The handbook which
products from contamination in
cape from the primary contain-
was started in 2010 and developed
the production environment and
ment systems, for example clean-
by numerous experts was published
reciprocally to protect people and the
rooms, air-lock systems, pressure
Containment | CLEANROOM MAGAZINE 1/2016
38 assured that the employee is able to
Life cycle of a containment: Consider disposal during the planning phase.
balance out the periods of high ex-
Planning: Manufacturers of highly active substances have to consider the entire life cycle of their facility. Thereof is derived the specifications document.
be health-endangering nor exceed
SCIENCE & TECHNOLOGY
Purchase: The first choice is not the most inexpensive but the safest. It has to be tight, keep to the safety limits but also easy to clean and to maintain. Construction: The facility should be ergonomically operable and make possible a hygienic, trouble-free cleaning of all surfaces, transition points and connections. Commissioning: The Factory Acceptance Test follows the Site Acceptance Test, carried out by customers for the assurance of all functions and interfaces.
posure with those of low exposure. The peak load is neither allowed to the eight-hour average value. Reinhold Maeck, Head of Corporate EHS&S Regulatory Intelligence of Boehringer Ingelheim Pharma GmbH, indicates that in the 2014 revision of the EU Chemical Guideline 98/24/EG, the definition of hazardous substances has been expanded: “Hazardous chemical agents as are all chemical agents dangerous and pose risks for the safety and health
Production: It is reasonable and rational to carry out unannounced swab tests of the containment and users during operation of the facility along with regular monitoring of critical areas. Also advisable is a concept in case of accidents.
of employees because of their inher-
Maintenance: All plant components are subject to mechanical wear and tear. These components have to be regularly maintained and kept in good working order in order to rule out a breach in the containment.
active chemical agents there exist
Disassembly: The decommissioning of a contaminated facility has to be done by trained personnel. The disposal of decontaminated parts or their resale is to be documented in writing.
ent physiochemical, chemical and toxic properties.” In practice, however, it should be observed that for no mandatory, uniform safety limits. This situation has an impact on the construction of plants and facilities. To be on the safe side, plant operators often place high demands on the manufacturer regarding the tightness of the plant. Maeck recommends complementing the technical with organizational measures such as additional training cours-
Source: Containment Handbook, 1 edition 2015
es and risk analyses. “Risk assessment is extremely important in cases where contamination becomes
cascade systems, decontamination
The precise design of the contain-
an issue. In such an event, the oper-
systems and adhesive mats.
ment depends on how dangerous
ator has to verify that he has eval-
the processed substances are. Tox-
uated the risks with a team of ex-
Experts recommend calibrating
icologists have determined exact
perts who have reasonably judged
the primary and secondary
safety limits for work places, the
and classified the risks” says Maeck.
containments to each other. For
so-called Occupational Exposure
this purpose, optimally the facility
Limits (OEL) which are divided in-
Besides the primary and second-
is planned from the inside to the
to several classes or bands, from
ary containment, the dust filtering
outside, that is to say, starting
very low to very high. These safe-
equipment also belongs to the is-
from the production process, a
ty limits are mostly taken as eight-
sue of plant safety. “Some producers
suitable containment is chosen
hour average values. The average
forget this completely because they
and afterwards it is determined
value means that an employee in
are only focused on GMP” says ISPE-
how the secondary containment
an eight-hour shift is allowed to be
D/A/CH Chairman Richard Denk
will look. A well-chosen primary
exposed to higher dosage levels for
and knows this from experience.
containment results in cost re-
short periods of time as long as the
“Plant operators have to consider
ductions with the secondary
toxicologists show no concerns re-
that the fine dust particles which
containment.
garding this exposure and it can be
become a finely processed powder
CLEANROOM MAGAZINE 1/2016 | Containment
39
The laboratory of the future does not looks like this. Soon the devices will have driven the laboratory technician from the room. Photo: Institute for Chemical Technology Hannover
are able to reach areas which even
the cleaning and maintenance prob-
skin and mucous membranes. “It
water is not able to penetrate.” This
lematical as the danger exists that
is enough when an employee un-
situation affects filters, threaded
employees will absorb these parti-
wittingly touches his face with his
fittings, pipe lines and other plant
cles not only by breathing them in
gloved hand – which happens more
equipment. This deposition makes
but also by absorption through the
often than one thinks” warns Denk.
Important Pharmaceutical Fairs and Congresses 2016 Lab Innovations Lausanne Trade Fair for Technology and Services in Laboratories Date: April 13-14, 2016 Location: Messe Beaulieu Lausanne , Avenue Bergières 10, 1004 Lausanne, Switzerland Exhibitions: • Lab equipment • Cleanrooms • Lab installations • Services • Consumable materials Medizin Innovativ – MedTech Summit 2016 Congress with exhibitions for medical technology, pharmaceutical and health care systems Date: June 15-16, 2016 Location: NCC Nürnberg Convention Center, Messezentrum 1, 90471 Nürnberg, Germany Exhibitions: • Medical imaging • Home care • Smart Medical Devices
• Hospital, workflow • Personalized diagnostics, personalized therapies • Innovation in the health care industry ILMAC Basel Industry Trade Fair for the Pharmaceutical and Chemical Industry Date: September 20-23, 2016 Location: Messe Basel, Messeplatz 1, 4058 Basel, Switzerland Exhibitions: • Laboratory planning, installation, requirements • Laboratory planning, installation, requirements • Analytics, automation, preparative techniques • Diagnostics, verification procedures, platform technologies • Sterile room technology, cleanroom technology, hygienic room technology • Planning and engineering of facilities and processes • Construction and operation of facilities • Environmental technologies, safety equipment, worker safety
Containment | CLEANROOM MAGAZINE 1/2016
SCIENCE & TECHNOLOGY
40 Basically, plant operators have the
Fixed containments demand
disposed of by specially trained
choice between fixed and flexible
higher initial investment costs,
personnel. This applies also for
containments. Fixed systems are
however generate lower operating
the periphery, such as walls, floors,
manufactured as a rule out of
costs. Flexible containments are
ceilings, air locks, built-in fixtures
stainless steel and glass and are
more inexpensive, but after every
and ventilation systems. During a
securely installed, for example
product changeover have to be
product changeover phase, special
isolators. Flexible containments, in
newly purchased. Moreover they
cleaning procedures often exist
contrast, consist of plastics and are
require a more elaborate stainless
for containments which have been
meant for temporary activities such
steel peripheral equipment and
constructed for the manufacture
as weighing, decanting, inspecting
material logistics such as for fixed
of diverse products. These pro-
and cleaning. Furthermore, flexible
containments. Dirk Collins, Product
cedures can be used during plant
containments are predestined to
Manager at Hermann Waldner
dismantling. In plants where only
become one-way technologies for
GmbH & Co.KG in Wangen, Germany
one product has been manufactured,
manufacturers with frequent product
advises: “Choose for the comparison
every single component which has
changeovers which after production
between fixed and flexible systems a
come into contact with the product
are disposed of to be replaced with
time frame of at least five years – one
has to be examined and assessed as
new containments for new products.
to two years is much too short!”
contact with particular substance-
In contrast, fixed systems have to
groups prohibits further use.
be thoroughly cleaned after every
Whether a fixed or flexible con-
Important is: Any resale or disposal
product changeover. Advantages of
tainment – in both cases the
of contaminated components has to
fixed systems are their stability. They
operator has to consider the future
be documented in writing.
stand up to pressure and collisions
decommissioning and disposal
and provide the user psychologically
activities even during the initial
more safety as he or she, standing
planning and acquisition stages.
behind a solid wall, feels better
Contaminated facilities are only
protected.
allowed to be dismantled and
Autor: Frank Baecke
Lausanne 2016 Expo Beaulieu
13 & 14 April 2016
The show for laboratory technologies & services
Your invitation code for a free entry
4260 (value CHF 20.–)
www.labinnovations.ch
CLEANROOM MAGAZINE 1/2016 | Containment
41
What do you do there Petra Hagel? Brief profiles of the clean room industry
Petra Hagel is the Operations Health Management Manager at Vetter Pharma-Fertigung GmbH & Co. KG, an internationally leading pharmaceutical service provider for the manufacture of aseptic pre-filled syringes, carpules and vials. Photo: Vetter
“My name is Petra Hagel. Since
and physical challenges in their
Here is where I come in as the
October, 2014, I have been the
daily work. As an example, any
Health Safety Manager. The support
Operations Health Management
additional movements outside of
of our employees in the cleanrooms
Department Manager at Vetter,
what is necessary to carry out a task
is particularly challenging because
an independent family-owned
should be avoided when possible.
this is only possible outside of the
company with locations in Germany
This, of course, contradicts not
cleanroom. I organize and provide
and the USA, as well as subsidiaries
only a body’s own natural need for
specific movement opportunities
in Singapore and Japan. The
movement but also an employee’s
such as an ‘Exercise Break’, or the
company employs 3,400 people.
inclination to show that he or she is
Group Thera-Band Training or our
working hard. Another example is
large selection of company sport
The customer-specific medicines
the predefined physical positioning
groups.”
and medicaments our company
of the body and arms which could
produces are filled under aseptic
lead to orthopedic problems that
conditions. These conditions and
could cause tension, headaches,
work environments present for our
back pain and possibly serious
employees significant ergonomic
circulation problems.
What do you do there …? | CLEANROOM MAGAZINE 1/2016
42
The Semi-Conductors of the next generation,
SCIENCE & TECHNOLOGY
will allow new materials to completely revolutionize existing applications.
The digitization of the economy and of everyday life is in full swing. Trends like big data, social media and the Internet of things determine the topics of the upcoming CeBIT. They all have something in common, they require significantly powerful semiconductors. Thus the cleanroom requirements increase. Smartphones, tablets and laptops are full of Semi-conductors.
Photo: Fotolia.
The Moorsche law was yesterday
Now these are used even in tooth-
digitalization of business and
brushes, toasters, refrigerators
industry and play a particularly
and garments. Even cars, trains
big role of importance: the so-
and planes would not work today
called industry 4.0 is inconceivable
For 50 years, Moore‘s law applied
if it were not for the invention
without strong chips and sensors
heavily in the semiconductor
of the semiconductor. These are
that control the enormous amounts
industry. Gordon Moore, the co-
even in our cars, for example the
of data and process that is required
founder of the chip manufacturer
Audi A8, has about 6,000 to 8,000
for such tasks.
Intel, in 1965 after six years of
semiconductors. Powerful micro-
observation, had found that the
electronics are also the progressive
density of integration, which would
CLEANROOM MAGAZINE 1/2016 | The Next-Generation
43 double the number of transistors on a unit of area in order to increase the performance of processors two year. In 1975, he then finally corrected this rule on doubling every two years. Today we double every 18 months. Experts however agree that the traditional semiconductor production will soon reach their physical limits.
Alternatives to Silicon came from Japan For decades, Silicon is the basis
Cleanroom employees in the production. Photo: Fotolia.
for the modern semiconductor in electronics. The material kept producing smaller and smaller transistors, but it is hard and became very brittle. Networked pieces of clothing, for example, require more flexible components that can be incorporated into the materials. Therefore much research was gathered, and it was found that gallium nitride (GaN) is considered to be the material of the future. The compound in semiconductors was for the first time in light-emitting diodes, known as LEDs. For the first,
Associate inspected a gallium nitride substrate. Photo Fraunhofer THM
time three Japanese researchers names Isamu Akasaki, Hiroshi Amano and Shuji Nakamura started developing this area in the early 1990s so that LEDs that emit blue light. For this they were awarded in 2014 the Nobel Prize for physics. GaN semiconductors are already used in power electronics. They promise a better performance in consumer electronics, electric cars or in data centres. Galiumnitrid has a better thermal conductivity than silicon and works more efficiently at higher temperatures. However, the production of GaN components is still very expensive. At the ‘Fraunhofer Technology Centre for semiconductor materials’ in Freiberg, researchers in 2011 gallium nitride substrate. Photo Fraunhofer THM
have already started with new
The Next-Generation | CLEANROOM MAGAZINE 1/2016
44 The semiconductor industry boom • Through the Internet of things, there will be an increase for the demand of sensors . The auditors from PricewaterhouseCoopers forecast an annual sales growth of 5.2 percent in the global semiconductor industry by 2019.
SCIENCE & TECHNOLOGY
• Europe will also benefit: the demand will rise by 2019. An average of 3.9 percent.
• Sensors in wearables: PwC experts predict that until 2019 they were sell over half a billion units. As a result, sales are rising rapidly. 15 million US dollars was made in 2013. It is expected that in 2019 seven billion dollar is to be made through sales. • Automotive engine of growth: In electric and hybrid cars, 1.5 to three times as many semiconductors are used as in conventional vehicles. The market for semiconductors will grow up to 2019 each year to 20.5 percent.
• Growth through smartphones, tablets, electric vehicles, and wearable’s: sales of the industry will grow by 2019 at $ 432 billion.
Source: PwC study „the Internet of things: the next engine for the seminconductir industry groth“
investment concepts. And last
IBM however thinks in a different
would deliver excellent results even
year, they developed a system in
way. The American company relies
in this case. The performance of
full working operation, which so
on carbon nanotubes instead of
computers could be with improved
far are showing good results. The
Silicon. With the new material, so
semiconductors. It could take
researchers are confident that in
the conviction of the IBM Developer
up to five to ten years to develop
the future, this will significantly
skips an important hurdle for the
this system, however until these
reduce manufacturing costs and
further reduction of semiconductors
new devices come to market, we
therefore release the burden on
and transistor contacts. So, carbon
could have already discovered and
businesses.
nanotubes under 10 nanometres
developed a different system and
Project Management Cleanroom Technology
Master every challenge by using our services.
Process Management Qualification
Benefit from our 360° Pharma Consulting to gain more efficiency, safety and quality. independent · transparent · sustainable Visit us at · booth A 24
Quality Management
Validation Computer System Validation
CLEANROOM MAGAZINE 1/2016 | The Next-Generation
www.avantalion.de
45 CeBIT trends. • Digital transformation: companies must be ready to face the challenges. • Big data: more and more data needs evaluating. This will increase the demands on data centers and will expect more performance. And the whole thing has to be with energy - and be cost-efficient. • Internet of things: increasing the networking of machines, products and everyday objects. But to maintain the standards are needed. • Social business: the digitalization changed the world of work. The cloud caused it and a collaboration of solution is needed to form new cooperation’s. • Security: When growing cybercrime there is a need for rises in effective security strategies and new architectures • Mobile: the future belongs to mobile devices. The industry looks for links from business software and mobile devices.
QUALIFIZIERUNG WARTUNG
• Date: CeBIT takes place from 14th to 18th March 2016 at the Hanover Trade fair.
STRÖMUNGSVISUALISIERUNG MONITORING MESSTECHNIK
therefore could replace silicon
Also, the production in cleanrooms
semiconductors, so the forecast of
is itself always smarter against the
IBM researchers.
background of the industry 4.0
SERVICE
concept. The cleanroom industry
BERATUNG
Testing before production
requirements will increase with the further automation. The
New materials in mass production
increasing use of semiconductors
means new challenges to manu-
in semiconductor production will
facturing facilities in the clean
make the production in the future
room. It is because of cost reasons a
faster and more cost-effectively.
new manufacturing line cannot be
New cleanroom standards are
built, and for any new material to be
necessary as new regulations are
developed. The chipmakers Infineon
drafted year after year.
are pursuing the claim to utilize existing facilities as efficiently as possible. But before new materials
Author: Thomas Köhler
KALIBRIERUNG
SCHULUNG
BSR Ingenieur-Büro BSR Meßtechnik GmbH Beratung und Service im Reinraum Marienstraße 156 68794 Oberhausen-Rheinhausen eMail: blattner@reinraum.info Tel. 07254-959 590 Fax 07254-959 5929
come into production, it depends on whether interactions are to be expected and which risks need checking to expose potential threats. Only in this way, high quality of the products can be guaranteed.
The Next-Generation | CLEANROOM MAGAZINE 1/2016
46
Photo: Fotolia.
SERVICE
Sitting for hours in front of a microscope or at safety work benches demands undue physical strain from muscles and the musculoskeletal system. The results can be tension, pain, or even illness-related absenteeism. With ergonomic work places, muscle-relaxing exercises and the re-consideration of incorrect postures and behaviors, cleanroom employees can remain healthy. CLEANROOM MAGAZINE interviewed cleanroom technician and certified Mental Trainer/ Fitness Coach Richard Reudelsdorf of the company Dittel Engineering about cleanroom-suitable, health-related prevention techniques.
Working in a cleanroom and staying healthy Risks of physical complications due to one-sided, repeated unilateral physical movements which put stress and strain on the body can be prevented. CLEANROOM MAGAZINE 1/2016
47 Working in a cleanroom requires considerably more from our bodies than comparable work in an office or production facility. The person is stuck inside cleanroom clothing, the air is dry and in constant circulation. Sweating hands in latex gloves, heavy breathing behind mouth protection, overheating, thanks to a full protective hood and other difficulties face cleanroom employees. The body and the psyche are heavily strained. The “Working Environment Cleanroom” is a closed environment and serves only one function: to keep research and production free from any kind of contamination. However not only robots are found working in this climatized, hermetically sealed world, the human employee also has to adapt to the special conditions found inside a cleanroom and remain physically and mentally productive.
Clothing, Comfort, Sitting Posture Ergonomics in cleanrooms begins with the clothing which has to provide the necessary protection from contamination, a level of comfort which offers the employee an unimposing fit as well as giving the employee unrestricted motoric and mental performance capabilities. Unaware of the effect, uncomfortable fabrics put strains on mental
while sitting at a microscope for
achieved by putting our musculature
capacities which leads to quickly
hours on end, or insufficient physical
under a load otherwise it becomes
becoming fatigued. Results are a
movement in the course of a working
weak and subject to complications.
reduction in concentration, longer
day. Health and product protection
As a fitness center will never become
reaction times and increased rates of
collide with each other under
part of a cleanroom’s design, muscles
error. When these negative mental
these conditions because regarding
have to be activated by alternating
processes operating in the background
the protection of products, it is
between contraction and relaxation.
are reduced with the correct clothing,
indispensable to move about inside
Balling the fist is one example
concentration and performance
a cleanroom as slowly as possible
of a strengthening exercise with
capabilities will improve.
and then only when necessary.
minimal movement.
However, sitting still or moving as Further physical stress factors in
slowly as possible contradict human
Regarding posture: Sitting bent over
cleanrooms come about through
nature. Our skeleton needs a strong
is for all intents and purposes taboo
improper sitting posture, for example
and stable musculature which is
as the back pain resulting from this
Ergonomics and Fitness in the cleanroom | CLEANROOM MAGAZINE 1/2016
48 Cleanroom adapted exercises for progressive muscle relaxation An exercise for working at a microscope: The goal of the exercise is to consciously relax a particular muscle group, whereby a condition of relaxation should be achieved regarding a particular muscle group. SERVICE
The employee slowly sits up straight and breaths three times slowly in and out. He raises the shoulders slowly upwards, breathing in at the same time and tries to hold the shoulder muscles in a tensed position for five seconds. A slight tension of the neck musculature is felt. (Important: do not tense up) The breath is held and after five seconds exhaled. The musculature is relaxed. The shoulders are slowly, consciously lowered. A relaxation of the musculature is clearly noticed. Attention should be given to the alternation between contraction and relaxation.
CLEANROOM MAGAZINE 1/2016
49 The baton to pass, this is in the cleanroom only mentally possible. Photo: Cleanroom Media.
constant strain and tension on the
have noticeable effects but unduly
a distinct seat mechanism supports
back is the number one problem
act on the metabolism and become
an employee’s spinal column while
in the modern working world.
addictive.
allowing him to concentrate on his
Every second German over 30 years
work with minimal movement.
old suffers from back problems.
“Healthy sitting” as a slogan sounds
In Part 2 (next issue), read more
Conventional medicine is only
contradictory but it refers to specific
about ergonomics and fitness in
able to ease the pain however will
sitting solutions inside a cleanroom,
cleanrooms.
never be able to combat the causes.
such as those from the company
Cortisone injections against pain
Dauphin HumanDesign Group. Here,
Author: Josef Kwasnitza
Cleanroom Magazin: Mr. Reudelsdorf, you have been working for quite some time in parallel as a coach and a trainer in the field of sport and as a cleanroom technician and are knowledgeable about the many kinds of variously equipped cleanrooms. You are aware of in a double sense, and tangibly measureable, how necessary physical movement is for cleanroom personnel on one side but also how movement significantly increases the likelihood of contamination on the other side. Richard Reudelsdorf: This problem has been well described in the article. Activities in a cleanroom underlie a person’s own specifics and the avoidance, respectively the prevention of contamination remains the number one priority. However, some things remain possible for employees to be able to stay productive. The progressive relaxation exercises for example for working at a microscope are offered in this article. Cleanroom Magazin: How often should the exercises be repeated? Richard Reudelsdorf: A person should carry out in all two repetitions. With some muscle groups, it might take several attempts before the correct musculature has been contracted. Of course, practicing the exercises should be logically done outside of the cleanroom. Cleanroom Magazin: Does a particular sequential order have to be followed? Richard Reudelsdorf: In order to achieve a sustainable relaxation effect, it is recommended to follow a particular sequence of muscle group exercises. This of course takes place outside of the cleanroom. It takes 30 minutes and requires a quiet environment. Many courses are available on the market. Together with the targeted strengthening of the musculature and by the way, the cardiopulmonary system, relaxation is essential for a healthy body and mind.
Ergonomics and Fitness in the cleanroom | CLEANROOM MAGAZINE 1/2016
50
What keeps its Longevity is goo
SERVICE
In the spring of 2016 the revised version of the DIN EN ISO 14644-1 and -2 will be published..
Since 2005, international experts are working on an upgrade of the DIN regulation introduced in 1999 EN ISO 14644 Cleanroom classification. Part 1 and 2 of this standard replaced the US Federal standard 209E. The update provides an adaptation to new circumstances and several facilities, critical to everyday working procedures.
classification; it must represent an upper confidence bound, derived from the measurements, and statistical projections. This fact requires a slightly different approach to determining the number and
The 1999 standard DIN EN ISO 14644
a particular class of the cleanroom
was the first international standard
to the main point of contention.
for detecting space Cleanroom
Described in the introduction of
classifications. At its adoption, it
the previous standard 14644-1 it was
was agreed that after at least every
explained how the new formula
In the current standard, the number
ten years there needed to be update
worked and it was not exactly clear,
of measurement points of the
of the standard, i.e. a correction of
even for experts it was not possible.
formula was determined: the number
errors and an adaptation to new
Therefore, this new introduction
of measuring points stems from
circumstances. This process was
describes what assumptions do
the root of the surface area in m2,
started in 2005. An international
underlie. In the future it should
rounded up to the next higher whole
team of experts should develop a
therefore be possible to follow the
number. This is not derived or 100%
rewrite, and his main priority will
adopted specifications. Thus one of
accurate but on the basis of the above
be to first define priorities requiring
the recognized gaps was closed.
assumptions, experts should find a
location of measuring points.
Number of points:
suitable scientific approach, which
urgent revision and work. In the current standard, it is as-
eliminates these inaccuracies that
The fact that this recast expected to
sumed that the particle load of a
may or may not arise.
be published in the spring of 2016, it
space is homogeneous, so that the
does make clear, the consultations
measured values are only scattered
According to the new version, this
were difficult. However, the draft now
around this mean. This was also the
number of measuring points must
has a good chance to be adopted in
required statistical procedure for
be, read in the future from a table
the near future. Here is an overview
the evaluation of the measurements
where the number is still on the
of the main changes.
that is only understood by a few. In
surface area that is dependent on.
the new version, the space must no
The difference with the old formula
longer be as homogeneous for it to be
is not so serious, in some places, one
considered, which is also not practical
or two measuring points must be
experience. In the future it „only“
used more than before. Only in very
comes to show that the required
large rooms from 1,000 square metres
limit of particle concentration is
is a linear increase in the number.
ISO 14644 part 1 Statistical analysis of measurements:
observed. This makes it obsolete to
Location of the measurement points:
To do this, there was controversy.
the subsequent statistical analysis
Multiple negotiations were close
and evaluation of measurements,
to failure. The topic number and
these will no longer be in the new
location of measuring points
version. Each single measurement
Whether more measuring points
counted for proof of conformity with
must now comply with the required
bring more security with regard
CLEANROOM MAGAZINE 1/2016 | Law and regulations
51
Photo: Berner International
to a possible breach to the required
the situation is once determined,
cleanroom quality, this remains to
everything in the standard should
be clearly known. The debates were
also be maintained.
Definition of clean room class: The basic chart for this definition of the cleanroom classes was adopted
fierce when it came to the location of the measurement points. The
The compromise is now: the location
and ended up virtually unchanged.
„theorists“ demanded that these
of the measurement points should
However, the particle sizes, which
should be newly determined via
be representative of the area. The set
would result in very low limits for
random number generators for
of points can be done through a risk
a classification to be met, has been
each qualification and requalifi-
assessment and should evenly cover
removed from the purer classes
cation. Select the location of the
the area. Can a purely statistical
in the classification as statistically
measurement point, chosen from
examination of the location of the
reliable evidence m this would mean
random number generators, and
measurement points capture all
a disproportionate effort to comply
that would cause the whole space
influences on the quality of the room
with. So the limit value for particles
to be examined in the course of
- around type of ventilation, location
of ≥ 5 µm was cancelled, in ISO class
time, and should respond a posi-
of vents, location of installations,
5. Due to this it has been disused
tive answer.
personnel, etc. - ? Although, this
enormously in the past, on whether
compromise represents a user
such low limits are useful. Now, it
friendly way.
has decided to adapt the existing
The „pragmatists“ could not reconcile themselves, and so in
classification.
most cases the conditions for the
Because the number of measuring
application of such a course of
points now must be read from a table,
Who needs a specification for
action is difficult. That‘s why the
many operators will need to revise
this size with such low limits,
„pragmatist“ chooses the location of
their documents and customize
which must rely now on the so-
the measurement points according
possibly one or two measurement
called macro descriptor. However,
to a completed risk assessment,
points that are used evaluate and
it is still preserved, allowing the
and after engineering the plan. If
redefine.
standardized specification of limits
Law and regulations | CLEANROOM MAGAZINE 1/2016
52 for large particles, even if they are
Who, however, with particles <
By chance, here is the set found
not in the focus of the standard.
0,1 µm wanted to work, for which
that the operator should make the
This should specifically comply
there was a U-descriptor (for
re qualification once a year. This is
in the European pharmaceutical
ultrafine particles). This should be
just pure classification, there are
industry, as the GMP class A date
replaced in favour of a new part
no recommendations for further
ISO class 5 that was almost equated
of ISO 14644, in which you wanted
testing, as they were called so far.
was with specifications both 0.5 µm
to deal with nanoparticles. This
Here, the operator due to its own
and 5 µm particles. The detour via
part was developed parallel to
specifications, for example on the
the macro descriptor means but
part 1 so that you wanted to deal
basis of a risk assessment, must now
only a change in the choice of words
with references to this new part
define the extent of testing required
requires only minor adjustments.
of the topic of very small particles.
and the intervals associated.
Unfortunately this part failed the Only for those, an ISO class 5 will
participants at the last moment,
only be granted on the basis of 5 µm
due to a missing consensus, so that
who wanted to specify the particle.
now there is a gap.
Compliance with the clean room classes:
Opposition phase now draft part 1 and 2 should be released as soon as
This will involve only a vanishingly small number of operators, if at all.
Opposition phase
ISO 14644 part 2
possible and presented to the public for commenting. As soon as the subsequent objections, for example to
Part 2 of the standard 14644 focused
errors or Unverständlichkeiten, are
on the measures for determining
edited, the final version is expected
The procedure for the determination
the on-going compliance with the
to be released in the spring of 2016.
of compliance with the cleanroom
requirements of part 1. It contained
classes is preserved. What is new is
among others notes to the intervals
that now all information (not only
for re qualifications. In the future,
the measuring process itself, but
the focus will be on monitoring, so
also the minimum requirements
on a more or less continuous mon-
for the measuring instruments) are
itoring selective process.
fully included in part 1, so that it is formally no longer instructed to
The display of aspects to be observed
look elsewhere for other parts of the
here plays an important role in the
standard. The concept of the macro
new part 2. Normative, it is not
descriptor was also preserved, as
codified but who needs a monitoring
mentioned above.
to a high extent. For example, this must define each operator based on a risk assessment itself and documented in a monitoring plan.
The person of Dr.-ing. Dirk Stanischewski leads a group which deals with the qualification of cleanrooms and systems of Bilfinger maintenance GmbH. In the course of these activities, he works with in national and international policy committees. The Bilfinger maintenance GmbH is specialized on maintenance and equipment of industrial plants.
CLEANROOM MAGAZINE 1/2016 | Law and regulations
Author: Dirk Stanischewski
CLEANROOM EXPERIENCE The license for knowledge surrounding everyday cleanroom use!
Makes work easier For all cleanroom supervisors Contents More than 500 topical articles including: · Best Practice · Presentations · Checklists · Key Standards · Training Materials · Operating Instructions Download A wide range of materials in PDF format Like us on Facebook!
Register It’s this easy: go to www.cl-ex.com Click on Register, and start using the knowledge.* For Cleanroom Users Cleanroom Suppliers Cleanroom Supervisors Cleanroom Trainees Instructors Students
* The license fee for one year constitutes a single payment of € 98.–
www.cl-ex.com The knowledge portal for the cleanroom industry. CLEANROOM MAGAZINE 1/2016
53
54
RobotScan Flex is the Industry’s Innovation of the Year
SERVICE
A robot for air filter inspections wins the Cleanroom Award 2015.
The award for the cleanroom innovation of the year and the first time ever awarding of the Creative Prize by the ReinraumAkademie (Cleanroom Academy) were the highlights of Cleanzone 2015. The International Cleanroom Trade Fair recorded an increase in attendance of 20 percent.
of Cleanzone’s broad spectrum of visitors, their concepts, ideas and solutions. The applicant who at the end of the presentations wins the Award is decided by Cleanzone’s
That was certainly a clean sweep: The
of the award for the best cleanroom
representatives of InfraSolution AG
innovation of the year.
attendees by ballot. InfraSolution AG received the
came for their first time as an exhibitor to last October’s Cleanzone, presented
“We are very pleased about winning
Cleanroom Award 2015 for its
a world premiere and promptly won
the award. In behalf of the entire
unprecedented, automated mea-
the ReinraumAkademie’s Cleanroom
team, I thank you all very much. It
suring system with the name of
Award. With RobotScan Flex, a robot for air filter inspections, this company
“Due to the absence of any manual work, we get timely, precise measurements with the minimal of human input.”
from Langen, Germany, convinced the visitors of Cleanzone and its competitors to select it as the winner
Mathias Itter, Chairman and CTO of InfraSolution AG
was an excellent idea to come here”
RobotScan Flex. This device enables
said Mathias Itter, Chairman and CTO
filter integrity tests in up until now
of InfraSolution AG during the award
unrivaled quality. A robot arm scans
presentation. The Award endowed
automatically, in accordance with the
with 3,000 Euros was presented by
valid norms and regulations, vertical
Yvonne Weis, representative of last
as well as horizontal terminal filters
year’s winner, Initial, and Frank
and Laminar Flow units. Intelligent
Duvernell, Managing Director of the
software meanwhile compiles
ReinraumAkademie.
the necessary documentation and analyses and visualizes the
Mathias Itter (left), Chairman and CTO of InfraSolution AG, is the winner of Cleanroom Award 2015. Photo Sandra Gaetke
With the Cleanroom Award, the
measurements in the form of an
ReinraumAkademie distinguishes
electronic test record. “The robot
every year a pioneering cleanroom
lingers neither too long nor too short
technology innovation. A profes-
in positions of incorrect spacing
sional jury selects beforehand, from
under the filter”, explains Mathias
all the applicants ,the final five. These
Itter. “In this way, there are no
five finalists then present in front
longer any distorted measurements.
CLEANROOM MAGAZINE 1/2016 | Cleanzone 2015
55 Besides, due to the absence of any manual work, we get timely, precise measurements with the most minimal of human input.” A further advantage is that the three-arm-robot is able to reach every point in the room and recognize obstacles such as sprinkler heads or walls. “Something like this was not possible five years ago, as the calculation technology was not yet available” emphasizes Itter. RobotScan Flex is planned to hit the market in the middle of 2016. Not only RobotScan celebrated its world premiere at Cleanzone. The ReinraumAkademie’s Creative Prize also made its debut. “With this special award presented extra to the Cleanroom Award, we want to bring to the attention of cleanroom planners and operators, the aspects of employee well-being and concentration influenced by ergonomics and color in the cleanroom” said Frank Duvernell, Managing Director of the
Creative Prize Awarding | The first-time awarding of the Creative Prize for the most attractive cleanroom went to MEDEL, represented by Christian Dragosits (middle) and Alexander Mayr (2nd from right). The award made of glass was designed and created by Beat Toniolo 2nd from left). Photo: Cleanroom Media
ReinraumAkademie. The winner of the first Creative Prize was the company
material. MED-EL representative
Overall, Cleanzone which is organ-
MED-EL from Innsbruck, Austria. The
Christian Dragosits who together with
ized by the Messe Frankfurt in part-
producer of hearing implants received
his colleague Alexander Mayr accepted
nership with the ReinraumAkade-
the award for the distinctly creative
the award, disclosed just how suitable
mie, in its fourth year of existence,
design and creation of a newly-built
the design and material were: “We used
closed with a remarkable balance
cleanroom complex. The Swiss artist,
a lot of glass for our new cleanroom
sheet: Compared with last year,
Beat Toniolo, designed the Creative
so that employees are able to see the
Cleanzone registered a two-digit in-
Prize and decided on glass for the
Autumn colors and the Winter snows.”
crease and this in all parameters – ex-
Call for application - Submit your project for the Clean Room Award 2016 Until when can projects be submitted? The deadline for applications is June 30, 2016. Participants can be companies, institutions and scientific establishments. What can be submitted? Sought are innovations which bring to the cleanroom industry technological advances, yields in efficiency or competitive advantages. All interesting ideas can be submitted whether they are sketches on sheets of paper or completely finished products.
Where should the applications be sent? Applications for the Cleanroom Award 2016 are to be sent to the following address: ReinraumAkademie GmbH Rosa-Luxemburg-Str. 12-14 04103 Leipzig Germany Tel.: +49/341/98989/303 E-Mail: info@reinraum-akademie.de Internet: www.reinraum-adademie.de
Cleanzone 2015 | CLEANROOM MAGAZINE 1/2016
56
SERVICE
Cleanroom Award 2015 – This innovation made it into the final and took the award. Smart Garment The company Berendsen (Arnheim, the Netherlands) introduced a textile management system which with UHF technology, RFID chips and intelligent software enables the tracking of every single piece of cleanroom clothing. The system takes into account which piece of clothing is being used at the moment, or which is in the stock room or even which piece is being cleaned. Thanks to this information, over-capacities in the stock room are visible, also clothing which is never worn. Moreover, the system is able to be used for controlling access for example in cleanroom air locks.
keyboard which can be used while wearing layered cleanroom gloves. Additionally, there is a hand scanner. The work station has neither ribbing nor edges and is completely encapsulated. The batteries are inductively recharged via a wall contact. Clothing Disinfection with Light A research fellowship affiliated with the company Ortner Reinraumtechnik GmbH (Villach, Austria) presented a solution for the continuous disinfection of cleanroom clothing while being worn. The basis is a special textile dye which produces oxygen when exposed to light and thus permanently sterilizes textile surfaces. This worldwide, unique development is not only interesting for the cleanroom industry but also for example, for doctors in disaster areas. Project partners were dastex, M. Dohmen and the TU Graz.
Trolley Light Inductive The company Systec & Solutions GmbH (Karlsruhe, Germany) presented a work station on wheels which thanks to the lithium-ion batteries can be used in cleanrooms without any electrical cables. The mobile work station consists of a stainless steel battery housing, a vertically adjustable display for working while standing and an inclinable glass
Robot-Supported Air Filter Inspection The company InfraSolutions AG (Langen, Germany) won the Award with its product RobotScan Flex, a unique, automated measurement system for carrying
out filter integrity tests. A robot arm automatically scans filter and Laminar Flow units while a software system prepares the necessary documentation and analyses. The robot is mobile and easy to operate. The measurements can be carried out using fewer personnel and much more precisely and more quickly than by hand. The measurements are archived without danger of manipulation. Surfaces for Cleanroom Equipment Senoplast Klepsch & Co. GmbH (Piesendorf, Austria) showed with its product Senomed a newly developed plastic material for surfaces in cleanrooms and air locks. The multilayered material is chemical-resistant, scratch-proof, abrasion resistant and producible in a limitless palette of colors. Furthermore, the material has an antibacterial effect. Micro-biological tests have shown that the material itself is neutralizing causing microbes to die off. This innovation is suitable for aseptic and non-aseptic areas and has the potential to steadily replace materials now in use.
hibitors, surface area, visitors and
the qualifying that is the verifica-
tor of the ReinraumAkademie and
internationality. With 731 profes-
tion whether the cleanroom has
Partner of Cleanzone says: “I am to-
sional visitors from 32 countries,
been built according to standards
tally convinced that Cleanzone will
Cleanzone was able to record 20
and norms, and operations.
continue to grow as it is here that
percent more vis-
all sectors of the industry have the
itors than in 2014.
Particularly found popular by
opportunity to meet. This event has
The number of ex-
Cleanzone’s visitors was the Clean-
once again shown that production
hibitors increased
zone Congress organized by the Re-
and assembly in cleanrooms is an
by 40 percent to 88
inraumAkademie. International,
international topic for the future
companies from
renowned cleanroom technology
and that it encompasses every sin-
12 countries. The
professionals imparted their prac-
gle industry.”
products and ser-
tice-oriented knowledge and also
vices on offer cov-
new technical discoveries.
ered the entire life
The next Cleanzone will take place on November 8th and 9th, 2016, in
cycle of a cleanroom
Cleanzone has reached and be-
from the construc-
come a permanent international
tion and planning,
and inter-disciplinary platform for the exchange of cleanroom tech-
Cleanroom Award 2015.
nologies of significant magnitude.
Photo: Cleanroom Media
Frank Duvernell, Managing Direc-
CLEANROOM MAGAZINE 1/2016 | Cleanzone 2015
Frankfurt am Main, Germany. Author: Frank Baecke.
Cleanroom Knowledge for Reference The CLEANROOM MAGAZINE editorial staff regularly scans publishers for their new publications with relevance to the cleanroom industry. These books – just published – we would like to introduce you to.
Good Transport Practice in the Pharmaceutical Industry The Good Transport Practice in the Pharmaceutical Industry is once again up to date, as new EU guidelines have set standards which have to be applied. Thereby it is not just about the standard practices which require fundamental improvements. It is much more about the formal requirements which additionally have to be posed particularly a quality assurance system which is able to document all activities and make them traceable. In this jungle of requirements and regulations, this book offers the reader a sense of orientation based on practice. In focus is the collaboration of diverse disciplines , the portrayal of the resulting effects of synergy, the exchange of information between the various professions, which occasionally are missing their cross-connections, consequently providing the recognition of significant relationships between all the players. Examples of real-life practice, tips and background information help loosen up the contents and make understanding much easier. “Gute Transportpraxis in der pharmazeutischen Industrie”, Detlef Werner, ECV Editio Cantor Publisher. 1st Edition 2015, 160 pages, softcover. ISBN 978-3-87193-427-8. Price: €78.11.
Containment Handbook Containment solutions are becoming more important for the manufacture of pharmaceutical products as new medical ingredients are often highly reactive even in small dosages. Therefore containments have to offer the highest degree of tightness in order to protect employees and the environment from contamination. At the same time, containments have to enable trouble-free material flows and maintenance. How to solve this technological balancing act, which regulatory requirements are to be fulfilled in the planning, construction and renovation of these facilities and how to safeguard employee safety, all of these issues are described in the newly published “Containment Handbook”. This publication has collected the widely scattered information about processes, technologies and regulations and has made available to laboratory operators and pharmaceutical producers a very worthwhile reference book. “Containment-Handbuch”. Publisher ISPE/D/A/CH Containment Work Group of the International Society for Pharmaceutical Engineering, 1st Edition 2015, 172 pages. The book can be ordered online via the ISPE-Dach website: http://ispe-dach.org/web/die-ispe-dach-arbeitsgruppen/regional-cop-containment
Cleanroom Knowledge for Reference | CLEANROOM MAGAZINE 1/2016
57
58
Trade Fairs and Congresses
Kiel
Schwerin
Hamburg
Germany
Bremen
SERVICE
Berlin 18.-19.03.2016 Interpharm Berlin Germany
Hannover
Berlin Potsdam Magdeburg
Leipzig
31.05.-02.06.2016 parts2clean Stuttgart Germany
Düsseldorf
Erfurt
Dresden
Köln
Wiesbaden
10.-11.02.2016 Pharmapack Europe Paris, France
Nürnberg Nürnberg
Mainz
19.-21.04.2016 Partec Nürnberg Germany
Saarbrücken
21.-23.04.2016 Austropharm Vienna Austria
StuttgartStuttgart
München
10.-13.05.2016 Analytica Munich Germany
München
13.-14.04.2016 Lab Innovations Lausanne Switzerland
Konstanz
Basel Aarau Delèmont Solothurn
12.-14.04.2016 MEDTEC EUROPE Stuttgart Germany
Zürich
St. Gallen
Wangen a.d. Aare
Neuenburg
Luzern Freiburg
Bern Chur
Lausanne
Genf
Switzerland
CLEANROOM MAGAZINE 1/2016 | Trade Fairs and Congresses
21. -23.04.2016 Cleanroom Exhibition Istanbul, Turkey
59
Events at the ReinraumAkademie, Germany and the CleanroomAcademy, Switzerland Reinraum-Expert Days| Cleanroom Expert Days 27.-28.01.2016 | Modern Cleanroom Design and Layout. ISO/DESIGN/GMP/AMC (Modular System – 4 Modules) | Leipzig, Germany 02.-03.02.2016 | Cleanroom and Hospital – one Topic, two Worlds | Wangen an der Aare, Switzerland 09.-10.03.2016 | Cleanroom Layout, Planning and Construction | Leipzig, Germany 11.-12.05.2016 | Flexible Cleanroom Design and the Integration of Production Facilities, Equipment and Furnishings in a Cleanroom | Leipzig, Germany 07.-08.06.2016 | Cleanroom Layout, Planning and Construction | Wangen an der Aare, Switzerland 28.-29.09.2016 | Flexible Cleanroom Design and the Integration of Production Facilities, Equipment and Furnishings in Cleanrooms | Wangen an der Aare, Switzerland 05.-06.10.2016 | Fundamentals and Optimization in Cleanroom Operations, Cleanroom and Qualification | Leipzig, Germany 23.-24.11.2016 | Optimal Cleanroom Personnel | Leipzig, Germany 07.-08.12.2016 | Optimization and Qualification of Cleanroom Operations | Wangen an der Aare, Switzerland
BEHAVIOR IN A CLEANROOM 23.02.2016 11.04.2016 27.09.2016 02.11.2016
| One-Day Training Plus | Aschaffenburg, Germany | One-Day Training Plus | Penzberg, Germany | One-Day Training Plus | Wangen an der Aare, Switzerland | One-Day Training Plus | Leipzig, Germany
BASICS OF PROFESSIONAL CLEANROOM CLEANING 24.-25.02.2016 | Two-Day Seminars | Aschaffenburg, Germany 17.-18.10.2016 | Two-Day Seminars | Leipzig, Germany
ADDITIONAL EVENTS 27.01.2016 02.02.2016 02.-03.05.2016 28.09.2016 05.10.2016
| International New Year Reception of the Cleanroom Industry and users | Leipzig, Germany | New Years Apéro of Swiss Cleanroom Industry and users | Wangen an der Aare, Switzerland | Seminar „Working in a Cleanroom“ | Nürnberg (D) | Swiss Cleanroom Industry’s Autumnal Reception | Wangen an der Aare, Switzerland | Cleanroom Industry’s Autumnal Reception | Leipzig, Germany
The events take place at: Cleanroom Experience Competence Center Rosa-Luxemburg-Str. 12-14, D-04103 Leipzig, Germany Tel.: +49/341/98989-0, Fax: +49/341/98989-200 info@reinraum-akademie.de, www.reinraum-akademie.de
Cleanroom Experience Competence Center Vorstadt 4, CH-3380 Wangen an der Aare, Switzerland Tel.: +41/326316050, Fax: +41/326316059 info@reinraum-akademie.de, www.cleanroom-academy.ch
Events | CLEANROOM MAGAZINE 1/2016
60
Order your free subscriptionn www.cleanroom-media.com
SERVICE | IMPRINT
Next issue | April, 2016 Ausgabe 2/2012
1/2013
Cleanroom Award
Cleanroom Award
Erster Innovationspreis für die Reinraumbranche First special award in the cleanroom industry
Monitoring fallender Partikel Monitoring Particle Deposition
Düsseldorf
Attraktives Reiseziel für Technologen Popular destination for technologists
2/2013
Ausgabe 2/2012 2/2014
Cleanroom Award
Erster Innovationspreis für die Reinraumbranche First special award in the cleanroom industry
Cleanzone
Paris
Attraktives Reiseziel für Technologen Popular destination for technologists
Düsseldorf Die Reinraumwelt trifft sich in Attraktives Frankfurt / The World ofReiseziel cleanfür Technologen room meets in Frankfurt Popular destination for technologists
Barbara
Sieglinde Sellemond
Norbert Otto Vordenken und Nachdenken Thinking Ahead and Reflecting
KanegsNorbert Otto berg
Vordenken und
Genuss, Kunst und Kultur Indulgence, art and culture
DasNachdenken Produkt steht im Thinking Ahead Mittelpunkt / The focus andonReflecting the product
Dresden
Attraktives Reiseziel für Technologen Popular destination for technologists
Jan Gerbrands Motivation und Leidenschaft Motivation and Passion
Well dressed in a Cleanroom
Cleanroom Award –
Tirol – Hightech im Bergparadies
Gut gekleidet im Reinraum www.cleanroom-media.com
EDITION 2/2012
MAGAZINE
Cleanroom Award – Advancement for the Cleanroom
Cleanroom Award – Challenging the branch
EDITION 1/2013
CLEANROOM
Cleanroom Award –
Gut gekleidet im Reinraum Fortschritt für den Reinraum
Herausforderung an die Branche
Tirol – High tech in mountain paradise
Well dressed in a Cleanroom
EDITION 2/2013
EDITION 1/2014 summer 2015
MAGAZINE
Thanks to the tiny components produced in cleanrooms, billions of devices are able to communicate with each other
How the vision of autonomous driving is gradually becoming a reality
Rules & regulations Annoying agree or a tip for money values? OLEDs The lighting revolution out of the cleanroom Hospital germs How cleanroom technologies prevent infections
Smart Textiles Intelligent fabric changes medicine, architecture, fashion and the car industry
Operating Theatre This is what the surgery workstation of the future looks like
Imprint CLEANROOM MAGAZINE Is issued and published by Cleanroom Media GmbH Rosa-Luxemburg-Straße 12-14 04103 Leipzig, Germany Internet www.cleanroom-media.com Management Frank Duvernell, (V.i.S.d.P.) Administration – Cleanroom Media Maja Franke Tel. +49 341 98989 404 maja.franke@cleanroom-media.com
EDITION 3/2015
Chief Editor Frank Baecke Tel. +49 341 98989 405 frank.baecke@cleanroom-media.com Translation Bill Hillman Daniel Read Authors Frank Baecke Frank Duvernell Piet Felber Maja Franke Gero Hassink Thomas Köhler Josef Kwasnitza Dirk Stanischewski
CLEANROOM MAGAZINE 1/2016 | Imprint
Circulation 10,000 copies Printer Löhnert-Druck, Leipzig ISSN 2364-0405
01
winter 2016
Approaching the Dimension 3D printing is opening new perspectives for cleanrooms
Outlook 2016
Experts estimate future prospects in the cleanroom industry
Talent Development
Cleanzone 2015 This international cleanroom trade fair gives momentum and impulse to the cleanroom industry
Newest revisions of ISO 14644-1 and ISO 14644-2
Advertisements/Notifications Maja Franke Tel. +49 341 98989 404 maja.franke@cleanroom-media.com
Publication Quarterly
MAGAZINE
Germs in Food Products How cleanroom technology aids in killing off dangerous food product germs
EDITION 4/2015
Implementation Wohlfahrt GmbH www.wohlfahrt.net
CLEANROOM Life & Science Information for Cleanroom Technology
The Internet of Things
Joy of Being Driven
The influence of pollen and air humidity on your production
EDITION 2/2015
04
autumn 2015
Life & Science Information for Cleanroom Technology
Blossoming Nature Dangerous Contamination
EDITION 1/2015
EDITION 2/2014
CLEANROOM
03
02
spring 2015
Life & Science Information for Cleanroom Technology
www.cleanroom-media.com
How employees become cleanroom operatives
Laws & Regulations
EDITION 1/2016
Reprints Reproduction and digital use of articles from this magazine, even partially, are only allowed subject to prior approval by the editorial staff. No liability is assumed for unsolicited manuscripts of photographs.