Cleanroom Magazine 03-2016

CLEANROOM MAGAZINE

03

summer 2016

Life & Science Information for Cleanroom Technology

Summer, Beach and Suncream Nano-particles are found in cosmetics and many other everyday products. Just how dangerous are they?

Cleanroom Art as per ISO 5

In 2005, artists built a cleanroom and since this time it has never been used.

These Chips get under your Skin

Intelligent implants are able to provide people with new, clever capabilities.

Register now!

3

Dear Readers!

The cleanroom industry is becoming more and more international.

Indonesia, for example, have convinced me of this. They showed that cleanroom technology is gaining worldwide importance in ever more markets and industrial sectors.

Accordingly, cleanrooms have to become more flexible in order to adapt to the new applications. Our contribution on page 38 shows which developments will be shaping the industry in the coming decades.

With the spread of cleanroom technology, the user's need for knowledge and know-how is also increasing. With more knowledge about cleanroom technology, the user will be more adept at discussing individual needs in line with his/her actual cleanroom requirements. In the enclosed Visitor satisfaction Assessment of visitor quality Visitor satisfaction Assessment visitortoquality “Reinraum Journal” you can learn about what is necessary observe in byofexhibitors by exhibitors 9 5 cleanroom planning, operations and personnel qualification.

9

Frank Duvernell: »I am totally convinced that Cleanzone will keep growing as various industries are able to meet here. The event

Visitor satisfaction Visitor satisfaction 9

in cleanrooms is a global future topic which

32 countries. They were very satisfied with the trade fair’s offerings. The exhibitors also expressed their satisfaction with the quality of visitors. Source: Messe Frankfurt GmbH.

12

64

64

27 Very satisfied 27 Very satisfied 64 Satisfied 64 Satisfied 9 Less satisfied 9 Less satisfied What about thinking

12

26

64

57

26

26

5

12

26 57

27 Very satisfied 27 Very satisfied 64 Satisfied 64 Satisfied 9 Less satisfied 9 Less satisfied

Grafics: Satisfaction at Cleanzone –

around 20 percent. Professionals came from

27 64

stretches across all industrial sectors.«

Visitors and Exhibitors

5

27

5

12

Assessment Assessment of visitor quality of visitor quality by exhibitors by exhibitors

9

shows that the production and manufacturing

Cleanzone 2015 closed with a visitor plus of

27

27

57

57

26 Very satisfied 26 Very satisfied 57 Satisfied 57 Satisfied 12 Less satisfied 12 Less satisfied5 No response 5 No response all figures in %

all figures in %

26 Very satisfied 26 Very satisfied

57 Satisfied 57 Satisfied of a cleanroom? We have done ahead of the concept 12 Less satisfied 12 Less satisfied

5 Noof response all figures in % Magazin, all figures in % No response some research. In this issue the5Cleanroom you will learn

among other things, what art has to do with cleanroom technology.

Creative ideas also stand in focus at Cleanzone. What I am highly curious about: What innovations and “attractive” cleanrooms will be presented?

Who will receive the Cleanroom Award and Creative Prize? Until August 31st you can apply for the awards (page 50). By the way, at the last Cleanzone, professionals from 32 countries made their way to the trade fair. As already mentioned, the cleanroom industry is becoming more international.

I wish you all the best while reading this issue.

Frank Duvervnell Editor

Editorial | CLEANROOM MAGAZINE 3/2016

EDITORIAL

My trade fair visits to Turkey as well as trips to Iran, South Africa and

4

CONTENTS 03/2016

CONTENTS

08

08 Cover Topic: Summer, Beach

and Sun cream – Nano-particles in everyday products

Nano-particles provide many products with formidable properties. At the same time the tiny particles are suspected of causing damage to people and the environment. The opinions concerning the risks are diametrically opposing.

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LIFE & BUSINESS New developments from the world of cleanrooms

06 Market Developments in brief • Display glass cover with built-in finger print sensor • Antennas against leukemia • Laser measures alcohol in the driver’s cabin of an automobile • The heart of medical technology will soon be beating in Nürnberg • Germs in a hospital quickly and reliably diagnosed • PC market at its lowest level since 2007 • World not prepared for Ebola, Yellow Fever and Zika Controversial: Nano-particles in everyday products. Photo: Nils Bröer

16

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16 Implantable chips

connect people and the internet

Saving passwords in the body, exchanging business cards with a handshake, opening doors without keys – intelligent chips under the skin make it all possible.

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22 Controversy: linked and

networked – the end of privacy?

Intelligent products generate more and more personal data. The National Security Officer of Microsoft Germany and a data protection campaigner from Digitalcourage e.V. offer their pros and cons on this digital networking.

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Getting under the skin: Injections for implanting intelligent chips. Photo: vetkit/Fotolia

CLEANROOM MAGAZINE 3/2016 | Contents

5

24 A portrait: Christine Schmidt

28

Working in a cleanroom requires disciplined compliance to the rules and clear communication. Horse training with Christine Schmidt makes learning this possible.

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28 A cleanroom in a garden’s summerhouse

Amidst Leipzig apple trees Swiss artists have carried out a particle-free art project. Their cleanroom has remained unopened in the summerhouse for ten years running.

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34 Insights: On the road with…

Art project: In this garden summer house, there is a cleanroom which hasn’t been used for ten years. Photo: Cleanroom Media

38

Heinz Martin Esser, Managing Director of Roth & Rau – Ortner GmbH in Dresden, Germany; serves also as the President of Silicon Saxony e. V., the most successful industry network in Europe.

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SCIENCE & TECHNOLOGY

Solutions for the world of cleanrooms

Four walls, a ceiling, floor: This principle is subject to negotiation for future cleanrooms. Photo: Montpellier

36 Technology in brief

45 What do you do there…?

• When medical devices communicate with each other in the OP • Sterilizing with LED light • Anti-microbial textiles against hospital infections • Automated cold sleep • New electric drive trains for the cleanroom • Up is now down: filter fan unit upside down • Dead-space lengthwise sight-glass seal

Rico Tengler, fitter and technician for the production processes for wezi-med, the medical-technical business sector of Weber GmbH & Co. KG in Dillenburg, Germany.

54 Suspiciously award-winning ideas wanted for the cleanroom

SERVICE

The ReinraumAkademie is searching for the best ideas in the innovation, sustainability and energy efficiency of cleanrooms. Application deadline is August 31, 2016.

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38 Modular, flexible and mobile

– the future of cleanrooms

Although the first cleanrooms date back 50 years, their development is still running at full speed. What trends will characterize the coming decades..

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42 Disinfectant cleaning –

does this even exist?

Cleaning and disinfecting are two different things. However when correctly combined both procedures could be in certain applications a logical and economical compromise.

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Events, Awards, regular columns

46 Laws and regulations:

Data integrity

Since 2014, the FDA has been putting particular attention on inspections of data integrity in pharmaceutical and active substance companies.

Manufacturers have to make sure that their data is available without any gaps and in original.

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50 Cleanzone 2016: See what

professionals will find everything that is needed for the planning, construction and maintenance of cleanrooms.

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56 Trade literature:

Cleanroom knowledge to gleen

• Pharmaceutical-water systems economically operated • GMP-/FDArequirements in quality assurance

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58 Trade Fairs and Events

................................................

60 Imprint

................................................

state-of-the-art looks like

At the cleanroom trade fair and congress on November 8/9 in Frankfurt am Main

Contents | CLEANROOM MAGAZINE 3/2016

6

Life&Business

Laser measures alcohol in the driver’s cabin of an automobile

LIFE & BUSINESS

Market Developments in Brief

Display glass cover with built in finger print sensor

of outfitting immune cells with

Martin Kamp and Professor Sven Höfling do their

cellular antennas which are able to

research in a cleanroom’s strictly controlled climate.

recognize cancer-typical features on

Photo: Vera Katzenberger

Hardware unnecessary | The Korean electronics manufacturer LG

Semiconductor research | Flashing

Innotek has developed a glass cover

instead of blowing – alcohol controls

with an integrated finger print sen-

in road traffic could soon be done

sor for Smartphone displays. They

this way. A newly developed laser

could make the finger print scanner

makes this possible. It tests the air

hardware buttons unnecessary

in automobiles driving past for

for future devices. The integrated

any alcohol content. The laser light

finger print recognition sensor is

radiates through passing cars from

found in a recess at the bottom of

a device set up alongside the road

the back side of the glass. The sensor

and is reflected back with a mirror.

is protected against influences from

On its way through the automobile,

outside such as scratches and water

the laser records if alcohol molecules

by high-strength glass. LG Innotek

are present in the car. However the

expects that the demand for finger

device doesn’t recognize if the driver

print sensors will significantly rise

With the help of cellular receptors (red area) immune

or passenger is under the influence

because of the increasing spread of

cells will be able to recognize cancer cells and destroy

of alcohol. “Police can use the sys-

pay services.

them in the future. Graphics: CARAT Consortium

tem as a screening device in order to more exactly check suspicious

degenerative cells. The researchers

automobiles” says Martin Kamp. The

are developing along with this a kind

physicist developed the new laser

of gene clippers which implant the

technology together with Professor

cellular antenna blueprint in the

Sven Höfling at the Würzburg Uni-

genome of the immune cells. As a

versity.

result of this, receptors are produced.

LG Innotek has introduced display glass with an integrated finger print sensor. Photo: LG Innotek

If such an immune cell comes into contact with a cancer cell, it recognizes them with the help of the receptors and destroys them. The innovative

Antennas against leukemia

procedure against leukemia should be widely operational in four years.

The American regulatory authority

Cancer therapy | Researchers at

, the Food and Drug Administration

the University Hospital Freiburg,

(FDA) sees this as a breakthrough in

The basis for the production of the alcohol measurement

are working on a cell-based cancer

the therapy of to date treatment-re-

laser is semiconductor material.

therapy. Their approach consists

sistant forms of leukemia.

CLEANROOM MAGAZINE 3/2016 | Market Developments in Brief

Photo: Vera Katzenberger

7 In the future the heart of medical technology will beat in Nürnberg

line for patient screening and microbiological diagnostics was opened.

The commissioning represented a premier for a German university

New MedTec Trade Fair | From 2017,

hospital and is at the same time the

the medical technology industry

go-ahead for a study which examines

in Nürnberg will be putting on its

how automation prevents the spread

own professional trade fair. In this

of germs in the hospital and how the

respect, the NürnbergMesse is plan-

dealings with antibiotic-resistance

The PC market (here without tablets) shrunk in the first

ning the trade fair in cooperation

can be improved. To date, four

quarter of 2016 to its lowest level since 2007. Source:

with the forum MedTech Pharma,

comparable systems are operated by

the largest healthcare industry

private providers for microbiological

buyers in developing countries are not

network in Germany and in Europe. .

diagnostics in Germany.

purchasing PC’s anymore but rather

Gartner. Graphics: Statista

Smartphones.

For Peter Ottmann, CEO of the NürnbergMesse Group the new event format is an important signal

The world is not prepared for Ebola, Yellow Fever and Zika

oriented towards economic decisions. “The world market for medical technology is continuing to develop in a positive direction and its heart

WHO-Warning | According to esti-

is beating in Nürnberg. To place a

mates of WHO General Director

new trade fair for the manufacture

Margaret Chan, the world is not

of medical technological products is

suitably prepared for the outbreak

in this respect consequent. We are

of dangerous pathogens. “What we

looking forward to greeting our new

are currently observing is that it is looking more and more like a dra-

trade fair baby!”

The new fully automated laboratory line for patient screening and microbiological diagnostics at the University Hospital Heidelberg. Photo: University Hospital Heidelberg

PC market at its lowest niveau since 2007

matic rise in the threat of new and resurging infectious diseases” warns Chan speaking in Geneva.

After the Ebola outbreak in West Africa, the world is because of the Zika outbreak in Brazil “once again taken by surprise without a vaccine and without

The trade fair center Nürnberg will be the host for

Decline in sales | The PC market

having enough reliable tests available

the new MedTec Trade Fair starting in 2017. Photo:

once again significantly shrunk in

for diagnosis”. Even “more brutal” had

NürnbergMesse

the first quarter of 2016. According to

been the lessons learned from the

Gartner, manufacturers sold 9.6 fewer

yellow fever outbreak in Angola.

units than in the same time period

Chan sees all 194 member countries

of the previous year. This was the

obligated to do more for the protection

Quickly and reliably diagnose germs in hospitals

sixth decline in a row. As a result, the

of people from dangerous infectious

Microbiological diagnostics | Is a new

industry sold for the first time since

diseases and to provide the resources

patient carrying dangerous bacteria?

2007, fewer than 65 million computers

for this.

Which germs inundate the body in

in one quarter.

the case of blood poisoning and are these germs resistant to antibiotics?

As reasons for this, analysts are

With which pathogens is a wound

naming the devaluation of various

infected? These key microbiologi-

currencies against the dollar, the

cal diagnostic questions can now

unexpected high levels of inventory

be more quickly answered by the

in warehouses after the fourth quar-

University Hospital Heidelberg. In

ter as well as the worldwide weak

spring, a fully automated laboratory

demand. Furthermore, potential

The World Health Organisation WHO speaks of a „dramatic rise of imminent danger“. Photo: jarun011/Fotolia

Market Developments in Brief | CLEANROOM MAGAZINE 3/2016

LIFE & BUSINESS

8

Summer, beach and sun cream

Where are the nanoparticles?

And just how dangerous are they in everyday products?

CLEANROOM MAGAZINE 3/2016 | Nanoparticles

9

Photo: Nils Brรถer

Nanoparticles provide many products with superior characteristics. This makes them highly interesting for numerous industries. At the same time, the tiny particles are suspected of having negative effects on both people and the environment. The opinions about the risks to consumers, production workers as well as to water, soil and air go in completely different directions. Clear is, nano does not automatically mean toxic. Complete rejection of the tiny particles is just as unacceptable as to deny the risks. The truth is, whether nanoparticles are as toxic as asbestos has so far neither been doubtlessly proven nor been ruled out.

CLEANROOM MAGAZINE 3/2016

10 proportions: nanoparticle to football and football to earth

It’s summer at last! Once again, we can enjoy the water, air and sun!

220.000.000 nm

22 cm

As small as a football compared to the Earth

12.713.000.000.000.000 nm

12.713 km

in textiles, thanks to the lotus-effect, they help prevent rain from penetrating into clothing.

But beware: Those who sunbathe all day long might end up looking

Nanoparticles are very tiny and

at a lobster red face in the mirror

invisible to the naked eye, ranging

The reverse side of the coin: Nano­

in the evening. Sunburn is com-

in size between 1 and 100 nanometers.

particles are suspected of pene-

parable to a first to second degree

Nano comes from the Greek “nannos”

trating the skin, the lungs and the

»When we wash textiles impregnated with nanoparticles, who can assure us that the particles will not end up in the water and via fish onto our dinner plate?«

Photo: Cleanroom Media

LIFE & BUSINESS

100 nm 0.1 µm

Professor Gernod Dittel, Dittel Engineering

burn. Sun creams offer protection

and means dwarf. A particle of one

intestinal tract, and similar to as-

against such burns. Yet until a few

nanometer diameter – this is one

bestos, causing harm and damage to

years ago, the popularity of the

millionth of a millimeter – is as tiny

the organism. Uncountable studies

thick, fluid products that left an

as a football when compared to the

have already proven the toxic effects

unattractive white film on the skin

Earth.

on people and the environment. Is this actually true?

had its limits. Today’s creams are thinner and easily rubbed in. This

Due to their interesting properties the

is possible because manufacturers

dwarf-sized particles are becoming

have shrunk the size of the mineral

increasingly important in science,

UV filter in sun cream, mostly ti-

medicine, electronics, cosmetics, food

tanium dioxide and zinc oxide, to

product equipment and consumer

nanoparticle dimensions.

goods production. In sun creams, for

CLEANROOM MAGAZINE 3/2016 | Nanoparticles

Studies have proven toxicity.

But how accurate are the findings?

example, they act as countless tiny

“You find a lot of false alarms out

mirrors that reflect UV radiation,

there”, reassures Professor Harald F.

in medicine they support the fight

Krug. The nanotoxicologist at Empa,

against tumors, in automobile paint

the Swiss Federal Laboratories for

they improve scratch-resistance and

Materials Science and Technology

11 in St. Gallen, Switzerland, has evaluated several thousand publications and has found that the half of these purported to be toxicological studies when in fact they were fundamental research oriented.

Hence, they do not allow a proper risk estimation. In many studies, for example, inflammation reactions were automatically associated with nanoparticles although in reality they arose from endotoxins. “This leads to misinterpretations and statements such as: Toothpaste is as dangerous as asbestos” says Harald F. Krug. In his estimation, sun creams can be used without worries, because the particles are not able to penetrate through the skin into the body. Waters also cannot be polluted by sun creams because titanium dioxide is already naturally present in the sediments.

Who can guarantee that nanoparticles do not end up in the water?

Why are nanoparticles so interesting for the industry?

If the particles of a substance are shrunk down to nano-range sizes, they change their physical and chemical properties. They begin to conduct electricity, become flexible and ductile, or change their melting point. These changes lead to new value-added products and applications.

What health risks do nanoparticles pose?

Free floating nanoparticles such as in sprays, are able to make their way into the body via the lungs. Nanoparticles in food products find their way via the stomach and intestinal tract into the blood system and organs. It is still unclear what risks this involves. Healthy skin acts as a secure barrier for example against nanoparticles in sun creams and cosmetics.

Should people avoid nanoproducts?

It is not possible to give a wholesale answer to this. Because of the uncertainty of the risks, this may be worth considering e.g. in the case of food products. The same applies to nanotextiles which could contaminate the water during washing whereas the use of sun creams containing nanoparticles as protection against skin cancer outweighs the possible risks of not doing so.

Where can one find out where nano is hidden?

BUND (Bund für Umwelt und Naturschutz Deutschland), the German Federation for Environment and Nature Conservation, has more than 1000 nanoproducts listed in their data bank. Consumers can target their search according to manufacturer, product category, sub-category and nanomaterial at www.bund. net/nanodatenbank

Professor Gernod Dittel sees this differently. “Nanoparticles are inde-

guest lecturer for “New Technolo-

on a “completely new and alterna-

structible, not combustible, they are

gies” at the Xi’an Jiaotong University

tive” basis. “However contracting

omnipresent, they pass through the

in China. “When we wash textiles

authorities leave planners no time

skin and destroy DNA and cells” says

impregnated with nanoparticles,

to do this” observes Dittel. “Also,

the owner of the engineering office

who can assure us that the particles

many manufacturers are reluctant

Dittel Engineering in Kochel am See/

do not end up in the water and via

to change their presently operating

Ried, Germany. Dittel teaches the

fish onto our dinner plates”, asks

cleanrooms and processes, true to

subject “Cleanroom Technology” at

Dittel. In his opinion, the issue of

the motto: Never change a running

the Carinthia University of Applied

safe handling in connection with

system.”

Sciences, Villach, Austria and is a

nanoparticles has to be reconsidered

»To date, there is no case known in which adverse effects to health have been caused by nanoparticles or nanomaterials.« German Federal Institute for Risk Assessment, Berlin

The world market for nanomaterials is growing yearly by 19 percent Meanwhile, the market for products with nanoparticles is rushing on, far ahead of the research of their risks, in chase of new profitable fields of business that nanotechnology is opening up for many industries. According to forecasts,

Nanoparticles | CLEANROOM MAGAZINE 3/2016

12 the world market for nanomateri-

that act as a barrier against water

als, which includes nanoparticles,

vapor, salt and oxygen. In the

nano-hollow bodies, nanofibers,

future, they could protect bridges

nanocomposites and nanocoatings,

and ships from corrosion. Further

will grow to 37 billion dollars by

highlights are a nanoglaze for use

2017. The annual growth rate is 19

in milk and juice production that

percent.

prevents the adhesion of microbes,

LIFE & BUSINESS

bacteria and fungi, also an ink with It is no wonder then that work in

metallic nanoparticles with which

the development departments and

electrical circuits can be applied

research laboratories worldwide

directly from the pen tip, and also

is running at full speed. In Silicon

luminous nanoparticles that make

Valley, for example, the Google

counterfeits clearly distinguishable

daughter company Verify Life

from original parts.

The nano-particles bound within products pose no dangers or risks according to the German Federal Environmental Ministry. Photo: Nils BrĂśer

Sciences is doing research on nan-

According to the Agency, danger

oparticles which, when swallowed

is hardly to be expected, as long as

in a capsule, are distributed via the blood stream in search of illnesses.

Nanoparticles are barely measurable in cleanrooms

the particles are permanently embedded within materials. A greater risk emanates from nanomaterials

In Saarbrucken, the INM Leibnitz Institute for New Materials as an

The multiplicity of possibilities is

that are contained as free particles,

international center for material

steadily pushing the number of

such as in sprays. Also risky are

research works on innovations for

nano-beefed up products upwards.

particles which through aging and

companies around the world. One

The consequence will be, as the

decomposition processes are able to escape out of the product. These free particles could make their

The transition from micro to nanotechnology toughens the demands on cleanroom technology.

way into breathing passages via the air. “So far, very little is known about the effect of nanoparticles on people and the environment� stated the Environmental Agency in May, 2016.

The processing of food products as well as long-lasting

of the most recent developments

German Federal Environmental

products such as bridges could benefit from nano-tech-

are new platelet-shaped nano-

Agency predicts, that people and

nology in the future. Milk can be bottled germ-free with

particles that stack up mural-like

the environment will be more

on top of each other in coatings

strongly exposed to nanoparticles.

CLEANROOM MAGAZINE 3/2016 | Nanoparticles

the help of nanos; corrosion can be significantly slowed down in steel bridges. Photos: markobe/Fotolia (left), gabort/Fotolia (right)

13 The danger of being exposed to

as well as the safe handling of

free nanoparticles exists also at

nanoparticles. Nanoparticles

work places. Particles can escape

under 20 nanometers can barely

into the environment because of

be separated using common

equipment and system defects

technologies. Instead of mass

and malfunctions during filling

or density, electrostatic forces

processes. They are much more

and molecular interactions play

difficult to detect than larger

essential roles. In this respect, a

particles with today’s measuring

lot more research is needed.

Ingenieur-Büro Messtechnik GmbH

Consulting & Service in the cleanroom

instrumentation. “The limits of optical particle counters lie at 0.1

The same applies to measuring

micrometers, which means 100

instrumentation. The transition

nanometers. Anything smaller

from micro to nanotechnology

can neither be recorded in re-

intensifies the demands on clean-

al-time nor differentiated with

room equipment. In the future,

today’s nano measuring devices

it will be necessary to create a

in the cleanroom” says Andreas

cleanroom classification beyond

Machmüller, Managing Director

the current strictest and cleanest

of MCRT Micro CleanRoom Tech-

ISO Class 1 in order to detect

nology GmbH in Heuchelheim,

and monitor nanoparticles. For measurement equipment manufacturers, this means firstly, to more finely calibrate devices and secondly, to enable correct result interpretations. Also, particles

SPECIALISTS

in

Consulting Measurement for Qualification Training Flow visualisation Measurement technology Calibration Maintenance Sales

smaller than 0.1 micrometers follow not only the law of gravity but also the theory of Brownian molecular motion. Which means

... we know the way!

they move irregularly in all Andreas Machmüller, Cleanroom Specialist.

Photo: Nils Bröer

directions.

Facility and measuring equipment have to be able to prevent

Germany. Worrying as well is the

the escape of nanoparticles

fact that nanoparticles quickly

respectively make them measur-

spread across considerable dis-

able in order to protect processes

tances through the air and thus

and employees. Strip conductors

are able to rapidly contaminate

of five nanometers in width

even remote areas. Mouth pro-

could quickly be destroyed by

tection or breathing masks are of

descending nanoparticles. The

little use in such areas.

particles also enter much more easily into the body than larger

Finer calibration of the measuring equipment is necessary

particles. Typical gateways are

BSR Ingenieur-Büro BSR Messtechnik GmbH Beratung & Service im Reinraum Marienstraße 156 68794 Oberhausen-Rheinhausen Switchboard: Fax: E-mail:

+49 7254 - 95 95 9-0 +49 7254 - 95 95 9-29

blattner@reinraum.info service@reinraum.info labor@reinraum.info

Internet: www.reinraum.info FS 518761

the lungs, the stomach-intestinal tract, injured and damaged skin and the olfactory nerve. Once the nanoparticles make it into the

In dealing with nanoparticles,

body, there is no stopping some

facility builders face two major

of them. Because of their small

challenges. They have to guar-

size, they cross through barriers

antee the safety of employees

that actually should provide

Nanoparticles | CLEANROOM MAGAZINE 3/2016

14 protection against invaders, for

Also little known is in what amounts

example the intestinal wall. In ex-

nanomaterials already occur in

periments with animals, this led in

the environment. This question

high concentrations to damages of

is now being researched by Swiss

genetic material and organs as well

scientists at Empa, ETH Zürich and

as inflammations that may trigger

the University of Zürich. They are

the formation of tumors.

developing a dynamic calculation model, which besides the increasing

To date, there is no proof of adverse health effects caused by nanoparticles

numbers of products, is also taking into account the differing uses of nanomaterials and their release into the water, air and soil. “Our

LIFE & BUSINESS

evaluations are at this time the The opinions of experts as to

best data available regarding the

whether these findings are appli-

mass flows of nanosilver, nanozink

cable to people are very divergent.

and nanotitanium dioxide as well

Long-term studies that provide

as carbon-nano tubules into the

sugar in a volume of water equiva-

proof for the feared threats to

environment” says Empa research-

lent to 1000 Olympic-size swimming

human health are still missing.

er Bernd Nowack. Understanding

pools. With this method, not only

Moreover the risks are different

the mass flows is the first step to

can many nanomaterials as before

for every kind of particle. Silicon

risk assessment. Early data from a

be detected in clear liquids but also

dioxide, for example, which is used

static model had shown no effects

in complex mixtures of substances

as an anti-caking agent in food

of the four nanomaterials on the

such as blood and soil samples. In

products and as a separating agent

environment.

the next step, researchers want to

Little is known to date, how many nano-materials exist in the environment. Photo: Nils Bröer

in instant coffee, salt and soups,

evaluate the behavior of nanomate-

causes no effects in the organs of

rials in the environment and their

rats. This suggests that it is also true for humans. The German Federal

Researchers are working on danger assessment models

potential danger to people, animals and the environment.

Institute for Risk Assessment (BfR) in Berlin explains: “Thus far, no

Researchers at the Fraunhofer In-

So a lot of time will pass until con-

case is known by the BfR in which

stitute for Biomedical Engineering,

firmed findings become available.

Until then, it is up to every consumer to use or to avoid products contain-

»The dosis alone declares that a thing itself bears no poison.«

ing nanoparticles. The proponents

Paracelsus, Swiss doctor, alchemist and philosopher (1493 – 1541)

other hand will find just as many

will find enough studies in which the products have been shown to cause no harm. The critics on the proofs which indicate their danger.

For those who waver between both sides and cannot decide whether

it has been proven that adverse

IBMT, in Sulzbach, Germany are

or not to buy the sun cream with

effects to health were caused by

investigating the presence of nan-

or without nanoparticles for the

nanoparticles or nanomaterials.”

oparticles not with mathematical

upcoming holiday, the 500-year old

Nevertheless, according to the

models but with environmental

advice of the Swiss doctor, alchemist

institute, there are still many open

samples. The interdisciplinary

and philosopher Theophrastus

questions and only limited data

team has developed a method

Bombastus von Hohenheim may

available regarding the behavior

which shows the presence of nano-

help. The man is better known as

and the whereabouts of nanopar-

materials in samples such as river

Paracelsus and said: “Only the dose

ticles in the body.

water or animal tissue with an ac-

makes a thing not a poison.”

curacy of one nanogram per liter.

This corresponds to a half cube of

CLEANROOM MAGAZINE 3/2016 | Nanoparticles

Author: Frank Baecke

15

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16

Piercing of another kind

LIFE & BUSINESS

Chips under the skin connect people with the Internet of Things.

Photo: Digiwell

The technological extension of the human body with implantable chips may, for some people, be a nightmare scenario. Others can hardly wait to try out the new possibilities.

CLEANROOM MAGAZINE 3/2016 | Implantable Chips

Photo: vetkit/Fotolia

17

Saving passwords in the body, exchanging business cards with a handshake, opening doors without

Prototypes are emerging in a garage from a mini-environment

in my garage in Seattle in a mini-en-

a key – a chip under the skin makes

vironment” says Graafstra, and

this possible. Packaged inside a

However this is nothing compared

explains that “garage” is not to be

sterile, bio-compatible glass tubule

to Kramer’s business partner at

imagined as a place to park the car

the size of a grain of rice, the mobile

Digiwell, the American Amal

along with a work bench but as a

data storage device is placed inside

Graafstra, who has been living as

small production site under clean-

the body with a syringe between the

a Cyborg for already eleven years.

room conditions and that the mass

thumb and the index finger. The

He is meanwhile carrying three

production of the chips of course

procedure is similar to a visit to a

chips from different generations

then takes place in the cleanrooms

piercing studio. “The chip is hidden

in the hand and in the underarm.

of an industrial manufacturer.

under the skin, the person does not

Graafstra founded the company

sense it, it doesn’t transmit anything

“Dangerous Things” in the USA

Digiwell created a furor at CeBIT not

and it doesn’t need its own energy

which among other things produces

only with the chips but also with

supply” says Patrick Kramer. “The

chip-implants. The man is a kind of

a live chip implantation. “It was

chip is programmed conveniently

pioneer of the Do-It-Yourself (DIY)

awesome what was taking place at

via a Smartphone-App.” Patrick Kramer is the founder and Managing Director of the 2014 founded Hamburger start-up “Digiwell – Smart-up your life!” The former strategy consultant is convinced that wearables can be not only worn on the skin but also underneath.

»In the future, we will be able to directly connect our brain with the internet via implants.« Dr. Patrick Kramer, Managing Director Digiwell

Therefore, a year and a half ago, he had a chip implanted under his skin.

Since then he has lived as a Cyborg.

implantation movement. Together

our stand” says Kramer. “The media

This acronym stands for cybernetic

with Kramer he presented several

downright snowballed us. We had

organism and designates a person

smart implants at the CeBIT 2016 in

everything from a visit from Al

whose body has been permanently

Hanover, Germany. “I produce the

Jazeera via a Russian broadcaster

supplemented with artificial parts.

prototypes of our new developments

to a CNBC Morning Television Live

Implantable Chips | CLEANROOM MAGAZINE 3/2016

18 broadcast. Besides this, we were designated the CeBIT Highlight.”

Kramer was equally surprised by

Implantable chips: How safe are these intelligent extensions of the body?

the onslaught of trade fair visitors.

The chips are sterile and bio-compatible. They can remain under the skin for years.

In the hustle and bustle around the

Since the chips do not coalesce with the body, they can be removed at any time. A small cut by a

small stand, many could hardly wait

doctor or piercer is enough and the chip can be easily pushed out.

to have the Digiwell chips implanted

The intelligent implants are passive. They can neither be located nor secretly read. Furthermore

under their skin. “We had reckoned

they can be protected with a password.

with two to three interested people

An electrical supply is not necessary. The RFID-NFC implants are read out by reading devices

LIFE & BUSINESS

per day”, relates Kramer. “there were up to 30. We were under siege”.

at short distances per radio signal (RFID=Radio Frequency Identification, NFC=Near Field

Actually, Kramer adds with a smile,

The chips cause no problems at airport security checkpoints. They are too small.

Communication).

what they had wanted was to present the next generation implantable chips at the trade fair. These are no longer grain-shaped, but flat, thin, perform better and are not at all noticeable under the skin. When

Chips under the skin are replacing keys and access cards

looking for a simple solution for entering his office and came across biometric possibilities. However they proved to be too expensive,

placed in the breast, they could for example monitor the rhythm

A paradox, but true: The enthusi-

too clumsy and too vulnerable to

of the heart and when danger is

asm of the CeBIT visitors pertained

vandalism. Then he discovered RFID

sensed, send a signal to the mobile

not to future, but to the already

solutions which identify objects via

telephone. “The new generation

available chips On-The-Go at the

radio signals (radio frequence iden-

enables 128 bit encoding whereby

trade fair stand. But even these

tification). These solutions were

the wallet could be replaced. Our

chips can already do quite a lot. The

cheap, available and easy to protect

digital ‘I’ is fusing together with our

triple-chipped Amal Graafstra is the

inside the body from weather and

biological ‘I’” says Kramer.

living proof for this. In 2005, he was

vandalism.

Therewith, the decision was made.

Amal Graafstra implanted an RFID tag under his skin and from then on no longer had to search in his jacket and wallet for his office access card.

The US pioneer has since used his chips for further applications. He unlocks his mobile telephone, logs onto his computer or starts his motorcycle. A simple movement of his hand in front of the reading device is enough, making pins, passwords and keys dispensable.

Users are able to do even more with the chips, for example share with friends contact data, YouTube videos and Facebook sites. For the latter, it is enough to simply scan the implants with a smartphone or tablet. Further possibilities are

With this chip under the skin, pins, passwords and keys will become unnecessary. Photo: Digiwell

CLEANROOM MAGAZINE 3/2016 | Implantable Chips

personal identification at events

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Implantierbare ChipsCLEANROOM | MAGAZINE 3/2016

20 or at public authorities, paying for

According to Sjöblad the advan-

purchases, the switching on and off

tages are even more far-reaching.

of alarm systems at home, boarding

He points out how difficult it is to

a plane at the airport or as season

protect his privacy in the digital

tickets at stadiums.

world. Chip implants could solve this problem. “Currently we have

LIFE & BUSINESS

Chipping of people – horror or hope?

absolutely no control over the data

Look how the chip gets under the skin.

which we put online” emphasizes the Swede. “Large search engines

from totally paralyzed patients” says

and social media collect as much in-

Chad Bouton, head of the Battelle

The chipped human – for some a

formation about us as they can, and

team. “Now, for the first time ever,

horror scenario, for others an awe-

do with it what they want.” If chip

these thoughts are being converted

some new possibility. Some propo-

implants provided with encryption

into movements.” The chip con-

nents argue that chips in house pets

systems are used for digital logging

verts brain activities into electrical

have long been accepted. According

in and verification, people would

stimulations targeting particular

to the opinion of Hannes Sjöblad

have better control over their digital

underarm muscles which make the

digital implants could become very

‘I’. “When everything you share is

hand movements possible.

useful for people. “They give the

encoded, you can decide who has

human body new capabilities” says

access to your data”, explains Sjöblad.

the Chief Disruption Officer at the Epicenter Stockholm and founder of the Swedish Biohacker Association.

Biohackers are hobby biologists who

However, human cyborgization makes much more possible. In Great

Nano computers which are swallowed

intervene in biological processes.

Britain, scientists are developing pills with micro-processors which send the doctor a message when the patient is not regularly taking his

The terminology includes activists

Implantable chips offer new possi-

medicine. In the USA, a chip giving

whose intention it is to make chang-

bilities also in medicine. Research-

off contraceptive hormones is being

es and alterations with the help of

ers at Ohio State University and

worked on which could replace the

chip implants in themselves or in

the Battelle Memorial Institute in

anti-baby pill. A further project is

others. Sjöblad himself carries a chip

Columbus, the capital city of Ohio,

“intelligent dust” made of countless

in his hand with which he is able to

USA, have had success in enabling

nano-computers which form a net-

open doors. He can now do without

a paraplegic man to move his right

work inside the body and monitor

his key ring, he says, a technology

hand thanks to a chip in his brain.

processes. They could for example

which hasn’t changed since the

“In the past decades we have learned

attack cancer cells or transport med-

Roman times.

how to decipher the brain signals

ications to their target and therefore make operations unnecessary. Even the linking of brain and computer is already possible. At Brown University in Providence, Rhode Island, USA, researchers are working on computers which read brain signals via implanted mini-electrodes in real time, and therewith operate external devices – a technology which could help severely handicapped people gain new independence.

Out of the Internet of Things is coming the Internet of Us The linking of brain and computer, The chip is implanted by using a syringe. It doesn’t adnate and can be removed at any time. Photo: Cleanroom Media

CLEANROOM MAGAZINE 3/2016 | Implantable Chips

this is exactly to Patrick Kramer’s

21 The chip implant needs no power supply and a reading device using radio signals reads out the data..

Photo: dny3d/Fotolia

liking. The Digiwell Managing Di-

chips. This is technically feasible.

of Us will be a curse or a blessing.

rector is completely convinced, “In

The worldwide web will therewith

Indisputable is only one thing: That

the future, we will be able to directly

reach its next level of evolution:

under-the-skin innovations now

connect our brain to the internet

“The Internet of Things will become

in progress would not be feasible

via implants”. He is fascinated with

the Internet of Us”, predicts the

without cleanroom production.

the idea that the human will one

techno-visionary.

day become part of the internet

It remains to be seen if this happens

of things thanks to implantable

or not and equally if the Internet

Author: Frank Baecke

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Implantable Chips | CLEANROOM MAGAZINE 3/2016

22

Networked and linked – the end of privacy?

Intelligent products supply their providers more and more personal data about their users.

LIFE & BUSINESS

Whether it be a mobile telephone, an automobile or a heating regulator, there is hardly a product which is found without micro-chips. The electronic components make possible intelligent functions and innovative services, generate however permanent data about locations and user-related behaviors. The Cleanroom Magazin asked two experts about the pros and cons of this digital networking. close the eyes to all this development.

looking for a route to Berlin, data

As a subjective significant risk, there

will be devolved. These are not in

is the feeling of intrusion into the

a narrow sense personally related

private sphere. Reservations are

however they do touch on the

often raised against a provider’s free

private sphere. In our networked

cloud services such as E-mail or stor-

world, such data are for service

Michael Kranawetter is the National

age and memory solutions because

providers very helpful and neces-

Security Officer at Microsoft Germany

these providers have aligned their

sary in order to provide modern

GmbH in Unterschleißheim near Munich,

business models on income from

offers. It is important here, that the

Germany. In his role as the Microsoft

targeted advertising. This adver-

provider makes the use and saving

Security Strategy Arbitrator, he deals

tising is based on the evaluation of

of data transparent so that the user

with all topics which are connected

a user’s voluntarily supplied data.

retains control.

with information security. Belonging additionally to this work are not only security products and security

regarding compliance such as technical

»More data doesn’t have to mean less privacy«

data protection and security awareness.

Michael Kranawetter

application solutions such as the cloud, but also risk management and questions

PRO PRO: Michael Kranawetter, National Security Officer, Microsoft Germany GmbH Digitization offers everyone advan-

Users are very generous with their

It is also clear that with more data,

data when services are free. It seems

more precise and more useful

as if consumers have made a deal:

answers can be supplied hence as-

services for data use. This is per se

sistance in very diverse situations

not bad as long as the conditions

is made possible – whether it be to

remain fair.

offer predictions or to give support

tages whether it be for professional

in everyday situations. This applies

or private reasons. This ranges from

The private sphere is not exhausted

in a person’s professional as well as

having fun playing games to enjoying

with personal data such as name,

private life. We are standing here

more comfort and health on up to per-

birth date and telephone number.

at the beginning of a development

sonal security. At the same time there

If a person wants to know about

and therefore it is important to

are risks and it would be foolhardy to

the weather at his location or is

determine the rules of the game.

CLEANROOM MAGAZINE 3/2016 | Controversy

23 More data doesn’t have to mean

and behavior profile. On the basis

Digitalcourage is not only opposed

less privacy. The prerequisite for

of this personality profile people are

to industry’s claim of omnipotence

this is that the data is evaluated

evaluated differentially addressed.

but also to governmental moni-

purposively and not be traceable

toring. With our constitutional

back to the individual user. Society

Digitization and networking will

appeals against data retention

has to be demanding in this respect

lead to this end that in the future

we want to – since 2010 already –

and fortunately this is happening.

decisions will be more frequently

overturn the controversial law.

made fully and automatically by

Together with the current vast

Naturally a person can remain

algorithms. The necessary data for

number of governmental mon-

offline. However how often have

this are accumulated from almost

itoring measures, the causeless

we learned from our mistakes with

everywhere. In this respect, people’s

compilation of all telephone and

the use of fire, metal, the wheel,

self-determination can be easily

the automobile or medicine and

overlooked.

through rules and laws (see EU Data Protection Ordinance) have

So that this doesn’t happen, technical

found more responsible ways

systems have to be data protection-

of dealing with the risks. Who in

friendly designed. This doesn’t mean

today’s world wants to live without

fewer functions and convenience but

all this?

more clarity over who is allowed to work with which data. The principles are: data protection-friendly default settings, data appropriation and data

CONTRA: Friedemann Ebelt, Editor and Campaigner, Digitalcourage e.V.

economy. Those who would like to process personal data have to clearly and distinctly ask for consent, give

Friedemann Ebelt works in Bielefeld

Vernetzung kann das Leben angene-

out information and also quickly

for the association Digitalcouage

Networking is able to make life more

delete the data.

e.V. as an editor and campaigner.

convenient. However networking

Digitalcourage has committed itself

is no reason for people to be regis-

The European Data Protection

since 1987 for fundamental rights and

tered and analyzed at every move

Basic Ordinance is for this a good

data protection and hosts the yearly BigBrotherAwards. Ebelt involves himself here with campaigns, articles

»The end of the private sphere would be the end of self-determination.« Friedemann Ebelt

and advocacy for a livable world in the digital age. Currently the media scientist is working towards bringing the new law for data retention before the Federal Constitutional Court.

CONTRA they make. Therefore in the future

foundation. Although the data

we have to vigorously fight for the

industry lobby in Brussels can

internet connections is absolutely

protection of our private spheres,

be very influential the efforts for

inacceptable.

for example by the deployment of a

the rights of all citizens has paid

data protection-friendly drafting of a

off. Digitalcourage will remain

It is very clear that: The end of privacy

European data protection ordinance.

committed and will accompany

would be the end of freedom and

Those who communicate, travel,

the creation process – and also

self-determination. There have to be

purchase, transfer money or surf

intervene as the Data Protection

more people coming forward who

in the internet is monitored. With

Ordinance will be individually and

will involve themselves in this issue

networked devices, programs and

specifically adapted by member

so that it doesn’t come to this.

data bases it is especially easy to

countries. Here, we will vigorously

compile a comprehensive movement

fight for data protection.

Autor: Frank Baecke

Controversy | CLEANROOM MAGAZINE 3/2016

24

LIFE & BUSINESS

Those who work in cleanrooms have to be disciplined and accurately follow work instructions, communicate clearly and be able to work in teams. Employees acquire these characteristics at Christine Schmidt’s horse stables in Switzerland. She herself has worked in cleanrooms and knows how procedures, quality and working climate can be improved.

Merciless Feedback How Christine Schmidt’s horses provide for better quality in the cleanroom.

With a Berlin accent at Lohnberg in Switzerland

Even the big know-it-all will sud-

for. The Managing Director of MTI

denly become meek when he is

Schmidt Management Training

standing alone facing a horse in the

Institute offers horse-supported

fenced-in Round-Pen. In contrast to

training at Lohnberg bei Zuzgen

Christine Schmidt was born in 1961

colleagues, the horse neither lets

in the Swiss region of Kanton

in Berlin, Germany, six days after

itself be influenced by someone

Aargau. “Horses follow those who

the building oft he wall. Soon after,

showing off, nor by drill-sergeant

handle them with respect and who

her parents left the city and first

like commands. Hence, some man-

they can trust. Those who try to

operated a hotel with restaurant

agement personnel suddenly find

overrun them and force them to

in Celle, then later in Hannover.

themselves standing helpless in the

do something will have no success.

Although Schmidt has lived in

arena because their usual way of

It isn’t any different when dealing

Switzerland since 1987, she has

giving orders isn’t working.

with employees” explains this li-

never lost her Berlin accent. This

censed horse trainer as she talks

sounds rather amusing on an

This is exactly the merciless feed-

about the lessons which will be

alpine mountain somewhere be-

back Christine Schmidt is looking

learned here.

tween Basel and Zürich, especially

CLEANROOM MAGAZINE 3/2016 | Portrait

25 her “Berliner Schnauze mit Herz”,

and a deep understanding for food

her Berlin bluntness with humor

product quality, cleanliness and hy-

and heart, occasionally mixed

giene. From her technical drafting

together with Swiss words.

work in mechanical engineering, she brought the understanding

“In the training facility, partici-

for qualification and validation.

pants get from me a task, but no

Building on these skills, she quickly

instructions on how to solve it“, says

advanced to being a cleanroom ex-

Schmidt. A typical exercise is for ex-

pert. She completed a GMP course,

ample to put over the horse’s neck

took further education courses in

a thin, soft leather hoop, then to

auditing and validation, did train-

send the horse away, then to bring

ing in coaching, graduated from

To be kept on short leads: From time to time also

the horse back and then to take the

the Institute for Psychology of the

necessary with employees. Photo: Cleanroom Media

hoop off. To do this, the person has

Zürcher Technical University with

to first gain the horse’s attention so

the Swiss Technical Credentials

that it will even approach him. An-

as Organisation Instructor and

other exercise consists of making it

she herself soon stood in front

understandable to the animal that

of employees and management

a carrot which the horse is allowed

staff as the Manager of Training.

It’s no wonder that books about

to eat has been hidden under a red-

“In 2008, my previous boss lured

training and psychology belong to

white traffic cone. “The difficulty

me away to Acino Pharma AG in

her favorite reading material, of

here is that a horse does not react

Basel where I became the Trainer

course books about horses as well.

to voice commands”, says Schmidt

in Quality Assurance and later

“During holidays, however, I enjoy

who has owned horses for more

the Head of Education”, recounts

reading novels”, says this energetic

than 40 years. “A person has to use

the Swiss national of choice, who

woman almost apologetically. She

other ways, non-verbal, to gain the

actually wanted to become a lawyer

radiates the zest, the drive for action

animal’s attention and then to lead

or a detective. “I have always had

and notices everything which is

and to train it.”

a penchant for rulebooks”, she

happening in and around the sta-

alludes to smiling.

bles with her keen, attentive eyes.

Giving up the job in industry for the horse training facility

Now and then, she says something

Leading and training, these have always belonged to Christine

Perhaps her professional ascent in

with her strong, slow voice to her

Schmidt’s professional life. In 1993,

the pharmaceutical industry would

speech-impaired apprentice Lea. “We

the certified Technical Draftsman

have kept on if she hadn’t been

take part in an integration program

made her way to Hoffmann La

offered to buy a gelding. Christine

for handicapped people”, she relates

Roche AG in Basel, Switzerland

Schmidt had sold her horses two

the MTI boss. “Lea is learning horse

where she worked for many years

years earlier on account of business

training from me which is a lot of

in blister packaging, in the packag-

reasons. However, fate once again

non-verbal work. I took her under

ing of pharmaceutical products in

waved its banner and without fur-

my wing at the beginning of the year

cleanrooms. “We were 120 employ-

ther ado she bought the horse and

but later she should be able to work

ees in eleven production lines in

with this, she made a decision which

on her own.”

three shifts. I am very familiar with

would change her life. In 2002, she

these jobs and know the problems

founded alongside her professional

After a time of ramping up, Christine

employees have to deal with”, says

life the company Horse Feelings

Schmidt began receiving so many

this lateral entrant to the industry.

in which she instructs natural

inquiries for her horse training that

horsemanship and riding as well as

she had to give up her job in indus-

offering experience-oriented lead-

try. “I was not able to constantly be

ership, team, personality and sales

splitting myself into two people” she

training courses. “I quickly realized

explains giving the reason for her

that education and training are my

decision which led her to working

passions.”

in a place where other people take

From the cleanroom production line to the training front From the parent’s hotel business,

their holidays, on a farm with a

she brought along leadership skills

panoramic view, six horses, six cats,

Portrait | CLEANROOM MAGAZINE 3/2016

26 two chickens, one billy goat and the

gestures and charisma. They reflect

they simply haven’t been able to get

training infrastructure with a round

the instantaneous behavior of a

the horse to respect and trust them.

pen, a green, natural area, seminar

person and accept him as a higher

What then? “He simply has to ask

rooms and a tipi.

Trained are groups ranging from the chocolate to the pharmceutical industry According to Schmidt, „groups ranging from the chocolate to the phar-

LIFE & BUSINESS

maceutical industry“ often arrive skeptical, with the attitude how this

»Horses follow those who treat them with respect and with whom they can trust. This is no different when dealing with employees.« Christine Schmidt, MTI Management Training Institute

is all supposed to help working in a cleanroom. However this question is clarified rather quickly because

ranking authority only when he acts

a colleague standing at the fence

participants immediately notice that

authentically and leads confidently.

to help“, says Schmidt. “Many are

how they deal with their daily tasks,

If he comes across unsure of himself

fully unaccustomed to doing this

their approaches to solving problems

or tries to play a role, the horse devel-

because in the company they never

in their companies, get nowhere with

ops no trust in him, turns away or

do it, however in a cleanroom, this

horses – a desired ‘Aha’ experience.

even tries to take over the lead.

is important. When I don’t know something then I have to ask or look

For the horse, neither title, nor rank nor even names matter. In order to get it to do anything, social position

To ask for help – for some people a new experience

it up in the instruction manual or let someone help me.”

For Christine Schmidt, quality and

and authority don’t help a bit. Other competencies are necessary and they

It can happen that even with the

keeping to the rules are somehow

have to be learned here. Horses don’t

easiest task, to put a hoop over the

are self-evidently of the highest

react to verbal language, rather to

neck of a horse, the task is seemingly

priority. “I cannot understand when

body language, facial expressions,

irresolvable for some people because

a person does something else instead

Trainer in control: Christine Schmidt and her mare Celia in the round-pen. Photo: Cleanroom Media

CLEANROOM MAGAZINE 3/2016 | Portrait

27 of following what has already been

these three people stood there at the

prescribed.” Not everybody shares her

fence wide-eyed and verified: “They

attitude and she recognizes this im-

act exactly the same at work”.

mediately in the riding arena. “Those who act inconsequentially in front of the horse, they are also inconsequential on the job.” In a cleanroom though, there must never be any

The people aren’t coming to terms with the horse but rather with themselves

inconsistencies when following rules

Regulations are to be followed. This is also learned in the horse seminar. Photo: Cleanroom Media

and working procedures. Ultimately,

A horse reflects the behavior of

in many cases it’s about products on

people. Cleanroom employees learn

made, product quality increased and

which human life depends whether

from this experience a lot about

even the documentation exhibited

it be medications or airbags.

themselves and their attitude to-

fewer shortcomings.

wards their job and the respective “Some people have looked for a job in

rules. Management personnel learn

For Christine Schmidt, such suc-

the pharmaceutical industry because

how they are able to improve their

cesses pose no surprise: “Cleanroom

the money is good, not because they

approaches and how they are able to

employees who work harmoniously

keenly stand behind the products.

enhance their non-verbal commu-

together, are aware of quality issues

The horses disclose these attitudes“,

nication. Everybody together acquire

and approach their work with shared

says Christine Schmidt whose sem-

the experience that some tasks can

and overlapping mindsets, will

inars always begin with theory and

only be solved by teamwork and that

simply yield better results.” Some-

safety instruction. She talks about

they have to more effectively com-

one working in a cleanroom needs

a group in which a participant fol-

municate with each other. Feedback

disciplined attitudes and cannot

lowed the given rules not because he

from seminar participants show

merely say: It’s ok the way it is. The

wanted to but only because he had

that the outdoor training course

more positive attitude can be learned

to. A second participant acted hap-

when at first sceptically considered

assures Christine Schmidt. “The per-

hazardly and inattentively so that

and contrary to expectations, did in

son who doesn’t have this attitude

the horse didn’t know what it was

fact bring very positive results and

won’t be able to get anything from me

supposed to do. A third participant, a

lasting effects long after the course

until he says: Now I understand why

very calm and quiet person followed

was completed, for example the

it is important to keep to the rules.”

all the rules stoically and he and the

working climate and communication

horse got on fantastically. The boss of

improved, fewer mistakes were being

Author: Frank Baecke

CLEANROOM EXPERTS DAYS » Optimal Cleanroom Personnel « 23rd - 24th Nov. 2016 in Leipzig ALL CLEANROOM EXPERTS DAYS: www.cl-ex.com www.reinraum-akademie.de

Portrait | CLEANROOM MAGAZINE 3/2016

Photo:

Nadin Maria Rüfenacht & Simon Rübesamen

LIFE & BUSINESS

28

Clean Art as per ISO 5 How does an artist view the concept of controlled conditions and the absence of particles? Somewhat differently. In 2005, a particle-free art project was created. A cleanroom in a summerhouse.

CLEANROOM MAGAZINE CLEANROOM MAGAZINE3/2016 3/2016 | Clean Art as per ISO 5

29 The surprise is perfect: A cleanroom stands among apple trees in the middle of a small garden plot in Leipzig. The cleanroom whose cleanliness classification can be taken as ISO Norm 5, was built ten years ago by cleanroom professionals according to Regulation VDI 2083, cleaned and is since then a closed, unused system.

The impression is stunning in its conflicting natures. In the garden’s foreground, the buzzing of bees can be heard, dust is dancing in the air and the fragrance of flowers and apple trees saturates the air. It smells like summer. A few steps through the grass lead to the veranda of a typical summerhouse.

Walking through the door, one

The cleanroom in the garden summer house. Graphics: Lifetime Europe; summer house plan © Haus am Gern

enters a wide open space. Looking around, he finds himself in a typical

and celebrated last year its 10th year

The almost 200 m² parcel lies in a

summerhouse. On the wall hangs

of existence. Barbara Meyer Cesta

small-garden area in a suburb of

and Rudolf Steiner, Swiss founders

Leipzig and consists of the usual

of the art label “Haus am Gern”, Biel/

mix of trees, flower and vegetable

Bienne, conceived and put together

beds, a lawn and a summerhouse.

the project. It came about within the

The previous tenants took care of

German-Swiss art exchange THE

the garden for over 30 years. “Haus

WORLD IS NOT ENOUGH. The name

am Gern” acquired it and left the

is the program: “Lifetime Europe – a

entire inventory in its original

history-free room”.

condition. The artists built inside

A look into the air lock. Photo: Cleanroom Media

a calendar from 1981, across from this wall stands kitchen furniture from the 1970’s and an old table with a plastic table cloth. Then one bumps directly into a cleanroom!

This is directly in the middle of the summerhouse, complete with an airlock in which the original cleanroom suits and mouth protection hang and a genuine air circulation system quietly hums along. A cleanroom-feeling as per ISO 5 dominates inside. Windows make it possible to take a look inside.

The art project – a clean room in the most unusual of places, a summerhouse garden – was created in 2005

The Swiss artist Barbara Meyer Cesta and Rudolf Steiner visit the garden yearly. Photo: Cleanroom Media

Clean Art as per ISO 5 | CLEANROOM MAGAZINE 3/2016

30 at that time. “Cleanrooms can definitely have a second dimension.

A cleanroom named »Lifetime Europe« becomes a history-free room

They can be thought or brought forward” says Duvernell, “Art and

LIFE & BUSINESS

»Haus am Gern«, the label of the Swiss artist Barbara Meyer Cesta and Rudolf Steiner travelled to Leipzig on the invitation of BBKL (Bund Bildender Künstler Leipzig-Association of Visual Artists Leipzig) as part of a large scale exchange of artists between Germany and Switzerland for the development of this project.

After the construction, the cleanroom was cleaned by cleanroom professionals according to the Regulation VDI 2083, sealed and is since that time has been a closed, sealed off for people system. The key was ritually thrown into the Pleiße River. In the summer of 2015, it celebrated its 10 year anniversary.

the cleanroom? That they complement each other or belong together, this is for most people still not clear.

But to tell you the truth, it works.”

The room is however not only a cleanroom as per DIN norms but more thoroughly clean. It is also ideological. There has taken place a revaluation of DIN Norm particle-free cleanrooms in a solely philo-

It has been since 2005 “in progress”, that is, it is a perpetually running art project.

The garden can be visited by arrangement.

sophically-measureable history-free room. For 10 years now it has been cut off from the “particle slinging human”. “Therefore it is free from every physical and emotional con-

the existing summerhouse enclosure a free-standing room with the measurements 2.10 x 2.12 x 2.14 meters. This room was conceived as a cleanroom as per EN ISO 14644 and consists of an airlock including the protective clothing racks as well as the cleanroom. A climate control

»He is physically and emotionally free from contamination. Materially and in form and content. These cleanliness is exciting for any artist.« Barbara Meyer Cesta, initiator

system provides for controlled-conditions operation.

Cleanroom specialists advise artists

and construction phases. Frank

tamination, not only in material

Duvernell, founder of profi-con

but also in form and content. This

Contamination Control GmbH

understanding of cleanliness is for

supported the project with the

artists downright exciting” summa-

Daniel Grimm, formerly the Secre-

planning and the finalization stage.

rizes Barbara Meyer Cesta about the

tary of the Swiss Society for Clean-

The company with its headquar-

fascination of the project.

room Technology, took over the job

ters in Leipzig is specialized in the

of the project’s consultant in 2005,

cleaning of clean and ultraclean

during the project’s conceptional

rooms. The professional cleanroom-cleaner from profi-con takes

The world itself is no cleanroom

care of the ensuing cleanroom-suitable final-cleaning in accordance

Daniel Grimm also finds this fas-

with Regulation VDI 2083.

cinating, today a specialist for the cleanest food product production.

Final cleaning done by profi-con. Photo: Haus am Gern

When the inquiry came in for

From the viewpoint of an engineer,

support from the artists he was at

by definition a cleanroom is a room

first toppled but then spontaneously

with controlled conditions. With

agreed to help out. Duvernell, who

cleanroom technology, one speaks

in the meantime has brought the

of contamination controls which

ReinraumAkademie into life, re-

in the future will be even more de-

members very well his involvement

tailed according to the cleanroom

CLEANROOM MAGAZINE 3/2016 | Clean Art as per ISO 5

31 professional. On the other hand: “…every look into a newspaper proves that the world itself can be no cleanroom.” He also sees people – in many respects- as the main source of contamination. He relates that air is really only clean and clear on the top of Mt. Everest and this only because there are no people nearby. “We will never find out how clean and clear a contamination-free room can actually be as people themselves contaminate it by discharging particles on up to his very presence, his thoughts and his energies. This room in the garden is however free from every contamination. For over 10 years, not a single person has entered it.”

The cleanroom becomes a history-free room For cleanroom insiders, the project’s perceived thoughts of a historyfree room appears ambiguous in that today’s archiving of all our data and thereby our histories per microchip, whose production takes place under controlled conditions, actually works. It is also captivating that data integrity requirements are themselves on the rise. (We have reported more on this topic on p. 46.)

Without cleanrooms, microchips would be unthinkable, without microchips the archiving of data would be unimaginable and data archiving means the manifestation of the existence of history. It is even bolder all the more, to portray the cleanroom

A profi-con trained Clean Operator carries out the professional final cleaning. Photo: Haus am Gern

as a “history-free room.”

Author: Maja Franke

Clean Art as per ISO 5 | CLEANROOM MAGAZINE 3/2016

LIFE & BUSINESS

Photo: Maja Franke

32

Cleanroom Magazine speaks with Haus am Gern, Barbara Meyer Cesta and Rudolf Steiner.

Interview with »Haus am Gern« »Cleanroom technology can be used to keep away history from a place.« CLEANROOM MAGAZINE 3/2016 | Art project

33 Is there a difference in the

both fascinated by the history and

reception of the project between

the present of this city. We succeeded

cleanroom-aware visitors and those

after intense three weeks to formu-

unfamiliar with the industry?

late an idea that puts together different levels to create a meaningful

Probably. Visitors who are unfamiliar

new whole, which has a permanent

with the industry understand the

contemporary relevance. Our desire

clear meaning of our art sometimes

to achieve sustainable profound

just after a while. And also the border:

and amiable work was - and still

the very limited options of cleanroom

is - not without the cooperation of

technology. It is certainly not easy

all involved partners and people.

to accept that we use the cleanroom technology to keep history far away

What will happen to the garden?

from a place. But for "cleanroom workers" who also thinks creative,

This will bring the future. But we

it may be liberating to know how far

hope that the garden with its clean-

this technique can be thought.

room continues to attract prospective customers and broadens horizons.

What induced you at that time to develop the project? How did you

What is for you as an artist the most

come up with the idea?

fascinating aspect regarding the cleanroomindustry?

We visited Leipzig in 2005. Here was

»Haus am Gern« Since 1998, the artists Barbara Meyer Cesta and Rudolf Steiner have been materializing joint projects under the label «Haus am Gern». They work not only with all possible media, but also utilize the label as a platform.

Often other artists or «artistically remote» specialists are involved in the realization of the concepts.

The editorial staf f has found especially interesting the concept of ‘cleanroom’ freely translated into artistic settings.

in the everyday flow of life - entropy - incorporate. A struggle which the

"Lifetime Europe - a history free

Artists are interested at least since

cleanroomindustry knows only too

space" instead. The curators Franzis-

modernity for the radical omission

well.

ka Ewald (Bern) and Jasper Friedrich

of something, of the opposite of the

(Leipzig) invited us to develop a

creation of the new. However, the

project in a public space. We are

expenditure, a vacuum, a void to

The interview was led by: Maja Franke

maintain is very interesting. Because Left: Barbara Meyer Cesta and Rudolf Steiner in May 2016

you always will find life -in the form

in the garden. In the background: The same apple tree as on

of dust and particles and aging pro-

page 28. Photo: Cleanroom Media.

cesses - in the void, to get them back

CLEANROOM CLEANING

www.profi-con.com

Art project | CLEANROOM MAGAZINE 3/2016

34

On the Road with Heinz Martin Esser Heinz Martin Esser is Managing Director at Roth & Rau – Ortner GmbH in Dresden and the President of Silicon Saxony e. V. The association connects over 300 members across the economic area of Saxony, including manufacturers, suppliers, service providers, universities, research institutes, and public institutions making it the most successful industry network in Europe.

How often are you on business travels? My

LIFE & BUSINESS

business trips take on a certain regularity because they are are customer-oriented. On average, I travel two to three times a month, including overnight long distance trips.

What is your favorite way of traveling?

Provided that everything runs smoothly, it is the airplane. I hate delays and long lines.

Immigration areas and security checks at international airports are often agonizing. In spring and summer, when the weather is pleasant, I enjoy driving.

What do you find particularly important when traveling? Safety and a smooth journey are certain to put me in a good mood. I always aim to keep my trips under my own control to the greatest possible extent. Stress comes up when something happens out of the blue that has a significant impact on trips such as delays, traffic jams and breakdowns.

What should never be missing on travels? It depends on how I travel. A good book, a current newspaper and also a mobile telephone or laptop are good ways to pass the time during long flights. During long drives through Germany, I always have chewing gum as a “waker-upper”.

And if I find a good radio station with plenty of information on current topics and good music with hardly any advertising, even these long hours pass by quickly.

Heinz Martin Esser standing in the Kremlin, Moscow, in front of the „Zarenglocke“ (Czar Bell), cast in 1735, during his visit to Semicon Russia in 2015. Photo: private

CLEANROOM MAGAZINE 3/2016 | On the Road with…

35 What kind of music do you listen

Can you relax from daily business

Which are destinations you favor

to on trips? I really enjoy listening

while traveling? To be honest, no!

and why? I really enjoy vast, spectac-

to classical music, especially piano

However, during travel there are many

ular landscapes, like for example the

music by Chopin. On long distance

opportunities to focus on particular

Grand Canyon, the Dolomites or the

flights I have simply to select. In the

issues of daily business and then ideas

Canadian wilderness. Also impressive

car, I have wonderful CDs. I also

on how to resolve specific tasks often

sea coasts belong to my favorites. I

enjoy a balanced mix of pop music

come up spontaneously. Travels to

also enjoy wonderful cities such as

from the last 30 years.

other regions inspire my creativity

Barcelona, New York or Tokyo each

through the new perspectives.

with their own special aura. The best

Which countries and regions are

journey is one which combines both,

frequently on your travel list? We

How do you relax most successfully?

have several customers in South

I can concentrate my thoughts on

Germany, abroad I am very often in

beautiful pictures and pleasant expe-

What is the first thing you would

Switzerland, Belgium and Holland,

riences, call up past events and relax

change if you had the unlimited possi-

in Western and Eastern US and also

as a result. When I want to rest and

bility to do so? Unlimited possibilities?

frequently in Japan. On private trips,

take a break, I often in my thoughts

This would be something towards

I regularly return to the western

go walking through my favorite forest.

world peace, ubiquitous justice includ-

regions of Germany. This is home to

I can even bring up in my mind the

ing a high standard of living and the

me and my children and grandchil-

sounds of the forest, the wind and the

acceptance of all cultures…

dren live there. The North Sea and

singing of the birds. If I need to put

Baltic Sea are also always attractive

myself in a good mood, I imagine my

destinations.

loved ones and good friends laughing

nature and life.

Author: Frank Baecke

out loud…this always helps.

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On the Road with… | CLEANROOM MAGAZINE 3/2016

36

Science & Technology

SCIENCE & TECHNOLOGY

Technology in Brief

When medical devices communicate with each other in the OP

UV lamps and has opened new

to make these models as realistically

possibilities for disinfection and

as possible, the researchers are

sterilizing.

taking into consideration several pa-

Networked OP | For the first time ever,

rameters such as representative test

medical devices having differing func-

germs, contact time, germ-stabilized

tions and from differing manufac-

bodily fluids and the washability of

turers are able to communicate with

the impregnated textiles. In simulat-

each other and also with the surgeon

ed infection chains, the textiles have

and the hospital’s IT infrastructure.

been contaminated with among

The new system for networked OP’s

others the common pathogens.

was developed over the time period of four years and from 80 partners

The study has shown that the newest

working together on the project “OR.

generation anti-microbial equipped

NET”. The system makes available to

textiles reduce the amount of germs

doctors in real time directly visualized

The new UV-LED solution proves itself by its highly

and germ propagation. Bacteria are

on the operating table the combined

effective germ-killing capacity. Photo: Crystal IS

killed, viruses deactivated and fungi limited in their growth. The new

information concerning the patient’s health condition which is being col-

“Klaran” has the sterilizing capacity

test models may be able to support

lected by the networked devices.

of 15 to 30 mw, radiates in the range

the textile industry to optimize

between 250 to 280 nm and thereby

application-oriented anti-microbial

Besides the small and middle-sized

kills any potential pathogens. The

materials.

medical technology companies, hospi-

UV-LED solution is especially suited

tals and clinics are above all profiting

for germ-free hospital areas, the con-

from the project. In the future, they

ditioning and preparation of water

are not dependent on the installation

and for the food industry. It is based

of total solutions coming from on

on a mesh of aluminum-nitrate

major manufacturer but will be able

substrates. There are no possibilities

to flexibly integrate devices coming

of overdoses and toxic side-effects

from differing manufacturers.

when using the device.

Sterilizing with LED light

Anti-microbial textiles against hospital infections

UV-Disinfection | The company

Researchers at the Hohenstein Institute are testing the effectivety of anti-microbial equipped textiles. Photo: Hohenstein Institute

Crystal IS, a US provider of LED

Infection prevention | Employees of

solutions for UV sterilization, has

the southwest German Hohenstein

introduced with “Klaran” the first in

Institute have developed new test

the world UV-LED disinfection line.

models made of anti-microbial tex-

With this development, Crystal IS

tiles which are being evaluated for

Cell sample treatment | Automated

has overcome the limits of previous

their suitability in practice. In order

processes such as what is found in

CLEANROOM MAGAZINE 3/2016 | Technology in Brief

Automated cold sleep

37 Limited dead space lengthwise sight-glass seal

the automobile industry is seldom found in the pharmaceutical industry. The reason for this is that

Pressure vessel | Occasionally there

the procedures are complex and require a fingertip feeling. Now researchers of the Fraunhofer Project Group for Automating in Medicine

New drive trains with higher positioning accuracy for use in cleanrooms. Photo:SMC

occurs breakage of the lengthwise sight-glass respectively problems with the seals in medium batching

and Biotechnology in Mannheim have built the first device which

and unloading of work pieces

autonomously treats cell samples

(vertical and horizontal transfer)

and under tight conditions freeze

for high-speed tracking controls

them without a lab technician even

or labeling. The cleanroom drive

having to lift a finger.

trains are equipped with vacuum pump connections. This allows

The so-called CryoMAT is able to

for the direct vacuuming off and

recognize barcodes, catalog cell

discharging of particles which can

samples, pipete solutions, blend,

arise during operations. Applications for the various models are

The space-saving cabinet filter only needs 0.4 m² in a cleanroom. Photo: Lindner Group

found for example in the semiconductor and LCD industries.. tanks for the production of pharmaceutical products. Sommer & Strass-

Up is now down: Filter Fan Unit upside down

burger GmbH & Co. KG in Bretten, Germany has found a solution: A special seal geometry with a guiding

Space-saving-Filter | For cleanrooms

groove aligned with the welding

with limited ceiling heights or

flanges and the glass offsets possible

Fraunhofer IPA

reduced working areas – keyword

light warping. At the same time, it

Design and Construction in Exist-

takes care of any limitations in dead

fill and freeze. While the facility

ing Contexts – the Lindner Rein-

space sealing. With the seal guiding

is autonomously doing its work,

raumtechnik GmbH has developed

groove, respectively retention groove,

the lab technicians have time for

the air filtering unit FFUSD. The

a relatively simple installation has

other tasks. The CryoMAT sends

abbreviation stands for “filter fan

been made possible.

an SMS as soon as the job has been

unit upside down” and indicates a

completed. The solution was devel-

high-performance filter which is

oped by order of a Scandinavian

installed as a space-saving cabinet

pharmaceutical company.

unit in cleanrooms and is suitable

Automated freezing of treated cell samples. Photo:

for cleanliness classes GMP B or ISO 6.

New electrical drive trains for cleanrooms

The air filtering unit makes possible the circulation of large amounts of air for the reduction of particles,

Pick and Place | SMC Pneumatik

the bringing in of fresh air with-

GmbH in Egelsbach, Germany has

out additional discharge and for

enlarged its range of electrical

tempering the circulating air. For

The correct seal geometry adapted to the lengthwise si-

drive trains of the LEJ series with

air circulation, the FFUSD unit is in-

ght-glass of a pressure tank prevents glass breakage and

new models. Many new products

stalled with a quiet-running radial

installation problems. Photo: Sommer & Strassburger

carry the prefix 11 which indicates

ventilator. This suctions out the air

that they are suitable for the use in

at floor level through a lint filter,

Class ISO 4 cleanrooms. The drive

directs it over a heat exchanger and

trains suit themselves for Pick and

moves it back into the room via a

Place applications, for the loading

particulate air filter.

Technology in Brief | CLEANROOM MAGAZINE 3/2016

38

Into a clean future

SCIENCE & TECHNOLOGY

Modular, flexible and mobile – these are only trends which will characterize the cleanroom in the future.

The latest innovations in cleanroom technology show that their development is still running at full speed, although the first cleanroom was established over 50 years ago. The growing demands for clean conditions in more and more industries will be influencing the development in the coming decades.

but also are requiring more diverse possibilities of use in the diverse industries using the technology. The number of companies is steadily increasing. Among others the au-

A study by the New York market

manufacture, processing and pack-

tomobile industry has meanwhile

research company Persistance

aging of products, an increasing

joined the classic industries such as

Market Research is predicting

demand for sterile pharmaceutical

the semiconductor, microelectronic

that the worldwide market for

products as well as the development

and pharmaceutical industries. In-

cleanroom technology will have a

of new biological compounds and

telligent, networked and driverless

growth in revenues of 4.3 billion

their increasing application in the

vehicles require absolutely reliable,

US dollars (2014: 3.1 billion US dol-

medical industry.

functioning systems. Such systems

lars) by the year 2020. The drivers

can only be produced with zero

of this growth according to the

These trends make for not only a

study are the stricter norms for the

quantitative increase in cleanrooms

defects in cleanrooms

A cleanroom comes into being. The classic construction will become supplemented possibly even replaced by more flexible and modular systems in the future. Future cleanrooms will consist of building kits or be delivered pre-fabricated. Modular designs will allow the size of a cleanroom to be easily adapted. The ideas range up to mobile, transportable solutions. Photo: Montpellier

CLEANROOM MAGAZINE 3/2016 | Cleanroom-Future

39

Hand disinfection in the past: At one time, the washing of hands and arms in a basin was considered advanced. Today exists

Hand disinfection today: Dispensers operated by using the

an elaborate „choreography“ technique of disinfecting. Photo: Horst Sturm

elbow allow practical, non-contact disinfecting. Photo: Nils Bröer

Dusting done by air showers

increasingly important. Robots

it possible to relatively simplify

make it possible to carry out work

changes in cleanroom size

A topic for the future is also the clas-

and processes such as filling more

without having to suffer facility

sification and quality of cleanrooms.

exactly and free from human

i nv e s t m e n t l o s s e s . T h e i d e a s

Besides the high-end cleanroom

intervention.

range up to mobile, transportable

used in the pharmaceutical and

cleanrooms which can be installed

semiconductor industries, Con-

anywhere and thus save costs in

trolled Not Classified environments (CNC) are increasingly emerging.

Change is the only constant in a cleanroom

re- or new construction. They will provide the most flexibility ever.

These cleanrooms are non-classified

The possibly dominating factor for

but still are rooms with controlled

When one considers the history of

future innovations could be the

conditions for example with filtered

cleanrooms, change is the only con-

air. Air is conducted turbulently

ventilation and access controls.

stant. This will not be different in

or unidirectionally, it is cooled,

the future. The increasing demand

warmed, dried, distributed and re-

This trend shows that the industry

from ever more industries for

distributed, blown in and pumped

has recognized the advantage of

cleanroom technology is requiring

out … in short, the efficiency of heat-

controlled environmental condi-

that cleanrooms become even more

ing, ventilation and conditioning

tions – also outside the cleanroom.

variable in order to meet the ever

equipment and systems will play

For example, using automatic, driv-

broader application possibilities.

a key role.

erless transport systems, material

It is very likely that new materials

out of the supply room will be dust-

and building techniques will be

The reduction of air volumes, more

ed down before it is brought into

developed in order to conform to

efficient energy consumption, accu-

production areas. For cleanrooms,

the new demands.

rate reporting and more thorough

there are mobile trolleys with built-

evaluation of the effects of differing

in ventilators and HEPA filters for

The future of cleanrooms will

system processes together with the

the transport between the various

be therefore characterized by

development of new materials and

areas or between cleanrooms.

f l e x ibi l i t y a n d m o d u l a r i t y.

construction techniques will signif-

Future cleanrooms will consist

icantly influence future solutions.

In order to minimize the influence

of building or assembly kits or

of people in critical areas, automa-

be delivered as pre-assembled

tion and robotics are becoming

modules. Modular designs make

Cleanroom-Future | CLEANROOM MAGAZINE 3/2016

SCIENCE & TECHNOLOGY

40

Cleanroom airlocks for separating clean and dirty areas get their role mo-

Here in comparison, it can be very well recognized: A bench for separating work and changing areas in mining

del from the mining industry, (see picture to the right). Photo: Stan Zurek

(above) and a cross-over bench in a cleanroom (see picture left). Photo: Slaunger

Black-White principle from the mining industry is taking over cleanrooms

in Germany is designated by the

the ceiling in nets or baskets. Doctors

separation of dirty, black areas and

also oriented themselves on this

clean, white areas.

Black-White principle and developed the classic operation room which was

Measures for contamination con-

The Black-White pPrinciple has

separated from the common areas by

trol go back to the 19th century.

its origins in the mining industry.

personnel sluices. In the meantime,

They have their roots in the prac-

From the 1920’s, the dirty work area

the Black-White principle is used by

tice whereby certain operational

with the filthy mining clothing was

civil and disaster control authorities

areas are separated from each

separated through shower rooms

in order to prevent the transmission

other. Out of this, the Black-White

from the area with the clean private

of pathogens and contaminated

principle was developed which

clothing . The latter was hung under

objects into clean areas.

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CLEANROOM MAGAZINE 3/2016 | Cleanroom-Future

w w w.r ibe.de

41 Based on the Black-White principle, terms have emerged for cleanrooms,

Cleanrooms as image-raising showrooms

Future cleanrooms will put a focus also on profitability and economic

black zone for outside areas, white

efficiency. New technologies will

zones for the cleanroom and grey

A further trend is coming from

increase efficiency, reduce the work

zone for the area leading into the

laboratory operators. In the past 12

involved and bring down the costs.

cleanroom. In order to keep the

months they have been intensely

The demands on cleanrooms go be-

inside areas really clean, efficient methods such as filtered air supplies, protective clothing for personnel, and cleaning equipment such as air showers have been developed.

In the air showers, employees stand with the arms held high and turn themselves slowly around 360° while the air cleans them off. Future

It is imaginable that in the future a material for cleanroom clothing will be developed which cannot be contaminated.

air showers will be built into the air locks and be outfitted with alarms which go off when an employee

demanding cleanroom designs

yond pure contamination control.

leaves the containment before the

which not only fulfill the current

The highest level of flexibility, min-

cleaning process has ended.

standards but also are equipped

imized investment expenditures

for the future. Therefore, the fu-

and the lowest possible operating

Even here, interesting develop-

ture design and configuration of

costs, these are the demands on

ments have cast their shadows

cleanrooms will be as important as

tomorrow’s developers.

ahead. It is thinkable that in the

their function. There is a growing

future a material will be developed

interest to configure cleanrooms as

Author: Michael Rodd,

for cleanroom clothing that cannot

image-raising showrooms whereby

Sales Manager at M+W Products

be contaminated. Another solution

the reliability and durability of the

which is currently being examined

technical systems and equipment

is photo-dynamic disinfection – a

will continue to be the central

procedure which uses laser tech-

focus.

nology to destroy micro-organisms.

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Cleanroom-Future | CLEANROOM MAGAZINE 3/2016

42

SCIENCE & TECHNOLOGY

Disinfectant Cleaning – Does this even exist?

Cleaning and disinfecting are two different processes. When combined together correctly, they can save time and money in certain applications.

Contamination under UV light. Photo: Cleanroom Media

Amazingly, surface areas after a thorough cleaning are still a very attractive living environment for several microorganisms, therefore disinfection is imperative. However, this doesn’t apply generally. For non-controlled areas, disinfectant cleaning can be a logical and economical compromise.

A well-known manufacturer

wipe and everything is spotlessly

together be taken care of in just a

promises that its disinfectant

clean. The cleanroom industry

single procedure?

cleaner removes “99.9 percent of

has been waiting for such a com-

the bacteria” and leaves “no streaks”

bi-product, but does it really work?

The term “disinfectant cleaning”

behind. Isn’t this fantastic? One

Can disinfection and cleaning

evolved with the increasing awareness of hygiene in everyday life and

Disinfectant-cleaning is predestined for areas where the separation of cleaning and disinfecting is logistically difficult.

CLEANROOM MAGAZINE 3/2016 | Disinfectant Cleaning

is gaining popularity due to the infection-biological challenges in the healthcare industry and in the cleanroom. The reason for this is the fact that even cleanrooms with their nearly sterile environments paradoxically provide habitats for germs and viruses.

43 Micro-organisms are able to survive for months in the tiniest cracks

Cleaning and Disinfecting: Each has its Strengths and Weaknesses

Barely visible grooves and cracks

When cleaning with water mixed

containing just a hint of moisture

with special additives, surfaces are

after cleaning help unwanted mi-

moistened whereby the contamina-

cro-organisms to survive. An Ebola

tion is loosened and then removed

virus, for example, survives in moist

with the cleaning equipment. When

cracks for days and even on dry

disinfecting, the surfaces are also

surfaces for hours. Staphylococcus

moistened, but the disinfectant is

aureus is even more resilient. This

left on the surfaces in order to kill

bacterium is able to live unscathed

or deactivate the micro-organisms.

for seven months on dry surfaces

The disinfectant is not removed, at

and in moist conditions considera-

least until the next cleaning.

bly longer.

This has its consequences: The disYet, how is it possible that viruses

infectant's residues together with

and bacteria still exist after a thor-

the dying germs form a layer under

ough cleaning and are able to survive

which any remaining germs survive

on clean surfaces for hours, days or

well-shielded against the outside

even months? Besides their being

environment. They nourish them-

highly resilient, this is above all due

selves from their dead comrades and

to the limitations of the cleaning

wait for better times.

and disinfecting procedures. Both procedures have their strengths and weaknesses.

Photos: Cleanroom Media

Germs survive disinfection due to usage faults

Definitions in Disinfection Sanitation: Germ reduction by cleaning using germ-inhibiting substances, also continuous disinfection and disinfection without control of reaction time. → 80% to 99.99 % germs killed off Disinfection: Killing off, respectively de-activating (irreversible impairment) all pathogenic germs so that an object is no longer infectious. → Low germ contamination 99.999 % Sterilization: Killing off all micro-organisms, including their perennial form, (spores). → Low germ contamination 99.9999 % Nosocomial Infection: Infection by pathogens or their toxins during an inpatient or out-patient medical procedure (hospital infection).

Disinfectant classes Class A: bacteria, fungi Class B: bacteria, fungi, viruses Class C: bacteria, fungi, viruses, bacteria spores including anthrax spores Class D: bacteria, fungi, viruses, bacteria spores and clostridium (gangrene, tetanus, etc.)

Germs survive a disinfection procedure above all when the chosen disinfectant exhibits weak penetration characteristics or poor efficacy. The latter results not only from using the wrong concentration but also from the layer formation mentioned above. The effectiveness of the disinfectant is also influenced by the protein-effect and the soap-effect.

With the protein-effect, the disinfectant’s active ingredients bind to the protein, blood or serum components and can no longer react effectively against pathogenic germs. With the soap-effect, residues of cleaning agents respectively surfactants, react with the disinfectant’s active ingredi-

Source: RAL Gütegemeinschaft Gebäudereinigung e.V.

ents and neutralize the disinfectant’s effect.

Disinfectant Cleaning | CLEANROOM MAGAZINE 3/2016

44 companies with aseptic production

Disinfectant-cleaning = kill plus remove

SCIENCE & TECHNOLOGY

processes to validate the efficiency of the disinfectants as well as their

Kill and remove – this leads to the

minimum contact times on diverse

term “disinfectant-cleaning”. Does

surfaces. Not only do they have to

this even exist? As described earlier,

verify the reproducibility of their

cleaning and disinfecting are two

results but also that their disin-

different procedures each with their

fectant is robust enough to react

own strengths and weaknesses. Nev-

reliably within specifications even

ertheless, cleaning materials can be

under differing conditions. Without

combined with sporicidal or bacte-

cleaning, the goals of disinfection

ricidal agents so that cleaning and

are not achieved.

disinfecting is possible in a single operation. However, be careful here:

Reduction of Micro-Organisms on surfacesof Micro-Organisms Reduction on surfaces 1.000.000 1.000.000 100.000 100.000 10.000 10.000 1.000 1.000 100 100 Quelle: RKI

Consequentially, it is necessary for

10 10 1 1 0 0

The requirements for validation are

To avoid undesired interactions

initial position 200.000 germs

still 100.000 germs

defined parameters, more simply

between the individual cleaning

200.000 germs

still 100.000 germs

said: clean surfaces. This implies

and disinfecting components when

that the cleaning must be done

combined, ensure the combinations

provides the removal of contam-

first, then the disinfecting. Cleaning

are expressly approved.

ination from floors, surfaces and

procedures lead to a 50 to 80 percent

initial position

cleaning

desinfection

cleaning

desinfection

just 1 germ just 1 germ

objects and the killing off of path-

reduction of micro-organisms on

Disinfectant-cleaning is predes-

ogenic germs in just one process.

surfaces. An optimal disinfection

tined for areas where the separa-

In short, with one wipe, almost

result, namely a reduction of the

tion of cleaning and disinfecting

everything is gone. However, to

micro-organism count to 1/100000 (a

is logistically difficult because

emphasize once again: “Almost” is

factor of 10 ) is achieved only then.

the reaction time of disinfectants

not enough for cleanroom or even

In other words, only ten in one

would block the use of required

sterile production environments.

million micro-organisms or one in

space. Such spaces are for example

100000 survive after disinfection. It

in hospitals and facilities for older

is self-evident that the dead germs

people and children frequented by

must be afterwards removed as

the public. Disinfectant-cleaning

they in turn present sources of

presents itself here as a logistical

contamination.

and economical compromise as it

-5

Author: Dr. Rüdiger Laub

What the numbers show: It is not enough to only disinfect, cleaning must also be done. The reason is simple. The cell walls of dead germs contain endotoxins and if dead germs are able to come into food or pharmaceutical products, the endotoxins may cause fever or chills in humans. Producers therefore have no other choice than to ensure that in their cleanroom production areas germs are killed and removed.

Disinfectant-Cleaning: This must be considered Cleaning and disinfecting are two different procedures with differing objectives Disinfectant-cleaning is a logistical and economical compromise for not controlled areas Cleaned surfaces facilitate subsequent disinfection Cleaned surfaces are the basis for the qualification of disinfectants and the validation of disinfecting procedures in controlled production environments (GMP) Disinfectant-cleaning requires chemical compatibility of components Disinfection and disinfectant-cleaning need suitable monitoring systems

Source: profi-con GmbH Contamination Control

CLEANROOM MAGAZINE 3/2016 | Disinfectant Cleaning

45

What do you do there, Rico Tengler?

A short profile from the cleanroom industry

Rico Tengler works as a fitter and technician within the manufacturing process at wezi-med , the medical technology sector of Weber GmbH & Co. KG in Dillenburg, Germany.

He assembles among other things kinematic plastic products for minimal invasive surgery. Photo: Weber GmbH & Co. KG

My name is Rico Tengler. I have

instruments which are used in

assembly of the finished plastic

been working here at wezi-med,

various OP techniques – especially

components. I assemble the so-

a business segment of the plastics

in minimal invasive surgery. Since

called specimen pouches which

technology company group Weber

these surgical instruments are

comprise a sealing body and an

GmbH & Co. KG in Dillenburg,

manufactured under controlled

extrusion profile and pack them in

Germany since 2012. I am respon-

conditions, I work in an ISO Class

PE bags that are then hermetically

sible for the monitoring and the

8 cleanroom and according to DIN

sealed. In laparoscopic surgery, the

planning of sterile and cleanroom

EN ISO 13485.

product allows the safe extraction

production as well as for setting up injection molding tools.

of tissue from the body.

Besides the testing of injection molding tools, my tasks also in-

Our company manufactures among

clude the configuration and val-

other things kinematic surgical

idation of new processes and the

What do you do there ‌.? | CLEANROOM MAGAZINE 3/2016

46

What does data integrity have to do with cleanrooms?

SERVICE

Ensuring data integrity is an important aspect of computerized system validation.

Since 2014, the FDA has been paying particular attention to data integrity when inspecting pharmaceutical and active substance manufacturers. This concerns providing the evidence that all operational data are complete and available in the original. Manufacturers have to ensure that their data recording is accurate and data alterations are not performed uncontrolled.

During various inspections car-

data integrity. Data integrity? This

also “virginity”. In this sense, integri-

ried out by the US Food and Drug

sounds like IT. What does this have

ty belongs – besides availability and

Administration (FDA) in past

to do with cleanrooms?

confidentiality – to the three classic

years, several pharmaceutical and

goals of information security.

active agent companies were not

According to Wikipedia, integritas

able to completely demonstrate

stands for “intactness”, “purity”, or

As automation and digitization is increasing with cleanroom technology, the computer systems used for this have to be qualified and validated. Photo: Sven Döring/Agentur Focus

CLEANROOM MAGAZINE 3/2016 | Laws and Regulations

47 Data has to be readable, exact and available in the original

(EU-GMP-Guidelines). Also to

specifications. Relevant parameters

consider are the United States

such as particle count, differential

Pharmacopeia <1116> and norms

pressure, microbiological param-

A uniform definition of integrity

such as “EN ISO 14644 Cleanrooms

eters, temperature and relative

does not exist. The German Federal

and associated controlled environ-

humidity should be monitored at

Office for Information Security

ments” and guidelines such as “VDI

best continuously and automatical-

denotes integrity as the “correct-

2083 Cleanroom technology”.

ly. Therefore, computer-supported

ness (intactness) of data”. The FDA,

systems take over the monitoring

however, understands it as com-

As cleanroom technology is facing

as well as the reporting of meas-

pleteness, consistency and accuracy

increasing digitization and auto-

urement data, warnings and events

of data meaning the data should be

mation of functions in nearly all

today.

Data integrity has to be ensured during both the validation and the operation phase of the computerized system.

Information on how to bring about data integrity is limited

attributable, legible, accurate and

industries, the computers used for

contemporaneously recorded (at

this purpose also have to be qualified

the time of performance) and be

and validated in compliance with EU

original or a true copy.

GMP guidelines Annex 11 in Europe

For computerized system validation,

or 21 CFR Part 11 in the USA.

the international guideline GAMP

1

Putting these definitions aside,

5 (Good Automated Manufacturing

what concerns the authorities is the

Practice, Version 5) recommends -

evidence that the data is correctly recorded and available in its original, unaltered form. It is the obligation

Continuous and automatic monitoring of relevant parameters are a must

similar to facility qualification - an approach in accordance with the well-known V-Model. The validation

of the cleanroom operator to provide this evidence.

It all begins with GxP regulated areas requirements For manufacturers of sterile medicinal products, there are various national and international requirements to observe. Operators have to plan, build and take up operation of their cleanroom equipped facilities according to the appropriate standards and user-specific requirements.

The guidelines for good manufacturing practice regulate the

is to focus on those aspects that are Moreover, metrological monitoring

crucial for patient safety, production

of operations according to defined

quality and data integrity.

procedures is required. Such cleanroom monitoring indicates whether

Having said this, explicit informa-

production is taking place within

tion in GAMP 5 on how data integrity

Data Integrity: This is what it means The recording of data has to be exact, attributable and readable.

Certain activities have to be documented at the time of their performance.

The data record has to comprise complete information from all tests.

Recorded data has to be saved as originals or as true copies.

The data has to be protected from inadvertent deletion or from loss.

The principles of electronic recording can be found in 21 CFR Part 11, in 21 CFR 211 and CFR 212 as well as in Appendix 11 of EU-GMP.

details of facility qualification

Laws and Regulations | CLEANROOM MAGAZINE 3/2016

48 can be brought about is still sparse.

This must be the reason and also

Data should be attributable, readable and accurately and contemporaneously recorded and be original or a true copy.

because monitoring authorities in recent times have been paying particular attention to this topic, why diverse conferences and expert groups are intensively devoting time to data integrity.

In March of last year, the British licensing and monitoring authority

SCIENCESERVICE & TECHNOLOGY

MHRA published a revised “Data Integrity Guidance”². In April, 2016, the American FDA brought forth

Data integrity does not start with operation, but with validation

However, before warranting data integrity in both phases, pharmaceutical companies and their IT service providers first have to be

the Draft Guidance “Data Integrity and Compliance with cGMP”. In this

Data integrity has to be ensured both

clear about which data is at all rel-

publication, the handling of data

during the validation phase and the

evant and if it is known. It should

is promoted as one of the central

operational phase of computer-sup-

also be clarified which data may

topics of quality assurance.

ported systems. This applies to all

be subject to an inspection by the

computerized systems used in GxP

FDA or by national authorities and

critical processes, thus to cleanroom

whether the inspection involves the

monitoring systems as well.

review of pertinent SOPs (Standard

The German Federal Office for Information Technology Security understands data integrity to mean the intactness and preservation of data. Photo: BSI

CLEANROOM MAGAZINE 3/2016 | Laws and Regulations

49 Operating Procedures), for instance

only the fundamental and basic

analytical processes, the experts

“Data Backup and Recovery” or

directions to take. Thus for example,

responsible for the qualification/

“User Concept – System Access”.

it is expected that regulated compa-

validation and quality assurance in

Besides, it is advisable to create a

nies develop flexible and risk-based

a company should consider making

concept for the control of access

strategies in order to avoid and de-

it a matter for the management.

to configuration, system operation

termine breaches of data integrity.

Author: Markus M. Schröder,

and administration and to make this a central feature of the entire

Of course, individual requirements

cleanroom system.

such as the creation of access control systems or an audit trail can be

Secured computer system, secured data

quickly determined and identified.

Managing Consultant, Avantalion

1

Source: FDA Draft Guidance for Industry „Data

Integrity and Compliance with cGMP“

However if approach to the issue

2

is to be risk-based and nearer to

Integrity Definitions and Guidance

See: https://www.gov.uk → MHRA GMP Data

In the validation phase, attention is focused on the way data is recorded, the definition and testing of relevant (system-) interfaces, the logging of results, the definition of access rights as well as the handling of test scripts and test deviations.

In the operation phase, data integrity of the validated system is ensured in that the system owner (IT operator)

Cleanroom Consumables

Clean. Pure. Sterile.

guarantees the correct functionality of the system. Belonging to this are established procedures for data protection and recovery. The system owner, moreover, archives operations data (including audit trails) and evaluates the effects of system adjustments, abnormal occurrences and failures on the data integrity.

The process owner (manufacturer) on the other hand concentrates on controlling critical data entered manually, for example by a double-check (four eyes principle), as well as on reviewing user rights and audit trails.

A selection of our Brands

Data integrity is a management-level issue The perpetuating, ongoing discussions about definitions and approaches to ensuring data integrity show that the topic is multilayered.

www.iab-reinraumprodukte.de

Current FDA requirements specify

Laws and Regulations | CLEANROOM MAGAZINE 3/2016

SERVICE

50

Ruth Lorenz of the Messe Frankfurt because of the considerable number of registrations for 2016, is counting on continued and further growth for Cleanzone.

See what state of the art is all about Cleanroom Trade Fair and Congress is becoming more and more important for users.

Cleanzone 2016 opens its doors on November 8th and 9th, 2016 in Frankfurt am Main, Germany. The number of registrations is already at a high level.

Professional visitors will find here everything needed for the planning, construction and maintenance of cleanrooms. The ReinraumAkademie will be hosting the Cleanzone Congress and podium discussions in the Plaza.

Providers of products and services for clean and sterile rooms have been able to register for the international trade fair and congress since February. Ruth Lorenz, Area Manager for Technology & Production at the Messe Frankfurt is delighted

Practice counts at Cleanzone. In the forums and at the trade fair stands, there will be given first-hand tips and information

with the brisk demand: â&#x20AC;&#x153;Because

from industry professionals. All photos page 50/51: Messe Frankfurt Exhibition GmbH, Sandra Gätke

of the considerable number of

CLEANROOM MAGAZINE 3/2016 | Cleanzone 2016

51

Cleanzone offers everything which is needed for the planning, construction and operation of cleanrooms. Participants value not only the new product innovations but also the close contact and exchange with colleagues.

registrations and the great interest

percent. 88 exhibitors from 12 coun-

– ranging from construction com-

coming from the industry we are

tries presented their innovations to

ponents, climate and ventilation

betting that Cleanzone 2016 will

the 731 professional visitors from

equipment and systems, consum-

continue on its course of growth.

32 countries (2014: 604 professional

able materials such as clothing or

The positive development of the

visitors from 30 countries). The fact

cleaning agents, measurement and

trade fair correlates directly with

that the trade fair in 2015 came across

controlling equipment and systems

the steadily climbing number of

very positively is shown by the high

such as monitoring software as

production areas worldwide.”

level of satisfaction of exhibitors

well as offers for apprenticeships

(83%) and visitors (91%). “In order to

and further education. Alongside

see what state-of-the-art is all about,

product innovations is above all

a visit to the trade fair is absolutely

the exchange of information with

worth every effort” says for example

colleagues and the expansion of

Dario Marty. The graduate techni-

networks which Cleanzone visitors

Cleanzone in October, 2015, closed

cian is responsible for cleanroom

especially appreciate.

with visitor-growth at about 20

maintenance at the Paul Scherer

Visitor satisfaction stands at 91 percent

Institute PSI, the largest research

The trade fair aligns itself towards

institute for natural and engineering

everyone who produces or works

science in Switzerland. “In the area

under controlled conditions, rang-

of cleanroom supports, I was able to

ing from hospitals, pharmacies,

acquire new ideas. Besides this, I was

food products and pharmaceuticals

able to make many new contacts.”

manufacturers, the industries of medical technology, semiconductors

Product innovations discovered, networks expanded

and laser manufacture, as well as the automobile and watch-making industries. This industrial trade fair will take place in Hall 4.0 in the

Cleanzone provides everything need-

Autumn of 2016.

ed for the planning, the construction and maintenance of cleanrooms

Cleanzone 2016 | CLEANROOM MAGAZINE 3/2016

52

TO CL Y A W R U YO

EA N

D WAR A M ROO

START

YOU‘RE BUILDING / PLANING / HAVING A CLEANROOM ?

BY CHANCE A CONCEPT IN YOUR POCKET?

SCIENCESERVICE & TECHNOLOGY

NO

YES

WITH ALREADY BUILD IN INNOVATIONS, OPERATING POSITIVE IN ENERGY EFFICIENCY AND SUSTAINABILITY.

GOOD D! IT‘S N I M R .

NEVE AYS ..

ANYW

NO

YES

NO

WITH INNOVATIONS, EXISTING AS A CONCEPT?

YES DO YOU HAVE THE REQUIRED CONTACTS?

YES

NO

APPLY NOW! CLEANROOM AWARD & CREATIVE PRIZE: DEADLINE

31st AUGUST 2016!

ION !

TULAT A R G CON GET INFO RMED A T THE CLE ANZONE FAIR.

STOP

all information on www.reinraum-akademie.de

CLEANROOM MAGAZINE 3/2016 | Your way to the Cleanroom Award

53 YOUR WAY TO CREAT

IVE PR IZ E

START

YOU‘VE GOT A BEAUTIFUL CLEANROOM?

YES

IS YOUR CLEANROOM REMARKABLY BEAUTIFUL, CREATIVE OR INCREASING MOTIVATION?

NO

TO BUT O BAD! Y THR OU‘VE G EE O OT ANY PTIONS WAY S

NO

YES

YOU RECOGNIZE, THAT EMPLOYEE MOTIVATION CAN BE RAISED BY CREATIVE WORKSPACES?

NO DO YOU PLAN IT FOR THE FUTURE?

YES

APPLY IN 2017!

YES NO

VISIT THE CLEANZONE FAIR & WINNERS PRESENTATION AT

09th NOVEMBER 2016!

Your Way to the Creative Prize | CLEANROOM MAGAZINE 3/2016

SERVICE

Photo: Messe Frankfurt Exhibition GmbH, Sandra Gätke

54

Wanted - award-winning ideas for the cleanroom Apply now for the Cleanroom Award and Creative Prize.

Itâ&#x20AC;&#x2122;s that time again: The ReinraumAkademie is looking for the best ideas in innovation, sustainability and energy efficiency in cleanrooms. The winner will be selected on November 9, 2016, at Cleanzone. Furthermore, the ReinraumAkademie will be awarding the Creative Prize for the most creatively designed cleanroom. Applications for both awards can be submitted up to August 31, 2016.

CLEANROOM MAGAZINE 3/2016 | Cleanroom Award and Creative Prize

55 direction regarding work-place

Cleanroom Award

design, motivation and employee health, it has also brought us a lot of recognition from outside”, says

In the previous year, the Cleanroom

Christian Dragosits, Group Leader at

Award went to Infrasolution AG for

MED-EL. “We are really pleased that

the intelligent measuring system “RobotScan Flex”, which provides a level of quality for filter integration tests unknown up to then. “The

we have received so much positive A happy winner: Infrasolutions won the Cleanroom Award 2015. Photo: Messe Frankfurt Exhibition GmbH,

attention for our efforts.”

Sandra Gätke

resonance at the award ceremony

Companies, organizations, research

was excellent”, says the Chairman

institutes and individuals world-

Mathias Itter. “There have been sev-

wide can apply for the Cleanroom

eral professional articles published

Award. The concept should be com-

which have made for numerous

pletely worked out and designate a

orders.”

revolutionary solution or influence a significant change in the industry.

3000 Euros prize money from the ReinraumAkademie is awarded together with the Cleanroom Award.

Creative Prize

Was awarded for the first time in 2015: the Creative Prize. The first winner was MED-EL. Photo: Messe Frankfurt Exhibition GmbH, Sandra Gätke

Applications for the Creative Prize and the Cleanroom Award can be submitted tot he ReinraumAkademie up to August 31, 2016.

Furthermore, the ReinraumAkademie has awarded since 2015 at Cleanroom Media interviews Frank Duvernell, the founder of ReinraumAkademie and the benefactor of both awards.

Follow the QR code for the interview. Photo: Messe Frankfurt Exhibition GmbH, Sandra Gätke

Author: Frank Baecke

Cleanzone, the Creative Prize for the most optic/ergonometric-creatively designed cleanroom. The first Creative Prize winner was the hearing implant manufacturer MED-EL in Innsbruck, Austria. “The Prize was not only internally the confirma-

Film: Cleanroom Media.

tion that we are going in the right

Submit your application documents now Cleanroom Award: Wanted are ideas regarding the topics of innovation, sustainability or energy efficiency in the cleanroom.

The concepts, products or services should designate a revolutionary solution or influence a significant change in the industry.

Creative Prize: Wanted are the most optic/ergonometric

creatively designed cleanrooms.

The solutions should provide a creative alternative to the »snowwhite noise« of cleanrooms.

Postal Address: Applications for the Cleanroom Award 2016 and the Creative Prize 2016 should be sent to the following address:

ReinraumAkademie GmbH Code word »Cleanroom Award« or »Creative Prize« Rosa-Luxemburg-Str. 12-14 D 04103 Leipzig Tel.: +49 341 98989 302 E-Mail: info@reinraum-akademie.de Web: www.reinraum-akademie.de Deadline for submission: Submission deadline for applications for the Cleanroom Award and the Creative Prize is August 31, 2016.

Cleanroom Award and Creative Prize | CLEANROOM MAGAZINE 3/2016

56

New professional literature on the market The Cleanroom Magazine editorial staff regularly scans publishers for their newest publications for their cleanroom relevance. These book – freshly released – we would like to present.

GMP-/FDA-requirements in qualitiy assurance SERVICE

How can expected and governmentally determined requirements be fulfilled?

How can quality and compliance in operative procedures be steadily assured and improved? How can the qualified person in a pharmaceutical quality system become integrated? Answers to all these questions are presented in the current book.

This practice-oriented book takes into consideration these quality assurance activities in pharmaceutical companies: quality assurance systems, GMP compliance, supplier qualification and GMP relevant agreements and contracts. You will learn how you are able to conform to the steadily changing GMP and FDA guidelines and specifications. „GMP-/FDA-Anforderungen an die Qualitätssicherung“, Amborn, J.; Bakhschai, B.; Engelhard, R. et.al., ECV Editio Cantor Publishers, 2. revised edition 2016, 216 pages, soft cover.

ISBN 978-3-87193-429-2. Price: 72.76 Euros

Project Management Cleanroom Technology

Master every challenge by using our services.

Process Management Qualification

Benefit from our 360° Pharma Consulting to gain more efficiency, safety and quality. independent · transparent · sustainable Visit us at LOUNGES 2016 · booth K3.8

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Validation Computer System Validation

CLEANROOM MAGAZINE 3/2016 | New professional literature on the market

www.avantalion.de

57

PROGRESS THROUGH WISDOM.

e u s s I e n o z n a WCEleSPEAK

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ber 4 eadline: Octo Advertising D line: September 10 d Editorial Dea

Know-how and News – for R&D and Industry. ◾ ◾ ◾ ◾

The leading trade publication in German speaking Europe for Operators and Users Volume 18, 2016 – 5 issues per annum 14,000 qualified readers (IVW)

Cleanroom technology

–

Sterile technology –

Hygiene

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| MAGAZINE 3/2016 Production Fachbücher neu auf dem MarktCLEANROOM

58

Trade Fairs and Congresses

Graphic: Fotolia

SERVICE

08.–09.11.2016 Cleanzone Frankfurt Germany 14.–17.11.2016 Medica/Compamed Düsseldorf Germany 25.-28.10.2016 IFAS Zürich Switzerland

Berlin

Germany Leipzig

12.-15.10.206 Expopharm Munich Germany

Düsseldorf Frankfurt a. Main

20.-23.09.2016 ILMAC Basel Switzerland 25.–27.10.2016 Semicon Europa Grenoble France

2 5 – 2 7 O C T 2 01 6 ALPEXPO G R E N O B L E , F RA N C E

Nürnberg Stuttgart

Munich Basel

Zürich Wangen an der Aare

Switzerland

08.-11.11.2016 electronica Munich Germany 14.-17.11.2017 productronica Munich Germany

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 3/2016 | Trade Fairs and Congresses

59

Events at the ReinraumAkademie (Germany) and the CleanroomAcademy (Switzerland) Cleanroom Expert Days | Reinraum-Expertentage 28.-29.09.2016 | Flexible Cleanroom Design and Integration of Production Facilities,

Equipment and Furnishings in Cleanrooms | Wangen an der Aare (Switzerland) 05.-06.10.2016 | Optimization and Qualification in Cleanroom Operations | Leipzig (Germany) 23.-24.11.2016 | Optimal Cleanroom Personnel | Leipzig (Germany) 07.-08.12.2016 | Optimization and Qualification in Cleanroom Operations | Wangen an der Aare (Switzerland)

BEHAVIOR IN A CLEANROOM 27.09.2016 | One-Day-Training Plus | Wangen an der Aare (Switzerland) 02.11.2016 | One-Day Training Plus | Leipzig (Germany)

TWO-DAY SEMINARS 17.-18.10.2016 | Basics of Professional Cleanroom Cleaning

| Leipzig (Germany)

ADDITIONAL EVENTS

APPLY NOW! CLEANROOM AWARD 2016

28.09.2016 | Swiss Cleanroom Industry Fall Reception

| Wangen an der Aare (Switzerland) 05.10.2016 | Cleanroom Industry Fall Reception

| Leipzig (Germany)

The events takes place in Cleanroom Experience Competence Center Rosa-Luxemburg-Str. 12-14, D-04103 Leipzig phone: +49 341 98989-0 fax: +49 341 98989-200 info@reinraum-akademie.de www.reinraum-akademie.de Cleanroom Experience Competence Center Vorstadt 4, CH-3380 Wangen an der Aare phone: +41 326316050 fax: +41 326316059 info@reinraum-akademie.de www.cleanroom-academy.ch

CREATIVE PRIZE 2016 apply now: 31st

August 2016 winners presentation: cleanzone 9th Nov. 2016

www.reinraum-akademie.de Events | CLEANROOM MAGAZINE 3/2016

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ne nzo a e l c u! issu dline

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Next Issue | October, 2016 CLEANROOM

2/2014

2/2013

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

MAGAZIN

02

Frühjahr 2015

Life & Science Informationen für die Reinraumtechnologie

Blossoming Nature Dangerous Contamination

SERVICE

The influence of pollen and air humidity on your production

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

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

Dresden

Attraktives Reiseziel für Technologen Popular destination for technologists

Blühende Natur Gefährliche Kontamination

Jan Gerbrands Motivation und Leidenschaft Motivation and Passion

So nehmen Pollen und Luftfeuchtigkeit Einfluss auf Ihre Produktion

Cleanroom Award – Fortschritt für den Reinraum

02 2016

CLEANROOM

02

Frühjahr

MAGAZIN

These Chips get under your Skin

2016

Cleanroom Award & Creative Prize 2016

Never stop thinking

How does the desire to have childten correlate with cleanrooms?

Life & Science Informationen für die Reinraumtechnologie

Life & Science Informationen für die Reinraumtechnologie

Nano-particles are found in cosmetics and many other everyday products. Just how dangerous are they?

Newest revisions of ISO 14644-1 and ISO 14644-2

Laws & Regulations

In-Vitro-Fertilisation

CLEANROOM

03

Sommer

MAGAZIN

2016

Life & Science Informationen für die Reinraumtechnologie

Throw out the sparks and protect sensitive products

Summer, Beach and Suncream

High Voltage in the Cleanroom

Talent Development

Experts estimate future prospects in the cleanroom industry

Thanks to the tiny components produced in cleanrooms, billions of devices are able to communicate with each other

Outlook 2016

3D printing is opening new perspectives for cleanrooms

The Internet of Things

Approaching the Dimension Der 3D-Druck eröffnet dem Reinraum neue Perspektiven

Wenn Milliarden von Geräten dank winzigster Bauteile aus dem Reinraum miteinander kommunizieren

So schätzen Experten die Aussichten der Reinraumbranche ein Wie Mitarbeiter zu Reinraummitarbeitern werden

MAGAZINE

02

MAGAZINE

CLEANROOM

2016-03-07_Ducklayout_Cover_mit_Schutzlack_CMYK.indd 1

MAGAZINE

CLEANROOM

winter 2016

01

EDITION 4/2015

EDITION 1/2016

autumn 2015

Impressum

Translation Bill Hillman

CLEANROOM MAGAZIN is edited and published by Cleanroom Media GmbH Rosa-Luxemburg-Straße 12-14 04103 Leipzig Germany www.cleanroom-media.com

Advertising Management Maja Franke Tel. +49 341 98989 404 maja.franke@cleanroom-media.com

Executive Management Frank Duvernell, v.i.S.d.P.

Information Graphics Cleanroom Media (René Dreyer und Daniel Read)

04

Cleanroom Media Management Maja Franke Tel. +49 341 98989 404 maja.franke@cleanroom-media.com

Cover Photo Nils Bröer

Implementation Wohlfahrt GmbH www.wohlfahrt.net

Editor in Chief Frank Baecke Tel. +49 341 98989 405 frank.baecke@cleanroom-media.com

Frequency of Publication quarterly

Authors Frank Baecke Frank Duvernell Maja Franke Dr. Rüdiger Laub Michael Rodd

Printer Löhnert-Druck, Leipzig

Circulation 10.000 copies

ISSN 2364-0405

CLEANROOM MAGAZINE 3/2016 | Imprint

Was hat der Kinderwunsch mit Reinräumen zu tun?

Never stop thinking

03

Life & Science Information for Cleanroom Technology

Life & Science Information for Cleanroom Technology spring 2016

2015-12-07_Ducklayout_Cover_mit_Schutzlack_CMYK.indd 1

09.07.15 12:53

Life & Science Information for Cleanroom Technology

So sieht der Chirurgen-Arbeitsplatz der nächsten Generation aus

Sommer, Strand & Sonnencreme

Nanopartikel stecken in Kosmetika und vielen Alltagsprodukten. Wie gefährlich sind sie?

Künstliche Befruchtung

Recht und Regularien

Das bringt die Neufassung der Norm ISO 14644-1 und 14644-2

CLEANROOM

Operationssaal der Zukunft

Cleanzone 2015 Die internationale Reinraummesse wird zum Impulsgeber der Branche

summer 2016

Mitdenkende Stoffe verändern Medizin, Architektur, Mode und Autoindustrie

Damit kein Funke überspringt — sensible Produkte schützen

Talententwicklung

MAGAZINE

Smarte Textilien

Hochspannung im Reinraum

Ausblick 2016

Keime im Essen Wie die Reinraumtechnik gefährlichen Lebensmittelkeimen den Garaus macht

Life & Science Information for Cleanroom Technology

C LE A N R OOM MA G A Z I N

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

EDITION 3/2015

Vorstoß in die dritte Dimension

Internet der Dinge

CLEANROOM

This is what the surg of the future looks li

Cleanzone 2015 This international cleanroom trade fair gives momentum and impulse to the cleanroom industry Germs in Food Products How cleanroom technology aids in killing off dangerous food product germs

How employees become cleanroom operatives

0 3 | SOMMER 2015

C LE A N R OOM MA G A Z I N

01

Winter

Intelligent implants are able to provide people with new, clever capabilities.

CLEANROOM

ISSN 2364-0405

EDITION 2/2015

Cleanroom Art as per ISO 5

2015

EDITION 1/2015

In 2005, artists built a cleanroom and since this time it has never been used.

04

Herbst

MAGAZIN

Life & Science Informationen für die Reinraumtechnologie

Freude am Gefahrenwerden

03 | SOMMER 2015

spring 2015

CLEANROOM

03

Sommer 2015

EDITION 2/2014

MAGAZINE

EDITION 1/2014

EDITION 2/2013

Regularien Lästige Pflicht oder geldwerte Tipps?

OLEDs Die Lichtrevolution aus dem Reinraum Krankenhauskeime Wie Raumtechnologien Infektionen verhindern

Life & Science Information for Cleanroom Technology

Cleanroom Award – Advancement for the Cleanroom

Cleanroom Award – Challenging the branch

CLEANROOM

Cleanroom Award – Herausforderung an die Branche

Cleanroom Award und Creative Prize 2016

07.12.15 16:38

Reinraum-Kunst nach ISO 5

Mit welchem Blick sehen Künstler Reinräume? Als partikelfreies Kunstprojekt.

Diese Chips gehen unter die Haut Smarte Implantate können dem Menschen smarte neue Fähigkeiten verleihen.

10.03.16 16:57

EDITION 2/2016

EDITION 3/2016

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