Cleanroom Magazine 01-2016

CLEANROOM MAGAZINE

01

winter 2016

Life & Science Information for Cleanroom Technology

Approaching the Dimension 3D printing is opening new perspectives for cleanrooms

Outlook 2016

Experts estimate future prospects in the cleanroom industry

Talent Development

How employees become cleanroom operatives

Laws & Regulations

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

Internationale Fachmesse und Kongress f端r Reinraumtechnologie International trade fair and congress for cleanroom technology Vision. Innovation. Expertise.

8. + 9. 11. 2016 Frankfurt am Main

Save the Date!

3

Dear Readers, What challenges are facing the cleanroom industry in 2016? We queried Netherlands and Switzerland (see page 16). Among the answers, a few topics were especially conspicuous because they were more frequently mentioned than others. Besides standardization, automation and Track and Trace, these topics were particularly dominant: finding and qualifying cleanroom employees as well as the establishment of new standards.

This is why we are emphasizing in this issue how you can develop new or existing employees into qualified cleanroom operatives (see page 28).

Furthermore you will learn about which changes for your production are applicable under the newly revised DIN EN ISO 14644-1 and -2 in our column “Laws and Regulations” (see page 50).

In your own opinion, Frank Duvernell: “We didn’t want to only know

do the cleanroom

which topics are relevant to you in a professional

technology users

cleanroom journal. We also asked if cleanroom

consitute as a

technology users and operators see themselves

seperate industry?

forming their own industry. The findings were conclusive: 47 percent answered with a yes. This was ten percent more than just one year ago.”

Of course, we focus the CLEANROOM MAGAZINE on the needs of our readers with this topic and all others which are presented in this issue.

We re-launched the magazine one year ago with the support from media scientists. The re-launch was based on market, competition and target group analyses. All this resulted in besides a new layout, a restructuring of the contents.

In order to find out how successful the re-launch was, we asked visitors and exhibitors at the last Cleanzone Trade Fair which topics in a professional journal for cleanroom technology are expected. The answers showed us that our mix of stories and articles correspond very well with current cleanroom issues, however we see potentials for making the magazine even better. Exploiting these potentials will be our biggest challenge in 2016 and we are looking forward to tackling these challenges.

I wish you all the best in the coming year and enjoyable reading.

Frank Duvernell Editor

Editorial | CLEANROOM MAGAZINE 1/2016

EDITORIAL

and interviewed cleanroom professionals from Germany, Austria, the

4

CONTENTS 01/2016

08

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08 Title Story: 3D Printing

INHALT

Three dimensional printed objects – everything from a tool, a work piece, even a part of the body – could soon be revolutionizing our lives. 3D printing will also open new perspectives for cleanrooms.

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LIFE & BUSINESS Current News from the World of Cleanrooms

06 What’s Happening in the Market Consumables for cleanrooms will become clearly, cleanly indicated • Semi-conductor investments decrease • German economy lags behind in respect to digitalization • Toyota invests in artificial intelligence • World not prepared for a new Ebola epidemic • Significance of Swiss pharmaceutical industry bigger than previously thought.

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16 Experts’ Forecasts 2016 Title theme: 3D-Printing

28

Cleanroom professionals from Germany, Austria, the Netherlands and Switzerland speak about the challenges facing the industry in 2016.

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20 Controversy: Pharmaceutical Manufacturers place Profit before Innovation

The pharmaceutical industry is more closely observing their profits and not the needs of patients, criticizes the Techniker Krankenkasse (Technician Medical Health Insurance Company). The pharmaceutical product manufacturers are rejecting this allegation as unfounded. We questioned both sides regarding this issue.

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Talent development: From employee to a cleanroom operative

CLEANROOM MAGAZINE 1/2016 | Contents

5 42

24 Portrait: Andreas Rauschenbach How a certified mechatronics technician who always had wanted to build and create things, suddenly became the person in charge of the cleanroom.

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28 Aptitude Development: From

Semiconductors: New materials, new applications

54

Employee to Cleanroom Operative

The best cleanroom equipment is useless if the personnel are not trained in proper cleanroom behaviors and techniques.

Such training courses have to regularly be repeated and the employee learning curve examined.

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32 Insights: On the Road with…

Steffen Röhm, Project Leader at Pharmaserv GmbH & Co KG in Marburg, Germany.

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SCIENCE & TECHNOLOGY Solutions for the World of Cleanrooms

34 Technology in Brief Researchers develop a new kind of data storage • Smarter wound bandages for nerve fibers • Giant molecules block entrance of the Ebola virus into the body • Head OP’s: Robot-worm munches around corners • Stem cell cultivation on algae skeletons • The smallest amounts of fluid exactly measured to the nano-liter • Electronic automobiles: batteries with a brain

Clean area, with a record number of vistors and exhibitors

42 Semi-conductors:

New Materials, New Applications

The digitization of the economy and everyday life is requiring more powerful semi-conductors. The next generation will be based on new materials. Therefore demands on cleanrooms will also be increasing.

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SERVICE

Events, Awards, Regular Columns

.................................................. 46 36 Containments:

Higher Process Safety Demands New medical agents are often in small dosages highly reactive. Therefore containments have to not only reliably protect the product but also employees.

How to achieve process safety.

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Ergonomics and Fitness: Well-being in the Cleanroom

Sitting for long periods of time in front of a microscope or a safety work bench puts one-sided physical demands on the body. By implementing simple but effective measures, cleanroom personnel remain healthy.

and Exhibitor Records

The company InfraSolution AG won the Cleanroom Award with its RobotScanFlex. The new Creative Prize experienced its inauguration. Its first winner is Med-El in Innsbruck, Austria.

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57 Professional Literature:

References for the Cleanroom Industry

• Containment Handbook • Good Transport Practices in the Pharmaceutical Industry

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58 Trade Fairs and Events

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60 Imprint

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41 What do you do there…?

50 Laws and Regulations: The new ISO 14644-1 and ISO 14644-2

Petra Hagel, Manager of Occupational Health Management at Vetter PharmaFertigung GmbH & Co. KG (Vetter Pharma-Manufacture GmbH & Co. KG).

The most important international cleanroom technology norms are being revised. What changes pertain to the production in cleanrooms.

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54 Cleanzone with Visitor

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Contents | CLEANROOM MAGAZINE 1/2016

6

life&Business

LIFE & BUSINESS

What’s Happening in the Market

Cleanroom consumables clearly and cleanly identified Standardization | The industry association “Cleanroom Suitable Consumables” (CSC) is working on laying the foundation for a uniform

the quality of their products. The

a possible 100 points. This is reported

CSC held a meeting in December

in the “Monitoring Report Wirtschaft

regarding this issue. Its long term

Digital 2015” published by the Federal

goal is an ISO standard.

Economics Ministry. By 2020, a cautious

Semi-conductor investments are decreasing

increase to 56 points is expected.

The report examined eleven core industries and arranged these into five categories: from strongly above-

cleanroom consumables cleanliness standard. This would encompass

Prognosis | Worldwide investments

average to strongly below-average.

clothing, gloves, cleaning towels,

in semi-conductors are supposed to

The results: Digitized strongly above-

packaging materials and much more.

decrease in 2016 by 3.3 percent to $61.7

average is only the IKT economy.

Up until now there have been no

billion. This prognosis comes from the

Applicable as digitally above-

consistent, uniform requirements

market research company Gartner.

average are information-intense

specifying how manufacturers in

The analysts are looking to 2017 for

service providers, financial services

regards to cleanroom suitability

renewed growth in the industry and

providers and insurance companies.

should test and appropriately

As digitally average are companies

label their products. Such a set of

in trade and commerce. Digitally

regulations is badly needed in the

below-average are those companies

industry. A survey carried out by the

in transport, logistics, machine

Fraunhofer IFA indicated that users

engineering and construction,

are demanding more comparability.

chemicals and pharmaceuticals.

Manufacturers and suppliers also

Digitally strongly below-average are

need this data as evidence for

businesses in health care, automobile Microchip. Photo: Jürgen Lösel

this growth will be vigorous at 5.5 percent to $65.2 billion. In 2018, the industry will grow by 6.6 percent ($69.4

production and other, miscellaneous production companies.

Toyota invests in artificial intelligence

billion) and in 2019 will grow by 5.1 percent ($73 billion). Expenditures for

A future industry | Toyota wants to

semi-conductor products are regarded

invest a billion dollars in the founding

as an indicator for the expected sales

of a subsidiary with the name Toyota

of electronic products.

Research Institute. This subsidiary

German economy lags behind regarding digitalization

will be concerned with artificial intelligence in two areas: self-driving automobiles and household robots.

The Toyota Research Institute will

Monitoring Report | The degree

start operations in January, 2016.

ent guidelines for cleanroom consumables cleanliness

of digitalization of the German

The investment will be distributed

specifications. Photo: Rainer Bez

economy has reached only 49 out of

over five years. According to Toyota,

The industry association CSC wants to establish consist-

CLEANROOM MAGAZINE 1/2016 | Life&Business – What’s Happening in the Market

7 Toyota investing heavily: in a car that drives accidentfree, regardless of the driver‘s own capabilites. In addition, research aims for robots to aid and support the elderly in and around the home. Photo: Fotolia, jim

artificial intelligence has the potential

dangerous diseases. The rest of the

supported by an Instituts Bakbasel

to create a whole new industry. The

countries are lacking laboratories

study. The reason for the upward

automobile corporation wants to

for the early and timely diagnosis of

correction is the inclusion of the

develop for the long term a vehicle

infections as well as the necessary

research and development data in

which independently of the driver’s

treatment possibilities especially

the calculation of the GVA due to the

ability will never cause an accident.

hospitals with quarantine wards.

change-over to the European system

Additionally, the researchers are

Without such facilities, infections

looking to develop robots to help eld-

could very quickly spread. In Africa,

erly people with household chores.

20 countries lie within the range of

World not prepared for a new Ebola epidemic

free-roaming animals which are capable of transmitting the Ebola virus. WHO reports that more than 28,000 people fell ill to Ebola and 11,000

Early warning system lacking |

died from the virus in the countries

According to the estimates of the

Guinea, Liberia and Sierra Leone

World Health Organization (WHO)

where the Ebola epidemic has only

the world is not properly prepared

recently been declared as ended.

for a new Ebola outbreak. Only

Significance of the Swiss pharmaceutical industry is bigger than thought

The gross value added (GVA) of the Swiss pharmaceutical industry amounted to one-third more than previously estimated. Photo: I-vista/pixelio.de

for national economic accounts. It should be born in mind that 100 Swiss franks of net-value-added in the pharmaceutical industry

Electronic microscopic picture of the Ebola virus.

Photo: Cynthia Goldsmith, CDC

Market Study | The gross value added,

effectuates a further 80 Swiss

the GVA, of the Swiss pharmaceutical

franks for suppliers. This means the

industry in 2014 amounted to over 25

contribution of the pharmaceutical

billion Swiss franks, nearly a third

industry amounts to just under 45

a third of the 194 WHO member

higher than previously assumed. The

billion Swiss franks respectively

countries have an early warning

industry association Interpharma

seven percent of the gross domestic

system for the recognition of

recently reported this information

product (GDP).

Life&Business – What’s Happening in the Market | CLEANROOM MAGAZINE 1/2016

8

Printing the World

Photo: Cleanroom Media

LIFE & BUSINESS

3D printers enable the production of many useful things, such as the printing of micro-structures in cleanrooms and implants in OP’s.

CLEANROOM MAGAZINE 1/2016

9

Complex geometry: finished part from a 3D printer. Photo: 3D Laserdruck

The 3D printer could soon revolutionize many domains of our life. Its areas of application include regenerative medicine, household goods, high-tech products and many more. The 3D printer poses no threat to cleanrooms, rather it will open new perspectives to this industry.

CLEANROOM MAGAZINE 1/2016

10 At the latest when the US law student Cody Wilson presented his selfmade pistol, the topic of 3D printing had become the talk of the town and the reputation of this technology with a very promising future was for the time being ruined. Wilson produced out of plastic 15 out of the 16 parts necessary for his pistol with a 3D printer. For the sixteenth part he used an ordinary nail which acted as the firing pin. The shocked

LIFE & BUSINESS

media invoked the idea as evidence for the 3D printer’s unpredictability and monstrosity.

Printing your own weapon?

The media not so easily frightened approached the 3D printer from the perspective as a device for hobbyists and do-it-yourselfers.

What home-use products were not

3D printer, respectively laser-melting: The actual printing area in which the part is created is hidden behind the door

able to be produced by a 3D printer:

upper left. Photo: 3D Laserdruck

Plates and cups, protective covers and cases for smart phones or

Some of the processes which today

important requirement for the

even plastic ducks for the bathtub

have been consolidated together

current hype in 3D printing was the

were imaginable. Everybody could

under the term 3D printer have

expiration of the American patent.

become a designer. That this

existed for nearly 30 years. Science

This enabled numerous companies

prospect was supported by many

and industry have known for some

and start-ups to further develop and

people was supported by a survey

time: The 3D printer is above all a

improve the 3D printer as well as to

conducted by the research institute

technology which solves problems.

offer models to every interested user

Emnid: 69 percent of Germans

Several utopians see in the 3D

for a few hundred Euros.”

could imagine buying a 3D printer

printer a solution for the issue

and anyway, two percent of those

of world hunger and initiatives

In the meantime, data banks have

surveyed already owned one.

already exist which are working

been compiled listing objects and

on the production of noodles and

products which make complex

meat using 3D printers.

designs using CAD programs

The technology is available with no restrictions

unnecessary. Materials used for printing have also been further developed and improved. “There are available now all imaginable

No fireworks, no magic: Laser-melting in a powder-bed.

Photo: Fraunhofer IFAM

CLEANROOM MAGAZINE 1/2016 | 3D-Print

That the 3D printer is making

materials: plastics, metals, glass

its way from the laboratory into

and ceramics” reports Godlinski.

living rooms and student flats, as

According to the prognosis of

in the case of Cody Wilson, there

the market research company

are a number of reasons for this.

Gartner, the number of 3D printers

Dirk Godlinski, Project Leader for

delivered will double yearly and by

Functional Printing at the Bremer

the year 2019, this number will lie

Fraunhofer Institute for Production

in the range of 5.6 million devices.

Technology and Applied Material

According to Gartner, the 3D printer

Research (IFAM) explains: “An

market will keep on developing out

11 of its niche into a worldwide market

amount to a mere 20 micrometers.

This revolutionary technique used

for consumers and companies.

However, there is more: A further

directly on location offers time-

highlight of this research project

wise advantages: The Mainz doctors

is the successful cultivation of

are able to plan a re-construction

fat tissues in a new kind of bio-

operation within four days by using

reactor. The combination of these

their newly acquired 3D printer. Up

Apart from the hype and all the

fat tissues with a skin model allows

until now, such procedures were

publicity regarding its possible

the production of a complete skin

done in cooperation with external

applications: What is the current

model with a thickness of up to 12

companies and could take up to

status of the 3D printer and what

millimeters.

weeks.

question, it is worthwhile to take

Researchers are hoping that the

Scientifically interesting is the 3D

a look at several current projects

principle of blood flow by using

printer technology additionally

going on in science and industry.

artificial blood vessels could in the

developed for the field of regen-

3D Printer Hype: What can it really do?

can it really do? In answer to this

future enable the production of entire

erative medicine. The central

The EU research project “ArtiVasc 3D”

organs. However the application

research question reads as follows:

is located at the Fraunhofer Institute

possibilities of the skin models are

How are tissues and cells integrated

for Laser Technology (ILT) in Aachen,

diverse: They promise quick help with

with materials and surfaces foreign

Germany. Researchers are working

skin injuries over large surface areas

to the body? The poor adherence of

on reproducing lower layers of

or they could serve as substitutes,

human skin. The reproduction of

replacing live test animals in the

upper layers has long been possible.

pharmaceutical industry.

These layers are very thin and don’t have to be supplied with blood. The

True to Original Patient Models

layers underneath, the subcutis, have to absolutely be supplied with

The Hospital for Mouth, Jaw and

blood and are interspersed with

Face Surgery (MKG) at the Medical

blood vessels, as without a blood

University Mainz in Germany, has

supply, no life.

revolutionized its métier with 3D printing. For example, with jaw re-

The scientists at the Fraunhofer ILT

construction, a piece of the fibula is

have developed a new procedure

removed in order to close the gap in

to produce artificial blood vessels

the jawbone. The 3D printer is able

which are biologically compatible,

to produce an exact model of the jaw

porous and branched, therefore

and the fibula. Subsequently, the

“An important requirement for the current hype in 3D printing was the expiration of the American patent.”

Dirk Godlinski, Fraunhofer IFAM

To print first. This is now possible. Photo: 3D-Laserdruck

implants as well as the body’s own defensive reactions could strongly influence a treatment’s success such as with artificial joints, heart pace makers, blood vessel prostheses or artificial teeth. Material research is therefore an important pillar in the research at MKG. Professor Bilal Al-Nawas explains: “The 3D printer

enabling a uniform and consistent

surgeon is then able to play through

enables us to plan re-construction

blood supply. This procedure is

the operation in advance, taking

operations for our patients within

based on 3D printing: The structures

into account all details and possible

a relatively short period of time

are mathematically simulated and

complications. This enables him to

and provides a link to other groups

then built layer for layer from a

plan the operation specifically for each

working intensively to develop

synthetic polymer in a 3D printer.

patient and to carry out the operation

innovative materials for implants

The individual layer-thicknesses

according to this individualized plan.

and re-construction operations.”

3D-Print | CLEANROOM MAGAZINE 1/2016

LIFE & BUSINESS

12 Besides the printing processes

immediately fully operational, for

replaced: “Our company produces

which are being driven towards

example as sensors for measuring

3D laser building components in

ever smaller resolutions, the second

forces. Alexander Kaya, Managing

a clean room environment which

fundamental problem of 3D printing

Director of Nanoss: “More than 250

is able to create reproducible

is: How do the printing materials –

complex process steps involving

climatic conditions in order to

the filaments, powders and metals

cleanroom equipment, from the

keep the production environment

– allow themselves to be produced

initial idea to the finished circuitry

stable for the highly sensitive

and processed so that the desired

have been required to roll out

metal-laser-melting equipment.”

properties are obtained at high

sophisticated micro-components

The processing powder demands

levels of dependability? Regarding

such as sensors with a guaranteed

constant temperature and air

medicine, printed structures

quality and quantities.” In contrast

humidity conditions.

have to be as bio-compatible as

to this is the Nanoss procedure “a

possible. In engineering, printed

revolutionary one-step procedure

Sven Skerbis gets the clean room

metal structures should have the

which makes it possible to completely

know-how from his company’s own

same rigidity and density as those

bypass the numerous, complex

“Family”: 3D Laserdruck belongs to

parts produced using conventional

cleanroom processes such as masking

the consortium of the ap-systems

casting procedures.

techniques” emphasizes Kaya.

GmbH, a Reutling cleanroom

Will ‘cleaner’ 3D printing make cleanrooms redundant?

turnkey supplier. Martin Hirlinger, Can the 3D printer make cleanrooms

the Managing Director of ap-

dispensable? Sven Skerbis who is

systems works next door to Sven

responsible for technical sales at

Skerbis and explains that the

With an example of a third app-

3D Laserdruck GbR in Reutlingen,

activities in the direction of 3D

lication, the meaning of 3D printers

Germany, doesn’t think so. The

printing have been expanded since

for the cleanroom industry comes

company is a specialist in the

the technology emerged a few years

to a head: The company Nanoss

field of metal-laser-melting and

ago. “The 3D printer is our youngest

GmbH in Darmstadt, Germany, a

produces for its customers’ diverse

child” says Hirlinger.

producer of micro-components

metal parts and components in a

such as sensors, is touting a new

3D printer.

3D printer-based product with the idea that it could make the complex and expensive traditional

Cleanrooms will always remain necessary

The Challenge of Series Production Sven Skerbis and Martin Hirlinger see their challenges with laser-

manufacturing processes of semiconductors and silicon as well as

In a dialogue with Skerbis, he

melting while the industry faces

cleanrooms themselves dispensable.

admits that in specific cases such as

the challenge of crossing over to

with the sensor manufacturer, this

mass production. This is the step

Nanoss is three-dimensionally

is certainly conceivable. However,

which the 3D printer still has to

printing micro-components onto

he can’t imagine for his company

take. Injection molding machines

arbitrary substrates. They are

that the cleanroom could ever be

produced in high volumes are

Seit 12 Jahren Kompetenz für generative Technologien

14. – 16. Juni 2016, Messe Erfurt • Fachmesse und Kongress

Rapid.Tech

• Anwendertagung „Neue Technologien“

International Trade Show & Conference for Additive Manufacturing

• Fachforen Wissenschaft, Medizintechnik, Luftfahrt und Werkzeuge

www.rapidtech.de

CLEANROOM MAGAZINE 1/2016 | 3D-Print

Titelmotiv: Bremspedal, EOS/Materialise Foto: Andreas Stedtler

13 still considerably faster and more

(see interview on the future of 3D

another question which end users

efficient than a 3D printer. As of

printing on page 14)

concerning their preferences have

yet. “Because of continued process optimization, 3D productivity continues to increase. In medical

Problem Solutions for a better Life

technology and in the aerospace

to ask.

In industry and in science, 3D printers are without a doubt tools with

industry, we are currently seeing

The news about producing weapons

great potentials, tools which solve

breakthroughs in small and

with 3D printers comes up again

problems on a small scale and on a

medium-size series production

and again since the time of Cody

large scale improve all our lives.

when complex geometries are

Wilson. However very few of

requested” observes Sven Skerbis.

the plastics used were actually

Author: Piet Felber

suitable for a plastic – weapon 3D printer manufacturers and

– imitation. In contrast, the list

cleanroom builders have a

of hopeful inventions which 3D

common nut to crack: How can

printing makes possible has in the

the 3D printer be better integrated

meantime become nearly endless:

into cleanroom processes even

Clothing without seams and waste

when under the demands of

material, less costly prostheses,

series production? For cleanroom

even automobiles produced in a 3D

builders and service providers this

printer are less today utopia than

question poses far-reaching fields

concrete developmental goals. If

of activities. Dirk Godlinski from

plates and cups produced in 3D

the Fraunhofer IFAM confirms.

printers are really necessary is

Complex geometry: finished part from a 3D printer.

Photo: 3D Laserdruck

How 3D printing works Under the terminology 3D printer, several production processes have been combined with which objects, assembly parts and tissues can be produced in diverse ways. More correctly, these processes should be designated as generative, respectively additive production processes. The oldest of these processes come from the 1980’s. Three fundamental types of processes should be differentiated: Stereolithographic respectively Liquid Material Procedure: With this procedure, a liquid plastic is selected and hardened layer for layer by using a laser. With some of these procedures, the created part is dipped again and again into the material whereby the next layer is put on. Other procedures use a large roller on which the part is created. These rollers can be turned inside a material bath: Finished parts can be removed from the roller outside of the material

bath while inside the fluid a new part can be created on the roller.

Powder-based Beam Fusion: The most established beam fusion procedure is selective lasermelting. The processing material is at first applied in powder form in a thin layer onto a base plate.

The material is selectively melted with a laser beam and forms a hard layer after solidification.

Further layers are applied and hardened until the part is finished.

Freeform Procedure: These are the processes which can be most closely compared with 2D printing processes: With “Fused Deposition Modeling” a solid filament (plastic, wax or wire) is fused using a hot nozzle and then applied onto a base plate. The object is built up layer for layer on this base plate without being supported by a material bath or bed of powder. Supporting structures may also have to be printed depending on the kind of object. These structures are then removed after the printing process has been completed.

3D-Print | CLEANROOM MAGAZINE 1/2016

14

“Printing processes mustn’t become mere particle accelerators.“

LIFE & BUSINESS

Dirk Godlinski, Project Leader Functional Printing at the Bremer Fraunhofer IFAM in consideration of the future of 3D printing.

Cleanroom Magazin: Promises

advances in 3D printing with high-

implants which have to be processed

are being made which indicate

performance materials concurrent

under clean, sterile conditions, or in

that advances in 3D printing are

with improved reproducibility

laser facilities which process with

significant, especially in the areas

there are enormous cost-saving

flammable or very fine, toxic metal

of medicine, the life sciences and

possibilities, when quantities are

powders. There are producers which

sensor technology. What does 3D

low and with respect to lightweight

are now attempting to appropriately

printing still have to ‘learn’?

construction and function-integra-

encapsulate their printers. In these

tion, in the aeronautic and space

cases, cooperation between printer

Dirk Godlinski: These areas of

industries, for example in the con-

manufacturers and cleanroom or

application are in fact the most

struction of satellites.

glove-box professionals would be

important. 3D printers are to date

rational. With the integration of

operated as ‘stand alone’ devices. A

Cleanroom Magazin: How has the

3D printers in production processes

qualitative break through would be

opinion arisen that 3D printing in

with cleanrooms, such as in the

for many experts the linking of 3D

some areas of application make

micro-electronics industry, it would

technologies with other industrial

cleanrooms redundant? Couldn’t

be important to consider the issue

production processes such as ‘pick and

it more be thought that synergies

of compatibility. The printing

place’. With such 3D hybrid processes,

would come about?

process should never become a

it would not only be possible to set

particle accelerator and in view of

up components geometrically but

its cleanroom suitability perhaps

also to simultaneously integrate the

be modified. In powder-based

electronics, connectors and so on.

processes, the risks are significant.

At the end, the final product would Cleanroom Magazin: Are there

emerge.

application areas in which 3D Cleanroom Magazin: In which other

printers will have to be deployed in

areas could there exist application

clean environments?

possibilities?

Dirk Godlinski: A current issue is the Dirk Godlinski: Further application

deployment of 3D printers in the

possibilities exist in the lighting

production of satellites and rocket

industry where low volume

components which is to take place

production often takes place. The

in clean environments in order to

conventional products could be

Dirk Godlinski is the Project Leader for Functional Prin-

minimize sources of error when put

replaced with functional LED

ting at the Bremer Fraunhofer Institute for Production

into operation in outer space. The

lighting products consisting of frames, housings and lamps

Technology and Applied Materials Research (IFAM).

Photo: Fraunhofer IFAM

next step would be the deployment under the conditions of outer space:

constructed, integrated and when

Dirk Godlinski: Some 3D printers

Aboard the International Space Sta-

as the case may be outfitted with

have to be encapsulated due their

tion ISS, a 3D printer has been in op-

additional sensors all with 3D hybrid

environments, for example printers

eration since 2014 for the production

printing processes. Because of

for biological materials, tissues and

of parts using synthetic materials.

CLEANROOM MAGAZINE 1/2016 | 3D-Print

15

6–8 March • Nice, France

ISS EUROPE 2016 Transforming Markets • New Applications • New Opportunities A new age is dawning in the micro/nano-electronics industry as the use of ever more complex and capable chips is complemented by a developing demand for smart systems to fuel, the Internet of Everything.

These market changes are driving a new era of industry value chains – extending beyond the

traditional semiconductor companies to the full ecosystem. This is being accompanied by a massive influx of new applications intended to meet societal needs with cost efficient electronic solutions, enabling intelligent mobility, future cities, smart power, health – to name but a few.

Speaker Outline:

Laith Altimime SEMI Europe

Cor Claeys imec

Christophe Frey ARM

Asit Goel NXP Semiconductors

Rob Hartman ASML

Dan Hutcheson VLSIresearch

Haruyoshi Kumura Nissan Global Foundation

Klaus-Dieter Lang Fraunhofer IZM

Philippe Magarshack STMicroelectronics

Bill McClean ICInsight

Denny McGuirk SEMI

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16

Experts‘ Forecast 2016

LIFE & BUSINESS

What Challenges are waiting for the Cleanroom Industry.

The CLEANROOM MAGAZINE interviewed cleanroom professionals in Germany, Austria, the Netherlands and Switzerland as to what topics and trends will influence and characterize the cleanroom industry in 2016.

could lead to needing new levels

Frans Saurwalt President of the International Cleanroom Society ICCCS, Leusden, the Netherlands

strumentation is able to count both

cleanroom behavior and more

separately. Up until now, for each,

thorough cleanroom cleaning.

of standardization and changes to our scales and indexes. Additionally, we will require more disciplined

individual microbial contamination measurement, an individual breeding substrate was needed which had to be incubated for days on end. To-

Michael Müller Managing Director vali.sys gmbH, Wetzikon, Switzerland

I see two formidable challenges for

day, a new process using lasers and

the cleanroom industy. For the first,

optical detectors immediately recog-

From my standpoint, the biggest

we arguably need new norms for the

nize all metabolisms at one go. New

challenge for the cleanroom industry

growing presence of germs, for the

devices, whose development was su-

lies in the assured acquisition

second we need to pay stronger at-

pervised by the Dutch Cleanroom So-

of professional, qualified future

tention to the cleanliness of the air

ciety ICCCS, available for the meas-

employees. Several colleges and

and surface areas.

urement of particles on surface areas

universities have already taken on

are much more exact than previous

the task of developing new study

devices.

programs, however these programs

The reason for this is founded on the new measurement technology

have yet to be implemented into their

available to the industry. Newly de-

The result is: We are suddenly ob-

curriculums. We here in Switzerland

veloped devices count not only parti-

serving that there is much more

are markedly noticing that there are

cles without differentiating between

contamination in cleanrooms

next to no trained, qualified cleanroom

germs and dust particles the new in-

than previously assumed. This

personnel available. In order to cover our company’s needs, we hire people with technical backgrounds and train them in-house.

An important issue in 2016 will be the continued development of sensor technology. The trend to obtain even more information from devices will continue to prevail. Many sensor manufacturers have been working in this direction for some time. The goal is to develop into industrial technology the mainstream technology such as is prevalent in mobile telephones. A mobile

Frans Saurwalt

CLEANROOM MAGAZINE 1/2016 | Experts‘ Forecast 2016

telephone is able to intuitively serve

17 expansion for which we will need trained, qualified employees.

From my point of view, the issues of energy-thematic, renewable energies and energy efficiency in cleanrooms will increasingly become more important in 2016. Additional trends will be the growing importance of health and ergonomics in work places. We want to keep our employees for as long as possible, as healthy as possible and for this a lot can be done in and around a cleanroom. Belonging to this aspect is Michael Müller

the factor of color and its positive ef-

Markus M. Schröder

fects which has up to now been largethe needs of any user. When this

ly underestimated.

legislative act in August, 2015, the

becomes successful in industrial

i m pl e m e n t a t i o n o f m ea s u r e s

technology and when the division

It is also important that companies

protecting against falsification,

between mobile communication

don’t get bogged down with regulations,

EU Directive 2011/62/EU is coming

devices and industrial technology

rather to find their own ways on this

closer. From then on time will be

is surmounted, the gains for users

‘Highway of Norms’. In this respect,

running, as until the official start in

would be substantial in view of data

seminars, trade fairs, conferencing

2019, the serialization of medications

and Apps inter-exchanges.

and exchanges of experience will

available only on prescription will

Christian Dragosits Group Leader MED-EL Medical Electronics, Innsbruck, Austria will be the continued training and

“Track-and trace will challenge companies in the pharmaceutical industry.”

schooling of our employees and to re-

Christian Dragosits, Group Leader MED-EL

The major challenge for us in 2016

main at up to date levels of knowledge and know-how. We have 200 people employed in our cleanroom and are

help. We have been supporting several

be binding in the EU. This means

currently in the planning stages for

colleagues who have had their problems

that companies will at first have

seeing the forest through the trees with

to initiate the serialization of

help and advice. Reciprocally, we are

individual packages. Pilot projects

also profiting with this support as we

have already been started in larger

are faced with questions which we

companies however many middle-

ourselves would never have asked.

sized companies don’t believe they have to start thinking about this

Christian Dragosits

Markus M. Schröder Managing Consultant, AVANTALION Consulting Germany GmbH, Berlin, Germany

issue. This is a false conclusion, as

From my standpoint, the topics of

but also the SOP’s and internal

Track and Trace will challenge

procedures in nearly every de-

pharmaceutical companies in

partment. Realistically, I see the

the coming year. With the release

implementation time frame as

of the first draft of the delegated

being at least one to two years.

to be able to trace every single box or bottle, not only the machines and IT systems have to be adapted to the new IT-supported processes,

Experts‘ Forecast 2016 | CLEANROOM MAGAZINE 1/2016

18 Gerhard Winter Professor Faculty Life Science, Albstadt-Sigmaringen University, Germany The classification of cleanroom cleanliness classes from ISO 9 to ISO 1 will not be sufficient in the future,

LIFE & BUSINESS

as technological developments are

longer will people be sent into clean-

all sensor indicators registered and

rooms, rather the production must

determined correct. Nothing in

and will be carried out by robots.

the future will be undetected or to go unnoticed as the indicator will

Andreas Fiebich Product and Project Manager, Division Pharma, Niotronic GmbH, Gratz, Austria

remain red and the cleanroom is protected against contamination.

Joachim Ludwig Founder and Managing Director COLANDIS GmbH, Kahla, Germany

encroaching into the nano-meter

I believe that the further and

range. This is making possible the

continued automation of cleanroom

production of completely new prod-

technology belongs to the most

ucts for example medications which

important developments in 2016.

The trend toward mini-environments

are absorbed by rubbing them in-

These developments include status

and isolators will continue in 2016.

to the skin thus eliminating many

signals and indications which will

The need exists in semi-conductor

side effects.

incorporate visualization technology, voice systems which will give employees acoustic instructions as well as authorization via RFID chips which will be able to specifically support and help employees inside air locks. The entering of cleanrooms by actuating the emergency stop button will no longer be possible in the future as the personnel will be guided by modern measurement, sensor and automation technology which will help to rule out errors.

Decisions will become as easy to make as possible for production employees for example via red and

Joachim Ludwig

green indicator lights. Therefore employees will carry out their

backend processes in which the

activities or enter a cleanroom

integrated circuits are isolated. Also

Our particle safety limits, however

only when all required sensors are

with injection molding processes

end for the cleanest cleanliness class

active, alarm systems are activated,

where clean air from ceiling vents

Gerhard Winter

ISO 1 at the value of 0.1 micrometer.

is barely able to reach the hot

Particles of this size will soon be-

machines, such developments are

come too big for production in clean-

economically reasonable in view of

rooms, as the topic of miniaturiza-

the operating costs as it makes more

tion will continue to advance. This

sense to put the essential processes in

trend has not only significant effects

clean environments than to put the

on cleanroom technology but also on

machines inside a large cleanroom.

measurement technology, cleaning

Within the word cleanroom, the

procedures and much more. There-

word room is included which makes

fore companies which produce in

many people to think on length,

clean environments will be facing

width and height instead of on the

brand-new challenges. This will con-

process. Consultation is necessary in

cern especially pharmaceutical pro-

these cases.

ducers and the semi-conductor inA further development can be seen

dustry. In practice, this all means in plain language: In the future, no

Andreas Fiebich

CLEANROOM MAGAZINE 1/2016 | Experts‘ Forecast 2016

in the advancement of controlled

19 environments into more and more

employees very difficult. Therefore it

industrial subsectors and sub-

is high time for the set up of academic

divisions, areas which today are

degrees and apprenticeships by the

hardly imaginable. The same applies

Chambers of Commerce and Industry

for new markets such as South

as well as by the various associations

America. In Brazil, a semi-conductor

and syndicates. What we need is

production facility is being built in

something like the universally

which many cleanroom peripheries

deployable cleanroom engineer or

are being set up. In the Arabian

the mechatronic technician for

world, new technologies are being

cleanroom technology.

developed for the time after the oil runs out and in Iran which can soon

The second challenge is standard-

count on the end of the sanctions,

ization. The cleanroom industry

there is a huge backlog for hospital

finds itself only in the early stages.

and high-tech technology.

Everyone is cooking his own brew.

For example, when we clean parts

Ludwig Költzsch

Ludwig Költzsch Founder MKF GmbH, Lederhose, Germany

require clean production conditions

customer says: Do it according to

are coming in from all sides. Take

our procedures, otherwise you won’t

for example the automotive industry

receive the order although we are able

The acquisition of employees and

whose very strict requirements are

to guarantee the same result using

standardization are for me the major

forcing more and more suppliers to

our own procedures. It is difficult to

challenges. The cleanroom industry

produce in cleanrooms. This is leading

adapt to every individual customer

will experience a further boost in 2016

to a shortage in employee potentials

instead of keeping to one standard

because new industrial sectors which

and is making the acquisition of new

fulfilling the same results.

PT16_175x125_CLEANROOM_MAGAZIN_C4_PHARMA.indd 1

for the automotive industry, the

14.12.15 13:40

Experts‘ Forecast 2016 | CLEANROOM MAGAZINE 1/2016

20

Profit versus innovation

Follows the return of the pharmaceutical industry, rather than the needs of the patient?

An expert dispute.

LIFE & BUSINESS

An industry in sectors with high profits is increasingly active and neglected diseases unprofitable. The pharmaceutical industry rejects the accusation as unfounded. We have 2 contrasting views on this topic.

PRO: Prof. Dr. Gerd Glaeske,

of striving for returns instead of

co-editor of Innovation Reports

medical progress, in other words innovation would find no place

Cleanroom Magazin: According

where it was needed. Are the lives

Innovation Report 2015, the

of patients at risk?

Techniker Krankenkasse, the pharmaceutical industry developed

Gerd Glaeske: That strive

over the needs of the patient. What

pharmaceutical companies make

is the basis your thesis?

in any sector, is not to criticize.

There are privately owned

Prof. Dr. Gerd Glaeske is co-editor of the Innovation Report

Gerd Glaeske: The Innovation

businesses that have obligations to

Report has always pointed out that

their shareholders, pension funds

the research of the pharmaceutical

or owners. The problem lies in the

industry is necessary. Because in

fact, that they will always try to

many disease effected areas new

make high profits with drugs that

or existing drugs are lacking.

shows no medical progress. The

2015, the Techniker Krankenkasse.

The pharmacologist studied one of the most famous health scientists in Germany. Glaeske was from 2003 until 2009 Member of the Advisory Council

“Research costs are not really transparent” Prof. Dr. Gerd Glaeske

on the Assessment of Developments in Healthcare. Since 1999, professor of medicinal, Glaeske applied research at the Center for Social Policy at the University of Bremen and is the head of the research unit “drug counseling and drug information”. Since 2007 he is Co-Director of the Department of Health Economics, Health Policy and Health Services Research. His research areas are the transparency, quality and efficiency of the drug market.

PRO

Currently, there is an increase in

welfare of the patient may then be

rare diseases, new antibiotics and

at risk. When with economically

antidepressants. Nevertheless,

oriented studies new drug offered

among the new drugs especially

as a therapeutic advance and

expensive supplments, special

prescribed widely. The examples

preparations are needing to be

of rheumatic agent Vioxx, the

applied in cronological diseases

cholesterol-lowering drug Lipobay

or multiple sclerosis, while in

or the appetite inhibitor Acomplia

the treatment of infections in

should teach us not to speak rashly

hospitals in Germany rises every

of therapeutic progress - all of

year up to 15,000 people, and these

these funds had to be taken off

people usually end up losing

the market as sometimes fatal

there life, due to a lack of effective

incidents did occur.

antiviral drugs.

Cleanroom Magazin: The report

CLEANROOM MAGAZINE 1/2016 | Controversy

Cleanroom Magazin: The pharma-

criticizes the fact that new cancer

ceutical companies are accused

drugs have a degree of innovation

21 but the medical benefits often bear

equation “Money for Value”, and

no reasonable relation to the price.

“Value for Money” with appropriate

Why is this so and through which

numbers.

pipelines of many companies, you can be sure, this will be like this also in the future.

health policy incentives this could potentially be changed?

Cleanroom Magazin: In your opinion, is the criticism justified,

Gerd Glaeske: With many new

that the pharmaceutical industry

oncology medicine, prices are

follows the return and not the

growing much faster than the

needs of the patient?

Cleanroom Magazin: The pharmaceutical companies are accused of striving for returns instead of medical progress, and innovation would find no place where it was needed. I ask again is

“Innovations has been repeatedly approved” Stefan Oelrich

the lives of patients at risk?

therapeutic benefit. We note that

Gerd Glaeske: Yes, and we urgently

there is an additional survival time

need to talk about priorities in

of 20 to 40 days up to a few months

research and about the value

in the majority of newly marketed

and benefits new drugs have to

agents. The cost of these treatments

have. We need to have absolutely

are however at 50,000 euros and

no doubt about what research

more. There should exist more

activities the pharmaceutical

contracts for cost containment

industry is undertaking. But

risk of companies: If the funds do

not all new medicines are also

not deliver what they promise,

innovative in terms of their added

the costs between insurers and

therapeutic value over existing

manufacturers should be divided.

Stefan Oelrich is since 2011 the

medicines. This shows the AMNOG

Managing Director of Sanofi-

In addition, the funds should

process (Pharmaceutical Market

Aventis Germany GmbH. The French

be more cost-effective and more

Restructuring Act), which shows the

umbrella company Sanofi-Aventis

frequent, as longer they are applied.

opinions of the Institute for Quality

is one of the largest pharmaceutical

and Efficiency in Health Care and Cleanroom Magazin: Let’s go back to

companies worldwide. From 1989-

demonstrates our Innovation

2011 Oelrich worked at Bayer inter

the accusation for profit. Have high

Report.

alia, in South America and in Paris

prices for new drugs not justified

at the head of Bayer HealthCare.

by the fact, that the industry needs to refinance their research and investment costs?

Gerd Glaeske: I could answer that question much better if the research costs would be really transparent. But it is not just about the research costs, it is also about the purchase price of innovative

CONTRA: Stefan Oelrich, CEO Sanofi-Aventis Germany GmbH Cleanroom Magazin: According Innovation Report 2015 the pharmaceutical industry is developing over the needs of the patient. What do you say to this argument?

drugs for other companies. And sometimes the whole biocompanie is bought equal. Research has

Stefan Oelrich: It is unfortunate that the Innovation Report

clearly changed: innovations were

repeats this assertion. The

bought, not developed. That is why

truth is that real innovations

it has become difficult to talk about reasonable prices and backed the

2003 went Oelrich to the US where he marketed as vice president of marketing the Bayer portfolio. From 2007 he also initiated in the USA as Senior Vice President the Women’s Healthcare business. Since 2013 Oelrich is member of the Association’s Research-Based Pharmaceutical Companies (VFA). In June 2015 Oelrich also took over the position as spokesman of the cluster from the health industry Berlin-Brandenburg.

CONTRA

have been approved during the current year. If you look at the

Controversy | CLEANROOM MAGAZINE 1/2016

LIFE & BUSINESS

22 Stefan Oelrich: The welfare of the

today, who are either tumor-

consistentlyfollow the return or

patient is always at the center of

free or could extend their lives,

in other words profit, and not the

our actions.

significantly are doing that.

needs of the patient?

Without the patient’s well-being,

there is no additional benefit

Cleanroom Magazin: Let’s go

Stefan Oelrich: That a company

in the German reimbursement

back to the accusation for profit.

would like to achieve a return on

system.

Have high prices for new drugs

its economic activity, is a driving

justified the fact, that the industry

force of the market economy. This

Cleanroom Magazin: The report

needs to refinance their research

combined with the patient’s well-

criticizes the fact, for example,

and investment costs?

being, is not a contradiction. A

that when new cancer drugs of

prescription drug that passes by

the degree of innovation and the

Stefan Oelrich: I do not understand

the needs of the patient, receives

medical benefits often bear no

this point. The cost of drugs

in Germany no added value and

reasonable relation to the price.

have remained stable over the

thus in consequence a price

Why is this so, and through which

last five years in Germany and

that can not be higher than the

health policy incentives is there a

therefore makes it possible to

current economical comparison

need for change?

compensate for the rising costs

of hospitals and doctors. Higher

Stefan Oelrich: The research

costs for innovations were able to

into cancer has made enormous

be compensated for by low-cost

progress over the past decade.

generics.

Here a mixed viewed discussion

takes place. What matters, is that

Cleanroom Magazin: This is the

many patients who live through

bottom line: Is the criticism of the

the innovative drugs in oncology

pharmaceutical industry that you

therapy.

Author: Gero Hassink

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Cleanroom technology

–

Sterile technology –

Hygiene

–

Production

CLEANROOM MAGAZINE 1/2016

24

How a Virgin found himself in the cleanroom

Photo: Cleanroom Media

LIFE & BUSINESS

Andreas Rauschenbach manages the mkf GmbH cleanroom.

Actually he always wanted to create, to build something, therefore he became a mechatronics technician. However instead of building clever and ingenious machines, Andreas Rauschenbach takes care of particle counters, air humidity, job orders and assignments. What went wrong? Nothing at all! He was merely asked one day if he wanted to be the person responsible for the cleanroom and he said yes.

How a simple, harmless question

ing and construction. However,

a 260 person community in the

can sometimes change into a life’s

what he didn’t know was: He was

federal state of Thuringia. Although

journey. It happened five years ago.

supposed to build these machines

Lederhose’s coat of arms does

“Rauschi, do you trust yourself to

inside a cleanroom. “That was my

indeed bear a pair of lederhosen,

do this?” the Production Manag-

first contact with this topic” re-

the town’s name has really nothing

er wanted to know. Andreas Raus-

counts the 30 year old.

to do with clothing. The name

chenbach didn’t need much time to

goes back to the Slavic name of

think about it. He was supposed to

Out of this “first contact” has in

Ludoraz. Today in Lederhose a

be building machines. No problem,

the meantime become his main

stone’s throw from the Autobahn

he was after all a qualified mecha-

job. Andreas Rauschenbach is the

A9, the company mfk GmbH with

tronics technician with experience

man responsible for the mkf GmbH

its 85 employees builds customer-

in specialized machine engineer-

cleanroom in Lederhose, Germany,

specific automation solutions. Since

CLEANROOM MAGAZINE 1/2016 | Portrait

25 2008, in addition to building high-

figure, the green polo shirt and the

and footlets. The cleanliness val-

tech assemblies and devices under

grey cargo trousers – the company’s

ues were nonetheless within lim-

cleanroom conditions, the company

working-clothes colors – emphasize

its” says Rauschenbach und sounds

provides services such as cleaning

this impression. However when

a little surprised himself at this. To-

and packaging inside cleanrooms.

speaking to him, it becomes obvious

day he can never imagine working

that no greenhorn is standing

under those conditions. In those

in front of you. Rauschenbach’s

days, however, there had been no

Concerning the latter, there was a customer who started the ball rolling. He had request a solution which was only possible to achieve inside a cleanroom. The company’s management decided to push forward into this new field of business and has never regretted this decision. Today, the products

“In the beginning, cleanroom employees wore only a gown, bonnet, gloves and footlets” Andreas Rauschenbach, mkf GmbH

coming out of the cleanroom are responsible for a large part of the yearly revenues. No one thought

entrance is that of an experienced,

one responsible for the cleanroom.

that this would be possible five years

mature, calm and articulate person

In 2010, as he entered the world of

ago. “We started really in a small

and he really understands his

cleanrooms, his production man-

way with very few square meters of

trade: His cleanroom competence

ager merely “gave a short introduc-

cleanroom space – virtually in a flow

gleams in every sentence whether

tion and initiation” and “roughly

box” says Rauschenbach jokingly.

the topic is about permanent versus

explained” the work to be done. “In

Because of his black beard, his

removable floor mats, or ultra-sound

this way, I slipped into the world of

teeth appear especially white when

cleaning with ultra-pure water,

cleanrooms” recounts Rauschen-

he laughs. Also, with his beard, he

FFU-alternating intervals, the re-

bach. “Whereby I continued to do

doesn’t come across to be only 30

ordering of gloves or calculation of

what I was trained to do when I

years old.

isopropyl mixing ratios.

was needed and when there wasn’t

Based on his appearance alone, this

This cleanroom know-how was

This training included: Mecha-

son of an industrial management

not always available at mkf GmbH.

tronics technician with specializa-

assistant and an electrician born in

“At the beginning, workers in the

tions in special machine construc-

1985 in Gera, Germany could still be

cleanroom were only wearing a

tion and welding. Rauschenbach

doing his apprenticeship. His slender

white work coat, a hood, gloves

learned his profession between the

much to do inside the cleanroom.”

EasyMop GMP

®

Reliable cleaning and disinfecting of pharmaceutical cleanrooms

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Portrait | CLEANROOM MAGAZINE 1/2016

26 2002 and 2006 at a Bavarian compa-

He trusted himself indeed and af-

A new cleanroom became necessary

ny near Ansbach. In this respect, he

ter working hours he started to re-

in 2012 and in 2013 a brand-new

differed from the rest of his family.

search this topic cleanroom and

cleanroom, cleanliness class ISO 6,

His father, his mother and his old-

learned about the requirements

nearly 90 square meters in size with

er sister all learned and now work

in cleanroom production environ-

an additional 15 square meters of

for the Deutsche Telecom. “I had

ments. He promptly determined:

material and personnel air locks

absolutely no interest to work for

“We have the wrong cleaning tow-

went into operation. Along with the

Telekom. I wanted more to create,

els!” These were not doubly-sealed

decision to build a new cleanroom

to build something.” It would take

thereby tearing and shredding eas-

was the decision to keep Andreas

two years after finishing his ap-

ily. “I addressed this issue and ex-

Rauschenbach active in both the

prenticeship before homesickness

plained to management what we

cleanroom and outside in the

and the 330 kilometer commute

really needed and showed the dif-

normal production areas. “You’ve

every weekend pulled Rauschen-

ferences between the products” says

already taken care of so much, don’t

bach from Bavaria back to his roots.

Rauschenbach. Although the new

you want to become the person

towels were more expensive, his

responsible for the cleanroom?”

Following his return to Thuringia

supervisors reacted with open ears.

asked his Production Manager.

in 2008, the young professional

Such stories are very encouraging.

Rauschi was indeed confident

started looking for a new employer.

enough in himself to say yes.

He turned down an offer to work

After taking care of the towel issue,

for a company which wanted to

he arranged that the PU gloves be

Since that time, everything has

hire him for maintenance and

exchanged for the better-suited

turned out differently. “It’s not any

repair activities. “I didn’t want to

nitrile gloves, he brought in overalls

more about working occasionally

repair things, I wanted to create

instead of lab coats, he organized

in the cleanroom, it’s about keeping

them” reiterates Rauschenbach. He

swabs for the cleaning of drilled

the cleanroom up and running”

then took a job at mkf in Lederhose

holes, he brought in adhesive

says the young man clearly aware

w h e r e h e n o t o n l y ‘c r e a t e d’

mats for the areas in front of and

of his responsibilities. This means

specialized machines but also was

behind the gray zones, he procured

instructing and monitoring the

able to assemble and disassemble

mouth protection and beard

cleanroom employees, organizing

them at customers’ sites. In 2010, the

nets. Presumably these peu à peu

orders and workflows, dealing

memorable moment came when he

improvements would have gone

with particle counters, filters, air

was challenged to set up a machine

on and on if it were not for the fact

humidity, to monitor temperatures,

inside a cleanroom for the first

that the cleanroom had become too

to write job and test instructions,

time in his life: “Rauschi, do you

small for the growing number of

to monitor and check material

trust yourself to do this?”

orders.

brought in through the air lock, to

A clean room arises from the mind www.cleanroom-academy.com ACADEMY – Training courses, seminars, coaching CLEANROOM EXPERTS DAYS – conferences KNOWLEDGE BASE – Trends and Innovations COMPETENCE CENTER – Cleanroom knowledge at your fingertips

CLEANROOM MAGAZINE 1/2016 | Portrait

27 organize maintenance schedules,

in the next work hall, still packed in

b i o g r a p h i e s ab o u t p e o p l e i n

to re-order disposable materials,

plastic and wooden boxes and this all

sports and is a fan of the DTM and

to check assemblies to be delivered

has to be organized and managed, to

Formula 1. When the latter takes

with UV lamps and much more. The

be “created”.

place at the Hockenheimring in

lists of things to do includes even to

Germany, he will “absolutely” be

sign holiday applications. As the

Andreas Rauschenbach is a frequent

present. He even takes his tent and

cleanroom Master, Rauschenbach is

visitor to the ReinraumAkademie

camps overnight for the DTM at

constantly peppered with a myriad of questions as he makes his way through the production areas. In order for the cleanroom employees to reach him easily, he carries with him a cordless telephone, as well as a small notebook. “I write down everything which people ask me as I’m walking along, otherwise I’ll forget the half of it.”

“I have already taken our quality manager there, because there is nothing worse than being enterprise blindsighted.”

Andreas Rauschenbach, mkf GmbH

Does all this have anything to do with “creating”? “Not really!” admits

(Cleanroom Academy) in Leipzig

the Lausitzring. Considering that

Rauschenbach frankly. “Nevertheless,

because of his cleanroom knowledge.

his favorite food is fast food, steaks

the work is quite motivating.” He

“I have even taken along our Quality

and noodles, it is a wonder that he

has the opportunity on five or ten

Manager as there is nothing worse

stays so slim. Perhaps the reason

days a month to assemble and build

than to suffer from tunnel vision.”

is, besides playing a lot of football,

something inside the cleanroom,

In the meantime, Rauschenbach

the fact that he doesn’t like to drink

but he would also like to implement

has become so knowledgeable in his

Germany’s traditional favorite: “I

many of his own ideas, for example

trade that in 2015 he held his first

don’t drink beer.” Oops! If that isn’t

to build a Handyclean device with

seminar.

a curiosity: The person in charge

which employees would be able to

of a cleanroom who despises of all

degrease their gloves under a fine

Privately, this freshly-married

things a product which is governed

spray. Another idea would be to

man is very interested in sports.

by the German Reinheitsgebot

replace the adhesive mats with a

He was a boxer earlier and won

(German Purity Law)!

permanent mat system. Besides all

championships in Thuringia and

this, the next cleanroom is standing

German-wide. He enjoys reading

Author: Frank Baecke

100% quality 100% service 100% know-how 100% confidence www.profi-con.com Professional cleanroom cleaning Life Science and Microtechnology

Training around Cleanroom cleaning and behavior

Portrait | CLEANROOM MAGAZINE 1/2016

28

How employees become cleanroom operatives

SCIENCE & TECHNOLOGY

The best cleanroom equipment is useless unless the personnel knows what they are doing.

For those companies which don’t want to suffer quality losses in production cleanrooms, they have to regularly train their personnel. In-house seminars and workshops when correctly organized are also able to assure quality in production processes.

employees how to move around in a cleanroom! Instruct your employees to keep their work places clean!”

This is easier said than done. How

This expert’s advice was outstand-

tion which is then distributed by

does one communicate to his

ing but in practice, pointless. “When

personnel moving around. Many

employees that the environmental

you want to keep your cleanrooms

particles can also be carrying mi-

conditions, process safety and product

clean, then refrain from sending

crobes” explained Agricola which

quality are decisively influenced

any people into them” advised Koos

describes operators’ age-old prob-

by correct or incorrect working

Agricola as a participant in the

lem. Even worse: when disrobing

behaviors. Furthermore, how does one

congress held at the International

in the air lock, these particles are

communicate this information so that

Cleanroom Trade Fair in Frankfurt

dispersed into the air, which before

in 14 days time it won’t be forgotten?

am Main in October, 2016. The Gen-

had been held back from an em-

eral Secretary of the International

ployee’s clothing, but during break

An excellent possibility is to have

Confederation of Contamination

times settle down onto the disrobed

this information mediated and em-

Control Societies (ICCCS) recom-

clothing and after the break are

ployees qualified and certified by

mended to an astonished audience

carried back into the cleanroom by

professional training centers, such

to send robots into cleanrooms in-

the employee. “There are five times

as the ReinraumAkademie (Clean-

stead of humans.

more particles on clothing than in

room Academy). For those compa-

the air” says Agricola. In order to

nies which would rather train their

Of course this comment was made

keep the cleanroom as clean as pos-

employees in-house, Claudia Pachl,

tongue in cheek, nevertheless it has

sible, Agricola gave his audience

Partner of Avantalion Consulting

a serious background. “The skin,

three pieces of sound advice: “Nev-

Switzerland AG in Luzern, Switzer-

the breath, the employees’ cloth-

er send more people into a clean-

land recommends for these compa-

ing – all of this causes contamina-

room than necessary! Teach your

nies to use standardized procedures

Regular training leads to qualified staff. ‚The cleanroom academy auditorium during an event on the topic staff‘. Photo: Cleanroom Media.

CLEANROOM MAGAZINE 1/2016 | How employees become cleanroom operatives

29

Koos Agricola at the cleanzone 2015. Photo: Cleanroom Media.

in the contents of their courses. Top-

certain behaviors are not followed.

With all these training activities,

ics for the seminars and workshops

Additionally, Ms. Pachl advised to

cleanroom operators should con-

could include hygiene, cleanroom

review how successful the training

stantly have in the back of their

working behaviors, production pro-

has been immediately following the

minds the idea that successful

cesses and so on, always keeping in

event as well as to monitor the effect

employee qualification is never a

mind to carry out the courses at the

of the newly learned information

permanent situation. Claudia Pachl

same level of quality. It is decisive

in practice. In order to assure the

urges “You must always be asking the

however for training courses to be

optimal transfer of knowledge,

question: How long can I consider a

successful that management places

it is helpful to document such

cleanroom employee qualified?”

a high value on employee qualifica-

proceedings in well-structured

tion and instruction. Thereby will

and easily understandable ways.

Many companies would gladly

the participants also find the train-

Only when the newly learned

share these concerns. When com-

ing worthwhile and not just an an-

information and its relationship to

pared to the problem of even find-

noying obligation.

working practices are internalized

ing qualified employees, training

by employees can the effects of

qualified employees becomes an

Besides the standardized procedures

such seminars and workshops be

issue of luxury. The demand for

and internal value of the seminars

sustainably successful. It is useful

professionals in the cleanroom

and workshops, the factor of regu-

to set minimum criteria in order

technology sector has increased

lar, repetitive training is also impor-

to review the success of employees’

enormously in the last years. The

tant to take into account. “You can

qualifications. This could be

industry is demanding specialized

bombard your employees with two

look like the following: The first

training and study courses which

hours of new information but how

qualification follows the successful

will prepare those participants spe-

much of this information will stick?

passing of three consecutive courses

cifically for cleanroom conditions

It is much better to repeat courses

on different days; re-qualification

and requirements. However, up to

at regular intervals” says Claudia

follows the successful passing of

now there are no recognized and

Pachl. To keep employees’ interest

further courses within a defined

certified professions in the fields of

peaked, the trainers should pres-

period of time. Further criteria might

cleanroom technology and too few

ent the topic using vivid and easi-

be added due to stricter demands

academic professionals and grad-

ly remembered techniques as well

and requirements, for example, “the

uates. Therefore many companies

as portraying why the topic is im-

successful partici-pation at MediaFill

are dealing with this crisis autodi-

portant and the consequences when

which deals with aseptic filling”.

dactically.

How employees become cleanroom operatives | CLEANROOM MAGAZINE 1/2016

30 However this will not be enough in

these activities exist” explains Jür-

The curriculum for this trade in-

the future emphasizes Frank Du-

gen Tausch. This is why it is criti-

cludes the topics of planning, mate-

vernell, Managing Director of the

cal that real and recognized profes-

rials management, automation and

ReinraumAkademie (Cleanroom

sions be created and publicized. In

production equipment” says Chris-

Academy). “The working world

order to raise the attractiveness of

tian Dragosits, Group Leader Main-

of cleanrooms has become in the

such professions, these should be

tenance and Environmental Con-

meantime commonplace, but that

comprehensively created and devel-

trol in the manufacture of implants.

of professional training hasn’t yet adapted itself to this situation. Just as the companies involved in warehousing, logistics and forwarding

SCIENCE & TECHNOLOGY

have fused together over the last 20 years into a single logistics industry, so too must the companies involved in cleanroom technology develop into a single industry. In order to acquire employees, the many new pro-

“You must always be asking the question: How long can I consider a cleanroom employee qualified?”

Claudia Pachl, Avantalion Consulting Switzerland AG

fessional fields have to be brought to the attention of the general public.” oped, the various professional fields

“We thoroughly train our Process

The personnel recruiter Jürgen

overlapping each other, thus mak-

Technicians inside and around

Tausch, proprietor of Jürgen Tausch

ing it easier for employees to switch

cleanrooms, thus they become at

Personnel Service and Associate of

companies and for companies to ac-

the end technical All-Rounders.”

Höfer and Tausch GmbH in Dres-

quire professionals who have grad-

However, even Dragosits would very

den, Germany sees in this situation

uated with the same or comparable

much like to see specific academic

an obligation of the Chambers of

degrees and who could be trained

training meant for the cleanroom

Trade and Crafts. These chambers

for their required tasks with lower

industry. “There are many providers

have to illustrate the many clean-

expenditures and effort.

of cleanroom seminars and work-

room professions and effectively

shops but no occupational profile.

make the general public aware of

Using this approach, MED-EL Elec-

Diplomas are up until now ‘only’

these opportunities. “Our biggest

tro-medical Devices Ges.m.b.H. in

a participation certificate even if

problem today is that we are sup-

Innsbruck, Austria, has successful-

these certificates suggest otherwise.

posed to be motivating people for

ly generated a part of its cleanroom

My opinion is why not designate the

the activities inside a cleanroom

staffing. “In Austria, there exists the

subject matter under other names,

while most people aren’t even aware

profession of Process Technician.

such as Filter Technology, Measure-

Training at the competence center at the cleanroom academy Leipzig, next to the training cleanroom. Photo: Cleanroom Media.

CLEANROOM MAGAZINE 1/2016 | How employees become cleanroom operatives

31 ment Technology, Climate Technol-

rectly on a company’s own premises.

ence and of course to build up rela-

ogy and Building Technology which

The seminars, workshops and coach-

tionships with other companies, to

would provide a fitting job descrip-

ings are pre-destined for providers

form partnerships and other net-

tion and occupational profile, perhaps consolidated under the desig-

because of time and personnel limi-

“Our biggest problem is that we should be motivating people for the activities taking place inside cleanrooms while most people are not even aware these activities exist.”

tations, many external training pro-

Jürgen Tausch, Proprieter of Jürgen Tausch Personnel Service

nation of ‘Cleanroom Technology’” Until the situation comes to this point, companies have to rely on their own strategies regarding the development of talent and future employees. For those companies with no in-house training program

viders are available to help out. The ReinraumAkademie (Cleanroom Academy) in Leipzig, Germany and

and users of cleanroom technology

working structures. All this enables

the CleanroomAcademy in Wan-

and equipment but also for service

companies to move themselves in-

gen an der Aare, Switzerland offer

providers in cleanroom planning

to the position of fulfilling the high

year-round courses, seminars and

and design or for cleanroom clean-

demands of clean production with-

workshops covering many diverse

ing companies. Participants receive

out having to follow the advice of

topics. The spectrum goes from Re-

first-hand knowledge and informa-

Koos Agricola (“If you want to keep

inraum-Expertentagen (Cleanroom

tion directly out of the practice. Also

your cleanrooms clean, don’t send

Expert Days) to two-day seminars,

participants are able to speak with

any people inside them”).

coachings and workshops as well

the people presenting the topics, are

as courses and seminars offered di-

able to exchange ideas and experi-

Author: Frank Baecke

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+41 43 495 92 50 +41 43 495 92 60 info@valisys.ch www.valisys.ch

How employees become cleanroom operatives | CLEANROOM MAGAZINE 1/2016

32

On the Road with …

Photos: Cleanroom Media.

SERVICE

Steffen Röhm

Steffen Röhm is a project leader at the Competence Center Engineering in the department of Equipment and Maintenance at the company Pharmaserv GmbH & Co KG in Marburg, Germany. He looks after customers in the area of cleanroom technology regarding various topics but focusing on the qualification of cleanroom technical equipment and facilities.

How often are you on the road? On

What is important to you when on

a notebook computer in order to be

the average, about two to three days

a business trip? When travelling by

reachable. These devices have become

a week, according to the particular

car, I like and prefer to drive when the

indispensable in the working world.

projects, sometimes an entire week.

streets and highways are free of traffic.

Business trips take place primarily in

Therefore I try to plan my trips during

What kind of music do you enjoy lis-

Germany.

off-peak travel times. Besides traffic-

tening to? Radio stations with a broad

free highways, I very much value

spectrum of Rock and Pop from re-

punctuality.

cent decades.

the car because I often have to take

What should never be missing on a

Which countries and regions are

with me various documents and

business trip? When travelling by car,

most often on your list of destina-

documentation as well as measuring

of course a good radio station. Other-

tions? For business, Germany has

instruments.

wise, a mobile telephone, a tablet and

been the destination in recent years.

What is your favorite means of transportation? In most cases, I use

CLEANROOM MAGAZINE 1/2016 | On the Road with …

33

Privately, northern Germany and

have in my luggage. At the moment,

What would be the first thing you

northern Europe are appealing.

I am reading Wolfgang Niedeckens

would change if you had the un-

autobiography “Zugabe. Die Geschichte

restricted possibility to do so? The

Are you able to relax when you are

einer Rückkehr” (Encore. The Story of

question is difficult to answer. There are

travelling on business? Yes and no,

a Comeback).

so many topics such as environmental

it always depends on what I have to do.

protection, the wasting of resources, Which travel destinations do you

wars and so on which affect and

favor and why? On business, I enjoy

concern us all. For me personally, it

How do you best unwind after a

travelling to Berlin and to Switzerland.

would be important that each of us

working day? I am best able to unwind

Privately, my absolute favorites are

think a little more on others and not

with a good book which I always

Finland, Sweden and Switzerland.

so much on ourselves.

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On the Road with … | CLEANROOM MAGAZINE 1/2016

34

Science & Technology

SCIENCE & TECHNOLOGY

Technolgy Briefs

Researchers develop a new kind of information storage device

Smarter wound dressing for nerve fibers

Ion Conductor | Scientists of the

Nano-membranes | Researchers at

University Kiel and University Bochum

the Leibniz Institute Dresden and

have developed an information storage

the TU Chemnitz are working on

device with uses ions to store data.

ultra-thin membranes which roll up

Common storage devices are based

by themselves into micro and nano-

on electrons which when current is

tubes. Such tubes provide medical

induced are displaced. As computers

technology enormous innovation

in use today need more time to

potentials. Equipped with integrated

move data than to do calculations,

electronics these tubes could serve as

researchers have wanted to get away

wound dressings for defect or healing

from charged-based storage to that

nerve bundles. The possibility to

based on electrical resistance. Such

open and close the sleeves by outside

A rolled up membrane used as a sleeve for nerve cells made of electronic components. Graphic: IFW Dresden

regarding physiological processes such as the healing of wounds.

Giant molecule blocks Ebola virus from entering the body Medical Research | A giant molecule developed by researchers of the University Madrid could soon provide effective protection from the Ebola virus. The molecule blocks the decisive docking site on cell’s surface and blocks the Ebola virus from entering the cell. In cell cultures it has already been shown to prevent infection. Should results in tests with live animals confirm this, Inspection of memory cells in the cleanroom of the Kiel Technical College. Photo: AG Nanoelectronic

the procedure could enable a way to produce an anti-viral medium

a component has emerged from the

influences makes their application

against Ebola. The custom-made

Kiel and Bochum laboratories. When

in the regeneration, monitoring

giant molecule which researchers

current is induced, ions are moved

and stimulation of nerves very

have created consists of fullerene,

between two electrodes in a solid state

attractive. Furthermore these smart

hollow carbon spheres which are

ion conductor. A further advantage:

nano-membranes can serve as

coated with appendages made of

Such structured cells can be reduced

antennas for implants which would

sugar. The latter protects a cell’s

to atomic sizes.

be able to transmit information

docking site from the Ebola virus.

CLEANROOM MAGAZINE 1/2016 | Science & Technology – Technolgy Briefs

35 Head OP: Robot worm grinds its way around corners

integrated with existing laboratory equipment and running processes.

With this device’s help, processes in

Medical technology | In order to

pharmaceutical, chemical, life sciences,

reach a tumor inside the inner

bio-technolgy, nano-technology as well

ear, doctors in most cases have to

as medical technology can become

remove a part of the temporal bone.

more easily automated. In comparison

In the future, a five millimeter tunnel through the bones which

to conventional pipette technology, Dual-flow nozzle apparatus for the production of algina-

the PipeJet-Tip-Technology is able

a new mini-robot has ground will

te globules. Photo: Fraunhofer IBMT

be enough. Unique here is: The

medicines. As the researchers

robot curves around blood vessels

have found out, the alginate acts

and nerves. This OP device was

as a particularly efficient source of

developed by Fraunhofer researchers

nutrition for the reproduction of

in Mannheim together with several

stem cells. British pharmaceutical

universities. The robot, thanks to its

companies have currently validated

Micro-controller | Stuttgart Fraunhofer

accordion-like construction is able

this process in their laboratories.

researchers have developed a battery

to creep forward like a worm. Its

Further trials are to be done by

for electronic automobiles, which is

direction is controlled by hydraulic

European partners in 2016. The goal

considerably more cost effective than

lines and pumps operated from the

is to produce with this process stable

present batteries and this over its

OP. This maneuverability makes it

pluripotent stem cells.

entire life cycle. If one of the over one

possible for the first time minimalinvasive operations of inner ear tumors. The innovation is supposed

Exactly dosing fluids in the smallest amounts

Robots could be used in the operating room in the future.

Photo: Fotolia

Stem cell cultivation on algae skeletons

amounts of fluid.

Electro-auto: Batteries with brains

hundred battery cells becomes defect, this can be modular-like exchanged.

Up until now, the entire battery had to be replaced. The exchanging of

to be ready for series production in two years.

to dispense 100 to 1000 times smaller

Micro-dosage systems |BioFluidix

single cells has been made possible

GmbH in Freiburg has won the STEP

as each cell is controlled by its own

Award 2015 in the category “Process”

integrated micro-controller. Therefore

with their pipette technology. The

each cell recognizes its own condition.

STEP Award distinguishes innovative

If a cell is empty, it simply disconnects

companies in Germany, Austria

itself from the other cells and directs

and Switzerland. BioFluidix won

the flow of current past itself. The

the award for their PipeJet-Tip-

car doesn’t have to stop dead. The

Technology which allows micro-

researchers have already developed

drop dosing. The BioFluidix pipette

a prototype. In the next phase, the

tips are compatible with common

researchers want to miniaturize the

pipettes and pipette equipment. The

electronics in the cells.

technology is therefore, able to be easily

Bio-technology | On the exoskeleton of algae, the gel-like alginate, Fraunhofer researchers in Sulzbach are cultivating pluripotent stem cells. These have the potential to transform into random body cells for example into inner organ cells.

The pharmaceutical industry requires such stem cells in large amounts for the testing of new Micro-controllers extend the driving range of electronic cars. Photo: estations

Science & Technology – Technolgy Briefs | CLEANROOM MAGAZINE 1/2016

36

Are you of sound mind?

Foto: Fotolia.

SCIENCE & TECHNOLOGY

Containments have to be able to protect not only the product but also employees.

New medical agents are of ten even in small dosages very potent.

The processing of these agents is putting higher demands on safety in laboratories and pharmaceutical production facilities. Containments have to provide the highest levels of tightness while at the same time providing straightforward material flows and maintenance. A technological balancing act.

CLEANROOM MAGAZINE 1/2016

37 Trends in the development of containments are clearly going in the direction: Preferably more protection as too little. The reason: Often the active agents of new medications are highly potent even in small amounts. This is making the planning, the production and operation of pharmaceutical facilities a considerable challenge. Production facilities have to fulfill complex toxicological requirements and ensure the lowest possible threshold values in work environments. In March, 2015, new and expanded EUGMP regulations and guidelines regarding process safety procedures became effective.

In order to make it easier for laboratory operators and pharmaceutical manufacturers to get an overview of the technologies, processes and regulations involved, the work group ‘Containment’ of the ISPE D/A/CH (International Society for Pharmaceutical Engineering – Germany, Austria, Switzerland) has worked for five years putting

The safety of process is important in the clean room. Photo: Fotolia.

together the widely scattered

in November, 2015. This publication

environment from contamination

knowledge into a single resource.

provides for the first time in one

from the substances being processed.

“Our goal was to compile an all-

volume, practice relevant support

The terminology containments does

encompassing handbook dealing

in the planning, construction and

not only speak about closed systems,

with highly active substances.

renovation of manufacturing

but all the measures involved which

Until now, nothing like this has

facilities.

limit the spread of highly potent substances.

“A well-chosen primary containment enables reductions in cost with the secondary containment.”

Containment can be differentiated into primary and secondary containment. Primary containment encompasses all measures which prevent the spread of substances out of the production facility, for example housings, isolators, continuous line systems, suction conveying systems and exhaust sys-

been available.” says Richard Denk,

Under the term, containment,

tems. Secondary containment are

Sales Manager Containment of the

various concepts and technologies are

those measures which collect and

company Skan AG in Allschwil,

to be understood, which safeguard

reduce those substances which es-

Switzerland. The handbook which

products from contamination in

cape from the primary contain-

was started in 2010 and developed

the production environment and

ment systems, for example clean-

by numerous experts was published

reciprocally to protect people and the

rooms, air-lock systems, pressure

Containment | CLEANROOM MAGAZINE 1/2016

38 assured that the employee is able to

Life cycle of a containment: Consider disposal during the planning phase.

balance out the periods of high ex-

Planning: Manufacturers of highly active substances have to consider the entire life cycle of their facility. Thereof is derived the specifications document.

be health-endangering nor exceed

SCIENCE & TECHNOLOGY

Purchase: The first choice is not the most inexpensive but the safest. It has to be tight, keep to the safety limits but also easy to clean and to maintain.

Construction: The facility should be ergonomically operable and make possible a hygienic, trouble-free cleaning of all surfaces, transition points and connections.

Commissioning: The Factory Acceptance Test follows the Site Acceptance Test, carried out by customers for the assurance of all functions and interfaces.

posure with those of low exposure.

The peak load is neither allowed to the eight-hour average value.

Reinhold Maeck, Head of Corporate EHS&S Regulatory Intelligence of Boehringer Ingelheim Pharma GmbH, indicates that in the 2014 revision of the EU Chemical Guideline 98/24/EG, the definition of hazardous substances has been expanded: “Hazardous chemical agents as are all chemical agents dangerous and pose risks for the safety and health

Production: It is reasonable and rational to carry out unannounced swab tests of the containment and users during operation of the facility along with regular monitoring of critical areas. Also advisable is a concept in case of accidents.

of employees because of their inher-

Maintenance: All plant components are subject to mechanical wear and tear.

These components have to be regularly maintained and kept in good working order in order to rule out a breach in the containment.

active chemical agents there exist

Disassembly: The decommissioning of a contaminated facility has to be done by trained personnel. The disposal of decontaminated parts or their resale is to be documented in writing.

ent physiochemical, chemical and toxic properties.” In practice, however, it should be observed that for no mandatory, uniform safety limits. This situation has an impact on the construction of plants and facilities. To be on the safe side, plant operators often place high demands on the manufacturer regarding the tightness of the plant. Maeck recommends complementing the technical with organizational measures such as additional training cours-

Source: Containment Handbook, 1 edition 2015

es and risk analyses. “Risk assessment is extremely important in cases where contamination becomes

cascade systems, decontamination

The precise design of the contain-

an issue. In such an event, the oper-

systems and adhesive mats.

ment depends on how dangerous

ator has to verify that he has eval-

the processed substances are. Tox-

uated the risks with a team of ex-

Experts recommend calibrating

icologists have determined exact

perts who have reasonably judged

the primary and secondary

safety limits for work places, the

and classified the risks” says Maeck.

containments to each other. For

so-called Occupational Exposure

this purpose, optimally the facility

Limits (OEL) which are divided in-

Besides the primary and second-

is planned from the inside to the

to several classes or bands, from

ary containment, the dust filtering

outside, that is to say, starting

very low to very high. These safe-

equipment also belongs to the is-

from the production process, a

ty limits are mostly taken as eight-

sue of plant safety. “Some producers

suitable containment is chosen

hour average values. The average

forget this completely because they

and afterwards it is determined

value means that an employee in

are only focused on GMP” says ISPE-

how the secondary containment

an eight-hour shift is allowed to be

D/A/CH Chairman Richard Denk

will look. A well-chosen primary

exposed to higher dosage levels for

and knows this from experience.

containment results in cost re-

short periods of time as long as the

“Plant operators have to consider

ductions with the secondary

toxicologists show no concerns re-

that the fine dust particles which

containment.

garding this exposure and it can be

become a finely processed powder

CLEANROOM MAGAZINE 1/2016 | Containment

39

The laboratory of the future does not looks like this. Soon the devices will have driven the laboratory technician from the room. Photo: Institute for Chemical Technology Hannover

are able to reach areas which even

the cleaning and maintenance prob-

skin and mucous membranes. “It

water is not able to penetrate.” This

lematical as the danger exists that

is enough when an employee un-

situation affects filters, threaded

employees will absorb these parti-

wittingly touches his face with his

fittings, pipe lines and other plant

cles not only by breathing them in

gloved hand – which happens more

equipment. This deposition makes

but also by absorption through the

often than one thinks” warns Denk.

Important Pharmaceutical Fairs and Congresses 2016 Lab Innovations Lausanne Trade Fair for Technology and Services in Laboratories Date: April 13-14, 2016 Location: Messe Beaulieu Lausanne , Avenue Bergières 10, 1004 Lausanne, Switzerland Exhibitions: • Lab equipment • Cleanrooms • Lab installations • Services • Consumable materials Medizin Innovativ – MedTech Summit 2016 Congress with exhibitions for medical technology, pharmaceutical and health care systems Date: June 15-16, 2016 Location: NCC Nürnberg Convention Center, Messezentrum 1, 90471 Nürnberg, Germany Exhibitions: • Medical imaging • Home care • Smart Medical Devices

• Hospital, workflow • Personalized diagnostics, personalized therapies • Innovation in the health care industry ILMAC Basel Industry Trade Fair for the Pharmaceutical and Chemical Industry Date: September 20-23, 2016 Location: Messe Basel, Messeplatz 1, 4058 Basel, Switzerland Exhibitions: • Laboratory planning, installation, requirements • Laboratory planning, installation, requirements • Analytics, automation, preparative techniques • Diagnostics, verification procedures, platform technologies • Sterile room technology, cleanroom technology, hygienic room technology • Planning and engineering of facilities and processes • Construction and operation of facilities • Environmental technologies, safety equipment, worker safety

Containment | CLEANROOM MAGAZINE 1/2016

SCIENCE & TECHNOLOGY

40 Basically, plant operators have the

Fixed containments demand

disposed of by specially trained

choice between fixed and flexible

higher initial investment costs,

personnel. This applies also for

containments. Fixed systems are

however generate lower operating

the periphery, such as walls, floors,

manufactured as a rule out of

costs. Flexible containments are

ceilings, air locks, built-in fixtures

stainless steel and glass and are

more inexpensive, but after every

and ventilation systems. During a

securely installed, for example

product changeover have to be

product changeover phase, special

isolators. Flexible containments, in

newly purchased. Moreover they

cleaning procedures often exist

contrast, consist of plastics and are

require a more elaborate stainless

for containments which have been

meant for temporary activities such

steel peripheral equipment and

constructed for the manufacture

as weighing, decanting, inspecting

material logistics such as for fixed

of diverse products. These pro-

and cleaning. Furthermore, flexible

containments. Dirk Collins, Product

cedures can be used during plant

containments are predestined to

Manager at Hermann Waldner

dismantling. In plants where only

become one-way technologies for

GmbH & Co.KG in Wangen, Germany

one product has been manufactured,

manufacturers with frequent product

advises: “Choose for the comparison

every single component which has

changeovers which after production

between fixed and flexible systems a

come into contact with the product

are disposed of to be replaced with

time frame of at least five years – one

has to be examined and assessed as

new containments for new products.

to two years is much too short!”

contact with particular substance-

In contrast, fixed systems have to

groups prohibits further use.

be thoroughly cleaned after every

Whether a fixed or flexible con-

Important is: Any resale or disposal

product changeover. Advantages of

tainment – in both cases the

of contaminated components has to

fixed systems are their stability. They

operator has to consider the future

be documented in writing.

stand up to pressure and collisions

decommissioning and disposal

and provide the user psychologically

activities even during the initial

more safety as he or she, standing

planning and acquisition stages.

behind a solid wall, feels better

Contaminated facilities are only

protected.

allowed to be dismantled and

Autor: Frank Baecke

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13 & 14 April 2016

The show for laboratory technologies & services

Your invitation code for a free entry

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www.labinnovations.ch

CLEANROOM MAGAZINE 1/2016 | Containment

41

What do you do there Petra Hagel?

Brief profiles of the clean room industry

Petra Hagel is the Operations Health Management Manager at Vetter Pharma-Fertigung GmbH & Co. KG, an internationally leading pharmaceutical service provider for the manufacture of aseptic pre-filled syringes, carpules and vials. Photo: Vetter

“My name is Petra Hagel. Since

and physical challenges in their

Here is where I come in as the

October, 2014, I have been the

daily work. As an example, any

Health Safety Manager. The support

Operations Health Management

additional movements outside of

of our employees in the cleanrooms

Department Manager at Vetter,

what is necessary to carry out a task

is particularly challenging because

an independent family-owned

should be avoided when possible.

this is only possible outside of the

company with locations in Germany

This, of course, contradicts not

cleanroom. I organize and provide

and the USA, as well as subsidiaries

only a body’s own natural need for

specific movement opportunities

in Singapore and Japan. The

movement but also an employee’s

such as an ‘Exercise Break’, or the

company employs 3,400 people.

inclination to show that he or she is

Group Thera-Band Training or our

working hard. Another example is

large selection of company sport

The customer-specific medicines

the predefined physical positioning

groups.”

and medicaments our company

of the body and arms which could

produces are filled under aseptic

lead to orthopedic problems that

conditions. These conditions and

could cause tension, headaches,

work environments present for our

back pain and possibly serious

employees significant ergonomic

circulation problems.

What do you do there …? | CLEANROOM MAGAZINE 1/2016

42

The Semi-Conductors of the next generation,

SCIENCE & TECHNOLOGY

will allow new materials to completely revolutionize existing applications.

The digitization of the economy and of everyday life is in full swing. Trends like big data, social media and the Internet of things determine the topics of the upcoming CeBIT. They all have something in common, they require significantly powerful semiconductors. Thus the cleanroom requirements increase.

Smartphones, tablets and laptops are full of Semi-conductors.

Photo: Fotolia.

The Moorsche law was yesterday

Now these are used even in tooth-

digitalization of business and

brushes, toasters, refrigerators

industry and play a particularly

and garments. Even cars, trains

big role of importance: the so-

and planes would not work today

called industry 4.0 is inconceivable

For 50 years, Moore‘s law applied

if it were not for the invention

without strong chips and sensors

heavily in the semiconductor

of the semiconductor. These are

that control the enormous amounts

industry. Gordon Moore, the co-

even in our cars, for example the

of data and process that is required

founder of the chip manufacturer

Audi A8, has about 6,000 to 8,000

for such tasks.

Intel, in 1965 after six years of

semiconductors. Powerful micro-

observation, had found that the

electronics are also the progressive

density of integration, which would

CLEANROOM MAGAZINE 1/2016 | The Next-Generation

43 double the number of transistors on a unit of area in order to increase the performance of processors two year. In 1975, he then finally corrected this rule on doubling every two years. Today we double every 18 months. Experts however agree that the traditional semiconductor production will soon reach their physical limits.

Alternatives to Silicon came from Japan For decades, Silicon is the basis

Cleanroom employees in the production. Photo: Fotolia.

for the modern semiconductor in electronics. The material kept producing smaller and smaller transistors, but it is hard and became very brittle. Networked pieces of clothing, for example, require more flexible components that can be incorporated into the materials. Therefore much research was gathered, and it was found that gallium nitride (GaN) is considered to be the material of the future. The compound in semiconductors was for the first time in light-emitting diodes, known as LEDs. For the first,

Associate inspected a gallium nitride substrate. Photo Fraunhofer THM

time three Japanese researchers names Isamu Akasaki, Hiroshi Amano and Shuji Nakamura started developing this area in the early 1990s so that LEDs that emit blue light. For this they were awarded in 2014 the Nobel Prize for physics.

GaN semiconductors are already used in power electronics. They promise a better performance in consumer electronics, electric cars or in data centres. Galiumnitrid has a better thermal conductivity than silicon and works more efficiently at higher temperatures. However, the production of GaN components is still very expensive. At the ‘Fraunhofer Technology Centre for semiconductor materials’ in Freiberg, researchers in 2011 gallium nitride substrate. Photo Fraunhofer THM

have already started with new

The Next-Generation | CLEANROOM MAGAZINE 1/2016

44 The semiconductor industry boom • Through the Internet of things, there will be an increase for the demand of sensors . The auditors from PricewaterhouseCoopers forecast an annual sales growth of 5.2 percent in the global semiconductor industry by 2019.

SCIENCE & TECHNOLOGY

• Europe will also benefit: the demand will rise by 2019. An average of 3.9 percent.

• Sensors in wearables: PwC experts predict that until 2019 they were sell over half a billion units.

As a result, sales are rising rapidly. 15 million US dollars was made in 2013. It is expected that in 2019 seven billion dollar is to be made through sales.

• Automotive engine of growth: In electric and hybrid cars, 1.5 to three times as many semiconductors are used as in conventional vehicles. The market for semiconductors will grow up to 2019 each year to 20.5 percent.

• Growth through smartphones, tablets, electric vehicles, and wearable’s: sales of the industry will grow by 2019 at $ 432 billion.

Source: PwC study „the Internet of things: the next engine for the seminconductir industry groth“

investment concepts. And last

IBM however thinks in a different

would deliver excellent results even

year, they developed a system in

way. The American company relies

in this case. The performance of

full working operation, which so

on carbon nanotubes instead of

computers could be with improved

far are showing good results. The

Silicon. With the new material, so

semiconductors. It could take

researchers are confident that in

the conviction of the IBM Developer

up to five to ten years to develop

the future, this will significantly

skips an important hurdle for the

this system, however until these

reduce manufacturing costs and

further reduction of semiconductors

new devices come to market, we

therefore release the burden on

and transistor contacts. So, carbon

could have already discovered and

businesses.

nanotubes under 10 nanometres

developed a different system and

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CLEANROOM MAGAZINE 1/2016 | The Next-Generation

www.avantalion.de

45 CeBIT trends.

• Digital transformation: companies must be ready to face the challenges.

• Big data: more and more data needs evaluating. This will increase the demands on data centers and will expect more performance.

And the whole thing has to be with energy - and be cost-efficient.

• Internet of things: increasing the networking of machines, products and everyday objects. But to maintain the standards are needed.

• Social business: the digitalization changed the world of work. The cloud caused it and a collaboration of solution is needed to form new cooperation’s.

• Security: When growing cybercrime there is a need for rises in effective security strategies and new architectures • Mobile: the future belongs to mobile devices. The industry looks for links from business software and mobile devices.

QUALIFIZIERUNG WARTUNG

• Date: CeBIT takes place from 14th to 18th March 2016 at the Hanover Trade fair.

STRÖMUNGSVISUALISIERUNG MONITORING MESSTECHNIK

therefore could replace silicon

Also, the production in cleanrooms

semiconductors, so the forecast of

is itself always smarter against the

IBM researchers.

background of the industry 4.0

SERVICE

concept. The cleanroom industry

BERATUNG

Testing before production

requirements will increase with the further automation. The

New materials in mass production

increasing use of semiconductors

means new challenges to manu-

in semiconductor production will

facturing facilities in the clean

make the production in the future

room. It is because of cost reasons a

faster and more cost-effectively.

new manufacturing line cannot be

New cleanroom standards are

built, and for any new material to be

necessary as new regulations are

developed. The chipmakers Infineon

drafted year after year.

are pursuing the claim to utilize existing facilities as efficiently as possible. But before new materials

Author: Thomas Köhler

KALIBRIERUNG

SCHULUNG

BSR Ingenieur-Büro BSR Meßtechnik GmbH Beratung und Service im Reinraum Marienstraße 156 68794 Oberhausen-Rheinhausen eMail: blattner@reinraum.info Tel. 07254-959 590 Fax 07254-959 5929

come into production, it depends on whether interactions are to be expected and which risks need checking to expose potential threats.

Only in this way, high quality of the products can be guaranteed.

The Next-Generation | CLEANROOM MAGAZINE 1/2016

46

Photo: Fotolia.

SERVICE

Sitting for hours in front of a microscope or at safety work benches demands undue physical strain from muscles and the musculoskeletal system. The results can be tension, pain, or even illness-related absenteeism. With ergonomic work places, muscle-relaxing exercises and the re-consideration of incorrect postures and behaviors, cleanroom employees can remain healthy. CLEANROOM MAGAZINE interviewed cleanroom technician and certified Mental Trainer/ Fitness Coach Richard Reudelsdorf of the company Dittel Engineering about cleanroom-suitable, health-related prevention techniques.

Working in a cleanroom and staying healthy Risks of physical complications due to one-sided, repeated unilateral physical movements which put stress and strain on the body can be prevented.

CLEANROOM MAGAZINE 1/2016

47 Working in a cleanroom requires considerably more from our bodies than comparable work in an office or production facility. The person is stuck inside cleanroom clothing, the air is dry and in constant circulation. Sweating hands in latex gloves, heavy breathing behind mouth protection, overheating, thanks to a full protective hood and other difficulties face cleanroom employees. The body and the psyche are heavily strained. The “Working Environment Cleanroom” is a closed environment and serves only one function: to keep research and production free from any kind of contamination. However not only robots are found working in this climatized, hermetically sealed world, the human employee also has to adapt to the special conditions found inside a cleanroom and remain physically and mentally productive.

Clothing, Comfort, Sitting Posture Ergonomics in cleanrooms begins with the clothing which has to provide the necessary protection from contamination, a level of comfort which offers the employee an unimposing fit as well as giving the employee unrestricted motoric and mental performance capabilities.

Unaware of the effect, uncomfortable fabrics put strains on mental

while sitting at a microscope for

achieved by putting our musculature

capacities which leads to quickly

hours on end, or insufficient physical

under a load otherwise it becomes

becoming fatigued. Results are a

movement in the course of a working

weak and subject to complications.

reduction in concentration, longer

day. Health and product protection

As a fitness center will never become

reaction times and increased rates of

collide with each other under

part of a cleanroom’s design, muscles

error. When these negative mental

these conditions because regarding

have to be activated by alternating

processes operating in the background

the protection of products, it is

between contraction and relaxation.

are reduced with the correct clothing,

indispensable to move about inside

Balling the fist is one example

concentration and performance

a cleanroom as slowly as possible

of a strengthening exercise with

capabilities will improve.

and then only when necessary.

minimal movement.

However, sitting still or moving as Further physical stress factors in

slowly as possible contradict human

Regarding posture: Sitting bent over

cleanrooms come about through

nature. Our skeleton needs a strong

is for all intents and purposes taboo

improper sitting posture, for example

and stable musculature which is

as the back pain resulting from this

Ergonomics and Fitness in the cleanroom | CLEANROOM MAGAZINE 1/2016

48 Cleanroom adapted exercises for progressive muscle relaxation An exercise for working at a microscope: The goal of the exercise is to consciously relax a particular muscle group, whereby a condition of relaxation should be achieved regarding a particular muscle group.

SERVICE

The employee slowly sits up straight and breaths three times slowly in and out. He raises the shoulders slowly upwards, breathing in at the same time and tries to hold the shoulder muscles in a tensed position for five seconds. A slight tension of the neck musculature is felt. (Important: do not tense up) The breath is held and after five seconds exhaled. The musculature is relaxed. The shoulders are slowly, consciously lowered. A relaxation of the musculature is clearly noticed.

Attention should be given to the alternation between contraction and relaxation.

CLEANROOM MAGAZINE 1/2016

49 The baton to pass, this is in the cleanroom only mentally possible.

Photo: Cleanroom Media.

constant strain and tension on the

have noticeable effects but unduly

a distinct seat mechanism supports

back is the number one problem

act on the metabolism and become

an employee’s spinal column while

in the modern working world.

addictive.

allowing him to concentrate on his

Every second German over 30 years

work with minimal movement.

old suffers from back problems.

“Healthy sitting” as a slogan sounds

In Part 2 (next issue), read more

Conventional medicine is only

contradictory but it refers to specific

about ergonomics and fitness in

able to ease the pain however will

sitting solutions inside a cleanroom,

cleanrooms.

never be able to combat the causes.

such as those from the company

Cortisone injections against pain

Dauphin HumanDesign Group. Here,

Author: Josef Kwasnitza

Cleanroom Magazin: Mr. Reudelsdorf, you have been working for quite some time in parallel as a coach and a trainer in the field of sport and as a cleanroom technician and are knowledgeable about the many kinds of variously equipped cleanrooms.

You are aware of in a double sense, and tangibly measureable, how necessary physical movement is for cleanroom personnel on one side but also how movement significantly increases the likelihood of contamination on the other side.

Richard Reudelsdorf: This problem has been well described in the article. Activities in a cleanroom underlie a person’s own specifics and the avoidance, respectively the prevention of contamination remains the number one priority. However, some things remain possible for employees to be able to stay productive. The progressive relaxation exercises for example for working at a microscope are offered in this article.

Cleanroom Magazin: How often should the exercises be repeated?

Richard Reudelsdorf: A person should carry out in all two repetitions. With some muscle groups, it might take several attempts before the correct musculature has been contracted. Of course, practicing the exercises should be logically done outside of the cleanroom.

Cleanroom Magazin: Does a particular sequential order have to be followed?

Richard Reudelsdorf: In order to achieve a sustainable relaxation effect, it is recommended to follow a particular sequence of muscle group exercises. This of course takes place outside of the cleanroom. It takes 30 minutes and requires a quiet environment. Many courses are available on the market. Together with the targeted strengthening of the musculature and by the way, the cardiopulmonary system, relaxation is essential for a healthy body and mind.

Ergonomics and Fitness in the cleanroom | CLEANROOM MAGAZINE 1/2016

50

What keeps its Longevity is goo

SERVICE

In the spring of 2016 the revised version of the DIN EN ISO 14644-1 and -2 will be published..

Since 2005, international experts are working on an upgrade of the DIN regulation introduced in 1999 EN ISO 14644 Cleanroom classification. Part 1 and 2 of this standard replaced the US Federal standard 209E. The update provides an adaptation to new circumstances and several facilities, critical to everyday working procedures.

classification; it must represent an upper confidence bound, derived from the measurements, and statistical projections. This fact requires a slightly different approach to determining the number and

The 1999 standard DIN EN ISO 14644

a particular class of the cleanroom

was the first international standard

to the main point of contention.

for detecting space Cleanroom

Described in the introduction of

classifications. At its adoption, it

the previous standard 14644-1 it was

was agreed that after at least every

explained how the new formula

In the current standard, the number

ten years there needed to be update

worked and it was not exactly clear,

of measurement points of the

of the standard, i.e. a correction of

even for experts it was not possible.

formula was determined: the number

errors and an adaptation to new

Therefore, this new introduction

of measuring points stems from

circumstances. This process was

describes what assumptions do

the root of the surface area in m2,

started in 2005. An international

underlie. In the future it should

rounded up to the next higher whole

team of experts should develop a

therefore be possible to follow the

number. This is not derived or 100%

rewrite, and his main priority will

adopted specifications. Thus one of

accurate but on the basis of the above

be to first define priorities requiring

the recognized gaps was closed.

assumptions, experts should find a

location of measuring points.

Number of points:

suitable scientific approach, which

urgent revision and work.

In the current standard, it is as-

eliminates these inaccuracies that

The fact that this recast expected to

sumed that the particle load of a

may or may not arise.

be published in the spring of 2016, it

space is homogeneous, so that the

does make clear, the consultations

measured values are only scattered

According to the new version, this

were difficult. However, the draft now

around this mean. This was also the

number of measuring points must

has a good chance to be adopted in

required statistical procedure for

be, read in the future from a table

the near future. Here is an overview

the evaluation of the measurements

where the number is still on the

of the main changes.

that is only understood by a few. In

surface area that is dependent on.

the new version, the space must no

The difference with the old formula

longer be as homogeneous for it to be

is not so serious, in some places, one

considered, which is also not practical

or two measuring points must be

experience. In the future it „only“

used more than before. Only in very

comes to show that the required

large rooms from 1,000 square metres

limit of particle concentration is

is a linear increase in the number.

ISO 14644 part 1 Statistical analysis of measurements:

observed. This makes it obsolete to

Location of the measurement points:

To do this, there was controversy.

the subsequent statistical analysis

Multiple negotiations were close

and evaluation of measurements,

to failure. The topic number and

these will no longer be in the new

location of measuring points

version. Each single measurement

Whether more measuring points

counted for proof of conformity with

must now comply with the required

bring more security with regard

CLEANROOM MAGAZINE 1/2016 | Law and regulations

51

Photo: Berner International

to a possible breach to the required

the situation is once determined,

cleanroom quality, this remains to

everything in the standard should

be clearly known. The debates were

also be maintained.

Definition of clean room class: The basic chart for this definition of the cleanroom classes was adopted

fierce when it came to the location of the measurement points. The

The compromise is now: the location

and ended up virtually unchanged.

„theorists“ demanded that these

of the measurement points should

However, the particle sizes, which

should be newly determined via

be representative of the area. The set

would result in very low limits for

random number generators for

of points can be done through a risk

a classification to be met, has been

each qualification and requalifi-

assessment and should evenly cover

removed from the purer classes

cation. Select the location of the

the area. Can a purely statistical

in the classification as statistically

measurement point, chosen from

examination of the location of the

reliable evidence m this would mean

random number generators, and

measurement points capture all

a disproportionate effort to comply

that would cause the whole space

influences on the quality of the room

with. So the limit value for particles

to be examined in the course of

- around type of ventilation, location

of ≥ 5 µm was cancelled, in ISO class

time, and should respond a posi-

of vents, location of installations,

5. Due to this it has been disused

tive answer.

personnel, etc. - ? Although, this

enormously in the past, on whether

compromise represents a user

such low limits are useful. Now, it

friendly way.

has decided to adapt the existing

The „pragmatists“ could not reconcile themselves, and so in

classification.

most cases the conditions for the

Because the number of measuring

application of such a course of

points now must be read from a table,

Who needs a specification for

action is difficult. That‘s why the

many operators will need to revise

this size with such low limits,

„pragmatist“ chooses the location of

their documents and customize

which must rely now on the so-

the measurement points according

possibly one or two measurement

called macro descriptor. However,

to a completed risk assessment,

points that are used evaluate and

it is still preserved, allowing the

and after engineering the plan. If

redefine.

standardized specification of limits

Law and regulations | CLEANROOM MAGAZINE 1/2016

52 for large particles, even if they are

Who, however, with particles <

By chance, here is the set found

not in the focus of the standard.

0,1 µm wanted to work, for which

that the operator should make the

This should specifically comply

there was a U-descriptor (for

re qualification once a year. This is

in the European pharmaceutical

ultrafine particles). This should be

just pure classification, there are

industry, as the GMP class A date

replaced in favour of a new part

no recommendations for further

ISO class 5 that was almost equated

of ISO 14644, in which you wanted

testing, as they were called so far.

was with specifications both 0.5 µm

to deal with nanoparticles. This

Here, the operator due to its own

and 5 µm particles. The detour via

part was developed parallel to

specifications, for example on the

the macro descriptor means but

part 1 so that you wanted to deal

basis of a risk assessment, must now

only a change in the choice of words

with references to this new part

define the extent of testing required

requires only minor adjustments.

of the topic of very small particles.

and the intervals associated.

Unfortunately this part failed the Only for those, an ISO class 5 will

participants at the last moment,

only be granted on the basis of 5 µm

due to a missing consensus, so that

who wanted to specify the particle.

now there is a gap.

Compliance with the clean room classes:

Opposition phase now draft part 1 and 2 should be released as soon as

This will involve only a vanishingly small number of operators, if at all.

Opposition phase

ISO 14644 part 2

possible and presented to the public for commenting. As soon as the subsequent objections, for example to

Part 2 of the standard 14644 focused

errors or Unverständlichkeiten, are

on the measures for determining

edited, the final version is expected

The procedure for the determination

the on-going compliance with the

to be released in the spring of 2016.

of compliance with the cleanroom

requirements of part 1. It contained

classes is preserved. What is new is

among others notes to the intervals

that now all information (not only

for re qualifications. In the future,

the measuring process itself, but

the focus will be on monitoring, so

also the minimum requirements

on a more or less continuous mon-

for the measuring instruments) are

itoring selective process.

fully included in part 1, so that it is formally no longer instructed to

The display of aspects to be observed

look elsewhere for other parts of the

here plays an important role in the

standard. The concept of the macro

new part 2. Normative, it is not

descriptor was also preserved, as

codified but who needs a monitoring

mentioned above.

to a high extent. For example, this must define each operator based on a risk assessment itself and documented in a monitoring plan.

The person of Dr.-ing. Dirk Stanischewski leads a group which deals with the qualification of cleanrooms and systems of Bilfinger maintenance GmbH. In the course of these activities, he works with in national and international policy committees. The Bilfinger maintenance GmbH is specialized on maintenance and equipment of industrial plants.

CLEANROOM MAGAZINE 1/2016 | Law and regulations

Author: Dirk Stanischewski

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www.cl-ex.com The knowledge portal for the cleanroom industry.

CLEANROOM MAGAZINE 1/2016

53

54

RobotScan Flex is the Industry’s Innovation of the Year

SERVICE

A robot for air filter inspections wins the Cleanroom Award 2015.

The award for the cleanroom innovation of the year and the first time ever awarding of the Creative Prize by the ReinraumAkademie (Cleanroom Academy) were the highlights of Cleanzone 2015. The International Cleanroom Trade Fair recorded an increase in attendance of 20 percent.

of Cleanzone’s broad spectrum of visitors, their concepts, ideas and solutions. The applicant who at the end of the presentations wins the Award is decided by Cleanzone’s

That was certainly a clean sweep: The

of the award for the best cleanroom

representatives of InfraSolution AG

innovation of the year.

attendees by ballot.

InfraSolution AG received the

came for their first time as an exhibitor to last October’s Cleanzone, presented

“We are very pleased about winning

Cleanroom Award 2015 for its

a world premiere and promptly won

the award. In behalf of the entire

unprecedented, automated mea-

the ReinraumAkademie’s Cleanroom

team, I thank you all very much. It

suring system with the name of

Award. With RobotScan Flex, a robot for air filter inspections, this company

“Due to the absence of any manual work, we get timely, precise measurements with the minimal of human input.”

from Langen, Germany, convinced the visitors of Cleanzone and its competitors to select it as the winner

Mathias Itter, Chairman and CTO of InfraSolution AG

was an excellent idea to come here”

RobotScan Flex. This device enables

said Mathias Itter, Chairman and CTO

filter integrity tests in up until now

of InfraSolution AG during the award

unrivaled quality. A robot arm scans

presentation. The Award endowed

automatically, in accordance with the

with 3,000 Euros was presented by

valid norms and regulations, vertical

Yvonne Weis, representative of last

as well as horizontal terminal filters

year’s winner, Initial, and Frank

and Laminar Flow units. Intelligent

Duvernell, Managing Director of the

software meanwhile compiles

ReinraumAkademie.

the necessary documentation and analyses and visualizes the

Mathias Itter (left), Chairman and CTO of InfraSolution AG, is the winner of Cleanroom Award 2015.

Photo Sandra Gaetke

With the Cleanroom Award, the

measurements in the form of an

ReinraumAkademie distinguishes

electronic test record. “The robot

every year a pioneering cleanroom

lingers neither too long nor too short

technology innovation. A profes-

in positions of incorrect spacing

sional jury selects beforehand, from

under the filter”, explains Mathias

all the applicants ,the final five. These

Itter. “In this way, there are no

five finalists then present in front

longer any distorted measurements.

CLEANROOM MAGAZINE 1/2016 | Cleanzone 2015

55 Besides, due to the absence of any manual work, we get timely, precise measurements with the most minimal of human input.” A further advantage is that the three-arm-robot is able to reach every point in the room and recognize obstacles such as sprinkler heads or walls. “Something like this was not possible five years ago, as the calculation technology was not yet available” emphasizes Itter.

RobotScan Flex is planned to hit the market in the middle of 2016.

Not only RobotScan celebrated its world premiere at Cleanzone. The ReinraumAkademie’s Creative Prize also made its debut. “With this special award presented extra to the Cleanroom Award, we want to bring to the attention of cleanroom planners and operators, the aspects of employee well-being and concentration influenced by ergonomics and color in the cleanroom” said Frank Duvernell, Managing Director of the

Creative Prize Awarding | The first-time awarding of the Creative Prize for the most attractive cleanroom went to MEDEL, represented by Christian Dragosits (middle) and Alexander Mayr (2nd from right). The award made of glass was designed and created by Beat Toniolo 2nd from left). Photo: Cleanroom Media

ReinraumAkademie. The winner of the first Creative Prize was the company

material. MED-EL representative

Overall, Cleanzone which is organ-

MED-EL from Innsbruck, Austria. The

Christian Dragosits who together with

ized by the Messe Frankfurt in part-

producer of hearing implants received

his colleague Alexander Mayr accepted

nership with the ReinraumAkade-

the award for the distinctly creative

the award, disclosed just how suitable

mie, in its fourth year of existence,

design and creation of a newly-built

the design and material were: “We used

closed with a remarkable balance

cleanroom complex. The Swiss artist,

a lot of glass for our new cleanroom

sheet: Compared with last year,

Beat Toniolo, designed the Creative

so that employees are able to see the

Cleanzone registered a two-digit in-

Prize and decided on glass for the

Autumn colors and the Winter snows.”

crease and this in all parameters – ex-

Call for application - Submit your project for the Clean Room Award 2016 Until when can projects be submitted?

The deadline for applications is June 30, 2016.

Participants can be companies, institutions and scientific establishments.

What can be submitted?

Sought are innovations which bring to the cleanroom industry technological advances, yields in efficiency or competitive advantages. All interesting ideas can be submitted whether they are sketches on sheets of paper or completely finished products.

Where should the applications be sent?

Applications for the Cleanroom Award 2016 are to be sent to the following address: ReinraumAkademie GmbH Rosa-Luxemburg-Str. 12-14 04103 Leipzig Germany Tel.: +49/341/98989/303 E-Mail: info@reinraum-akademie.de Internet: www.reinraum-adademie.de

Cleanzone 2015 | CLEANROOM MAGAZINE 1/2016

56

SERVICE

Cleanroom Award 2015 – This innovation made it into the final and took the award.

Smart Garment The company Berendsen (Arnheim, the Netherlands) introduced a textile management system which with UHF technology, RFID chips and intelligent software enables the tracking of every single piece of cleanroom clothing. The system takes into account which piece of clothing is being used at the moment, or which is in the stock room or even which piece is being cleaned. Thanks to this information, over-capacities in the stock room are visible, also clothing which is never worn. Moreover, the system is able to be used for controlling access for example in cleanroom air locks.

keyboard which can be used while wearing layered cleanroom gloves. Additionally, there is a hand scanner. The work station has neither ribbing nor edges and is completely encapsulated. The batteries are inductively recharged via a wall contact.

Clothing Disinfection with Light A research fellowship affiliated with the company Ortner Reinraumtechnik GmbH (Villach, Austria) presented a solution for the continuous disinfection of cleanroom clothing while being worn. The basis is a special textile dye which produces oxygen when exposed to light and thus permanently sterilizes textile surfaces.

This worldwide, unique development is not only interesting for the cleanroom industry but also for example, for doctors in disaster areas. Project partners were dastex, M. Dohmen and the TU Graz.

Trolley Light Inductive The company Systec & Solutions GmbH (Karlsruhe, Germany) presented a work station on wheels which thanks to the lithium-ion batteries can be used in cleanrooms without any electrical cables. The mobile work station consists of a stainless steel battery housing, a vertically adjustable display for working while standing and an inclinable glass

Robot-Supported Air Filter Inspection The company InfraSolutions AG (Langen, Germany) won the Award with its product RobotScan Flex, a unique, automated measurement system for carrying

out filter integrity tests. A robot arm automatically scans filter and Laminar Flow units while a software system prepares the necessary documentation and analyses. The robot is mobile and easy to operate. The measurements can be carried out using fewer personnel and much more precisely and more quickly than by hand. The measurements are archived without danger of manipulation.

Surfaces for Cleanroom Equipment Senoplast Klepsch & Co. GmbH (Piesendorf, Austria) showed with its product Senomed a newly developed plastic material for surfaces in cleanrooms and air locks. The multilayered material is chemical-resistant, scratch-proof, abrasion resistant and producible in a limitless palette of colors.

Furthermore, the material has an antibacterial effect. Micro-biological tests have shown that the material itself is neutralizing causing microbes to die off.

This innovation is suitable for aseptic and non-aseptic areas and has the potential to steadily replace materials now in use.

hibitors, surface area, visitors and

the qualifying that is the verifica-

tor of the ReinraumAkademie and

internationality. With 731 profes-

tion whether the cleanroom has

Partner of Cleanzone says: “I am to-

sional visitors from 32 countries,

been built according to standards

tally convinced that Cleanzone will

Cleanzone was able to record 20

and norms, and operations.

continue to grow as it is here that

percent more vis-

all sectors of the industry have the

itors than in 2014.

Particularly found popular by

opportunity to meet. This event has

The number of ex-

Cleanzone’s visitors was the Clean-

once again shown that production

hibitors increased

zone Congress organized by the Re-

and assembly in cleanrooms is an

by 40 percent to 88

inraumAkademie. International,

international topic for the future

companies from

renowned cleanroom technology

and that it encompasses every sin-

12 countries. The

professionals imparted their prac-

gle industry.”

products and ser-

tice-oriented knowledge and also

vices on offer cov-

new technical discoveries.

ered the entire life

The next Cleanzone will take place on November 8th and 9th, 2016, in

cycle of a cleanroom

Cleanzone has reached and be-

from the construc-

come a permanent international

tion and planning,

and inter-disciplinary platform for the exchange of cleanroom tech-

Cleanroom Award 2015.

nologies of significant magnitude.

Photo: Cleanroom Media

Frank Duvernell, Managing Direc-

CLEANROOM MAGAZINE 1/2016 | Cleanzone 2015

Frankfurt am Main, Germany.

Author: Frank Baecke.

Cleanroom Knowledge for Reference The CLEANROOM MAGAZINE editorial staff regularly scans publishers for their new publications with relevance to the cleanroom industry. These books – just published – we would like to introduce you to.

Good Transport Practice in the Pharmaceutical Industry The Good Transport Practice in the Pharmaceutical Industry is once again up to date, as new EU guidelines have set standards which have to be applied. Thereby it is not just about the standard practices which require fundamental improvements.

It is much more about the formal requirements which additionally have to be posed particularly a quality assurance system which is able to document all activities and make them traceable. In this jungle of requirements and regulations, this book offers the reader a sense of orientation based on practice. In focus is the collaboration of diverse disciplines , the portrayal of the resulting effects of synergy, the exchange of information between the various professions, which occasionally are missing their cross-connections, consequently providing the recognition of significant relationships between all the players. Examples of real-life practice, tips and background information help loosen up the contents and make understanding much easier.

“Gute Transportpraxis in der pharmazeutischen Industrie”, Detlef Werner, ECV Editio Cantor Publisher. 1st Edition 2015, 160 pages, softcover. ISBN 978-3-87193-427-8. Price: €78.11.

Containment Handbook Containment solutions are becoming more important for the manufacture of pharmaceutical products as new medical ingredients are often highly reactive even in small dosages. Therefore containments have to offer the highest degree of tightness in order to protect employees and the environment from contamination.

At the same time, containments have to enable trouble-free material flows and maintenance. How to solve this technological balancing act, which regulatory requirements are to be fulfilled in the planning, construction and renovation of these facilities and how to safeguard employee safety, all of these issues are described in the newly published “Containment Handbook”. This publication has collected the widely scattered information about processes, technologies and regulations and has made available to laboratory operators and pharmaceutical producers a very worthwhile reference book.

“Containment-Handbuch”. Publisher ISPE/D/A/CH Containment Work Group of the International Society for Pharmaceutical Engineering, 1st Edition 2015, 172 pages.

The book can be ordered online via the ISPE-Dach website: http://ispe-dach.org/web/die-ispe-dach-arbeitsgruppen/regional-cop-containment

Cleanroom Knowledge for Reference | CLEANROOM MAGAZINE 1/2016

57

58

Trade Fairs and Congresses

Kiel

Schwerin

Hamburg

Germany

Bremen

SERVICE

Berlin 18.-19.03.2016 Interpharm Berlin Germany

Hannover

Berlin Potsdam Magdeburg

Leipzig

31.05.-02.06.2016 parts2clean Stuttgart Germany

Düsseldorf

Erfurt

Dresden

Köln

Wiesbaden

10.-11.02.2016 Pharmapack Europe Paris, France

Nürnberg Nürnberg

Mainz

19.-21.04.2016 Partec Nürnberg Germany

Saarbrücken

21.-23.04.2016 Austropharm Vienna Austria

StuttgartStuttgart

München

10.-13.05.2016 Analytica Munich Germany

München

13.-14.04.2016 Lab Innovations Lausanne Switzerland

Konstanz

Basel Aarau Delèmont Solothurn

12.-14.04.2016 MEDTEC EUROPE Stuttgart Germany

Zürich

St. Gallen

Wangen a.d. Aare

Neuenburg

Luzern Freiburg

Bern Chur

Lausanne

Genf

Switzerland

CLEANROOM MAGAZINE 1/2016 | Trade Fairs and Congresses

21. -23.04.2016 Cleanroom Exhibition Istanbul, Turkey

59

Events at the ReinraumAkademie, Germany and the CleanroomAcademy, Switzerland Reinraum-Expert Days| Cleanroom Expert Days 27.-28.01.2016 | Modern Cleanroom Design and Layout. ISO/DESIGN/GMP/AMC (Modular System – 4 Modules) | Leipzig, Germany 02.-03.02.2016 | Cleanroom and Hospital – one Topic, two Worlds | Wangen an der Aare, Switzerland 09.-10.03.2016 | Cleanroom Layout, Planning and Construction | Leipzig, Germany 11.-12.05.2016 | Flexible Cleanroom Design and the Integration of Production Facilities, Equipment and Furnishings in a Cleanroom | Leipzig, Germany 07.-08.06.2016 | Cleanroom Layout, Planning and Construction | Wangen an der Aare, Switzerland 28.-29.09.2016 | Flexible Cleanroom Design and the Integration of Production Facilities, Equipment and Furnishings in Cleanrooms | Wangen an der Aare, Switzerland 05.-06.10.2016 | Fundamentals and Optimization in Cleanroom Operations, Cleanroom and Qualification | Leipzig, Germany 23.-24.11.2016 | Optimal Cleanroom Personnel | Leipzig, Germany 07.-08.12.2016 | Optimization and Qualification of Cleanroom Operations | Wangen an der Aare, Switzerland

BEHAVIOR IN A CLEANROOM 23.02.2016 11.04.2016 27.09.2016 02.11.2016

| One-Day Training Plus | Aschaffenburg, Germany | One-Day Training Plus | Penzberg, Germany | One-Day Training Plus | Wangen an der Aare, Switzerland | One-Day Training Plus | Leipzig, Germany

BASICS OF PROFESSIONAL CLEANROOM CLEANING 24.-25.02.2016 | Two-Day Seminars | Aschaffenburg, Germany 17.-18.10.2016 | Two-Day Seminars | Leipzig, Germany

ADDITIONAL EVENTS 27.01.2016 02.02.2016 02.-03.05.2016 28.09.2016 05.10.2016

| International New Year Reception of the Cleanroom Industry and users | Leipzig, Germany | New Years Apéro of Swiss Cleanroom Industry and users | Wangen an der Aare, Switzerland | Seminar „Working in a Cleanroom“ | Nürnberg (D) | Swiss Cleanroom Industry’s Autumnal Reception | Wangen an der Aare, Switzerland | Cleanroom Industry’s Autumnal Reception | Leipzig, Germany

The events take place at: Cleanroom Experience Competence Center Rosa-Luxemburg-Str. 12-14, D-04103 Leipzig, Germany Tel.: +49/341/98989-0, Fax: +49/341/98989-200 info@reinraum-akademie.de, www.reinraum-akademie.de

Cleanroom Experience Competence Center Vorstadt 4, CH-3380 Wangen an der Aare, Switzerland Tel.: +41/326316050, Fax: +41/326316059 info@reinraum-akademie.de, www.cleanroom-academy.ch

Events | CLEANROOM MAGAZINE 1/2016

60

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Next issue | April, 2016 Ausgabe 2/2012

1/2013

Cleanroom Award

Cleanroom Award

Erster Innovationspreis für die Reinraumbranche First special award in the cleanroom industry

Monitoring fallender Partikel Monitoring Particle Deposition

Düsseldorf

Attraktives Reiseziel für Technologen Popular destination for technologists

2/2013

Ausgabe 2/2012 2/2014

Cleanroom Award

Erster Innovationspreis für die Reinraumbranche First special award in the cleanroom industry

Cleanzone

Paris

Attraktives Reiseziel für Technologen Popular destination for technologists

Düsseldorf Die Reinraumwelt trifft sich in Attraktives Frankfurt / The World ofReiseziel cleanfür Technologen room meets in Frankfurt Popular destination for technologists

Barbara

Sieglinde Sellemond

Norbert Otto Vordenken und Nachdenken Thinking Ahead and Reflecting

KanegsNorbert Otto berg

Vordenken und

Genuss, Kunst und Kultur Indulgence, art and culture

DasNachdenken Produkt steht im Thinking Ahead Mittelpunkt / The focus andonReflecting the product

Dresden

Attraktives Reiseziel für Technologen Popular destination for technologists

Jan Gerbrands Motivation und Leidenschaft Motivation and Passion

Well dressed in a Cleanroom

Cleanroom Award –

Tirol – Hightech im Bergparadies

Gut gekleidet im Reinraum www.cleanroom-media.com

EDITION 2/2012

MAGAZINE

Cleanroom Award – Advancement for the Cleanroom

Cleanroom Award – Challenging the branch

EDITION 1/2013

CLEANROOM

Cleanroom Award –

Gut gekleidet im Reinraum Fortschritt für den Reinraum

Herausforderung an die Branche

Tirol – High tech in mountain paradise

Well dressed in a Cleanroom

EDITION 2/2013

EDITION 1/2014 summer 2015

MAGAZINE

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

How the vision of autonomous driving is gradually becoming a reality

Rules & regulations Annoying agree or a tip for money values?

OLEDs The lighting revolution out of the cleanroom Hospital germs How cleanroom technologies prevent infections

Smart Textiles Intelligent fabric changes medicine, architecture, fashion and the car industry

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

Imprint CLEANROOM MAGAZINE Is issued and published by Cleanroom Media GmbH Rosa-Luxemburg-Straße 12-14 04103 Leipzig, Germany Internet www.cleanroom-media.com Management Frank Duvernell, (V.i.S.d.P.) Administration – Cleanroom Media Maja Franke Tel. +49 341 98989 404 maja.franke@cleanroom-media.com

EDITION 3/2015

Chief Editor Frank Baecke Tel. +49 341 98989 405 frank.baecke@cleanroom-media.com Translation Bill Hillman Daniel Read Authors Frank Baecke Frank Duvernell Piet Felber Maja Franke Gero Hassink Thomas Köhler Josef Kwasnitza Dirk Stanischewski

CLEANROOM MAGAZINE 1/2016 | Imprint

Circulation 10,000 copies Printer Löhnert-Druck, Leipzig ISSN 2364-0405

01

winter 2016

Approaching the Dimension 3D printing is opening new perspectives for cleanrooms

Outlook 2016

Experts estimate future prospects in the cleanroom industry

Talent Development

Cleanzone 2015 This international cleanroom trade fair gives momentum and impulse to the cleanroom industry

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

Advertisements/Notifications Maja Franke Tel. +49 341 98989 404 maja.franke@cleanroom-media.com

Publication Quarterly

MAGAZINE

Germs in Food Products How cleanroom technology aids in killing off dangerous food product germs

EDITION 4/2015

Implementation Wohlfahrt GmbH www.wohlfahrt.net

CLEANROOM Life & Science Information for Cleanroom Technology

The Internet of Things

Joy of Being Driven

The influence of pollen and air humidity on your production

EDITION 2/2015

04

autumn 2015

Life & Science Information for Cleanroom Technology

Blossoming Nature Dangerous Contamination

EDITION 1/2015

EDITION 2/2014

CLEANROOM

03

02

spring 2015

Life & Science Information for Cleanroom Technology

www.cleanroom-media.com

How employees become cleanroom operatives

Laws & Regulations

EDITION 1/2016

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