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

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

CLEANROOMMAGAZINE

Life & Science Information for Cleanroom Technology

autumn 2015

04

Vision. Innovation. Expertise.27 + 28. 10. 2015Frankfurt am Main

International trade fairand congress forcleanroom 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

Savethe Date!

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The Internet of Things begins in cleanrooms. Tiny micro-electronic-me-chanical systems, the so-called MEMS, are the components and building blocks of our digital future. They are perfectly suited to being mass-pro-duced 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 every-day 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 in-creases in productivity – known as “Industry 4.0”.

That all these innovations are being made possible by cleanroom technol-ogies 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 hap-pening in the world of cleanrooms. I am directing this invitation specifi-cally to those professionals who will be able to discover the highly attrac-tive but little known employment possibilities in the cleanroom industry.

Frank DuvernellEditor

Frank Duvernell: “According to a Gartner Study, more than 25 billion devices are likely to be networked with each

other by the year 2020. Isn’t it frightening to think that everything will be able to integrate itself with everything? I say, NO! The computers embedded everywhere will make

our lives safer and more comfortable. Gartner estimates 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!”

Dear Readers!

EDITOR

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Number of networked devices:

2014: 4 billion

2020: 25 billion

Gartner market researchers expect that the Internet

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

25 Mrd.

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CONTENTS 04/2015

..................................................08 Title Story: The Internet of Things

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

LIFE & BUSINESSWhat’s New in the World of Cleanrooms

06 Market Developments in BriefWhere 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? 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 in-dustry innovative solutions to eliminate germs from food products...................................................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..................................................

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

Life&Business: Every second chip is from Saxony.

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SERVICEEvents, Awards, Regular Columns

46 Laws and Regulations: Mis-takes are no grounds for dismissalThe 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 submittedBy 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 industryFrom October 27th to 28th, 2015, Clean-zone 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.

SCIENCE & TECHNOLOGYSolutions for the Cleanroom World 28 Technology in BriefSmart Contact Lenses Testing in 2016 • Robots revolutionize Cleanroom Tech-nology • 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..................................................30 Future Laboratories: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 DisputeAt 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 validatedSo that computer systems are able to model operational processes more effi-ciently, a transparent, comprehensible user requirement specification document is necessary to formulate before imple-mentation. Specialists advise to base the modeling of requirements on a pro-cess-based approach...................................................44 What do you do there…?Mathias Ortner, Service Technician at the Swiss company Elpro-Buchs AG.

................................................52 In Interview: Koos AgricolaThe 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 conceptAt 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 toCleaning and hygiene technology • Particles in pharmaceutical produc-tion • IT trends in GxP environments................................................58 Trade fairs and events................................................60 Imprint

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Essay: Which skills will we need in the future?

Laboratories of the future: smartlab.

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Where Swiss Pharmaceutical Exports are heading

Export Study | Pharmaceutical ex-ports from Switzerland have been growing every year on the aver-age by 8.5 percent. This statistic is shown by the customs administra-tion. What is interesting about this statistic is the geographical break-down. Since 2000, the pharmaceuti-cal exports to China have been in-creasing yearly on the average by 25 percent while exports to India and Russia have increased by an im-pressive 14 and 13 percent. Exports to the five largest European markets, Germany, Great Britain, France, It-aly and Spain, have been growing yearly by only seven percent. Notable are exports to the USA which have reached a volume of 58 percent of the five largest European sales markets. This percent was on-

ly at 29 percent in the year 2000. This shows that expenditures for medi-cine in the USA have increased sig-nificantly more than in the Europe-an countries.

Smartphone Core with the Lowest Rate of Growth since 2013

Market Saturation | The worldwide Smartphone market experienced in the second quarter of 2015 its lowest growth rate going back two years. Ac-cording to an analysis of the market research company Gartner, 330 mil-lion units were sold to end customers in the regions investigated, which was a plus of 13.5 percent in comparison with the same time period last year. The strongest growth took place in the regions of Asia-Pacific, Eastern Europe, the Middle East and Africa. In contrast, for the first time Smart-phone sales declined by 4 percent in China over the same time period. However, China remains the larg-est Smartphone market in the world with a market share of 30 percent. “China has reached saturation – its Smartphone market is character-ized by the purchase of replacement phones. There are fewer first-time buyers”, says Gartner analyst An-shul Gupta. Only premium devices could possibly revive the market.

Cared for by Robots?

Survey | Robots used in personal care or as implants for better mem-ory retention– many Germans have little fear of being touched when it comes to visionary medical technol-ogy. This is the result from the re-search agency ZukunftsMonitor’s

survey “New Thinking Regarding Health” – a representative survey which commissioned by the Feder-al Ministry for Education and Re-search (BMBF). Around a fourth of the people surveyed (26 percent) could imagine to be taken care of by robots. 51 percent of those sur-veyed were in favor of implants for better memory retention. Especial-ly younger people find this idea of interest. Among those between the ages of 14 and 19, the approval rate reached 62.3 percent.

LG invests in OLED Technology

Billions invested | The Korean Man-ufacturer LG wants to invest near-ly 8.5 million US dollars in OLED display technology in order to keep a step ahead of the competition in this business sector. The major part

of the money is supposed to go into the development of OLED panels for televisions and mobile devices such as Smartphones, tablets and weara-bles. Furthermore, LG wants to do re-

Life&BusinessMarket developments in brief

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

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

Photo: Jpramirez

The manufacture of pharmaceuticals. Photo: Kadmy

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search in finding ways to use OLED’s in the fields of automotive manufac-ture and digital signage. OLED’s are organic light emitting diodes. In con-trast to liquid crystal displays (LCD), OLED’s are more flexible, provide more brilliant colors and better con-trast, need no backlighting and make it possible to build thinner devices.

Every second chip comes from Saxony

Silicon Saxony | German Federal Chancellor Angela Merkel toured in July, 2015, together with other pol-iticians and representatives from in-dustry and science, two chip man-ufacturers Globalfoundries and Infineon in Dresden, Germany. Both companies were promoted by the German Federal Research Min-istry. Globalfoundries is working, with support from the federal gov-ernment, on new chip technologies and Infineon on numerous pilot pro-jects in high performance electron-ics, also with federal support.Dresden, the capital city of the free-state Saxony, has become for the mi-croelectronic industry the strong-est location economically in Europe. Every second chip manufactured in Europe comes from Saxony. This lo-cation is now known as “Silicon Sax-

ony” the name stemming from Sili-con Valley in California. The Saxony microelectronic and nano-electron-ic industries generate revenues of around six billion Euros per year.

Ebola could be defeated this year

WHO-Prognosis | According to esti-mates of the World Health Organi-zation WHO, the Ebola virus could be completely eradicated by the end of this year. More than 11,000 people have died from the Ebola outbreak in West Africa. Howev-er, Liberia, Guinea and Sierra Le-one have been able to greatly drive back the epidemic. In as much as the discovery rate of new cases of

infection and ways of contacting the disease remains high, the vi-rus could “by the end of the year become stably defeated”, says WHO Director Margaret Chan. Newly developed vaccines are providing hope. According to WHO, one of these vaccines in clinical tests on 4000 people has led to 100 percent protection from the disease with-in ten days.

ZVEI-Trend Analysis by 2019

Microelectronic Market | Asia will reach by 2019 a 59 percent market share in the worldwide microe-lectronic market, whereby China’s share will alone amount to 28 per-cent. This figure is forecasted by the Zentralverband Elektrotechnik and Elektronikindustrie e.V. (ZVEI) (Central Association of Electron-ic Technology and Electronics In-dustry), one of the most important German industrial associations, in its trend analysis to the year 2019. America’s market share will grow to 21 percent, Europe will have an eleven percent market share and Japan with nine percent will bring up the rear.

By 2019, the fields of communica-tion, computers and entertainment electronics will remain the most important market segments. In Ger-many, the fields of automotive and industry will also gain in impor-tance.

German Federal Chancellor Angela Merkel visiting the chip manufacturer Infineon in Dresden, Germany. Photo: German Federal Government/Kugler

Test vaccine against the ebola virus. Foto: science photo

0

50 6985

38 3855

120

38 4335

92

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Amerika Europa Japan AsienChina

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

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Veränderung der Marktanteile im weltweiten Smartphone-Markt

Hersteller2. Quartal 2014Einheiten in Tausend

2. Quartal 2014Marktanteil in %

2. Quartal 2015Einheiten in Tausend

2. Quartal 2015Marktanteil in %

Samsung 72.072,5 21,9 76.129,2 26,2

Apple 48.085,5 14,6 35.345,3 12,2

Huawei 25.825,8 7,8 17.657,7 6,1

Lenovo* 16.405,9 5,0 19.081,2 6,6

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

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

Changes in the Market Shares of the worldwide Smartphone MarketManufacturer 2. Quarter 2014

units/thousands2. Quarter 2014m.sh. /percent

2. Quarter 2015units/thousands

2. Quarter 2015m.sh. /percent

Samsung 72.072,5 21,9 76.129,2 26,2

Apple 48.085,5 14,6 35.345,3 12,2

Huawei 25.825,8 7,8 17.657,7 6,1

Lenovo* 16.405,9 5,0 19.081,2 6,6

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

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

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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.

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The stationary computer is disap-pearing more and more out of our day-to-day lives. In its place, “intelli-gent devices, objects and materials” are stepping in. The US American computer scientist Mark Weiser formulated such a vision at the be-ginning 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 of Things has imperceptibly moved in to support people in their every-day lives, the computer, respective-ly 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 be-come omnipresent at home – not only in smart phones and the tele-vision but increasingly in heating systems thermostats, washing ma-chines 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 bil-lion US dollars. That, which at that point in time generated quite a bit of buzz, appears today as the logi-cal consequence of the rise of net-working. Recently, Google has radi-cally re-structured itself. Under the

new designation of Alphabet, Goog-le will most likely remain the core business and earn the money for the other divisions. Among these di-visions is the company Nest which will also help to drive forward the networking of things: Under the name of Fiber, the company pro-vides in several US cities ultra-fast fiber-optic connections – the tech-nical band-widths which are the pre-requisites for the growing in-terconnectivity. Google X is another division, the innovations laboratory of Google, which has been develop-ing autonomous driving cars. (We reported on this topic in the 03/2015 issue)

The conventional becomes the intelligent device

How the Internet of Things has changed and is able to make every-day life more practical was one of the major issues presented at the International Communications Ex-hibition and Trade Fair at the be-ginning of September in Berlin, Germany. At this worldwide lead-ing trade fair for Consumer Elec-tronics and Home Appliances, the industry association of the German digital industry, BITKOM, togeth-er with the consulting company Deloitte, presented a new consumer electronics study. The findings: The Internet of Things is currently the

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| The Internet of Things

In smart homes exists a communication between devices.Picture: fotolia

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most important trend in entertain-ment electronics. “Networking is making out of conventional devic-

es, intelligent devices, which is pav-ing the way for countless new and creative potential uses”, says Timm Lutter, the Consumer Electronics and Digital Media Area Manager for BITKOM. “Users can therefore de-

sign and set up their entertainment systems not only more conveniently but also more flexibly and individ-ually. Non-networked devices have much more difficulty in establish-ing themselves with consumers.”

Networking is growing rapidly

Networked devices, powered by the tiniest microelectronic clean-room-produced components, will clearly establish themselves in the coming years in entertainment electronics. This development is driven forward by an ever faster mobile data network. The mobile communication industry is work-ing on a new super-fast standard with the name of 5G, which will transmit data a hundred times faster than the present day 4G net-work. The current standard will soon reach its limits in view of rapidly growing machine-to-ma-chine communication (M2M) via sensors. Klaus Böhm, Media Direc-tor of Deloitte, predicts: “By 2020, Germans will be using some 100 million networked devices – not counting smart phones and tab-let computers.” Market researchers from the company Gartner reckon with over 25 billion networked de-vices and machines worldwide by the year 2020. With the increasing

integration of smart devices in us-ers’ everyday lives, their demands and will also increase. Therefore the need for digital products will grow, whose components are manu-factured exclusively in cleanrooms.

Data, Data, Data

When the refrigerator sends the shopping list to the smart phone, or the home owner activates his home’s heating system via his mo-bile telephone, this doesn’t just mean practicality. The constant growth of networks and commu-nication between evermore devic-es is producing an unimaginable amount of data. Experts are to date in disagreement how this river of data can be responsibly dealt with. Companies, on the other hand are

promising important information in order to make their offers more efficient and more practical. Un-mitigated on the side, these com-panies are collecting sensitive per-sonal customer data. The Federal Association of the German Inter-net Industry e.V., eco, thus empha-sizes that in the future it will not just come down to creating efficient smart-device communication with international standards. When the Internet of Things networks nearly everything with everything, proper and responsible approaches will be in demand. The risk of abuse is in-creasing according to eco in that not only concerning the loss of privacy but also industrial sabotage for ex-ample by the paralyzation of critical infrastructure such as the power supply. Experts from eco are there-fore asking for more clarification and investment in security. Con-cerning these issues, well-known companies in the USA, such as Mi-crosoft, Symantec and AVG found-ed the Online Trust Alliance at the

The Internet of Things |

“Non-networked devices have much more difficulty in establishing themselves with consumers.” Timm Lutter, Consumer Electronics Area Manager

Everything starts in the mind. Picture: fotolia

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beginning of this year. With a co-dex of self-regulation, they want to bring about better protection of the private sphere in the Internet of Things.

Growth through IoT

The business with the Internet of Things is booming. The consultants at Gartner are calculating that in five years, companies will be turn-ing in this sector will be turning over 300 billion Euros. Industry ex-perts see huge growth potentials in the so-called market ‘Wearables’ – smart watches, fitness trackers and digital glasses. Smart watches in particular have seemingly expe-rienced a boom brought on by the presentation of the Apple Watch in April of this year. It isn’t surpris-ing then, that numerous compa-nies presented their new models in the Berlin trade fair halls. BIT-KOM estimates the sales of smart watches will grow this year by 350 percent with a volume of 645,000

units. In the area of consumer goods, smart devices will bring about great changes in companies. “The Internet of Things is revolu-tionizing classic business models.” states Klaus Böhm of Deloitte. In the future, it’s not only about the prod-ucts, but above all about those with their associated services and con-tents. Besides the smart devices for

the body, large numbers of applica-tions for networking at home were presented at IFA: audio systems which are controlled via a smart phone, mobile control systems for heating facilities, or refrigerators which on demand send the shop-ping list to the mobile phone.

Small, energy-saving and inexpensive

One thing about all these smart solutions is the same. Internally is found ever smaller semiconductor products such as tiny, powerful mi-cro-processors and memory chips as well as intelligent components which combine sensors and cir-

cuits onto one chip. These so-called MEMS sensors have become indis-pensable in smart phones. They measure the rotary and other move-ments and provide for photo stabi-lization while taking pictures. Mi-cro-antennae are becoming more powerful and more intelligent. Not just for these reasons are networked sensor systems being regarded as the most important components for new powerful applications in the Internet of Things. Micro-techno-logical components are being pro-duced more inexpensively and in greater numbers. An example: At Bosch Sensortec, one of the lead-ing companies in the MEMS tech-nology market, 4 billion MEMS sen-sors have been shipped since the start of production in 1995. Indus-try insiders are promising a fur-ther leap forward with the develop-ment of still smaller components: nano-electro-mechanical systems, analogous to MEMS, named NEMS for short.

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tionizing classic business models.” Klaus Böhm, Deloitte

Cleanroom technical challenges in producing MEMS, NEMS & Co.

Air quality and cleanliness: Air quality is negatively affected with parti-cle sizes under 0.1 micrometers – particularly with the so-called NOEMS (na-no-opto-electromechanical-systems) with structure sizes in part of only 5 or even 3 nanometers.

Surface cleanliness: Absolute avoidance even from minimal film-like con-tamination, 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 clean-ing of nano-technical production facilities as well as suitable cleaning materi-als and resources.

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

| The Internet of Things

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Smaller components, larger demands from cleanrooms

For the production of MEMS and NEMS certain production condi-tions are required. The tiny sensor systems are built onto so-called wa-fers, circa 1 millimeter thin sheets made mostly out of silicon. For ze-ro-defect production, clean air quality in the room is extremely im-portant. The smallest dust particle which finds its way onto a wafer or component is able to make the af-

fected chip useless. To date, regard-ing air quality, a particle size of 0.1 micrometer is the accepted limit, which in the future will no longer be enough. A consequence of the further development of MEMS to NEMS is that the cleanroom tech-nology industry will have to react to these new developments. Demand-ed are innovative solutions in or-der to assure optimal conditions in production environments. It is ev-ident: Developments in micro and nano-technology and the success

of the Internet of Things is closely interrelated with cleanroom tech-nology.

Author: Thomas Köhler

Wearables – Smart Potential

Fitness Trackers are presently the most successful wearable product. Via electronic sensors on the body, these small de-vices 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 incor-poration 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 cle-anrooms are being integrated into textile fabrics.

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

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

EasyMop GMP®

Reliable cleaning and disinfecting ofpharmaceutical cleanrooms

The Internet of Things |

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Silicon-Sa xony 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”.

Cleanroom Journal: Mr. Esser, what role will the topic of Industry 4.0 play in the cleanroom industry?

Heinz Martin Esser: A very large role because intelligent produc-tion brings with it many advan-tages. Many industries which pro-duce under cleanroom conditions use the most modern produc-tion control systems and are very far advanced in the direction of the “smart fab”, enabling them to make their factories even smarter. Self-navigating robots are in a posi-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 Journal: How wide-spread is robot technology in cleanrooms?

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

the worldwide semiconductor in-dustry has been highly automat-ed for years. Chip manufactur-ers belong to the first companies which have interfaced their pro-duction machines with intelligent software systems and are utilizing the so-called Manufacturing Exe-cution System (MES) to effectively control and monitor production. As a consequence, quality and yield

increase, lead and cycle times are shortened and machine availabil-ity as well as production capacity are optimized.

Cleanroom Journal: What advan-tages does automation bring to cleanroom operators?

Heinz Martin Esser: Robots are tak-ing over the monotonous and phys-ically demanding jobs. Personnel which then become available can be trained when required and ap-propriate and be placed in produc-tion to do more meaningful work. In addition, automation contrib-utes decisively to the avoidance of mistakes and to reach a consistent level of product quality. Last but not least, automation helps clean-room operators to reduce the entry of human-originating particulate matter into cleanrooms.

Is “Industry 4.0” interesting for the Cleanroom?Silicon Saxony managing director Heinz Martin Esser speaks about networking, robotics and automation in 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-eral State of Saxony. Silicon Saxony brings together more than 300 manufacturers, suppliers, service providers, universities, research institutes and public agencies mak-ing Saxony a focal point for microelectronics. Photo: Roth & Rau – Ortner GmbH.

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© N

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WE SPEAK CLEANROOMS!

Editorial Deadline: October 01

Advertising Deadline: October 15

Medica Issue Focus: Healthcare, Hospital, Pharmacy

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

DO YOU SPEAK

CLEANROOMS?

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Germs in food – now what? Cleanroom technology makes the

processing of food products safer and more hygienic.

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.

Foto

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In January, 2015, Germans sudden-ly acquired a taste for turkey meat. What had happened to instigate this? The German Federal Office for Envi-ronmental Protection (BUND) had fresh, packaged turkey meat from Al-di, Lidl, Netto, Penny and Real test-ed in the laboratory. The result: 88 percent of the test samples contained MRSA germs and ESBL-generated germs.

MRSA germs (multi-resistant Staph-ylococcus aureus) cause open wound infections, are resistant to many an-tibiotics and acquired sad notoriety as the so-called hospital germs. ES-BL-generated germs produce the en-zyme Extended Spectrum Beta-Lacta-mase (ESBL) which make many antibiotics ineffective.

The dust raised by the turkey meat excitement had hardly settled when in February, 2015, Stiftung Warentest (Quality Control Foundation) deter-mined that ground meat from pork and beef contained too many of these dangerous germs. Shortly after, the European Food Safety Authority (EF-SA) and the European Commission for Disease Control (ECDC) put out warnings for antibiotic-resistant bac-teria.

Resistances are the result of frequent use of antibiotics.

The more frequent occurrence of germs is the result of the rampant use of antibiotics in intensive live-stock farming. The antibiotics are meant to prevent the spread of dis-

ease among the densely packed ani-mals. Often a whole herd is treated via their drinking water and this several times although only individual ani-mals become ill. The result: The bac-teria develop resistance to the very antibiotic meant to kill them.

Eating meat loaded with resistant germs doesn’t mean that a person im-mediately becomes ill. A healthy body is able to eliminate the germs on its own. It becomes dangerous when the germ-infected person in the case of

illness needs an antibiotic. The anti-biotic kills off all bacteria except for the resistant ones which are then able to reproduce unhindered.

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

Infections with ESBL-generated germs and MRSA germs can lead to death in old people, young chil-dren, ill people and pregnant wom-en. These germs are especially dan-gerous for immune-deficient patients in the hospital. According to estima-tions of the Berlin Charité, 10,000 to 15,000 people die each year in Germa-ny alone, as a result of hospital infec-tions with multi-resistant germs. The pathogens are able to cross the barrier between animal and human in various ways. They find their way over to humans via contact with an-imals, slaughtering and food prepa-ration 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-ed fields. The multi-resistant germs also get into the soil, water and in veg-etable crops.

“To take measures which improve hygienic situation.And to decrease new resistance formation.” Lothar Kreienbrock, RESET-Project Hannover

Germs in food – now what? |

Testing food in laboratorys. Foto: fotolia

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Measures against the formation of resistance are necessary.

The German research group RE-SET is currently examining where and how often the dangerous bac-teria are found in agriculture. The first results are alarming: in 34 of 34 meat chicken farms examined, ESBL-generated germs were found. In pig and cattle stockyards the rate was only slightly lower.

In the view of Professor Lothar Kreienbrock, Director of the RE-SET project and Institute Director at the Veterinary University Han-nover, these results show that it is necessary “...to take measures which for example improve hygienic situ-ations which would minimize the formation and spread of bacterial resistance”.

From stomachache to serious food poisoning and infection

The list of dangerous food product germs is much longer than the list of antibiotic-resistant bacteria. Sal-monella, Listeria, Clostridia, Shigella, Staphylococcus, Yersinia, Escherichia coli and EHEC bacteria belong to this list. Their effects reach from harmless stomachaches to serious food poison-ing and infection.

Higher standards are demanded from food product producers in their pro-duction facilities. Along with the law-ful guidelines come the demands from retailers and consumers: Food prod-ucts should be fresh, clean and germ-free. Consumers are demanding more often that producers refrain from us-ing unpopular preservatives and addi-tives. All these demands are making a germ-free food product manufactur-ing environment indispensable.

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

The guarantor for germ-free food product production is cleanroom technology which provides clever solutions for the elimination of mi-croscopic pathogens. An overview of current developments of the newest innovations was offered in March of this year at the leading trade fair for food products and beverages, the Anuga FoodTec which is held in Cologne, Germany every three years. Included among the fair’s highlights was a continuous-run-ning UV de-germination system in which the food product or packag-ing is treated with UV-C radiation. UV-C radiation is part of sunlight and extremely aggressive. This radi-ation is filtered out by the ozone lay-er. Unfiltered, the radiation kills off bacteria, viruses, yeasts and mold spores within seconds. The beauty of the system is: the UV de-germi-nation requires no chemicals, no heat, leaves the product unchanged and doesn’t lead to the formation of resistance.

34 of 34 investigated chickenfarms were contaminated.

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

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Fluid nitrogen reduces germs by 90 percent

The Rapid Surface Chilling proce-dure was presented at the Anuga FoodTec Trade Fair, a procedure for the effective reduction of germs in poultry meat. A lot of chicken meat is loaded with Campylobacter bac-teria which bring on intestinal in-fections. To prevent this from oc-

curring, the meat is sprayed with fluid nitrogen cooled to a very low temperature. This procedure re-duces the germ load by 90 percent. The taste and color of the meat re-main unchanged.

A further possibility to keep mi-cro-biological danger away from food products is UV-light treatment of package surfaces. This intensive,

cold light kills off bacteria, yeasts and fungi and markedly increases the storability of products such as yoghurt, quark and milk.

Filters hold back micro-organisms

Belonging to cleanroom technolo-gy for food product production is 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-organ-isms (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 co-li (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? |

Food production with cleanroom technology. Foto: fotolia

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self but also the surrounding clean-room areas. These serve to protect the open products during the removal of contamination from room air. Ul-tra-clean air is fed into the cleanroom or into machine housings where overpressure drives unclean air out. High-efficiency particulate air filters through which cleanroom air flows trap the most minute particles and micro-organisms down to the size of 0.5 micrometers. Most bacteria are in the range of one to five micrometers. However: Every square meter of a cleanroom is expensive. The trend is operate small cleanrooms, isolators, mini-environments and Restricted Access Barriers (RABS). The goal is to maintain the highest-standard clean-room conditions only directly in loca-tions of food product processing.

Virtually germ-free

How clean production environments have to be depends on the product be-ing processed. It makes a difference if fresh, moist meat or dry zwieback

is being processed. Because of the differing cleanliness requirements, cleanroom are divided into class-es 1 to 9 according to the DIN Norm ISO 14644-1, whereby 1 describes the cleanest class. The Norm stipulates for each cleanroom class how many particles at which sizes a cubic me-ter of air is allowed to contain. As a rule, food product production takes place in class 5 to class 8 cleanrooms. In contrast to semiconductor produc-tion, in food product production the particles themselves don’t present the risk for the product but the number of particles with attached germs. In a class 5 cleanroom, the particles are already so small that the air is virtu-ally germ-free.

Globalization increases health risk attributed to food products

This brings many advantages for the safe production and packaging of food products as the products re-main fresh longer, do not prema-turely spoil, are able to be stored

| Germs in food – now what?

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Chocolateproduction under clean conditions. Picture: Fotolia.

Storage of food earlier. Picture: Fotolia.

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longer and no longer require pre-servatives as the production areas are germ-free. The cleanliness of food product production environ-ments is therefore so important as our food supply chains are becom-ing longer and more complex than ever in the past. We have access to a wide range of food products which are produced outside of their nor-mal growing seasons, which are transported from continent to con-tinent, which are processed for con-venient consumption and which are increasingly consumed while travelling. However this globaliza-tion of trade and logistics, migra-tion, climate change and new tech-nologies bring along with them an increase in health risks attributed to food products.

Considerable impact on health and economies

“The fact is that we strongly underes-timate how many people fall ill due to chemicals in the food supply chain and the wide-spread micro-organ-isms such as Salmonella and Cam-

pylobacter. Alarm bells should be sounding from every involved agency, department and company which has in some way something to do with our food supply chain”, says Dr. Zsuzsanna Jakab, WHO Regional Director for Eu-rope. A mistake in food product safety in just one link of this chain, or con-

tamination from a single source could have significant health and economic impacts. For example, the EHEC out-break 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 agricultur-al 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 prod-uct infection development, spread, abatement and resulting social conse-quences. This task group is to support governmental authorities responsi-ble for food product safety and other agencies responsible for determin-ing 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 de-crease in such risks. The task group consists of internationally renowned experts from disciplines which are active in the investigation of the de-velopment, global spread and control strategies of disease caused by food products. Cleanroom technology pos-es many advantages in this respect. The task group’s final report will be made public in October, 2015.

Germs in food – now what? |

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

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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 recruit-ment and training of new staff lags far behind the growth of the cleanroom industry. What should be done?

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Cleanrooms are special produc-tion and working environments in which processes are protected from contamination. The products pro-duced in cleanrooms are sensitive, have life-saving effects, and fulfill safety relevant functions. The spec-trum of these products reach from medicines, implants, water marks 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 the automobile industry.

Cleanrooms are divided into vari-ous classes according to what’s pro-duced inside them. Where high standards on cleanliness are de-manded, employees inside this cleanroom should refrain from speaking and move slowly and carefully. Eating and drinking

are not allowed, chewing gum al-so not, ideally employees should

be non-smokers. Make-up, visible skin problems and unbound hair are taboo as well.

What exactly is a cleanroom work-er? This can be an engineer, a mem-ber of the cleaning staff, a produc-tion assistant, a process technician,

a lab assistant or a sales clerk. Now begins the dilemma. The ability to work in a cleanroom is “only” an additional qualification. There is 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 em-ployment needs in any specific di-rection. Even when a job description is created which specifies a clean-room cleaning technician, this person has also to be found. On-ly the professions one is aware of are searched for. The impact is that public awareness concerning clean-rooms is simply too little.

Where will tomorrow’s professionals come from? |

A clean room arises from the mind

www.cleanroom-academy.com

ACADEMY – Training courses, seminars, coachingCLEANROOM EXPERTS DAYS – conferencesKNOWLEDGE BASE – Trends and InnovationsCOMPETENCE CENTER – Cleanroom knowledge at your fingertips

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

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Cleanroom cleaning takes place in technologically demanding envi-ronments and cleanliness of the production facility muss be as-sured, therefore cleanroom clean-ing can in no way be compared with home and office cleaning. Ultimate-ly there are also wiping procedures of surface areas but for the work in a cleanroom, the employee needs a to-tally different scientific background than merely, putting it crudely, wip-ing a surface until it shines.

Therefore, we at profi-con began for over 20 years ago our own internal training program in order to pro-

vide the necessary knowledge to our employees and to qualify them for working in cleanrooms. This pro-gram developed itself into such a high caliber that in 2007 we found-ed our own training center.

Let’s go back to the beginning. The first hurdle is always the recruit-ment of new employees for this job. We created at first the job ti-tle, “Clean Operator”. However with this terminology recruitment be-came even more difficult, with the Employment Agency, in placing job advertisements and in the internet. The problem was who would search for the job “Clean Operator”? How-ever “Cleaning Professional” is also not the right designation.

As a consequence of all this, we have taken steps in creating profes-sional recruitment strategies which

show our Clean Operators in the administration of their duties and this in print, video and social media channels. Additionally we have put the responsibility for the results of their work in the foreground.

In 2007, we received the award “50 plus” from the German Feder-al Minister for Employment and Welfare at that time, Franz Münte-fering. This was the beginning of incorporating people over the age of 50 as a target group into the job market. This market is currently no longer available. There are just no longer suitable candidates from this age group.

Young people have other identifica-tion problems with these work ac-tivities. Who talks about his work in the cleaning sector within his circle of friends, even if this is the most demanding job in the world? The word “cleaning” remains stuck in the minds of society and this kind of employment is not especial-ly highly regarded in our society. Presently, women over 68 are being discovered as a target group of peo-ple wanting to get back into profes-sional life. However the physical ac-tivity of our work is just too much for seniors. Even the generation of 50-year-olds reaches their physical limits at the age of 65.

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

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

2007, we received an award »50 plus« by Federal Minister for Labour and Social, Franz Müntefering.

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sional lives. As there has been a growth of diverse jobs within the cleanroom technology industry, one really cannot speak of pre-qual-ified people entering the job mar-ket. New qualifications are categor-ically needed.

It is also proving difficult for those already employed to change profes-sions. 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-es? One thing we are able to deter-mine and this that working under cleanroom conditions will not be more abstract or rare than 20 or 30 years ago. The demands for clean products are growing in industry as well as by consumers. Safety and functionality are standing in the foreground. Nearly every business sector will have some sort of rela-tionship to cleanroom technolo-gy and therefore will be facing the task of qualifying employees. This means as a result: The work with cleanroom technology should and will create jobs in professional ed-

ucation and training. The first ef-forts are being made in expanding courses of study into the spec-trum of cleanroom technology. In this respect, the University of Alb-stadt-Sigmaringen is a forerunner as well as the University Graz.

If our companies are to remain com-petitive, a unified and open educa-tional system is necessary, which is available to everyone, when possible also outside of our national bound-aries. The effect: When qualified employees come from abroad, they could already exhibit a foundation of basic knowledge. In this respect, norms, guidelines and examples for this already exist.

If production processes become even further automated in the fu-ture, the activities of a cleanroom

cleaning technician would not able to be accomplished by robots. The economy and especially the middle class can no longer ignore the top-ic of cleanroom technology and to trust that everything will contin-ue to function as it has up to now.

I really would like to see a lively, deeply sincere discussion between the various players in business and industry take place so that we don’t lapse into the two principles which have always spoken against change. The first principle: We have always done it this way. Second principle: We have never done it differently.

Author: Frank Duvernell, CEOprofi-con Contamination Control, since 30 years professionally in cleanroom industry.

Where will tomorrow’s professionals come from? |

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

»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

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What is your most favorite means of transportation? | My car. I am very happy to be driving an Audi. This is a very good German automobile. I drive an 853 Turbo Diesel. I like to drive along and listen to music or au-dio books.

What do you value when travelling?For me it is important that I give my-self a lot of time when I am on the road. Also that the people I plan to meet don’t suddenly change their plans.

What should never be missing on a business trip? | In my case, my iP-hone 6, and naturally the charging adaptor plug so that I can recharge while driving.

On the road with… 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.

| On the road with…

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What kind of music do you enjoy lis-tening to? | I prefer music from peo-ple like Neil Young and Mark Knop-fler or from bands like Pink Floyd and Queen. I also like listening to rock bands.

Which countries and regions are most often on your list of journeys? | I vis-it most often France, Germany and the USA.

Are you able to wind down when you are on business trips? | Yes, I try to plan my trips abroad so that I have enough time for myself. This is possible in that I try before the trip to prepare as many things as possible and this is done with my new toy, an Apple MacBook. I am totally enthused with it.

How do you relax at best? | As said, when I am travelling, I give atten-tion to having enough free time for myself. Otherwise I enjoy time with my family and friends outdoors. As this isn’t possible during a business trip – a good bottle of wine and a good meal are very relaxing and help to wind down after a day of work.

Which travel destinations do you fa-vor and why? | When I am able to ar-range it, I try to work in wine tours when travelling in Germany and France. Presently I prefer the USA. I very much enjoy travelling there, to visit family and friends, to have a look at the varying localities and to simply be outdoors.

What would be the first thing you would do if you had the unlimited possibility to do so? | I would very much like to take my wife with me on my travels. But she knows that I cannot give her any attention as the trip involves business. After busi-ness has been concluded I have to deal with the WiFi-Roaming-Ac-cess. It is always most difficult to...

On the road with… |

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

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Science & TechnologyTechnology in brief

Smart contact lenses in testing in 2016

Pharmaceutical industry | The Swiss pharmaceutical company Novartis and the US technology company Google want to develop together intelligent contact lens-es and begin testing them on peo-ple in 2016. This was made public by Novartis Director Joseph Jimen-ez. He said that the project is mov-ing forward in great strides. Intel-ligent contact lenses could in the future make life easier for those who for example suffer from Dia-betes, in that the lenses would mon-itor blood sugar levels and transmit the data wirelessly to a mobile de-vice. Those with diabetes no longer will have to prick themselves in the finger several times daily in order to determine their blood sugar lev-els. Novartis and Google made their cooperation public a year ago and at that time announced that the prod-uct would be ready for the market in five years.

Robots revolutionize cleanroom technology

Measurement automation | At Cleanzone 2015 in Frankfurt, Ger-many (October, 27-28) the company InfraSolutions AG will be showing a new kind of automated measur-ing system which offers a level of quality for testing filter integrity which up to now has not been avail-

able. A robotic arm automatically scans vertical and horizontal termi-nal filters and laminar flow units while intelligent software compiles the documentation and analysis. The measurement results are visu-alized in the form of an electronic test report. The system is called Ro-botscanflex and makes possible “a precise measurement given quick-ly and with minimal personnel in-volvement” emphasizes Mathias Itter, Chairman and CTO of InfraSo-lution AG. The Robotscanflex proto-type will be presented at Cleanzone and series production is planned for the middle of 2016.

Germ-free to Mars

Mars-Rover | Is there or was there ever life on Mars? An unmanned vehicle is supposed to find this out in three years. For this purpose the Rover has to be clinically clean shot

into space. Researchers of the Stutt-gart Fraunhofer Institute IPA have developed a special cleanroom de-signed for this purpose. The vehicle will be sterilized before its mission in order that no organic material from the Earth be dragged along. The Mars Rover is part of the “Ex-oMars” mission of the European space agency Esa and the Russian space authority Roskosmos. The Rover together with a Russian Mars station is planned to start its mis-sion in 2018, then fly through the Solar System and once on Mars, ex-amine the surface up to two me-ters deep.

First electric light-antenna in the world

Nano-technology | Physicists from the University Würzburg have suc-cessfully lit up a nano-antenna us-ing electricity. In the future, these tiny sources of light could be used in Smartphone displays or in com-puter chips in order to exchange data at light speeds between pro-cessors. The way to such light sourc-es is now being smoothed out by the Würzburg researchers. Their light antenna, only 250 nanometers long, has two arms. A nano-parti-cle made of gold has been placed between these arms. This particle touches one arm and has a distance to the other arm of one nanome-ter. When electrons pass between this gap, visible light is created. The

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| Science & Technology – Technologie in Kürze

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

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Würzburg physicists have thereby created as of yet the most compact electrically-operated light source in the world.

TU Ilmenau brings major investments into operation

First class research | The Center for Micro and Nano-Technolo-gies of the Technical University Il-menau, four new vital devices have been acquired. Therewith the uni-versity has supported its reputa-tion as the top location in Germa-ny for micro-systems equipment, nano-technology and for micro and nano-structuring. In their labora-tories and cleanrooms, 275 scien-tists from 39 disciplines conduct first class research in the fields of life sciences, energy efficiency and

photonics. In order to provide the researchers with even larger pos-sibilities for research and exper-imentation, their research facili-ties have been expanded with two etching devices for micro and nano structuring, a photoelectron spec-trometer and a pivotal device for la-ser processing.

Medicinal products more exactly dosed

Suspension control | As the first researchers worldwide, scientists of the University Saarland and the

Paris University for Applied Phys-ics and Chemistry have discovered how and why drops in suspension

dissolve. Their discovery can help medicinal products to be more ex-actly dosed, can refine the print im-age from ink-jet printers and to ap-ply more exactly special coatings.The researchers found out that sol-id state particles can actuate the re-lease of drops in fluids by disturb-ing and smoothing out the surface of the fluid. This raises capillary pressure and accelerates the sepa-ration process as the surface ten-sion strives to shrink the surface. The latter ultimately leads to drop separation.

US Army develops efficient solar panels

Photovoltaic | Researchers of the US Army have made a breakthrough in the development of solar cells. Their new panel is smaller, more robust and cheaper than all other standard models. Very thin layers of metal such as silver and gold are put between the semiconductor layers which more efficiently utilize sun-light. A further advantage is that no difference is made as to which angle sunlight strikes the surface.

Expensive devices which have to be directed to the sun according to the sun’s intensity have now become redundant. The US Army has com-municated that the development is still in its early stages, however further research is progressing at high speed.

Science & Technology – Technologie in Kürze |

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

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

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.

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.

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

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For Sascha Beutel of the Institu-te for Technical Chemistry (TCI) of the Leibniz University in Hannover, Germany, Labvolution was an im-portant date to keep. Labvolution is the new sister trade fair of the fair Biotechnica, both taking place at the same time at the beginning of Octo-ber in Hannover, Germany. The fru-its of a whole year of work could be examined at Labvolution. The TCI coordinated the project Smartlab. Sascha Beutel is the work group’s speaker, a group of twelve compa-nies and institutions which are in-volved in the project and will con-tinue development on the project after the trade fair has concluded.

This work group consists of an il-lustrated collection of companies and individuals - a laboratory equip-ment producer, a robot manufactu-rer, software developers and natu-

rally scientists from the Fraunhofer Institute for Production Technolo-gy and Automation (IPA) and also from the TCI.

Functioning future laboratory

The Smartlab represents a vision of tomorrow’s intelligent laboratory and provides the professional wor-ld with a central platform for the di-scussion of the laboratory’s future. For nearly a year, scientists and re-presentatives from industry bund-led their energies together with the help of a functioning future labora-tory to show the opportunities open for laboratory environments thanks

to automation, information techno-logy, human-machine interaction and Big Data. Central elements of the presentation were besides the flexible lab furnishings, the integra-

tion of hard and software, the use of robotics and the topic of wearables. At TCI, the threads of the Smart-lab project not came together but became interwoven. Sascha Beutel’s team portrayed with the fundamen-tal conception of Smartlab’s const-ruction and the integration of com-ponents supplied by their partners, a digitally networked laboratory en-vironment.

New stages of evolution

The necessity to raise the laborato-ry to a new stage of evolution sho-wed itself clearly as Beutel together with TCI doctoral students initiated a competition for the improvement of working conditions inside the in-stitute’s laboratories. The doctoral

Laboratories of the FutureSmarter 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, Germa-ny. Researchers demonstrated how digitalization and Industry 4.0 are chang-ing present-day laboratories and ways of working in a lab.

“It deals with standards for networking and integrated processes.” Sascha Beutel, Spokesman for the Smartlab work group

Dr. Sascha Beutel from the Institute for Technical Chem-istry at the Leibniz University Hannover is the Spokesman for the Smartlab work group. Photo: Institute for Techni-cal Chemistry Hannover.

Laboratories of the Future |

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students wanted to create at first simply more room to work. “It was asked whether it was possible to sim-ply make the equipment disappear.” says Beutel.

As the number of devices has in-creased over the years, the working area inside a laboratory has consi-derably shrunk. Many lab technici-ans are able to work only at the ed-ges of work surfaces, they have to push away lab equipment when they need more room to work or they wri-te their lab reports at home instead of inside the laboratory.

When the problem is looked at more closely, it can be recognized that the lack of working space was laid out in the planning and design stages. Working areas were separately built depending on the individual func-tion of each lab technician, instead of looking at the shifting tasks and work processes. Laboratory rooms are typically and specifically built for example, one for the chemist, another for the biologist, still ano-ther for the IT specialist and across the hall office rooms for the admi-nistration.

Networking is the highest precept

The goals toward which Smartlab’s partners are working designate a quantum jump for the work inside a laboratory. Sascha Beutel describes it as follows: “Until now, we have had to adapt experiments, mostly biolo-gical or chemical, to the available equipment. Now we are at the stage at which the equipment adapts to our questions, inquiries and issues.”The key lies in the mutual integra-bility of the lab components. “We are interested in defining common standards for networking, for inte-grating processes and thus to crea-te a laboratory environment which

is flexible and individualized, tailo-red to every individual requirement and demand.” continues Beutel. Insi-de future laboratories, there will be high performance computers which will be able to interpret the outputs of the diverse devices made by di-verse manufacturers and make it possible for these different devices to communicate with and among each other.

The trend heads towards cleanroom laboratories

The Department for Laboratory Automation and Bio-production Technology of the project partner Fraunhofer IPA, has brought into the project their competencies dea-ling with the development of auto-mated solutions for life science la-boratories. IPA activities focus on a high level of reproducibility, more throughput and fewer cases of out-side influences while assuring the flexibility in the laboratory and the maintenance of sterile and certifia-ble environmental conditions.

Such requirements for tomorrow’s laboratories have to be considered by researchers and also medium-si-ze companies when they want to successfully do business in the life sciences’ market. The company Ge-sim, Society for Silicon-Micro-Sys-tems mbH located in Rossendorf, Germany, near Dresden, Germany, does this. The company produces highly specialized lab equipment for bio-technical applications. The assembly of components for the-se devices as well as the testing on such devices takes place in a clean-room. These devices will later be placed, in part, in micrometer and even smaller environments. Every particle can limit the functionality of a device or the products manu-factured by these devices can beco-me unusable, for example printed

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The future laboratory will have much more space. Photo: Institute for Technical Chemistry Hannover.

| Laboratories of the Future

nano-structures. The cleanroom with its nearly particle-free air has become an indispensable prerequi-site for the company’s production. Gesim’s Managing Director Stef-fen Howitz reports that customers occasionally inquire about cont-amination potentials of materi-

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als in the laboratory equipment. The background: Moving parts such as drive belts, cause abrasion and this measurably impairs cle-anroom quality. In such cases li-near drive trains are preferable as they move assembly parts without any mechanical abrasion in a ma-gnetic field. According to Howitz, the manufacturer of laboratory de-vices has to consider the environ-mental conditions of every locati-

on and site in which the customer will place and use the devices. “The automation of laboratory proces-ses and the changes in laboratory work practices are for us real chal-lenges.” sums up Howitz and refers with that said, to a trend: More and more often, laboratories are beco-ming cleanrooms, above all in the field of life sciences.

Like in a beehive

Going back to the lack of space in present-day laboratories: Accor-ding to Sascha Beutel, this is the most pressing problem which the Smartlab work group has to solve. The times are past in which small spaces become converted into lab ni-ches where only a limited number of applications are allowed.

Laboratories of the Future |

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Lab environments have to be desi-gned with variability in mind. Large companies no longer go for labora-tories only for biologists or only for chemists. They set up project-rela-ted work environments. Optimally, teams work together in the laborato-ries whose members are able to take on very diverse tasks – comparable to a beehive. In the best cases, laborato-ries provide enough room for IT spe-cialists, the IT personnel being able to assure smooth processing of the enormous amounts of data. After all, laboratories have become real data factories. When the project is con-cluded, the work environment is di-sassembled and the area makes way for a new environment with other requirements and demands.

The company Roche its activities stretching round the globe, has be-en working in this direction for qui-te some time now. Roche’s headquar-ters are located in Basel, Switzerland. “Activities have become very diver-

se” says Jürg Erb-Tanner, the Roche Basel location architect. “We are se-parating no longer into disciplines, but into projects. This means that the differing disciplines located in the same building, even in the same rooms, are working together.” A wor-ker has to look at the work and be ab-le to switch tasks, likewise the buil-dings themselves have to be able to be converted when changes in work processes occur. A practical soluti-on would be to design laboratories according to the ballroom concept.

Flexible honeycombs – the ballroom concept

Since the 1960’s, it has proven itself to construct laboratories according to the ballroom concept. The Ame-rican architect Louis Kahn built the Salk Institute for Biological Studies in La Jolla, California. The institu-te’s laboratories can be flexibly sca-led-down with dividing walls, or en-larged, the facility allows itself to be

arranged according to the intended use. This flexibility has proven itself in practice for more than 50 years.

In the Smartlab, the problem of space is solved by using an outstan-dingly designed modular approach: The lab furnishings have been con-ceived as hexagons and can be ar-ranged together into use-orienta-ted honeycomb-structures. To stay in the picture: like in a beehive. The available space can be subdivided into various activity zones between which personnel with variable tasks are able to fluctuate. This approach creates an area with a space-saving and flexible, utilizable structure.

In addition to new room-space con-cepts, solutions for the growing flood of data are in demand. Data volumes in the terabyte and peta-byte ranges are already routine data volumes in many fields of medicine and research. The terminology “Big Data” stands for the immense flood

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

| Laboratories of the Future

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Short keyword glossary: Future Laboratories

Networking inside a laboratory | The future laboratory will assure that de-vices from diverse manufacturers “understand” each other. It will integrate de-vices 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.

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.

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

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.

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

of data which is created by automa-ted processes. Estimations call for a doubling of this data volume every two years. Therefore it is decisive for all laboratories with automated pro-cesses to develop effective and rea-sonable data management systems which allow flexible allocation of data – be it for exchange with other laboratories or for their own use.The concept of Smartlab could beco-me the approach for many laborato-ry operators to solve current prob-

lems: heterogenic device landscapes, rapidly growing data volumes and diverse data formats. Whether in pharmaceuticals, biotechnology or diagnostics – a future-oriented single standard in view of the highly complex and lab-specific processes is not possible. The future of laborato-ries belongs to scalable systems, in-tegrated platforms and standardized interfaces.

Author: Piet Felber

Laboratories of the Future |

 

   

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Cleanroom Magazin: What are the advantages of dry cleaning proce-dures?

Martin Lutz: Firstly we should speak of dust binding wiping instead of dry cleaning as this is the correct indus-try terminology. There are in addi-tion to the special dry dust binding cloths and microfiber mop covers, oil impregnated or slightly damp dust binding cloths which are used in dust binding wiping. Dust bind-ing wiping procedures effectively remove loose, easily airborne con-taminants, while wet mopping/wip-ing only partially removes these fine lightly airborne contaminants re-

spectively only redistributes the con-taminants over large areas. In com-parison to wet wiping, dust binding wiping is essentially more rational and is significantly more ergonom-ic due to the lower wiping resistance of the wiping materials.

Cleanroom Magazin: What disadvan-tages do dust binding procedures have?

Martin Lutz: There are in this sense no disadvantages with dust bind-ing procedures, only limitations. Regarding which procedure to use, the kind of contaminant – easily air-borne particles or adherent particles

– should be considered. When main-ly loose easily airborne contamina-tion respectively particles are to be removed and no disinfectant clean-ing necessary, the dust binding pro-cedure is sufficient. Adherent con-tamination which originates from fluid substances is of course not re-moved using dust binding proce-dures. We recommend in this case dust binding procedures to be com-bined with need-oriented wet wip-ing. Furthermore, no disinfection is possible following dust binding wiping however a strong reduction in germs is achieved. This has been proven in direct contact tests. Are-as with high germ-free standards should continue to be cleaned using disinfectants.

Cleanroom Magazin: In which areas do you see the dust binding proce-dures having the best possibilities?

Dry versus Wet CleaningA 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.

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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 ma-

terials 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”

| Dry versus Wet Cleaning

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Martin Lutz: I see possibilities in all those places where the removal of contaminant particles stands in the foreground. Diverse tests and tri-als in our institute have shown that the highest germ reduction and the best cleaning results can be achieved when before the wet cleaning or dis-infecting, a dust binding wiping pro-cedure is carried out. A significantly higher reduction of germs and par-ticles 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 ex-ample bonding-agent impregnated disposable dust binding cloths put-ting 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 implemen-tation of environmentally friendly measures in cleanroom cleaning?

Martin Lutz: Considering that dust binding wiping foregoes using clean-ing chemicals and at the same time reduces the use of water, the choice of the proper cleaning procedure certainly plays its part in consider-ation of environmentally friendly cleanroom cleaning, although this influence mustn’t be considered all

that large as in many cleanroom ar-eas cleaning with disinfectants can-not be dispensed with.

Cleanroom Magazin: What are the advantages of dry cleaning?

Dr. Rüdiger Laub: First of all, we should define what is meant by dry

cleaning: This is a procedure for the removal of contamination without using fluids. Dry cleaning proce-dures are quick and uncomplicated. They are able to quickly remove visi-ble contamination. In everyday situ-ations, such procedures are the rule. These procedures include domestic vacuuming, sweeping, dusting and

Contra

Dr. Rüdiger Laub was active as a biologist for 20 years in the area of research and de-velopment of bio-pharmaceuticals. With the establishment of GMP manufacturing pro-cesses he was able to bring his experience into the cleanroom by developing clean-room 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 |

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

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the removal of particles from deli-cate objects by using a fine brush. In these instances, dry cleaning pro-cedures offer definite advantages as many surfaces are not at all suitable for wet cleaning procedures. Parquet floors, veneers, or electronic devices are quickly damaged when cleaned using wet procedures.

Cleanroom Magazin: What disadvan-tages does dust binding wiping have?

Dr. Rüdiger Laub: This procedure runs quickly into limits as some very adhering contamination has to be cleaned with solvents – in most cases with plain water. Considering small, non-visible particles, there is the risk that by using dry cleaning procedures, the particles become airborne and simply re-distribute themselves. The same goes for mi-crobiological contamination such as bacteria, fungi or spores. The dis-advantages of dry cleaning proce-dures present themselves clearly here. Clean areas are defined by cer-tain threshold values for particulate and/or microbiological contamina-tion. The cleaning processes are de-signed above all for the removal of those particles not visible to the na-ked eye. This counts also for micro-

biological contamination. The lat-ter is only made harmless by using fluid-bound processes. The biocidal active agents are evenly distributed by using fluids. Wet cleaning pro-cedures are in these cases essential. Cleanroom Magazin: In which areas do you see dust binding wiping hav-ing the best possibilities?

Dr. Rüdiger Laub: Dry cleaning procedures are able to remove coarse and larger contaminants and are useful for the purposes of pre-cleaning. The final degree of cleanliness can often only be achieved by using wet cleaning pro-cedures. These procedures howev-er lead to a temporary increase in the air humidity. Dry cleaning pro-cedures could prove to be the bet-ter choice in those instances where the environmental air conditions must be absolutely dry, for exam-ple in certain areas of micro-tech-nology. Nevertheless, dry cleaning procedures should be complement-ed in regular cycles with wet clean-ing procedures as the dissolving of contamination requires some kind of solvent, for example some water mixed together with clean-room-suitable additives.

Dry cleaning procedures are able to serve as complementary measures to my mind, for example to remove any residues remaining after wet cleaning. In these cases, dry cloths or wiping materials can be used, on one hand for the removal of any residues and on the other for the post-treatment and fine cleaning of surfaces such as glass.

Cleanroom Magazin: In your opin-ion, have dust binding wiping pro-cedures had any influence on the implementation of environmental-ly friendly cleaning procedures in the cleanroom?

Dr. Rüdiger Laub: Federal restric-tions apply in this case. Of course it is advantageous for the environ-ment when residue-free cleaning procedures are used. The residues are only the bound-together par-ticulate contamination. Disinfect-ant materials clearly illustrate this: While additives used in cleaning materials are biologically degrada-ble, the disinfectant materials are bio-degradable only to a certain extent. In accordance with regu-lations, the disinfectant materials should kill micro-organisms, not just biodegrade them.

Study Compares Dry and Wet Cleaning Procedures

The University Hospital Freiburg has been in-vestigating dry and wet cleaning procedures with respect to their hygienic efficiency. The reduction of germs using wet cleaning pro-cedures served as a baseline value: this val-ue 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 re-sult: after applying dry cleaning procedures germ reduction was on the average 60 per-cent (Figure 2).

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

Graphs: University Hospital Freiburg

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Figure 1 Figure 2

| Dry versus Wet Cleaning

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The requirements of a computer system are in the user’s opinion to be described and documented in the form of a user requirements specification document. This doc-ument serves as a means of com-munication between the user and the system provider and makes pos-sible understanding in both direc-tions. It is important to describe re-quirements as comprehensively and as detailed as possible so that risk analysis, functional specifica-tion generation, system design and verification can be adequately sup-ported.

In practice, users draw on the sup-port of their business processes preferably with standard solutions.

However, when a configurable sys-tem due to missing functionality cannot provide the user with sat-isfactory solutions, the specifica-tions complexity rises significantly. When dealing with complex expan-sions, in addition to the user re-quirements specification document and functional specification docu-ment, a design specification docu-ment and a module specification document are necessary to create.

Describing functional and qualitative requirements

In such a situation, users tend to set the technical aspects of the solution which the software provider has al-ready described in the user require-

ments specification document. This most often happens when the rela-tionship between the customer and software provider has not yet been established. The user wants to make sure that he, in fact, gets the ser-vice expected and required. At the same time, such customers over-look the requirements described in detail which explain for what and under which operating conditions the computer system should later be used for.

Computer systems developed for such situations involve for the user the risk to recognize in the frame-work of the performance qualifi-cation if all system functions have been optimally and suitably set up

The Challenge of Putting Together Requirement SpecificationsDocumented Processes relieve the validation of computer systems

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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 intro-duction of prcess-based IT application systems. Moreover he consults organisations with the development and introduction of IT quality management systems.

| The Challenge of Putting Together Requirement Specifications

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for the intended use. When this is not the case, complex modifications and adaptations are necessary. The user can avoid these modifications in the forefront when he goes back to and limits himself to the detailed descriptions of the functional and qualitative requirements of the in-itial intended use.

A further problem comes up when the requirements description is in the form of text only. The more ex-tensive and complex the scope of the problem is, the more difficult it will be to make the requirements

description transparent and un-derstandable. However this trans-parency and understandability of the document are the decisive pre-requisites in planning and imple-menting phases of the system de-velopment and validation which are to follow.

Understanding and portraying processes

When the descriptions of the tech-nical requirements and intended use are portrayed using graphical figures and pictures which comple-

ment the supported processes, un-derstanding and transparency will significantly increase. Also the ap-proval of the requirements specifi-cations from the various involved groups in the company (quality management, engineering, IT, etc.) will be simplified. For GxP regulat-ed process areas, it is also expect-ed that the risks for patient safety, product quality and data integri-ty be identified and evaluated. On the basis of graphically document-ed process models, these tasks are much more easily fulfilled.

The Challenge of Putting Together Requirement Specifications |

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The palette of symbols for graphi-cal representations of the technical processes is unfortunately small. Symbols are used for the portrayal of results and process steps, the var-ious people involved in the process, the supported computer system as well as those for the processed da-ta-objects. It is important that pro-duction runs display the time-log-ic procedures of the value creation process steps from the user’s point of view. If the customer has no ex-perience in the modeling of graphi-cal processing runs, then he should fall back on the support of an expe-rienced process designer.

Process modeling supports not on-ly the development of new systems but also the introduction of com-plex ERP, MES or Workflow Man-

agement Systems. When it comes to the introduction of information systems for the support of manual procedures, process models pro-vide valuable explanations of a sys-tem’s expected support functions.

A pragmatic approach

Such technical processes which are supported with computer sys-tems, it is practical to transparently show the link between system func-

tions and the processes. To reduce the complexity, a process hierarchy should be designed in order to iden-tify the constructed processes on the level of their technical func-tions.

The requirements of the computer system can be derived from the doc-umented process model and then the various levels of the process hi-erarchy up to the individual pro-cess steps can be assigned. The GxP criticality and risk level as well as the newness and complexity of the technical processes will influence to which requirement is assigned to which level of the process mod-el. If the pharmaceutical risk is es-timated to be small, the require-ments of the computer system can be more coarsely specified and for example be assigned to the level of parts processing. If the opposite is the case, the requirements should be assigned to the individual pro-cess steps in order to enable a de-tailed verification of the solution.

GxP Kritikalitat and risk classifi-cation,Novelty and complexityof technical processesinfluence the allocation ofModel plane.

1

Prozessbasierte Vorgehensweise bei der Einführung von Computersystemen

Prozess- & risikobasierte Verifizierung

Prozess- & risikobasierte Spezifikation / Realisierung

Funktionale Anforderungen

Qualitätive Anforderungen

Risiko- bewertung

Detail- Prozesse

Risiko- bewertung

Prozess- Landkarte

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| The Challenge of Putting Together Requirement Specifications

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Uses and chances for the company

The combination of graphical pro-cess runs together with clear refer-ences to the technical requirements, form a process-based user require-ments specification document. As a reference point for the system im-plementation or system expansion in continuous project phases, the user requirements specification document makes possible an un-broken traceability of the process or process steps, even of individual tests. The required validation meas-

ures are also easier to plan and im-plement when descriptions of the technical processes are made avail-able early on and can be added to an already existing user require-ments specification document. The process-based document is the best prerequisite for the avoidance of failures during the project’s initial implementation and to reduce the complexity and costs of validation.

The process-based approach in com-piling a user requirements speci-fication document very well com-plements the standard risk-based

validation approach and provides the company together with the se-curity of regulation-conformity also the foundation for continued improvement of the processes and the associated process verification. There is a profound incorporation of the areas involved in the processes of a computer system implementa-tion which raises the acceptance of viable solutions.

Text: Markus Schröder, Avantalion Business Consulting GmbH

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telefon: +41 43 495 92 50fax: +41 43 495 92 60e-mail: info@valisys.chinternet: www.valisys.ch

Ihr Partner für validierte Systeme!Kompetente, faire und zuverlässige Beratung und

Ausführung rund um Monitoring-Systeme und industrielle Automatisationen.

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The Challenge of Putting Together Requirement Specifications |

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“My name is Mathias Ortner. I have been employed as a service tech-nician at the Swiss company El-pro-Buchs AG for four years. I in-stall new systems and equipment and check their functions using calibration procedures and by do-ing detailed installation and func-tionality qualification checks. An important part of my work is the yearly maintenance and re-cali-bration of systems and facilities already in operation.

With the Elpro-Buchs central mon-itoring system, I am able to reliably record all relevant climate data in

a cleanroom. The sensors for the monitoring systems in cleanrooms must meet especially high stand-ards and requirements. Specifica-tions must be met for materials, construction design, compactness, signal function as well as assembly and the level of service.

My tasks as a service technician in-clude the professional, clean and exact installation of the data log-ger and sensors as well as their cor-rect positioning. The sensors are assembled and installed according to GMP guidelines and are re-cali-brated yearly.

This applies also to the visible sen-sor panel. The transmitter for the differential pressure is built in-to a cleanroom suitable stainless steel foreside and is calibrated by means of a pressure generator. In the course of the yearly service, I take care of the calibration of the sensors, the function control, the flow rate measurement and the ze-ro filter tests of the particle coun-ters.

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

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| What do you do Mathias Ortner?

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The case in question deals with an employee of a medical technolo-gy manufacturer. She was a clean-room employee. The employer gave the employee at first an official warning that she had not been fol-lowing the quality criteria which apply in the cleanroom. The follow-ing dismissal was founded on the premise that the employee had at-tempted to take receptacles into the cleanroom which were not author-ized to be used there.

The Labor Court in Berlin declared the dismissal to be void (Az.: 28 Ca 5695/14). The court founded its de-cision on the premise that it could not be proved that the employee had intentionally taken the unauthor-ized receptacle into the cleanroom. Two types of receptacle are used in the operations of the medical technology manufacturer but on-ly one of these is authorized to be taken through the airlock into the cleanroom. Both types of receptacle are nearly identical in appearance and can only be differentiated by a small imprint.

In the opinion of the Labor Court in Berlin, the employer should have taken the necessary technical and organizational measures in order to ensure that distinctions between the two receptacles are clear and that mistakes in identification are ruled out.

Incorrect cleanroom behavior pose no grounds for dismissalCourt 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.

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| Incorrect cleanroom behavior pose no grounds for dismissal

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It is anticipated that by the end of the year, the new DIN 12980 “Labo-ratory Furnishings – Safety Work Benches and Isolators for Cytostat-ics and other CMR medicinal prod-ucts” will come into effect. This was declared by Egon Buchta, the Chairman of the responsible work committee in the DIN Norm Com-mission “Laboratory Equipment and Laboratory Facilities” and the Managing Director of “Ingenieur-büro & Reinraumservie Egon Bu-chta GmbH” (Engineering Offices & Cleanroom Services Egon Buchta GmbH), in Wannweil near Reutlin-gen, Germany. Until September 30th, 2015, industry representatives will be able to submit their com-ments on the amended Norm.

Buchta indicated that the most im-portant change regards the integra-tion of isolators within the Norm. “Up until now, there have been no regulations concerning this device.” As the Pharmacy Operations Regu-lations have provided for the pro-

duction of cytostatics in isolators – also known as ‘glove boxes’ – for quite some time, now it is time that the DIN 12989 be suitably adapted. The new Norm makes it possible for isolator manufacturers to have type tests carried out for their de-vices in the future. “Up till now, there have been no clear guide-lines for manufacturers and users for performance criteria for the op-eration of an isolator which has led to a wide-ranging interpretation of the criteria” says Egon Buchta. “This gap will now become significantly narrower.”

For quite a few pharmacies, the new requirements will likely lead to the situation whereby they will them-selves no longer produce cytostatics. The DIN Norm demands for exam-ple, the use of special gloves which daily have to be checked for leaks. A potentially necessary glove re-placement will not only cost a lot of money, but also temporarily stop production. Therefore Buch-

ta is betting that the production of cytostatics will be concentrated in larger pharmacies. They have as a rule a much higher number of de-vices and employees at hand.

Regarding safety work benches, the work committee, which consists of 20 representatives from manu-facturers, service companies, us-ers, trade associations and testing organizations, resolved to initiate changes. As an example, Buchta mentioned the expanded valida-tion of capacity reserves for air-flows at designated as well as diver-gent operation points and also the boundaries (provocations). A fur-ther reform is the verification of the reactionless operation of safety work benches in connection with exhaust air systems in the frame-work of scheduled maintenance. Up to now, this has only been valid for new installations.

Text: Klaus Eckardt

Draft of the new DIN 12980 has been submitted

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 |

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Cleanzone, which this year takes place in Hall 4.0 of the Messe Frank-furt, will be offering events encom-passing the entire cleanroom life cycle, from the planning and de-sign, the construction and opera-tion to the control and monitoring of cleanrooms. The knowledge of all these aspects will be available not only at the various stands but also from a very attractive mix of a congress, presentations, lectures, forums and workshops.

International Alignment across All Cross-Sectional Industries

“The concept of Cleanzone with its interdisciplinary and internation-al approaches has firmly anchored itself in the market.” says Ruth Lorenz, Area Manager for Technol-ogy & Production at Messe Frank-furt. This shows itself through the growing number of exhibitors and professional visitors, this number significantly being over last year’s niveau. At Cleanzone 2015, round-about 80 exhibitors are expected, a third of these coming from out-side Germany, for example from Finland, Great Britain, France, It-

aly, Switzerland and Austria. Prod-ucts offered encompass the areas of construction and planning, climate and ventilation technology, con-sumable materials, clothing, mon-itoring and quality control, as well as training and further education. Frank Duvernell, Managing Di-rector of the ReinraumAkademie (Cleanroom Academy) and Clean-zone Partner, speaks out very en-thusiastically about the develop-ment of this trade fair: “Cleanzone has proven that the concept of the trade fair with an international alignment across all cross-sectional industries has been accepted. With-in two years, Cleanzone has proven itself as a stand-alone event. This shows that the market needs this trade fair.”

ICCCS appears at Cleanzone for the First Time

For the first time, the Internation-al Confederation of Contamina-tion Control Societies (ICCCS) will be appearing at Cleanzone. For Koos Agricola, the General Secretary of ICCCS, this trade fair is the right place to present the work of this

international parent organization. “We want to use this opportunity to inform the international audience about the direction the ICCCS is tak-ing. We will be able to encourage the visitors from around the world who are not yet members to found their own national associations.” The ICCCS plans to more intensive-ly support member organizations in promoting the international knowledge transfer of cleanroom technology.

Congress with High-Quality Professional Presentations

The transfer of knowledge is the goal of a two-day Cleanzone Con-gress at which highly regarded ex-perts will be conveying their valu-able practice-oriented experience and knowledge. Because of last year’s good resonance, the congress will be divided into a Basis Module and an Advanced Module. On Oc-

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 clean-room 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.

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tober 27th and 28th, the Basis Mod-ule will be held in the mornings of both days, covering the topics of “Getting Started with Cleanroom Technology” and “Planning-Lay-out-Construction”. In the afternoon of both days, the Advanced Mod-ule will be covering the topics of “Qualification” and “Process Opti-mization”. Among the top speak-ers will be the ICCCS General Sec-retary Koos Agricola, Conor Murray, Chairman of the Board of the Irish Cleanroom Society and Dr. Jürgen Mählitz, GMP Inspector in the area of Pharmacy for the government of Upper Bavaria.

EU Project MetAMC presents Results

New insights about contamination will be presented by the European research project “MetAMC Metrolo-gy for Airborne Molecular contam-ination in Manufacturing Environ-ments”. Several research institutes came together in 2013 in order to develop a new laser-based measur-ing procedure and to better under-stand the origins of chemical parti-cles. The researchers’ focused their attention to the smallest chemical contamination, for example ammo-nia, acids and organic compounds which under certain conditions can lead to losses and breakdowns in the production of photovoltaic cells, LED’s and OLED’s.

Cleanzone visitors will be able to learn about the status of current research at MetAMC’s stand. Tuo-mas Hieta, a scientist at the Finish National Institute for Metrology (Mikes), says: “Cleanzone is an im-portant event for cleanroom tech-nology in Europe and is an out-standing choice for our EU project ‘MetAMC’ as a platform for present-ing our results and insights into new sources of contamination in cleanrooms. As a representative of a scientific society it is important for our project consortium to meet with cleanroom operators and ex-perts in order to find out about what operating levels and instruments will be required in the future.”

Occupational Perspectives for Qualified Professionals

A further highlight of Cleanzone is the Plaza, which serves as an open forum for presentations, lec-tures, initiatives and podium dis-cussions, concurrent with all oth-er Cleanzone events. A focus point for this year’s Cleanzone is the top-ic of trainees, young talent and fur-ther education. “This positioning of topics supports the cleanroom in-dustry in overcoming the relative unawareness of cleanroom profes-sions.” says Thomas Raupach, Man-ager of the ReinraumAkademie (Cleanroom Academy) in Leipzig, Germany. “Professional and qual-

ified staff can become acquainted with the attractive professional pos-sibilities in cleanroom technology at the Plaza events.”

All presentations, lectures and spe-cial events at the Cleanzone Plaza are free to all visitors. Interested visitors can receive information on the daily schedule of events from the Messe Frankfurt or from their website or even via App and cata-logue. This allows visits to the Pla-za, participation at congresses and discussions to be optimally planned in advance.

Two Awards to be presented for the First Time

A premier is taking place at this year’s Cleanzone during the award-ing of the Cleanroom Award which has been awarded to the cleanroom innovation of the year since 2012. For the first time, the Reinrau-mAkademie (Cleanroom Acade-my) will be awarding an addition-al award, the Creative Prize, which will be presented to the designer of the most creative cleanroom. “The Creative Prize has been designed to direct the attention of cleanroom operators to the advantages of er-gonomic and colorfully attractive cleanrooms.” says Frank Duveer-nell, Managing Director of the Rein-raumAkademie (Cleanroom Acad-emy). Cleanrooms are still being

Trending: Cleanzone is attracting an increasing number of visitors.

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Planning, Construction, Operation | • Construction Components• Modular Technologies• Equipment and Systems• Air Lock Systems• Work Places• Handling and Warehouse Systems• Decontamination• Measuring Systems

Consumable Materials | • Clothing and Accessories• Cleaning Equipment• Cleaning Mediums• Packaging• Microbiology• 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

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

More and more professionals in research, production, logistics and ser-vice have to acquire current cleanroom knowledge as production in clean environments and under clean conditions is becoming the case in ever more industries. The “World Cleanroom Report” from the US American market research association, McIlvaine Company confirms this trend.

More and more cleanroomsThe McIlvaine Report states that the use of cleanroom surface area in-creased from last year to 12.17 million square meters, an increase of five percent from 2013.

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

Asia has become a large-scale consumerAsia is expected to increase in this year to the world’s largest user of cleanroom consumable materials.

The need for consumable materials is increasingThe market for cleanroom consumable materials is expected to in-crease in 2015 to a value of eight billion US dollars. (in 2013: seven bil-lion US dollars)

The pharmaceutical industry is increasing the purchase of cleanroom productsThe pharmaceutical and biotechnical industries became the world’s third largest users of cleanroom products in 2014.

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

Trend to mini-environmentsThe semiconductor industry is paving the way to mini-environment concepts which in the meantime are in strong demand by the pharma-ceutical industry.

Strong Growth in RevenuesThe 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.

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

designed using only the color white although experts have proven that by using more colors in a cleanroom reduce eye strain, increase concen-tration and reduce error rates. The new Creative Prize is intended to

motivate and give impulse to clean-room planners and operators to de-sign more attractive working en-vironments which provide more pleasant working conditions. The Cleanroom Award and the Cre-

ative Prize will be awarded on Oc-tober 28th, 2015, at Cleanzone in Frankfurt am Main, Germany in front of fair visitors and the press. Text: Thomas Köhler

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Koos Agricola, General Secretary of the International Confederation of Contamination Control Societies (ICCCS), wants to encourage an in-ternational dialogue dealing with cleanroom technology at Clean-zone.

Cleanroom Magazin: The interna-tional confederation for cleanroom technology ICCCS will be appearing for the first time at Cleanzone. What are the reasons for this appearance?

Koos Agricola: The ICCCS has sup-ported Cleanzone from its very be-ginnings. As the General Secretary of ICCCS, it is my opinion that Clean-zone is the right place to present this year’s decisions made at ICCCS’s meeting in Germany and the impor-tant changes associated with these decisions. ICCCS’s Board plans to better support its members with the communication of knowledge and this not only with cleanrooms in mind but also in view of all the ac-

tivities which have something to do with contamination control such as training, further education, events, presentations and standards. The ICCCS wants to bring together and unite its members at Cleanzone as well as to assist in forming strong-er relationships between related organizations. Furthermore, we will be promoting the Internation-al Symposium for Contamination Control in September, 2016, in Brazil.

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

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).

The International Confederation of Contamination Control Societies (ICCCS) was founded in 1972. It is the parent organization for 17 national cleanroom technical associations from around the world. Each coun-

try is allowed only one cleanroom association to become a member of ICCCS and to represent its country. The tasks of ICCCS are to promote an international exchange of expe-rience and information and inter-

national norms in cleanroom tech-nology as well as to break down technical trade barriers.

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

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

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Cleanroom Magazin: What are your expectations for your first appear-ance at Cleanzone?

Koos Agricola: We would like to use this opportunity to inform an in-ternational audience the direction ICCCS is taking. In Frankfurt, we will have the opportunity to encour-age visitors from countries round the world who do not yet have clean-room organizations, to form their own national associations and to be-come members of ICCCS. The ICCCS wants to also use its appearance at Cleanzone to exchange experience and knowledge with its new mem-bers.

Cleanroom Magazin: What are the most important projects which the ICCCS is planning in the next years?Koos Agricola: In addition to the in-ternational certification of the In-ternational Education Board ICEB, the ICCCS will be offering to its member associations, standard courses which they will be able to

hold in their own countries or in non-member areas within their re-gions. Moreover, the ICCCS would like to put together a package which would provide help to call up na-tional regional contamination con-trol events.

Cleanroom Magazin: The market for cleanroom technology is very dy-namic. In which areas will clean-room technology in the next years be taking?

Koos Agricola: Cleanrooms are re-quired to control contamination. Contamination control is being de-manded from more and more in-dustries and service providers. Be-longing to these industries and services are for example the auto-mobile industry, hospitals, infec-tion abatement agencies, the food products industry and numerous companies offering new technical products.

Cleanroom Magazin: Concerning these developments, are interna-tional trade fairs, such as Clean-zone, gaining in importance?

Koos Agricola: International trade fairs have the chance to comply with new requirements in that they show products which come into ques-tion. International trade fairs al-so offer information exchange and strengthen the transfer of knowl-edge, above all for those companies new in cleanroom operation. Be-cause of this background, Clean-zone will be able to attract more and more visitors.

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

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Punctually for its 40th anniversa-ry, the world leading trade fair for the development and production of electronics will be rejuvenating it-self. The as yet 19 different segments will be integrated into a new clus-ter structure along the lines of a supply chain. The five new clusters are: Cluster PCB & EMS; Cluster SMT; Cluster Semiconductor; Cluster Ca-bles, Coils & Hybrids; and the Clus-ter Future Markets.

The new structure will pull a com-mon thread through the entire trade fair concept. The event forums will

also be newly conceived: In the fu-ture, each cluster will have its own Speakers Corner in Halls A1, B1, B2 and B3. The topics of Industrial Elec-tronics, Automotive and PCB & EMS will be put into focus at this year’s trade fair.

The special exhibition “Electronics.Production.Augmented.” will pro-vide a real highlight. This exhibition will have the motto: To make pro-duction innovations from the five new clusters come alive. This world leading trade fair for electronics pro-duction will show the trending top-

ic of Industry 4.0 under new aspects: Visitors will be able to experience firsthand the as yet hidden process-es, machines and production equip-ment and to visually tie in the peo-ple involved. This live exhibition will be assisted by augmented and virtual reality at five carefully selected pro-duction machines.

Event Stage Presenting Cleanroom Technology

Cleanroom technology is gain-ing more and more importance in the microelectronics industry. A strongly increasing number of manufacturers are already pro-ducing in clean environments. The automobile industry is de-manding from its suppliers high-

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

The entire electronics production supply chain under one roof can be expe-rienced 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.

Cleanroom specific demonstration during productronica. Foto: Cleanroom Media.

| Rejuvenating the productronica

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er and higher levels of cleanliness in their products. The Productron-ica Trade Fair in catering to the in-creasing needs for knowledge and technology will be offering com-prehensive information regarding cleanroom technology at a distinc-tive special exhibition, on the event stage, “Cleanroom” in Hall B3, Stand 151. This event stage has been organ-ized by the companies, cleanroom.de, Gerflor, Kemmlit and profi-con.

A clean production environment can, but not necessarily be a clean-room. Local, defined and zoned off environments such as Laminar Flow Boxes, or Isolators are gaining more and more importance. The smaller the clean environment is, the lower the purchasing and oper-ating costs are. Those companies who want to or have to deal with clean environ-ments will have to acquire a thor-ough understanding of interrelat-ed production processes. Only those companies which know exactly where to put their attention, will be able to select the suitable equip-ment and to have it professionally installed.

However, cleanroom technology is only one side of the coin. To produce

in a protected environment, clean-room furniture, cleanroom cloth-ing and consumable supplies are needed. Questions which then arise are: What kind of clothing is suita-ble? What kind of gloves should be used? What kind of furniture will work for my processes? What kind

of flooring do I need? All these are questions which will be sooner or later asked when the topic of clean-rooms comes up. Presentations rel-ative to these questions will be giv-en at the event stage “Cleanroom”.

No Proper Staff Training, No Clean Production

A topic which is often neglected or even forgotten is that of the train-ing and education of staff and col-leagues. The largest source of par-ticulate matter in a cleanroom is very often the human component. For this reason it is of utmost im-portance to teach employees prop-er cleanroom operation behavior. Workshops and seminars which show and explain how to enter and exit a cleanroom through the air lock, how to properly put on clean-

room clothing and how to move around inside a clean production environment are becoming in-creasingly more important.

Cleanrooms must be continually cleaned. There are special cleaning materials which have to be adapt-

ed to each individual production process. Many companies give the cleaning responsibility to external cleaning companies or they have their own cleaning department. Special coaching and training me-diates the necessary fundamentals and supports a sustainable, high level of cleanliness in the clean-room. Cleanroom operators should be aware that cleanroom cleaning is not comparable to standard of-fice cleaning. Cleanroom cleaning demands extreme precision in or-der to remove all particles and mi-crobial contamination at 100% res-idue-free levels. Only under these conditions is it possible to guaran-tee f lawless product quality and functionality whether it be phar-maceutical products or automo-bile brake systems. In other words: Cleanroom cleaning has really lit-tle to do with cleaning in itself, but is in reality a part of the produc-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 knowledge spectrum and make the entry into the realm of cleanroom technology as easy and uncompli-cated as possible.

Visitors at productronica. Foto: Cleanroom Media.

Rejuvenating the productronica |

The pure clean productioninitially needs a deep understandingof the outstandingproductionprocesses.

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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 ProductionThe 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 wa-ter used in preparation. Not only is the testing for particle-free environ-ments relevant, but also detection and accurate characterization. This practice-oriented book deals with the regulatory requirements and meth-ods 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 Charakterisi-erung • Regulatorische Anforderungen“ (Particles in Pharma-Production – Meas-uring 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 EquipmentAmong 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 min-imizing 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 statuto-ry 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 up-dated deliveries until the subscription is cancelled.

“Reinigungs-und Hygienetechnik” (Cleaning and Hygiene Equipment), Loose-leaf 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.

| Cleanroom Knowledge to refer to

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IT Trends in a GxP EnvironmentThe field of IT is strongly characterized by innovative changes. The com-plexity 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 re-port and reference book. It enables an efficient execution of GMP require-ments in daily operations. The series of papers is bound in individual vol-umes 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, Val-idation) Publisher Concept Heidelberg. ECV Editio Cantor Verlag (Publish-ing 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 |

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

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

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NürnbergMainz

Stuttgart

München

Magdeburg

Hannover

ErfurtDresden

PotsdamBerlin

Wiesbaden

Saarbrücken

Bremen

SchwerinHamburg

Kiel

Düsseldorf

Luzern

Basel

Wangen

Chur

St. GallenZürichAarau

SolothurnDelèmont

FreiburgBern

Neuenburg

Konstanz

Lausanne

Genf

Frankfurt am Main

Germany

Switzerland

Leipzig

Trade Fairs and Congresses

Köln

13.-14.04.2016Lab InnovationsLausanneSwitzerland

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18.–19.11.2015Precision FairVeldhovenThe Netherlands

15.-17.01.2016OptiMunichGermany

27.-28.10.2015CleanzoneFrankfurt am MainGermany

10.-13.11.2015ProductronicaMunichGermanyMünchen

16.-19.11.2015Medica and CompamedDüsseldorfGermany

10.–11.02.2016Pharmapack 2016ParisFrance

27.-28.11.2015Implant expo ViennaViennaAustria

| Trade Fairs and Congresses

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Events ReinraumAkademie (D) and CleanroomAcademy (CH)Cleanroom Expert DaysNovember 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, SwitzerlandMarch 9- 10, 2016 | Cleanroom Layout, Planning and Construction | Leipzig (Germany)

Events |

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

ONE DAY TRAINING PLUSNovember 10th, 2015 | Leipzig (Germany)

Here could be your event. Want more information? Please contact the cleanroom academy. www.ReinraumAkademie.de

16. basan Reinraumforum für Apotheker/innenDas Thema: Die neue Apothekenbetriebsordnung (§ 35 ApBetrO) – Erste Erfahrungen zur effizienten Umsetzung in der ApothekenpraxisDie Novellierung der Apothekenbetriebsordnung hat nun in der Apothekenpraxis allgemeine Umsetzung gefunden. Apotheken pro-duzieren parenterale und zytostatische Produkte unter sterilen Bedingungen. Wie hat der Einstieg für die Apotheken geklappt? Wel-che Verbesserungen hat die neue ApBetrO gebracht? Aber auch: Wo gibt es noch Schwierigkeiten? Auch wenn die Rahmenbedingun-gen 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

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Imprint CLEANROOM MAGAZIN Is issued and published byCleanroom Media GmbHRosa-Luxemburg-Straße 12-1404103 LeipzigGermany

Internetwww.cleanroom-media.com

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

Administration – Cleanroom Media Maja FrankeTel. +49 341 98989 404maja.franke@cleanroom-media.com

Chief EditorFrank BaeckeTel. +49 341 98989 405frank.baecke@cleanroom-media.com

Translation Bill Hillman

AuthorsFrank BaeckeFrank DuvernellKlaus EckardtPiet FelberMaja FrankeThomas KöhlerRichard ReudelsdorfMarkus M. Schröder

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

Implementation Wohlfahrt GmbHwww.wohlfahrt.net

Publication Quarterly

Circulation 10,000 copies

Printer Löhnert-Druck, Leipzig

ISSN  2364-0405

Reprints Reproduction and digital use of ar-ticles from this magazine, even parti-ally, are only allowed subject to prior approval by the editorial staff. No lia-bility is assumed for unsolicited manu-scripts of photographs.

Order your free subscriptionn www.cleanroom-media.com

Next issue | January, 2016

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IMPR

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FrankfurtAttraktives Reiseziel für TechnologenPopular destination for technologists

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

ArchitekturGestaltungs-möglichkeiten von ReinräumenCleanroom design ideas

Eine Branche geht auf EmpfangAn industrial sector gets new impulses

Ausgabe 1/2012

NEU / NEW

Ersterscheinung Juni 2

012

www.cleanroom-media.com

CleanroomAwardErster Innovations-preis für die Reinraum-brancheFirst special award in the cleanroom industry

DüsseldorfAttraktives Reiseziel für TechnologenPopular destination for technologists

Norbert OttoVordenken und NachdenkenThinking Ahead and Reflecting

Gut gekleidet im Reinraum

Ausgabe 2/2012

www.cleanroom-media.comWell dressed in a Cleanroom

CleanroomAwardMonitoring fallenderPartikelMonitoring ParticleDeposition

ParisAttraktives Reiseziel für TechnologenPopular destination for technologists

Sieglinde SellemondGenuss, Kunst und KulturIndulgence, artand culture

Tirol – Hightech im Bergparadies

1/2013

Tirol – High tech in mountain paradise

DresdenAttraktives Reiseziel für TechnologenPopular destination for technologists

Jan GerbrandsMotivation und LeidenschaftMotivation andPassion

Cleanroom Award – Herausforderung an die Branche

2/2013

Cleanroom Award – Challenging the branch

CleanroomAwardErster Innovations-preis für die Reinraum-brancheFirst special award in the cleanroom industry

DüsseldorfAttraktives Reiseziel für TechnologenPopular destination for technologists

Norbert OttoVordenken und NachdenkenThinking Ahead and Reflecting

Gut gekleidet im Reinraum

Ausgabe 2/2012

www.cleanroom-media.comWell dressed in a Cleanroom

2/2014

Cleanroom Award –Fortschritt für den ReinraumCleanroom Award – Advancement for the Cleanroom

2/2014

Cleanzone Die Reinraumwelt trifft sich in

Frankfurt / The World of clean-room meets in Frankfurt

BarbaraKanegs-

berg Das Produkt steht im

Mittelpunkt / The focus on the product

Cleanzone Die Reinraumwelt trifft sich in

Frankfurt / The World of clean-room meets in Frankfurt

BarbaraKanegs-

berg Das Produkt steht im

Mittelpunkt / The focus on the product

CLEANROOMLife & ScienceInformationen für die Reinraumtechnologie

MAGAZIN

RegularienLästige Pfl icht oder geldwerte Tipps?OLEDs Die Lichtrevolution aus dem ReinraumKrankenhauskeime Wie Raumtechnologien Infektionen verhindern

Frühjahr 2015

Blühende NaturGefährliche KontaminationSo nehmen Pollen und Luftfeuchtigkeit Einfl uss auf Ihre Produktion

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Freude am GefahrenwerdenWie die Vision vom autonomen Fahren mitProdukten aus dem Reinraum Wirklichkeit wird

Smarte TextilienMitdenkende Stoff e verändern Medizin, Architektur, Mode und Autoindustrie

Operationssaal der ZukunftSo sieht der Chirurgen-Arbeitsplatz der nächsten Generation aus

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2015 CLEANROOMLife & ScienceInformationen für die Reinraumtechnologie

MAGAZIN

Keime im Essen Wie die Reinraumtechnik gefährlichen Lebensmittelkeimen den Garaus macht

Cleanzone 2015 Die internationale Reinraummesse wird zum Impulsgeber der Branche

Herbst 2015

Internet der DingeWenn Milliarden von Geräten dank winzigster Bauteile aus dem Reinraum miteinander kommunizieren

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