Cleanroom Magazine 04-2015

CLEANROOM MAGAZINE

04

autumn 2015

Life & Science Information for Cleanroom Technology

The Internet of Things

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

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

Save the Date!

Vision. Innovation. Expertise.

27 + 28. 10. 2015 Frankfurt am Main

International trade fair and congress for cleanroom technology.

No matter what type of cleanroom you require, Cleanzone offers innovative and interdisciplinary solutions for every sector.

You will find more information and impressions at: www.cleanzone.messefrankfurt.com

3

Dear Readers!

The Internet of Things begins in cleanrooms. Tiny micro-electronic-meblocks of our digital future. They are perfectly suited to being mass-produced using methods from the semiconductor industry and intelligent programming. Equipped with micro-controllers, miniature batteries and radio chips, MEMS is bringing every object into the internet thanks to the communication networks now available everywhere.

This makes possible completely new services which will change our everyday lives. They include services such as a razor being able to automatically order new blades, or a chain of coffee shops which are able to adjust their beverages according to customer preferences via Real-Time-Analytics. For industry, real-time, optimized supply chains are emerging through the availability of all relevant information which will enable tremendous increases in productivity – known as “Industry 4.0”.

Frank Duvernell: “According to a Gartner Study, more

25 Mrd.

than 25 billion devices are likely to be networked with each

2014: 4 billion

other by the year 2020. Isn’t it frightening to think that everything will be able to integrate itself with everything?

2020: 25 billion

4 Mrd.

I say, NO! The computers embedded everywhere will make our lives safer and more comfortable. Gartner estimates

Gartner market researchers expect that the Internet 2014

2020

that companies in 2020 will generate earnings of more than 300 billion Euros in additional revenues with the Internet of Things. If to say these aren’t good prospects for the cleanroom industry!”

Number of networked devices:

of Things will rapidly grow until 2020. Source: Gartner, Inc.

That all these innovations are being made possible by cleanroom technologies is known only by the few. In order to give this issue more publicity, the ReinraumAkademie (Cleanroom Academy) has created the Cleanroom Award. It is awarded yearly at Cleanzone and brings the most exciting and interesting developments from the cleanroom world out into the public light. I most heartedly invite you all to be present on October 27th and 28th, 2015, in Frankfurt am Main, Germany, to see for yourselves just what is happening in the world of cleanrooms. I am directing this invitation specifically to those professionals who will be able to discover the highly attractive but little known employment possibilities in the cleanroom industry.

Frank Duvernell Editor

Editorial |

4/2015

EDITORIAL

chanical systems, the so-called MEMS, are the components and building

4

CONTENTS 04/2015 ..................................................

08

08 Title Story: The Internet of Things

CONTENTS

How the billion-times over networking of devices with electronic components made in cleanrooms have changed our private and work lives.

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

LIFE & BUSINESS

What’s New in the World of Cleanrooms

06 Market Developments in Brief Where Swiss Pharmaceutical Exports are Heading • Smartphone Core with the Slightest Growth since 2013 • Cared for by Robots? • LG invests in OLED Technology • Every second Chip comes from Saxony • Ebola could be eradicated by the end of this Year • ZVEI Trend Analysis by 2019

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

16 Food Product Production: Germs in Food – Now what?

Title Story: Internet of things: when devices communicate with each other

Germs are being found more and more often in the food supply chain and bring on illness and even death. Cleanroom technology offers the food product industry innovative solutions to eliminate germs from food products.

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

06

22 Essay: Where will we find

tomorrow’s qualified Professionals?

Industry is wringing its hands in its search for cleanroom professionals. However, these people cannot be found quick enough to cover the needs. What should be done about this situation? An essay by profi-con Managing Director Frank Duvernell.

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

26 In-depth look – On the road with…

Conor Murray, Chairman of the Irish Cleanroom Society ICS

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

Life&Business: Every second chip is from Saxony.

4/2015 | Contents

5

22 Essay: Which skills will we need in the future?

SCIENCE & TECHNOLOGY

Solutions for the Cleanroom World

28 Technology in Brief Smart Contact Lenses Testing in 2016 • Robots revolutionize Cleanroom Technology • Germ-free to Mars • World’s first electric Light Antenna • TU Ilmenau puts important new devices into Operation • Medicinal products more exactly dosed • US Army develops more efficient solar panels

Laboratories of the future: smartlab.

30 Future Laboratories:

SERVICE

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

Smartlab celebrated its world premiere at the trade fair Labvolution. It shows how digitization and Industry 4.0 are changing present day laboratories and working practices inside them..

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

36 Controversy: Dry versus Wet

Cleaning – a Professional Dispute

At the University Hospital Freiburg, cleaning is predominantly done using dry methods, wet cleaning is done only when necessary. Are dry cleaning methods able to meet the required hygiene standards?

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

40 User requirement specificati-

on: Computer systems more easily validated So that computer systems are able to model operational processes more efficiently, a transparent, comprehensible user requirement specification document is necessary to formulate before implementation. Specialists advise to base the modeling of requirements on a process-based approach.

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

44 What do you do there…?

Mathias Ortner, Service Technician at the Swiss company Elpro-Buchs AG.

30

Events, Awards, Regular Columns

46 Laws and Regulations: Mis-

takes are no grounds for dismissal The court has decided in favor of an employee. This employee had taken unauthorized receptacles into the cleanroom – a source of error which the court decided is the responsibility of the employer to rule out.

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

47 Laws and Regulations: Draft of the new DIN 12980 has been submitted

By the end of the year, it is expected that the new DIN 12980 regulation “Laboratory furnishings – Safety Work Benches and Isolators for Cytostatics and other CMR Medicinal Products” will come into effect.

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

48 Cleanzone 2015: Gives impulse and momentum to the cleanroom industry

From October 27th to 28th, 2015, Cleanzone will become once again the meeting point for the international cleanroom industry. For the first time, the Creative Award will be presented as a special Cleanroom Award recognition.

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

52 In Interview: Koos Agricola The General Secretary of ICCCS will be present at Cleanzone to promote international communication within the cleanroom technology industry.

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

54 Productronica: Electronics Trade Fair with a new concept

At the world leading trade fair for the development and production of electronics (November 10-13, 2015 in Munich, Germany), the cleanroom technology industry will present itself with a special exhibition.

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

56 Professional Literature:

Cleanroom Knowledge to refer to

Cleaning and hygiene technology • Particles in pharmaceutical production • IT trends in GxP environments

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

58 Trade fairs and events

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

60 Imprint

Contents |

4/2015

6

Life&Business

Market developments in brief

The colorful world of Apps: The Smartphone keeps growing but the first signs of saturation have appeared.

LIFE & BUSINESS

Photo: Jpramirez

Where Swiss Pharmaceutical Exports are heading

Smartphone Core with the Lowest Rate of Growth since 2013

Export Study | Pharmaceutical ex-

survey “New Thinking Regarding Health” – a representative survey which commissioned by the Federal Ministry for Education and Re-

ports from Switzerland have been

Market Saturation | The worldwide

search (BMBF). Around a fourth

growing every year on the aver-

Smartphone market experienced in

of the people surveyed (26 percent)

age by 8.5 percent. This statistic is

the second quarter of 2015 its lowest

could imagine to be taken care of

shown by the customs administra-

growth rate going back two years. Ac-

by robots. 51 percent of those sur-

tion. What is interesting about this

cording to an analysis of the market

veyed were in favor of implants for

statistic is the geographical break-

research company Gartner, 330 mil-

better memory retention. Especial-

down. Since 2000, the pharmaceuti-

lion units were sold to end customers

ly younger people find this idea of

cal exports to China have been in-

in the regions investigated, which was

interest. Among those between the

creasing yearly on the average by 25

a plus of 13.5 percent in comparison

ages of 14 and 19, the approval rate

percent while exports to India and

with the same time period last year.

reached 62.3 percent.

Russia have increased by an im-

The strongest growth took place in

pressive 14 and 13 percent. Exports to

the regions of Asia-Pacific, Eastern

the five largest European markets,

Europe, the Middle East and Africa.

Germany, Great Britain, France, It-

In contrast, for the first time Smart-

Billions invested | The Korean Man-

aly and Spain, have been growing

phone sales declined by 4 percent in

ufacturer LG wants to invest near-

yearly by only seven percent.

China over the same time period.

ly 8.5 million US dollars in OLED

Notable are exports to the USA

However, China remains the larg-

display technology in order to keep

which have reached a volume of 58

est Smartphone market in the world

a step ahead of the competition in

percent of the five largest European

with a market share of 30 percent.

this business sector. The major part

sales markets. This percent was on-

“China has reached saturation – its

LG invests in OLED Technology

Smartphone market is characterized by the purchase of replacement phones. There are fewer first-time buyers”, says Gartner analyst Anshul Gupta. Only premium devices could possibly revive the market.

Cared for by Robots?

The Care-O-Bot, developed by the Fraunhofer IPA, is a mobile Robot Assistant for the active support of people

The manufacture of pharmaceuticals. Photo: Kadmy

Survey | Robots used in personal

ly at 29 percent in the year 2000. This

care or as implants for better mem-

shows that expenditures for medi-

ory retention– many Germans have

of the money is supposed to go into

cine in the USA have increased sig-

little fear of being touched when it

the development of OLED panels for

nificantly more than in the Europe-

comes to visionary medical technol-

televisions and mobile devices such

an countries.

ogy. This is the result from the re-

as Smartphones, tablets and weara-

search agency ZukunftsMonitor’s

bles. Furthermore, LG wants to do re-

4/2015 | Life&Business – Market developments in brief

in domestic settings.

Andere

151.221,7

45,9

129.630,2

44,6

Gesamt

329.676,4

100,0

290.384,4

100,0

7

Quelle: Gartner (August 2015) * Die Ergebnisse für Lenovo enthalten auch die Verkäufe von Motorola

search in finding ways to use OLED’s in the fields of automotive manufacture and digital signage. OLED’s are organic light emitting diodes. In con-

Changes in the Market Shares of the worldwide Smartphone Market Manufacturer

2. Quarter 2014 units/thousands

2. Quarter 2014 m.sh. /percent

2. Quarter 2015 units/thousands

2. Quarter 2015 m.sh. /percent

Samsung

72.072,5

21,9

76.129,2

26,2

Apple

48.085,5

14,6

35.345,3

12,2

more brilliant colors and better con-

Huawei

25.825,8

7,8

17.657,7

6,1

trast, need no backlighting and make

Lenovo*

16.405,9

5,0

19.081,2

6,6

it possible to build thinner devices.

Xiaomi

16.064,9

4,9

12.540,8

4,3

Andere

151.221,7

45,9

129.630,2

44,6

Gesamt

329.676,4

100,0

290.384,4

100,0

trast to liquid crystal displays (LCD), OLED’s are more flexible, provide

Every second chip comes from Saxony

Source: Gartner (August 2015) * The results for Lenovo include sales from Motorola.

Silicon Saxony | German Federal Chancellor Angela Merkel toured in July, 2015, together with other politicians and representatives from in-

Ebola could be defeated this year

ZVEI-Trend Analysis by 2019 Microelectronic Market | Asia will

dustry and science, two chip manufacturers Globalfoundries and

WHO-Prognosis | According to esti-

reach by 2019 a 59 percent market

Infineon in Dresden, Germany.

mates of the World Health Organi-

share in the worldwide microe-

Both companies were promoted by

zation WHO, the Ebola virus could

lectronic market, whereby China’s

the German Federal Research Min-

be completely eradicated by the

share will alone amount to 28 per-

istry. Globalfoundries is working,

end of this year. More than 11,000

cent. This figure is forecasted by

with support from the federal gov-

people have died from the Ebola

the Zentralverband Elektrotechnik

ernment, on new chip technologies

outbreak in West Africa. Howev-

and Elektronikindustrie e.V. (ZVEI)

and Infineon on numerous pilot pro-

er, Liberia, Guinea and Sierra Le-

(Central Association of Electron-

jects in high performance electron-

one have been able to greatly drive

ic Technology and Electronics In-

ics, also with federal support.

back the epidemic. In as much as

dustry), one of the most important

Dresden, the capital city of the free-

the discovery rate of new cases of

German industrial associations, in

state Saxony, has become for the mi-

its trend analysis to the year 2019.

croelectronic industry the strong-

America’s market share will grow

est location economically in Europe.

to 21 percent, Europe will have an

Every second chip manufactured in

eleven percent market share and

Europe comes from Saxony. This lo-

Japan with nine percent will bring

cation is now known as “Silicon Sax-

up the rear.

250

Test vaccine against the ebola virus. Foto: science photo

infection and ways of contacting the disease remains high, the virus could “by the end of the year become stably defeated”, says WHO German Federal Chancellor Angela Merkel visiting the chip manufacturer Infineon in Dresden, Germany. Photo: German Federal Government/Kugler

Milliarden Dollar pro Jahr

200

Wert 1: 2009 Wert 2: 2014 Wert 3: 2019

236 194

150 120

100 69

50 38 0

Amerika

Director Margaret Chan. Newly

111 92

85

30

38 43

Europa

55 38 35 36 Japan

Asien China

developed vaccines are providing

By 2019, the fields of communica-

hope. According to WHO, one of

tion, computers and entertainment

these vaccines in clinical tests on

electronics will remain the most

ony” the name stemming from Sili-

4000 people has led to 100 percent

important market segments. In Ger-

con Valley in California. The Saxony

protection from the disease with-

many, the fields of automotive and

microelectronic and nano-electron-

in ten days.

industry will also gain in impor-

ic industries generate revenues of

tance.

around six billion Euros per year.

Life&Business – Market developments in brief |

4/2015

LIFE & BUSINESS

8

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

4/2015

9

The Internet of Things

Without Cleanrooms, An Impossibility (AT)

The Internet of Things (IoT) is advancing into the people’s everyday lives. The digital networking of objects promises to users above all: more comfort and convenience. This beautiful new world, providing us with smarter household appliances, fitness trackers and smart watches, is becoming possible particularly because of the semiconductor industry with its ever more powerful and simultaneously smaller chips and sensors.

All this would never be possible without cleanrooms.

4/2015

10 The stationary computer is disappearing more and more out of our day-to-day lives. In its place, “intelligent devices, objects and materials” are stepping in. The US American computer scientist Mark Weiser formulated such a vision at the beginning of the 1990’s. In his highly regarded essay “The Computer for the 21st Century” written in 1991, he describes life within and with the world of the computer: The Internet

LIFE & BUSINESS

of Things has imperceptibly moved in to support people in their everyday lives, the computer, respectively the internet are no longer objects commanding so much attention.

Weiser’s vision is boldly moving forward to becoming reality.

Vision becomes Reality The internet has meanwhile become omnipresent at home – not only in smart phones and the television but increasingly in heating systems thermostats, washing machines and light switches. Google recognized this trend back in 2014, as this internet company bought the thermostat and fire alarm manufacturer Nest Labs for 3.2 billion US dollars. That, which at that

The conventional becomes the intelligent device

point in time generated quite a bit

new designation of Alphabet, Goog-

of buzz, appears today as the logi-

le will most likely remain the core

cal consequence of the rise of net-

business and earn the money for

working. Recently, Google has radi-

the other divisions. Among these di-

How the Internet of Things has

cally re-structured itself. Under the

visions is the company Nest which

changed and is able to make every-

will also help to drive forward the

day life more practical was one of

networking of things: Under the

the major issues presented at the

name of Fiber, the company pro-

International Communications Ex-

vides in several US cities ultra-fast

hibition and Trade Fair at the be-

fiber-optic connections – the tech-

ginning of September in Berlin,

nical band-widths which are the

Germany. At this worldwide lead-

pre-requisites for the growing in-

ing trade fair for Consumer Elec-

terconnectivity. Google X is another

tronics and Home Appliances, the

division, the innovations laboratory

industry association of the German

of Google, which has been develop-

digital industry, BITKOM, togeth-

ing autonomous driving cars. (We

er with the consulting company

reported on this topic in the 03/2015

Deloitte, presented a new consumer

issue)

electronics study. The findings: The

In smart homes exists a communication between devices.

Internet of Things is currently the

Picture: fotolia

4/2015 | The Internet of Things

11 sign and set up their entertainment

Data, Data, Data

systems not only more conveniently but also more flexibly and individ-

When the refrigerator sends the

ually. Non-networked devices have

shopping list to the smart phone,

much more difficulty in establish-

or the home owner activates his

ing themselves with consumers.”

home’s heating system via his mo-

Networking is growing rapidly

bile telephone, this doesn’t just mean practicality. The constant growth of networks and commu-

Networked devices, powered by

nication between evermore devic-

the tiniest microelectronic clean-

es is producing an unimaginable

room-produced components, will

amount of data. Experts are to date

clearly establish themselves in the

in disagreement how this river of

coming years in entertainment

data can be responsibly dealt with.

electronics. This development is

Companies, on the other hand are

driven forward by an ever faster mobile data network. The mobile communication industry is working on a new super-fast standard with the name of 5G, which will transmit data a hundred times faster than the present day 4G network. The current standard will soon reach its limits in view of

Everything starts in the mind. Picture: fotolia

rapidly growing machine-to-ma-

promising important information

chine communication (M2M) via

in order to make their offers more

sensors. Klaus Böhm, Media Direc-

efficient and more practical. Un-

tor of Deloitte, predicts: “By 2020,

mitigated on the side, these com-

Germans will be using some 100

panies are collecting sensitive per-

million networked devices – not

sonal customer data. The Federal

counting smart phones and tab-

Association of the German Inter-

let computers.” Market researchers

net Industry e.V., eco, thus empha-

from the company Gartner reckon

sizes that in the future it will not

most important trend in entertain-

with over 25 billion networked de-

just come down to creating efficient

ment electronics. “Networking is

vices and machines worldwide by

smart-device communication with

making out of conventional devic-

the year 2020. With the increasing

international standards. When the Internet of Things networks nearly

“Non-networked devices have much more difficulty in establishing themselves with consumers.”

Timm Lutter, Consumer Electronics Area Manager

everything with everything, proper and responsible approaches will be in demand. The risk of abuse is increasing according to eco in that not only concerning the loss of privacy but also industrial sabotage for example by the paralyzation of critical infrastructure such as the power supply. Experts from eco are there-

es, intelligent devices, which is pav-

integration of smart devices in us-

fore asking for more clarification

ing the way for countless new and

ers’ everyday lives, their demands

and investment in security. Con-

creative potential uses”, says Timm

and will also increase. Therefore

cerning these issues, well-known

Lutter, the Consumer Electronics

the need for digital products will

companies in the USA, such as Mi-

and Digital Media Area Manager for

grow, whose components are manu-

crosoft, Symantec and AVG found-

BITKOM. “Users can therefore de-

factured exclusively in cleanrooms.

ed the Online Trust Alliance at the

The Internet of Things |

4/2015

12 Small, energy-saving and inexpensive

beginning of this year. With a co-

units. In the area of consumer

dex of self-regulation, they want

goods, smart devices will bring

to bring about better protection of

about great changes in companies.

the private sphere in the Internet

“The Internet of Things is revolu-

One thing about all these smart

of Things.

tionizing classic business models.”

solutions is the same. Internally is

states Klaus Böhm of Deloitte. In the

found ever smaller semiconductor

future, it’s not only about the prod-

products such as tiny, powerful mi-

ucts, but above all about those with

cro-processors and memory chips

The business with the Internet of

their associated services and con-

as well as intelligent components

Things is booming. The consultants

tents. Besides the smart devices for

which combine sensors and cir-

Growth through IoT

at Gartner are calculating that in five years, companies will be turn-

“The Internet of Things is revolutionizing classic business models.”

LIFE & BUSINESS

ing in this sector will be turning over 300 billion Euros. Industry experts see huge growth potentials in the so-called market ‘Wearables’

Klaus Böhm, Deloitte

– smart watches, fitness trackers and digital glasses. Smart watches in particular have seemingly experienced a boom brought on by the

the body, large numbers of applica-

cuits onto one chip. These so-called

presentation of the Apple Watch in

tions for networking at home were

MEMS sensors have become indis-

April of this year. It isn’t surpris-

presented at IFA: audio systems

pensable in smart phones. They

ing then, that numerous compa-

which are controlled via a smart

measure the rotary and other move-

nies presented their new models

phone, mobile control systems for

ments and provide for photo stabi-

in the Berlin trade fair halls. BIT-

heating facilities, or refrigerators

lization while taking pictures. Mi-

KOM estimates the sales of smart

which on demand send the shop-

cro-antennae are becoming more

watches will grow this year by 350

ping list to the mobile phone.

powerful and more intelligent. Not

percent with a volume of 645,000

just for these reasons are networked sensor systems being regarded as

Cleanroom technical challenges in producing MEMS, NEMS & Co. Air quality and cleanliness: Air quality is negatively affected with particle sizes under 0.1 micrometers – particularly with the so-called NOEMS (nano-opto-electromechanical-systems) with structure sizes in part of only 5 or even 3 nanometers.

Surface cleanliness: Absolute avoidance even from minimal film-like contamination, this means in the one-atom range (for example in the coating of surfaces). A particular challenge: complex assemblies with moving sensors and bio-sensors.

Device cleanliness: The training of cleaning personnel in the setup and cleaning of nano-technical production facilities as well as suitable cleaning materials and resources.

Modification of the VDI 2083 recommendation: Most likely is a stricter specification beyond the cleanroom class ISO 1 which will draw to it the production of extensive new products and innovations, for example the realignment of measuring devices and the integration of additional techniques.

4/2015 | The Internet of Things

the most important components for new powerful applications in the Internet of Things. Micro-technological components are being produced more inexpensively and in greater numbers. An example: At Bosch Sensortec, one of the leading companies in the MEMS technology market, 4 billion MEMS sensors have been shipped since the start of production in 1995. Industry insiders are promising a further leap forward with the development of still smaller components: nano-electro-mechanical systems, analogous to MEMS, named NEMS for short.

13 Wearables – Smart Potential Fitness Trackers are presently the most successful wearable product. Via electronic sensors on the body, these small devices collect data such as calorie consumption, heart rate or running distances. Sales in Germany will increase from 650,000 sold units in 2014 to over an estimated one million units in 2015.

Smart watches are able to take over a range of mobile telephone functions – for example to show emails, SMS’s or incoming calls. The smart phone can remain in your pocket. Interest in the intelligent watches is significant. Four out of ten Germans can imagine using a smart watch.

Smart glasses are presently only in the starting blocks. Augmented Reality is coming into day-to-day life with the incorporation of additional information. 63% of those people interested in this product see its use as adding value to their lives.

Smart clothing is held as the logical further development of Wearables. Smaller and more powerful sensors made in cleanrooms are being integrated into textile fabrics.

Source: Study “The Future of Consumer Electronics 2015” BITKOM

Smaller components, larger demands from cleanrooms

fected chip useless. To date, regard-

of the Internet of Things is closely

ing air quality, a particle size of 0.1

interrelated with cleanroom tech-

micrometer is the accepted limit,

nology.

For the production of MEMS and

which in the future will no longer

NEMS certain production condi-

be enough. A consequence of the

tions are required. The tiny sensor

further development of MEMS to

systems are built onto so-called wa-

NEMS is that the cleanroom tech-

fers, circa 1 millimeter thin sheets

nology industry will have to react to

made mostly out of silicon. For ze-

these new developments. Demand-

ro-defect production, clean air

ed are innovative solutions in or-

quality in the room is extremely im-

der to assure optimal conditions in

portant. The smallest dust particle

production environments. It is ev-

which finds its way onto a wafer or

ident: Developments in micro and

component is able to make the af-

nano-technology and the success

Author: Thomas Köhler

EasyMop GMP

®

Reliable cleaning and disinfecting of pharmaceutical cleanrooms

Pfennig Reinigungstechnik GmbH · Heubachstr. 1 · 87471 Durach · ✆ +49 (0) 8 31 / 5 61 22 - 0 · www.pps-pfennig.de

The Internet of Things |

4/2015

14

Is “Industry 4.0” interesting for the Cleanroom?

LIFE & BUSINESS

Silicon Saxony managing director Heinz Martin Esser speaks about networking, robotics and automation in cleanrooms.

Silicon-Saxony Chairman of the Board, Heinz Martin Esser will be giving a presentation on October 28, 2015, at the Cleanzone Congress dealing with the topic “Automation in the Cleanroom – the Advent of Robot Technology in Logistics and Handling”.

the worldwide semiconductor in-

increase, lead and cycle times are

dustry has been highly automat-

shortened and machine availabil-

ed for years. Chip manufactur-

ity as well as production capacity

ers belong to the first companies

are optimized.

which have interfaced their production machines with intelligent

Cleanroom Journal: What advan-

software systems and are utilizing

tages does automation bring to

the so-called Manufacturing Exe-

cleanroom operators?

cution System (MES) to effectively Cleanroom Journal: Mr. Esser, what

control and monitor production.

Heinz Martin Esser: Robots are tak-

role will the topic of Industry 4.0

As a consequence, quality and yield

ing over the monotonous and phys-

play in the cleanroom industry?

ically demanding jobs. Personnel which then become available can

Heinz Martin Esser: A very large

be trained when required and ap-

role because intelligent produc-

propriate and be placed in produc-

tion brings with it many advan-

tion to do more meaningful work.

tages. Many industries which pro-

In addition, automation contrib-

duce under cleanroom conditions

utes decisively to the avoidance of

use t he most modern produc-

mistakes and to reach a consistent

tion control systems and are very

level of product quality. Last but

far advanced in the direction of

not least, automation helps clean-

the “smart fab”, enabling them to

room operators to reduce the entry

make their factories even smarter.

of human-originating particulate

Self-navigating robots are in a posi-

matter into cleanrooms.

tion today to dependably transport materials and products between any desired points of delivery. The Industry 4.0 is after all the result of complex production methods with many individual components and systems.

Cleanroom Jour nal: How w idespread is robot tec h nology i n cleanrooms?

Porträt: Heinz Martin Esser is the Managing Director of Roth & Rau – Ortner GmbH and the Chairman of the Board of the high-tech association Silicon Saxony e.V., both being located in Dresden, the capital city of the Fed-

Heinz Martin Esser: Robots have been in use in cleanrooms for some years now. Apart from industry specific differences, production in

eral State of Saxony. Silicon Saxony brings together more than 300 manufacturers, suppliers, service providers, universities, research institutes and public agencies making Saxony a focal point for microelectronics. Photo: Roth & Rau – Ortner GmbH.

4/2015 | Is this new industry interesting for us?

15

DO YOU SPEAK CLEANROOMS?

e u s s I a c i d e E SPEAK WM !

S M O O R N A E L C

© NEJRON PHOTO | Fotolia

Pharmacy re, Hospital, ca h lt a e H s: Focu 01 line: October Editorial Dead dline: October 15 ea Advertising D

More information?

Editor in Chief | Roy Fox Tel.: +49 (0) 6201 606714 | roy.fox@wiley.com Advertising | Roland Thomé Tel.: +49 (0) 6201 606757 | roland.thome@wiley.com ä www.gitverlag.com/go/reinraumtechnik 4/2015

16

Germs in food – now what?

Cleanroom technology makes the processing of food products safer and more hygienic.

Foto: fotolia

LIFE & BUSINESS

The use of antibiotics in intensive livestock farming promotes the spread of multi-resistant germs. Germs are finding their way more frequently into the food chain and bring with them disease and death. Cleanroom technology provides the food product industry innovative solutions which eradicate germs but leave the products undamaged.

4/2015

17 In January, 2015, Germans suddenly acquired a taste for turkey meat.

What had happened to instigate this?

The German Federal Office for Environmental Protection (BUND) had fresh, packaged turkey meat from Aldi, Lidl, Netto, Penny and Real tested in the laboratory. The result: 88 percent of the test samples contained MRSA germs and ESBL-generated germs.

MRSA germs (multi-resistant Staphylococcus aureus) cause open wound infections, are resistant to many antibiotics and acquired sad notoriety as the so-called hospital germs. ESBL-generated germs produce the enzyme Extended Spectrum Beta-Lacta-

Testing food in laboratorys. Foto: fotolia

mase ( ESBL) which make many antibiotics ineffective.

ease among the densely packed animals. Often a whole herd is treated via

Up to 15,000 deaths caused by multi-resistant germs

The dust raised by the turkey meat

their drinking water and this several

excitement had hardly settled when

times although only individual ani-

Infections w ith ESBL-generated

in February, 2015, Stiftung Warentest

mals become ill. The result: The bac-

germs and MRSA germs can lead

(Quality Control Foundation) deter-

teria develop resistance to the very

to death in old people, young chil-

mined that ground meat from pork

antibiotic meant to kill them.

dren, ill people and pregnant women. These germs are especially dan-

and beef contained too many of these dangerous germs. Shortly after, the

Eating meat loaded with resistant

gerous for immune-deficient patients

European Food Safety Authority (EF-

germs doesn’t mean that a person im-

in the hospital. According to estima-

SA) and the European Commission

mediately becomes ill. A healthy body

tions of the Berlin Charité, 10,000 to

for Disease Control (ECDC) put out

is able to eliminate the germs on its

15,000 people die each year in Germa-

warnings for antibiotic-resistant bac-

own. It becomes dangerous when the

ny alone, as a result of hospital infec-

teria.

germ-infected person in the case of

tions with multi-resistant germs.

The pathogens are able to cross the

“To take measures which improve hygienic situation.And to decrease new resistance formation.”

Lothar Kreienbrock, RESET-Project Hannover

barrier between animal and human in various ways. They find their way over to humans via contact with animals, slaughtering and food preparation and are able to enter the body via open wounds. Another way of crossing over is via livestock manure which is used as fertilizer in cultivat-

Resistances are the result of frequent use of antibiotics.

ed fields. The multi-resistant germs illness needs an antibiotic. The anti-

also get into the soil, water and in veg-

biotic kills off all bacteria except for

etable crops.

the resistant ones which are then able The more frequent occurrence of

to reproduce unhindered.

germs is the result of the rampant use of antibiotics in intensive livestock farming. The antibiotics are meant to prevent the spread of dis-

Germs in food – now what? |

4/2015

LIFE & BUSINESS

18

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

Harmful germs and their detection in the laboratory. Picture: fotolia.

Measures against the formation of resistance are necessary.

From stomachache to serious food poisoning and infection

Cleanroom technology makes it possible to produce germ-free food products

The German research group RE-

The list of dangerous food product

SET is currently examining where

germs is much longer than the list

The guarantor for germ-free food

and how often the dangerous bac-

of antibiotic-resistant bacteria. Sal-

product production is cleanroom

teria are found in agriculture. The

monella, Listeria, Clostridia, Shigella,

technology which provides clever

first results are alarming: in 34 of

Staphylococcus, Yersinia, Escherichia

solutions for the elimination of mi-

34 meat chicken farms examined,

coli and EHEC bacteria belong to this

croscopic pathogens. An overview of

ESBL-generated germs were found.

list. Their effects reach from harmless

current developments of the newest

In pig and cattle stockyards the rate

stomachaches to serious food poison-

innovations was offered in March

was only slightly lower.

ing and infection.

of this year at the leading trade fair for food products and beverages,

34 of 34 investigated chickenfarms were contaminated.

the Anuga FoodTec which is held in Cologne, Germany every three years. Included among the fair’s highlights was a continuous-running UV de-germination system in which the food product or packag-

In the view of Professor Lothar

Higher standards are demanded from

ing is treated with UV-C radiation.

Kreienbrock, Director of the RE-

food product producers in their pro-

UV-C radiation is part of sunlight

SET project and Institute Director

duction facilities. Along with the law-

and extremely aggressive. This radi-

at the Veterinary University Han-

ful guidelines come the demands from

ation is filtered out by the ozone lay-

nover, these results show that it is

retailers and consumers: Food prod-

er. Unfiltered, the radiation kills off

necessary “...to take measures which

ucts should be fresh, clean and germ-

bacteria, viruses, yeasts and mold

for example improve hygienic situ-

free. Consumers are demanding more

spores within seconds. The beauty

ations which would minimize the

often that producers refrain from us-

of the system is: the UV de-germi-

formation and spread of bacterial

ing unpopular preservatives and addi-

nation requires no chemicals, no

resistance”.

tives. All these demands are making a

heat, leaves the product unchanged

germ-free food product manufactur-

and doesn’t lead to the formation of

ing environment indispensable.

resistance.

4/2015 | Germs in food – now what?

19

Food production with cleanroom technology. Foto: fotolia

Fluid nitrogen reduces germs by 90 percent

curring, the meat is sprayed with

cold light kills off bacteria, yeasts

fluid nitrogen cooled to a very low

and fungi and markedly increases

temperature. This procedure re-

the storability of products such as

The Rapid Surface Chilling proce-

duces the germ load by 90 percent.

yoghurt, quark and milk.

dure was presented at the Anuga

The taste and color of the meat re-

FoodTec Trade Fair, a procedure for

main unchanged.

the effective reduction of germs in

Filters hold back micro-organisms

poultry meat. A lot of chicken meat

A further possibility to keep mi-

is loaded with Campylobacter bac-

cro-biological danger away from

Belonging to cleanroom technolo-

teria which bring on intestinal in-

food products is UV-light treatment

gy for food product production is

fections. To prevent this from oc-

of package surfaces. This intensive,

of course the production facility it-

Facts on Food Product Safety • More than 200 diseases can be can be transmitted by food products.

• Diseases from food products can be caused by micro-organisms (bacteria, viruses, fungi, prions, parasites), by chemicals or by physical agents.

• Food product infections can evoke a wide spectrum of acute as well as chronic symptoms, from diarrhea to cancer.

• According to current estimates, some two million people die worldwide every year, among these many children, from diarrhea caused by food product and water contamination.

• In 2013, alone in the countries of the European Union (EU) and the European Economic Zone (EWR) 310,000 cases of

people with food product infections were recorded, 322 of these cases ended in death.

• In the EU, 85,000 cases of people infected with Salmonella are recorded yearly. The associated costs run up to three billion Euros.

• Due to the outbreak of entero-haemorrhagic Escherichia coli (EHEC) in Germany and France, which was connected with contaminated Bockshorn clover sprouts, nearly 4000 cases of infection resulted in 16 countries in 2011.

Source: WHO-Regionalbüro für Europa

Germs in food – now what? |

4/2015

LIFE & BUSINESS

20 self but also the surrounding clean-

is being processed. Because of the

room areas. These serve to protect the

differing cleanliness requirements,

open products during the removal

cleanroom are divided into class-

of contamination from room air. Ul-

es 1 to 9 according to the DIN Norm

tra-clean air is fed into the cleanroom

ISO 14644-1, whereby 1 describes the

or into machine housings where

cleanest class. The Norm stipulates

overpressure drives unclean air out.

for each cleanroom class how many

High-efficiency particulate air filters

particles at which sizes a cubic me-

through which cleanroom air flows

ter of air is allowed to contain. As a

trap the most minute particles and

rule, food product production takes

micro-organisms down to the size of

place in class 5 to class 8 cleanrooms.

0.5 micrometers. Most bacteria are in

In contrast to semiconductor produc-

the range of one to five micrometers.

tion, in food product production the

However: Every square meter of a

particles themselves don’t present the

cleanroom is expensive. The trend is

risk for the product but the number

operate small cleanrooms, isolators,

of particles with attached germs. In

mini-environments and Restricted

a class 5 cleanroom, the particles are

Access Barriers (RABS). The goal is to

already so small that the air is virtu-

maintain the highest-standard clean-

ally germ-free.

room conditions only directly in locations of food product processing.

Virtually germ-free

Globalization increases health risk attributed to food products This brings many advantages for

How clean production environments

the safe production and packaging

have to be depends on the product be-

of food products as the products re-

ing processed. It makes a difference

main fresh longer, do not prema-

if fresh, moist meat or dry zwieback

turely spoil, are able to be stored Storage of food earlier. Picture: Fotolia.

Chocolateproduction under clean conditions. Picture: Fotolia.

4/2015 | Germs in food – now what?

21 tamination from a single source could have significant health and economic impacts. For example, the EHEC outbreak in 2011 in Germany and France led to nearly 4000 cases of infection in 16 countries, 55 of these cases ending in death. The losses for the agricultural and food product industries were estimated to be 1.3 billion US dollars.

WHO recommendations expected in October In consideration of such dangers, the WHO appointed in 2006 a task group for the investigation of food product infection development, spread, abatement and resulting social consequences. This task group is to support governmental authorities responsible for food product safety and other agencies responsible for determining priorities in food product safety.

The goal is to protect consumers from risks connected with the food supply chain as well as to determine the best possible control measures for the decrease in such risks. The task group longer and no longer require preservatives as the production areas

consists of internationally renowned

Considerable impact on health and economies

experts from disciplines which are active in the investigation of the development, global spread and control

are germ-free. The cleanliness of food product production environ-

“The fact is that we strongly underes-

strategies of disease caused by food

ments is therefore so important as

timate how many people fall ill due

products. Cleanroom technology pos-

our food supply chains are becom-

to chemicals in the food supply chain

es many advantages in this respect.

ing longer and more complex than

and the wide-spread micro-organ-

The task group’s final report will be

ever in the past. We have access to a

isms such as Salmonella and Cam-

made public in October, 2015.

wide range of food products which are produced outside of their normal growing seasons, which are transported from continent to continent, which are processed for convenient consumption and which

The task group’s final report will be made public in October, 2015.

are increasingly consumed while travelling. However this globaliza-

pylobacter. Alarm bells should be

tion of trade and logistics, migra-

sounding from every involved agency,

tion, climate change and new tech-

department and company which has

nologies bring along with them an

in some way something to do with our

increase in health risks attributed

food supply chain”, says Dr. Zsuzsanna

to food products.

Jakab, WHO Regional Director for Europe. A mistake in food product safety in just one link of this chain, or con-

Germs in food – now what? |

4/2015

Foto: fotolia

LIFE & BUSINESS

22

Where will tomorrow’s professionals come from?

An essay by Frank Duvernell, Managing Director of profi-con GmbH Contamination Control Industry is wringing its hands in the search for qualified cleanroom professionals. However, the recruitment and training of new sta lags far behind the growth of the cleanroom industry. What should be done?

4/2015

23 Cleanrooms are special production and working environments in which processes are protected from contamination. The products produced in cleanrooms are sensitive, have life-saving effects, and fulfill safety relevant functions. The spectrum of these products reach from medicines, implants, water marks Foto: fotolia

and other distinguishing features in monetary notes, the filling of bottles of mineral water and juice, the production of eye glass and camera lenses, electronic control systems and brake components for

are not allowed, chewing gum al-

a lab assistant or a sales clerk. Now

the automobile industry.

so not, ideally employees should

begins the dilemma. The ability to work in a cleanroom is “only” an additional qualification. There is

»Eating, drinking, chewing gum, smoking: all that is for Cleanroom employees not allowed.« Frank Duvernell, profi-con Contamination Control

no professional description for a cleanroom engineer, none for the cleanroom lab assistant, nor for the cleanroom service technician or the cleanroom cleaning technician.

There’s more: The Employment Agency is not able to navigate employment needs in any specific di-

Cleanrooms are divided into vari-

be non-smokers. Make-up, visible

rection. Even when a job description

ous classes according to what’s pro-

skin problems and unbound hair

is created which specifies a clean-

duced inside them. Where high

are taboo as well.

room cleaning technician, this

standards on cleanliness are de-

person has also to be found. On-

manded, employees inside this

What exactly is a cleanroom work-

ly the professions one is aware of

cleanroom should refrain from

er? This can be an engineer, a mem-

are searched for. The impact is that

speaking and move slowly and

ber of the cleaning staff, a produc-

public awareness concerning clean-

carefully. Eating and drinking

tion assistant, a process technician,

rooms is simply too little.

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

Where will tomorrow’s professionals come from? |

4/2015

LIFE & BUSINESS

24

What skills needs specialists of tomorrow and where do they come from? Picture: Fotolia.

Cleanroom cleaning takes place in

Let’s go back to the beginning. The

In 2007, we received the award

technologically demanding envi-

first hurdle is always the recruit-

“50 plus” from the German Feder-

ronments and cleanliness of the

ment of new employees for this

al Minister for Employment and

production facility muss be as-

job. We created at first the job ti-

Welfare at that time, Franz Münte-

sured, therefore cleanroom clean-

tle, “Clean Operator”. However with

fering. This was the beginning of

ing can in no way be compared with

this terminology recruitment be-

incorporating people over the age

home and office cleaning. Ultimate-

came even more difficult, with the

of 50 as a target group into the job

ly there are also wiping procedures

Employment Agency, in placing job

market. This market is currently

of surface areas but for the work in a

advertisements and in the internet.

no longer available. There are just

cleanroom, the employee needs a to-

The problem was who would search

no longer suitable candidates from

tally different scientific background

for the job “Clean Operator”? How-

this age group.

than merely, putting it crudely, wip-

ever “Cleaning Professional” is also

ing a surface until it shines.

not the right designation.

Therefore, we at profi-con began for

As a consequence of all this, we

tivities. Who talks about his work

over 20 years ago our own internal

have taken steps in creating profes-

in the cleaning sector within his

training program in order to pro-

sional recruitment strategies which

circle of friends, even if this is the

Young people have other identification problems with these work ac-

most demanding job in the world?

2007, we received an award »50 plus«

by Federal Minister for Labour and Social, Franz Müntefering.

The word “cleaning” remains stuck in the minds of society and this kind of employment is not especially highly regarded in our society.

Presently, women over 68 are being discovered as a target group of people wanting to get back into professional life. However the physical ac-

vide the necessary knowledge to our

show our Clean Operators in the

tivity of our work is just too much

employees and to qualify them for

administration of their duties and

for seniors. Even the generation of

working in cleanrooms. This pro-

this in print, video and social media

50-year-olds reaches their physical

gram developed itself into such a

channels. Additionally we have put

limits at the age of 65.

high caliber that in 2007 we found-

the responsibility for the results of

ed our own training center.

their work in the foreground.

It will be interesting to observe the return of women to their profes-

4/2015 | Where will tomorrow’s professionals come from?

25

To work in clean rooms are special skills needed. Picture: Fotolia.

sional lives. As there has been a

ucation and training. The first ef-

cleaning technician would not able

growth of diverse jobs within the

forts are being made in expanding

to be accomplished by robots. The

cleanroom technology industry,

courses of study into the spec-

economy and especially the middle

one really cannot speak of pre-qual-

trum of cleanroom technology. In

class can no longer ignore the top-

ified people entering the job mar-

this respect, the University of Alb-

ic of cleanroom technology and to

ket. New qualifications are categor-

stadt-Sigmaringen is a forerunner

trust that everything will contin-

ically needed.

as well as the University Graz.

ue to function as it has up to now.

It is also proving difficult for those already employed to change professions. The thought to work under cleanroom conditions is more of a negative criterion in deciding for a new profession.

So, what should be done? What are the future tasks and challeng-

»I really would like to see a lively, deeply sincere discussion between the various players in business and industry« Frank Duvernell, profi-con Contamination Control

es? One thing we are able to determine and this that working under

If our companies are to remain com-

I really would like to see a lively,

cleanroom conditions will not be

petitive, a unified and open educa-

deeply sincere discussion between

more abstract or rare than 20 or 30

tional system is necessary, which is

the various players in business and

years ago. The demands for clean

available to everyone, when possible

industry take place so that we don’t

products are growing in industry

also outside of our national bound-

lapse into the two principles which

as well as by consumers. Safety and

aries. The effect: When qualified

have always spoken against change.

functionality are standing in the

employees come from abroad, they

The first principle: We have always

foreground. Nearly every business

could already exhibit a foundation

done it this way. Second principle:

sector will have some sort of rela-

of basic knowledge. In this respect,

We have never done it differently.

tionship to cleanroom technolo-

norms, guidelines and examples for

gy and therefore will be facing the

this already exist.

Author: Frank Duvernell, CEOprofi-con Contamination Control, since 30 years

task of qualifying employees. This means as a result: The work with

If production processes become

cleanroom technology should and

even further automated in the fu-

will create jobs in professional ed-

ture, the activities of a cleanroom

professionally in cleanroom industry.

Where will tomorrow’s professionals come from? |

4/2015

26

On the road with…

LIFE & BUSINESS

Conor Murray, Chairman of the Irish Cleanroom Society ICS

Conor Murray is the Chairman of the Irish Cleanroom Society (ICS). This non-profit organization is dedicated to the support of cleanroom companies in Ireland. Belonging to its tasks is to raise the awareness and knowledge of those people employed in the semiconductor, medical, pharmaceutical, health and food product industries. In this respect, Conor Murray will be giving a presentation on the topic of “Cleanroom Design, Planning, Layout and Logistics” at the Cleanzone Congress in Frankfurt am Main on October 28th, 2015.

What is your most favorite means of

What do you value when travelling?

What should never be missing on a

transportation? | My car. I am very

For me it is important that I give my-

business trip? | In my case, my iP-

happy to be driving an Audi. This

self a lot of time when I am on the

hone 6, and naturally the charging

is a very good German automobile.

road. Also that the people I plan to

adaptor plug so that I can recharge

I drive an 853 Turbo Diesel. I like to

meet don’t suddenly change their

while driving.

drive along and listen to music or au-

plans.

dio books.

4/2015 | On the road with…

27

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Tel: 09841 – 40140850 E-Mail: info@decontam.de Internet: www.decontam.de

What kind of music do you enjoy lis-

How do you relax at best? | As said,

What would be the first thing you

tening to? | I prefer music from peo-

when I am travelling, I give atten-

would do if you had the unlimited

ple like Neil Young and Mark Knop-

tion to having enough free time for

possibility to do so? | I would very

fler or from bands like Pink Floyd

myself. Otherwise I enjoy time with

much like to take my wife with me

and Queen. I also like listening to

my family and friends outdoors. As

on my travels. But she knows that I

rock bands.

this isn’t possible during a business

cannot give her any attention as the

trip – a good bottle of wine and a

trip involves business. After busi-

Which countries and regions are most

good meal are very relaxing and

ness has been concluded I have to

often on your list of journeys? | I vis-

help to wind down after a day of

deal with the WiFi-Roaming-Ac-

it most often France, Germany and

work.

cess. It is always most difficult to...

the USA. Which travel destinations do you faAre you able to wind down when

vor and why? | When I am able to ar-

you are on business trips? | Yes, I

range it, I try to work in wine tours

try to plan my trips abroad so that

when travelling in Germany and

I have enough time for myself. This

France. Presently I prefer the USA. I

is possible in that I try before the

very much enjoy travelling there, to

trip to prepare as many things as

visit family and friends, to have a look

possible and this is done with my

at the varying localities and to simply

new toy, an Apple MacBook. I am

be outdoors.

totally enthused with it.

On the road with… |

4/2015

28

Science & Technology

SCIENCE & TECHNOLOGY

Technology in brief

Smart contact lenses in testing in 2016

able. A robotic arm automatically

into space. Researchers of the Stutt-

scans vertical and horizontal termi-

gart Fraunhofer Institute IPA have

nal filters and laminar flow units

developed a special cleanroom de-

Pharmaceutical industry | The

while intelligent software compiles

signed for this purpose. The vehicle

Swiss pharmaceutical company

the documentation and analysis.

will be sterilized before its mission

Novartis and the US technology

The measurement results are visu-

in order that no organic material

company Google want to develop

alized in the form of an electronic

from the Earth be dragged along.

together intelligent contact lens-

test report. The system is called Ro-

The Mars Rover is part of the “Ex-

es and begin testing them on peo-

botscanflex and makes possible “a

oMars” mission of the European

ple in 2016. This was made public

precise measurement given quick-

space agency Esa and the Russian

by Novartis Director Joseph Jimen-

ly and with minimal personnel in-

space authority Roskosmos. The

ez. He said that the project is mov-

volvement” emphasizes Mathias

Rover together with a Russian Mars

ing forward in great strides. Intel-

Itter, Chairman and CTO of InfraSo-

station is planned to start its mis-

ligent contact lenses could in the

lution AG. The Robotscanflex proto-

sion in 2018, then fly through the

future make life easier for those

type will be presented at Cleanzone

Solar System and once on Mars, ex-

who for example suffer from Dia-

and series production is planned for

amine the surface up to two me-

betes, in that the lenses would mon-

the middle of 2016.

ters deep.

Germ-free to Mars

First electric lightantenna in the world

itor blood sugar levels and transmit the data wirelessly to a mobile device. Those with diabetes no longer will have to prick themselves in the

Mars-Rover | Is there or was there

finger several times daily in order

ever life on Mars? An unmanned

Nano-technology | Physicists from

to determine their blood sugar lev-

vehicle is supposed to find this out

the University Würzburg have suc-

els. Novartis and Google made their

in three years. For this purpose the

cessfully lit up a nano-antenna us-

cooperation public a year ago and at

Rover has to be clinically clean shot

ing electricity. In the future, these

that time announced that the prod-

tiny sources of light could be used

uct would be ready for the market

in Smartphone displays or in com-

in five years.

puter chips in order to exchange data at light speeds between pro-

Robots revolutionize cleanroom technology

cessors. The way to such light sources is now being smoothed out by the Würzburg researchers. Their

Measurement automation | At

light antenna, only 250 nanometers

Cleanzone 2015 in Frankfurt, Ger-

long, has two arms. A nano-parti-

many (October, 27-28) the company

cle made of gold has been placed

InfraSolutions AG will be showing

between these arms. This particle

a new kind of automated measur-

touches one arm and has a distance

ing system which offers a level of

to the other arm of one nanome-

quality for testing filter integrity which up to now has not been avail-

Before the Mars Rover will start into space, it will be sterilized in a special cleanroom in Stuttgart, Germany.

4/2015 | Science & Technology – Technologie in Kürze

ter. When electrons pass between this gap, visible light is created. The

29

The first electrically-operated light antenna in the world: When electrons pass between the nano-gap, light is emitted. Photo: Physics Institute University Würzburg.

photonics. In order to provide the

dissolve. Their discovery can help

researchers with even larger pos-

medicinal products to be more ex-

sibilities for research and exper-

actly dosed, can refine the print im-

imentation, their research facili-

age from ink-jet printers and to ap-

ties have been expanded with two

ply more exactly special coatings.

etching devices for micro and nano

The researchers found out that sol-

structuring, a photoelectron spec-

id state particles can actuate the re-

trometer and a pivotal device for la-

lease of drops in fluids by disturb-

ser processing.

ing and smoothing out the surface

Medicinal products more exactly dosed

Würzburg physicists have thereby

of the fluid. This raises capillary pressure and accelerates the separation process as the surface tension strives to shrink the surface.

created as of yet the most compact

Suspension control | As the first

The latter ultimately leads to drop

electrically-operated light source

researchers worldwide, scientists

separation.

in the world.

of the University Saarland and the

TU Ilmenau brings major investments into operation

US Army develops efficient solar panels Photovoltaic | Researchers of the US

First class research | The Center

Army have made a breakthrough

for Micro and Nano -Technolo -

in the development of solar cells.

gies of the Technical University Il-

Their new panel is smaller, more

menau, four new vital devices have

robust and cheaper than all other

been acquired. Therewith the uni-

standard models. Very thin layers of

versity has supported its reputa-

metal such as silver and gold are put

tion as the top location in Germa-

between the semiconductor layers

ny for micro-systems equipment, nano-technology and for micro and nano-structuring. In their labora-

Professor Christian Wagner of the University Saarland shown sitting in front of the equipment in which the drop experiments are carried out. Photo: Uni/Claudia Ehrlich.

tories and cleanrooms, 275 scien-

which more efficiently utilize sunlight. A further advantage is that no difference is made as to which angle sunlight strikes the surface.

tists from 39 disciplines conduct

Paris University for Applied Phys-

first class research in the fields of

ics and Chemistry have discovered

life sciences, energy efficiency and

how and why drops in suspension

The US Army is working on solar panels which are smaller and cheaper than all other models presently on the market. Photo: styleuneed/fotolia.

Expensive devices which have to be directed to the sun according to the sun’s intensity have now become redundant. The US Army has communicated that the development is still in its early stages, however With the installation and start-up of these crucial devices, the TU Ilmenau sees itself very well equipped for research in micro-nano integration in the fields of life sciences, energy efficiency and photonics. Photo: TU Ilmenau.

further research is progressing at high speed.

Science & Technology – Technologie in Kürze |

4/2015

SCIENCE & TECHNOLOGY

30

The future laboratory will not look like this. Devices will soon drive out laboratory technicians. Photo: Institute for Technical Chemistry Hannover.

4/2015

31

Laboratories of the Future Smarter Laboratories – With Smartlab, researchers received visions of future laboratories.

The laboratory of the future is intelligent, networked and automated. At the beginning of October, this future laboratory celebrated its world premiere at the new Laboratory Technology Trade Fair, Labvolution, in Hannover, Germany. Researchers demonstrated how digitalization and Industry 4.0 are changing present-day laboratories and ways of working in a lab.

For Sascha Beutel of the Institu-

rally scientists from the Fraunhofer

te for Technical Chemistry (TCI) of

Institute for Production Technolo-

the Leibniz University in Hannover,

gy and Automation (IPA) and also

Germany, Labvolution was an im-

from the TCI.

portant date to keep. Labvolution is the new sister trade fair of the fair

Functioning future laboratory

Biotechnica, both taking place at the same time at the beginning of Octo-

The Smartlab represents a vision of

ber in Hannover, Germany. The fru-

tomorrow’s intelligent laboratory

Dr. Sascha Beutel from the Institute for Technical Chem-

its of a whole year of work could be

and provides the professional wor-

istry at the Leibniz University Hannover is the Spokesman

examined at Labvolution. The TCI

ld with a central platform for the di-

coordinated the project Smartlab.

scussion of the laboratory’s future.

Sascha Beutel is the work group’s

For nearly a year, scientists and re-

speaker, a group of twelve compa-

presentatives from industry bund-

tion of hard and software, the use of

nies and institutions which are in-

led their energies together with the

robotics and the topic of wearables.

volved in the project and will con-

help of a functioning future labora-

At TCI, the threads of the Smart-

tinue development on the project

tory to show the opportunities open

lab project not came together but

after the trade fair has concluded.

for laboratory environments thanks

became interwoven. Sascha Beutel’s

for the Smartlab work group. Photo: Institute for Technical Chemistry Hannover.

team portrayed with the fundamental conception of Smartlab’s const-

“It deals with standards for networking and integrated processes.”

ruction and the integration of components supplied by their partners, a digitally networked laboratory environment.

Sascha Beutel, Spokesman for the Smartlab work group

New stages of evolution The necessity to raise the laboratory to a new stage of evolution sho-

This work group consists of an il-

to automation, information techno-

wed itself clearly as Beutel together

lustrated collection of companies

logy, human-machine interaction

with TCI doctoral students initiated

and individuals - a laboratory equip-

and Big Data. Central elements of

a competition for the improvement

ment producer, a robot manufactu-

the presentation were besides the

of working conditions inside the in-

rer, software developers and natu-

flexible lab furnishings, the integra-

stitute’s laboratories. The doctoral

Laboratories of the Future |

4/2015

32 students wanted to create at first

is flexible and individualized, tailo-

simply more room to work. “It was

red to every individual requirement

asked whether it was possible to sim-

and demand.” continues Beutel. Insi-

ply make the equipment disappear.”

de future laboratories, there will be

says Beutel.

high performance computers which will be able to interpret the outputs

As the number of devices has in-

of the diverse devices made by di-

creased over the years, the working

verse manufacturers and make it

area inside a laboratory has consi-

possible for these different devices

derably shrunk. Many lab technici-

to communicate with and among

ans are able to work only at the ed-

each other.

SCIENCE & TECHNOLOGY

ges of work surfaces, they have to push away lab equipment when they need more room to work or they wri-

The trend heads towards cleanroom laboratories

te their lab reports at home instead of inside the laboratory.

The Department for Laboratory Automation and Bio-production

When the problem is looked at more

Technology of the project partner

closely, it can be recognized that the

Fraunhofer IPA, has brought into

lack of working space was laid out

the project their competencies dea-

in the planning and design stages.

ling with the development of auto-

Working areas were separately built

mated solutions for life science la-

depending on the individual func-

boratories. IPA activities focus on a

tion of each lab technician, instead

high level of reproducibility, more

of looking at the shifting tasks and

throughput and fewer cases of out-

work processes. Laboratory rooms

side influences while assuring the

are typically and specifically built

flexibility in the laboratory and the

for example, one for the chemist,

maintenance of sterile and certifia-

another for the biologist, still ano-

ble environmental conditions.

ther for the IT specialist and across the hall office rooms for the admi-

Such requirements for tomorrow’s

nistration.

laboratories have to be considered by researchers and also medium-si-

Networking is the highest precept

ze companies when they want to successfully do business in the life sciences’ market. The company Ge-

The goals toward which Smartlab’s

sim, Society for Silicon-Micro-Sys-

partners are working designate a

tems mbH located in Rossendorf,

quantum jump for the work inside

Germany, near Dresden, Germany,

a laboratory. Sascha Beutel describes

does this. The company produces

it as follows: “Until now, we have had

highly specialized lab equipment

to adapt experiments, mostly biolo-

for bio-technical applications. The

gical or chemical, to the available

assembly of components for the-

equipment. Now we are at the stage

se devices as well as the testing on

at which the equipment adapts to

such devices takes place in a clean-

nano-structures. The cleanroom

our questions, inquiries and issues.”

room. These devices will later be

with its nearly particle-free air has

The key lies in the mutual integra-

placed, in part, in micrometer and

become an indispensable prerequi-

bility of the lab components. “We

even smaller environments. Every

site for the company’s production.

are interested in defining common

particle can limit the functionality

Gesim’s Managing Director Stef-

standards for networking, for inte-

of a device or the products manu-

fen Howitz reports that customers

grating processes and thus to crea-

factured by these devices can beco-

occasionally inquire about cont-

te a laboratory environment which

me unusable, for example printed

amination potentials of materi-

4/2015 | Laboratories of the Future

The future laboratory will have much more space.

Photo: Institute for Technical Chemistry Hannover.

33

Like in a beehive

als in the laboratory equipment.

on and site in which the customer

The background: Moving parts

will place and use the devices. “The

such as drive belts, cause abrasion

automation of laboratory proces-

Going back to the lack of space in

and this measurably impairs cle-

ses and the changes in laboratory

present-day laboratories: Accor-

anroom quality. In such cases li-

work practices are for us real chal-

ding to Sascha Beutel, this is the

near drive trains are preferable as

lenges.� sums up Howitz and refers

most pressing problem which the

they move assembly parts without

with that said, to a trend: More and

Smartlab work group has to solve.

any mechanical abrasion in a ma-

more often, laboratories are beco-

The times are past in which small

gnetic field. According to Howitz,

ming cleanrooms, above all in the

spaces become converted into lab ni-

the manufacturer of laboratory de-

field of life sciences.

ches where only a limited number of

vices has to consider the environ-

applications are allowed.

mental conditions of every locati-

Laboratories of the Future |

4/2015

SCIENCE & TECHNOLOGY

34 Lab environments have to be desi-

se” says Jürg Erb-Tanner, the Roche

arranged according to the intended

gned with variability in mind. Large

Basel location architect. “We are se-

use. This flexibility has proven itself

companies no longer go for labora-

parating no longer into disciplines,

in practice for more than 50 years.

tories only for biologists or only for

but into projects. This means that

chemists. They set up project-rela-

the differing disciplines located in

In the Smartlab, the problem of

ted work environments. Optimally,

the same building, even in the same

space is solved by using an outstan-

teams work together in the laborato-

rooms, are working together.” A wor-

dingly designed modular approach:

ries whose members are able to take

ker has to look at the work and be ab-

The lab furnishings have been con-

on very diverse tasks – comparable to

le to switch tasks, likewise the buil-

ceived as hexagons and can be ar-

a beehive. In the best cases, laborato-

dings themselves have to be able to

ranged together into use-orienta-

ries provide enough room for IT spe-

be converted when changes in work

ted honeycomb-structures. To stay

cialists, the IT personnel being able

processes occur. A practical soluti-

in the picture: like in a beehive. The

to assure smooth processing of the

on would be to design laboratories

available space can be subdivided

enormous amounts of data. After all,

according to the ballroom concept.

into various activity zones between

laboratories have become real data factories. When the project is concluded, the work environment is di-

Flexible honeycombs – the ballroom concept

sassembled and the area makes way

which personnel with variable tasks are able to fluctuate. This approach creates an area with a space-saving and flexible, utilizable structure.

for a new environment with other

Since the 1960’s, it has proven itself

requirements and demands.

to construct laboratories according

In addition to new room-space con-

to the ballroom concept. The Ame-

cepts, solutions for the growing

The company Roche its activities

rican architect Louis Kahn built the

flood of data are in demand. Data

stretching round the globe, has be-

Salk Institute for Biological Studies

volumes in the terabyte and peta-

en working in this direction for qui-

in La Jolla, California. The institu-

byte ranges are already routine data

te some time now. Roche’s headquar-

te’s laboratories can be flexibly sca-

volumes in many fields of medicine

ters are located in Basel, Switzerland.

led-down with dividing walls, or en-

and research. The terminology “Big

“Activities have become very diver-

larged, the facility allows itself to be

Data” stands for the immense flood

Modern honeycomb structure: The elements of the future laboratory allow themselves to be arranged in user-friendly ways.

4/2015 | Laboratories of the Future

35 Short keyword glossary: Future Laboratories Networking inside a laboratory | The future laboratory will assure that devices from diverse manufacturers “understand” each other. It will integrate devices and driver standards (see “SiLA”).

Networking outside of the laboratory | Laboratories will be networked with each other in order to enable decentralized work on common projects.

BSR

Messtechnik GmbH Calibration - Service & Disposal

Big Data | Laboratories are in most cases data factories. Data volumes in the terabyte and petabyte ranges already accumulate in present data systems. A mark of quality for future laboratories would be to safely be able to process these data volumes and to make them quickly available for evaluation.

Automation and robotics | Laboratory applications should be reproducible as much as possible, that is, to be repeated under conditions remaining constant and be able to be applied. The more automated a laboratory operates, the more efficient it is. Repeated actions can be taken over by robots.

Calibration Service

Ballroom concept | Laboratories and work environments which follow the ballroom concept provide room for integrated lab work – and not only for individual applications. This is made possible by variable room floor plans, modular arrangement of furnishings and a device pool which allows for project-based equipping of a laboratory.

Disposal Consulting

SiLA | “Standardization in Lab Automation”: a consortium residing in Switzerland which works for unified and consistent device, interface and data standards for laboratory equipment.

DSCN6316 | The future laboratory will not look like this. Devices will soon drive out laboratory technicians. Photo: Institute for Technical Chemistry Hannover.

Sascha Beutel | Dr. Sascha Beutel from the Institute for Technical Chemistry at the Leibniz University Hannover is the Spokesman for the Smartlab work group.

Photo: Institute for Technical Chemistry Hannover.

measuring instruments:

Smartlab | Modern honeycomb structure: The elements of the future laboratory allow themselves to be arranged in user-friendly ways.

particle counter anvironmental sensors germ sampler aerosol metrology

of data which is created by automa-

lems: heterogenic device landscapes,

ted processes. Estimations call for a

rapidly growing data volumes and

doubling of this data volume every

diverse data formats. Whether in

two years. Therefore it is decisive for

pharmaceuticals, biotechnology

all laboratories with automated pro-

or diagnostics – a future-oriented

cesses to develop effective and rea-

single standard in view of the highly

sonable data management systems

complex and lab-specific processes is

which allow flexible allocation of

not possible. The future of laborato-

data – be it for exchange with other

ries belongs to scalable systems, in-

e-Mail: blattner@reinraum.info ederle@reinraum.info

laboratories or for their own use.

tegrated platforms and standardized

Tel. Zentrale: +49 7254 - 95 95 9-0

The concept of Smartlab could beco-

interfaces.

Tel. Labor:

+49 7254 - 95 95 9-16

Fax:

+49 7254 - 95 95 9-29

me the approach for many laboratory operators to solve current prob-

BSR Messtechnik GmbH Calibration - Service & Disposal Marinestraße 156 68794 Oberhausen-Rheinhausen

Author: Piet Felber

Laboratories of the Future |

4/2015

36

Dry versus Wet Cleaning

SCIENCE & TECHNOLOGY

A Dispute among Experts Concerning the Pro and Contra of Dust-Binding Wiping Procedures

At the University Hospital Freiburg, the predominant procedure for cleaning is dry wiping whereas wet wiping follows only when necessary. Is dry wiping able to satisfy the required hygiene standards? “Yes” says Martin Lutz, Managing Director of FIGR Research and Testing Institute for Facility Management. “Of course, not” counters Dr. Rüdiger Laub, Quality Manager of the cleanroom cleaning service provider profi-con GmbH Contamination Control.

– should be considered. When mainly loose easily airborne contamination respectively particles are to be removed and no disinfectant cleaning necessary, the dust binding procedure is sufficient. Adherent contamination which originates from

Cleanroom Magazin: What are the

spectively only redistributes the con-

fluid substances is of course not re-

advantages of dry cleaning proce-

taminants over large areas. In com-

moved using dust binding proce-

dures?

parison to wet wiping, dust binding

dures. We recommend in this case

wiping is essentially more rational

dust binding procedures to be com-

Martin Lutz: Firstly we should speak

and is significantly more ergonom-

bined with need-oriented wet wip-

of dust binding wiping instead of dry

ic due to the lower wiping resistance

ing. Furthermore, no disinfection

cleaning as this is the correct indus-

of the wiping materials.

is possible following dust binding

try terminology. There are in addi-

wiping however a strong reduction

tion to the special dry dust binding

Cleanroom Magazin: What disadvan-

in germs is achieved. This has been

cloths and microfiber mop covers,

tages do dust binding procedures

proven in direct contact tests. Are-

oil impregnated or slightly damp

have?

as with high germ-free standards should continue to be cleaned using

dust binding cloths which are used in dust binding wiping. Dust bind-

Martin Lutz: There are in this sense

ing wiping procedures effectively

no disadvantages with dust bind-

remove loose, easily airborne con-

ing procedures, only limitations.

Cleanroom Magazin: In which areas

taminants, while wet mopping/wip-

Regarding which procedure to use,

do you see the dust binding proce-

ing only partially removes these fine

the kind of contaminant – easily air-

dures having the best possibilities?

lightly airborne contaminants re-

borne particles or adherent particles

Pro Martin Lutz is the Managing Director and Scientific Director of FIGR Research and Testing Institute for Facility Management GmbH in Metzingen, Germany, located south of Stuttgart. The institute offers further education courses, quality testing of cleaning and maintenance products, devices, machines and floor materials as well as the development of new procedures and processes. Martin Lutz is the author of the book “The Handbook of Cleaning and Hygiene Techniques”

4/2015 | Dry versus Wet Cleaning

disinfectants.

37 Martin Lutz: I see possibilities in all those places where the removal of contaminant particles stands in the foreground. Diverse tests and trials in our institute have shown that the highest germ reduction and the best cleaning results can be achieved when before the wet cleaning or disinfecting, a dust binding wiping procedure is carried out. A significantly higher reduction of germs and particles is achieved than by carrying out only wet wiping procedures. It is also recommended when using dust binding procedures to work with suitable cleaning materials, for example bonding-agent impregnated disposable dust binding cloths putting no limit on how many cloths are needed. These procedures also apply in hygiene-sensitive areas.

Cleanroom Magazin: In your opinion, do dust binding wiping procedures have an influence on the implementation of environmentally friendly measures in cleanroom cleaning?

Use of special wipes. Foto: Universitätsklinikum Freiburg, Britt Schilling.

Martin Lutz: Considering that dust

that large as in many cleanroom ar-

cleaning: This is a procedure for the

binding wiping foregoes using clean-

eas cleaning with disinfectants can-

removal of contamination without

ing chemicals and at the same time

not be dispensed with.

using f luids. Dry cleaning procedures are quick and uncomplicated.

reduces the use of water, the choice of the proper cleaning procedure

Cleanroom Magazin: What are the

They are able to quickly remove visi-

certainly plays its part in consider-

advantages of dry cleaning?

ble contamination. In everyday situ-

ation of environmentally friendly

ations, such procedures are the rule.

cleanroom cleaning, although this

Dr. Rüdiger Laub: First of all, we

These procedures include domestic

influence mustn’t be considered all

should define what is meant by dry

vacuuming, sweeping, dusting and

Contra Dr. Rüdiger Laub was active as a biologist for 20 years in the area of research and development of bio-pharmaceuticals. With the establishment of GMP manufacturing processes he was able to bring his experience into the cleanroom by developing cleanroom concepts and cleanroom monitoring processes. He brought this experience in 2011 to profi-con GmbH where he started in the quality management department. He is the Training Manager for the qualification of profi-con employees as well as the Training Manager, respectively Coach for cleanroom operators working in the pharmaceutical and micro-technology industries. Alongside his role as knowledge mediator, Dr. Laub works on F&E projects in the area of the decontamination of production environments.

Dry versus Wet Cleaning |

4/2015

38

SCIENCE & TECHNOLOGY

Study Compares Dry and Wet Cleaning Procedures The University Hospital Freiburg has been investigating dry and wet cleaning procedures with respect to their hygienic efficiency. The reduction of germs using wet cleaning procedures served as a baseline value: this value amounted to 60 percent (Figure 1). The question was what value would result from dry cleaning procedures? Direct contact tests were carried out over several days. The result: after applying dry cleaning procedures germ reduction was on the average 60 percent (Figure 2).

This leads to the conclusion that dry and wet cleaning procedures in view of hygiene are comparable.

Graphs: University Hospital Freiburg

the removal of particles from deli-

biological contamination. The lat-

Dry cleaning procedures are able to

cate objects by using a fine brush. In

ter is only made harmless by using

serve as complementary measures

these instances, dry cleaning pro-

fluid-bound processes. The biocidal

to my mind, for example to remove

cedures offer definite advantages as

active agents are evenly distributed

any residues remaining after wet

many surfaces are not at all suitable

by using fluids. Wet cleaning pro-

cleaning. In these cases, dry cloths

for wet cleaning procedures. Parquet

cedures are in these cases essential.

or wiping materials can be used,

Figure 1

floors, veneers, or electronic devices

Figure 2

on one hand for the removal of any

are quickly damaged when cleaned

Cleanroom Magazin: In which areas

residues and on the other for the

using wet procedures.

do you see dust binding wiping hav-

post-treatment and fine cleaning

ing the best possibilities?

of surfaces such as glass.

Dr. Rüdiger Laub: Dry cleaning

Cleanroom Magazin: In your opin-

Cleanroom Magazin: What disadvantages does dust binding wiping have?

procedures are able to remove

ion, have dust binding wiping pro-

Dr. Rüdiger Laub: This procedure

coarse and larger contaminants

cedures had any influence on the

runs quickly into limits as some

and are useful for the purposes

implementation of environmental-

very adhering contamination has to

of pre-cleaning. The final degree

ly friendly cleaning procedures in

be cleaned with solvents – in most

of cleanliness can often only be

the cleanroom?

cases with plain water. Considering

achieved by using wet cleaning pro-

small, non-visible particles, there is

cedures. These procedures howev-

Dr. Rüdiger Laub: Federal restric-

the risk that by using dry cleaning

er lead to a temporary increase in

tions apply in this case. Of course

procedures, the particles become

the air humidity. Dry cleaning pro-

it is advantageous for the environ-

airborne and simply re-distribute

cedures could prove to be the bet-

ment when residue-free cleaning

themselves. The same goes for mi-

ter choice in those instances where

procedures are used. The residues

crobiological contamination such

the environmental air conditions

are only the bound-together par-

as bacteria, fungi or spores. The dis-

must be absolutely dry, for exam-

ticulate contamination. Disinfect-

advantages of dry cleaning proce-

ple in certain areas of micro-tech-

ant materials clearly illustrate this:

dures present themselves clearly

nology. Nevertheless, dry cleaning

While additives used in cleaning

here. Clean areas are defined by cer-

procedures should be complement-

materials are biologically degrada-

tain threshold values for particulate

ed in regular cycles with wet clean-

ble, the disinfectant materials are

and/or microbiological contamina-

ing procedures as the dissolving

bio-degradable only to a certain

tion. The cleaning processes are de-

of contamination requires some

extent. In accordance with regu-

signed above all for the removal of

kind of solvent, for example some

lations, the disinfectant materials

those particles not visible to the na-

water mixed together with clean-

should kill micro-organisms, not

ked eye. This counts also for micro-

room-suitable additives.

just biodegrade them.

4/2015 | Dry versus Wet Cleaning

39

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4/2015

40

The Challenge of Putting Together Requirement Specifications

SCIENCE & TECHNOLOGY

Documented Processes relieve the validation of computer systems

Increasing regulatory demands and the rising pressures of costs are increasing the necessity of designing more eďŹƒcient ways of documenting operating procedures via computer systems. So that expenditures remain at reasonable levels, a transparent, comprehensive specification book is needed. Experts advise to portray the requirements in a process-based manner.

The requirements of a computer

However, when a configurable sys-

ments specification document. This

system are in the user’s opinion to

tem due to missing functionality

most often happens when the rela-

be described and documented in

cannot provide the user with sat-

tionship between the customer and

the form of a user requirements

isfactory solutions, the specifica-

software provider has not yet been

specification document. This doc-

tions complexity rises significantly.

established. The user wants to make

ument serves as a means of com-

When dealing with complex expan-

sure that he, in fact, gets the ser-

munication between the user and

sions, in addition to the user re-

vice expected and required. At the

the system provider and makes pos-

quirements specification document

same time, such customers over-

sible understanding in both direc-

and functional specification docu-

look the requirements described in

tions. It is important to describe re-

ment, a design specification docu-

detail which explain for what and

quirements as comprehensively

ment and a module specification

under which operating conditions

and as detailed as possible so that

document are necessary to create.

the computer system should later

risk analysis, functional specification generation, system design and verification can be adequately sup-

Describing functional and qualitative requirements

be used for.

Computer systems developed for such situations involve for the user

ported.

In such a situation, users tend to set

the risk to recognize in the frame-

In practice, users draw on the sup-

the technical aspects of the solution

work of the performance qualifi-

port of their business processes

which the software provider has al-

cation if all system functions have

preferably with standard solutions.

ready described in the user require-

been optimally and suitably set up

Zur Person Markus M. Shroder is a Managing Consultant at AVANTALION Consulting Group and a specialist for process management and IT project management. He supports companies in the pharmaceutical insdustry with their computer system validations and the introduction of prcess-based IT application systems. Moreover he consults organisations with the development and introduction of IT quality management systems.

4/2015 | The Challenge of Putting Together Requirement Specifications

41

for the intended use. When this is

description transparent and un-

ment the supported processes, un-

not the case, complex modifications

derstandable. However this trans-

derstanding and transparency will

and adaptations are necessary. The

parency and understandability of

significantly increase. Also the ap-

user can avoid these modifications

the document are the decisive pre-

proval of the requirements specifi-

in the forefront when he goes back

requisites in planning and imple-

cations from the various involved

to and limits himself to the detailed

menting phases of the system de-

groups in the company (quality

descriptions of the functional and

velopment and validation which

management, engineering, IT, etc.)

qualitative requirements of the in-

are to follow.

will be simplified. For GxP regulat-

itial intended use.

A further problem comes up when

Understanding and portraying processes

the requirements description is in

ed process areas, it is also expected that the risks for patient safety, product quality and data integrity be identified and evaluated. On

the form of text only. The more ex-

When the descriptions of the tech-

the basis of graphically document-

tensive and complex the scope of

nical requirements and intended

ed process models, these tasks are

the problem is, the more difficult it

use are portrayed using graphical

much more easily fulfilled.

will be to make the requirements

figures and pictures which comple-

The Challenge of Putting Together Requirement Specifications |

4/2015

42 A pragmatic approach

The palette of symbols for graphi-

agement Systems. When it comes

cal representations of the technical

to the introduction of information

processes is unfortunately small.

systems for the support of manual

Such technical processes which

Symbols are used for the portrayal

procedures, process models pro-

are supported with computer sys-

of results and process steps, the var-

vide valuable explanations of a sys-

tems, it is practical to transparently

ious people involved in the process,

tem’s expected support functions.

show the link between system func-

the supported computer system as well as those for the processed data-objects. It is important that production runs display the time-logic procedures of the value creation

SCIENCE & TECHNOLOGY

process steps from the user’s point of view. If the customer has no experience in the modeling of graphical processing runs, then he should

GxP Kritikalitat and risk classification,Novelty and complexityof technical processesinfluence the allocation ofModel plane.

fall back on the support of an experienced process designer.

Process modeling supports not on-

tions and the processes. To reduce

ly the development of new systems

the complexity, a process hierarchy

but also the introduction of com-

should be designed in order to iden-

plex ERP, MES or Workflow Man-

tify the constructed processes on the level of their technical func-

Prozessbasierte Vorgehensweise bei der Einführung von Computersystemen

tions.

The requirements of the computer system can be derived from the doc-

ProzessLandkarte

DetailProzesse

umented process model and then the various levels of the process hierarchy up to the individual process steps can be assigned. The GxP criticality and risk level as well as

Risikobewertung

Risikobewertung

the newness and complexity of the technical processes will influence to which requirement is assigned to which level of the process model. If the pharmaceutical risk is es-

Qualitätive Anforderungen

Funktionale Anforderungen

timated to be small, the requirements of the computer system can be more coarsely specified and for example be assigned to the level of parts processing. If the opposite is

Prozess- & risikobasierte Spezifikation / Realisierung

the case, the requirements should be assigned to the individual process steps in order to enable a detailed verification of the solution.

Prozess- & risikobasierte Verifizierung

4/2015 | The Challenge of Putting Together Requirement Specifications

43

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Uses and chances for the company

ures are also easier to plan and im-

validation approach and provides

plement when descriptions of the

the company together with the se-

technical processes are made avail-

curity of regulation-conformity

The combination of graphical pro-

able early on and can be added to

also the foundation for continued

cess runs together with clear refer-

an already existing user require-

improvement of the processes and

ences to the technical requirements,

ments specification document. The

the associated process verification.

form a process-based user require-

process-based document is the best

There is a profound incorporation of

ments specification document. As a

prerequisite for the avoidance of

the areas involved in the processes

reference point for the system im-

failures during the project’s initial

of a computer system implementa-

plementation or system expansion

implementation and to reduce the

tion which raises the acceptance of

in continuous project phases, the

complexity and costs of validation.

viable solutions.

document makes possible an un-

The process-based approach in com-

Text: Markus Schröder,

broken traceability of the process

piling a user requirements speci-

Avantalion Business Consulting GmbH

or process steps, even of individual

fication document very well com-

tests. The required validation meas-

plements the standard risk-based

user requirements specification

The Challenge of Putting Together Requirement Specifications |

4/2015

44

What do you do Mathias Ortner?

A short personal profile from the cleanroom industry Mathias Ortner is a service technician at Elpro in Switzerland, a leading international manufacturer of monitoring systems

SCIENCE & TECHNOLOGY

and data loggers for the documentation of environmental conditions in production, in cleanrooms, in warehouses and during transport.

“My name is Mathias Ortner. I have

a cleanroom. The sensors for the

This applies also to the visible sen-

been employed as a service tech-

monitoring systems in cleanrooms

sor panel. The transmitter for the

nician at the Swiss company El-

must meet especially high stand-

differential pressure is built in-

pro-Buchs AG for four years. I in-

ards and requirements. Specifica-

to a cleanroom suitable stainless

stall new systems and equipment

tions must be met for materials,

steel foreside and is calibrated by

and check their functions using

construction design, compactness,

means of a pressure generator. In

calibration procedures and by do-

signal function as well as assembly

the course of the yearly service, I

ing detailed installation and func-

and the level of service.

take care of the calibration of the

tionality qualification checks. An

sensors, the function control, the

important part of my work is the

My tasks as a service technician in-

flow rate measurement and the ze-

yearly maintenance and re-cali-

clude the professional, clean and

ro filter tests of the particle coun-

bration of systems and facilities

exact installation of the data log-

ters.

already in operation.

ger and sensors as well as their correct positioning. The sensors are

With the Elpro-Buchs central mon-

assembled and installed according

itoring system, I am able to reliably

to GMP guidelines and are re-cali-

record all relevant climate data in

brated yearly.

4/2015 | What do you do Mathias Ortner?

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* The license fee for one year constitutes a single payment of € 98.–

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

4/2015

45

46

Incorrect cleanroom behavior pose no grounds for dismissal

SERVICE

Court decides in dismissal dispute in favor of cleanroom employee.

This means: When something goes wrong in a single instance, this does not count as a mistake or error. With the second instance, this does count. If employers are allowed to dismiss an employee after a single instance of incorrect behavior, the Labor Court in Berlin, Germany took on this case and came to the decision: The employer has to first eliminate the source of fault before an employee is allowed to be dismissed, otherwise the dismissal becomes void.

The case in question deals with an

The Labor Court in Berlin declared

In the opinion of the Labor Court

employee of a medical technolo-

the dismissal to be void (Az.: 28 Ca

in Berlin, the employer should have

gy manufacturer. She was a clean-

5695/14). The court founded its de-

taken the necessary technical and

room employee. The employer gave

cision on the premise that it could

organizational measures in order

the employee at first an official

not be proved that the employee had

to ensure that distinctions between

warning that she had not been fol-

intentionally taken the unauthor-

the two receptacles are clear and

lowing the quality criteria which

ized receptacle into the cleanroom.

that mistakes in identification are

apply in the cleanroom. The follow-

Two types of receptacle are used

ruled out.

ing dismissal was founded on the

in the operations of the medical

premise that the employee had at-

technology manufacturer but on-

tempted to take receptacles into the

ly one of these is authorized to be

cleanroom which were not author-

taken through the airlock into the

ized to be used there.

cleanroom. Both types of receptacle are nearly identical in appearance and can only be differentiated by a small imprint.

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

4/2015 | Incorrect cleanroom behavior pose no grounds for dismissal

47

For safety work benches and isolators, a new Norm is likely to come into effect by the end of this year. Photo: Cleanroom Media

Draft of the new DIN 12980 has been submitted It is anticipated that by the end of

duction of cytostatics in isolators

ta is betting that the production of

the year, the new DIN 12980 “Labo-

– also known as ‘glove boxes’ – for

cytostatics will be concentrated in

ratory Furnishings – Safety Work

quite some time, now it is time that

larger pharmacies. They have as a

Benches and Isolators for Cytostat-

the DIN 12989 be suitably adapted.

rule a much higher number of de-

ics and other CMR medicinal prod-

The new Norm makes it possible

vices and employees at hand.

ucts” will come into effect. This

for isolator manufacturers to have

was declared by Egon Buchta, the

type tests carried out for their de-

Regarding safety work benches, the

Chairman of the responsible work

vices in the future. “Up till now,

work committee, which consists

committee in the DIN Norm Com-

there have been no clear guide-

of 20 representatives from manu-

mission “Laboratory Equipment

lines for manufacturers and users

facturers, service companies, us-

and Laboratory Facilities” and the

for performance criteria for the op-

ers, trade associations and testing

Managing Director of “Ingenieur-

eration of an isolator which has led

organizations, resolved to initiate

büro & Reinraumservie Egon Bu-

to a wide-ranging interpretation of

changes. As an example, Buchta

chta GmbH” (Engineering Offices

the criteria” says Egon Buchta. “This

mentioned the expanded valida-

& Cleanroom Services Egon Buchta

gap will now become significantly

tion of capacity reserves for air-

GmbH), in Wannweil near Reutlin-

narrower.”

flows at designated as well as diver-

gen, Germany. Until September

gent operation points and also the

30th, 2015, industry representatives

For quite a few pharmacies, the new

boundaries (provocations). A fur-

will be able to submit their com-

requirements will likely lead to the

ther reform is the verification of

ments on the amended Norm.

situation whereby they will them-

the reactionless operation of safety

selves no longer produce cytostatics.

work benches in connection with

Buchta indicated that the most im-

The DIN Norm demands for exam-

exhaust air systems in the frame-

portant change regards the integra-

ple, the use of special gloves which

work of scheduled maintenance. Up

tion of isolators within the Norm.

daily have to be checked for leaks.

to now, this has only been valid for

“Up until now, there have been no

A potentially necessary glove re-

new installations.

regulations concerning this device.”

placement will not only cost a lot

As the Pharmacy Operations Regu-

of money, but also temporarily

lations have provided for the pro-

stop production. Therefore Buch-

Text: Klaus Eckardt

Draft of the new DIN 12980 has been submitted |

4/2015

SERVICE

48

4/2015

49

Cleanzone gives momentum and impulse to the industry.

First time awarding of the Creative Prize for the most creatively designed cleanroom.

From October 27th to October 28th, 2015, in Frankfurt am Main, Germany, Cleanzone will once again be the meeting point for the international cleanroom industry. Besides the innovations and presentations, this trade fair will be offering practice-oriented Plaza discussions and a congress with highly regarded speakers. Furthermore the ReinraumAkademie (Cleanroom Academy) will be awarding for the first time the Creative Prize as a special cleanroom award.

Cleanzone, which this year takes

aly, Switzerland and Austria. Prod-

place in Hall 4.0 of the Messe Frank-

ucts offered encompass the areas of

furt, will be offering events encom-

construction and planning, climate

passing the entire cleanroom life

and ventilation technology, con-

cycle, from the planning and de-

sumable materials, clothing, mon-

sign, the construction and opera-

itoring and quality control, as well

tion to the control and monitoring

as training and further education.

international parent organization.

of cleanrooms. The knowledge of

Frank Duvernell, Managing Di-

“We want to use this opportunity to

all these aspects will be available

rector of the ReinraumAkademie

inform the international audience

not only at the various stands but

(Cleanroom Academy) and Clean-

about the direction the ICCCS is tak-

also from a very attractive mix of

zone Partner, speaks out very en-

ing. We will be able to encourage

a congress, presentations, lectures,

thusiastically about the develop-

the visitors from around the world

forums and workshops.

ment of this trade fair: “Cleanzone

who are not yet members to found

has proven that the concept of the

their own national associations.”

trade fair with an international

The ICCCS plans to more intensive-

alignment across all cross-sectional

ly support member organizations

International Alignment across All Cross-Sectional Industries

industries has been accepted. With-

in promoting the international

“The concept of Cleanzone with its

in two years, Cleanzone has proven

knowledge transfer of cleanroom

interdisciplinary and internation-

itself as a stand-alone event. This

technology.

al approaches has firmly anchored

shows that the market needs this

itself in the market.” says Ruth

trade fair.”

Lorenz, Area Manager for Technology & Production at Messe Frankfurt. This shows itself through the

ICCCS appears at Cleanzone for the First Time

Congress with High-Quality Professional Presentations The transfer of knowledge is the goal of a two-day Cleanzone Con-

growing number of exhibitors and professional visitors, this number

For the first time, the Internation-

gress at which highly regarded ex-

significantly being over last year’s

al Confederation of Contamina-

perts will be conveying their valu-

niveau. At Cleanzone 2015, round-

tion Control Societies (ICCCS) will

able practice-oriented experience

about 80 exhibitors are expected,

be appearing at Cleanzone. For Koos

and knowledge. Because of last

a third of these coming from out-

Agricola, the General Secretary of

year’s good resonance, the congress

side Germany, for example from

ICCCS, this trade fair is the right

will be divided into a Basis Module

Finland, Great Britain, France, It-

place to present the work of this

and an Advanced Module. On Oc-

Cleanzone gives momentum and impulse to the industry. |

4/2015

50

SERVICE

Trending: Cleanzone is attracting an increasing number of visitors.

tober 27th and 28th, the Basis Mod-

Cleanzone visitors will be able to

ified staff can become acquainted

ule will be held in the mornings

learn about the status of current

with the attractive professional pos-

of both days, covering the topics of

research at MetAMC’s stand. Tuo-

sibilities in cleanroom technology

“Getting Started with Cleanroom

mas Hieta, a scientist at the Finish

at the Plaza events.”

Technology” and “Planning-Lay-

National Institute for Metrology

out-Construction”. In the afternoon

(Mikes), says: “Cleanzone is an im-

All presentations, lectures and spe-

of both days, the Advanced Mod-

portant event for cleanroom tech-

cial events at the Cleanzone Plaza

ule will be covering the topics of

nology in Europe and is an out-

are free to all visitors. Interested

“Qualification” and “Process Opti-

standing choice for our EU project

visitors can receive information on

mization”. Among the top speak-

‘MetAMC’ as a platform for present-

the daily schedule of events from

ers will be the ICCCS General Sec-

ing our results and insights into

the Messe Frankfurt or from their

retary Koos Agricola, Conor Murray,

new sources of contamination in

website or even via App and cata-

Chairman of the Board of the Irish

cleanrooms. As a representative of

logue. This allows visits to the Pla-

Cleanroom Society and Dr. Jürgen

a scientific society it is important

za, participation at congresses and

Mählitz, GMP Inspector in the area

for our project consortium to meet

discussions to be optimally planned

of Pharmacy for the government of

with cleanroom operators and ex-

in advance.

Upper Bavaria.

perts in order to find out about what

EU Project MetAMC presents Results New insights about contamination

operating levels and instruments will be required in the future.”

Occupational Perspectives for Qualified Professionals

will be presented by the European

Two Awards to be presented for the First Time A premier is taking place at this year’s Cleanzone during the awarding of the Cleanroom Award which

research project “MetAMC Metrolo-

A further highlight of Cleanzone

has been awarded to the cleanroom

gy for Airborne Molecular contam-

is the Plaza, which serves as an

innovation of the year since 2012.

ination in Manufacturing Environ-

open forum for presentations, lec-

For the first time, the Reinrau-

ments”. Several research institutes

tures, initiatives and podium dis-

mAkademie (Cleanroom Acade-

came together in 2013 in order to

cussions, concurrent with all oth-

my) will be awarding an addition-

develop a new laser-based measur-

er Cleanzone events. A focus point

al award, the Creative Prize, which

ing procedure and to better under-

for this year’s Cleanzone is the top-

will be presented to the designer of

stand the origins of chemical parti-

ic of trainees, young talent and fur-

the most creative cleanroom. “The

cles. The researchers’ focused their

ther education. “This positioning of

Creative Prize has been designed to

attention to the smallest chemical

topics supports the cleanroom in-

direct the attention of cleanroom

contamination, for example ammo-

dustry in overcoming the relative

operators to the advantages of er-

nia, acids and organic compounds

unawareness of cleanroom profes-

gonomic and colorfully attractive

which under certain conditions can

sions.” says Thomas Raupach, Man-

cleanrooms.” says Frank Duveer-

lead to losses and breakdowns in

ager of the ReinraumAkademie

nell, Managing Director of the Rein-

the production of photovoltaic cells,

(Cleanroom Academy) in Leipzig,

raumAkademie (Cleanroom Acad-

LED’s and OLED’s.

Germany. “Professional and qual-

emy). Cleanrooms are still being

4/2015 | Cleanzone gives momentum and impulse to the industry.

51 A small trade fair planner: Cleanzone visitors will find at this year’s event:

Cleanroom Industry Continues to Grow, Production in clean environments is increasing worldwide.

More and more professionals in research, production, logistics and ser-

Planning, Construction,

vice have to acquire current cleanroom knowledge as production in clean

Operation |

environments and under clean conditions is becoming the case in ever

• Construction Components

more industries. The “World Cleanroom Report” from the US American

• Modular Technologies

market research association, McIlvaine Company confirms this trend.

• Equipment and Systems • Air Lock Systems

More and more cleanrooms

• Work Places

The McIlvaine Report states that the use of cleanroom surface area in-

• Handling and Warehouse Systems

creased from last year to 12.17 million square meters, an increase of five

• Decontamination

percent from 2013.

• Measuring Systems Consumable Materials | • Clothing and Accessories • Cleaning Equipment

The pharmaceutical industry needs more staff The pharmaceutical industry employed in 2013 around 2.3 million people in cleanrooms. In 2015, this figure should rise to 2.4 million people.

• Cleaning Mediums

Asia has become a large-scale consumer

• Packaging

Asia is expected to increase in this year to the world’s largest user of

• Microbiology

cleanroom consumable materials.

• Office Materials Services | • Consultation • Technical Planning • Inspection and Certification • Software/Media • Cleaning and Disinfection • Maintenance and Repair • Logistics, Testing Laboratories, etc.

Further Education/F&E | • Training/Seminars • Research and Development • Software/Media Documentation | • QMS • ISO 9000, GMP, FDA • Operating Guidelines/ Instructions • Work Procedures/ Guidelines • Forms

The need for consumable materials is increasing The market for cleanroom consumable materials is expected to increase in 2015 to a value of eight billion US dollars. (in 2013: seven billion US dollars) The pharmaceutical industry is increasing the purchase of cleanroom products The pharmaceutical and biotechnical industries became the world’s third largest users of cleanroom products in 2014.

Asia’s growth is booming Asia is the largest and fastest growing region for cleanroom products and consumable materials.

Trend to mini-environments The semiconductor industry is paving the way to mini-environment concepts which in the meantime are in strong demand by the pharmaceutical industry.

Strong Growth in Revenues The revenues and turnovers in global pharmaceutical production are expected to grow from 13.43 billion US dollars in 2012 to 18.49 billion US dollars in 2017.

designed using only the color white

motivate and give impulse to clean-

ative Prize will be awarded on Oc-

although experts have proven that

room planners and operators to de-

tober 28th, 2015, at Cleanzone in

by using more colors in a cleanroom

sign more attractive working en-

Frankfurt am Main, Germany in

reduce eye strain, increase concen-

vironments which provide more

front of fair visitors and the press.

tration and reduce error rates. The

pleasant working conditions.

new Creative Prize is intended to

The Cleanroom Award and the Cre-

Text: Thomas Köhler

Cleanzone gives momentum and impulse to the industry. |

4/2015

52

»Contamination control is becoming in more and more industries necessary« Im Interview: Koos Agricola

SERVICE

ICCCS: The worldwide parent organization of cleanroom technical professional societies.

The International Confederation

try is allowed only one cleanroom

national norms in cleanroom tech-

of Contamination Control Societies

association to become a member of

nology as well as to break down

(ICCCS) was founded in 1972. It is the

ICCCS and to represent its country.

technical trade barriers.

parent organization for 17 national

The tasks of ICCCS are to promote

cleanroom technical associations

an international exchange of expe-

from around the world. Each coun-

rience and information and inter-

Koos Agricola, General Secretary

Koos Agricola: The ICCCS has sup-

tivities which have something to do

of the International Confederation

ported Cleanzone from its very be-

with contamination control such as

of Contamination Control Societies

ginnings. As the General Secretary

training, further education, events,

(ICCCS), wants to encourage an in-

of ICCCS, it is my opinion that Clean-

presentations and standards. The

ternational dialogue dealing with

zone is the right place to present this

ICCCS wants to bring together and

cleanroom technology at Clean-

year’s decisions made at ICCCS’s

unite its members at Cleanzone as

zone.

meeting in Germany and the impor-

well as to assist in forming strong-

tant changes associated with these

er relationships between related

Cleanroom Magazin: The interna-

decisions. ICCCS’s Board plans to

organizations. Furthermore, we

tional confederation for cleanroom

better support its members with the

will be promoting the Internation-

technology ICCCS will be appearing

communication of knowledge and

al Symposium for Contamination

for the first time at Cleanzone. What

this not only with cleanrooms in

Control in September, 2016, in Brazil.

are the reasons for this appearance?

mind but also in view of all the ac-

Portrait Koos Agricola studied Applied Physics at the Dutch University Twente near Enschede and worked there as a researcher before he took a position as a scientist at the University of Zambia in Lusaka. Afterwards he moved over to industry to Océ Technologies BV as a process engineer where he is still working.

Alongside his function as the General Secretary of the International Confederation of Contamination Control Societies (ICCCS), Koos Agricola is also active in the International Cleanroom Education Board (ICEB) and in the association Contamination Control Netherlands (VCCN).

4/2015 | »Contamination control is becoming in more and more industries necessary«

53 Project Management Cleanroom Technology

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Cleanroom Magazin: What are your

hold in their own countries or in

Cleanroom Magazin: Concerning

expectations for your first appear-

non-member areas within their re-

these developments, are interna-

ance at Cleanzone?

gions. Moreover, the ICCCS would

tional trade fairs, such as Clean-

like to put together a package which

zone, gaining in importance?

Koos Agricola: We would like to use

would provide help to call up na-

this opportunity to inform an in-

tional regional contamination con-

Koos Agricola: International trade

ternational audience the direction

trol events.

fairs have the chance to comply with

ICCCS is taking. In Frankfurt, we

new requirements in that they show

will have the opportunity to encour-

Cleanroom Magazin: The market for

products which come into ques-

age visitors from countries round

cleanroom technology is very dy-

tion. International trade fairs al-

the world who do not yet have clean-

namic. In which areas will clean-

so offer information exchange and

room organizations, to form their

room technology in the next years

strengthen the transfer of knowl-

own national associations and to be-

be taking?

edge, above all for those companies

come members of ICCCS. The ICCCS

new in cleanroom operation. Be-

wants to also use its appearance at

Koos Agricola: Cleanrooms are re-

cause of this background, Clean-

Cleanzone to exchange experience

quired to control contamination.

zone will be able to attract more and

and knowledge with its new mem-

Contamination control is being de-

more visitors.

bers.

manded from more and more industries and service providers. Be-

Cleanroom Magazin: What are the

longing to these industries and

most important projects which the

services are for example the auto-

ICCCS is planning in the next years?

mobile industry, hospitals, infec-

Koos Agricola: In addition to the in-

tion abatement agencies, the food

ternational certification of the In-

products industry and numerous

ternational Education Board ICEB,

companies offering new technical

the ICCCS will be offering to its

products.

member associations, standard courses which they will be able to

»Contamination control is becoming in more and more industries necessary« |

4/2015

54

Rejuvenating the productronica

SERVICE

World leading trade fair for the development and production of electronics with new concepts.

The entire electronics production supply chain under one roof can be experienced from November 10th to November 13th, 2015 in Munich, Germany at the Productronica Trade Fair. The cleanroom technology industry will present itself here with its own special exhibition.

ic of Industry 4.0 under new aspects: Visitors will be able to experience firsthand the as yet hidden processes, machines and production equipment and to visually tie in the peo-

Punctually for its 40th anniversa-

also be newly conceived: In the fu-

ple involved. This live exhibition will

ry, the world leading trade fair for

ture, each cluster will have its own

be assisted by augmented and virtual

the development and production of

Speakers Corner in Halls A1, B1, B2

reality at five carefully selected pro-

electronics will be rejuvenating it-

and B3. The topics of Industrial Elec-

duction machines.

self. The as yet 19 different segments

tronics, Automotive and PCB & EMS

will be integrated into a new clus-

will be put into focus at this year’s

ter structure along the lines of a

trade fair.

Event Stage Presenting Cleanroom Technology

are: Cluster PCB & EMS; Cluster SMT;

The special exhibition “Electronics.

Cleanroom technology is gain-

Cluster Semiconductor; Cluster Ca-

Production.Augmented.” will pro-

ing more and more importance

bles, Coils & Hybrids; and the Clus-

vide a real highlight. This exhibition

in the microelectronics industry.

ter Future Markets.

will have the motto: To make pro-

A strongly increasing number of

duction innovations from the five

manufacturers are already pro-

The new structure will pull a com-

new clusters come alive. This world

ducing in clean environments.

mon thread through the entire trade

leading trade fair for electronics pro-

The automobile industry is de-

fair concept. The event forums will

duction will show the trending top-

manding from its suppliers high-

supply chain. The five new clusters

Cleanroom specific demonstration during productronica. Foto: Cleanroom Media.

4/2015 | Rejuvenating the productronica

55 er and higher levels of cleanliness in their products. The Productronica Trade Fair in catering to the increasing needs for knowledge and technology will be offering comprehensive information regarding cleanroom technology at a distinctive special exhibition, on the event stage, “Cleanroom” in Hall B3, Stand 151. This event stage has been organized by the companies, cleanroom.

Visitors at productronica. Foto: Cleanroom Media.

de, Gerflor, Kemmlit and profi-con. of flooring do I need? All these are

ed to each individual production

A clean production environment

questions which will be sooner or

process. Many companies give the

can, but not necessarily be a clean-

later asked when the topic of clean-

cleaning responsibility to external

room. Local, defined and zoned off

rooms comes up. Presentations rel-

cleaning companies or they have

environments such as Laminar

ative to these questions will be giv-

their own cleaning department.

Flow Boxes, or Isolators are gaining

en at the event stage “Cleanroom”.

Special coaching and training me-

more and more importance. The smaller the clean environment is, the lower the purchasing and oper-

No Proper Staff Training, No Clean Production

ating costs are.

diates the necessary fundamentals and supports a sustainable, high level of cleanliness in the cleanroom. Cleanroom operators should

Those companies who want to or

A topic which is often neglected or

be aware that cleanroom cleaning

have to deal with clean environ-

even forgotten is that of the train-

is not comparable to standard of-

ments will have to acquire a thor-

ing and education of staff and col-

fice cleaning. Cleanroom cleaning

ough understanding of interrelat-

leagues. The largest source of par-

demands extreme precision in or-

ed production processes. Only those

ticulate matter in a cleanroom is

der to remove all particles and mi-

companies which know exactly

very often the human component.

crobial contamination at 100% res-

where to put their attention, will

For this reason it is of utmost im-

idue-free levels. Only under these

be able to select the suitable equip-

portance to teach employees prop-

conditions is it possible to guaran-

ment and to have it professionally

er cleanroom operation behavior.

tee f lawless product quality and

installed.

Workshops and seminars which

functionality whether it be phar-

show and explain how to enter and

maceutical products or automo-

However, cleanroom technology is

exit a cleanroom through the air

bile brake systems. In other words:

only one side of the coin. To produce

lock, how to properly put on clean-

Cleanroom cleaning has really little to do with cleaning in itself, but is in reality a part of the produc-

The pure clean productioninitially needs a deep understandingof the outstandingproductionprocesses.

tion process.

These and similar insights are those which this year’s event stage “Cleanroom” participants want to convey. The goal is to offer to all visitors the most comprehensive

in a protected environment, clean-

room clothing and how to move

knowledge spectrum and make the

room furniture, cleanroom cloth-

around inside a clean production

entry into the realm of cleanroom

ing and consumable supplies are

environment are becoming in-

technology as easy and uncompli-

needed. Questions which then arise

creasingly more important.

cated as possible.

are: What kind of clothing is suitable? What kind of gloves should be

Cleanrooms must be continually

used? What kind of furniture will

cleaned. There are special cleaning

work for my processes? What kind

materials which have to be adapt-

Rejuvenating the productronica |

4/2015

56

Cleanroom Knowledge to refer to The editors of the magazine scans the CleanroomNew publications of publishers regularlyCleanroom relevance.

These books - freshappeared - we want to introduce.

Particles in Pharmaceutical Production SERVICE

The detection and characterization of particles is a central issue in the pharmaceutical industry, as particles affect all areas: They are present in the development of medicinal products as well as in the production and quality control areas. Particles can be generated by the manufacturing process. They also come in by median such as air, air pressure or the water used in preparation. Not only is the testing for particle-free environments relevant, but also detection and accurate characterization. This practice-oriented book deals with the regulatory requirements and methods of Pharmacopoeia concerning the toxicology of particulate systems, their carrier functions and the diverse measuring methods available and comprehensively covers the topic in the light of relevant forms of dosage.

“Partikel in der Pharmaproduktion – Messtechnik • Detektion und Charakterisierung • Regulatorische Anforderungen“ (Particles in Pharma-Production – Measuring Equipment • Detection and Characterization • Regulatory Requirements) Publisher Frank Stieneker, ECV Editio Cantor Verlag (Publishing House), Series “ecv basics – practice” first edition 2015, 216 pages.

ISBN 978-3-87193-409-4. Price: €72.76.

Cleaning and Hygiene Equipment Among the biggest issues of this new edition are the fundamentals of cleaning and hygiene, practice-oriented cleaning technologies taking into consideration work safety and environmental protection and the maintenance of value of surfaces, invitations to bid, submitting offers, the organization of cleaning services as well as support with the minimizing of consequential costs of building maintenance seen from a technical cleaning perspective. The accompanying CD-ROM (only for Windows) offers quick access to important information such as statutory regulations, helpful tools and tables (sample contracts, performance descriptions, price sheets), all which can be directly accessed and filled out, saved and printed with a computer. Tip: This handbook is in the form of a loose-leaf book. The purchase activates a subscription of updated deliveries until the subscription is cancelled.

“Reinigungs-und Hygienetechnik” (Cleaning and Hygiene Equipment), Looseleaf book including updates, in a binder with CD-ROM. Publisher Martin Lutz.

First appeared at ecomed Sicherheit, stand 51. Updated August, 2015.

ISBN 978-3-609-75660-8. Price: €149.99.

4/2015 | Cleanroom Knowledge to refer to

57

Your partner for critical environment solutions • Full service solutions for cleanrooms and critical environments • Highly skilled specialists and high level of flexibility to turn your needs into a custom-made supply concept • Supply chain excellence to provide 100% security of supply and JIT-deliveries • Comprehensive portfolio of premium-products and services • Global network of suppliers and partners

VWR | basan - the cleanroom division of VWR | info.basan@eu.vwr.com | vwr.com/basan

IT Trends in a GxP Environment The field of IT is strongly characterized by innovative changes. The complexity of systems are becoming larger and web-based applications with Single-Sign-On which in the past a person would shudder, have in the meantime become the standard. Also company-specific GxP Apps are on the rise despite considerable risks with security and control and Cloud Computing is experiencing its zenith. Renowned authors from industry, consulting and the supply sector give insights into the current trends and their application in the field of GxP. The “pharmaceutical technology journal” is both a practice-oriented report and reference book. It enables an efficient execution of GMP requirements in daily operations. The series of papers is bound in individual volumes each dedicated to a special pharmaceutical technology topic.

“IT Trends im GxP-Umfeld – Technologien, Qualitätssicherung, Validierung” (IT Trends in the GxP Environment – Technologies, Quality Assurance, Validation) Publisher Concept Heidelberg. ECV Editio Cantor Verlag (Publishing House), series “pharma technologie journal” First edition 2015, 176 pages.

ISBN: 978-3-87193-302-8. Price: €72.76. weitere Informationen: www.ecv.de Cleanroom Knowledge to refer to |

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58

Trade Fairs and Congresses

Kiel

Schwerin

Hamburg

Germany

SERVICE

Bremen

18.–19.11.2015 Precision Fair Veldhoven The Netherlands

Hannover

Berlin Potsdam Magdeburg

Leipzig

16.-19.11.2015 Medica and Compamed Düsseldorf Germany

Düsseldorf

Erfurt

Dresden

Köln

Frankfurt am Main

Wiesbaden

Nürnberg

Mainz

10.–11.02.2016 Pharmapack 2016 Paris France

Saarbrücken

10.-13.11.2015 Productronica Munich Germany

Stuttgart

27.-28.11.2015 Implant expo Vienna Vienna Austria 13.-14.04.2016 Lab Innovations Lausanne Switzerland

27.-28.10.2015 Cleanzone Frankfurt am Main Germany

München München

Konstanz

Basel Aarau Delèmont Solothurn

15.-17.01.2016 Opti Munich Germany

Zürich

St. Gallen

Wangen

Neuenburg

Luzern Freiburg

Bern Chur

Lausanne

Genf

Switzerland

4/2015 | Trade Fairs and Congresses

59

Events ReinraumAkademie (D) and CleanroomAcademy (CH) Cleanroom Expert Days November 18-19, 2015 | Cleanroom Design | Wangen an der Aare (Switzerland) November 24-25, 2015 | Behaviors in a Cleanroom, Cleaning and Training | Leipzig (Germany) January 27-28, 2016 | Modern Cleanroom Design and Configuration | Leipzig (Germany) February 2-3, 2016 | Cleanrooms and Hospitals – One Issue, Two Worlds | Wangen an der Aare, Switzerland March 9- 10, 2016 | Cleanroom Layout, Planning and Construction | Leipzig (Germany)

PROFESSIONAL SEMINARS

ONE DAY TRAINING PLUS

November 11-12, 2015 | Fundamentals of Professional Cleanroom Cleaning | Leipzig (Germany)

November 10th, 2015 | Leipzig (Germany)

16. basan Reinraumforum für Apotheker/innen Das Thema: Die neue Apothekenbetriebsordnung (§ 35 ApBetrO) – Erste Erfahrungen zur effizienten Umsetzung in der Apothekenpraxis

Die Novellierung der Apothekenbetriebsordnung hat nun in der Apothekenpraxis allgemeine Umsetzung gefunden. Apotheken produzieren parenterale und zytostatische Produkte unter sterilen Bedingungen. Wie hat der Einstieg für die Apotheken geklappt? Welche Verbesserungen hat die neue ApBetrO gebracht? Aber auch: Wo gibt es noch Schwierigkeiten? Auch wenn die Rahmenbedingungen für die neue ApBetrO in jeder Apotheke nun erfüllt sind, so müssen die neuen Arbeitsabläufe und Strukturen implementiert, von den Mitarbeitern beherrscht und zur Routine gebracht sein, um einen effizienten Ablauf in die sterile Produktion zu bekommen.

Das 16. basan Reinraumforum will sich mit der – noch neuen – Praxis des Apothekenalltages mit der ApBetrO befassen. Mit spannenden Vorträgen von Experten aus der Praxis und mit Workshops, die konkret für die neuen Prozesse der sterilen Produktion schulen.

Die Eckdaten: Termin: 03.+04. November 2015 | Ort: ReinraumAkademie GmbH, Rosa-Luxemburg-Str.

12-14, 04103 Leipzig | Programm: 5 Vorträge und 2 Workshops | Kosten: € 280,00 (zzgl. MwSt.) | Veranstalter: VWR International GmbH basan – the cleanroom division of VWR

Die Veranstaltung ist mit 10 Punkten bei der Sächsischen Landesapothekerkammer anerkannt.

Eingeladen sind: Apotheker/innen, die in der sterilen Produktion kompetent, effizient und wirtschaftlich arbeiten wollen.

Anmeldung: Anmeldemöglichkeiten unter www.vwr.com/basan in der Rubrik Veranstaltungen oder per Fax: +49 (0) 6107-9008 509, Kontakt: Dr. Daniela Golz, +49 (0) 6107-9008 853, daniela.golz@de.vwr.com

Here could be your event.

Want more information? Please contact the cleanroom academy. www.ReinraumAkademie.de

Events |

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60

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Ers

„Können, Fleiß und Glück“ Ability, Diligence and Luck

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

Paris

Attraktives Reiseziel für Technologen Popular destination for technologists

Architektur

Gestaltungsmöglichkeiten von Reinräumen Cleanroom design ideas

2/2013

Sieglinde Sellemond

Norbert Otto Vordenken und Nachdenken Thinking Ahead and Reflecting

Genuss, Kunst und Kultur Indulgence, art and culture

Dresden

Attraktives Reiseziel für Technologen Popular destination for technologists

Jan Gerbrands Motivation und Leidenschaft Motivation and Passion

An industrial sector gets new impulses

Well dressed in a Cleanroom

EDITION 1/2012

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Tirol – Hightech im Bergparadies

Gut gekleidet im Reinraum www.cleanroom-media.com

www.cleanroom-media.com

EDITION 2/2012

Cleanroom Award – Challenging the branch

EDITION 1/2013

EDITION 2/2013

CLEANROOM

Ausgabe 2/2012 2/2014

Herausforderung an die Branche

Tirol – High tech in mountain paradise

MAGAZIN

EDITION 1/2014 03

02

Sommer 2015

Frühjahr 2015

Life & Science Informationen für die Reinraumtechnologie

CLEANROOM

04

Herbst

MAGAZIN

2015

Life & Science Informationen für die Reinraumtechnologie

0 3 | S O M M E R 2 015

Cleanroom Award

C LE AN R O O M M AG AZ I N

Eine Branche geht auf Empfang

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

Cleanzone

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

Barbara

KanegsNorbert Otto berg

Vordenken und

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

Blühende Natur Gefährliche Kontamination So nehmen Pollen und Luftfeuchtigkeit Einfluss auf Ihre Produktion

Cleanroom Award –

Gut gekleidet im Reinraum Fortschritt für den Reinraum Cleanroom Award – Advancement for the Cleanroom

Well dressed in a Cleanroom

C LE AN R O O M M AG AZ I N

Regularien Lästige Pflicht oder geldwerte Tipps?

OLEDs Die Lichtrevolution aus dem Reinraum Krankenhauskeime Wie Raumtechnologien Infektionen verhindern

0 3 | S O M M E R 2 015

SERVICE | IMPRINT

Ausgabe 1/2012

Internet der Dinge

Freude am Gefahrenwerden

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

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

Keime im Essen Wie die Reinraumtechnik gefährlichen Lebensmittelkeimen den Garaus macht

Smarte Textilien Mitdenkende Stoffe verändern Medizin, Architektur, Mode und Autoindustrie

Cleanzone 2015 Die internationale Reinraummesse wird zum Impulsgeber der Branche

Operationssaal der Zukunft So sieht der Chirurgen-Arbeitsplatz der nächsten Generation aus

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ISSN 2364-0405

EDITION 2/2014

EDITION 1/2015

Imprint CLEANROOM MAGAZIN 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 2/2015

Chief Editor Frank Baecke Tel. +49 341 98989 405 frank.baecke@cleanroom-media.com Translation Bill Hillman Authors Frank Baecke Frank Duvernell Klaus Eckardt Piet Felber Maja Franke Thomas Köhler Richard Reudelsdorf Markus M. Schröder

4/2015 | Imprint

EDITION 3/2015

Advertisements/Notifications Maja Franke Tel. +49 341 98989 404 maja.franke@cleanroom-media.com Implementation Wohlfahrt GmbH www.wohlfahrt.net Publication Quarterly Circulation 10,000 copies Printer Löhnert-Druck, Leipzig ISSN 2364-0405

EDITION 4/2015

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