Cleanroom Magazine 01-2016

CLEANROOMLife & ScienceInformationen für die Reinraumtechnologie

Ausblick 2016 So schätzen Experten die Aussichtender Reinraumbranche ein

Talententwicklung Wie Mitarbeiter zu Reinraummitarbeitern werden

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

Winter 2016

Vorstoß in die dritte Dimension Der 3D-Druck eröff net dem Reinraum neue Perspektiven

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CLEANROOMMAGAZINE

Life & Science Information for Cleanroom Technology

winter 2016

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Outlook 2016 Experts estimate future prospects in the cleanroom industry

Talent Development How employees become cleanroom operatives

Laws & Regulations Newest revisions of ISO 14644-1 and ISO 14644-2

Approaching the Dimension3D printing is opening new perspectives for cleanrooms

Internationale Fachmesse und Kongress für ReinraumtechnologieInternational trade fair and congress for cleanroom technology

Vision. Innovation. Expertise.8. + 9. 11. 2016Frankfurt am Main

Save the Date!

Cleanzone2016_Anzeige_210x297_englisch.indd 1 25.11.2015 13:27:25

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CLEANROOM MAGAZINE 1/2016

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

This is why we are emphasizing in this issue how you can develop new or existing employees into qualified cleanroom operatives (see page 28). Furthermore you will learn about which changes for your production are applicable under the newly revised DIN EN ISO 14644-1 and -2 in our column “Laws and Regulations” (see page 50).

Of course, we focus the CLEANROOM MAGAZINE on the needs of our readers with this topic and all others which are presented in this issue. We re-launched the magazine one year ago with the support from media scientists. The re-launch was based on market, competition and target group analyses. All this resulted in besides a new layout, a re-structuring of the contents.

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

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

Frank Duvernell Editor

Frank Duvernell: “We didn’t want to only know which topics are relevant to you in a professional

cleanroom journal. We also asked if cleanroom technology users and operators see themselves forming their own industry. The f indings were conclusive: 47 percent answered with a yes. This

was ten percent more than just one year ago.”

Dear Readers,

EDITOR

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In your own opinion,

do the cleanroom

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CONTENTS 01/2016

..................................................08 Title Story: 3D Printing

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

LIFE & BUSINESSCurrent News from the World of Cleanrooms

06 What’s Happening in the MarketConsumables for cleanrooms will become clearly, cleanly indicated • Semi-conductor investments decrease • German economy lags behind in respect to digitalization • Toyota invests in artificial intelligence • World not prepared for a new Ebola epidemic • Significance of Swiss pharma-ceutical industry bigger than previously thought......................................................16 Experts’ Forecasts 2016Cleanroom professionals from Germany, Austria, the Netherlands and Switzerland speak about the challenges facing the industry in 2016...................................................20 Controversy: Pharmaceutical Manufacturers place Profit before InnovationThe pharmaceutical industry is more closely observing their profits and not the needs of patients, criticizes the Techniker Krankenkasse (Technician Medical Health Insurance Company). The pharmaceutical product manufacturers are rejecting this allegation as unfounded. We questioned both sides regarding this issue.................................................

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Title theme: 3D-Printing

Talent development: From employee to a cleanroom operative

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

SERVICEEvents, Awards, Regular Columns

46 Ergonomics and Fitness: Well-being in the Cleanroom

Sitting for long periods of time in front of a microscope or a safety work bench puts one-sided physical demands on the body. By implementing simple but effective measures, cleanroom personnel remain healthy................................................. 50 Laws and Regulations: The new ISO 14644-1 and ISO 14644-2The most important international cleanroom technology norms are being revised. What changes pertain to the production in cleanrooms.................................................

24 Portrait: Andreas Rauschenbach

How a certified mechatronics technician who always had wanted to build and create things, suddenly became the person in charge of the cleanroom. ................................................28 Aptitude Development: From Employee to Cleanroom Operative

The best cleanroom equipment is useless if the personnel are not trained in proper cleanroom behaviors and techniques. Such training courses have to regularly be repeated and the employee learning curve examined................................................. 32 Insights: On the Road with…

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

SCIENCE & TECHNOLOGYSolutions for the World of Cleanrooms

34 Technology in BriefResearchers develop a new kind of data storage • Smarter wound bandages for nerve f ibers • Giant molecules block entrance of the Ebola virus into the body • Head OP’s: Robot-worm munches around corners • Stem cell cultivation on algae skeletons • The smallest amounts of fluid exactly measured to the nano-liter • Elec-tronic automobiles: batteries with a brain..................................................36 Containments: Higher Process Safety DemandsNew medical agents are often in small dosages highly reactive. Therefore containments have to not only reliably protect the product but also employees. How to achieve process safety..............................................41 What do you do there…?Petra Hagel, Manager of Occupational Health Management at Vetter Pharma- Fertigung GmbH & Co. KG (Vetter Pharma-Manufacture GmbH & Co. KG)..............................................

54 Cleanzone with Visitor and Exhibitor RecordsThe company InfraSolution AG won the Cleanroom Award with its RobotScanFlex. The new Creative Prize experienced its inauguration. Its first winner is Med-El in Innsbruck, Austria.................................................57 Professional Literature: References for the Cleanroom Industry• Containment Handbook• Good Transport Practices in the Pharmaceutical Industry ................................................58 Trade Fairs and Events................................................60 Imprint

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Semiconductors: New materials, new applications

Clean area, with a record number of vistors and exhibitors

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Cleanroom consumables clearly and cleanly identified

Standardization | The industry association “Cleanroom Suitable Consumables” (CSC) is working on laying the foundation for a uniform cleanroom consumables cleanliness standard. This would encompass clothing, gloves, cleaning towels, packaging materials and much more. Up until now there have been no consistent, uniform requirements specifying how manufacturers in regards to cleanroom suitability should test and appropriately label their products. Such a set of regulations is badly needed in the industry. A survey carried out by the Fraunhofer IFA indicated that users are demanding more comparability. Manufacturers and suppliers also need this data as evidence for

the quality of their products. The CSC held a meeting in December regarding this issue. Its long term goal is an ISO standard.

Semi-conductor investments are decreasing

Prognosis | Worldwide investments in semi-conductors are supposed to decrease in 2016 by 3.3 percent to $61.7 billion. This prognosis comes from the market research company Gartner. The analysts are looking to 2017 for renewed growth in the industry and

this growth will be vigorous at 5.5 percent to $65.2 billion. In 2018, the industry will grow by 6.6 percent ($69.4 billion) and in 2019 will grow by 5.1 percent ($73 billion). Expenditures for semi-conductor products are regarded as an indicator for the expected sales of electronic products.

German economy lags behind regarding digitalization

Monitoring Report | The degree of digitalization of the German economy has reached only 49 out of

a possible 100 points. This is reported in the “Monitoring Report Wirtschaft Digital 2015” published by the Federal Economics Ministry. By 2020, a cautious increase to 56 points is expected. The report examined eleven core industries and arranged these into five categories: from strongly above-average to strongly below-average. The results: Digitized strongly above-average is only the IKT economy. Applicable as digitally above-average are information-intense service providers, financial services providers and insurance companies. As digitally average are companies in trade and commerce. Digitally below-average are those companies in transport, logistics, machine engineering and construction, chemicals and pharmaceuticals. Digitally strongly below-average are businesses in health care, automobile production and other, miscellaneous production companies.

Toyota invests in artificial intelligence

A future industry | Toyota wants to invest a billion dollars in the founding of a subsidiary with the name Toyota Research Institute. This subsidiary will be concerned with artificial intelligence in two areas: self-driving automobiles and household robots. The Toyota Research Institute will start operations in January, 2016. The investment will be distributed over five years. According to Toyota,

life&BusinessWhat’s Happening in the Market

The industry association CSC wants to establish consist-ent guidelines for cleanroom consumables cleanliness specifications. Photo: Rainer Bez

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Microchip. Photo: Jürgen Lösel

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artificial intelligence has the potential to create a whole new industry. The automobile corporation wants to develop for the long term a vehicle which independently of the driver’s ability will never cause an accident. Additionally, the researchers are looking to develop robots to help eld-erly people with household chores.

World not prepared for a new Ebola epidemic

Early warning system lacking | According to the estimates of the World Health Organization (WHO) the world is not properly prepared for a new Ebola outbreak. Only

a third of the 194 WHO member countries have an early warning system for the recognition of

dangerous diseases. The rest of the countries are lacking laboratories for the early and timely diagnosis of infections as well as the necessary treatment possibilities especially hospitals with quarantine wards. Without such facilities, infections could very quickly spread. In Africa, 20 countries lie within the range of free-roaming animals which are capable of transmitting the Ebola virus. WHO reports that more than 28,000 people fell ill to Ebola and 11,000 died from the virus in the countries Guinea, Liberia and Sierra Leone where the Ebola epidemic has only recently been declared as ended.

Significance of the Swiss pharmaceutical industry is bigger than thought

Market Study | The gross value added, the GVA, of the Swiss pharmaceutical industry in 2014 amounted to over 25 billion Swiss franks, nearly a third higher than previously assumed. The industry association Interpharma recently reported this information

supported by an Instituts Bakbasel study. The reason for the upward correction is the inclusion of the research and development data in the calculation of the GVA due to the change-over to the European system

for national economic accounts. It should be born in mind that 100 Swiss franks of net-value-added in the pharmaceutical industry effectuates a further 80 Swiss franks for suppliers. This means the contribution of the pharmaceutical industry amounts to just under 45 billion Swiss franks respectively seven percent of the gross domestic product (GDP).

Electronic microscopic picture of the Ebola virus. Photo: Cynthia Goldsmith, CDC

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

Life&Business – What’s Happening in the Market |

Toyota investing heavily: in a car that drives accidentfree, regardless of the driver‘s own capabilites. In addition, research aims for

robots to aid and support the elderly in and around the home. Photo: Fotolia, jim

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

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

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

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

Printing your own weapon?

The media not so easily frightened approached the 3D printer from the perspective as a device for hobbyists and do-it-yourselfers. What home-use products were not able to be produced by a 3D printer: Plates and cups, protective covers and cases for smart phones or even plastic ducks for the bathtub were imaginable. Everybody could become a designer. That this prospect was supported by many people was supported by a survey conducted by the research institute Emnid: 69 percent of Germans could imagine buying a 3D printer and anyway, two percent of those surveyed already owned one.

Some of the processes which today have been consolidated together under the term 3D printer have existed for nearly 30 years. Science and industry have known for some time: The 3D printer is above all a technology which solves problems. Several utopians see in the 3D printer a solution for the issue of world hunger and initiatives already exist which are working on the production of noodles and meat using 3D printers.

The technology is available with no restrictions

That the 3D printer is making its way from the laboratory into living rooms and student flats, as in the case of Cody Wilson, there are a number of reasons for this. Dirk Godlinski, Project Leader for Functional Printing at the Bremer Fraunhofer Institute for Production Technology and Applied Material Research (IFAM) explains: “An

important requirement for the current hype in 3D printing was the expiration of the American patent. This enabled numerous companies and start-ups to further develop and improve the 3D printer as well as to offer models to every interested user for a few hundred Euros.”

In the meantime, data banks have been compiled listing objects and products which make complex designs using CAD programs unnecessary. Materials used for printing have also been further developed and improved. “There are available now all imaginable materials: plastics, metals, glass and ceramics” reports Godlinski. According to the prognosis of the market research company Gartner, the number of 3D printers delivered will double yearly and by the year 2019, this number will lie in the range of 5.6 million devices. According to Gartner, the 3D printer market will keep on developing out

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

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

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of its niche into a worldwide market for consumers and companies.

3D Printer Hype: What can it really do?

Apart from the hype and all the publicity regarding its possible applications: What is the current status of the 3D printer and what can it really do? In answer to this question, it is worthwhile to take a look at several current projects going on in science and industry.

The EU research project “ArtiVasc 3D” is located at the Fraunhofer Institute for Laser Technology (ILT) in Aachen, Germany. Researchers are working on reproducing lower layers of human skin. The reproduction of upper layers has long been possible. These layers are very thin and don’t have to be supplied with blood. The layers underneath, the subcutis, have to absolutely be supplied with blood and are interspersed with blood vessels, as without a blood supply, no life.

The scientists at the Fraunhofer ILT have developed a new procedure to produce artificial blood vessels which are biologically compatible, porous and branched, therefore

enabling a uniform and consistent blood supply. This procedure is based on 3D printing: The structures are mathematically simulated and then built layer for layer from a synthetic polymer in a 3D printer. The individual layer-thicknesses

amount to a mere 20 micrometers. However, there is more: A further highlight of this research project is the successful cultivation of fat tissues in a new kind of bio-reactor. The combination of these fat tissues with a skin model allows the production of a complete skin model with a thickness of up to 12 millimeters.

Researchers are hoping that the principle of blood flow by using artificial blood vessels could in the future enable the production of entire organs. However the application possibilities of the skin models are diverse: They promise quick help with skin injuries over large surface areas or they could serve as substitutes, replacing live test animals in the pharmaceutical industry.

True to Original Patient Models

The Hospital for Mouth, Jaw and Face Surgery (MKG) at the Medical University Mainz in Germany, has revolutionized its métier with 3D printing. For example, with jaw re-construction, a piece of the fibula is removed in order to close the gap in the jawbone. The 3D printer is able to produce an exact model of the jaw and the fibula. Subsequently, the

surgeon is then able to play through the operation in advance, taking into account all details and possible complications. This enables him to plan the operation specifically for each patient and to carry out the operation according to this individualized plan.

This revolutionary technique used directly on location offers time-wise advantages: The Mainz doctors are able to plan a re-construction operation within four days by using their newly acquired 3D printer. Up until now, such procedures were done in cooperation with external companies and could take up to weeks.

Scientifically interesting is the 3D printer technology additionally developed for the field of regen-erative medicine. The central research question reads as follows: How are tissues and cells integrated with materials and surfaces foreign to the body? The poor adherence of

implants as well as the body’s own defensive reactions could strongly influence a treatment’s success such as with artificial joints, heart pace makers, blood vessel prostheses or artificial teeth. Material research is therefore an important pillar in the research at MKG. Professor Bilal Al-Nawas explains: “The 3D printer enables us to plan re-construction operations for our patients within a relatively short period of time and provides a link to other groups working intensively to develop innovative materials for implants and re-construction operations.”

3D-Print |

“An important requirement for the current hype in 3D printing was the expiration of the American patent.” Dirk Godlinski, Fraunhofer IFAM

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

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Besides the printing processes which are being driven towards ever smaller resolutions, the second fundamental problem of 3D printing is: How do the printing materials – the filaments, powders and metals – allow themselves to be produced and processed so that the desired properties are obtained at high levels of dependability? Regarding medicine, printed structures have to be as bio-compatible as possible. In engineering, printed metal structures should have the same rigidity and density as those parts produced using conventional casting procedures.

Will ‘cleaner’ 3D printing make cleanrooms redundant?

With an example of a third app-lication, the meaning of 3D printers for the cleanroom industry comes to a head: The company Nanoss GmbH in Darmstadt, Germany, a producer of micro-components such as sensors, is touting a new 3D printer-based product with the idea that it could make the complex and expensive traditional manufacturing processes of semi-conductors and silicon as well as cleanrooms themselves dispensable.

Nanoss is three-dimensionally printing micro-components onto arbitrary substrates. They are

immediately fully operational, for example as sensors for measuring forces. Alexander Kaya, Managing Director of Nanoss: “More than 250 complex process steps involving cleanroom equipment, from the initial idea to the finished circuitry have been required to roll out sophisticated micro-components such as sensors with a guaranteed quality and quantities.” In contrast to this is the Nanoss procedure “a revolutionary one-step procedure which makes it possible to completely bypass the numerous, complex cleanroom processes such as masking techniques” emphasizes Kaya.

Can the 3D printer make cleanrooms dispensable? Sven Skerbis who is responsible for technical sales at 3D Laserdruck GbR in Reutlingen, Germany, doesn’t think so. The company is a specialist in the field of metal-laser-melting and produces for its customers’ diverse metal parts and components in a 3D printer.

Cleanrooms will always remain necessary

In a dialogue with Skerbis, he admits that in specific cases such as with the sensor manufacturer, this is certainly conceivable. However, he can’t imagine for his company that the cleanroom could ever be

replaced: “Our company produces 3D laser building components in a clean room environment which is able to create reproducible climatic conditions in order to keep the production environment stable for the highly sensitive metal-laser-melting equipment.” The processing powder demands constant temperature and air humidity conditions.

Sven Skerbis gets the clean room know-how from his company’s own “Family”: 3D Laserdruck belongs to the consortium of the ap-systems GmbH, a Reutling cleanroom turnkey supplier. Martin Hirlinger, the Managing Director of ap-systems works next door to Sven Skerbis and explains that the activities in the direction of 3D printing have been expanded since the technology emerged a few years ago. “The 3D printer is our youngest child” says Hirlinger.

The Challenge of Series Production

Sven Skerbis and Martin Hirlinger see their challenges with laser-melting while the industry faces the challenge of crossing over to mass production. This is the step which the 3D printer still has to take. Injection molding machines produced in high volumes are

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Rapid.TechInternational Trade Show & Conference for Additive Manufacturing

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• Fachmesse und Kongress

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14. – 16. Juni 2016, Messe Erfurt

Titelmotiv: Bremspedal, EOS/MaterialiseFoto: Andreas Stedtler

| 3D-Print

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still considerably faster and more efficient than a 3D printer. As of yet. “Because of continued process optimization, 3D productivity continues to increase. In medical technology and in the aerospace industry, we are currently seeing breakthroughs in small and medium-size series production when complex geometries are requested” observes Sven Skerbis.

3D printer manufacturers and c l e a n r o o m b u i l d e r s h a v e a common nut to crack: How can the 3D printer be better integrated into cleanroom processes even when under the demands of series production? For cleanroom builders and service providers this question poses far-reaching fields of activities. Dirk Godlinski from the Fraunhofer IFAM confirms.

(see interview on the future of 3D printing on page 14) Problem Solutions for a better Life

The news about producing weapons with 3D printers comes up again and again since the time of Cody Wilson. However very few of the plastics used were actually suitable for a plastic – weapon – imitation. In contrast, the list of hopeful inventions which 3D printing makes possible has in the meantime become nearly endless: Clothing without seams and waste material, less costly prostheses, even automobiles produced in a 3D printer are less today utopia than concrete developmental goals. If plates and cups produced in 3D printers are really necessary is

another question which end users concerning their preferences have to ask.

In industry and in science, 3D print-ers are without a doubt tools with great potentials, tools which solve problems on a small scale and on a large scale improve all our lives.

Author: Piet Felber

How 3D printing worksUnder the terminology 3D printer, several production processes have been combined with which objects, assembly parts and tissues can be produced in diverse ways. More correctly, these processes should be designated as generative, respectively additive production processes. The oldest of these processes come from the 1980’s. Three fundamental types of processes should be differentiated:

Stereolithographic respecti-vely Liquid Material Procedure:

With this procedure, a liquid plastic is selected and hardened layer for layer by using a laser. With some of these procedures, the created part is dipped again and again into the material whereby the next layer is put on. Other procedures use a large roller on which the part is created. These rollers can be turned inside a material bath: Finished parts can be removed from the roller outside of the material

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

Powder-based Beam Fusion:

The most established beam fusion procedure is selective laser-melting. The processing material is at first applied in powder form in a thin layer onto a base plate. The material is selectively melted with a laser beam and forms a hard layer after solidification. Further layers are applied and hardened until the part is finished.

Freeform Procedure:

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

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

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Cleanroom Magazin: Promises are being made which indicate that advances in 3D printing are significant, especially in the areas of medicine, the life sciences and sensor technology. What does 3D printing still have to ‘learn’?

Dirk Godlinski: These areas of application are in fact the most important. 3D printers are to date operated as ‘stand alone’ devices. A qualitative break through would be for many experts the linking of 3D technologies with other industrial production processes such as ‘pick and place’. With such 3D hybrid processes, it would not only be possible to set up components geometrically but also to simultaneously integrate the electronics, connectors and so on. At the end, the final product would emerge.

Cleanroom Magazin: In which other areas could there exist application possibilities?

Dirk Godlinski: Further application possibilities exist in the lighting i n d u s t r y w h e r e l o w v ol u m e production often takes place. The conventional products could be replaced with functional LED lighting products consisting of frames, housings and lamps constructed, integrated and when as the case may be outfitted with additional sensors all with 3D hybrid printing processes. Because of

advances in 3D printing with high-performance materials concurrent with improved reproducibility there are enormous cost-saving possibilities, when quantities are low and with respect to lightweight construction and function-integra-tion, in the aeronautic and space industries, for example in the con-struction of satellites.

Cleanroom Magazin: How has the opinion arisen that 3D printing in some areas of application make cleanrooms redundant? Couldn’t it more be thought that synergies would come about?

Dirk Godlinski: Some 3D printers have to be encapsulated due their environments, for example printers for biological materials, tissues and

implants which have to be processed under clean, sterile conditions, or in laser facilities which process with flammable or very fine, toxic metal powders. There are producers which are now attempting to appropriately encapsulate their printers. In these cases, cooperation between printer manufacturers and cleanroom or glove-box professionals would be rational. With the integration of 3D printers in production processes with cleanrooms, such as in the micro-electronics industry, it would be important to consider the issue of compatibility. The printing process should never become a particle accelerator and in view of its cleanroom suitability perhaps be modified. In powder-based processes, the risks are significant.

Cleanroom Magazin: Are there application areas in which 3D printers will have to be deployed in clean environments?

Dirk Godlinski: A current issue is the deployment of 3D printers in the production of satellites and rocket components which is to take place in clean environments in order to minimize sources of error when put into operation in outer space. The next step would be the deployment under the conditions of outer space: Aboard the International Space Sta-tion ISS, a 3D printer has been in op-eration since 2014 for the production of parts using synthetic materials.

“Printing processes mustn’t become mere particle accelerators.“Dirk Godlinski, Project Leader Functional Printing at the Bremer Fraunhofer IFAM in consideration of the future of 3D printing.

Dirk Godlinski is the Project Leader for Functional Prin-ting at the Bremer Fraunhofer Institute for Production Technology and Applied Materials Research (IFAM). Photo: Fraunhofer IFAM

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

I see two formidable challenges for the cleanroom industy. For the first, we arguably need new norms for the growing presence of germs, for the second we need to pay stronger at-tention to the cleanliness of the air and surface areas.

The reason for this is founded on the new measurement technology available to the industry. Newly de-veloped devices count not only parti-cles without differentiating between germs and dust particles the new in-

strumentation is able to count both separately. Up until now, for each, individual microbial contamination measurement, an individual breed-ing substrate was needed which had to be incubated for days on end. To-day, a new process using lasers and optical detectors immediately recog-nize all metabolisms at one go. New devices, whose development was su-pervised by the Dutch Cleanroom So-ciety ICCCS, available for the meas-urement of particles on surface areas are much more exact than previous devices.

The result is: We are suddenly ob-serving that there is much more contamination in cleanrooms than previously assumed. This

could lead to needing new levels of standardization and changes to our scales and indexes. Additionally, we will require more disciplined cleanroom behavior and more thorough cleanroom cleaning.

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

From my standpoint, the biggest challenge for the cleanroom industry lies in the assured acquisition of professional, qualified future employees. Several colleges and universities have already taken on the task of developing new study programs, however these programs have yet to be implemented into their curriculums. We here in Switzerland are markedly noticing that there are next to no trained, qualified cleanroom personnel available. In order to cover our company’s needs, we hire people with technical backgrounds and train them in-house.

An important issue in 2016 will be the continued development of sensor technology. The trend to obtain even more information from devices will continue to prevail. Many sensor manufacturers have been working in this direction for some time. The goal is to develop into industrial t e c h n o l o g y t h e m a i n s t r e a m technology such as is prevalent in mobile telephones. A mobile telephone is able to intuitively serve

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Experts‘ Forecast 2016What Challenges are waiting for the Cleanroom Industry.

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

Frans Saurwalt

| Experts‘ Forecast 2016

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the needs of any user. When this becomes successful in industrial technology and when the division between mobile communication devices and industrial technology is surmounted, the gains for users would be substantial in view of data and Apps inter-exchanges.

Christian DragositsGroup Leader MED-EL Medical Electronics, Innsbruck, Austria

The major challenge for us in 2016 will be the continued training and schooling of our employees and to re-main at up to date levels of knowledge and know-how. We have 200 people employed in our cleanroom and are currently in the planning stages for

expansion for which we will need trained, qualified employees.

From my point of view, the issues of energy-thematic, renewable energies and energy efficiency in cleanrooms will increasingly become more impor-tant in 2016. Additional trends will be the growing importance of health and ergonomics in work places. We want to keep our employees for as long as possible, as healthy as possible and for this a lot can be done in and around a cleanroom. Belonging to this aspect is the factor of color and its positive ef-fects which has up to now been large-ly underestimated.

It is also important that companies don’t get bogged down with regulations, rather to find their own ways on this ‘Highway of Norms’. In this respect, seminars, trade fairs, conferencing and exchanges of experience will

help. We have been supporting several colleagues who have had their problems seeing the forest through the trees with help and advice. Reciprocally, we are also profiting with this support as we are faced with questions which we ourselves would never have asked.

Markus M. SchröderManaging Consultant, AVANTALION Consulting Germany GmbH, Berlin, GermanyFrom my standpoint, the topics of Track and Trace will challenge pharmaceutical companies in the coming year. With the release of the first draft of the delegated

legislative act in August, 2015, the implementation of measures protecting against falsification, EU Directive 2011/62/EU is coming closer. From then on time will be running, as until the official start in 2019, the serialization of medications available only on prescription will

be binding in the EU. This means that companies will at first have to initiate the serialization of individual packages. Pilot projects have already been started in larger companies however many middle-sized companies don’t believe they have to start thinking about this issue. This is a false conclusion, as to be able to trace every single box or bottle, not only the machines and IT systems have to be adapted to the new IT-supported processes, but also the SOP’s and internal procedures in nearly every de-partment. Realistically, I see the implementation time frame as being at least one to two years.

“Track-and trace will challenge companies in the pharmaceutical industry.” Christian Dragosits, Group Leader MED-EL

Experts‘ Forecast 2016 |

Michael Müller Markus M. Schröder

Christian Dragosits

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Gerhard WinterProfessor Faculty Life Science, Albstadt-Sigmaringen University, Germany

The classification of cleanroom cleanliness classes from ISO 9 to ISO 1 will not be sufficient in the future, as technological developments are encroaching into the nano-meter range. This is making possible the production of completely new prod-ucts for example medications which are absorbed by rubbing them in-to the skin thus eliminating many side effects.

Our particle safety limits, however end for the cleanest cleanliness class ISO 1 at the value of 0.1 micrometer. Particles of this size will soon be-come too big for production in clean-rooms, as the topic of miniaturiza-tion will continue to advance. This trend has not only significant effects on cleanroom technology but also on measurement technology, cleaning procedures and much more. There-fore companies which produce in clean environments will be facing brand-new challenges. This will con-cern especially pharmaceutical pro-ducers and the semi-conductor in-dustry. In practice, this all means in plain language: In the future, no

longer will people be sent into clean-rooms, rather the production must and will be carried out by robots.

Andreas FiebichProduct and Project Manager, Division Pharma, Niotronic GmbH, Gratz, AustriaI believe that the further and continued automation of cleanroom technology belongs to the most important developments in 2016. These developments include status signals and indications which will incorporate visualization technology, voice systems which will give employees acoustic instructions as well as authorization via RFID chips which will be able to specifically support and help employees inside air locks. The entering of cleanrooms by actuating the emergency stop button will no longer be possible in the future as the personnel will be guided by modern measurement, sensor and automation technology which will help to rule out errors. Decisions will become as easy to make as possible for production employees for example via red and green indicator lights. Therefore employees will carry out their activities or enter a cleanroom only when all required sensors are active, alarm systems are activated,

all sensor indicators registered and determined correct. Nothing in the future will be undetected or to go unnoticed as the indicator will remain red and the cleanroom is protected against contamination.

Joachim LudwigFounder and Managing Director COLANDIS GmbH, Kahla, GermanyThe trend toward mini-environments and isolators will continue in 2016. The need exists in semi-conductor

backend processes in which the integrated circuits are isolated. Also with injection molding processes where clean air from ceiling vents is barely able to reach the hot machines, such developments are economically reasonable in view of the operating costs as it makes more sense to put the essential processes in clean environments than to put the machines inside a large cleanroom. Within the word cleanroom, the word room is included which makes many people to think on length, width and height instead of on the process. Consultation is necessary in these cases.

A further development can be seen in the advancement of controlled

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Gerhard Winter

Andreas Fiebich

Joachim Ludwig

| Experts‘ Forecast 2016

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environments into more and more industrial subsectors and sub-divisions, areas which today are hardly imaginable. The same applies for new markets such as South America. In Brazil, a semi-conductor production facility is being built in which many cleanroom peripheries are being set up. In the Arabian world, new technologies are being developed for the time after the oil runs out and in Iran which can soon count on the end of the sanctions, there is a huge backlog for hospital and high-tech technology.

Ludwig Költzsch Founder MKF GmbH, Lederhose, Germany

The acquisition of employees and standardization are for me the major challenges. The cleanroom industry will experience a further boost in 2016 because new industrial sectors which

require clean production conditions are coming in from all sides. Take for example the automotive industry whose very strict requirements are forcing more and more suppliers to produce in cleanrooms. This is leading to a shortage in employee potentials and is making the acquisition of new

employees very difficult. Therefore it is high time for the set up of academic degrees and apprenticeships by the Chambers of Commerce and Industry as well as by the various associations and syndicates. What we need is something like the universally deployable cleanroom engineer or the mechatronic technician for cleanroom technology.

The second challenge is standard-ization. The cleanroom industry finds itself only in the early stages. Everyone is cooking his own brew. For example, when we clean parts for the automotive industry, the customer says: Do it according to our procedures, otherwise you won’t receive the order although we are able to guarantee the same result using our own procedures. It is difficult to adapt to every individual customer instead of keeping to one standard fulfilling the same results.

Ludwig Költzsch

PT16_175x125_CLEANROOM_MAGAZIN_C4_PHARMA.indd 1 14.12.15 13:40Experts‘ Forecast 2016 |

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PRO: Prof. Dr. Gerd Glaeske, co-editor of Innovation Reports

Cleanroom Magazin: According Innovation Report 2015, the Techniker Krankenkasse, the pharmaceutical industry developed over the needs of the patient. What is the basis your thesis?

Gerd Glaeske: The Innovation Report has always pointed out that the research of the pharmaceutical industry is necessary. Because in many disease effected areas new or existing drugs are lacking.

Currently, there is an increase in rare diseases, new antibiotics and antidepressants. Nevertheless, among the new drugs especially expensive supplments, special preparations are needing to be applied in cronological diseases or multiple sclerosis, while in the treatment of infections in hospitals in Germany rises every year up to 15,000 people, and these people usually end up losing there life, due to a lack of effective antiviral drugs.

Cleanroom Magazin: The pharma-ceutical companies are accused

of striving for returns instead of medical progress, in other words innovation would find no place where it was needed. Are the lives of patients at risk?

Gerd Glaeske: That strive pharmaceutical companies make in any sector, is not to criticize. There are privately owned businesses that have obligations to their shareholders, pension funds or owners. The problem lies in the fact, that they will always try to make high profits with drugs that shows no medical progress. The

welfare of the patient may then be at risk. When with economically oriented studies new drug offered as a therapeutic advance and prescribed widely. The examples of rheumatic agent Vioxx, the cholesterol-lowering drug Lipobay or the appetite inhibitor Acomplia should teach us not to speak rashly of therapeutic progress - all of these funds had to be taken off the market as sometimes fatal incidents did occur.

Cleanroom Magazin: The report criticizes the fact that new cancer drugs have a degree of innovation

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Profit versus innovation Follows the return of the pharmaceutical industry,

rather than the needs of the patient? An expert dispute.

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

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

| Controversy

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

2015, the Techniker Krankenkasse. The pharmacologist studied one of

the most famous health scientists in Germany. Glaeske was from 2003 until

2009 Member of the Advisory Council on the Assessment of Developments

in Healthcare. Since 1999, professor of medicinal, Glaeske applied research at the Center for Social Policy at the

University of Bremen and is the head of the research unit “drug counseling and drug information”. Since 2007 he

is Co-Director of the Department of Health Economics, Health Policy and

Health Services Research. His research areas are the transparency, quality

and efficiency of the drug market.

PRO

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CLEANROOM MAGAZINE 1/2016Controversy |

Stefan Oelrich is since 2011 the Managing Director of Sanofi-Aventis Germany GmbH. The French umbrella company Sanofi-Aventis is one of the largest pharmaceutical companies worldwide. From 1989-2011 Oelrich worked at Bayer inter alia, in South America and in Paris at the head of Bayer HealthCare. 2003 went Oelrich to the US where he marketed as vice president of marketing the Bayer portfolio. From 2007 he also initiated in the USA as Senior Vice President the Women’s Healthcare business. Since 2013 Oelrich is member of the Association’s Research-Based Pharmaceutical Companies (VFA). In June 2015 Oelrich also took over the position as spokesman of the cluster from the health industry Berlin-Brandenburg.

CONTRA

but the medical benefits often bear no reasonable relation to the price. Why is this so and through which health policy incentives this could potentially be changed?

Gerd Glaeske: With many new oncology medicine, prices are growing much faster than the

therapeutic benefit. We note that there is an additional survival time of 20 to 40 days up to a few months in the majority of newly marketed agents. The cost of these treatments are however at 50,000 euros and more. There should exist more contracts for cost containment risk of companies: If the funds do not deliver what they promise, the costs between insurers and manufacturers should be divided. In addition, the funds should be more cost-effective and more frequent, as longer they are applied.

Cleanroom Magazin: Let’s go back to the accusation for profit. Have high prices for new drugs not justified by the fact, that the industry needs to refinance their research and investment costs?

Gerd Glaeske: I could answer that question much better if the research costs would be really transparent. But it is not just about the research costs, it is also about the purchase price of innovative drugs for other companies. And sometimes the whole biocompanie is bought equal. Research has clearly changed: innovations were bought, not developed. That is why it has become difficult to talk about reasonable prices and backed the

equation “Money for Value”, and “Value for Money” with appropriate numbers.

Cleanroom Magazin: In your opinion, is the criticism justified, that the pharmaceutical industry follows the return and not the needs of the patient?

Gerd Glaeske: Yes, and we urgently need to talk about priorities in research and about the value and benefits new drugs have to have. We need to have absolutely no doubt about what research activities the pharmaceutical industry is undertaking. But not all new medicines are also innovative in terms of their added therapeutic value over existing medicines. This shows the AMNOG process (Pharmaceutical Market Restructuring Act), which shows the opinions of the Institute for Quality and Efficiency in Health Care and demonstrates our Innovation Report.

CONTRA: Stefan Oelrich, CEO Sanofi-Aventis Germany GmbH

Cleanroom Magazin: According Innovation Report 2015 the

pharmaceutical industry is developing over the needs of the patient. What do you say to this

argument?

Stefan Oelrich: It is unfortunate that the Innovation Report repeats this assertion. The

truth is that real innovations have been approved during the current year. If you look at the

pipelines of many companies, you can be sure, this will be like

this also in the future.

Cleanroom Magazin: The pharmaceutical companies are accused of striving for returns

instead of medical progress, and innovation would find no place

where it was needed. I ask again is the lives of patients at risk?

“Innovations has been repeatedly approved” Stefan Oelrich

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Stefan Oelrich: The welfare of the patient is always at the center of

our actions.Without the patient’s well-being,

there is no additional benefit in the German reimbursement

system.

Cleanroom Magazin: The report criticizes the fact, for example, that when new cancer drugs of

the degree of innovation and the medical benefits often bear no

reasonable relation to the price. Why is this so, and through which health policy incentives is there a

need for change?

Stefan Oelrich: The research into cancer has made enormous

progress over the past decade. Here a mixed viewed discussion

takes place. What matters, is that many patients who live through

the innovative drugs in oncology

today, who are either tumor-free or could extend their lives,

significantly are doing that.

Cleanroom Magazin: Let’s go back to the accusation for profit.

Have high prices for new drugs justified the fact, that the industry

needs to refinance their research and investment costs?

Stefan Oelrich: I do not understand

this point. The cost of drugs have remained stable over the last five years in Germany and therefore makes it possible to

compensate for the rising costs of hospitals and doctors. Higher

costs for innovations were able to be compensated for by low-cost

generics.

Cleanroom Magazin: This is the bottom line: Is the criticism of the pharmaceutical industry that you

consistentlyfollow the return or in other words profit, and not the

needs of the patient?

Stefan Oelrich: That a company would like to achieve a return on its economic activity, is a driving

force of the market economy. This combined with the patient’s well-

being, is not a contradiction. A prescription drug that passes by

the needs of the patient, receives in Germany no added value and

thus in consequence a price that can not be higher than the

current economical comparison therapy.

Author: Gero Hassink

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How a simple, harmless question can sometimes change into a life’s journey. It happened five years ago. “Rauschi, do you trust yourself to do this?” the Production Manag-er wanted to know. Andreas Raus-chenbach didn’t need much time to think about it. He was supposed to be building machines. No problem, he was after all a qualified mecha-tronics technician with experience in specialized machine engineer-

ing and construction. However, what he didn’t know was: He was supposed to build these machines inside a cleanroom. “That was my first contact with this topic” re-counts the 30 year old.

Out of this “first contact” has in the meantime become his main job. Andreas Rauschenbach is the man responsible for the mkf GmbH cleanroom in Lederhose, Germany,

a 260 person community in the federal state of Thuringia. Although Lederhose’s coat of arms does indeed bear a pair of lederhosen, the town’s name has really nothing to do with clothing. The name goes back to the Slavic name of Ludoraz. Today in Lederhose a stone’s throw from the Autobahn A9, the company mfk GmbH with its 85 employees builds customer-specific automation solutions. Since

How a Virgin found himself in the cleanroom Andreas Rauschenbach manages the mkf GmbH cleanroom.

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

| Portrait

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2008, in addition to building high-tech assemblies and devices under cleanroom conditions, the company provides services such as cleaning and packaging inside cleanrooms.

Concerning the latter, there was a customer who started the ball rolling. He had request a solution which was only possible to achieve inside a cleanroom. The company’s management decided to push forward into this new field of business and has never regretted this decision. Today, the products coming out of the cleanroom are responsible for a large part of the yearly revenues. No one thought that this would be possible five years ago. “We started really in a small way with very few square meters of cleanroom space – virtually in a flow box” says Rauschenbach jokingly. Because of his black beard, his teeth appear especially white when he laughs. Also, with his beard, he doesn’t come across to be only 30 years old.

Based on his appearance alone, this son of an industrial management assistant and an electrician born in 1985 in Gera, Germany could still be doing his apprenticeship. His slender

figure, the green polo shirt and the grey cargo trousers – the company’s working-clothes colors – emphasize this impression. However when speaking to him, it becomes obvious that no greenhorn is standing in front of you. Rauschenbach’s

entrance is that of an experienced, mature, calm and articulate person and he really understands his trade: His cleanroom competence gleams in every sentence whether the topic is about permanent versus removable floor mats, or ultra-sound cleaning with ultra-pure water, FFU-alternating intervals, the re-ordering of gloves or calculation of isopropyl mixing ratios.

This cleanroom know-how was not always available at mkf GmbH. “At the beginning, workers in the cleanroom were only wearing a white work coat, a hood, gloves

and footlets. The cleanliness val-ues were nonetheless within lim-its” says Rauschenbach und sounds a little surprised himself at this. To-day he can never imagine working under those conditions. In those days, however, there had been no

one responsible for the cleanroom. In 2010, as he entered the world of cleanrooms, his production man-ager merely “gave a short introduc-tion and initiation” and “roughly explained” the work to be done. “In this way, I slipped into the world of cleanrooms” recounts Rauschen-bach. “Whereby I continued to do what I was trained to do when I was needed and when there wasn’t much to do inside the cleanroom.”This training included: Mecha-tronics technician with specializa-tions in special machine construc-tion and welding. Rauschenbach learned his profession between the

Portrait |

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

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

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2002 and 2006 at a Bavarian compa-ny near Ansbach. In this respect, he differed from the rest of his family. His father, his mother and his old-er sister all learned and now work for the Deutsche Telecom. “I had absolutely no interest to work for Telekom. I wanted more to create, to build something.” It would take two years after finishing his ap-prenticeship before homesickness and the 330 kilometer commute every weekend pulled Rauschen-bach from Bavaria back to his roots.

Following his return to Thuringia in 2008, the young professional started looking for a new employer. He turned down an offer to work for a company which wanted to hire him for maintenance and repair activities. “I didn’t want to repair things, I wanted to create them” reiterates Rauschenbach. He then took a job at mkf in Lederhose w h e r e h e n o t o n l y ‘c r ea t e d’ specialized machines but also was able to assemble and disassemble them at customers’ sites. In 2010, the memorable moment came when he was challenged to set up a machine inside a cleanroom for the first time in his life: “Rauschi, do you trust yourself to do this?”

He trusted himself indeed and af-ter working hours he started to re-search this topic cleanroom and learned about the requirements in cleanroom production environ-ments. He promptly determined: “We have the wrong cleaning tow-els!” These were not doubly-sealed thereby tearing and shredding eas-ily. “I addressed this issue and ex-plained to management what we really needed and showed the dif-ferences between the products” says Rauschenbach. Although the new towels were more expensive, his supervisors reacted with open ears. Such stories are very encouraging.

After taking care of the towel issue, he arranged that the PU gloves be exchanged for the better-suited nitrile gloves, he brought in overalls instead of lab coats, he organized swabs for the cleaning of drilled holes, he brought in adhesive mats for the areas in front of and behind the gray zones, he procured mouth protection and beard nets. Presumably these peu à peu improvements would have gone on and on if it were not for the fact that the cleanroom had become too small for the growing number of orders.

A new cleanroom became necessary in 2012 and in 2013 a brand-new cleanroom, cleanliness class ISO 6, nearly 90 square meters in size with an additional 15 square meters of material and personnel air locks went into operation. Along with the decision to build a new cleanroom was the decision to keep Andreas Rauschenbach active in both the cleanroom and outside in the normal production areas. “You’ve already taken care of so much, don’t you want to become the person responsible for the cleanroom?” asked his Production Manager. Rauschi was indeed confident enough in himself to say yes.

Since that time, everything has turned out differently. “It’s not any more about working occasionally in the cleanroom, it’s about keeping the cleanroom up and running” says the young man clearly aware of his responsibilities. This means instructing and monitoring the cleanroom employees, organizing orders and workflows, dealing with particle counters, filters, air humidity, to monitor temperatures, to write job and test instructions, to monitor and check material brought in through the air lock, to

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organize maintenance schedules, to re-order disposable materials, to check assemblies to be delivered with UV lamps and much more. The lists of things to do includes even to sign holiday applications. As the cleanroom Master, Rauschenbach is constantly peppered with a myriad of questions as he makes his way through the production areas. In order for the cleanroom employees to reach him easily, he carries with him a cordless telephone, as well as a small notebook. “I write down everything which people ask me as I’m walking along, otherwise I’ll forget the half of it.”

Does all this have anything to do with “creating”? “Not really!” admits Rauschenbach frankly. “Nevertheless, the work is quite motivating.” He has the opportunity on five or ten days a month to assemble and build something inside the cleanroom, but he would also like to implement many of his own ideas, for example to build a Handyclean device with which employees would be able to degrease their gloves under a fine spray. Another idea would be to replace the adhesive mats with a permanent mat system. Besides all this, the next cleanroom is standing

in the next work hall, still packed in plastic and wooden boxes and this all has to be organized and managed, to be “created”.

Andreas Rauschenbach is a frequent visitor to the ReinraumAkademie

(Cleanroom Academy) in Leipzig because of his cleanroom knowledge. “I have even taken along our Quality Manager as there is nothing worse than to suffer from tunnel vision.” In the meantime, Rauschenbach has become so knowledgeable in his trade that in 2015 he held his first seminar.

Privately, this freshly-married man is very interested in sports. He was a boxer earlier and won championships in Thuringia and German-wide. He enjoys reading

biographies about people in sports and is a fan of the DTM and Formula 1. When the latter takes place at the Hockenheimring in Germany, he will “absolutely” be present. He even takes his tent and camps overnight for the DTM at

the Lausitzring. Considering that his favorite food is fast food, steaks and noodles, it is a wonder that he stays so slim. Perhaps the reason is, besides playing a lot of football, the fact that he doesn’t like to drink Germany’s traditional favorite: “I don’t drink beer.” Oops! If that isn’t a curiosity: The person in charge of a cleanroom who despises of all things a product which is governed by the German Reinheitsgebot (German Purity Law)!

Author: Frank Baecke

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

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This expert’s advice was outstand-ing but in practice, pointless. “When you want to keep your cleanrooms clean, then refrain from sending any people into them” advised Koos Agricola as a participant in the congress held at the International Cleanroom Trade Fair in Frankfurt am Main in October, 2016. The Gen-eral Secretary of the International Confederation of Contamination Control Societies (ICCCS) recom-mended to an astonished audience to send robots into cleanrooms in-stead of humans.

Of course this comment was made tongue in cheek, nevertheless it has a serious background. “The skin, the breath, the employees’ cloth-ing – all of this causes contamina-

tion which is then distributed by personnel moving around. Many particles can also be carrying mi-crobes” explained Agricola which describes operators’ age-old prob-lem. Even worse: when disrobing in the air lock, these particles are dispersed into the air, which before had been held back from an em-ployee’s clothing, but during break times settle down onto the disrobed clothing and after the break are carried back into the cleanroom by the employee. “There are five times more particles on clothing than in the air” says Agricola. In order to keep the cleanroom as clean as pos-sible, Agricola gave his audience three pieces of sound advice: “Nev-er send more people into a clean-room than necessary! Teach your

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

This is easier said than done. How does one communicate to his employees that the environmental conditions, process safety and product quality are decisively influenced by correct or incorrect working behaviors. Furthermore, how does one communicate this information so that in 14 days time it won’t be forgotten?

An excellent possibility is to have this information mediated and em-ployees qualified and certified by professional training centers, such as the ReinraumAkademie (Clean-room Academy). For those compa-nies which would rather train their employees in-house, Claudia Pachl, Partner of Avantalion Consulting Switzerland AG in Luzern, Switzer-land recommends for these compa-nies to use standardized procedures

How employees become cleanroom operativesThe best cleanroom equipment is useless unless the personnel knows what they are doing.

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

| How employees become cleanroom operatives

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

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in the contents of their courses. Top-ics for the seminars and workshops could include hygiene, cleanroom working behaviors, production pro-cesses and so on, always keeping in mind to carry out the courses at the same level of quality. It is decisive however for training courses to be successful that management places a high value on employee qualifica-tion and instruction. Thereby will the participants also find the train-ing worthwhile and not just an an-noying obligation.

Besides the standardized procedures and internal value of the seminars and workshops, the factor of regu-lar, repetitive training is also impor-tant to take into account. “You can bombard your employees with two hours of new information but how much of this information will stick? It is much better to repeat courses at regular intervals” says Claudia Pachl. To keep employees’ interest peaked, the trainers should pres-ent the topic using vivid and easi-ly remembered techniques as well as portraying why the topic is im-portant and the consequences when

certain behaviors are not followed. Additionally, Ms. Pachl advised to review how successful the training has been immediately following the event as well as to monitor the effect of the newly learned information in practice. In order to assure the optimal transfer of knowledge, it is helpful to document such proceedings in well-structured and easily understandable ways. Only when the newly learned information and its relationship to working practices are internalized by employees can the effects of such seminars and workshops be sustainably successful. It is useful to set minimum criteria in order to review the success of employees’ qualifications. This could be look like the following: The first qualification follows the successful passing of three consecutive courses on different days; re-qualification follows the successful passing of further courses within a defined period of time. Further criteria might be added due to stricter demands and requirements, for example, “the successful partici-pation at MediaFill which deals with aseptic filling”.

With all these training activities, cleanroom operators should con-stantly have in the back of their minds the idea that successful employee qualification is never a permanent situation. Claudia Pachl urges “You must always be asking the question: How long can I consider a cleanroom employee qualified?”

Many companies would gladly share these concerns. When com-pared to the problem of even find-ing qualified employees, training qualified employees becomes an issue of luxury. The demand for professionals in the cleanroom technology sector has increased enormously in the last years. The industry is demanding specialized training and study courses which will prepare those participants spe-cifically for cleanroom conditions and requirements. However, up to now there are no recognized and certified professions in the fields of cleanroom technology and too few academic professionals and grad-uates. Therefore many companies are dealing with this crisis autodi-dactically.

How employees become cleanroom operatives |

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

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However this will not be enough in the future emphasizes Frank Du-vernell, Managing Director of the ReinraumAkademie (Cleanroom Academy). “The working world of cleanrooms has become in the meantime commonplace, but that of professional training hasn’t yet adapted itself to this situation. Just as the companies involved in ware-housing, logistics and forwarding have fused together over the last 20 years into a single logistics industry, so too must the companies involved in cleanroom technology develop into a single industry. In order to ac-quire employees, the many new pro-fessional fields have to be brought to the attention of the general public.”

The personnel recruiter Jürgen Tausch, proprietor of Jürgen Tausch Personnel Service and Associate of Höfer and Tausch GmbH in Dres-den, Germany sees in this situation an obligation of the Chambers of Trade and Crafts. These chambers have to illustrate the many clean-room professions and effectively make the general public aware of these opportunities. “Our biggest problem today is that we are sup-posed to be motivating people for the activities inside a cleanroom while most people aren’t even aware

these activities exist” explains Jür-gen Tausch. This is why it is criti-cal that real and recognized profes-sions be created and publicized. In order to raise the attractiveness of such professions, these should be comprehensively created and devel-

oped, the various professional fields overlapping each other, thus mak-ing it easier for employees to switch companies and for companies to ac-quire professionals who have grad-uated with the same or comparable degrees and who could be trained for their required tasks with lower expenditures and effort.

Using this approach, MED-EL Elec-tro-medical Devices Ges.m.b.H. in Innsbruck, Austria, has successful-ly generated a part of its cleanroom staffing. “In Austria, there exists the profession of Process Technician.

The curriculum for this trade in-cludes the topics of planning, mate-rials management, automation and production equipment” says Chris-tian Dragosits, Group Leader Main-tenance and Environmental Con-trol in the manufacture of implants.

“We thoroughly train our Process Technicians inside and around cleanrooms, thus they become at the end technical All-Rounders.” However, even Dragosits would very much like to see specific academic training meant for the cleanroom industry. “There are many providers of cleanroom seminars and work-shops but no occupational profile. Diplomas are up until now ‘only’ a participation certificate even if these certificates suggest otherwise. My opinion is why not designate the subject matter under other names, such as Filter Technology, Measure-

“You must always be asking the question: How long can I consider a cleanroom employee qualified?” Claudia Pachl, Avantalion Consulting Switzerland AG

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

| How employees become cleanroom operatives

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ment Technology, Climate Technol-ogy and Building Technology which would provide a fitting job descrip-tion and occupational profile, per-haps consolidated under the desig-nation of ‘Cleanroom Technology’”Until the situation comes to this point, companies have to rely on their own strategies regarding the development of talent and future employees. For those companies with no in-house training program because of time and personnel limi-tations, many external training pro-viders are available to help out. The ReinraumAkademie (Cleanroom Academy) in Leipzig, Germany and the CleanroomAcademy in Wan-gen an der Aare, Switzerland offer year-round courses, seminars and workshops covering many diverse topics. The spectrum goes from Re-inraum-Expertentagen (Cleanroom Expert Days) to two-day seminars, coachings and workshops as well as courses and seminars offered di-

rectly on a company’s own premises.The seminars, workshops and coach-ings are pre-destined for providers

and users of cleanroom technology and equipment but also for service providers in cleanroom planning and design or for cleanroom clean-ing companies. Participants receive first-hand knowledge and informa-tion directly out of the practice. Also participants are able to speak with the people presenting the topics, are able to exchange ideas and experi-

ence and of course to build up rela-tionships with other companies, to form partnerships and other net-

working structures. All this enables companies to move themselves in-to the position of fulfilling the high demands of clean production with-out having to follow the advice of Koos Agricola (“If you want to keep your cleanrooms clean, don’t send any people inside them”).

Author: Frank Baecke

vali.sys gmbhhofstrasse 94ch-8620 wetzikon

telefon: +41 43 495 92 50fax: +41 43 495 92 60e-mail: [email protected]: www.valisys.ch

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

Ausführung rund um Monitoring-Systeme und industrielle Automatisationen.

innovativ – kompetent – kundenspezifisch

“Our biggest problem is that we should be motivating people for the activities taking place inside clean-rooms while most people are not even aware these activities exist.” Jürgen Tausch, Proprieter of Jürgen Tausch Personnel Service

How employees become cleanroom operatives |

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How often are you on the road? On the average, about two to three days a week, according to the particular projects, sometimes an entire week. Business trips take place primarily in Germany.

What is your favorite means of transportation? In most cases, I use the car because I often have to take with me various documents and documentation as well as measuring instruments.

What is important to you when on a business trip? When travelling by car, I like and prefer to drive when the streets and highways are free of traffic. Therefore I try to plan my trips during off-peak travel times. Besides traffic-free highways, I very much value punctuality.

What should never be missing on a business trip? When travelling by car, of course a good radio station. Other-wise, a mobile telephone, a tablet and

a notebook computer in order to be reachable. These devices have become indispensable in the working world. What kind of music do you enjoy lis-tening to? Radio stations with a broad spectrum of Rock and Pop from re-cent decades.

Which countries and regions are most often on your list of destina-tions? For business, Germany has been the destination in recent years.

On the Road with …Steffen Röhm

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| On the Road with …

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

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Privately, northern Germany and northern Europe are appealing.

Are you able to relax when you are travelling on business? Yes and no, it always depends on what I have to do.

How do you best unwind after a working day? I am best able to unwind with a good book which I always

have in my luggage. At the moment, I am reading Wolfgang Niedeckens autobiography “Zugabe. Die Geschichte einer Rückkehr” (Encore. The Story of a Comeback).

Which travel destinations do you favor and why? On business, I enjoy travelling to Berlin and to Switzerland. Privately, my absolute favorites are Finland, Sweden and Switzerland.

What would be the first thing you would change if you had the un-restricted possibility to do so? The question is difficult to answer. There are so many topics such as environmental protection, the wasting of resources, wars and so on which affect and concern us all. For me personally, it would be important that each of us think a little more on others and not so much on ourselves.

On the Road with … |

VWR International | basan - the cleanroom division of VWR | [email protected] | vwr.com/basan

Your partner for critical environment solutions• Full service solutions for cleanrooms and critical environments

• Highlyskilledspecialistsandhighlevelofflexibilitytoturnyourneedsintoa custom-madesupplyconcept

• Supplychainexcellencetoprovide100%securityofsupplyandJIT-deliveries

• Comprehensive portfolio of premium-products and services

• Global network of suppliers and partners

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| Science & Technology – Technolgy Briefs

Science & TechnologyTechnolgy Briefs

Researchers develop a new kind of information storage device

Ion Conductor | Scientists of the University Kiel and University Bochum have developed an information storage device with uses ions to store data. Common storage devices are based on electrons which when current is induced are displaced. As computers in use today need more time to move data than to do calculations, researchers have wanted to get away from charged-based storage to that based on electrical resistance. Such

a component has emerged from the Kiel and Bochum laboratories. When current is induced, ions are moved between two electrodes in a solid state ion conductor. A further advantage: Such structured cells can be reduced to atomic sizes.

Smarter wound dressing for nerve fibers

Nano-membranes | Researchers at the Leibniz Institute Dresden and the TU Chemnitz are working on ultra-thin membranes which roll up by themselves into micro and nano-tubes. Such tubes provide medical technology enormous innovation potentials. Equipped with integrated electronics these tubes could serve as wound dressings for defect or healing nerve bundles. The possibility to open and close the sleeves by outside

influences makes their application in the regeneration, monitoring and stimulation of nerves very attractive. Furthermore these smart nano-membranes can serve as antennas for implants which would be able to transmit information

regarding physiological processes such as the healing of wounds.

Giant molecule blocks Ebola virus from entering the body

Medical Research | A giant molecule developed by researchers of the University Madrid could soon provide effective protection from the Ebola virus. The molecule blocks the decisive docking site on cell’s surface and blocks the Ebola virus from entering the cell. In cell cultures it has already been shown to prevent infection. Should results in tests with live animals confirm this, the procedure could enable a way to produce an anti-viral medium against Ebola. The custom-made giant molecule which researchers have created consists of fullerene, hollow carbon spheres which are coated with appendages made of sugar. The latter protects a cell’s docking site from the Ebola virus.

Inspection of memory cells in the cleanroom of the Kiel Technical College. Photo: AG Nanoelectronic

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

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

Head OP: Robot worm grinds its way around corners

Medical technology | In order to reach a tumor inside the inner ear, doctors in most cases have to remove a part of the temporal bone. In the future, a five millimeter tunnel through the bones which a new mini-robot has ground will be enough. Unique here is: The robot curves around blood vessels and nerves. This OP device was developed by Fraunhofer researchers in Mannheim together with several universities. The robot, thanks to its accordion-like construction is able to creep forward like a worm. Its direction is controlled by hydraulic lines and pumps operated from the OP. This maneuverability makes it possible for the first time minimal-invasive operations of inner ear tumors. The innovation is supposed to be ready for series production in two years.

Stem cell cultivation on algae skeletons

Bio-technology | On the exoskeleton of algae, the gel-like alginate, Fraunhofer researchers in Sulzbach are cultivating pluripotent stem cells. These have the potential to transform into random body cells for example into inner organ cells. The pharmaceutical industry requires such stem cells in large amounts for the testing of new

medicines. As the researchers have found out, the alginate acts as a particularly efficient source of nutrition for the reproduction of stem cells. British pharmaceutical companies have currently validated this process in their laboratories. Further trials are to be done by European partners in 2016. The goal is to produce with this process stable pluripotent stem cells.

Exactly dosing fluids in the smallest amounts

Micro-dosage systems |BioFluidix GmbH in Freiburg has won the STEP Award 2015 in the category “Process” with their pipette technology. The STEP Award distinguishes innovative companies in Germany, Austria and Switzerland. BioFluidix won the award for their PipeJet-Tip-Technology which allows micro-drop dosing. The BioFluidix pipette tips are compatible with common pipettes and pipette equipment. The technology is therefore, able to be easily

integrated with existing laboratory equipment and running processes. With this device’s help, processes in pharmaceutical, chemical, life sciences, bio-technolgy, nano-technology as well as medical technology can become more easily automated. In comparison to conventional pipette technology, the PipeJet-Tip-Technology is able to dispense 100 to 1000 times smaller amounts of fluid.

Electro-auto: Batteries with brains

Micro-controller | Stuttgart Fraunhofer researchers have developed a battery for electronic automobiles, which is considerably more cost effective than present batteries and this over its entire life cycle. If one of the over one hundred battery cells becomes defect, this can be modular-like exchanged. Up until now, the entire battery had to be replaced. The exchanging of single cells has been made possible as each cell is controlled by its own integrated micro-controller. Therefore each cell recognizes its own condition. If a cell is empty, it simply disconnects itself from the other cells and directs the flow of current past itself. The car doesn’t have to stop dead. The researchers have already developed a prototype. In the next phase, the researchers want to miniaturize the electronics in the cells.

Micro-controllers extend the driving range of electronic cars. Photo: estations

Dual-flow nozzle apparatus for the production of algina-te globules. Photo: Fraunhofer IBMT

Robots could be used in the operating room in the future. Photo: Fotolia

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Are you of sound mind?Containments have to be able to protect not only the product but also employees.

New medical agent s are of ten even in small dosages very potent. The processing of these agents is putting higher demands on safety in laboratories and pharmaceutical production facilities. Containments have to provide the highest levels of tightness while at the same time providing straightfor ward material flows and maintenance. A technological balancing act.

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

In order to make it easier for laboratory operators and pharma-ceutical manufacturers to get an overview of the technologies, processes and regulations involved, the work group ‘Containment’ of the ISPE D/A/CH (International Society for Pharmaceutical Engineering – Germany, Austria, Switzerland) has worked for five years putting together the widely scattered knowledge into a single resource. “Our goal was to compile an all-encompassing handbook dealing with highly active substances. Until now, nothing like this has

been available.” says Richard Denk, Sales Manager Containment of the company Skan AG in Allschwil, Switzerland. The handbook which was started in 2010 and developed by numerous experts was published

in November, 2015. This publication provides for the first time in one volume, practice relevant support in the planning, construction and renovation of manufacturing facilities.

Under the term, containment, various concepts and technologies are to be understood, which safeguard products from contamination in the production environment and reciprocally to protect people and the

environment from contamination from the substances being processed. The terminology containments does not only speak about closed systems, but all the measures involved which limit the spread of highly potent substances.

Containment can be differentiated into primary and secondary con-tainment. Primary containment encompasses all measures which prevent the spread of substances out of the production facility, for example housings, isolators, con-tinuous line systems, suction con-veying systems and exhaust sys-tems. Secondary containment are those measures which collect and reduce those substances which es-cape from the primary contain-ment systems, for example clean-rooms, air-lock systems, pressure

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

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

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cascade systems, decontamination systems and adhesive mats.

Experts recommend calibrating t h e p r i m a r y a n d s e c o n d a r y containments to each other. For this purpose, optimally the facility is planned from the inside to the outside, that is to say, starting from the production process, a suitable containment is chosen and afterwards it is determined how the secondary containment will look. A well-chosen primary containment results in cost re-ductions with the secondary containment.

The precise design of the contain-ment depends on how dangerous the processed substances are. Tox-icologists have determined exact safety limits for work places, the so-called Occupational Exposure Limits (OEL) which are divided in-to several classes or bands, from very low to very high. These safe-ty limits are mostly taken as eight-hour average values. The average value means that an employee in an eight-hour shift is allowed to be exposed to higher dosage levels for short periods of time as long as the toxicologists show no concerns re-garding this exposure and it can be

assured that the employee is able to balance out the periods of high ex-posure with those of low exposure. The peak load is neither allowed to be health-endangering nor exceed the eight-hour average value.

Reinhold Maeck, Head of Corpo-rate EHS&S Regulatory Intelligence of Boehringer Ingelheim Pharma GmbH, indicates that in the 2014 re-vision of the EU Chemical Guideline 98/24/EG, the definition of hazard-ous substances has been expanded: “Hazardous chemical agents as are all chemical agents dangerous and pose risks for the safety and health of employees because of their inher-ent physiochemical, chemical and toxic properties.” In practice, how-ever, it should be observed that for active chemical agents there exist no mandatory, uniform safety lim-its. This situation has an impact on the construction of plants and fa-cilities. To be on the safe side, plant operators often place high demands on the manufacturer regarding the tightness of the plant. Maeck recom-mends complementing the techni-cal with organizational measures such as additional training cours-es and risk analyses. “Risk assess-ment is extremely important in cas-es where contamination becomes an issue. In such an event, the oper-ator has to verify that he has eval-uated the risks with a team of ex-perts who have reasonably judged and classified the risks” says Maeck.

Besides the primary and second-ary containment, the dust filtering equipment also belongs to the is-sue of plant safety. “Some producers forget this completely because they are only focused on GMP” says ISPE-D/A/CH Chairman Richard Denk and knows this from experience. “Plant operators have to consider that the fine dust particles which become a finely processed powder

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| Containment

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

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

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

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

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

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

Maintenance: All plant components are subject to mechanical wear and tear. These components have to be regularly maintained and kept in good working order in order to rule out a breach in the containment.

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

Source: Containment Handbook, 1 edition 2015

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are able to reach areas which even water is not able to penetrate.” This situation affects filters, threaded fittings, pipe lines and other plant equipment. This deposition makes

the cleaning and maintenance prob-lematical as the danger exists that employees will absorb these parti-cles not only by breathing them in but also by absorption through the

skin and mucous membranes. “It is enough when an employee un-wittingly touches his face with his gloved hand – which happens more often than one thinks” warns Denk.

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

Important Pharmaceutical Fairs and Congresses 2016

Lab Innovations LausanneTrade Fair for Technology and Services in LaboratoriesDate: April 13-14, 2016Location: Messe Beaulieu Lausanne , Avenue Bergières 10, 1004 Lausanne, SwitzerlandExhibitions:• Lab equipment• Cleanrooms• Lab installations• Services• Consumable materials

Medizin Innovativ – MedTech Summit 2016Congress with exhibitions for medical technology, pharmaceutical and health care systemsDate: June 15-16, 2016Location: NCC Nürnberg Convention Center, Messezentrum 1, 90471 Nürnberg, GermanyExhibitions:• Medical imaging• Home care• Smart Medical Devices

• Hospital, workflow• Personalized diagnostics, personalized therapies• Innovation in the health care industry

ILMAC BaselIndustry Trade Fair for the Pharmaceutical and Chemical Industry Date: September 20-23, 2016Location: Messe Basel, Messeplatz 1, 4058 Basel, SwitzerlandExhibitions: • Laboratory planning, installation, requirements• Laboratory planning, installation, requirements• Analytics, automation, preparative techniques• Diagnostics, verification procedures, platform technologies• Sterile room technology, cleanroom technology, hygienic room technology• Planning and engineering of facilities and processes• Construction and operation of facilities• Environmental technologies, safety equipment, worker safety

Containment |

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Basically, plant operators have the choice between fixed and flexible containments. Fixed systems are manufactured as a rule out of stainless steel and glass and are securely installed, for example isolators. Flexible containments, in contrast, consist of plastics and are meant for temporary activities such as weighing, decanting, inspecting and cleaning. Furthermore, flexible containments are predestined to become one-way technologies for manufacturers with frequent product changeovers which after production are disposed of to be replaced with new containments for new products. In contrast, fixed systems have to be thoroughly cleaned after every product changeover. Advantages of fixed systems are their stability. They stand up to pressure and collisions and provide the user psychologically more safety as he or she, standing behind a solid wall, feels better protected.

F i x e d c o n t a i n m e n t s d e m a n d higher initial investment costs, however generate lower operating costs. Flexible containments are more inexpensive, but after every product changeover have to be newly purchased. Moreover they require a more elaborate stainless steel peripheral equipment and material logistics such as for fixed containments. Dirk Collins, Product Manager at Hermann Waldner GmbH & Co.KG in Wangen, Germany advises: “Choose for the comparison between fixed and flexible systems a time frame of at least five years – one to two years is much too short!”

Whether a fixed or flexible con-tainment – in both cases the operator has to consider the future decommissioning and disposal activities even during the initial planning and acquisition stages. Contaminated facilities are only allowed to be dismantled and

disposed of by specially trained personnel. This applies also for the periphery, such as walls, floors, ceilings, air locks, built-in fixtures and ventilation systems. During a product changeover phase, special cleaning procedures often exist for containments which have been constructed for the manufacture of diverse products. These pro-cedures can be used during plant dismantling. In plants where only one product has been manufactured, every single component which has come into contact with the product has to be examined and assessed as contact with particular substance-groups prohibits further use. Important is: Any resale or disposal of contaminated components has to be documented in writing.

Autor: Frank Baecke

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The show for laboratory technologies & services

13 & 14 April 2016 Expo Beaulieu

Lausanne 2016

www.labinnovations.ch

Your invitation code for a free entry

4260(value CHF 20.–)

| Containment

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

“My name is Petra Hagel. Since October, 2014, I have been the Operations Health Management Department Manager at Vetter, an independent family-owned company with locations in Germany and the USA, as well as subsidiaries in Singapore and Japan. The company employs 3,400 people.

The customer-specific medicines and medicaments our company produces are filled under aseptic conditions. These conditions and work environments present for our employees significant ergonomic

and physical challenges in their daily work. As an example, any additional movements outside of what is necessary to carry out a task should be avoided when possible. This, of course, contradicts not only a body’s own natural need for movement but also an employee’s inclination to show that he or she is working hard. Another example is the predefined physical positioning of the body and arms which could lead to orthopedic problems that could cause tension, headaches, back pain and possibly serious circulation problems.

Here is where I come in as the Health Safety Manager. The support of our employees in the cleanrooms is particularly challenging because this is only possible outside of the cleanroom. I organize and provide specific movement opportunities such as an ‘Exercise Break’, or the Group Thera-Band Training or our large selection of company sport groups.”

What do you do there Petra Hagel?Brief profiles of the clean room industry

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

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Now these are used even in tooth-brushes, toasters, refrigerators and garments. Even cars, trains and planes would not work today if it were not for the invention of the semiconductor. These are even in our cars, for example the Audi A8, has about 6,000 to 8,000 semiconductors. Powerful micro-electronics are also the progressive

digitalization of business and industry and play a particularly big role of importance: the so-called industry 4.0 is inconceivable without strong chips and sensors that control the enormous amounts of data and process that is required for such tasks.

The Moorsche law was yesterday

For 50 years, Moore‘s law applied heavily in the semiconductor industry. Gordon Moore, the co-founder of the chip manufacturer Intel, in 1965 after six years of observation, had found that the density of integration, which would

| The Next-Generation

The Semi-Conductors of the next generation,will allow new materials to completely revolutionize existing applications.

The digitization of the economy and of everyday life is in full swing. Trends like big data, social media and the Internet of things determine the topics of the upcoming CeBIT. They all

have something in common, they require significantly powerful semiconductors. Thus the cleanroom requirements increase.

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

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Photo: Fotolia.

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CLEANROOM MAGAZINE 1/2016The Next-Generation |

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

Alternatives to Silicon came from Japan

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

time three Japanese researchers names Isamu Akasaki, Hiroshi Amano and Shuji Nakamura started developing this area in the early 1990s so that LEDs that emit blue light. For this they were awarded in 2014 the Nobel Prize for physics. GaN semiconductors are already used in power electronics. They promise a better performance in consumer electronics, electric cars or in data centres. Galiumnitrid has a better thermal conductivity than silicon and works more efficiently at higher temperatures. However, the production of GaN components is still very expensive. At the ‘Fraunhofer Technology Centre for semiconductor materials ’ in Freiberg, researchers in 2011 have already started with new

Associate inspected a gallium nitride substrate. Photo Fraunhofer THM

Cleanroom employees in the production. Photo: Fotolia.

gallium nitride substrate. Photo Fraunhofer THM

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investment concepts. And last year, they developed a system in full working operation, which so far are showing good results. The researchers are confident that in the future, this will significantly reduce manufacturing costs and therefore release the burden on businesses.

IBM however thinks in a different way. The American company relies on carbon nanotubes instead of Silicon. With the new material, so the conviction of the IBM Developer skips an important hurdle for the further reduction of semiconductors and transistor contacts. So, carbon nanotubes under 10 nanometres

would deliver excellent results even in this case. The performance of computers could be with improved semiconductors. It could take up to five to ten years to develop this system, however until these new devices come to market, we could have already discovered and developed a different system and

The semiconductor industry boom

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

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

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

• Sensors in wearables: PwC experts predict that until 2019 they were sell over half a billion units. As a result, sales are rising rapidly. 15 million US dollars was made in 2013. It is expected that in 2019 seven billion dollar is to be made through sales.

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

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

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| The Next-Generation

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therefore could replace silicon semiconductors, so the forecast of IBM researchers.

Testing before production

New materials in mass production means new challenges to manu-facturing facilities in the clean room. It is because of cost reasons a new manufacturing line cannot be built, and for any new material to be developed. The chipmakers Infineon are pursuing the claim to utilize existing facilities as efficiently as possible. But before new materials come into production, it depends on whether interactions are to be expected and which risks need checking to expose potential threats. Only in this way, high quality of the products can be guaranteed.

Also, the production in cleanrooms is itself always smarter against the background of the industry 4.0 concept. The cleanroom industry requirements will increase with the further automation. The increasing use of semiconductors in semiconductor production will make the production in the future faster and more cost-effectively. New cleanroom standards are necessary as new regulations are drafted year after year.

Author: Thomas Köhler

CeBIT trends.

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

• Big data: more and more data needs evaluating. This will increase the demands on data centers and will expect more performance. And the whole thing has to be with energy - and be cost-efficient.

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

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

• Security: When growing cybercrime there is a need for rises in effective security strategies and new architectures

• Mobile: the future belongs to mobile devices. The industry looks for links from business software and mobile devices.

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

The Next-Generation |

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

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Sitting for hours in front of a microscope or at safety work benches demands undue physical strain from muscles and the musculoskeletal

system. The results can be tension, pain, or even illness-related absenteeism. With ergonomic work places, muscle-relaxing exercises

and the re-consideration of incorrect postures and behaviors, cleanroom employees can remain healthy. CLEANROOM MAGAZINE

interviewed cleanroom technician and certified Mental Trainer/Fitness Coach Richard Reudelsdorf of the company Dittel Engineering

about cleanroom-suitable, health-related prevention techniques.

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

Clothing, Comfort, Sitting Posture

Ergonomics in cleanrooms begins with the clothing which has to provide the necessary protection from contamination, a level of comfort which offers the employee an unimposing fit as well as giving the employee unrestricted motoric and mental performance capabilities. Unaware of the effect, uncomfortable fabrics put strains on mental capacities which leads to quickly becoming fatigued. Results are a reduction in concentration, longer reaction times and increased rates of error. When these negative mental processes operating in the background are reduced with the correct clothing, concentration and performance capabilities will improve. Further physical stress factors in cleanrooms come about through improper sitting posture, for example

while sitting at a microscope for hours on end, or insufficient physical movement in the course of a working day. Health and product protection collide with each other under these conditions because regarding the protection of products, it is indispensable to move about inside a cleanroom as slowly as possible and then only when necessary. However, sitting still or moving as slowly as possible contradict human nature. Our skeleton needs a strong and stable musculature which is

achieved by putting our musculature under a load otherwise it becomes weak and subject to complications. As a fitness center will never become part of a cleanroom’s design, muscles have to be activated by alternating between contraction and relaxation. Balling the fist is one example of a strengthening exercise with minimal movement.

Regarding posture: Sitting bent over is for all intents and purposes taboo as the back pain resulting from this

Ergonomics and Fitness in the cleanroom |

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Cleanroom adapted exercises for progressive muscle relaxationAn exercise for working at a microscope:

The goal of the exercise is to con-sciously relax a particular muscle group, whereby a condition of relax-ation should be achieved regarding a particular muscle group.

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

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The baton to pass, this is in the cleanroom only mentally possible. Photo: Cleanroom Media.

constant strain and tension on the back is the number one problem in the modern working world. Every second German over 30 years old suffers from back problems. Conventional medicine is only able to ease the pain however will never be able to combat the causes. Cortisone injections against pain

have noticeable effects but unduly act on the metabolism and become addictive.

“Healthy sitting” as a slogan sounds contradictory but it refers to specific sitting solutions inside a cleanroom, such as those from the company Dauphin HumanDesign Group. Here,

a distinct seat mechanism supports an employee’s spinal column while allowing him to concentrate on his work with minimal movement.In Part 2 (next issue), read more about ergonomics and fitness in cleanrooms.

Author: Josef Kwasnitza

Ergonomics and Fitness in the cleanroom |

Cleanroom Magazin: Mr. Reudelsdorf, you have been working for quite some time in parallel as a coach and a trainer in the field of sport and as a cleanroom technician and are knowledgeable about the many kinds of variously equipped cleanrooms. You are aware of in a double sense, and tangibly measureable, how necessary physical movement is for cleanroom personnel on one side but also how movement significantly increases the likelihood of contamination on the other side. Richard Reudelsdorf: This problem has been well described in the article. Activities in a cleanroom underlie a person’s own specifics and the avoidance, respectively the prevention of contamination remains the number one priority. However, some things remain possible for employees to be able to stay productive. The progressive relaxation exercises for example for working at a microscope are offered in this article.

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

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

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The 1999 standard DIN EN ISO 14644 was the first international standard for detecting space Cleanroom classifications. At its adoption, it was agreed that after at least every ten years there needed to be update of the standard, i.e. a correction of errors and an adaptation to new circumstances. This process was started in 2005. An international team of experts should develop a rewrite, and his main priority will be to first define priorities requiring urgent revision and work.

The fact that this recast expected to be published in the spring of 2016, it does make clear, the consultations were difficult. However, the draft now has a good chance to be adopted in the near future. Here is an overview of the main changes.

ISO 14644 part 1

Statistical analysis of measurements:

To do this, there was controversy. Multiple negotiations were close to failure. The topic number and location of measuring points counted for proof of conformity with

a particular class of the cleanroom to the main point of contention. Described in the introduction of the previous standard 14644-1 it was explained how the new formula worked and it was not exactly clear, even for experts it was not possible. Therefore, this new introduction describes what assumptions do underlie. In the future it should therefore be possible to follow the adopted specifications. Thus one of the recognized gaps was closed.

In the current standard, it is as-sumed that the particle load of a space is homogeneous, so that the measured values are only scattered around this mean. This was also the required statistical procedure for the evaluation of the measurements that is only understood by a few. In the new version, the space must no longer be as homogeneous for it to be considered, which is also not practical experience. In the future it „only“ comes to show that the required limit of particle concentration is observed. This makes it obsolete to the subsequent statistical analysis and evaluation of measurements, these will no longer be in the new version. Each single measurement must now comply with the required

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

Number of points:

In the current standard, the number of measurement points of the formula was determined: the number of measuring points stems from the root of the surface area in m2, rounded up to the next higher whole number. This is not derived or 100% accurate but on the basis of the above assumptions, experts should find a suitable scientific approach, which eliminates these inaccuracies that may or may not arise.

According to the new version, this number of measuring points must be, read in the future from a table where the number is still on the surface area that is dependent on. The difference with the old formula is not so serious, in some places, one or two measuring points must be used more than before. Only in very large rooms from 1,000 square metres is a linear increase in the number.

Location of the measurement points:

Whether more measuring points bring more security with regard

What keeps its Longevity is gooIn the spring of 2016 the revised version of the DIN EN ISO 14644-1 and -2 will be published..

| Law and regulations

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

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to a possible breach to the required cleanroom quality, this remains to be clearly known. The debates were fierce when it came to the location of the measurement points. The „theorists“ demanded that these should be newly determined via random number generators for each qualification and requalifi-cation. Select the location of the measurement point, chosen from random number generators, and that would cause the whole space to be examined in the course of time, and should respond a posi-tive answer.

T h e „ p ra g m a t i s t s “ c o u l d n o t reconcile themselves, and so in most cases the conditions for the application of such a course of action is difficult. That‘s why the „pragmatist“ chooses the location of the measurement points according to a completed risk assessment, and after engineering the plan. If

the situation is once determined, everything in the standard should also be maintained.

The compromise is now: the location of the measurement points should be representative of the area. The set of points can be done through a risk assessment and should evenly cover the area. Can a purely statistical examination of the location of the measurement points capture all influences on the quality of the room - around type of ventilation, location of vents, location of installations, personnel, etc. - ? Although, this compromise represents a user friendly way.

Because the number of measuring points now must be read from a table, many operators will need to revise their documents and customize possibly one or two measurement points that are used evaluate and redefine.

Definition of clean room class:

The basic chart for this definition of the cleanroom classes was adopted and ended up virtually unchanged. However, the particle sizes, which would result in very low limits for a classification to be met, has been removed from the purer classes in the classification as statistically reliable evidence m this would mean a disproportionate effort to comply with. So the limit value for particles of ≥ 5 µm was cancelled, in ISO class 5. Due to this it has been disused enormously in the past, on whether such low limits are useful. Now, it has decided to adapt the existing classification.

Who needs a specification for this size with such low limits, which must rely now on the so-called macro descriptor. However, it is still preserved, allowing the standardized specification of limits

Law and regulations |

Photo: Berner International

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for large particles, even if they are not in the focus of the standard. This should specifically comply in the European pharmaceutical industry, as the GMP class A date ISO class 5 that was almost equated was with specifications both 0.5 µm and 5 µm particles. The detour via the macro descriptor means but only a change in the choice of words requires only minor adjustments.

Only for those, an ISO class 5 will only be granted on the basis of 5 µm who wanted to specify the particle. This will involve only a vanishingly small number of operators, if at all.

Compliance with the clean room classes:

The procedure for the determination of compliance with the cleanroom classes is preserved. What is new is that now all information (not only the measuring process itself, but also the minimum requirements for the measuring instruments) are fully included in part 1, so that it is formally no longer instructed to look elsewhere for other parts of the standard. The concept of the macro descriptor was also preserved, as mentioned above.

Who, however, with particles < 0,1 µm wanted to work, for which there was a U-descriptor (for ultrafine particles). This should be replaced in favour of a new part of ISO 14644, in which you wanted to deal with nanoparticles. This part was developed parallel to part 1 so that you wanted to deal with references to this new part of the topic of very small particles. Unfortunately this part failed the participants at the last moment, due to a missing consensus, so that now there is a gap.

ISO 14644 part 2

Part 2 of the standard 14644 focused on the measures for determining the on-going compliance with the requirements of part 1. It contained among others notes to the intervals for re qualifications. In the future, the focus will be on monitoring, so on a more or less continuous mon-itoring selective process.

The display of aspects to be observed here plays an important role in the new part 2. Normative, it is not codified but who needs a monitoring to a high extent. For example, this must define each operator based on a risk assessment itself and documented in a monitoring plan.

By chance, here is the set found that the operator should make the re qualification once a year. This is just pure classification, there are no recommendations for further testing, as they were called so far. Here, the operator due to its own specifications, for example on the basis of a risk assessment, must now define the extent of testing required and the intervals associated.

Opposition phase

Opposition phase now draft part 1 and 2 should be released as soon as possible and presented to the public for commenting. As soon as the subsequent objections, for example to errors or Unverständlichkeiten, are edited, the final version is expected to be released in the spring of 2016.

Author: Dirk Stanischewski

The person of

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

| Law and regulations

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That was certainly a clean sweep: The representatives of InfraSolution AG came for their first time as an exhibitor to last October’s Cleanzone, presented a world premiere and promptly won the ReinraumAkademie’s Cleanroom Award. With RobotScan Flex, a robot for air filter inspections, this company from Langen, Germany, convinced the visitors of Cleanzone and its competitors to select it as the winner

of the award for the best cleanroom innovation of the year.

“We are very pleased about winning the award. In behalf of the entire team, I thank you all very much. It

was an excellent idea to come here” said Mathias Itter, Chairman and CTO of InfraSolution AG during the award presentation. The Award endowed with 3,000 Euros was presented by Yvonne Weis, representative of last year’s winner, Initial, and Frank Duvernell, Managing Director of the ReinraumAkademie.

With the Cleanroom Award, the ReinraumAkademie distinguishes every year a pioneering cleanroom technology innovation. A profes-sional jury selects beforehand, from all the applicants ,the final five. These five finalists then present in front

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

InfraSolution AG received the Cleanroom Award 2015 for its unprecedented, automated mea-suring system with the name of

RobotScan Flex. This device enables filter integrity tests in up until now unrivaled quality. A robot arm scans automatically, in accordance with the valid norms and regulations, vertical as well as horizontal terminal filters and Laminar Flow units. Intelligent software meanwhile compiles the necessary documentation and analyses and visualizes the measurements in the form of an electronic test record. “The robot lingers neither too long nor too short in positions of incorrect spacing under the filter”, explains Mathias Itter. “In this way, there are no longer any distorted measurements.

RobotScan Flex is the Industry’s Innovation of the Year A robot for air filter inspections wins the Cleanroom Award 2015.

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

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

| Cleanzone 2015

“Due to the absence of any manual work, we get timely, precise measurements with the minimal of human input.”Mathias Itter, Chairman and CTO of InfraSolution AG

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Besides, due to the absence of any manual work, we get timely, precise measurements with the most mini-mal of human input.” A further advantage is that the three-arm-robot is able to reach every point in the room and recognize obstacles such as sprinkler heads or walls. “Something like this was not possible five years ago, as the calculation technology was not yet available” emphasizes Itter. RobotScan Flex is planned to hit the market in the middle of 2016.

Not only RobotScan celebrated its world premiere at Cleanzone. The ReinraumAkademie’s Creative Prize also made its debut. “With this special award presented extra to the Cleanroom Award, we want to bring to the attention of cleanroom planners and operators, the aspects of employee w e l l - b e i n g a n d c o n c e n t r a t i o n influenced by ergonomics and color in the cleanroom” said Frank Duvernell, Managing Director of the ReinraumAkademie. The winner of the first Creative Prize was the company MED-EL from Innsbruck, Austria. The producer of hearing implants received the award for the distinctly creative design and creation of a newly-built cleanroom complex. The Swiss artist, Beat Toniolo, designed the Creative Prize and decided on glass for the

material. MED-EL representative Christian Dragosits who together with his colleague Alexander Mayr accepted the award, disclosed just how suitable the design and material were: “We used a lot of glass for our new cleanroom so that employees are able to see the Autumn colors and the Winter snows.”

Overall, Cleanzone which is organ-ized by the Messe Frankfurt in part-nership with the ReinraumAkade-mie, in its fourth year of existence, closed with a remarkable balance sheet: Compared with last year, Cleanzone registered a two-digit in-crease and this in all parameters – ex-

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

Cleanzone 2015 |

Call for application - Submit your project for the Clean Room Award 2016 Until when can projects be submitted?The deadline for applications is June 30, 2016. Participants can be companies, institutions and scientific establishments.

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

Where should the applications be sent?Applications for the Cleanroom Award 2016 are to be sent to the following address:ReinraumAkademie GmbHRosa-Luxemburg-Str. 12-1404103 LeipzigGermanyTel.: +49/341/98989/303E-Mail: [email protected]: www.reinraum-adademie.de

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hibitors, surface area, visitors and internationality. With 731 profes-sional visitors from 32 countries, Cleanzone was able to record 20

percent more vis-itors than in 2014. The number of ex-hibitors increased by 40 percent to 88 companies from 12 countries. The products and ser-vices on offer cov-ered the entire life cycle of a cleanroom from the construc-tion and planning,

the qualifying that is the verifica-tion whether the cleanroom has been built according to standards and norms, and operations.

Particularly found popular by Cleanzone’s visitors was the Clean-zone Congress organized by the Re-inraumAkademie. International, renowned cleanroom technology professionals imparted their prac-tice-oriented knowledge and also new technical discoveries.

Cleanzone has reached and be-come a permanent international and inter-disciplinary platform for the exchange of cleanroom tech-nologies of significant magnitude. Frank Duvernell, Managing Direc-

tor of the ReinraumAkademie and Partner of Cleanzone says: “I am to-tally convinced that Cleanzone will continue to grow as it is here that all sectors of the industry have the opportunity to meet. This event has once again shown that production and assembly in cleanrooms is an international topic for the future and that it encompasses every sin-gle industry.”

The next Cleanzone will take place on November 8th and 9th, 2016, in Frankfurt am Main, Germany.

Author: Frank Baecke.

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

Smart Garment The company Berendsen (Arnheim, the Netherlands) introduced a textile management system which with UHF technology, RFID chips and intelligent software enables the tracking of every single piece of cleanroom clothing. The system takes into account which piece of clothing is being used at the moment, or which is in the stock room or even which piece is being cleaned. Thanks to this information, over-capacities in the stock room are visible, also clothing which is never worn. Moreover, the system is able to be used for controlling access for example in cleanroom air locks. Trolley Light Inductive The company Systec & Solutions GmbH (Karlsruhe, Germany) presented a work station on wheels which thanks to the lithium-ion batteries can be used in cleanrooms without any electrical cables. The mobile work station consists of a stainless steel battery housing, a vertically adjustable display for working while standing and an inclinable glass

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

Clothing Disinfection with LightA research fellowship affiliated with the company Ortner Reinraumtechnik GmbH (Villach, Austria) presented a solution for the continuous disinfection of cleanroom clothing while being worn. The basis is a special textile dye which produces oxygen when exposed to light and thus permanently sterilizes textile surfaces. This worldwide, unique development is not only interesting for the cleanroom industry but also for example, for doctors in disaster areas. Project partners were dastex, M. Dohmen and the TU Graz.

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

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

Surfaces for Cleanroom EquipmentSenoplast Klepsch & Co. GmbH (Piesendorf, Austria) showed with its product Senomed a newly developed plastic material for surfaces in cleanrooms and air locks. The multi-layered material is chemical-resistant, scratch-proof, abrasion resistant and producible in a limitless palette of colors. Furthermore, the material has an anti-bacterial effect. Micro-biological tests have shown that the material itself is neutralizing causing microbes to die off. This innovation is suitable for aseptic and non-aseptic areas and has the potential to steadily replace materials now in use.

Cleanroom Award 2015. Photo: Cleanroom Media

| Cleanzone 2015

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

Cleanroom Knowledge for Reference |

Containment HandbookContainment solutions are becoming more important for the manufacture of pharmaceutical products as new medical ingredients are often highly reactive even in small dosages. Therefore containments have to offer the highest degree of tightness in order to protect employees and the environment from contamination. At the same time, containments have to enable trouble-free material flows and maintenance. How to solve this technological balancing act, which regulatory requirements are to be fulfilled in the planning, construction and renovation of these facilities and how to safeguard employee safety, all of these issues are described in the newly published “Containment Handbook”. This publication has collected the widely scattered information about processes, technologies and regulations and has made available to laboratory operators and pharmaceutical producers a very worthwhile reference book.

“Containment-Handbuch”. Publisher ISPE/D/A/CH Containment Work Group of the International Society for Pharmaceutical Engineering, 1st Edition 2015, 172 pages. The book can be ordered online via the ISPE-Dach website: http://ispe-dach.org/web/die-ispe-dach-arbeitsgruppen/regional-cop-containment

Good Transport Practice in the Pharmaceutical IndustryThe Good Transport Practice in the Pharmaceutical Industry is once again up to date, as new EU guidelines have set standards which have to be applied. Thereby it is not just about the standard practices which require fundamental improvements. It is much more about the formal requirements which additionally have to be posed particularly a quality assurance system which is able to document all activities and make them traceable. In this jungle of requirements and regulations, this book offers the reader a sense of orientation based on practice. In focus is the collaboration of diverse disciplines , the portrayal of the resulting effects of synergy, the exchange of information between the various professions, which occasionally are missing their cross-connections, consequently providing the recognition of significant relationships between all the players. Examples of real-life practice, tips and background information help loosen up the contents and make understanding much easier.

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

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NürnbergMainz

Stuttgart

München

Magdeburg

Hannover

ErfurtDresden

PotsdamBerlin

Wiesbaden

Saarbrücken

Bremen

SchwerinHamburg

Kiel

Düsseldorf

Luzern

Basel

Wangen a.d. Aare

Chur

St. GallenZürichAarau

SolothurnDelèmont

FreiburgBern

Neuenburg

Konstanz

Lausanne

Genf

Nürnberg

Germany

Switzerland

Leipzig

Trade Fairs and Congresses

Köln

13.-14.04.2016Lab InnovationsLausanne Switzerland

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München

21. -23.04.2016Cleanroom ExhibitionIstanbul, Turkey

10.-11.02.2016Pharmapack Europe Paris, France

21.-23.04.2016AustropharmVienna Austria

| Trade Fairs and Congresses

Berlin18.-19.03.2016InterpharmBerlin Germany

19.-21.04.2016PartecNürnberg Germany

10.-13.05.2016AnalyticaMunich Germany

31.05.-02.06.2016parts2cleanStuttgart Germany

Stuttgart

12.-14.04.2016MEDTEC EUROPEStuttgart Germany

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Events at the ReinraumAkademie, Germany and the CleanroomAcademy, SwitzerlandReinraum-Expert Days| Cleanroom Expert Days27.-28.01.2016 | Modern Cleanroom Design and Layout. ISO/DESIGN/GMP/AMC (Modular System – 4 Modules) | Leipzig, Germany02.-03.02.2016 | Cleanroom and Hospital – one Topic, two Worlds | Wangen an der Aare, Switzerland09.-10.03.2016 | Cleanroom Layout, Planning and Construction | Leipzig, Germany11.-12.05.2016 | Flexible Cleanroom Design and the Integration of Production Facilities, Equipment and Furnishings in a Cleanroom | Leipzig, Germany07.-08.06.2016 | Cleanroom Layout, Planning and Construction | Wangen an der Aare, Switzerland28.-29.09.2016 | Flexible Cleanroom Design and the Integration of Production Facilities, Equipment and Furnishings in Cleanrooms | Wangen an der Aare, Switzerland05.-06.10.2016 | Fundamentals and Optimization in Cleanroom Operations, Cleanroom and Qualification | Leipzig, Germany23.-24.11.2016 | Optimal Cleanroom Personnel | Leipzig, Germany07.-08.12.2016 | Optimization and Qualification of Cleanroom Operations | Wangen an der Aare, Switzerland

BEHAVIOR IN A CLEANROOM23.02.2016 | One-Day Training Plus | Aschaffenburg, Germany11.04.2016 | One-Day Training Plus | Penzberg, Germany27.09.2016 | One-Day Training Plus | Wangen an der Aare, Switzerland02.11.2016 | One-Day Training Plus | Leipzig, Germany

BASICS OF PROFESSIONAL CLEANROOM CLEANING

24.-25.02.2016 | Two-Day Seminars | Aschaffenburg, Germany17.-18.10.2016 | Two-Day Seminars | Leipzig, Germany

ADDITIONAL EVENTS27.01.2016 | International New Year Reception of the Cleanroom Industry and users | Leipzig, Germany 02.02.2016 | New Years Apéro of Swiss Cleanroom Industry and users | Wangen an der Aare, Switzerland02.-03.05.2016 | Seminar „Working in a Cleanroom“ | Nürnberg (D)28.09.2016 | Swiss Cleanroom Industry’s Autumnal Reception | Wangen an der Aare, Switzerland05.10.2016 | Cleanroom Industry’s Autumnal Reception | Leipzig, Germany

Events |

The events take place at:Cleanroom Experience Competence CenterRosa-Luxemburg-Str. 12-14, D-04103 Leipzig, GermanyTel.: +49/341/98989-0, Fax: +49/341/[email protected], www.reinraum-akademie.de

Cleanroom Experience Competence CenterVorstadt 4, CH-3380 Wangen an der Aare, SwitzerlandTel.: +41/326316050, Fax: +41/[email protected], www.cleanroom-academy.ch

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Imprint CLEANROOM MAGAZINE Is issued and published byCleanroom Media GmbHRosa-Luxemburg-Straße 12-1404103 Leipzig, Germany

Internetwww.cleanroom-media.com

Management Frank Duvernell, (V.i.S.d.P.)

Administration – Cleanroom Media Maja FrankeTel. +49 341 98989 [email protected]

Chief EditorFrank BaeckeTel. +49 341 98989 [email protected]

Translation Bill HillmanDaniel Read

AuthorsFrank BaeckeFrank DuvernellPiet FelberMaja Franke Gero HassinkThomas KöhlerJosef KwasnitzaDirk Stanischewski

Advertisements/Notifications Maja FrankeTel. +49 341 98989 [email protected]

Implementation Wohlfahrt GmbHwww.wohlfahrt.net

Publication Quarterly

Circulation 10,000 copies

Printer Löhnert-Druck, Leipzig

ISSN 2364-0405

Reprints Reproduction and digital use of articles from this magazine, even partially, are only allowed subject to prior approval by the editorial staff. No liability is assumed for unsolicited manuscripts of photographs.

Order your free subscriptionn www.cleanroom-media.com

Next issue | April, 2016

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E D I T I O N 2 / 2 0 1 2 E D I T I O N 1 / 2 0 1 3 E D I T I O N 2 / 2 0 1 3 E D I T I O N 1 / 2 0 1 4 E D I T I O N 2 / 2 0 1 4

E D I T I O N 1 / 2 0 1 5 E D I T I O N 2 / 2 0 1 5 E D I T I O N 3 / 2 0 1 5 E D I T I O N 4 / 2 0 1 5 E D I T I O N 1 / 2 0 1 6

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

CLEANROOMMAGAZINE


spring 2015

02

Rules & regulationsAnnoying agree or a tip for money values?OLEDs The lighting revolution out of the cleanroom Hospital germsHow cleanroom technologies prevent infections

Blossoming NatureDangerousContaminationThe infl uence of pollen and air humidity on your production

Joy of Being DrivenHow the vision of autonomous driving is gradually becoming a reality

Smart TextilesIntelligent fabric changes medicine, architecture, fashion and the car industry

Operating TheatreThis is what the surgery workstation of the future looks like

03summer

2015

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


autumn 2015

04 CLEANROOMMAGAZINE


winter 2016

01

Outlook 2016 Experts estimate future prospects in the cleanroom industry

Talent Development How employees become cleanroom operatives

Laws & Regulations Newest revisions of ISO 14644-1 and ISO 14644-2

Approaching the Dimension3D printing is opening new perspectives for cleanrooms

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Documents

Cleanroom Magazine 01-2016