CLEANROOM CLEANROOM MAGAZIN
Life & Science Informationen für die Reinraumtechnologie
MAGAZINE
03
Somme
04
autumn 2016
201
Life & Science Information for Cleanroom Technology
From Cleanroom into Outer Space Sommer, Strand
& Sonnencreme
Is there life in outer space? This can only be found out with technology made in cleanrooms. In light of this, a space craft stecken has recently landed on Mars. Nanopartikel in Kosmetika und vielen
Alltagsprodukten. Wie gefährlich sind sie?
Using Computers in Cleanrooms The Challenges of FDA Regulations
Reinraum-Kunst nach ISO 5 To produce Dieseaccording Chips to gehen unter die Haut Modern solutions make costly FDA regulations, Mit welchem sehen Künstler Rein-lay aside Smarte können dem Menschen encapsulation andBlick built-ins unnecessary. theirImplantate EU GMP thinking. räume? Als partikelfreies Kunstprojekt.
smarte neue Fähigkeiten verleihen.
Dear Readers!
3
The space module Schiaparelli will land on Mars in just a few days and then not only the European Space Agency ESA and their Russian partner
International trade fair and congress for cleanroom technology 8 + 9. 11. 2016, Frankfurt am Main
Roskosmos will be celebrating an awesome success. The project ExoMars which will search for traces of life on the Red Planet is likewise a triumph
Without the module’s fabrication under cleanroom conditions, no space flight would be possible. Even the smallest amount of contamination on the electronics or the sensors or the instruments could lead to system failures and thereby endanger the entire mission. Read more about this project in our cover story on page 8. By the way: The inspiration for the name of the Mars Lander is the Italian astronomer Giovanni Schiaparelli. Thanks to him, we have this map of Mars dating back to 1877. Without the tremendous advances in cleanroom Frank Duvernell: “Without cleanroom technology there would be no space travel technology, and this can be said without exaggeration. However
technology, we would still be thinking today that Mars looked like the map of 1877.
clean production and assembly environments have become vital for many other business sectors. Cleanzone provides this information on the current status of technology.”
Graphics: Historical map of the surface of Mars according to Schiaparelli The Italian astonomer Giovanni Schiaparelli (1835-1910) became famous above all for his observations of Mercury, Venus and Mars.
The advances cleanroom technology is making will be shown from the 8th tot he 9th, November, 2016 at the International Trade Fair Cleanzone in Frankfurt am Main. Standing in focus this year are the topics of Life Sciences, Micro-technology and Technical Cleanliness. We have reported more about this on page 50. I warmly invite you to visit Cleanzone and the professional presentations and discussions at the Congress. Experience
Did you know that cleaning a cleanroom removes particles <10μm? From production to cleanliness: Cleanrooms are subject to the strictest quality standards for hygiene and sterility. Discover more clean facts at Cleanzone. You will find all of the information and impressions at: www.cleanzone.messefrankfurt.com
here first hand the latest cleanroom developments and trends. I wish you enjoyable reading of this issue of Cleanroom Magazin.
Frank Duvervnell Editor
Editorial | CLEANROOM MAGAZINE 4/2016
EDITORIAL
for cleanroom technology.
4
Contents 04/2016
5
22 Controversy: Are attractive
38
cleanrooms sensible or simply bells and whistles?
The company which contracts out a cleanroom, has the choice between an architectural agency or an engineering office. “Cleanroom Magazin” interviewed respectively a representative from each camp regarding the pros and cons of cleanroom design.
................................................
The use of computers is because is problematic because of the air. Modern solutions save the costly wall built-ins or the hermetically encapsulation. Photo: AdLink Technology GmbH
24 Switzerland: What has 08 Title Story:
No Space Technology without Cleanroom Technology
Is there life on Mars? In the near future two spacecrafts begin their missions of searching for such on the Red Planet. So that this life is not introduced by the Earth, spacecraft and instruments were built in cleanrooms.
................................................
LIFE & BUSINESS New developments from the world of cleanrooms
06 Market happenings in brief • Colleague Blech helps with learning • Researchers anticipate the end of the Zika virus epidemic • Stents with bacteria-inhibiting coatings • Brexit: Pharmaceutical companies are reacting • Shopping via Mobile • Nano-medicine against cancer
................................................ 16 A portrait: Dr. Jochen Vogl The ExoMars ESA mission will be arriving at the Red Planet. On October 19, the Landing Module Schiaparelli (bottom in photo) will be setting down on Mars. Photo: ESA/ATG medialab
16
The tracking analyst produces socalled reference materials which apply worldwide as measurement standards. Therefor he has to work super-clean.
................................................ 20 Well-intended doesn’t
automatically mean well-done The unmotivated person who works in a cleanroom, he could become negligent in maintaining cleanliness requirements and threshold values. Find out what can be done against this.
................................................ Dr. Jochen Vogl is a trace elememt analyst at the German Federal Institute for Materials Research and Testing in Berlin. It is required for his research that he work in a completely metal-free cleanroom. Photo: Cleanroom Media
CLEANROOM MAGAZINE 4/2016 | Contents
Graphics: Fotolia/Cleanroom Media
INHALT
08
44
resulted from the discussions at the New Year’s Reception?
At the beginning of 2016, professionals from the Swiss cleanroom industry gave their viewpoints and expectations concerning the challenges in the coming year. “Cleanroom Magazin” posed the question: What has happened since then?
................................................ 26 Insights: On the
road with Jürgen Lederer Jürgen Lederer, Key Account Manager CE for the field Cleanroom at Vileda Professional.
................................................
SCIENCE & TECHNOLOGY
Solutions for the world of cleanrooms
28 Technology in brief • Dry batteries against self ignition • Lightest half-transparent OLED display glasses • Advanced Smartlab • Piggyback battery • Re-useable protective textiles • Palletizing concept • Scrubbing-drying machines
Only those who fastidiously hold to FDA regulations are allowed to export cleanroom products into the USA.
38 Computer Use in Cleanrooms The stricter the cleanroom class, the more difficult is becomes to hermetically enclose computers in special housings or in niches built into walls. Modern solutions save these costs and efforts. They are enclosed, fanless and easy to disinfect.
................................................ 42 What do you do there, … ? Samuel Pinto, Plastics Processing Technician/Mechanic at Ernst Rittinghaus GmbH in Halver, Germany.
................................................
SERVICE ................................................ Events, awards, regular columns 30 Monitor with Eyes and Ears
Fraunhofer researchers have developed an intelligent monitor which evaluates dangerous situations and supports doctors having to make decisions. The monitor can be remotely controlled with gestures and voice commands.
................................................ 34 AMC: The unseen enemy Product contamination from airborne molecular contamination (AMC) provides manufacturers with increasing worry. Those solutions which are currently available against the molecule problem will soon be shown at Cleanzone.
.............................................
44 Laws and Regulations:
FDA-compliant Production The implementation of FDA regulations is for European manufacturers a challenge. Uncertainty often prevails regarding the interpretation of requirements. The causes are false interpretations and the orientation towards EU GxP regulations.
................................................ 48 Professional/Reference Literature: Cleanroom Knowledge to refer to
economically operated - Purest water for manufacturing and the laboratory.
................................................ 50 Cleanzone draws in international Market Leaders From the 8th to the 9th November, 2016, this cleanroom trade fair will open its gates in Frankfurt am Main. In focus, the topics of Life Sciences, MicroTechnology and Technical Cleanliness will be standing in focus.
................................................ 54 Tomorrow’s Trends in Cleanroom Technology At the Cleanzone Congress, international speakers will be providing information on the foundations and trends in cleanroom technology.
................................................ 58 Trade Fairs and Events
................................................ 59 ReinraumAkademie Events The ReinraumAkademie in Leipzig supports companies in the optimization of their work processes and with the qualification of all personnel working in cleanrooms. An overview of what will be offered in 2017.
................................................ 60 Imprint
• Pharmaceutical water systems
Contents | CLEANROOM MAGAZINE 4/2016
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Life&Business
LIFE & BUSINESS
Researchers see the end of the Zika virus epidemic in three years
Tomorrow’s customer prefers shopping mobile
Nano-medicine against cancer
The first precautionary measures
Shopping per Smartphone | By
multi-functional, magnetic nano-par-
| German pharmaceutical and
the year 2020, mobile shopping is
ticles should be able to detect and
chemical companies are looking
expected to routinely belong to 75
combat cancer cells. Towards this goal,
worriedly to the future after the
percent of the population’s everyday
radiologists of the University Hospital
Brixit vote. A study by Camelot
shopping habits, at least in selected
Jena have been working together with
Management Consultants has
product categories. This conclusion
scientists from ten partner institu-
revealed that two thirds of the
was reached by the PwC study “Total
large companies surveyed have
Retail 2016 – the Race for Relevance”
already taken, respectively want to
According to the study, the per-
take precautionary measures for
centage of customers in Germany
the United Kingdom’s EU exit. 20
who at least one time a month buy
EU-Follow-up project | In the future,
Market Happenings in Brief
When colleague Blech helps with learning something and caring for somebody
Brexit: Pharmaceutical companies are already reacting
Stents with bacteria-inhibiting coating
percent of these companies envis-
something using their Smartphone
Tissue-like properties | Patients
age considerable consequences for
has increased from 11% to 35% in
Social Robot | The startup company
Study | Scientists from Imperial Col-
with bilious disease can hope for
their businesses. In contrast, the
the past four years. In the same time
LuxAI develops and builds so-called
lege London anticipate an end to the
near-future improvements in the
small firm sector has adapted a wait
period the percent of consumers who
social robots. The company origi-
Zika virus epidemic in Latin America
often-difficult treatments. Research-
and see attitude. About half of Ger-
had never bought mobile decreased
nated from a research project at the
within the next three years. They base
ers at the University Rostock have
man chemical and pharmaceutical
With cytostatics provided nanoparticles may eventually
University Luxembourg. The robots
this prediction on a mathematical
developed new bile duct stents with
company managers believe that
enable new cancer therapies. Photo: benicoma / Fotolia
suit themselves for use in education
model which with the help of all
intelligent construction and a new
Brexit will considerably influence
and health care systems where they
existing data, depicts the current and
kind of bacteria-inhibiting coating.
the choice of company headquar-
tions from five European countries.
are able to support therapists and
future spread of the pathogen.
The project is called GastroFreeFlow,
ters’ locations and production sites.
Their trick: They provide the particles
trainers. The robots could for ex-
The principal author of the study,
in which tubules develop having dif-
Three quarters of those surveyed
with specific anti-bodies and cyto-
ample train and practice vocabulary
Professor Neil Ferguson explains:
fering surfaces, forms and openings.
also expect consequences for sales
static agents in a carrier substance
with children or do rehabilitation
“Our analysis suggests that the spread
markets and supplier structures
of bound nano-particles so that the
exercises with patients.
of the Zika virus cannot be detained
in Europe, also when only at small
particles when they are purposely
but the epidemic will have finished
magnitudes.
attached to the cancer cells are able
itself off within three years.” The
to bring the chemo-therapeutic
reason is the so-called phenomenon,
agents directly to the target site. The
the herd immunity: As the Zika virus
magnetic properties of the particles make it possible to detect and make
is not able to infect the same person twice, with progressive spreading
Researchers have developed a new kind of stent with
there will be too few non-infected
differing surfaces, forms and openings which have in
people remaining who are able to pass on the virus.
Mobile Shopping with a Smartphone is on the rise. This
addition bacteria-inhibiting coatings. Photo: Fotolia/ Zarathustra
is most prominent for consumers between the ages of 18
with MRT and to precisely heat up and
and 34. Photo: Fotolia/vege
activate the chemo-therapeutic agents using outside magnetic fields.
Building social robots: The LuxAI founders Aida Nazariklor-
Furthermore, the Rostock scientists
from 70% to 48%. This development
ram (left) and Pouyan Ziafati. Photo: ScienceRELATIONS
are looking for chemical composi-
is driven, above all by consumers
tions or coatings which decisively
between 18 and 34 years old. 1,000 Ger-
The prototype has already passed
prolong the lifespan. Current stents
the first test in practice. “In doing so,
have the disadvantage that they are
it received good notes for its social
stiff, irritate the bile ducts, quickly
aspects, emotionality, and ease in
clog and at the latest have to be re-
operability” says LuxAI founder Dr.
newed after a half a year – and also
Pouyan Ziafati. The robot can be
because bacteria quickly settle onto
programmed by anybody. LuxAI has
the tubules.
been presented with several awards
Products such as heart catheters and
for the development of the robot.
stents find application in vascular
visible even the smallest metastases
man online-shoppers were queried German pharmaceutical and chemical companies are expecting appreciable consequences for their businesses after Brexit. Photo: Fotolia/bluedesign
in the survey. The analysis is part of a worldwide survey with more than 23,000 participants in 25 countries.
surgery and are manufactured with The Zika virus is transferred in most cases by the bite of infected mosquitoes. Photo: Fotolia/Gordzam
CLEANROOM MAGAZINE 4/2016 | Market Happenings in Brief
the highest hygienic standards under cleanroom conditions.
Market Happenings in Brief | CLEANROOM MAGAZINE 4/2016
Is there life on Mars? Research instruments produced in cleanrooms examine the Red Planet.
LIFE & BUSINESS
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On October 19, 2016, the module Schiaparelli is scheduled to land on Mars. The landing is part of a larger mission in which ESA is looking for traces of life on our neighbor planet. To prevent this life from being imported from Earth, space vehicles and measuring instruments are built in cleanrooms.
No Cleanrooms, No Space Research Artistâ&#x20AC;&#x2122;s depiction of the Trace Gas Orbiter (left), which will be examining the atmosphere of Mars for trace gases such as methane. It will separate from the Lander Schiaparelli (middle) which will gently drop to the surface of Mars. Graphics: ESA/ATG medialab
CLEANROOM MAGAZINE 4/2016 | On to Mars
MAGAZINE 4/2016 On to Mars CLEANROOM | CLEANROOMMAGAZINE
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A depiction of our Solar System: With the sun as the center point, Earth is located in the third position and Mars in the fourth. Together with the first two planets, Mercury and Venus, they form the inner part of the planetary system. Outside of this part are located the planets Jupiter, Saturn, Uranus and Neptune which consist of gas. Graphics: Fotolia/tmass. Page on right: The Trace Gas Orbiter with the Landing Module Schiaparelli. While the latter is scheduled to land on Mars, the Orbiter will be orbiting the planet and investigating its atmosphere.
LIFE & BUSINESS
Photo: DLR
Is there or was there life on Mars? The
with the launching of a proton rocket
find their way to Mars, this could
European-Russian mission ExoMars
from the Kosmodrom Baikonur in
falsify our measurements from
will be dealing with this question lit-
Kazakhstan. Two space vehicles fitted
ExoMars and for future missions
erally on the ground. ExoMars stands
with scientific instruments for closer
as well. This we have to prevent at
for “Exo-biology on Mars” and is a re-
investigations on Mars were placed in
all costs”, says Petra Rettberg. The
search program of the European Space
the rocket’s belly: the 3.7 ton Trace Gas
astro-biologist from Cologne works
Agency ESA and their Russian partner
Orbiter and the 600 kilogram EDM-
for the German National Center for
Roskosmos. The goal of the mission
Lander Schiaparelli. Approximately
Aeronautic and Space Research
is to coax out the Red Planet’s secrets
eleven hours after the launch, these
(Deutschen Zentrum für Luft- und
with a range of special instruments.
vehicles separated from the rocket,
Raumfahrt DLR) at the Institute
folded out their solar panels and the
for Aeronautic and Space Medicine
communication antenna and began
and has carried out with her team
their mutual trip through inter-plan-
all the ESA Planetary Protection
space craft during its entry into the atmosphere of Mars.
etary space to the Red Planet. In the
Control measurements.
Photo: DLR (CC-BY 3.0)
Does the methane originate from Mars-microbes?
The Lander Schiaparelli has been equipped with DLR sensors. They continually measure the heat flow, the temperature and the pressure on various positions of the
meantime, they have nearly reached Of particular interest for the re-
their goal. After arriving, they will
“For missions to planets and
searchers is the methane gas. It has
separate and begin their respective
moons of astrobiological interest,
already been detected by the Mars
missions.
there are particular requirements
to gassing with H2O2 , it is effective
when killed off can constitute crit-
orbiter Express in small amounts in
for the avoidance of biological
not only on surfaces but also pen-
ical, organic contamination. The
the atmosphere of Mars. What is the
contamination”, explains Rettberg.
etrates into the inside of a device.”
requirements for cleanliness are
origin of this methane? Could biological organisms be the source for it? To
Bio-contamination mustn’t ever leave the Earth
indeed dependent on whether the
Space vehicles are therefore built in cleanrooms of ISO Class 8 or
Particularly strict requirements
space vehicle will be landing on a
Does the amount of biocontamination in cleanrooms change because of switches in personnel?
better, for instruments, higher
on cleanliness apply for the in-
planet of astrobiological interest or
Petra Rettberg tested cleanrooms
pay a visit to the still-living or long-
In able to find traces of life on Mars,
cleanliness classes are necessary.
struments on board the lander.
only orbiting the planet concedes
meant for the ExoMars mission at
since dead, extraterrestrial microbes
researchers had to assure that no
“The subsequent sterilization for
“Contamination on instruments
Rettberg. However, even with or-
the facilities of responsible partners
suspected of existing on Mars.
biological traces from their home
completed devices is done after an
can endanger the success of the
biters, there should never be any
in Turin as well as other cleanrooms
find this out, the researchers want to
planet were being introduced into
intensive general cleaning carried
entire mission”, says Rettberg. This
cases of negligence as this vehicle
where ExoMars instruments were
As the Red Planet, depending on the
a possible eco-system on the neigh-
out by heating. Heat has established
is not just applicable for small
could crash land and thereby con-
assembled. “New instruments were
constellation, lies between 56 and 401
bor planet. “If micro-organisms
itself as reliable because in contrast
particles as micro-organisms even
taminate the planet.
constantly being assembled by dif-
million kilometers from the Earth, the
fering teams using differing equip-
flight for the colonizing units doesn’t
ment and because of this, we had to
come so cheaply. The ESA figures
monitor how the bio-contamination
the excursion to our exo-biological neighbor will cost more than 1.3 billion Euros. Roskosmos is throwing in additional billions to contribute to the success of the mission.
»Contamination on the instruments could endanger the entire mission« Petra Rettberg, Astrobiologist at the German National Center for Aeronautic and Space Research (DLR)
was changing when the differing teams switched”, reports the professional from Cologne. Additionally, DLR (German National Center for Aeronautic and Space Research) by order of ESA continually took and
The enterprise began on March 14, 2016,
analyzed samples from the instru-
at 10:31 a.m. middle-European time
ments and the cleanrooms.
CLEANROOM MAGAZINE 4/2016 | On to Mars
On to Mars | CLEANROOM MAGAZINE 4/2016
13
12 Finally, three Antonow-transport planes brought the entire ultra-clean and hermetically-sealed ExoMars space vehicles with all the associated equipment to Baikonur. After removing the packaging
The final assembly took place in a cleanroom the size of a factory building.
gas composition, lower densities and more dust particles. This influences the aerodynamic stability as well as the heating up and abrasion of the
which prevented any re-contami-
protective heat shield. In order to
nation during transport, the final
land Schiaparelli safely, the landing capsule was tested in wind tunnels
assembly took place in a cleanroom
LIFE & BUSINESS
Planet’s atmosphere significantly differs that of the Earth.” It has a different
the size of a factory building. Petra
will separate from the Trace Gas
over which further reduces the speed
and its flight through the atmosphere
Rettberg’s task consisted of carrying
Orbiter so that the Orbiter is able
until the height of two meters above
of Mars simulated. Furthermore, it
out the final control inspection and
to swing into a 400 kilometer high
ground zero. At this altitude, the en-
is travelling with a kind of weather
examination before ExoMars was
orbit over the surface of Mars.
gines shut off and Schiaparelli falls to
station which measures for example
brought into the rocket.
“Schiaparelli will initially fly in a
the surface. The data and experience
wind speed, humidity and pressure.
deep sleep until being woken up
which the capsule collects during its
A “Mars Weather Report” could be
several hours before its entry into
flight through the atmosphere of Mars
helpful for landing future space craft.
the atmosphere”, says Oliver An-
and during the landing maneuvers
gerer, Group Leader for Exploration
will be used by ESA for the landing of
at DLR Space Flight Management.
a Rover in 2018. It is planned for this
Upon entry into the atmosphere
Rover to drill down into the crust of
“That we assure the highest stand-
and the resulting friction, the
Mars and extract cores from depths
ards of cleanliness for the instru-
landing capsule will slow down
down to two meters.
ments, doesn’t serve as protection
from 21,000 to 1.650 kilometers per
for the planet merely for ethical
hour. The capsule’s heat shield will
The current mission is “unarmed”.
task of establishing the facts on the
reasons”, explains Rettberg. “The
keep it from burning up during the
Schiaparelli is solely equipped with
ground, the Trace Gas Orbiter is
point is to protect our scientific
braking procedure.
measuring sensors from DLR. They
destined for higher tasks. It will be
research with this but also with
will continuously measure the
searching in the Martian atmosphere
future missions from false findings
pressure, thermal flow, the gas radi-
for trace gases such as methane with
ation and the surface temperature
its four instruments and taking color
on various positions of the space
images of the planet’s surface in strips
Schiaparelli flies in a deep sleep until entry into the atmosphere
and conclusions”.
Two meters above ground zero, the braking engines shut off
The orbiter will photograph regions from where trace gases potentially originate PWhile Schiaparelli is executing its
craft during its flight. Ali Gülhan,
several kilometers wide. For this task,
to plan, the Schiaparelli lander can
For further slowing down of the
Department Manager Supersonic
the Orbiter is equipped with a stereo
touch down on the Red Planet on
capsule, a parachute is used which at
and Hypersonic Technologies at the
camera system which is also able to
October 19, 2016, with a clean slate.
a height of 1000 meters is disengaged.
DLR Institute for Aerodynamics and
take individual 3D stereo images of
Three days before this, the lander
Subsequently, a braking engine takes
Fluid Mechanics emphasizes: “The Red
local, interesting areas for example of
When everything goes according
Without cleanrooms, modern space flight would not be possible. Only assembly in particle-free environments makes sure that the modules and measuring instruments will work flawlessly work in outer space. Furthermore, this also prevents micro-organisms from reaching other planets. Photo: Nils Bröer
Mars: A short profile of the Red Planet The red color of Mars comes from the iron-oxide dust (rust) which has been dispersed over the surface and atmosphere of Mars. Mars is located at the fourth position in the Solar System (counted from the sun outwards) and is Earth’s next neighbor travelling away from the direction of the Sun. It is located about 1.5 times farther from the Sun than the Earth. Mars’ diameter is 6,800 kilometers, about half the size of Earth. This makes Mars the second smallest planet after Mercury in the Solar System. Mars has the highest volcano of all planets in the Solar System. The planet is because of its orange to red color was named Mars, after the Roman god of war. Mars has two moons: Phobos and Deimos (Greek: fear and panic).
In the past and today: Nasa scientists mount the solar module on Mariner 8 (left). The space craft was expected to take photos of Mars but the rocket exploded at launch. Right - the ESA Landing
CLEANROOM MAGAZINE 4/2016 | On to Mars
Module Schiaparelli from 2016. Photos: NASA-KSC, DLR.
Source: Wikipedia
On to Mars | CLEANROOM MAGAZINE 4/2016
15
14 Map of the surface of Mars according to Giovanni Virginio Schiaparelli (1835 – 1910). Map: Wikipedia/Meyers Konversations-Lexikon; Portrait: Wikipedia/Achille Beltrame
detector is able to detect hydrogen directly on the surface as well as
CLEANROOM AWARD 2016 INNOVATION, SUSTAINABILITY & EFFICIENCY IN THE CLEANROOM
down to one meter under the surface and compile a water-ice map. The orbiter Mars Express rendered significant groundwork for the current mission. It has been orbit-
LIFE & BUSINESS
ing our neighbor planet since 2003 and is still providing important data. From the data and photos of its high resolution stereo camera, researchers are able to compute digital altitude models which help to analyze slope gradients. “These data helped an Italian team of scientists to find the landing place for the EDM Lander”, says Professor Ralf Jaumann, Department Manager Planet Geology at the DLR Institute for Planetary Research. When the Trace Gas Orbiter and the EDM Lander Schiaparelli reach the Red Planet, they will have a seven month voyage of over 496 million kilometers behind them. Schiaparelli’s landing place lies in the plains of Meridiani Planum in the equatorial highlands of Mars. This region is particularly interesting for the scientists because numerous minerals have been discovered there which develop in the presence of water. If Schiaparelregions where trace gases potentially
originate. The Orbiter with its neutron
li is able to make a gentle landing
Who was Giovanni Schiaparelli?
there, the landing maneuvers will
The Mars space craft Schiaparelli is named after the Italian astronomer Giovanni Schiaparelli
provide decisive insights for the
(1835-1910). He is known as the sharpest eye astronomer of his century and was especially known
second part of the mission – the
for his observations of the planets Mercury, Venus, and Mars. On Mars, he discovered in 1877, straight lines which he designated as “canali”. The word was in other languages falsely translated as “canals” instead of “grooves” or “furrows”. Therefore the idea of irrigation canals, allegedly built by intelligent beings was propagated. In the 20th century, photos of Mars’ surface cleared up this misunderstanding. The structures discovered by Schiaparelli were only optical illusions. However scientists still suspect that micro-organisms could exist or could have existed on Mars.
landing of the drill-equipped Rover in 2018 which is intended to extract cores as deep as two meters. Only there, protected from the deadly
CREATIVE PRIZE 2016 CREATIVITY & BEAUTY IN THE CLEANROOM
Award Ceremony 9th November 2016 cleanzone, Messe Frankfurt, Halle 4.0
UV surface radiation, is life able to exist – or was able. Author: Frank Baecke
CLEANROOM MAGAZINE 4/2016 | On to Mars
NanopartikelCLEANROOM | MAGAZINE 4/2016
www.reinraum-akademie.de
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LIFE & BUSINESS
The trace element analyst at the Berlin Institute for Materials Research and Testing analyzes besides inorganic isotope signatures, the tiniest amounts of contamination in metals. This brings to him, at times unusual tasks, for example the examination of ancient curse tablets whose lead isotopes revealed the unexpected.
negotiated these obstacles and has
A cleanroom made of plastics: In order to analyze metals and their chemical impurities, Dr. Jochen Vogl has to work
climbed the green-carpeted stairs to
inside a completely metal-free cleanroom. Photo: Cleanroom Media
the second floor, he arrives at Jochen Vogl’s office. The graduate chemist
Tracking down Isotopes Jochen Vogl looks for certain elements in sizes of millionths or billionths of a gram.
is the scientist responsible here for
and certified, this is known as
isotopes. Isotopes are atoms whose
isotope analysis. He therefore is one
primary calibration substances.
nucleus contains the same number
of the users of a cleanroom which
Such a property is a particular
of protons but differing numbers
has been completely constructed out
challenge because of the required
of neutrons. “As isotope relation-
of plastic, the door hinges, the draw-
very high identification thresholds.
ships can be regionally different,
er handles, the cupboard feet and
Keeping within time limits is also a
information on the origins of not
even the screws, nothing is made of
challenge. Fellow scientists in this
only artifacts and materials but
metal and this has its reasons. “We
field need one to two years to
also of plant and animal products
do here chemical analyses and the
develop and validate appropriate
can be obtained”, explains the
acids used would lead to corrosion
methods. The primary calibration
scientist.
of any metal parts. The particles
substances are subsequently made
released into the air could falsify
available at the National Metrology
It is doubtless a fascinating task
our measurements”, explains Vogl.
Institute (metrology = the science of
to track down swindlers with
measurements).
the help of isotope analysis, for
The measurements deal with trace
example finding out if Beelitz
analysis that is the search for certain
asparagus is actually from Beelitz
elements in the ranges of millionths or billionths of a gram. Vogl’s ele-
Isotope analysis reveals false statements of origin
ever is not Jochen Vogl’s job. He develops and certifies inorganic
ments are inorganic – metals and their chemical contamination.
Jochen Vogl is interested in boron,
isotope standards which ensure
When both are exactly determined
strontium, magnesium and lead
reliable measurement readings for dependability in engineering and
Photo: Cleanroom Media
A cleanroom made only of plastics
The new laboratory and engineering
clinically clean, safe, dangerous and
building of the German Institute
life-threatening. Scientists have been
for Materials Research and Testing
doing research here in the state-of-
(BAM – Bundesanstalt für Materi-
the-art technologies of materials
Even the entry is at a high-tech
alforschung und –prüfung) in Ber-
science and materials engineering.
niveau. Without a chip-card and a
lin-Adlerhof connects laboratories
The building is accordingly equipped
code number entered on a beeping
whose requirements-profiles range
with high-tech equipment, laborato-
controller, the glass doors will
from dirty, clean, particularly clean,
ries and cleanrooms.
not open. When the visitor has
CLEANROOM MAGAZINE 4/2016 | Portait
and not from Greece. This how-
»We create here benchmarks which are applied as worldwide standards. Therefore we have to work in immaculately clean ways.« Dr. Jochen Vogl, Scientist for isotopic analysis
chemistry. Sometimes though, Jochen Vogl is allowed to play the role of a forensic specialist, for example when investigating ancient curse tablets. These are platelets made of lead on which people once carved evil wishes, curses or drawings. The platelets were then folded or rolled
Portait | CLEANROOM MAGAZINE 4/2016
19
LIFE & BUSINESS
18 up and nailed onto something,
computers, light green cupboards.
about the work I do, for example
Vogl. Only 20 percent of BAM’s
sometimes even buried next to ho-
The room has against all expecta-
about these curse tablets. These
work deals with materials in-
ly shrines. They now belong to the
tions nothing which would indicate
are somewhat like current ‘off
vestigations, 80 percent dwells
collection of antiquities in Berlin’s
a study belonging to a high-caliber
the wall’ humor and expressions.
on research. Belonging to this
public museums. The lead isotope
scientist. The only thing which
One can learn more from these
research is the development of
analysis provided information on
reveals that one is sitting across
curse tablets about life in those
so-called reference materials.
their origins. Vogl first dissolved
from a scientist is a tidy stack of
days than from the official stone
T h e s e a r e s ub s t a n c e s w i t h
small material samples in an acid
chemical journals and the large
tablets.” This applies also for the
defined properties which are
bath which he calls “chemical di-
Karlsruhe Nuclide Chart which
so-called revenge figures, a kind of
used as benchmarks in research
gestion” and undertook the isotope
impressively fills an entire wall.
Voodoo doll on which the owner
laboratories and in industry. “The
analysis in a mass spectrometer.
The chart distantly resembles the
engraved several names of people
development and creation of such
“Our analysis showed that the lead
Periodic Table of Elements, show-
resident in Athens. “According
reference materials belongs to
for nearly all of the curse tablets
ing countless differently colored
to our measurements, the dolls
our work duties. We establish
came from silver mines near
boxes with chemical symbols and
originate from Keos and Keos at
benchmarks here which are
Athens“, reports Vogl. “Therefore
nucleon numbers.
that time was in fierce, mortal
applied as worldwide standards.
battle with Athens.”
Therefore we have to work in
we were able to prove that the
Touch panel for the hotplate control. Photo: Cleanroom Media
his childhood days. He received
raw material from some so-called
It was not predetermined at home
once as a present, as nearly every
Egyptian curse tablets actually
that one day Jochen Vogl would find
young boy, a chemical discovery kit,
In autumn, the researcher
the trace element analyst who
came from Greece.”
himself in the world of atoms. His
but for a budding researcher, this
received some teeth and bones
enjoys taking photographs in his
father worked in commerce and
was literally only kid stuff. “That
which he was to investigate
free time as well as listen to his
his mother was a teacher. “I have no
kit was quickly crossed off my list”,
for magnesium and strontium
favorite music, rock from the 80’s.
role models in my family leading
says the 49 year old with a wave of
isotopes. Both elements become
to a scientific career”, says Vogl
his hand.
stored in the body via ingested
Furthermore, Vogl together with
food and drinking water. This
his colleagues do research on
For a career in science, no family role models
born in Regensburg. His uncle was
immaculately clean ways”, says
Jochen Vogl wears jeans and a
indeed a chemistry teacher but that
Later, three professional directions
makes possible comparisons
methods for more quickly pre-
polo shirt. His office is equipped
had little influence on him. Natural
crystallized for him: chemistry,
between differing habitats and
paring and analyzing samples. “It
in a modern way, two desks, two
science has interested Vogl since
oceanography and archeology.
therewith the determination of
often takes today a week before a
“Because I heard that archeologists
the origin of the teeth and bones.
value can be obtained. It would be
had only slight chances of finding a
“We receive only a milligram of
better when a researcher knew
job and I lived too far from the sea,
material, this is comparable to
after only two days which sam-
there remained only chemistry”,
the tip of a strand of hair”, says
ples he can disregard and which
says the man who studied and grad-
Vogl. “When we have such small
he should start with the complex
uated in Regensburg, had a stay in
amounts of sample material, we
and tedious testing procedures.”
Geel, Belgium and since 2000 has
have to absolutely assure that no
As the material to be investigated
been working at BAM and living in
false measurements are obtained
is often non-visible and too small
Berlin. His wife works at a health
due to contamination. Our met-
to be seen with the naked eye, Vogl
insurance company and is active
al-free cleanroom provides us this
incidentally mentions: “We often
in a health promotion project for
assurance.”
dry out the sample before further preparation, but one only sees
children.
A Voodoo doll with the name Citizen Athens
The creation of reference materials which set worldwide standards
an empty testing dish as on the bottom of the dish only a micro or nano-gram remains behind.” Upon leaving the building, down
Cleaned and well-packed: the ion optics of the Thermo-ion mass spectrometer. Photo: Cleanroom Media
CLEANROOM MAGAZINE 4/2016 | Portait
The question is evident if she un-
On this cue, Jochen Vogl stops
the light green stairs, the building
derstands exactly what her husband
reciting one scientific anecdote
which on first sight left a rather
does professionally when he comes
after the next. Ultimately his
unspectacular impression, is now
home in the evening and talks about
report should not be giving any
seen with different eyes. It is on
isotope fracturing and high-vacuum
false impressions about BAM’s
the contrary very spectacular,
sublimation. “Oh yes”, says Jochen
isotopic analysis work. “We do no
what is accomplished here…
Vogl. “My wife finds what I do fasci-
commercial investigations here,
nating and likes to discuss with me
but rather research”, emphasizes
Ingenieur-Büro Messtechnik GmbH
Consulting & Service in the cleanroom
SPECIALISTS
in
Consulting Measurement for Qualification Training Flow visualisation Measurement technology Calibration Maintenance Sales
... we know the way!
BSR Ingenieur-Büro BSR Messtechnik GmbH Beratung & Service im Reinraum Marienstraße 156 68794 Oberhausen-Rheinhausen Switchboard: Fax: E-mail:
+49 7254 - 95 95 9-0 +49 7254 - 95 95 9-29
blattner@reinraum.info service@reinraum.info labor@reinraum.info
Internet: www.reinraum.info FS 518761
Author: Frank Baecke
Portrait | CLEANROOM MAGAZINE 4/2016
Well intended doesn’t automaticaly mean well done Employee motivation is of the highest priority in a cleanroom. Working in a cleanroom demands constant performance of the highest caliber while maintaining the highest degree of concentration. Those employees who are unmotivated or even in their minds have resigned cannot meet these demands. However, employers are able to take measures to improve employee motivation.
21 developed a routine and begins to optimize the procedures. He is able FoTo: Digiwell
20
to perceive his personal learning curve and is anxious for greater challenges. However – and this
motivation is, is shown by a new study published by the consulting company Deloitte together with the opinion research institute Gallup
The relevance of the so-called in-
concerning the topic of productivity
lose their zest as soon as a situation
trinsic, the internally-born source
and productive efficiency. The study
becomes difficult. At this point, it
of motivation, becomes clear at
documents: There is a significant
becomes critical for a company as
this point. Belonging to this is the
connection between a high level of
the design and threshold values are
internal conception of self, this
productivity and the statement “I
still to be maintained.
orientation of individual values
have the possibility every day to do
and standards, such as the internal
that which I am best able to do.”
processes of motivation which express satisfaction when carrying out an activity. Both sources of motivation are highly subjective which
The key to assuring performance motivation
What is responsible for the abate-
leads to individual quantifying
ment in vim and vigor? Why is this
respectively validation of a chief
Within this knowledge lies a key to
especially notable phenomenon
motive’s sub-aspects. Where the
the sustainable assurance of perfor-
in a cleanroom? This becomes
one employee becomes frustrated
mance motivation: We put employ-
quickly obvious in the example of
because the results of his work
ees in a cleanroom exactly in places
a cleanroom cleaning technician.
cannot be seen, another employee
where because of their own personal
Cleanrooms are as a rule not con-
simply enjoys being able to carry
motives they are able to bring forth
taminated with visible and tangible
out the procedures or he is satisfied
the best results. A curious, interested
particles. The cleaning technicians
to know that he is an important part
in progress and variety person is in
generally don’t see any results of
of the whole.
any case best suited for rotating projects. An employee who prefers
their work and because the brain Photos: Nils Bröer
Just how important extrinsic
is human – some contemporaries
The brain lacks the optical and haptic feedback
LIFE & BUSINESS
The boss cannot change intrinsic motivation, however he can do something about extrinsic motivation.
lacks any optical and haptic feed-
An employer can do nothing to
stability is more in his element
back, they don’t see any reason for
influence intrinsic motivation and
following daily routine procedures.
continuing their efforts.
this isn’t his task. He can, however,
Prestige oriented employees in
become active in another aspect:
contrast blossom doing special tasks
Exactly two of the three classic chief
the extrinsic motivation. This deals
involving a high degree of difficulty.
motives, performance, power and
with other motivating factors such
To be a little pregnant doesn’t exist,
employee will carry out his duties
necessarily lead to good results. The
belonging, are not attended to here:
as bonuses, positive assessments
Discover for yourselves the fasci-
to be a little cleanroom capable also
at unacceptable quality levels.
will indicates solely the willingness
The first one is the performance mo-
or other similar evoked forms of
nating search for the motives of the
to reach a goal. In other words: Well
tive, as it isn’t comprehensible to the
motivation. Training courses and
people around you and always keep
intended doesn’t automatically
employee if he has correctly carried
workshops also help to freshen up
an open mind for the wonderful
mean well done.
out the task fulfilling the required
and revive motivation. Numerous
world of motivation.
not. In order to assure a constant high product quality in a cleanroom, all statutory, customer-specified and company-specified requirements
Where there is no will, there is no quality
quality standards. The second is the
providers offer further training and
This is humanly understandable
power motive as the employee is
qualification courses for example
The opposite of a negative work at-
as when starting a new job, there is
not conscious if his work has even
the ReinraumAkademie in Leipzig
titude is the so-called performance
at first a large surge of motivation
contributed to the desired result.
which is offering in November,
The author is a freelance lecturer, mod-
If proper cleanroom work proce-
motivation. According to current
just as when starting a new hobby
Our brain searches constantly for
2016 an event which deals exactly
erator and trainer in Dortmund and was
dures have been adequately passed
psychological research, this is de-
or getting involved in an up and
meaning and associated patterns
with this topic entitled, “Optimal
previously employed as an Operational
over to employees, the adherence to
fined as a person’s will or driving
coming trend. It isn’t difficult to put
and this is exactly what is missing
Cleanroom Personnel”.
Supervisor and Quality Performance
the rules works even with unmoti-
force to execute an essentially
oneself in the position of a newly
here. In the worst case, the employee
Manager in the department dealing with
vated employees. Nevertheless, this
important task to its successful
hired cleanroom employee. He is
feels useless and powerless.
employee training at profi-con GmbH
situation won’t last forever as to be
completion. The word “essential”
curious about his tasks, wants to
unmotivated leads sooner or later to
assumes a predetermined quality
know everything and do everything
negative work attitudes and by this
standard and it becomes decisive at
correctly and is happy with himself
time, the situation will have become
this point to be aware that the will to
when he is able to maintain critical
critical. The danger arises that an
successfully complete a task doesn’t
and threshold values. Soon he has
are to be strictly adhered to and not just a little bit.
CLEANROOM MAGAZINE 4/2016 | Performance motivation
Author: Alexander Scheibe
Contamination Control.
CLEANROOM MAGAZINE 4/2016
LIFE & BUSINESS
22
Architects versus Engineers – Do attractive-looking cleanrooms make sense or is this only bells and whistles? Those who contract out the building of a cleanroom have the choice between an architectural office or an engineering office.
23 Fees for Services by Architects
This knowledge should prevent no-
the rare breed of architects who
and Engineers, is responsible for
body from putting up attractive and
are masters in the planning and
the entire planning coordination
beautiful buildings in which people
implementation of cleanrooms.
and has the task to also integrate
enjoy working and which appeal to
Then outstanding visually attractive
additional planners. It should also
customers. Nevertheless the old ad-
and functional structures can be
be evident that when dealing with
age still applies: Form follows func-
built – which we indeed experience
the process planning, the architect
tion. What use is the most attractive
in practice.
has to involve an engineering office.
visual effect when it is impractical
The architect is not able to deal with
or even counter-productive.
planning the processes.
Matthias Brödel
Matthias Brödel was employed as an architect in an international architectural and general planning office in Munich. Later, he took over the management of the building department of a pharmaceutical company in Karlsruhe. Currently, he manages the concept planning as well as the execution and commissioning/qualification phases of pharmaceutical production facilities in the Life Sciences Division of the Drees & Sommer Group in Stuttgart.
PRO
CLEANROOM MAGAZINE 4/2016 | Controversy
PRO: Matthias Brödel, Project Partner Life Sciences at Drees & Sommer
contractor asks me if he should
Therefore the processes have to
The building contractor should
stand in the foreground in the plan-
have both an architect as well as
ning of cleanrooms. The steps which
an engineer on board his team.
are necessary for the production
commission an architect or an
»In the planning of cleanrooms, the processes have to stand in the foreground.«
Companies often have when planning and designing a cleanroom creative ideas and requests. Therefore they come across open ears when dealing with an architect. Engineering offices place the emphasis in contrast on the production processes. “Cleanroom Magazin” spoke with two professionals about the pros and cons of creative design in cleanrooms.
»Architects think not only in technical-functional terms, but also in creative-artistic terms.«
Nevertheless: When a building
Gernod Dittel
Professor Gernod Dittel is the
Together they are able to combine
of products determine the layout.
their strengths. It doesn’t work
The architecture takes care of the
out very well working with only
outside shell. Good planners know
one approach. A building not only
this. They recognize the technical
deals with optical aspects but also
necessities and requirements in
with processes. When the processes
the construction of cleanrooms and
are not suitable or don’t match,
firstly deal with the processes and
then even the most attractive and
afterwards the design.
the Board of the German Cleanroom e. V.) and the chairman respectively
founder of the engineering office Dittel Engineering in Kochel am See/ Ried (Bavaria) as well as the Adriatic Institute of Technology (AIT) with headquarters in Ancona (Italy). Furthermore he is the Chairman of Institute (Deutschen Reinrauminstituts
when the cleanroom operator was
aesthetic building will fall short of
satisfied with the proportions, work
its purpose. When architects and
Unfortunately the decisions con-
place ergonomics, the color and the
process planners work and coop-
cerning a building project often
acoustics incorporated into the
erate harmoniously together, then
land in management levels which
In my opinion, architects plan more
cleanroom. The attractiveness and
cleanrooms are able to be designed
are far removed from daily prac-
integratively than engineering
aesthetics of the building and the
which are both functional and
tices. This often leads to situations
offices because they pay attention
well-being of employees stand in
attractive.
in which the decision makers let
not only to the technical-functional
direct relationship with each other.
themselves be dazzled by the at-
aspects but also the design and crea-
tive aspects. They give thought to the
There are even pharmaceutical
effects of the room on the employ-
companies which integrate artwork
ees. They also take into account the
into their cleanrooms. This not only
operational and urban development
provides a pleasant atmosphere but
context within which the building
also signalizes how valuable their
As beautiful and attractive futuris-
Once again: Nothing against ar-
the situation when both scientific
will be erected.
employees are to them.
tic designs may be, the architect is
chitects. They play an absolutely
faculties – architecture and technol-
the only one earning money. Those
important role in the building
ogy – co-operate and work together
As an architect, I have planned and
An architect according to HOAI,
who build cleanrooms bring their
process – however concerning
to the greatest extent.
built numerous cleanrooms. For me,
(Honorarordnung für Architekten
revenues in through technological
cleanrooms not necessarily the first
it has always been an affirmation
und Ingenieure) Official Scale of
processes.
violin, except when they belong to
CONTRA: Prof. Gernod Dittel, Managing Director Dittel Engineering
vice chairman of various national and international norm committees.
CONTRA
tractive and alluring visual effects
engineer in the planning of a clean-
and commission architects instead
room, I advise the engineer, except
of engineers. The results of this are
when the architect can provide
costly additions and improvements.
proof of the necessary cleanroom competence. The ideal case rests in
Controversy | CLEANROOM MAGAZINE 4/2016
LIFE & BUSINESS
Foto: Cleanroom Media
24
25 that inexperienced operators fall
conflict, such as cost-pressures,
the cleanroom clothing forms the
for the so-called alibi-cleanrooms
hygienic requirements, protection
only barrier between person and
and this situation has to change!
from infections, customer demands
product respectively in aseptic
New personnel have to be more
and employee requests. Concerning
production areas.
adequately trained. For this reason,
other challenges, we have to deal
Therefore it is not only decisive the
during the reception, I sounded the
with employees from differing
correct cleanroom clothing aseptic
alarm to come to our conferences
countries and with servicing a large
dressing procedures but also the
and sessions. However cleanroom
clinical area with facilities and OP’s,
correct working behavior in clean-
operators themselves have to want
some dating back to the 1950’s. Our
rooms in order to assure flawless
to become more knowledgeable.
task was to bring this all together.
cleanroom conditions for the
Unfortunately only a few operators
To this end, we analyzed the mar-
production of sterile products. For
are still active in this aspect. Conse-
ket, looked at customer demands
this reason, employee training and
quently, in regards to this situation,
and then implemented employee
qualification doesn’t stop at how to
nothing has changed since the New
training programs as employees
correctly dress, but will continually
Year’s Reception.”
are demanding a greater amount
be carried forward with training
of flexibility – not only during
in how to correctly work inside a
working times but also concerning
cleanroom.
Brigitte Finke, Area ManagerCleaning at the Insel HospitalUniversity Hospital Bern
What came out of the New Year’s Reception discussions?
held at the New Year’s Reception were all very interesting and provid-
the beginning of the year to now it
ed insights which in part adversely
Campus Bern as the service provider
has been an intensive, challenging
astonished me, for example hospital
and demanding time, but we are
hygiene and cleaning in OP’s.
heading in a positive direction.” Also in my field of sterile pro-
Barbara Schmitz, Senior QA Specialist at Novartis in Stein, Aargau
duction, continuous, enhanced and stricter measures are being implemented. The responsibility concerning products and patients stands thereby in the foreground.
With my presentation “Hygiene
We must never forget that our prod-
in the Pharmaceutical Industry” I
ucts touch on human life, therefore
gave to viewpoint how important
quality is of utmost importance. 100
hygiene in sterile production areas
percent quality is every patient’s
their belief is that cleanroom
is and what we have to do to main-
right and the responsibility of every
technology is nothing more than a
tain high standards. In cleanrooms,
employee.
cabinet with clean air inside and yet the solutions are long since specif-
Brigitte Finke. Photo: private
“I called the cleanroom technolo-
ically tailored for the industry and
gy professionals into action and
are widespread. It namely makes a
for cleaning and transport. During
participate in the society’s events
difference if food products or semi-
the New Year’s Reception, I reported
during the New Year’s Reception.
conductors are being produced in a
that we were faced with the task of
The industry is facing the problem
cleanroom. However this is totally
overcoming a change in philosophy.
of recruitment and finding young
underestimated by new operators
We have to internalize that we are
talent. With the retirement of the
because the know-how is lacking.
no longer a part of the infirmaries
older, experienced professionals
Many have the feeling that nothing
as we were in the past, but the infir-
from their respective companies,
new is happening in the cleanroom
maries have become our customers.
their know-how and knowledge also
industry and they don’t have to take
This has resulted in the rise of com-
disappears. The younger employees
part in seminars or workshops
plex and multilayered challenges.
make the same mistakes which
dealing with equipment, norms and
Concerning one of these challenges,
were made 20 years ago because
regulations, therefore is happens
we are moving between areas of
CLEANROOM MAGAZINE 4/2016 | New Year’s Reception
The presentations and discussions
in only one ward and another only in OP. Looking back I can say: From
The Swiss cleanroom industry meets yearly in the rooms of the Cleanroom Experience Center in Wangen an der Aare. The host is the CleanroomAcademy. At the beginning of 2016, cleanroom professionals gave their views on the challenges facing the cleanroom industry in the coming year. “Cleanroom Magazin” poses the question: What has happened since then?
Werner Straub. Photo: SRRT-SwissCCS
that a person is limited to working
“We support the infirmaries of the
The first look back at the year 2016
Werner Straub, Secretary of the Swiss Contamination Control Society, SwissCCS
competencies. It no longer applies
Barbara Schmitz. Photo: Cleanroom Media
New Year’s Reception | CLEANROOM MAGAZINE 4/2016
26
On the road with Jürgen Lederer Jürgen Lederer is the Key Account Manager CE in the field of cleanrooms at Vileda Professional. The company with headquarters in Weinheim in southwest Germany offers cleaning solutions and systems for professionals.
27 What is your favorite means of trav-
Which countries and regions stand
Which travel destinations do you
el? This is naturally my automobile. I
most often on your list when on the
favor and why?I am a fan of the
love driving!
road? I travel throughout Germany
northwest USA. This immense area of
and to the countries of Austria and
pure nature with its mountains and
Switzerland.
forests – especially the Redwoods – as
What is important to think about when travelling?I put a lot of value on
well as its lakes and the sea….I simply
comfort. It’s very important to go to
Are you able to switch off the business
customer appointments relaxed and
done during the day when you are on
ready to work. .
the road? Yes, this I can do. It took me
love this region’s vastness.
a long time to learn how to accomplish
What would the first thing you would
What should never be missing when on
this. Contributing to being able to is
change if you had the unlimited
the road? Coffee and a CD with good
that I am always able to depend on my
possibility to do so? That is a difficult
music on it.!
colleagues in customer service.
question! I would do away with the
LIFE & BUSINESS
ignorance and bigotry of some people. What kind of music do you like listen-
How do you best switch off the daily
Unfortunately I am not used to having
ing to when travelling? I very much
business? In that, I take a break in a
so much power, but to be frank, I’m
like to listen to well-played rock and
place where nature dominates. While
happy not having this power.
roll or good hard rock.
moving around in the fresh air I am able Author: Frank Baecke
to recharge my batteries.
vali.sys gmbh hofstrasse 94 ch-8620 wetzikon +41 43 495 92 50 info@valisys.ch www.valisys.ch
innovative – competent – customized
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Photo: private
How often are you on the road?
consultation but also product demon-
concerning cleanrooms and in so doing
Normally I am on the road for my
strations for interested parties and
I go especially into the topic of cleaning
customers every day. Belonging to
customers. Furthermore I give lectures
in cleanrooms.
my work responsibilities are of course
and presentations on everything
CLEANROOM MAGAZINE 4/2016 | On the road with…
On the road with… | CLEANROOM MAGAZINE 4/2016
28
29
Science & Technology
comfort has to be considered. Scientists at the Hohenstein Institute are working within the framework of a research co-operative, on improve-
For clean and ultra-cleanrooms | The
ments by optimizing textile tech-
IP Gansow GmbH has developed a
nical and physiological functions.
product particularly suited for
Parallel to this project, the project
cleanrooms and ultra-cleanrooms
Micro-battery: Graz researchers use mono-crystalline
partner wfk – Cleaning Technology
with its scrubber-dryer machine
semiconductor silicon from microchips as the battery
Institute e.V. are doing research
Premium Green Line RR. The fine
electrode. Photo: Lunghammer, TU Graz
in developing a gentle recycling
dust particles which arise when in
procedure in order to assure and
operation are drawn back into a
maintain textile functionality.
dirty water tank at the back of the
SCIENCE & TECHNOLOGY
Technology in Brief
Dry battery against auto ignition
World’s lightest half-transparent OLED display glasses
New kind of lithium-ion battery |
Custom-made scrubber-dryer machine developed
An advanced SmartLAB will be presented in 2017
simultaneously a part of a mini-battery which provides the electrical
machine by using negative pressure
power, for example to send or receive
via a hub-motor. The machine body
information. This on-board energy Future laboratory | The smartLAB
supply on the microchip could
Palletizing concept for cleanroom applications
is connected to the floor with an anti-static grounding band. Therefore
Researchers at ETH Zürich have de-
Augmented Reality | Epson pre-
which was presented at the trade
considerably expand the application
veloped a lithium-ion battery which
sented in the previous month, for
fair Labvolution 2015 as a future
spectrum of micro-electronics. The
Motek-innovation | Highly accurate
and the resulting particle adherence
consists solely out of solid material.
the first time in Germany at IFA
intelligent laboratory will be further
micro-battery is only a few millime-
production processes in cleanrooms
is avoided. The machine is cus-
It contains neither fluids nor gels
2016 in Berlin the third generation
developed. State supported funding
ters in size and reaches performance
are increasingly taking place in au-
and cannot auto-ignite even at high
of their Smart Glasses Moverio.
is making possible. The results will
levels which are comparable to stand-
tomatic facilities. For this reason, the
temperatures.
Compared to the previous model,
be presented from May 16th to 18th,
ard lithium battery systems.
automation specialist IEF Wernere
the new augmented reality glasses
2017 at the next Labvolution/Biotech-
presented at Motek Trade Fair in
are around 20 percent lighter and
nica. In 2015, a group of scientists and
Stuttgart in October a fully integrated
offer high-contrast images in HD
companies from all around Germany
resolution. The heart of the intelli-
started the ball rolling. In the mean-
gent Moverio BT-300 is comprised of
time, a smartLAB innovation network
two OLED projectors which provide
has been formed which applies itself
Wearing comfort | Disposable OP
for cleanroom production. It provides
the two displays with images. The
in developing and standardizing
textiles such as wrap gowns/coats or
for example a minimal generation of
resolution for each eye amounts to
laboratory technologies.
coverings prevent because of their
Innovative reusable protective textiles
the machine’s electrostatic charges
palletizing concept with the name “Variostack CF Clean Factory”. The supplier has optimized the system
barrier effect the transfer of germs
1280 x 720 pixels. With ist Quadcore processor, the 5 mega-pixel front
SmartLAB shows the visions and
between OP personnel and the pa-
camera and the range of sensors,
solutions for life in laboratories in
tient. Nevertheless, they cause a large
the glasses are able to compute 3D
this age of digitzation and Industry
volume of waste material after use.
4.0. Standing in focus is the deploy-
Reusable OP textiles help to avoid
Classic lithium-ion batteries are in
ment of automation and robotics, a
this problem however they have
contrast not without their risks. If
modular and flexible construction
to fulfill additional requirements.
The product carrying-transport system is not only
they are overcharged o rare left in
approach, integrated functional sur-
Besides the high level of protection,
extremely compact but can be retrofitted and serviced in
tom-made and manufactured to the
the thermo-physiological wearing
running operations. Photo: IEF-Werner
specific application parameters. The
A lithium garnet electrolyte disk, layered with a black lithium contact functioning as the minus pole. Photo: ETH Zürich / Fabio Bergamin
direct sunlight, the fluid between
faces as well as the digital networking
the electrodes is able to ignite or
at horizontal and vertical levels.
the gel can swell up. In the new batteries, the Zurich researchers
developed for use in cleanrooms and ultra-cleanrooms. Photo: IP Gansow
designation RR (Reinraum – clean-
The new Epson smart glasses with OLED projectors are 20 percent lighter. Photo: Epson
have used an electrolyte made out
The new scrubber-dryer machine has been particularly
Piggyback battery for microchips
foreign particles and short cycle times.
room) stands for the compliance to
As the palletizing system has an open
the requirements of the ISO Norm
and modular design, it can be adapted
EN ISO 14644 with regards to the
to any task description. Furthermore
materials used and the filtering of
the extremely compact palletizing
the turbine’s exhaust air.
of lithium garnet. This solid ma-
objects in real-time and to integrate
terial makes it possible to operate
the real, actual surroundings. The
batteries at higher temperatures as
glasses are expected to be on the
New battery concept | Electro-chem-
system can be loaded with standard
well as to build thin-film batteries,
market from October, 2016 at a price
ists at TU Graz have succeeded in
pallet carts and transport/conveyor
including such which can be direct-
of approximately 799 Euros.
using the mono-crystalline semi-
belts – even with from the side with
conductor silicon from microchips
the belt- loader version.
ly placed onto silicon chips.
directly as a battery electrode (anode). Therefore the microchip accommodates not only the electronics but is
CLEANROOM MAGAZINE 4/2016 | Technology in Brief
Surgical textiles are discarded after use. To reduce waste, researchers are working on reusable fabrics with optimized functions. Photo: Fotolia / bst2012
Technology in Brief | CLEANROOM MAGAZINE 4/2016
30
31
A monitor with eyes and ears
SCIENCE & TECHNOLOGY
A new kind of monitor for intensive care units reacts to gestures and language.
Fraunhofer researchers have developed an intelligent monitor which not only shows a patient’s vital data but also evaluates dangerous situations and supports doctors who have to make decisions. The monitor allows itself to be remotely controlled with gestures and voice command which lowers the risk of passing on hospital germs. Everything was quiet in the intensive
in such hectic situations” says Paul
m o n i t o r. T h i s q u i c k l y s h o ws
care unit control room. All of a sud-
Chojecki. He is a scientist in the de-
doctors and nurses the most im-
den things started getting anxious:
partment “Vision & Imaging Technol-
portant vital data of patients in the
Several medical devices in different
ogy” at the Fraunhofer Institute for
intensive care unit, but not only the
hospital rooms were simultaneously
Information Technology, Heinrich
data. The newly developed monitor
blaring alarm! Monitors were every-
Hertz Institute, HHI in Berlin and
is equipped with interfaces for all
where blinking and beeping. Doctors
supervises the work in non-contact
other medical devices in the room
and nurses were rushing to patients’
Human-Computer-Interaction.
as well as the hospital’s IT system.
rooms where the various medical de-
“With the linkup of other devices
vices were displaying more detailed
and data bases, we want to achieve
information about patients’ conditions. The medical personnel had to
Monitor display adapts itself to the distance of the viewer
quickly filter out the most important
The intelligent monitor is connected with the data base via a computer and brings together all vital data for intensive care unit patients. Photo: Fraunhofer HHI
The IT network provides the issuance of intelligent alarms
an intelligent acoustic alarm” ex-
system a dummy patient, which is
hospital personnel” says Chojecki.
connected to the system, assesses
The new system will overcome
and evaluates the dummy and how
these disadvantages.
plains the project manager. “In the
A demonstrator respectively pro-
doctors and hospital personnel react
future, when a threshold value has
totype of this so-called Proxemic
to situations of danger with the help
information from the numerous
Chojecki has developed in a joint
been exceeded, every single device
Monitor was shown by the project
of the system” announces Chojecki.
digital displays and monitors. “It isn’t
project „Control Room“ together
shouldn’t start beeping. The system
partners at CeBIT 2016. The term
easy to maintain an overview here
w i th h is team an in te llig e n t
should first alert the doctors and
Proxemic comes from the Latin
The University Hospital RWTH
nurses when out of the multitude
word proximus and stands for “the
Aachen belongs to the partners
A further advantage is that doctors
of data a dangerous situation has
next”. The proxemic is a sub-domain
in the project “Control Room” and
and nurses don’t have to touch the
been detected.”
of psychology and communication
is supporting and contributing
device which avoids and prevents
science. It examines how spatial and
to the intelligent alarm system
the spread of germs. “The transfer
A further innovation entails con-
physical distance affects the interac-
concept. This should in the future
of pathogens is still a problem in
trolling the intelligent monitor
tion between humans and objects.
help to avoid the annoying and
hospitals and especially in intensive
with gestures and voice commands.
“What we presented at CeBIT was
cost-intensive false alarms. “The
care units. Sometimes the obligatory
The picture on the display adapts
the device which a doctor will later
doctors of the intensive care unit
hand disinfection is forgotten which
automatically to the distance of
have in front of him. Now we are
have described false alarms as a
allows viruses and bacteria to be
the viewer. “From the door, the
working on what happens in the
major problem” reports Chojecki.
carried from room to room” accord-
doctor is able to see the data in
background and what communi-
Current devices stubbornly keep to
ing to the Fraunhofer professional.
the appropriate size. If he comes
cation is occurring at the interfaces
fixed threshold values and are not
The transfer of contamination via
nearer, the monitor shows more
between the devices and the data
able to bring in all factors which
the hands is not only a problem in
detailed information” explains
base in order to make possible an
are necessary to thoroughly assess
hospitals and intensive care units,
Chojecki. A 3D camera makes sure
intelligent alarm system.”
a serious and dangerous situation.
but also in cleanrooms. In order to
“Furthermore, the acoustic signals
bring this situation under control,
that the respective necessary data
Non-contact control means fewer pathogens are transfered
A first practice test is planned for
which are activated present a very
there is the need for well-trained
Paul Chojecki is a specialist in contactless human-computer-interaction. The scientist works in the department “Vision &
the fourth quarter with the Uni-
significant level of noise which
employees and appropriate disin-
Imaging Technology” at the Fraunhofer Institute for Information Technology, Heinrich-Hertz Institute in Berlin.
versity Hospital RWTH Aachen.
is definitely not conducive to the
fection measures – or non-contact
“We will simulate and test how the
health of the patients, nor of the
operable devices.
is shown.
Photo: Fraunhofer HHI
CLEANROOM MAGAZINE 4/2016 | Medical technology
Medical technology | CLEANROOM MAGAZINE 4/2016
33
32 voice commands or short reports are
decision-supporting information
able to be entered. Thanks to these
for example context sensitive Work-
possibilities, a doctor is for example
flows. An additional goal for 2017 is
remotely able to start a video call in
the incorporation of camera-based
order to interact with colleagues in or
recognition of users respectively their
outside of the hospital.
roles and rights. This will simplify the
Photo: Fraunhofer HHI
operation for authorized users and The work on the intelligent monitor
access to information can be denied
will continue until May, 2017. The
to unauthorized persons.
SCIENCE & TECHNOLOGY
further development of the monitor will subsequently be taken over by
Cleanroom Magazin: What are the
the joint project’s industrial partners
current trends in your field of work
in order to prepare the product for the
“Vision & Imaging Technology”?
market. However even in its present
Cameras scan the room directly from the monitor so that the display and functionalities can be adjusted for the respective distance from monitor to person, see video (QR code).
The cursor is remotely controlled by arm movements
The Person: Paul Chojecki is the Project Manager of the joint project “Control Room” in which a voiceactivated and gesture controlled monitor for intensive care units is being developed. The scientist works in the department “Vision & Imaging Technology” at the Fraunhofer Institute for Information Technology, Heinrich Hertz Institute, HHI in Berlin and is an expert in non-contact Human-Computer-Interaction.
developmental condition the Prox-
Paul Chojecki: These are obviously
emic Monitor makes possible a “mul-
applications for Augmented and Vir-
ti-modal interaction between user
tual Reality. Professional 360 degree
and system” as Chojecki scientifically
recording systems are getting better
formulates. He is able to do this, in
and better in depicting the real world
describing what he and his partners
in VR glasses. With non-contact in-
have accomplished, but converting
teraction via gestures, a user is able to
number of systems and solutions with
this into everyday terms: “We have
more easily move in the virtual world.
non-contact interaction is increasing.
given the monitor eyes and ears.”
Besides this, it is possible to reconstruct
Stronger standards have to be put into
people in 3D and to integrate them in
place in the future. Therefore users
an interactive TV format or VR world.
will not have to re-learn the operation
For the non-contact control of the
are performing. The display as well
Fraunhofer monitor, three differ-
as the functionality of the monitor
ent cameras and a microphone
change depending on the distance.
are provided. They scan the room
“Our monitor differentiates dis-
The software interprets the distances
in front of the monitor. System
tances between near, intermediate
and movements of users and converts
software analyses by means of the
and far. At maximum, the cameras
them into commands for the estab-
Cleanroom Magazin: What are the next
video data if people are present in
cover distances up to four meters”
lished operating systems. From the
steps for the “Control Room” project?
the room, how far they are from the
explains Chojecki.
intermediate distances, the cursor is
Paul Chojecki: We want to project
Paul Chojecki: We are describing
91333 – Non-contact Gesture Control
controlled by arm movements and
on the Proxemic Monitor further
and standardizing gestures. The
for Human-System-Interaction”.
monitor and what activities they
Three questions to Paul Chojecki
concepts of a new gesture-controlled Cleanroom Magazin: On which
system. We are developing in this
additional topics are you currently
respect, a gesture-description-system
working on?
and are working together with other partners on the norm “DIN SPEC
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CLEANROOM MAGAZINE 4/2016 | Medical technology
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Medical technology | CLEANROOM MAGAZINE 4/2016
34
The Unseen Enemy
Product contamination by airborne molecular contamination (AMC) gives reasons for increasing worry to manufacturers.
35 of the study showed that ammoniac
can for example destroy electronic
In order to hold production losses
and formaldehyde are among these
components as in cases where acids
as small as possible, the molecular
contaminants. Anne Rausch, a PTB
or bases are used, they can cause
contaminants have not only to be
researcher emphasizes: “Ammoniac
corrosion or in cases where silicon
quickly detected, but the causes of
adheres to everything and therefore
is used, they can lead to effects of
their origins have to be recognized
can be easily carried from outside ar-
non-conductivity causing breaks in
and resolved. This is a task because
eas into a cleanroom. Furthermore,
electric circuits.
of two reasons will be difficult to
it sometimes arises directly from the
“Molecular contamination has
solve: The first reason is that the
production processes themselves.”
of course always been present in
molecular combination possibili-
cleanrooms, but they have never
ties are so multifaceted making a
played up to now an important role”
universally-applicable approach
explains Markus Thamm. “In the
impossible. The second reason is
meantime, structural dimensions
that there is no really all-around,
in the semiconductor industry
appropriate measuring equipment
The crux of the matter regarding
are getting down into the range of
available on the market.
airborne molecular contaminants
seven nano-meters – this is below
is that despite their unimaginable
various molecule sizes. In the field
small size – they are only a few
of micro-technology, the structures
atoms in size – they can cause pro-
are not yet so small but the chemical
duction losses. The reason: If the
processes due to molecules play in
molecules come into contact with
this case an increasingly more im-
products this can cause undesired
portant role” exhorts the cleanroom
“The companies which have already
chemical or physical changes on
professional.
recognized AMC as a problem, often
surfaces. Sensitive micro-structures
Therefore manufacturers are being
use sheets which are laid out and
are as a result ruined. The molecules
faced with a significant challenge.
analyzed after a week” says Markus
SCIENCE & TECHNOLOGY
Molecular contaminants destroy micro-structures
Photo: Fotolia/Petrovich12
The structures in the semiconductor and micro-technology are meanwhile becoming so small that besides particulate matter, small, tiny molecules are also endangering product quality. The development of appropriate filter and measurement equipment still finds itself in its infancy. The solutions which are currently available will be shown at the forthcoming Cleanzone. The attempt to measure airborne
the nano-particles had disappeared.
technology and can be reduced by
molecular contamination in a
They had combined with other
using the appropriate measures”
cleanroom is comparable to finding
molecules.
sums up Markus Thamm who is
the proverbial needle in a haystack. matter which allow themselves to be detected and filtered out, molecular
responsible for Sales and Marketing
Industry has particles under control, molecules not yet
contamination is extremely elusive,
at cleanroom.de GmbH in Heidelberg. “However, it is relatively new that companies are increasingly becoming worried about AMC.”
not only because the measurement
The incognisable atomic-sized
AMC stands for Airborne Molecular
equipment due to its configuration
clumps are increasingly becoming
Contamination. The term desig-
is barely able to detect it but also be-
a problem above all for manufactur-
nates the airborne contamination
cause it readily combines itself with
ers in the semiconductor industry,
in question at molecular levels. The
other atoms creating new molecules
in the aeronautic and space industry
molecules arise due to gas emissions
and therefore eludes every room-
as well as in the micro-technology
from solvents, acids, bases or silicon.
air surveillance done by measuring
industry. Because of the increas-
These molecules are not detected by
devices and monitoring systems.
ingly smaller product dimensions,
the classic particle counters.
the molecules are meanwhile
The National Metrology Institute of
Researchers at semiconductor
presenting greater dangers for
Germany (Physikalisch-Technische
companies have vividly shown
product quality than the common
Bundesanstalt PTB) in Braun-
this in an experiment. They spread
particulate matter. Industry has the
schweig examined in a research
nano-particles over the surface of
latter under control in the cleanest
project the air quality in cleanrooms
silicon wafers and left the wafers to
cleanrooms of ISO Class 1.
in regards to airborne contamina-
stand for 20 minutes. The following
“In our opinion, particles are
tion, in order to identify the most
measurement showed that most of
detectable by current cleanroom
important contaminants. Results
CLEANROOM MAGAZINE 4/2016 | Airborne Molecular Contamination
Graphic: Fotolia/Zffoto
In contrast to common particulate
Industry is wringing their hands searching for AMC measuring technology
Airborne Molecular Contamination | CLEANROOM MAGAZINE 4/2016
37
36 Thamm. “For this reason, they unfortunately only have a statement which indicates if within a week anything has occurred or not, but
measurement with detection limits
manufacturers are already working
Cleanzone offers AMC Workshop for companies in the semiconductor industry
Markus Thamm is meanwhile fa-
not when. This is not enough for critical processes.” The European co-operations project MetAMC, among others, are searching for a measurement-technical solution. The partners from several
SCIENCE & TECHNOLOGY
international institutes are working on methods which make possible real-time monitoring of AMC concentrations in cleanroom air. The applications of such a solution would be significant. “When a rise in AMC concentration is registered,
Cleanzone informs about current AMC measurement and filter technology
For the first time, a workshop regarding the topic “AMC – a Challenge for Cleanroom Technology” will be taking place at this year’s cleanroom trade fair Cleanzone. The Workshop will bring the problem of molecular contamination into focus and present new findings regarding the topic of measurement equipment and filter technology. The Workshop will address companies in the semiconductor, aeronautic and space industries as well as the high-end synthetic materials business sector. “Cleanzone” is presented by the Messe Frankfurt in co-operation with the ReinraumAkademie.
miliar with such requirements. His company modernized a customer’s cleanroom in which inspection systems are built into satellites. Thamm has already reported on his AMC experience at a Workshop at the ReinraumAkademie in Leipzig in January of this year. At the cleanroom trade fair Clean-
Location and dates: Cleanzone – International Trade Fair and Congress for Cleanroom Technology, November 8th to 9th, 2016, Frankfurt am Main, Germany.
zone from November 8th to 9th, 2016 in Frankfurt am Main, Thamm will be giving a further Workshop
the production can be interrupted.
together with his network partners.
The affected components can be
The professionals will be informing about how production losses caused
inspected and in cases of necessity, be disposed of” says Anne Rausch
of tiny AMC particles in the range
on the problematic. In the mean-
by airborne molecular contami-
from the PTB. The MetAMC project
of billionths for the entire particle.
time, there are monitoring systems
nants can be minimized and which
is striving to achieve real-time
The first measurement technology
which provide around the clock
measurement equipment and filter
monitoring and exact real-time
solutions are currently available on
alarms. However, according to
the market.
Markus Thamm these systems are only able to detect a small number
Find more about Cleanzone’s pro-
of chemical substances. “For the
gram offerings on page…as well as
many customers who have classi-
on the internet at www.cleanzone.
fied substances such as siloxane,
de and www.facebook.com/clean-
epoxide or other such substances as
zoneFFM.
critical, there are currently no solutions. Therefore we at cleanroom.
In order to avoid production losses, molecular harmful substances have not only to be detected quickly, but also recog-
Author: Frank Baecke
nized the causes of their origin and fixed. Photo: Cleanroom Media
de together with our partners are driving forward the development of measuring devices.” For the reduction of AMC contamination in a cleanroom, the filter technology is decisive. The conception and implementation
Become an expert in ISO + GMP:
CLEANROOM TRAINING
of a cleanroom with a low level of contamination of airborne molecular contamination is considerable more complex than the planning
clean
of a classic cleanroom with conven-
08. +
tional particle filtration. Every AMC
Messe
substance classification, whether it be hydrochloric acid or elusive organic combinations, separate Markus Thamm will be hosting a workshop on AMV Issues and Difficulties at Cleanzone. Photo: Cleanroom Media
CLEANROOM MAGAZINE 4/2016 | Airborne Molecular Contamination
filtration equipment is required.
www.reinraum-akademie.de
zone
09.11
.2016
Frankf
Hall 4 Booth .0 A30
urt
Airborne Molecular Contamination | CLEANROOM MAGAZINE 4/2016
38
Computer Use in Cleanrooms New solutions often make costly installations and additional encapsulation unnecessary.
39 Watts is converted into heat.” This isn’t hard to do as everyone knows how hot a classic 100 Watt light bulb is. A system such as this, by necessity, needs active cooling. The problem: Where the fans are installed, the systems as a rule remain open however exhaust air which permanently blows out of open devices is taboo in a cleanroom. For this reason computers are
SCIENCE & TECHNOLOGY
generally hermetically sealed and isolated from the cleanroom. In GMP cleanrooms of Classes D and C, this procedure is not as strictly managed. In these cases normal, standard PC’s are mostly used. However from Class B, PC’s are no longer installed in the open, but often built into a wall and sealed off with glass. IN GMP cleanrooms of Class A, PC’s are even become integrated into the laminar flow work benches as a standard component.
Systems with active ventilation are particle centrifuges - here exaggerated. A passive cooling without fan and ventilation slots is a must in a cleanroom. Photo: Adlink Technology GmbH
Yesterday’s ways of thinking The question comes up though: Do these significant expenses really have to be? Hasn’t PC technology developed to this effect that alternative solutions are now possible? Helmut Müller is convinced that the customary ways of thinking have to be put under scrutiny. “When one takes into consideration that components in a cleanroom are generally smooth and should have no dirt-collecting crevices and must not
PC work station requirements for the cleanroom are very demanding. From GMP Cleanroom Class B, it is common practice to build computers into special housings to hermetically seal them off. Modern solutions do away with these expenses. Such solutions are closed, without fans and easy to disinfect.
emit any particles, than I ask myself, why are PC’s with fans still installed in cleanrooms of Classes C and D”, says Müller. For him, the premises
“Habit is habit and not to be flung
in order to make them suitable for
the company which manufactures
are already wrong to equip a PC with
out of the window by any man,
use in a cleanroom.
fanless PC systems is specialized in
a fan. “These are yesterday’s ways of
the optimization of hardware sup-
thinking!” As Mark Twain already
but coaxed downstairs a step at a time” As Mark Twain noted down
“These habits come from the time
plications in medicine, industry and
has put it, a person cannot simply
these words of wisdom, he certainly
when computers consumed more
logistics. To illustrate the problematic,
throw out the window.
wasn’t thinking on habits dealing
than 100 Watts“, says Helmut Müller,
Müller takes the example of a high
with computers, nevertheless his
Vice President of Sales at Adlink
performance PC which carries out
insight is fitting, namely concern-
Technology GmbH subsidiary in
complex real-time analyses. “Imagine
ing the habit to encase or recess PC’s
Deggendorf, Germany. This part of
that its electrical consumption of 100
CLEANROOM MAGAZINE 4/2016 | Cleanroom Computers
Picture left side above: Systems with hardened glass fronts are able to be disinfected using standard materials so that contamination can be effectively prevented. Photo: Adlink. Small picture above: Thanks to excellent graphic efficiency modern Panel-pc’s are able to independently and separately administer up to three high resolution screens. Photo: Fotolia/sudok1
Yet, according to Müller, there have been for a while convenient solutions which make the
Cleanroom Computers | CLEANROOM MAGAZINE 4/2016
41
40 Recommends in many cases enclosed, fanless systems
categorical, hermetical sealing of PC’s and therewith the problem
ISO 14644 is always possible. It is definitely worth thinking about,
built into work benches for GMP
and to change to systems which
cleanrooms of Classes A and B. If
from their form and function often
they are not built in but operated
are more suitable in cleanrooms
and food industries, in research and
»The whole expense of installing PC’s in niches with glass fronts or in work bench housings in not absolutely necessary.«
unenclosed as stand-alone systems
than the classic PC’s which have to
experimentation laboratories and
Helmut Müller, VP-Sales Adlink Technology GmbH
with fans superfluous. These systems are completely closed, fanless and can easily be disinfected. They superbly suit themselves for use in cleanrooms of the pharmaceutical
SCIENCE & TECHNOLOGY
instead of expensive built-in computers: Helmut Müller, VP-Sales Adlink Technology GmbH
á la Mark Twain to coax habits of the past down the stairs step by step
they have to be equipped with the
be enclosed or operated as “germ
in pharmacies, in short, in those
appropriate exhaust air connec-
centrifuges” with open venting
locations where product contam-
tions in order to create the required
slots.
ination has to be prevented. “We
negative pressure. A cleanroom qualification in accordance with
install such panel PC systems in hospital OP’s where the highest level
contact, foreign bodies, water and
are keen on avoiding these costs.
Have the costs for running oper-
of hygiene has to be maintained
humidity, the higher the number,
What this can mean is described
ations also been considered and
and also to prevent the spread of
the higher the protection.
by Müller: “Imagine how germs
included? Müller laughs. “Yes, of
establish themselves in classic PC’s.
course. Completely enclosed IP65
With modern glass fronts for dis-
With conventional internal temper-
protected systems save even here
plays as well as metal and stainless
atures they find the ideal climate to
costs. They consume as a rule, less
steel housings, systems with high
reproduce themselves. Because of
energy than systems with fans.”
quality surface finishes can be
the ventilation, they are continually
They could be atmospherically
implemented which are able to
supplied with the surrounding air.”
separated with considerably lower
hospital germs” says Müller naming a further example of application.
Enclosed, fanless and easy to disinfect
costs than systems with fans and
achieve the required maximum “Why don’t cleanroom outfitters
peak to valley height of less than
Fanless systems provide in contrast
venting slots. To atmospherically
generally change over to completely
0.8 µm which for contact with the
per se an improvement in clean-
separate a classic PC with a fan
fanless and closed systems? The ex-
product is for example required in
room air. They can also be optimized
requires the suction power of good
penses for today’s common practice
the pharmaceutical industry. “The
with other cleanroom equipment
vacuum cleaner. “This is much too
of built-ins in Classes A and B far
whole expense of installing PC’s in
for example work benches or digital
expensive”, says Müller. „This is
exceed the additional costs for such
niches with glass fronts or in work
monitoring systems. Even the new-
why it wasn’t possible to do previ-
systems” argues Helmut Müller.
bench housings isn’t necessary in
est PC technology such as the fifth
ously.” As the IP65 protected system
Think on the costs for installing
every case when the system design
generation Intel Core i7 processors
is nearly airtight, only a marginal
PC’s in a laminar flow work bench.
is planned from the onset with
can be operated without using
amount of energy is needed to
A fanless system could be used in-
cleanrooms in mind” explains Hel-
ventilation.
create the necessary air stream
stead. “A completely closed system
mut Müller. Concerning this, IP65
fulfills all current requirements
systems essentially need only an
„I am willing to put our systems up
the system. In the amortization
which have been imposed on built-
additional exhaust unit so that no
against the test of particle coun-
calculation, only a few Euros need
ins in cleanrooms”, says Müller.
particles are emitted into the clean-
ters, airborne germ collectors and
to be entered, to be distributed over
Such systems are in comparison to
room which can even be installed
contact plates” challenges Müller
the entire operating life.
conventional PC’s not only easy to
later on.
operators and outfitters. As a testing
clean and disinfect but also resistant to cleaning and disinfecting agents and to materials used in operations. Glass-touch-panels of today’s PC’s
Cleanroom Consumables
Clean. Pure. Sterile.
respectively negative pressure in
device, he recommends the new 21
Operators are keen on avoiding costs
Autor: Daniel Piper
inch panel-PC MLC 5-21 with its Quadcore-Performance, the newest Intel processor. A system such
Closed systems can also be used in cleanroom Classes A and B.
A selection of our Brands
as this is of course not as cheap as
have flush-mounted junctions and
The Adlink Technology-Sales Vice
a standard PC from a discounter.
It remains to adhere to the fact
therewith no inaccessible cavities.
President points out that completely
“In areas where the concern is
that enclosed IP65 protected sys-
Even the external interfaces are
enclosed panel PC’s also for GMP
the prevention of contamination,
tems wih metal or stainless steel
provided with IP65 protection
cleanroom Class C help minimize
systems easy to disinfect are in any
housings suit themselves well for
against dust, humidity and water. IP
respectively reduce the risk of
case a must” says the sales boss. In
cleanrooms of Classes C and D
stands for International Protection,
contamination. However, its use
this respect, completely enclosed,
which obtain the high demands on
the numbers 6 and 5 for the level of
in C and D areas is not officially
easily disinfected systems will soon
the avoidance of contamination.
protection of the housing against
required so that some operators
be considered.
The enclosed systems can also be
CLEANROOM MAGAZINE 4/2016 | Cleanroom Computers
www.iab-reinraumprodukte.de
Cleanroom Computers | CLEANROOM MAGAZINE 4/2016
43
What do you do there, Samuel Pinto?
PROGRESS THROUGH WISDOM.
SCIENCE & TECHNOLOGY
A brief cleanroom industry profile
Mein Name ist Samuel Pinto, ich bin
precision injection molding and
Belonging to this work is the installation of the packaging periphery and the material feed area as well as the setup and maintenance of the cleanroom work places. With the activation of the respective production order at the machine using a mobile tablet, a charge number is issued for the article. This is linked by me via the barcode scanner integrated with the tablet, with the current raw material charge being used. In doing so, it is immediately reported back to me if the correct material corresponding to the stock list was supplied. Automatically, a test order is created in the CAQ system for the in-process SPC tests with which I carry out the first piece test as well as the in-process tests. I also carry out the process steps and activities pre-determined by the QM system. As examples of
Samuel Pinto works as a synthetic materials process technician at Ernst Rittinghaus GmbH in Halver, Germany and initiates production runs for retrofitted injection molding tools. Photo: Ernst Rittinghaus GmbH.
these activities are the drawing up of setup protocols by means of checklists, the implementation of line clearance after retrofitting,
My name is Samuel Pinto and I am
mold construction which is increas-
operation data administration via
a technician for synthetic materials
ingly focusing on the production
our Arburg host computer system
processes. I have been working as a
of thermo-plastic injection molded
as well as the creation of tool-repair
fitter at Ernst Rittinghaus GmbH
parts for medical technology. Many
orders when tool problems occur.
in Halver, Germany and my duties
of these products have to be pro-
include working in the production
duced under cleanroom conditions.
of cleanroom medical-technical
ue s s I s e g n u K o A L E WE SP
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42
My tasks consist of putting into place
Know-how and News – for R&D and Industry.
and connecting the injection mold-
◾
Ernst Rittinghaus GmbH is a small
ing machines with the cleanroom
◾
middle-sized company dealing with
and with the production periphery.
plastic parts and component groups.
CLEANROOM MAGAZINE 4/2016 | What do you do there,…?
◾ ◾
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 4/2016
44
45
Only mumbo jumbo or a signpost for success with exports? The implementation of FDA regulations is a challenge for European manufacturers.
SERVICE
When European pharmaceutical production procedures do not conform to FDA expectations the US authorities can stop exports into the USA. Photos: Fotolia/Kadmy
processes after foreign particles had
procedure of the processes and not
about situations and the hence the
been found in active agent batches.
of our products. We have taken this
resulting diverging perceptions
The FDA, responsible for monitoring
matter seriously and together with
of regulations. “For example, the
food products and pharmaceutical
the FDA have formulated a plan
terminology such as ‘validation’
product licensing in the USA, there-
of action and have optimized our
is not the same in the USA as in
upon released a Warning Letter.
quality assurance system – and this
Europe” says Gross. “In addition,
not only at our Ingelheim location
there is the differing points of view
but worldwide.” The payoff for
regarding the law, Americans think
these efforts: In June, 2014, the FDA
universalistically, the Europeans
annulled the Warning Letter. How
particularistically“, says Gross.
The FDA can stop exports into the USA
Graphics: Fotolia/Cleanroom Media
this was achieved by Boehringer A Warning Letter is equal to an offi-
Ingelheim, Gerhard Köller reports
In order to make it a bit more
cial warning or reprimand and can
in an interview on page…
transparent: In Europe a product
have serious consequences. If the
contaminated by a foreign particle
company doesn’t turn around the
but still meeting the corresponding
deficiencies, the FDA can stop the entry of products into the USA from
Europeans and Americans have different attitudes towards the law
the affected factory. In the Warning
For those who want to export products to the USA, the regulations of the US Food and Drug Administration (FDA) have to be fastidiously held to. Uncertainty often prevails concerning the interpretation of the requirements. The causes for this are misunderstandings, false interpretations and the orientation towards EU GxP regulations.
risk evaluation requirements will be approved and accepted, but this is not the case in the USA because
Letter of May, 2013, to Boehringer
Dr. Dietmar Gross can explain
the law says: The product has to be
Ingelheim, it was unmistakably
why European companies time
clean. The FDA is interested in nei-
formulated: “Until all corrections
and again run aground against
ther foreign regulations, nor in the
have been completed and FDA has
FDA regulations. The pharmacist
interpretation and adaptation pos-
confirmed corrections of the vio-
and Senior Consultant at the con-
sibilities of such regulations. This is
lations and your firm’s compliance
sulting firm GMP Experts GmbH
why according to Gross Europeans
with CGMP, FDA may withhold
in Neustadt an der Weistraße sees
with their “old-continental pride”
approval of any new applications
the reason being the different ways
and their “We don’t see it that way”
or supplements listing your firm
Europeans and Americans think
attitudes, from time to time don’t
as a drug product manufacturer. In addition, your failure to correct these violations may result in FDA
Sometimes even with companies
company in Germany and counts
authorities from around the world
Pharma & Co KG Ingelheim, Germa-
with a long traditions and a wealth
internationally as one of the top 20
have been successfully resolved.
ny into the United States”.
of experience lapses and slips occur,
leading pharmaceutical companies
as happens at Boehringer Ingelheim.
and of all companies, this industry gi-
What had happened? Inspectors of
Dr. Gerhard Köller, Director of Global
»After receiving the Warning Letter, we have optimized our quality system and this not only at our Ingelheim location but worldwide.« Dr. Gerhard Köller,
The chemical company founded by
ant hasn’t passed an FDA inspection,
the US Food and Drug Administra-
Quality Management at Boehringer
Head of Global Quality Management Boehringer Ingelheim
Albert Boehringer in 1885 is today
although 22 preceding tests within the
tion (FDA) had complained about
Ingelheim clearly states: “The FDA
the largest pharmaceutical/research
last five years carried out by various
the quality assurance of production
has found fault in the manner and
refusing admission of articles manufactured at Boehringer-Ingelheim
CLEANROOM MAGAZINE 4/2016 | FDA Regulations for Europeans
FDA Regulations for Europeans | CLEANROOM MAGAZINE 4/2016
47
46 detailed enough, something like
only possible, but also desired,
is little accommodation“, knows
mumbo jumbo. Furthermore, the
reports Dietmar Gross. Inquiries
this professional from experience.
word “should” often is stands in the
per email as a rule will always be
This is why he advises: “When you
regulations which cause additional
answered. Direct calling would
However, inspections are not avoid-
have anything to do with cGMP,
difficulties in interpretation. “Don’t
offer more flexibility. “In direct
able. The FDA cannot of course be
always think universalistically!”
try to understand FDA documents
contact, useful tips and sugges-
simultaneously everywhere, but it
with your EU GMP thinking, this
tions are often received regarding
sends its inspectors above all to those
A good overview of the require-
will only fog up your perceptions
intentions and applicability of reg-
places where it sees a particular
ments for cleanroom operators
and lead to false interpretations”,
ulatory text. An enquirer can often
risk. The FDA comes to inspections
which want to export pharmaceu-
warns Gross. “Read the text without
find out about documentation or
at companies with detailed compli-
tical products, cosmetics, medical
ance and inspection manuals. These
devices, food products, bio-technol-
manuals are publicly accessible on
ogy products and so on into the USA
the FDA website. On inspection day,
is offered by the website www.fda.
SERVICE
The FDA arrives at companies with detailed manuals
survive the FDA inspections. “There
gov. It provides a real treasure trove of guidelines for everyone who has to deal with FDA regulations.
Uncertainty in the inter pretation of FDA regualtions
»Don’t try to understand FDA documents with your EU GMP thinking, this will only fog up your perceptions and lead to false interpretations.« Dietmar Gross, Senior Consultant GMP-Experts GmbH
management should have ready the current organizational charts, supplier agreements, monitoring schedules and reports, qualification and training documentation as well as SOP’s with references to the reasons for inspection. An FDA inspection concentrates
In many European companies,
itself on six systems which are
there is a great deal of uncertainty
required for the manufacture and
Important FDA regulations for Europeans Code of Federal Regulations The Code of Federal Regulations (CFR) ia a kind of collection of federal guidelines. It contains administrative regulations issued from the US governmental authorities and is divided into 50 so-called titles. The CFR Title 21 “Food and Drugs” forms the basis of all US GMP rules which apply to FDA regulated products. It contains in addition to cGMP for pharmaceutical products, also rules for food, medical devices and so on. Guidance for Industry The Guidance for Industry document contains current FDA considerations concerning particular topics. They outline practical interpretations of regulatory requirements. The FDA allows the use of alternative approaches when these fulfill the requirements of current laws and regulations. Compliance Manuals and Inspection Guides The FDA inspectors have at their disposal detailed compliance and inspections guidelines which are publically accessible at www.fda.gov. The manuals are extremely detailed for every system inspected. Therefore they serve as excellent reference material for self-inspections.
in how to interpret FDA regula-
thinking of the EU GMP terminolo-
sections of text which were com-
monitoring of products: The quality
quality systems is always inspected
cases resort to measures that you on-
tions. Negative experience with
gy and pay attention to the context.
pletely unknown or overlooked”,
system, the system for rooms and
and at least one other system. The
ly think will solve the problem. You
inspections is able to strengthen
Find out what the writer wants to
says Gross. The FDA also offers
equipment, the material system, the
FDA is very rigorous in the process:
have to take on measures which you
these uncertainties. Consultant Di-
say and not what you want to read
help to small and middle sized
production systems, the packaging
If they find an error in one system,
are sure will remediate the error.”
etmar Gross is acquainted with the
into it.”
companies. Companies have to
system and the laboratory control
then for them all of the systems are
worries of management personnel.
If a person is doubtful whether he
break away from false thinking
system. During a “Full Inspection” at
out of control because they are all
Management complaints often
has correctly interpreted the US
that the FDA should in no wise be
least four of the six systems will be
sequentially configured. “The FDA
express that the regulations are too
regulations, he can get in direct
contacted which could bring in
inspected, during an “Abbreviated
can be painful”, confirms Dietmar
old, are inexactly defined, are not
contact with the FDA which is not
any unnecessary inspections.
Inspection” at least two systems. The
Gross. “You should never, in such
It’s not about quick, but the correct answers Dr. Godehard Kraemer has already had four experiences with US FDA inspections. He is a pharmacist and specialist at Glatt GmbH in Binzen, Baden-Württemberg, Germany. The company is the market leader in Life-Science facility construction for the refinement and processing of solid pharmaceutical products. Furthermore Glatt develops and produces in the business sector of pharmaceutical services solid pharmaceutical products for customer orders especially using in-house technologies above all for customers within the EU and in the USA. Separate production lines for the
Lipstick production: Left is the agitator of the melting machine, right is the end product. Many international cosmetic companies produce in Europe. However, regardless of how clean the processing procedures are, before the products are allowed to be shipped to the USA, the FDA authorities check how exactly the US regulations are being complied to.
CLEANROOM MAGAZINE 4/2016 | FDA Regulations for Europeans
Photos: Roberta Valerio; FDA/ Michael J. Ermarth
European market and the US market provide Kraemer with an overview
FDA Regulations for Europeans | CLEANROOM MAGAZINE 4/2016
SERVICE
48 of the respective applicable GMP
“Try not to obviously hide short-
you in his eyes have no idea about
regulations for both regions howev-
comings and deficiencies from
the standards.” One more thing
er he doesn’t hold this as necessary.
the inspectors. Always answer
Gross takes to heart concerning
Facing an upcoming FDA inspec-
truthfully”, are his most important
German pharmaceutical compa-
tion he said: “From the experience
recommendations. The reason:
nies: “Be careful when during an
of previous successfully passed
The FDA inspectors have gone
inspection you talk about some-
inspections, one is more relaxed,
through in part an FBI supported
thing with your colleagues. You
adept and quicker when answering
training program so that they are
can never know if the US inspectors
questions. However it isn’t about
able to recognize when someone
understand German.”
how quickly the answers are given
is hiding something. Furthermore
but above all about the correctness
Gross advises a certain reservation:
In a nutshell, with appropriate
of content and the sureness in how
“Don’t blabber out everything and
preparation for the demands and
the answers are given. Therefore
anything. Answer only what has
expectations of the FDA inspectors,
the person answering the questions
been asked and only show what has
the knowledge of the still-to-
should be the one who has the most
been demanded.”It should also be
be ironed out weak points and
competence.”
avoided discussing with the inspec-
professional conduct during the
tors about the meaningfulness or
inspection nothing should stand in
For the correct conduct during
interpretability of regulations. “Be
the way of successfully exporting
an FDA inspection, GMP Experts
careful with statements such as: I
into the USA.
consultant Dietmar Gross a few
see that differently. The inspector
additional suggestions at hand.
could construe this to mean that
Author: Frank Baecke
49
New Reference Books on the Market The Cleanroom Magazin editorial staff regularly scans publishers’ new arrivals for cleanroom industry relevance. These book – freshly published – we would like to present them to you. Pharmaceutical water systems economically operated You learn in this book which details and approaches you need to consider in the operation and monitoring of ultra pure water facilities. Included in these considerations are the instructions for work and sampling procedures, the determination of warning and alarm limits as well as how to deal with injuries. In addition to water monitoring procedures, troubleshooting procedures are described in detail. You receive suggestions and support in quickly finding causes for errors. Three different examples are given for calculating operating costs for water preparation systems in laboratories and pharmaceutical production facilities. Furthermore you receive extensive information on reducing costs, maintenance and service and calibration. Additional subject matter cited in the book includes the fundamental requirements for pharmaceuticals producers which also have to be considered by external partners. Numerous tips in how to prepare for GMP inspections and audits of ultra pure water
How to get a Warning Letter repealed Interview with Dr. Gerhard Köller, Director Global Quality Management at Boehringer Ingelheim.
The FDA issued your company a Warn-
What does this mean? We set up a new
ing Letter in 2013. Where was fault
organization which analyzed needs
found? The inspectors monitored the
for improvement – not only in the
procedures in manufacturing process-
processes criticized but in all processes.
es. It dealt not at all with the suitability
Procedures and processes were opti-
of our products or product recalls.
mized, achievements monitored over
systems round out the topics covered. “Pharmawasser-Systeme wirtschaftlich betreiben – Reinstwasser für Herstellung und Labor” (Pharmaceutical Water Systems economically operated – Ultra Pure Water for Production and Laboratories), Fritz Röder, Maas & Peither AG GMP-Publisher, First edition 2016, 78 pages, Hardcover. ISBN: 978-3-95807-037-0. Price: 63.13 Euros
time and then this knowledge passed What happened after receiving the
on to all locations.
Warning Letter? The inspectors only say what they find fault with, not how
And how were you able to get the
to solve the problem. There is also no
Warning Letter repealed? We informed
only had undertaken improvements
time limit or deadline for this. One
the authorities that the follow-up
point by point but company-wide, the
simply lets the FDA know when the
inspection could be carried out. The
inspections proceeded successfully and
situation has been corrected. We took
inspectors came and looked at not
the FDA repealed the Warning Letter in
the Warning Letter as an occasion
only the things which they previously
the middle of 2014.
to start a global quality-culture
found fault with but at everything
initiative.
else they wanted to inspect. As we not
CLEANROOM MAGAZINE 4/2016 | FDA Regulations for Europeans
Author: Frank Baecke
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
FDA Regulations for Europeans | CLEANROOM MAGAZINE 4/2016
50
Cleanzone draws in international market leaders
SCIENCESERVICE & TECHNOLOGY
Life-sciences, micro-technology and technical cleanliness are in focus.
Photo: Messe Frankfurt Exhibition GmbH, Sandra Gätke
51 Interdisciplinary approach distinguishes Cleanzone
cover the entire cleanroom like
the areas of AMC, cleaning and
cycle. Respectively large is not only
cleanroom construction.”
the range of producers, but also Cleanzone as an interdisciplinary
the number of industry affiliations
The syndicate Pharmabau 3000
platform brings since its debut in
and associations exhibiting at
(VIP3000) is once again exhibiting
2012, all high-tech industries which
Cleanzone.
at the trade fair in a joint/common
produce in cleanrooms together.
stand. Vice President Rino Woyczyk
The trade fair shows solutions for
has pronounce: “As last year, around
clean production environments which are free from the smallest
Several and multiple industry affiliations will be present
15 members of VIP3000 will be present on Cleanzone’s premises.” This
particles and germs. Many high-
will assure that every visitor will
tech products such as mobile
Belonging to the latter is the com-
find someone from the applicable
telephones, computers, solar cells,
pany cleanroom.de. This company
supplier or consultancy sector to
LED’s, displays, lithium ion batter-
offers primarily micro-technology
answer questions about his plant or
ies, bio-technolgical pharmaceu-
solutions and is exhibiting for
property, his process technology or
tical products, medical-technical
the first time this year together
his facility-technical components.
products and highly-sensitive food
with five partner companies at a
Also once again on hand in Frank-
products are produced in today’s
common stand. Markus Thamm
furt will be the company Cleaning
cleanrooms. Therefore the trade
of cleanroom.de GmbH explains:
Excellence Center Leonberg in a
fair’s product spectrum ranges
“With our partner companies we
joint/common stand ready to give
from equipment for sterile rooms to
will be demonstrating various
out information on all aspects of
products for ISO Class 1 cleanrooms.
fields of cleanroom technology in
technical cleanliness.
However this is not everything.
individual events and informing
Whether the interest is in planning,
customers about the possibilities
layout, construction, qualifying, or
of how to solve their specific chal-
operations, Cleanzone’s offerings
lenges, dealing principally with
Cleanroom clothing is an indispensable requirement for
Users and providers of cleanroom technology in
Airborne germ collector for the micro-biological
working in controlled environments. An overview of what
discussion: Many Cleanzone exhibitors see the quality
monitoring of the air in cleanrooms and sterile rooms
is currently on the market can be found by cleanroom
of contact between visitors and exhibitors as very high.
belongs to Cleanzone’s regular repertoire which among
operators at Cleanzone.
A further plus of Cleanzone is its internationality.
its many other topics will focus this year on Life Sciences.
From the 8th to the 9th, November, 2016 Cleanzone will once again be opening its gates in Frankfurt am Main. This young trade fair has established itself as an international industry venue, at which manufacturers and users of cleanroom technology come to exchange and compare their experience with the newest trends. Among one of the highlights is the awarding of the Cleanroom Award and the Creative Prize.
More and more market leading companies are using Cleanzone as an attractive platform.
Cleanzone 2016 is moving forward
Thorsten Schmitt of Business De-
on its path of growth. Many inter-
velopment Life Science Germany
national market leaders will be
of Siemens Division Building
present on November 8th and 9th,
Technologies says: “Buildings and
2016 in Frankfurt at Cleanzone, the
the infrastructure in the life science
Once again represented among the
International Trade Fair and Con-
industry have to fulfill specialized
market leaders at Cleanzone will
gress for Cleanroom Technology.
requirements.” This is why Clean-
be AAF, Basan, Contec, Daldrop +
Among the companies attending
zone at which the Siemens Division
Dr. Ing. Huber, Decontam, Drees +
are Aeropur, Alsco, APSystems,
will be taking part in for the first
Sommer, Gerflor, Kemmlit, Nitri-
Block, Clear & Clean, Dastex Rein-
time, is an “attractive platform to
tex, Particle Measureing Systems,
raumzubehör (Cleanroom Supplies
present our extensive portfolio as
profi-con and Weiss Klimatechnik.
and Accessories), Mann + Hummel,
well as our specific know-how to
Siemens Building Technologies and
industry professionals and decision
Skeratschoppe.
makers.”
CLEANROOM MAGAZINE 4/2016 | Cleanzone 2016
Cleanzone 2016 | CLEANROOM MAGAZINE 4/2016
53
SCIENCESERVICE & TECHNOLOGY
Graphics:: Messe Frankfurt Exhibition GmbH
52
Schematic representation of a cleanroom: Users will find all the components on the Cleanzone.
discussion and directly amidst
will be acting this year as the trade
Wolfgang Marzin, Managing Chair-
Cleanzone’s events will be awarding
fair’s patron. “I have gladly taken on
man of the Messe Frankfurt says,
its Bachelor and Master graduate
the patronage for Cleanzone 2016.
“Because the Hessian Ministry for
certificates.
Cleanrooms play substantial roles
Science and Art will be Cleanzone’s
especially for Hessen as a location
acting patron, this will strengthen
for research and production in the
and underline the importance of
fields of pharmaceuticals, optics,
the trade fair as a platform of ex-
aerospace, micro and nano-technol-
change for research, development,
ogy, university hospitals, medical
production and implementation.
technology and food product tech-
Cleanzone will obtain valuable
For the first time, the Hessian Min-
nology”, says Rhein, explaining his
momentum as a result of this in-
ister of Science and Art, Boris Rhein,
involvement.
volvement.”
For the first time, the trade fair will be under the patronage of a Hessian Minister Congress, Plaza and Award add to Cleanzone’s highlights
these awards pioneering cleanroom
ergonomically. The Creative Prize
technology innovations. A jury
goes to the company which is able
comprised of industry professionals
to promote employee motivation
Alongside the trade fair, the Clean-
chooses in advance five finalists
and productivity through design,
room Congress will be concurrently
out of all the applicants. These
color, and ergonomics integrated
taking place where excellent op-
finalists present their innovative,
into the cleanroom. The solutions
portunities present themselves in
sustainable and energy efficiency
should provide a creative alternative
which to deepen one’s knowledge in
ideas pertaining to cleanrooms in
to the conventional “white noise” in
cleanroom topics. Further current
front of Cleanzone’s diversified
cleanrooms.
industry topics can be discussed in
and wide-ranging audience. The
All previous winners as well as
the Cleanzone Plaza located directly
trade fair’s audience decides who
information on how to apply for the
in the middle of all of Cleanzone’s
wins by means of a secret ballot.
Cleanroom Award and the Creative
events with its highly rated podium
The winner receives along with the
Prize can be found on the website
participants.
award €3,000 in prize money from
www.cleanroom-award.com.
Contamination Control
Our expertise in ISO and GMP:
CLEANROOM CLEANING clean 08. +
the ReinraumAkademie. Belonging to Cleanzone’s highlights
Since 2015, the ReinraumAkademie
An additional highlight is being
is the awarding of the Cleanroom
additionally awards the Creative
planned by the Mentoring Program
Awards. Every year, the Reinrau-
Prize for the most creatively de-
of the German Cleanroom Insti-
mAkademie distinguishes with
signed cleanroom both optically and
tute. It will be hosting a podium
CLEANROOM MAGAZINE 4/2016 | Cleanzone 2016
Messe www.profi-con.com
zone
09.11
.2016
Frankf
Hall 4 Booth .0 A30
urt
Cleanzone 2016 | CLEANROOM MAGAZINE 4/2016
55
54 International contributors will be speaking over the fundamentals and trends in cleanroom technology at the Cleanzone Congress from the 8th to the 9th, November, 2016. Particularly attractive will be its modular setup allowing visitors to put together their own individual program participation and conveniently combine this with a visit to the Cleanzone Trade Fair.
take into consideration all aspects of production in cleanrooms from construction to operation. Therefore participants will be able to comprehensively find out about all the latest trends regarding cleanrooms. I am especially pleased that we have been successful in once again bringing in international speakers as well as renowned industry experts.” The module, „Starting Up with Cleanroom Technology“ provides a look into the various aspects
SERVICE
of production under controlled conditions. This ranges from
Tomorrow’s Trends
standardization and setting norms
cleanrooms. In their presentation at
field is Professor Hans-Hermann
to the selection of materials on up
the Cleanzone Congress, they will be
Dirksen, Attorney at Law at Lieben-
to work behavior in cleanrooms and
putting the question to the audience
stein Law. “An increasing amount of
cleanroom cleaning. Frans Saurwalt,
to what extent processes from the
Industry 4.0 technology is making
Technical Manager at Kropman
automobile industry can be carried
independent, autonomous decisions,
Contamination Control is one of
over to cleanroom production.
without any human intervention”
the speakers participating in the
emphasizes Dirksen. This is why the
Congress. He will be speaking about
question comes up of where to place
requirements for walls, floors and ceilings. As Saurwalt participates in setting international standards
Industry 4.0 poses questions of liability – the Congress will give answers
the responsibility. Who carries the liability for errors and losses, who for the products? “My presentation will show that the liability risks for
in cleanroom, Congress visitors
The entire spectrum of cleanroom technology presented at the Cleanzone Congress
Speaker at the Cleanzone 2015. Photos: Messe Frankfurt Exhibition GmbH, Sandra Gätke
will learn about the most current
The module “Planning, Layout,
self-contained user systems have to
developments in norms and process
Construction” dedicates itself to a
be governed above all by contractual,
optimization in cleanrooms.
complex of topics, “How should a
stipulated participant conditions
cleanroom be planned so that it opti-
for the operators of such systems in
Michael Skerat, Managing Director
mally fulfills all requirements?” Very
order to narrow down the scope of
of Skeratschoppe GmbH and Lukas
current is for example the question
the liability.”
Schober, Managing Director of
of how to deal with the liability when
Kalucon GmbH will be speaking
using intelligent and autonomous
A further significant topic in the
about potentials in economizing in
technical systems. An expert in this
module “Planning, Layout, Construction” is the draft of Norm E
Congress program encompasses all aspects of clean production
The Cleanzone Congress with its
Area Manager for Technology &
cast of high-caliber cleanroom
Production at the Messe Frankfurt
professionals, will be organized
says, “The production demands
into four modules, “Fundamen-
in cleanrooms constantly change,
tals of Cleanroom Technology”,
for example with new norms and
The program was developed by
“Planning, Layout, Construction”,
guidelines. The Congress running
the ReinraumAkademie and an
“ Q u a l i f i c a t i o n” a n d “M o d e r n
parallel with the Trade Fair pro-
international congress jury in
Cleanroom Production and Opti-
vides an excellent opportunity
co-operation with the Messe Frank-
mization in running Operations”.
for learning about all the newest
furt. Regarding the concept of this
By implementing this arrangement
changes and innovations taking
year’s Cleanzone Congress Frank
at the two-day event, all aspects of
place pertaining to cleanrooms.”
Duvernell, Managing Director of
production under controlled condi-
the ReinraumAkademie says: “We
tions will be covered. Ruth Lorenz,
have put particular emphasis to
CLEANROOM MAGAZINE 4/2016 | Cleanzone 2016
DIN 1946-4:2016-06 for room-air
»The Congress running parallel with the Trade Fair provides an excellent opportunity for learning about all the newest changes and innovations pertaining to cleanrooms.« Ruth Lorenz, Messe Frankfurt
technical equipment in buildings and rooms dealing with health care. Detailed information on this topic will be presented by Ralph Langholz, Area Manager at Mann + Hummel Vokes Air.
Why documentation is not just annoying, but also helpful After the planning and construction have been completed, a cleanroom
Cleanzone 2016 | CLEANROOM MAGAZINE 4/2016
57
SCIENCESERVICE & TECHNOLOGY
56 then has to be qualified. Dealing with
Optimization in Running Oper-
Whether 100 micro-meters or 100
this topic is the Congress module
ations”, the topics deal with the
nano-meters: The particles which
“Qualification”. How to deal with
requirements for tomorrow’s clean-
are considered in production under
crises both during the planning as
rooms and the resulting changes
controlled conditions vary in size
well as during the finalization stages
in standards. Reporting on the
round the factor of 1,000 or more.
will be reported on by Rino Woyczyk,
current revisions to the Norm ISO/
The structures are increasingly
Head of the Life Science Division at
TC 209 “Cleanrooms and associated
becoming smaller as well. The re-
Drees & Sommer and Vice President
controlled environments” will be
sulting requirements for measuring
of syndicate Pharmabau 3000. That
Dr. Berthold Düthorn, Department
strategies will be explained by Dr.
documentation also belongs to
Manager Packaging Technology
Udo Gommel of the Fraunhofer
qualification will be lectured on by
Divisio of Robert Bosch GmbH.
IPA. To conclude the Cleanzone
Claudia Pachl, Managing Director of
Düthorn is the Chairman in several
Congress, Josef Ortner, Managing
Valtec GmbH: “I will expound on why
and various ISO/TC 209 work groups.
Director of Ortner Reinraumtech-
documentation is not just annoying, but by all means can be helpful and beneficial as well as how qualification efforts can be more efficiently organized by utilizing the appropriate
nik GmbH will be speaking on the future requirements for working
Future cleanrooms need new standards and measuring strategies
in cleanrooms. The Congress will concurrently take
documentation.”
Impression from Cleanzone Congress, 2015.
place with the trade fair Cleanzone Not only the standards but also
from the 8th to the 9th, November,
In the fourth module, “Modern
measuring strategies have to satisfy
2016 in the foyer of fairground hall
Cleanroom Production and
new requirements in the future.
4.0 in the Europa Hall.
Photo: Messe Frankfurt Exhibition GmbH, Sandra Gätke
Cleanzone Congress Program on 8th and 9th, November, 2016 08.11.2016 - Module “Fundamentals of Cleanroom Technology” 10.00 – 10.25: Norms and Guidelines – an Overview. Dr. Lothar Gail 10.30 – 10.55: Orientation and Initial Qualification: Floors, Walls, Ceilings. Frans Saurwalt 11.00 – 11.25: Logistics – in the Supply Chain of Clean Rooms: Processes, Data Flow, Information Flow, Material Flow. Michael Skerat, Lukas Schober 11.30 – 11.55: Behavior Requirements in Cleanrooms. Frank Duvernell 12.00 – 12.30: The Optimal Cleanroom Towel – a difficult Choice. Stefan Haupt 08.11. 2016 - Module “Planning, Layout, Construction” 14.00 – 14.35: From the Idea to the finished Cleanroom: Key Factors of Professional Planning Management. Florian Dittel 14.40 – 15.15: Cleanroom Design and Construction
CLEANROOM MAGAZINE 4/2016 | Cleanzone 2016
Requirements. Connor Murray 15.20 – 15.55: Industry 4.0: Intelligent Cleanrooms – Intelligent Liability? Prof. Hans-Hermann Dirksen 16.00 – 16.30: Which Changes is the new draft of E DIN 19464:2016-06 „Room-Air Technical Equipment in Buildings and Rooms dealing with Health Care“ bringing to Hospitals? Ralph Langholu 09.11.2016 – Module “Qualification” 09.30 – 10.05: Active Handling of Crises in the Planning and upon Completion. Rino Woyczyk 10.10 – 10.45: Improved Qualification with Optimal Documentation. Claudia Pachl 10.50 – 11.25: Practice Example: Facility Qualification with Medical Equipment. Alexander Mayr 11.30 – 12.00: Opportunities through Monitoring Systems. Michael Müller
09.11.2016 – Module “Modern Cleanroom Production and Optimization in Running Operations” 13:00 - 13:40: ISO TC 209 “Cleanrooms and associated controlled environment” – Current Revisions of the Norm and Prospects. Dr. Berthold Düthorn 13.40 – 14.15: From Nano to Macro: Cleanliness-Technical Challenges for Modern Measuring Strategies. Dr. Udo Gommel 14.20 – 14.55: Planning and Operations of Energy Efficient Cleanrooms. Dirk Steil 15.00 – 15.30: Concluding Considerations: Future Requirements for Working in Cleanrooms. Josef Ortner
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Cleanzone 2016 | CLEANROOM MAGAZINE 4/2016
58
Trade Fairs and Congresses
Events at the ReinraumAkademie (Germany) and the CleanroomAcademy (Switzerland)
07.-09.11.2016 World Pharma Congress Las Vegas - USA
SERVICE
Graphic: Fotolia
CLEANROOM EXPERT DAYS
14. -17.11.2016 Medica und Compamed Düsseldorf Germany
16.-18.05.2017 Biotechnica Hannover Germany
08.-09.11.2016 Cleanzone Frankfurt am Main Germany
28.-29.03.2017 Pharma Kongress Düsseldorf Germany
Hannover Leipzig
Düsseldorf
Bonn
31.03.-01.04.2017 Interpharm Bonn Germany
Frankfurt am Main Prague
Germany Stuttgart
25.-27.10.2016 Semicon Europa Grenoble France
Wangen an der Aare
Switzerland
23.-24.03.2017 ICCCS 2017 Prague Czech Republic 04.-06.04.2017 Medtec Europe Stuttgart Germany
Grenoble
2 5 – 2 7 O C T 2 01 6 ALPEXPO G R E N O B L E , F RA N C E
SEMICON is the premier European showcase for business and exploration in areas like MedTech, MEMS, Electronics for Automotive, Imaging, SMART Manufacturing, Advanced Materials, Photonics, Lithography, and more. Register now! More Moreinformation informationat: at: www.semiconeuropa www.semiconeuropa.com .org
CLEANROOM MAGAZINE 4/2016 | Trade Fairs and Congresses
23.-24.11.2016 | Optimal Cleanroom Personnel | Leipzig (Germany) 07.-08.12.2016 | Optimization and Qualification in Cleanroom Operations | Wangen an der Aare (Switzerland) 25.-26.01.2017 | Cleanrooms: New Construction and Expansions | Leipzig (Germany) 08.02.2017 | Cleanrooms and Hospitals, same topic, two worlds | Wangen an der Aare (Switzerland) 09.02.2017 | Cleanrooms: Qualification and Re-qualification | Wangen an der Aare (Switzerland) 15.-16.03.2017 | Modern Cleanroom Technology (Planning, Layout, Construction) | Leipzig (Germany) 05.-06.04.2017 | Cleanrooms, Cleaning and Training | Wangen an der Aare (Switzerland) 16.-17.05.2017 | Cleanrooms: Maintenance, Servicing and Cleaning | Leipzig (Germany) 20.06.2017 | Cleanrooms and Food Products | Wangen an der Aare (Switzerland) 21.06.2017 | Cleanrooms and Packaging | Wangen an der Aare (Switzerland) 20.-21.09.2017 | Optimal Personnel in Cleanrooms | Leipzig (Germany) 10.-11.10.2017 | Cleanrooms: New Construction and Expansions | Wangen an der Aare (Switzerland) 21.-22.11.2017 | Digitization in Cleanrooms | Leipzig (Germany)
ONE-DAY TRAINING 21.03.2017 | Conduct and Procedures in Cleanrooms | Leipzig (Germany) 22.03.2017 | Professional Cleanroom Cleaning | Leipzig (Germany) 22.06.2017 | Conduct and Procedures in Cleanrooms | Wangen an der Aare (Switzerland) 23.06.2017 | Professional Cleanroom Cleaning | Wangen an der Aare (Switzerland) 23.11.2017 | Conduct and Procedures in Cleanrooms | Leipzig (Germany) 24.11.2017 | Professional Cleanroom Cleaning | Leipzig (Germany)
ADDITIONAL EVENTS 25.01.2017 | International New Year’s Reception for the Cleanroom Industry | Leipzig (Germany) 08.02.2017 | New Year’s Apėro for the Cleanroom Industry | Wangen an der Aare (Switzerland)
The events takes place at: Cleanroom Experience Competence Center Rosa-Luxemburg-Str. 12-14, D-04103 Leipzig Tel.: +49 341 98 989-0 Fax: +49 341 98 989-200 info@reinraum-akademie.de www.reinraum-akademie.de
Cleanroom Experience Competence Center Vorstadt 4, CH-3380 Wangen an der Aare Tel.: +41 326 316 050 Fax: +41 326 316 059 info@cleanroom-academy.com www.cleanroom-academy.ch Trade Fairs and Congresses | CLEANROOM MAGAZINE 4/2016
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So sieht der Chirurgen-Arbeitsplatz der nächsten Generation aus
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So nehmen Pollen und Luftfeuchtigkeit Einfluss auf Ihre Produktion
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0 3 | S OMME R 2 015
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Reinraum-Kunst nach ISO 5
Smarte Implantate können dem Menschen smarte neue Fähigkeiten verleihen.
Diese Chips gehen unter die Haut
Life & Science Information for Cleanroom Technology
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summer 2016
Life & Science Information for Cleanroom Technology
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autumn 2016
Life & Science Information for Cleanroom Technology
Gibt es Leben im All? Das ist nur mit Hilfe von Reinraumtechnik herauszufinden. Im Oktober 2016 landet Schiaparelli auf dem Mars.
02
spring 2016
Nanopartikel stecken in Kosmetika und vielen Alltagsprodukten. Wie gefährlich sind sie?
Sommer, Strand & Sonnencreme
Aus dem Reinraum in den Weltraum
10.03.16 16:57
07.12.15 16:38
Cleanroom Award und Creative Prize 2016
Never stop thinking
Was hat der Kinderwunsch mit Reinräumen zu tun?
Das bringt die Neufassung der Norm ISO 14644-1 und 14644-2
Recht und Regularien
Künstliche Befruchtung
Wie Mitarbeiter zu Reinraummitarbeitern werden
Damit kein Funke überspringt — sensible Produkte schützen
Talententwicklung
Hochspannung im Reinraum
So schätzen Experten die Aussichten der Reinraumbranche ein
Der 3D-Druck eröffnet dem Reinraum neue Perspektiven
Vorstoß in die dritte Dimension 3D printing is opening new perspectives for cleanrooms
High Voltage in the Cleanroom
Outlook 2016
Experts estimate future prospects in the cleanroom industry
I d
02
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Winter
01
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03
CLEANROOM
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Frühjahr
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EDITION 2/2016
Cleanroom Award & Creative Prize 2016
Cleanroom Art as per ISO 5
In 2005, artists built a cleanroom and since this time it has never been used.
04
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Executive Management Frank Duvernell, V.i.S.d.P.
2016
Internet www.cleanroom-media.com
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CLEANROOM
EDITION 1/2016
Never stop thinking
2016
How does the desire to have childten correlate with cleanrooms?
Newest revisions of ISO 14644-1 and ISO 14644-2
Herbst
Laws & Regulations
Cleanzone 2015 This international cleanroom trade fair gives momentum and impulse to the cleanroom industry
These Chips get under your Skin
Intelligent implants are able to provide people with new, clever capabilities.
EDITION 3/2016
Authors Frank Baecke Frank Duvernell Daniel Piper Alexander Scheibe
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Is there life in outer space? This can only be found out with technology made in cleanrooms. In light of this, a space craft has recently landed on Mars.
Nano-particles are found in cosmetics and many other everyday products. Just how dangerous are they?
In-Vitro-Fertilisation
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How employees become cleanroom operatives
From Cleanroom into Outer Space
Summer, Beach and Suncream
Throw out the sparks and protect sensitive products
Talent Development
Germs in Food Products How cleanroom technology aids in killing off dangerous food product germs
Life & Science Informationen für die Reinraumtechnologie
Keim Wie d Leben
Thanks to the tiny components produced in cleanrooms, billions of devices are able to communicate with each other
CLEANROOM
Clean Die in zum I Wenn winzi mitei
Ausblick 2016
Approaching the Dimension
The Internet of Things
EDITION 4/2015
Intelligent fabric changes medicine, architecture, fashion and the car industry
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Wer FDA-konform produzieren will, darf nicht mit EU-GMP-Denken an die Texte herangehen.
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Smart Textiles
EDITION 3/2015 03
Computer in Reinräumen
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Moderne Lösungen ersparen aufwändige Verkapselungen und Einbauten.
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Cleanroom Award – Advancement for the Cleanroom
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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
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Using Computers in Cleanrooms The Challenges of FDA Regulations Modern solutions make costly encapsulation and built-ins unnecessary.
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