Cleanroom Magazine 04-2016

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

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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.

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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

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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.

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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.

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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?

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26 Insights: On the

road with Jürgen Lederer Jürgen Lederer, Key Account Manager CE for the field Cleanroom at Vileda Professional.

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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.

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42 What do you do there, … ?

Samuel Pinto, Plastics Processing Technician/Mechanic at Ernst Rittinghaus GmbH in Halver, Germany.

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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.

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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.

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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.

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48 Professional/Reference Literature: Cleanroom Knowledge to refer to

economically operated - Purest water for manufacturing and the laboratory.

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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.

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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.

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58 Trade Fairs and Events

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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.

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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

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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

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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

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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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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

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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

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Sterile technology –

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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

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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

Operationssaal der Zukunft

Regularien Lästige Pflicht oder geldwerte Tipps?

OLEDs Die Lichtrevolution aus dem Reinraum Krankenhauskeime Wie Raumtechnologien Infektionen verhindern

summer 2015 C LEANROOM MAGAZI N

Mitdenkende Stoffe verändern Medizin, Architektur, Mode und Autoindustrie

Smarte Textilien

Wie die Vision vom autonomen Fahren mit Produkten aus dem Reinraum Wirklichkeit wird

Freude am Gefahrenwerden

So nehmen Pollen und Luftfeuchtigkeit Einfluss auf Ihre Produktion

Blühende Natur Gefährliche Kontamination

Cleanzone Die Reinraumwelt trifft sich in Frankfurt / The World of cleanroom meets in Frankfurt

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spring 2015

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0 3 | S OMME R 2 015

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Barbara Kanegsberg Das Produkt steht im Mittelpunkt / The focus on the product

Life & Science Informationen für die Reinraumtechnologie

Frühjahr 2015

02

Operating Theatre This is what the surgery workstation of the future looks like

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Mit welchem Blick sehen Künstler Reinräume? Als partikelfreies Kunstprojekt.

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

CLEANROOM MAGAZINE

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

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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.

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2016

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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

MAGAZIN

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

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Computer in Reinräumen

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Moderne Lösungen ersparen aufwändige Verkapselungen und Einbauten.

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How the vision of autonomous driving is gradually becoming a reality

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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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The influence of pollen and air humidity on your production

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Joy of Being Driven

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