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Künstliche Befruchtung Was hat der Kinderwunsch mit Reinräumen zu tun? Never stop thinkingCleanroom Award und Creative Prize 2016

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In-Vitro-Fertilisation How does the desire to have children correlate with cleanrooms?

Never stop thinkingCleanroom Award & Creative Prize 2016

High Voltage in the Cleanroom Throw out the sparks and protect sensitive products

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CLEANROOM MAGAZINE 2/2016

You can remember from past issues that we reported on the Internet of Things and the 3D Printer, on the Operation Theater of the future and on Driverless Driving. All these innovations have induced significant changes although they are based on tiny component parts. Micro-controllers, miniature batteries, communication chips and micro-systems are the foundation on which the digital world of tomorrow will arise.

In order for this foundation to be sustainable, the components have to be produced to the exclusion of contamination. That’s why we have clean-rooms. However there lurks still another danger, which cannot be kept away from products with air locks, ventilation systems and isopropyl alcohol: Electrostatic discharge. Everyone is familiar with this for example when touching a door handle.

These tiny sparks can be disastrous for production. For a micro-electronic component, the energy of electrostatic discharge is comparable to lightning striking a tree. Respectively, the results are also enormously devastating for integrated switches, instrumentation or small-structured components. Learn about how lightning strikes can be prevented inside a cleanroom in our cover story.

Change of subject: The ReinraumAkademie is looking for the best ideas in respect to innovation, sustainability and energy efficiency in cleanrooms for the Cleanroom Award 2016. Join in! You can submit your projects until August 31th, 2016. The winner will be announced at Cleanzone. Read about how to participate in our Service section.

I wish you pleasant reading in our new issue.

Frank DuvernellEditor

Frank Duvernell: „I have been convinced for some time that cleanroom technology is a vastly interesting topic. This enthusiasm I

would like to bring out into the minds of the general public in order to make professionals

and talented students more aware of the relatively unknown but exciting professional

opportunities in the field of cleanroom technology. There is only one place where any

kind of potential has to be avoided, namely, the cleanroom. Why? Please see right.“

Dear Readers!

EDIT

ORIA

L

Editorial |

Electrostatic Charges

generate High Voltages

Picking up a plastic bag from

a table: 1.200 bis 20.000 Volt (a)

Walking on untreated vinyl

floors: 250 bis 12.000 Volt (b)

Source: DGUV

(a) (b)

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CONTENTS 02/2016

08 Title Story: Lightning Strike in the Cleanroom

Electrostatic discharges are able to destroy electronic and micro-structured component parts. How to prevent eclectrostatic sparks when producing in a cleanroom.................................................

LIFE & BUSINESSLatest News from the World of Cleanrooms

06 The Market in Brief• Cannabis used more frequently for medical purposes • India is on the Way to becoming the World’s Pharmacy • 3D-Televisions are on the Way Out • Experts expect Approvals for New Medi-cations in 2016 • A Fish could save People with Eye Disease from becoming Blind • Replace Body Parts and improve the Treatment of Diseases • Hospital Group does away with Doctor’s White Coat................................................16 The next big thing?Virtual reality devices are expected to replace computers and Smartphones. The business models are still vague and the contens meager but the new possibilities are fantastic.................................................20 Portrait: Joachim Ludwig

On May 1st, 2016, Colandis GmbH will be celebrating its 20 year anniversary. How Managing Director Joachim Ludwig formed his one-man engineering office into a company operating worldwide.................................................

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Coverstory: throw out the sparks and protect sensitive products. Photo: Cleanroom Media

Virtual Reality: VR goggles are considered the next big thing. Photo: Eugenio Marongiu/Fotolia

CONT

ENTS

| Contents

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44 New Surfaces for Cleanroom TechnologySenomed is a chemically-resistant, scrub-resistant and anti-bacterial synthetic film for surfaces in cleanrooms and air locks. It has the potential to replace existing materials..............................................50 What do you do there, …?Birgit Kriegesmann, responsible for the micro-biological quality controlat Bremer Pharma GmbH in Wartburg, Germany.................................................

SERVICEEvents, Awards, Columns

52 Laws and Regulations: What it comes down toWhen everything is already written down in the regulations, why don’t we have the perfect cleanroom?................................................

24 When new Life emerges from the CleanroomFor involuntary childless couples, artif icial insemination is one of the ways to founding a family. This way often begins in a cleanroom.................................................32 Controversy:More Cleanroom Technology against Hospital Germs?

If the use of more cleanroom technology is able to prevent hospital infections is discussed by Professor Arnold Brunner of the University Luzern Technology and Architecture and Dr. Uli Lösch of the University Hospital Basel. ................................................36 Behind the Scenes: On the road with René Hecker

René Hecker, Account & Project Manager at the Dutch measurement instrumentation company Pedak.................................................

SCIENCE & TECHNOLOGYSolutions for the World of Cleanrooms

38 Technology in Brief• The lightest Solar Cell in the World • Pharmaceutical Products dosed cleanly without any Filaments or Dripping • Pipe Fittings meeting GMP Requirements • The Production of Y-Connectors in Cleanroom Facilities • Granulate Production in High Containment • Microbiological Air Monitoring accomplished more easily • New Product Generation of Premium Pocket Filters................................................40 Keep It CleanCleaning procedures critically inf luence product quality but also the costs. How procedures are able to be economically set up will be shown at the part2clean trade fair at the end of May in Stuttgart, Germany.................................................

54 Cleanroom Award 2016: Send in your Applications nowUntil August 31th, 2016, the Reinraum-Akademie (Cleanroom Academy) will be accepting the best ideas in innovation, sustainability and energy saving in the cleanroom. The award will be presented at the beginning of November at Cleanzone 2016.................................................57 Professional Literature: References for the Cleanroom Industry• EU Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use................................................58 Trade Fairs and Events................................................60 Imprint

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Cleanroom technology can help couples to fertility. Photo: xolibu/Fotolia

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And the winner wil be? Read more about the cleanroom award 2016. Photo: Nils Bröer

Contents |

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Cannabis used more frequently for Medical Purposes

Approval Debate | Cannabis anti-in-flammatory, relieves pain and is far better tolerated thatn morphine and opiates. For pharmaceutical com-panies it is nevertheless difficult to get approvals for cannabis-based medications. In Germany for example, it is neither allowed to plant cannabis, to possess nor to be sold. This situation could soon be changed. The Federal Public Health Ministry is considering putting in the hands of a federal “Cannabis Agency”, the cultivation and sale of cannabis. The plant’s ingredients suit themselves for a wide range of medical applications. The spectrum ranges from wound medications, the treatment of Multiple Sclerosis to the treatment of neurological illnesses such as the Tourette-Syn-drome and ADHS.

India is on the Way to becoming the World’s Pharmacy

Generics Market | The market research company Global Data forecasts for the Indian pharmaceutical market a tremendous surge in growth. Market volumes are expected to more than double from 20 to 55 billion dollars in the next five years. The driver of this development is the tremendous growth in the generics industry. Ac-cording to Global Data India covers 20 percent of the worldwide generics market and is therefore the world’s largest exporter of imitations drugs. The success of the Indian generics

industry is a result of the low produc-tion costs and a worldwide increase in the demand for cheaper medicinal products.

3D Television on the Way Out

VR and HD dominate | The Korean manufacturers Samsung and LG are pulling out on the much-praised 3D technology for televisions. LG wants to halve its production of 3D devices,

Samsung will not produce any new products with 3D functions. The reasons for this is the low demand caused by the need to wear 3D glasses and the lack of standards for the glasses. Another reason is the com-petition from the new technologies such as ultra HD and virtual reality. Industry observers forecast that 3D televisions will make a comeback as soon as it becomes possible to build a 3D panel which can be used without glasses.

Experts expect Approvalsfor new Medications in 2016

Pharmaceuticals | The Association of Pharmaceutical Companies doing Research in Germany (VfA) believes that in this year several new medi-cations will be receiving approvals. Included are two-digit numbers of new pharmaceuticals which aid in the treatment of leukemia, lung cancer and bone marrow cancer. Several of these pharmaceuticals are based on newly developed prin-ciples of operation, for example, the use of oncolytical viruses which attack cancer cells and activate the

Life&BusinessThe Market in Brief

For medical purposes it is expected the cultivation and

sale of cannabis will be allowed. Photo: stokkete/Fotolilo

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| The Market in Brief

The worldwide demand for generics is causing a boom for

India’s pharmaceutical manufacturers. Photo: arsdigital/

Fotolia

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immune system to act against these cells. Additionally, other antibiotics against problem germs (MRSA and others) as well as medications for the treatment of hepatitis C, the treatment of hemophilia A and B, and new vaccines against anthrax are expected to reach the market. Moreover, more than ten new med-ications for the treatment of patients with rare diseases are expected to be approved in 2016.

A Fish could save Those with Eye Disease from becoming Blind

Corneal Transplantation | The much-eaten fish Tilapia from the family cichild could save thousands of people from becoming blind. As researchers have reported in the

journal “Der Ophthalmologe” (The Ophthalmologist), an artificial cornea made out of Tilapia scales is currently being tested. The back-ground of this research is the large need for donated corneas which until now have been supplied by deceased doners. On the search for alternatives, researchers at the Uni-versity Hospital for Eye Care Cologne and the University Hospital Leiden are examining a substance which comes from the fish’s scales. These are cultured in aquacultures, the fish’s scales consequently providing a base material whose Type 1 collagen is similar to a human cornea. With an experiment on rats, the artificial cornea grew as well as the natural cornea on other rats.

Replace Body Parts and improve Treatment of Disease

Stem Cell Research | In Switzerland, the five-year national research pro-gram “Stem Cells and Regenerative Medicine” has come to its close. The results which have been recently presented are very promising. The

researchers have found out that the risk of tumors don’t only come from stem cells but also from immature intermediate forms. They also dis-covered that the pancreas following the destruction of all insulin pro-ducing cells is able to reproduce new cells from closely related cell types. This discovery could make insulin injections for diabetics unnecessary.

In another project, a new material was developed which replaces human cartilage. Enriched with a patient’s own cells, the material is able to support the development of natural tissue.

Hospital Group does away with Doctors’ White Coats

WHO-Recommendation | The Askle-pios Group is the first hospital oper-ator which has done away with the traditional long sleeved white coat in all of its 100 medical facilities. A short sleeved garment for doctors, the so-called tunic, has taken its place, which in many medical centers is already the rule. The occasion for

this change is the recommendation from the Robert Koch Institute and the World Health Organization WHO. They have shown in several studies that pathogens are more frequently found on long sleeved coats. Asklepios is the first hospital operator which has implemented the recommendation. Related to this issue, according to a recent survey conducted by Asklepios, 65 percent of the people surveyed are concerned about being infected with multi-re-sistant germs in a hospital.

The Swiss stem cell research focuses on regenerative

medicine. Photo: kwanchaift/Fotolia

The Market in Brief |

The scales of the Tilapia supply the base material for

artificial human corneas. Photo: KonArt/Fotolia

Long sleeved doctor’s coats are often permeated with

germs and should be replaced with short sleeved tunics.

Photo: Syda Productions/Fotolia

3D-Televisions will see their breakthrough when they can

be used without glasses.And maybe when

this kid is big.

Photo: Sunny studio/Fotolia

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Mini Sparks with Maxi Damage

Electrostatic discharges are able to damage integrated switches, instrumentation and small-structured component parts. It is nearly impossible to prevent these static discharges but it is possible to render them harmless. Materials suitable for use in a cleanroom, anti-static measures and grounding protect against spark discharges.

Product loss threatens those who take no precautions against electrostatic discharging.

Phot

o: C

lean

room

Med

ia

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“A lack of gap will certainly mean that some of the sparks will jump the seam.” With these words the poet Er-ich Limpach (1899-1965) described in a lyrical form what manufacturers of sensitive components describe with a balled fist: electrostatic discharges.

The mini sparks which are known when combing hair or grabbing a door handle come across as being harmless but in the production of small and sensitive products they often result in fatal consequences. For a micro-electronic component for example, the energy of an elec-trostatic discharge is comparable to lightning striking a tree.

Proportionately the results are disastrous. They range from the damage or destruction of electronic components, instrumentation errors, breakdowns and faults in electroni-cally controlled production processes on up to the danger of explosion in areas with flammable gases, vapors and dust.

Out of every defect which is detected, there are two to five which remain undetected.

“The nasty thing about electrostatic discharges is that according to industrial estimates, out of every defect which is detected in produc-tion, there are two to five which are detected after delivery” says Ricco Scheibel, Sales Manager of

PMT Partikel-Messtechnik GmbH. The company located in Heimsheim, Germany is specialized in the mon-itoring of clean and sterile rooms as well as the management of electro-static charges. As Scheibel reports, the defective components find their way to customers and later cause losses in production which causes considerable costs in downtime and replacements. Intact components are also vulnerable. “An electrostatic discharge at any position along a robot-controlled assembly line is enough to interfere with the process regulation in the micro-controllers and to stop the entire assembly line.”

Cleanroom Air no longer offsets Electrostatic Charges

That mini sparks are able to cause such maximal damage has diverse reasons. Besides the flooring, table mats, gloves, overalls, brushes and tools being used, the air condition-ing above all is the reason for two boosting effects: With one effect, the

air conditioning systems reduce the ion content in the air entering the cleanroom and the other effect is that this air is no longer able to offset the electrostatic charges due to the reduced air humidity. Therefore the materials, products and machines in the cleanroom are able to take on electrostatic charges.

Amber as a Clothing Brush

The term electrostatic means latent electricity and comes from the Greek natural philosopher Thales von Milet (625-546 BC). During his lifetime, people in well-to-do homes made use of the amber phenomenon, which was described by Thales. It is based on the discovery that an amber stone which is rubbed on animal fur or on a piece of cloth is able to attract pieces of straw or feathers. Larger amber stones were used as clothing brushes because they attracted dust particles when glided along the clothing. The old Greek word for amber is “electron”, the origin of the word electricity.

Terms such as Anti-Static don’t belong to the Study of Architecture

Electrostatically charged surfaces in cleanrooms are in two respects critical. Firstly, a spark-like discharge threatens to damage or destroy products. Secondly, charged surfaces

attract particles. Studies show that a heavy load of particles on charged surfaces is able to reduce locally the cleanroom classification up to two steps lower than the ISO classifica-tion of the cleanroom. Moreover particle deposition is not easy to remove from charged sur-faces. The electrostatic suspension

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| Electrostatic Discharge

“The nasty thing about electrostatic discharges is that for every one defective product detected, two to five defects will

be detected after the delivery.” Ricco Scheibel, Sales Manager PMT Partikel-Messtechnik GmbH

Indispensable in electronics: tool with ESD symbol.

Photo: Cleanroom Media

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of contamination is able to cause in sensitive areas for example in semi-conductor cleanrooms or in pharma-ceutical labs, critical quality issues which are imperative to prevent.

It’s no wonder then that the demand for consultation in respect to the issue of electrostatic and ESD protec-tion (ESD = electrostatic discharge) is increasingly growing. “The demand is large” observes Christian Fleuren, Market Segment Manager Industry at Nora Systems GmbH. The company located in Weinheim, Germany pro-duces flooring and shoe components. Fleuren emphasizes: “Terminology such as electrostatic dissipation, conductivity or anti-static are not an integral part of an Architectural study.” Building contractors however expect pertinent knowledge in the construction of production sites and laboratories.

ESD-Network provides Know-how and Equipment

In order to make this knowledge available to the market, the German ESD Network was founded one year ago. Four large companies have joined their ESP lines of business whereby each company has its own focus and core topic. Andreas Karl GmbH & Co. KG is specialized in ESD-safe work places. Keinath Electronic GmbH offers seminars, workshops, consulting and equipment for the

entire ESD sector. Nora Systems GmbH is a specialist for flooring in ESD protected areas. Wanzl Metall-warenfabrik GmbH produces access controls for Electrostatic Protected Areas (EPA). “In this combination we are able to provide in respect to ESD protection a comprehensive portfolio in know-how and equipment” says Andreas F. Karl Managing Director of Andreas Karl GmbH & Co. KG.

Electrostatic Discharge |

“Terminology such as discharge capability, conductivity or antistatic are not an

integral part of an architectural study.” Christian Fleuren, Market Segment Manager Industry,

Nora Systems GmbH

Impressions of the Cleanzone 2015:

Between footwear and flooring arise

charging voltages when walking.

Thus there will be no uncontrolled

discharges have clothing, footwear

and flooring - as demonstrated here

- have static dissipative properties.


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The German ESD Network presented itself for the first time in May, 2015 in Nürnberg, Germany at the SMT, Europe’s leading trade fair for system integration in micro-electronics. Fur-thermore the newly produced ESD guidebook was presented. “With this guidebook, we would like to support companies and specialists in their daily work and to sensitize them to the relevance of this topic”, says Andreas F. Karl. The avoidance of damage by electrostatic discharge not only prevents a company from accru-ing higher costs but also increases customer satisfaction and retention.

Devastating Killer-Events are preventable

How is damage caused by elec-trostatic discharge preventable? „Fundamentally in practice, it is impossible to completely keep static electricity out of production facilities” says Ricco Scheibel of PMT Partikel-Messtechnik GmbH. Charge voltages are generated while walking

over a floor between the shoe and flooring material. People are not ex-posed to any danger in this instance but electronic components and devices are. Sitting on ungrounded chairs with rollers as well as wearing clothing unsuitable in ESD areas can cause people to accumulate charges. So that no uncontrolled discharging takes place, people, clothing, shoes and floors have to have electrostatic dissipating properties.

“In order to suppress particle-at-traction and ESD-killer events, there is a range of pragmatic and effective approaches” says PMT

expert Ricco Scheibel. “Firstly all electrically condutive components are to be equipped with ground-ing. Concretely this means: All personnel are to be grounded with antistatic clothing, this measure supported by the wearing of grounding straps on the wrists and ankles. Additionally, work places are protected by grounding table tops, mats and conductive flooring.”

Producers of cleanroom needs offer a wide range of products. Modern cleanroom clothing reinforced with conductive carbon fibers for dissipating electrical charges is available which should be worn in the production of sensitive technical devices. Cleanroom gloves for chip production and microprocessor processing are also furnished with anti-static accessory equipment. ESD protection also provides over-boots, which thanks to anti-static properties no longer electrically charge those who wear them. Other anti-static measures which are rec-ommended are charge-dissipating ESD work places and ESD rubber flooring systems.

It should be observed that charge dissipation by grounding only works with conductive materials. There are in every work environment so-called insulators that is materials on whose surfaces electrical charges are not able to move. In such cases,

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For a micro-electronic component the energy of an electrostatic discharge

is comparable to the energy of lightning striking a tree.

Source: Wikipedia

Important ESD Norms and Policies

EN 61340: Theses European norms deal with the protection of electronic

components against electrical phenomena. The various norm sections support

the user with the selection of suitable protection measures.

ANSI/ESD S 20.20: This industry-overlapping standard describes the

administrative and technical demands of the ESD control program for the

protection of sensitive electronic components, assembly groups, devices and

facilities against ESD damage and downtimes.

SEMI E78-0998: This guideline aims at minimizing the negative impacts on

productivity by static charges and electrical fields in semiconductor production

equipment. It is the guideline for the use of electrostatic tolerant operating

supplies in the semiconductor industry.

Source: PMT Partikel-Messtechnik GmbH

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grounding doesn’t work. In order to remove electrical charges from insulated surfaces other solutions are required.

Air Ionization is effective where Grounding fails

As an effective method for neutral-izing insulated materials, active air ionization has proven itself because it improves the electrical conductivity of the dry cleanroom air. The dryness of the air has a large influence on the electrostatic charging. The drier the air is, the stronger the electrostatic charging is. As the cleanroom air is itself a relatively good insulator, it is actually very easy to raise air con-ductivity by increasing air humidity. However upon closer examination, this is not an option for cleanroom operators. The method is not only expensive and not very effective, but also could favor the growth of micro-organisms.

As an alternative to air humidifica-tion, air ionization has proven itself. Ionizers via air flows intensively provide the cleanroom with air mol-ecules which have an ion too many or

too few. If these ionized air molecules come into contact with an electrically charged surface, the ions will change their polarities and the surface will

practically neutralize itself. Several technical ionization processes have been established. Depending on the process environment, cleanroom operators are able to choose from among various possibilities available the most optimal ion distribution system for their environments.Those who choose to protect their production in respect to the ways described with an all-encompassing “lightning rod”, they will not have to heed to the poet’s warning „ A lack of gap will certainly mean that some of the sparks will jump the seam”. The mini sparks with maxi damage will thereby be passé.

Author: Frank Baecke

Electrostatic Discharge |

Measures against electrostatic Discharge

Antistatic Mats protect people and products against electrostatic charging and

discharging, and makes it possible to work safely in ESD endangered areas (ESD

= electrostatic discharge). The mats have to be supplemented with further an-

tistatic measures for example ESD approved clothing, work places and tools.

Grounding directs electrostatic charges on products, facilities and people to the

ground. Grounding straps are to be used for wrists and ankles as well as for table

mats and tools with conductive grips. Grounding also prevents explosions due

to electrostatic discharges.

ESD-Work Place Systems consist of conductive worktops and table frames with

grounding for the dissipation of electrostatic charges. Such conductive work place

systems are necessary everywhere component parts are processed or handled

which could be damaged or destroyed by electrostatic discharge.

Packaging play an important role in the protection of sensitive components. The

common packaging chips and bubble wrap are good electrical charge carriers

and therefore are ruled out. Against undesired discharges during transport and

storage, special antistatic or electrostatic dissipating materials provide protection.

Source: www.arbeitsschutz-portal.de

The moment at which the spark might be dangerous - if

no precautions were taken. Photo: gammaburst/Fotolia

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Cleanroom Magazin: In cleanrooms the constant issue it the ellimination of particles and germs. However there isn’t much said or written about the risks to products by elec-trostatic discharges. Why is this?

Ralf Keinath: Well as the name itself indicates, the demands on cleanrooms deal primarily with cleanliness, either in the sense of particles and/or in the sense of germs. However, there is also present the natural phenomenon of electrostatic discharge. It is im-portant to always be aware of this.

Cleanroom Magazin: Is the awareness of ESD risk lower because it presents a lower risk than contamination?

Ralf Keinath: The question concern-ing risks has to be differentiated from case to case. At first, it must be clarified to what extent the prod-ucts handled in the cleanroom are electrostatically sensitive.

Cleanroom Magazin: Back to my question: Is the awareness of ESD risk lower?

Ralf Keinath: I would say: Yes. Everybo-dy knows about electrical discharges from everyday life, like the electrical shock when touching a door handle or the crackling sound when pulling on a sweater. People perceive a discharge from 3000 volts under this we don’t feel anything. From 10,000 volts we can see

a spark with our own eyes. Semicon-ductor components are sensitive to even just a few volts!

Cleanroom Magazin: How large are the damages and product losses due to ESD?

Ralf Keinath: It can be assumed that 15 to 20 percent of all electrical fail-ures of semiconductor components can be traced back to an ESD event. These values were confirmed by different and independent analyses over a period of many years and at several different semiconductor manufacturers.

Cleanroom Magazin: How can cleanroom operators neutralize or prevent electrostatic discharges?

Ralf Keinath: ESD can effectively be controlled with three methods. The first: To avoid electrostatic charging

as well as possible. The second: To controllably dissipate charges, whereby a gentle discharging is meant which is best done with the appropriate room and personnel equipment in the grey rooms. In cleanrooms, this is conditionally possible as such equipment present contamination issues. Moreover the metal surface areas which are preferred in cleanrooms cannot be gently discharged as they are low-impedance objects. This leads to the undesired hard discharge which can cause ESD damage. And now for the third method: The neutralization of the charges with neutralization devices. This is in a cleanroom as a rule the method of choice!

Cleanroom Magazin: Is it possible to build cleanrooms ESD neutral or is this condition only seen after the cleanroom is put into operation, if and where it sparks?

Ralf Keinath: The latter should be in any case avoided. If the products handled are electrostatically sensi-tive, than the ESD protection has to be and should be considered in the initial planning of a cleanroom.

*ESD = electrostatic discharge

“Neutralization by ionization is the method of choice” Ralf Keinath, the Executive Managing Partner of Keinath Electronic GmbH, comments on the risks to products by electrostatic discharges.

Ralf Keinath is the Executive Managing Partner of Kein-

ath Electronic GmbH. The company counts as one of the

founding members of the German ESD Network (Deutschen

ESD-Netzwerkes). Grafik: kutukupret/Fotolia

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CLEANROOM MAGAZINE 2/20163D-Druck |

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www.cl-ex.comThe knowledge portal for the cleanroom industry.

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To set up a cleanroom today which will be built tomorrow? Virtual Reality (VR) makes this possible. The technology generates an artificial world on a computer in which the observer is able to virtually move through as if he is actually on site.

Bc-technology GmbH already offers for its customers the use of such virtual 3D worlds for the design of cleanrooms. The company located in Dettingen, Germany is specialized

in the planning, construction and qualification of cleanrooms. With stereo-visualization using CAD data, the specialists provide for their customers virtual tours through the planned cleanrooms. Customers are able to view machines, devices and equipment from every perspective and – also with ergonomic consid-erations – play through, reality-true, their individual solutions. Produc-tion processes are also able to be simulated in real-time.

“With modern cleanroom technol-ogy, modular and flexible solutions are increasingly in demand. There-fore the transparent and individual planning of cleanrooms for oper-ators is becoming more and more important”, says Harald Wodtke, Project Manager at bc-technology. “With the help of VR technology, we have found a medium which makes it possible for a customer to step into his cleanroom also when the project is only in its conception phase.”

The Risks are decreasing, The Planning Dependability is increasing

These possibilities are providing cleanroom operators major advan-tages: They are able to determine in virtual reality the optimal uti-lization of their rooms, to resolve any critical issues before beginning construction and to estimate more realistically the expenditures. Po-tentials for reducing costs become visible, risks decrease and planning dependability increases.

Virtual reality holds to be “the next big thing”. The global IT and electronics industries see in this technology their future markets, they are expected to become the platform which will replace PC’s and Smartphones. This was the message from the big market players at the recent Mobile World Congress in

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The next big thing?Virtual Reality-Devices are expected to replace Smartphones.

Facebook, Google and Microsoft are putting millions of dollars into the de-velopment of VR-technologies, and together with device manufacturers such as Samsung, LG and Co. are creating fascinating worlds of illusion. The de-vices are still rather vague and the contents meager, but one thing is sure: The market prognosis looks splendid.

...and ready to go into the 3-D-Future. Photo: Monika Wisniewska/Fotolia

| Virtual Reality

14-29 years: 28%

30-49 years 25%

Over 50 years: 13%

Other: 34%34%

25%

28%

13%

Virtual-Reality-Glasses: 20% of Germans are interested in imaginary 3D worlds

Source: Bitkom

14-29 years: 28%

30-49 years 25%

Over 50 years: 13%

Other: 34%34%

25%

28%

13%

Virtual-Reality-Glasses: 20% of Germans are interested in imaginary 3D worlds

Source: Bitkom

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Barcelona, Spain, Europe’s largest Mobile Communication Trade Fair. From the end of February to the be-ginning of March, 2016, manufactur-ers presented their latest solutions and devices for working and playing virtually.

The technological approaches are real-ly quite different. That company which will be leading the pack is still open. Facebook founder Mark Zuckerberg announced during his presentation at the Mobile World Congress: “Virtual reality will be the next major platform. It will change every facet of life.” To-gether with Samsung, Facebook wants to become the market leader in this anticipated billion-dollar market. The New York investment banking and securities trading company Goldman Sachs forecasts that turnovers with virtual reality will reach 110 billion dollars in 2025.

Instead of looking at old Photos, immerse yourself once again in the Scene

Facebook boss Zuckerberg believed early on in the new technology. He has already invested since March, 2014, two billion dollars in the pur-chase of the company Oculus VR which with its Head-Mounted-Dis-play with the name of Oculus Rift is considered the forerunner among providers of VR entertainment. The glasses give the user the feeling that he is really able to move around in the virtual world.

The Oculus glasses were devel-oped for especially realistic game enactments however Zuckerberg has long been thinking of further applications. These range from education to the marketing of real estate and tourism on up to a per-son’s private life. After the birth of his daughter, he realized that later

on in life he didn’t want to only look at photos and films of her but fully immerse himself into these earlier scenes. Together with Samsung his company has developed the Virtu-

al-Reality-Glasses Gear VR, which uses the Smartphone as its display. Facebook has piloted its software know-how into the partnership which has raised eyebrows among market observers. Forrester analyst Juli Ask said when interviewed on n-tv: “The combination of social media and communication is the Killer-App.”

2016 is expected to bring the Breakthrough for VR Technologies

Facebook and Samsung are however, not the only ones which will make 2016 the year for Breakthroughs for the new technologies. LG is

charging ahead with its VR glasses which are far lighter and therefore more comfortable. The trick is: The Smartphone is not connected to the glasses but only a connection cable.

HTC wants to seize the market from the top end and bring to the market in April a highly-praised high-tech headset. Apple is also hoping for new growth outside of the saturated Smartphone market and therefore has called into life a top secret di-vision for Virtual and Augmented Reality.

According to forecasts from IHS, by the end of 2016 seven million VR headsets are expected to be flaunted by their enraptured new owners. The market researchers at CCS expect a jump in sales of VR glasses to 20 million in 2018. By 2020, IHS forecasts that 37 million headsets will be sold. The euphoria over the new tech-nology does not however include

“Virtual reality will be the next major platform. It will change

every facet of life.” Mark Zuckerberg, CEO Facebook Inc.

Virtual Reality |

Put the smartphone with the relevant content in the glasses.... Photo: Monika Wisniewska/Fotolia

18


all management boards. Sony for example is keeping to its Playstation VR glasses and is staying out of the mobile communication market. For Sony Mobile boss Hiroki Totoki it is not about putting still another VR glasses device on the market. He is more concerned with the question where enough good content ma-terial for the virtual world will be coming from.

Sales alone of Glasses is not enough, There has to be Content

Thereby the Sony manager has put a finger in the wound. Apart from

the small gamer niche, good content material for the mass market is still scarce. Oculus founder Palmer Luckey doesn’t see in the sales of VR glasses a long term sustainable business model. At the first “VR/AR Summit” presented by the software company Unity at the beginning of February in Los Angeles. California, Luckey stated that money can only be made with material content: “It only counts how often the buyer returns to experience something new.”

The drawing card for the new technology should be in the busi-ness applications. For example pilots could train how to control an airplane in a virtual world.

Doctors would have the possibility to digitally simulate risky proce-dures. Architects and city planners could create walk-in designs. The logistician could be assisted in the optimization of goods-storage with the help of VR glasses. Applications have also been devoted to business communications. The Canadian company Summit Tech for example, has developed a solution with which globally scattered colleagues are able to sit themselves in their host’s conference room during a video conference by using VR glasses and are able to look around and see all of the participants.

Augmented Reality Highly Interesting for Industry

For many industries, it is more interesting the linking of real envi-ronments with virtual components which can be merged into the user’s field of vision. This augmented real-ity is able to facilitate the work from production to logistics facilities on up to the OP in that technicians, assemblers or surgeons are shown instructions for the necessary proce-dural steps on the data glasses. The

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| Virtual Reality

Ready to go into a cleanroom before it is build? VR technology makes it possible. Photo: bc-technology GmbH

“With the help of VR technology we have found the medium which will

make it possible for a customer to step into his cleanroom also when the

project is only in its conception phase.” Harald Wodtke, Project Manager bc-technology GmbH

19


Mercedes Benz factory in Bremen has implemented Google Glasses in the construction of automobiles whereby the tools necessary for the assembly of external parts are displayed. With these augmented reality glasses the tools can be mod-ified and the data immediately sent to the factory in Peking where the tool implementation is just taking place. Augmented reality or the merging of immediate information in real time, is for industry useful above all where employees don’t

have direct access to information or need both hands for their tasks.

It is imaginable to use such applica-tions in the cleanroom. The textile service and lavatory hygiene provider CWS-boco offers its customers an App for Android and Apple Smartphones which makes it possible to virtually equip a real room with CWS dispens-ers. Therefore customers or potential customers can see in advance which solutions optically and functionally at best suit their premises. However

this world of illusion provides not only the optimization of facilities. Cleanroom operators can generate training environments in which they are able to prepare new employees for their work in a cleanroom. If this is the way it is going, then the situation has come full circle. Elec-tronic systems are able to virtually resurrect cleanroom worlds from which they themselves have just emerged.


Virtual Reality |

Sources: IHS, CCS Insight

2,2 Million

20 Million

37 Million

2015 2018

2020

Sales of Virtual-Reality glasses

Sources: IHS, CCS Insight

2,2 Million

20 Million

37 Million

2015 2018

2020

Sales of Virtual-Reality glasses

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It is really amazing. The man earns his money with products and process solutions for cleanroom technology and at the same time says: “The best cleanroom is that which is not needed.” This is like saying: Let me have my cake and eat it too.

However for Joachim Ludwig the founder and Managing Director of Colandis GmbH in Kahla, Germa-ny, this is no contradiction: “The cleanroom can be a solution but doesn’t have to be.” The question is, though, does the customer always need a complete cleanroom? Some-times a simpler solution is better, whereby employees are kept out of the production processes. “I always think in broad terms and discuss with my customers technological alternatives” explains Ludwig and refers to Henry Ford. Ford said: “If I had asked people what they wanted, they would have said: faster horses.” Colandis’ boss ticks in the same way: “For me, it’s always about new ideas, about how to do it differently.”

Obviously it is exactly this way of thinking which one day brought a member of staff to become an entrepreneur. This day was for Joachim Ludwig July 1st, 1995. On this Saturday, seven years after graduating from the university, he became his own boss in an engi-neering office. At that point in time,

Two Desks, a Drawing Board and a lot of Courage From these ingredients, Joachim Ludwig created the nucleus of today’s Colandis GmbH.

| Portrait

Colandis CEO Joachim Ludwig.


On May 1st, 2016, Colandis GmbH will celebrate its 20 year anniversary. In an interview with “Cleanroom Magazin” Managing Director Joachim Ludwig reports on how he out of a one-man engineering office built up his Clean Air Company which is active worldwide and which role his daughter’s Latin book played.

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he couldn’t imagine that out of this one-man office, the company Col-andis GmbH would one day arise.

Only Five One-Thousandth Kelvin Tolerance

This native of Jena, Germany, started his career after finishing his Engineering Diploma at Carl Zeiss Jena. At Zeiss, he had three possible choices. “The one was too involved with optics, the other too much mechanics but nevertheless better, and the third was cleanroom technology – this I didn’t know so I took up this one” recounts Ludwig.

The business sector in which he worked built large machines for the semiconductor industry and was to some extent a competitor for the Dutch lithograph systems manufac-turer ASML, at that time known as ASM. “It was always gripping when we brought our own assemblies into operation. For example, we ensured constant temperatures of precision optics in wafer steppers. There was only a five one-thousandth Kelvin tolerance and this had to be strictly maintained” portrays this former as-sembly group/component developer.

In Jena, they were already two steps ahead of the Fraunhofer-IPA

The German re-unification came two years later and the Kombinat Carl Zeiss Jena was divided into several independent companies. Joachim Ludwig landed at the new Jenoptik Infab GmbH. At this company he took up the initiative to collect information from various and diverse sectors of industry. “I vis-ited many congresses and meetings and often paid for these trips out of my own pocket” recounts Ludwig.

However his efforts paid off. With Ludwig’s support, the company de-veloped new product ranges among them one of the first circuit board direct exposure machines. “We could directly go to the circuit board with the laser which omitted the round-about film exposure procedure” says Ludwig. A further important development was the automation of wafer handling and transport into the cleanroom. The terms SMIF and FOUP are well known in the semi-conductor industry. “At that time, we were in respect to the state of knowledge comparable

Portrait |

Company Portrait COLANDIS GmbH

COLANDIS GmbH located in Kahla, Germany is specialized in the construction of

customer-specified cleanroom solutions. Besides consultation, development and

construction, the production of proprietary products in cleanroom conditions be-

longs to its spectrum of services.

Furthermore, the company possesses a high degree of know-how in the carrying

out of inspections for suitable cleanliness-conditions according to VDI 2083-9.1.

Additional services include assembly and machine cleaning under cleanroom

conditions, consultation in all issues concerning cleanroom technology as well

as process-specific employee training.

CLEANROOM TRAINING

www.reinraum-akademie.de

22


to the Fraunhofer IPA in Stuttgart” remembers the Colandis owner. At the time he was visiting a presenta-tion on the optimization of wafer steppers at the IPA, he advised the referent: “Come on over to Jena, we’re already a step further.” As the referent did indeed come to Jena, he was astonished: “You are already two steps ahead!” Prompt-ly, he invited Joachim Ludwig to be part of the VDI Guidelines 2083 Work Group, in which he was sig-nificantly contributing to on page 8, today’s page 9.1 (Suitability of operation supplies and equipment in respect to cleanliness as well as

technical ventilation components in sterile environments). Joachim Ludwig is still working today in this and in many other commit-tees: “I’m the dinosaur there.”

The Jump to Self-Employment begins with a packed-full Cardboard Box

Then came the hammer. At the end of 1994, the company management announced: “We have to dismiss further employees, but you are allowed to bring any running projects to their finish.” Ludwig sought a dialogue with his boss: “We had made the appointment for 4.00 p.m. The kids were in the car. At 5.00 p.m., I still hadn’t been called in. I called my wife and she said to me: You have known for a long time what you really want to do. So, after the conversation with my boss, I cleaned out my desk and as it is known from news reports about the USA, marched out of the company with a full cardboard box under my arm.”

Joachim Ludwig talks about this setback in his life with crossed arms, but a smile on his face. The crossed arms give the impression as if he retrospectively would like to protect himself from the inter-vention on his professional life. However his smile shows: Looking back, leaving the company was the right thing to do. A short time later, he was the boss of his own engineering office.

Two Desks and a Drawing Board

At first, the projects were sporadic. Then came the search for a col-league and finally the founding of a GbR with the name Cleanroom Technology Jena. This was on May 1st, 1996, the day on which today’s Colandis GmbH will be celebrating its 20th anniversary. “We started in Kahla which is nearby Jena in a 40 square meter office. Below the office was an equally-large garage which we could use as a work shop. Two desks and a drawing board were all we had” depicts Joachim Ludwig about his start.

In the garage, which was soon equipped with used work benches and surface plates, emerged the first company product, a joint de-velopment with Mannesmann-Re-inraumtechnik. The small GbR grew quickly. After two years, the 80 square meters in Kahla had be-come too cramped. There followed a move to Jena into an area of 300 square meters, which after a half year also became too small. For the necessary size for his company, Joachim Ludwig had already had “a super piece of property in sight”, however the city of Jena put a stone in his way. They wanted to pass on the costs for a retaining wall on the property to Cleanroom Technology GbR. “I called the mayor of Jena about this who immediately offered me an alternative piece of property. A week later, I was able to sign the deed of sale” says Ludwig.

The Daughter’s Latin Book

The new construction in Kahla made it necessary to found a GmbH. However this had a catch to it. According to a new court deci-sion, the GbR could not name itself Cleanroom Technology Jena GmbH,

| Portrait

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“For me, it’s always about new ideas, about how to do it differently.”

Joachim Ludwig, Managing Director Colandis GmbH

In the days of beginning 1990 / 1991.

Photo: Colandis GmbH

23


as the company resided in Kahla. “At this time, my middle daughter discovered in her Latin book that ‘colandi instumentum’ means approximately filter instrument or filter element.” Thus the idea for the new company name was born. Indeed in September, 2001,

Cleanroom Technology Jena GbR became Colandis GmbH. Joachim Ludwig freely admits that he has experienced times in the last 20 years which he “would rather have done without”. However to give up was never a question: “The company is my baby!” This admirer of Manfred von Ardenne is today the possessor of several patents, the author of numerous publications as well as a speaker in all corners of the world. “To enjoy what I do is always first priority” says the father of two daughters and one son. He also enjoys good hard-rock music and the crime stories by the Islander Arnaldur Indridason. “I

don’t usually enjoy crime stories but these I do” raves the 54-year old.

Colandis Production Highlights

Today the company employs 23 peo-ple and has a turnover of around three million Euros. When asked about the major highlights from the last 20 years, the Colandis boss crosses his arms once again and leans back in his chair. It seems that something is running by his inner eye as the answer has to wait a moment. “Let’s take our Ventila-tion-Filter-Module” he eventually says. “Instead of a standard dis-posable product, we offer custom-er-specific solutions which achieve higher prices in Asia because we provide better performance.”

Further highlights of Colandis’ production are x-ray safe mini-en-vironments , a nine-meter high cleanroom with an integrated ca-ble-crane system for an aerospace company and above all the com-pany’s proprietary portable rent-al-cleanroom. “We build a 20 square meter portable rental-cleanroom with an ISO Class 5 specification, without using any tools in less than 15 minutes, plus two minutes for laying out the flooring” emphasiz-es Joachim Ludwig. This kind of modular installation of a sterile environment is unparalleled in the world. Joachim Ludwig glances at the clock, the next appointment is calling. “Oh, one more thing”, he adds while standing up, “Colandis was among the finalists for the Small and Medium-Sized Compa-nies Award in 2014…”

So many highlights, so many rea-sons to celebrate. Happy Birthday, Colandis!


Portrait |

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Colandis CEO Joachim Ludwig celebrates the 20th anni-

versary of his company. Photo: Colandis GmbH

24


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When New Life emerges

from the Cleanroom

Couples want to have children. Is not the

natural way possible, artificial insemination

may be a solution.

CLEANROOM MAGAZINE 2/2016 | Artificial fertilization

Phot

o: g

-sto

ckst

udio

/shu

tter

stoc

k.co

m

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How can new life arise in a clean-room when these environmental conditions should be preventing the growth of cells capable of re-production? How can human life thrive, of all things, under such hostile environments?

To answer these questions, the Practice for Fertility Dr. Peet and Dr. Wilkening in Berlin, Germany commissioned the experts at the Avantalion Consulting Group an international expert consulting service in the areas of Pharmaceu-ticals, mechanical engineering and

automotive financing, The goal of the project was to obtain the per-mission in regards to the Medicinal Products Act for the Operation of Practices to fulfill childless couples’ desire to have a family. The devel-opment of a concept was necessary which enabled the safe execution of the demanding processes of han-dling the germ cells and in addition complying to all regulatory and technical requirements.

The latter comes across as self- evident but in fact, it isn’t. The Ava n t a l i o n P r o j e c t M a n a g e r Claudia Pachl reports that various

regulations have to be considered whose diverse work group and ex-pert’s interpretations oppose and conflict with each other, which contradict statutory requirements. These contradictory challenges have to be overcome in order to lead the practice toward obtaining an operating license.

The First In-Vitro Procreated Baby was born in 1978

No other medical procedure was able to cause such a furor in past times than artificial insemination. Louise Joy Brown, born on July 25th, 1978 in Oldham near Manchester, England, was the first in-vitro procreated human in the world. The egg cell was fertilized outside of the womb in a test tube (in-vitro fertilization) and the embryo after-wards placed back into the womb. The method rapidly spread itself around the world. In Germany, the first test-tube baby was born in 1981, in Erlangen, Germany.

The wish to have children belongs to one of the most intensive longings of couples who remain involuntari-ly childless. Artificial insemination promises help. The use of cleanroom technology ensures that contamina-tion and other negative influences are to the greatest possible extent kept away from the sensitive cells.

Artificial fertilization |

In in-vitro fertilization, the fertilization of the eggs takes place in a test tube. Then the embryos are implanted into

the mother. Photo: Dan Race/Fotolia

“If a wafer is dropped, money is lost. If a Petri dish is

dropped, life is destroyed.” Claudia Pachl, Avantalion Consulting Group

26


Artificial insemination is always applied in medicine when a diag-nosis has been submitted which indicates, for example, a defect in the oviduct, serious limitations in sperm quality, or when only very few eggs are available. “In every case, because of ethical reasons, the best-suited environment for the artificial insemination to take place has to be provided.” Says the Avantalion Managing Director and Partner Claudia Pachl.

Between the Conflicting Priorities of Life and Technology

With the so-called Assisted Repro-duction Technique, better known as In-Vitro-Fertilization or artificial insemination, the practice-opera-tors face major challenges: In order to properly carry out the procedure within the regulatory framework of artificial insemination, the balanc-ing act between the fulfillment of

federal regulations, which require the use of cleanroom technology, and the particular needs of working with human cells in connection with the procedures in a doctor’s

office or clinic have to be dealt with. Just how complex these challeng-es are, the owners of the Berlin Practice for Fertility Dr. Peet and Dr. Wilkening could sing out loud. David Peet founded togeth-er with his colleague, Dr. Wibke

Wilening, the new Practice for Fertility in Berlin in March, 2015. The doctor looks back on over 20 years of experience in artificial insemination. In order to operate

the new practice in the Friedrich-straße, he needed a new license meeting the requirements of the Medicinal Products Act which was applied for at the relevant State Office for Public Health and Social Affairs (LaGeSo).

“There are more and more in-vitro-fertilization practices and clinics opening which with the implementation of cleanroom

technology are obtaining better results.”

Claudia Pachl, Avantalion Consulting Group

| Artificial fertilization

Intracytoplasmic Sperm Injection: In this method, a sperm with a very fine needle is injected directly into the egg cell (see image page 25 bottom right). Photo: VILevi/Fotolia

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Laws, Laws and still more Laws

However, there is more. Those who want to provide Assisted Reproduction Techniques have to also deal with not only the Medicinal Products Act, but also the Transplantation Law, The Pharmaceutical and Active Agent Production Ordinance, the Industrial Code as well as the Directives for the Implementation of Tissues and Cells. The last two deal with donating, pro-curing, testing, processing, conserving, storing and distributing human tissues and cells. Furthermore, the Infections Protection Law and the Embryo Protec-tion Law have to be considered.

The Pharmaceutical and Active Agent Production Ordinance requires for the treatment and processing of the germ cells the highest degree of cleanroom air quality according to

EU-GMP-Guidelines, in other words, Class A. In order for a Class A working environment, equipped with special air treatment and air flow regulation systems, to reduce particulate and microbial contamination risks to a minimum, the adjoining areas have to be constructed to support the ster-ile conditions inside the cleanroom. For the treatment and processing of tissues, cleanroom not less than Class D is required.

Moreover the qualification of critical equipment and devices is required, the validation of critical treatment and processing procedures is required, appropriate hygiene measures are required, traceability procedures are required, training is required, internal inspections are required, procedural instructions showing standards are required and much more.

Experts in Disagreement over the Use of Cleanroom Technology

In addition to all this, there are nu-merous guidelines and publications from associations and scientists whose recommendations are over-whelmingly contradictory with the requirements written down in the Pharmaceutical and Active Agent Production Ordinance and reject the use of applicable measures.

“This is principally plausible” ex-plains Claudia Pachl. The built-in air flows in the Class A areas could cause changes in the pH values and in the worst case make the germ cells unusable due to cooling effects. In addition, the transfer of the fertilized cells back into the womb, which in nature takes place over a


View into the new cleanroom of the practice for fertility Dr. Peet and Dr. Wilkening in Berlin-Mitte. Photo: Praxis Dr. Peet and Dr. Wilkening

28


germ-charged body opening which mustn’t be disinfected, namely the female vagina, contradicts the sterility requirements of Class A. Moreover the necessary micro-scope, heated table and incubators which have to be utilized in the Class A area seem to make the situation senseless as the warmth emitted, the movement of the microscope and the intervention of the reproduction biologists make the required air flow relationships impossible to maintain.

„Nevertheless, there are more and more in-vitro fertilization prac-tices and clinics opening which with the installation of cleanroom

technology are obtaining better results although some experts dis-agree with this” observes Claudia Pachl. “Often it is argued that the Assisted Reproduction Technique has been carried out for many years under poor environmental conditions.” There are, however, experts in the world who have the opinion that the use of cleanroom technology contribute substantially to the increase in pregnancy rates.

The Key to Success is the Safe Handling of the Germ Cells

Independent of the various opin-ions and recommendations, the

authorities in Berlin represent a clear standpoint: The have not recognized the often-quoted ex-ceptions coming from experts and associations. Although Dr. Peet has been successfully operating three in-vitro-fertilization practices in Berlin for many years, the LaGeSo (State Office for Public Health and Social Affairs) is demanding for the new practice, measurements for the qualification of treatment rooms as well as verification of a Clean-up-Phase. In addition, a verified and controlled pressure cascade which includes monitor-ing is being required as well as the qualification of the critical equipment and devices.

These environmental conditions requirements could only be im-plemented by using cleanroom technology. In this respect, the Avantalion Consultants have been able to support and help and have drawn up a concept which fulfills all regulatory demands and ensures safe processes when w o r k i n g w i t h g e r m c e l l s . A particular focus was put on the safe handling of germ cells. “If a wafer is dropped, money is lost. If a Petri dish with germ cells is


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A Small Glossary:

IVF stands for In-Vitro-Fertilization. With this procedure, egg cells and sperm

cells are brought together in a glass (in-vitro). In the nutrient fluid, egg fertili-

zation should take place. When the fusion of one or several egg cells with sperm

cells is successful, the embryo is transferred to the womb after a few days.

ICSI stands for Intra-Cyto-Plasma Sperm Injection. With this method the sperm

cells are directly injected into the egg cells with a very fine needle. In Germany,

ICSI is much more often done as in-vitro-fertilization. In 2011, over 75 percent of

artificial inseminations were done using the ICSI method.

CLEANROOM CLEANING

www.profi-con.com

29


dropped, life is destroyed” empha-sizes Claudia Pachl. Therefore the cleanroom equipment is installed in such a way that the germ cells are optimally protected. Likewise the consultants have perfected all the procedures and walk ways so that the reproduction biologists are able to safely work without limitation among all the technical devices and installations.

This concept was presented before the authorities and it was accept-ed. Within a very short time, the cleanroom-technical and organ-izational measures were carried out and implemented so that in November, 2015, the LaGeSo (State Office for Public Health and Social Affairs), following an inspection of practice rooms and procedures, issued the pertinent license.

New Hope for Childless Couples

The first practice results point towards hope: Pregnancy rates averaged over all age groups from November, 2015 to February, 2016, come to 41.9 percent. The numbers show that the germ cells and

pregnancy rates have been nega-tively influenced by the cleanroom equipment. In order to have signif-icant statistics over the possible positive influences on pregnancy rates due to the implementation of cleanroom technology, the data will have to be collected over a longer period of time.

“Inherently, the positive feeling re-mains that everything possible has

been done to protect germ cells and patients with the support and im-plementation of cleanroom-tech-nical possibilities” says Claudia Pachl. New life can also emerge from cleanrooms. For childless couples who long for offspring, this is indeed good news.

Author: Frank Baecke. Professional and Expert Consultation: Avantalion Consulting Group, Claudia Pachl

Successful Artificial Insemination Statistics

Up to 2014, approximately 225,625 children were born in Germany using the

methods of IVF and ICSI (see box, „A Small Glossary). Worldwide, this number

was more than five million.

Every sixth to seventh couple has difficulties to become pregnant without medical

support.

Over 2.5 percent of all children born alive in 2013 were the result of fertilization

outside of the body. Statistically, in every class of school children, one of 30

children was born due to artificial insemination.

Due to conventional IVF, in 2014, 36.2 percent of all embryo transfers resulted

in pregnancy. With the ICSI method, the probability of pregnancy came to 34.5

percent.

Source: Deutsches IVF-Register e.V.


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Cleanroom Magazine: You have advised a Berlin IVF clinic during the installation of a cleanroom and accompanied by the grant of permission to Medicines Act. What was the initial situation?

Claudia Pachl: The building in which the clinic was located had no con-trolled environment in accordance with GMP standards. Therefore at the moment, the authority refused permission, to carry out artificial

IVF treatment there. Our task was thus to integrate the required clean-room technology in such a way that not only fit all legal requirements but also fit into the daily processes of the clinic.

Cleanroom Magazine: What were the difficulties?

Claudia Pachl: Since the cleanroom was to be implemented into an already existing structure, we had to

think about how we could get elec-tricity and water in the cleanroom, how to deal with ventilation, install the air conditioning and how to in-stall the equipment and appliances. The cleanroom is about 60 square meters, divided into cleanroom classes A and D. The main hurdle was to fit in all appliances so that the clinic workflow wasn’t impeded. If an employee carries open petri dishes from one table to another, we can’t have any edges or raised floors,


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“Cleanroom technology must prevent damage to the germ cells” Claudia Pachl, managing director and consultant at Avantalion Consulting Group, explains the challenges of building an IVF Laboratory.

Tel: 09841 – 40140850 E-Mail: [email protected] Internet: www.decontam.de

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no vibrations or circulating air cur-rents that damage the germ cells or cause a shift in Ph of the germ cell solution. The latter is incidentally one of the reasons why some experts say, one must not expose germ cells to the conditions of class A.

Cleanroom Magazine: Why was a cleanroom in the Berlin clinic necessary?

Claudia Pachl: Because the govern-ment agency has a different point of view than the experts. For example, they didn’t allow the exception clause described in the regulations that experts rely on.

Cleanroom Magazine: How did you implement these requirements?

Claudia Pachl: We looked closely at the workflows in the clinic and identified all steps that carry an

increased risk for the cells. We were then able to determine whether we needed a class A and class D range and how much space and equip-ment was required. The derived cleanroom concept was discussed with the government agency to en-sure that we had taken into account their ideas. This was especially im-portant because we could not build a typical A class cleanroom to Annex 1 of the EU GMP Guidelines. Rather, we designed our own concept in reference to the Annex 1.

Cleanroom Magazine: ‘In reference’, What does that mean exactly?

Claudia Pachl: For example, we had to change the prescribed airflow speed slightly to find a variation that did not damage the germ cells when exposed to air, but also main-tained the needed preservation. Furthermore, the particle limits of a

class A cannot be met during an op-erative state. We faced several such balancing acts between regulations and daily workflow practicality. All in all, a mammoth task. Thankfully, all went well in the end. The gov-ernment agency has granted an operation permission for the clinic after a second walkthrough.


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VWR International GmbH · basan – the cleanroom division of VWR | Tel. +49 6107 9008-500 | [email protected] | vwr.com/cleanroom

Claudia Pachl is a partner of the international Avantalion

Consulting Group and managing director for the

location Lucerne. She has over 15 years of experience

in the pharmaceutical industry, especially in the areas

of quality management, qualification, validation and

cleanroom technology. Photo: Avantalion


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PRO: Dr. Uli Lösch, Director of Hospital Pharmaceutical Production, Hospital Pharmacy, University Hospital, Basel, Switzerland

Cleanroom Magazin: Would the application of more cleanroom technology help prevent most cases of hospital germ infections?

Dr. Uli Lösch: ABecause of the abundance of germs which people and thereby patients bring into a hospital, cleanroom technology is not able to induce an effect by itself.

From my point of view, cleanroom technology would be an important addition to other measures of ensuring hygiene. Together with thorough room disinfection, staff hand disinfection, appropriate hygiene-clothing, sterile materials and an antibiotic patient covering , all available technical measures have been taken to effectively prevent infections.

Cleanroom Magazin: Hospital germs are in most cases, as was recently shown in Wiesbaden, carried in from the outside. Wouldn’t it make more sense to approach the issue of pathogen prevention by using cleanroom technology in the entire hospital and not only in individual departments or in the OP?

Dr. Uli Lösch: As every person carries around with him or herself a flora of germs and pathogens are transferred via diverse ways such as hand contact, sneezing, etc., a solitary application of cleanroom technology is not able to disrupt the infection-chain. The high velocity of a sneeze, for example, is not able to be captured by the installed air flow system.

Furthermore, the many people present in a hospital and the speed of their movements disrupt air flows and considerably reduce protection measures. Therefore the hospital-wide application of cleanroom technology would not have any great effect. Cleanroom technology is able to help in local

Cleanroom Technology versus Hospital Germs Can more cleanroom technology prevent the much feared hospital germs?

The discovery of MRSA germs in a premature baby unit in the middle of February in Wiesbaden re-fired up the fear of hospital germ outbreaks. “Cleanroom Magazin” interviewed Dr. Uli Lösch of the University Hospital Basel as to which possibilities cleanroom technology could offer in the prevention of germs in hospitals.

Doctor of Science (DSc) Uli Lösch

completed a pharmaceutical study

by dissertation at the University

Heidelberg. Afterwards he worked for

15 years as an Industrial Pharmacist

in the areas of production and quality

assurance. Since 2010, Uli Lösch has

been employed as the Director of

Production in the Hospital Pharmacy

of the University Hospital Basel.

PRO“Cleanroom technology is to my mind indispensable as an

additional measure of protection for patients against microbiological

contamination.” Dr. Uli Lösch

| Controversy

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CLEANROOM MAGAZINE 2/2016Controversy |

applications, for example in the OP to safeguard a patient undergoing open surgery against additional germ infections. Cleanroom technology is in any case standard equipment in a hospital pharmacy for the protection of the manufac-tured pharmaceutical products.

Cleanroom Magazin: What role do room ventilation systems play? Are they a main source of patient infection or is it more the patient’s own flora of pathogenic organisms or is the source the OP personnel themselves?

Dr. Uli Lösch: I don’t see the HVAC technology and equipment as being the main source of patient infection. If anything, the entry of germs into an OP is effectively in-hibited by a regularly maintained system equipped with modern filter and air flow technology. Furthermore, the installation of a pressure gradient system ensures that no microbiological organisms contained in outside air are able to flow into an OP.

A patient’s own germ flora can be viewed as the main source of contamination which even disinfection cannot completely eliminate. For this same reason, the hygiene of OP staff is of course absolutely essential.

Cleanroom Magazin: Going back to the main issue here: Is the application of cleanroom technology in hospitals necessary and meaningful or is it completely overstated and unaffordable?

Dr. Uli Lösch: Cleanroom technol-ogy is to my mind indispensable as an additional measure of protection for patients against microbiological contamination. In view of patients’ growing

resistance against antibiotic therapy and the increasing spread of multi-resistant pathogens, it is expedient to install this technology in an OP. However, these costs have to be considered by medical institutions as well as when calculating package-priced treatments.

CONTRA: Professor Arnold Brunner, university lecturer for building and cleanroom technology at the University Luzern and con-sultant at Brunner Haustechnik AG in Wallisellen-Zürich, Switzerland.

Cleanroom Magazin: Can the use of more cleanroom technology prevent the majority of hospital infections?

Prof. Arnold Brunner: No. Clean-room technology is only able to re-duce the risk of hospital infections. The difference between sterile pharmaceutical production and a hospital is that the products of the pharmaceutical industry emit no germs. In contrast, the patient is not sterile and arguably the major source of germs in a hospital. He brings along his own flora of pathogens into the hospital, not to mention the doctors, nurses and visitors doing the same. From everywhere bacteria strains are imported into the hospital. In Germany, this risk has long been neglected. The result: There are more MRSA related deaths in a hospital than traffic deaths.

Cleanroom Magazin: If hospital germs are imported from the outside, doesn’t this mean that cleanroom technology has to be in-stalled in the entire hospital against pathogens and not just in individual departments such as the OP?

Prof. Arnold Brunner: No, because the probability that an individual passing on his/her own flora of bacteria through the air is rela-tively small. The focus has to be put more on the transmission of germs by direct contact, that is, on measures which prevent the transfer of germs by direct contact from person to person. In this re-spect, a hospital-wide installation

of cleanroom technology would contribute little. In order to prohibit the transfer-ence of germs, hand disinfection, the cleaning of contact surfaces,

Prof. Arnold Brunner is the founder of

Brunner Haustechnik AG in Wallisellen-

Zürich, Switzerland and is still active as a

consultant. This graduate HLK engineer

is a full-time lecturer for Building and

Cleanroom Technology at the University

Luzern Department of Technology and

Architecture as well as the Chairman

of the Work Group for Guidelines

SWKI VA 105-01 “Ventilation and Air

Conditioning Technology in Rooms

used for Medical Purposes” (Hospital

Guidelines) and Swiss Delegate in the

CEN Norms Work Group TC156 WG18

“Ventilation in Hospitals”. Furthermore

he is a Board Member of the Swiss

Association of Cleanroom Technology

SwissCCS/SRRT and on the VDI Specialist

Committee for Cleanroom Technology.

CONTRA

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the changing of clothes and so on would be far more effective. Cleanliness is a chain of measures which comes down to every single link. If hand disinfection is already poor, than all the technical meas-ures taken also become ineffective.

Cleanroom Magazin: Which roles do room ventilation and air conditioning systems play? Are they a main source of infections for patients or is this more the patient’s own bacterial flora or that of the OP personnel?

Prof. Arnold Brunner: DRoom ventilation and air conditioning systems are able to filter out airborne spores and bacteria, but if the patient carries in these pathogens in his hair or on his skin, then cleanroom technology can do nothing against this. A patient doesn’t allow himself to be so disinfected that all of the germs are eliminated. Therefore when a scalpel makes a cut, germs are able to enter the body via the wound. These germs are then rendered harmless with antibiotics. However, the problem is that many germs become re-sistant to antibiotics. Therefore it is far more important to strictly

observe all hygienic measures and to avoid germ transfer by direct contact in order to avoid hospital infections.

The ventilation and air condi-tioning systems function more to dissipate warm air and odors out of the OP. The same is for

surgical fumes which are formed by cutting with laser beams. These fumes are really unhealthy for personnel. Cleanroom Magazin: Let’s get back to the original point: Is the use of cleanroom technology in a hospital necessary and sensible or fully over-exaggerated and unaffordable?

Prof. Arnold Brunner: Cleanroom technology selectively plays an important role, perhaps in sterile treatments, in isolation wards or in the OP. In a normal hospital room, normal building technology is enough. Hospitals are also not qualified under GMP guidelines because the major

source of germs is namely the patient, only partially the system itself.

*HVAC: heating, ventilation, air conditioning


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| Controversy

RIBE® – IHR ENTWICKLUNGSPARTNER FÜR TECHNISCHE FEDERN

RIBE® Technische Federn

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• Wir sind gelisteter Lieferant der FDA• Produktion im Sauber- oder Reinraum (ISO Klasse 8)• Prozessdesign incl. Logistik- und Verpackungskonzepten• Bauteilereinigung mit Lösemitteln oder auf wässriger Basis w w w . r i b e . d e

“In order to prohibit the transference of germs, hand disinfection, the cleaning of contact surfaces, the

changing of clothes and so on would be far more effective.”

Prof. Arnold Brunner

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© K

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PROGRESS

THROUGH WISDOM.

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

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

Cleanroom technology – Sterile technology – Hygiene – Production

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How often are you on the road on business? On the average, I am on the road three days a week in Germany where I visit customers and business partners who are looking for meas-urement equipment solutions for their cleanrooms. Besides Germany, I reg-ularly visit the company Novasina in Switzerland for meetings and training workshops.

What is your favorite mode of trans-portation? When I visit customers, I take with me the sensors from Novasina and our own cleanroom displays so that my customers are able to experience this equipment “live”. Therefore I prefer to travel by car. This way I am flexible, quickly at a customer’s location and have enough room in the car to pack everything I need. If no other means of transport is possible, then I fly.

What is important for you when travelling? Of the highest priority for me is to strictly keep appointments with customers, as an appointment is just that, an appointment. I try to plan trips so that I am the least time stuck in traffic jams. When I am on the road, my car is at the same time my office. A comfortable car with a mobile access to the internet enables me to take care of my work. When I have to stay somewhere overnight, I am mindful of a comfortable bed in order to be fit for work the next day. This is important if a person wants to get the best out of him or herself.

What should never be forgotten when travelling? My mobile telephone, my laptop and my products. It is impor-tant for my customers that I always be available in order to be able to quickly answer their questions.

What kind of music do you enjoy listening to when travelling? My taste in music is diverse. The kind of music I enjoy listening to depends on my mood at the time. I enjoy listening to classical music for example Rachmaninow, but the group Queen also belongs to repertoire of music.

Which countries and regions are on the list of those you most often visit? Our office is located in the south of the Netherlands and I am able to reach the German border in only 15 minutes by car. This is absolutely ideal as I travel quite a lot and I like to travel through Germany for my work. Additionally, I am regularly in Switzerland at the company Novasina, the producer of our sensors. As I am the contact person for all our international

On the road with René Hecker René Hecker, Account & Project Manager at Pedak

René Hecker is at Pedak, a measurement instrumentation specialist in Heythuysen in the Netherlands and is responsible for the sales of measurement equipment solutions for room climate control systems and the monitoring of cleanroom conditions. Pedak, together with the Swiss company Novasina, has been active in this business for more than 40 years.

| On the road with…

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customers, it often happens that I have to travel outside of Germany.

Are you able to relax after a day’s work when travelling on business? The days are hectic and often long but luckily I am able to come down quickly by listening to music. When the weather is nice, mostly in the sum-mer, I really enjoy riding a motorcycle. This gives me a wonderful feeling of freedom and an unbelievable amount of energy which makes it so much easier to cope with stress.

How do you unwind at best? Music is also here my miracle drug. Together with a good book, this is absolutely the best way to come down.

Which travel destinations do you favor and why? Germany naturally! Germany is so much larger than the Netherlands and offers an incredible number of possibilities for me and my company. I am faced again and again with the challenges of offering the best solutions to my customers and meeting these challenges is for me very fulfilling.

What would be the first thing you would do if you had the unlimited opportunity to do so? II would provide for the political stability of the entire world as I hold as my life’s motto: The common folk, the servant and the conqueror alike, confess and affirm at all times: The supreme fortune of Earth’s great populace is solely a person’s caliber and character.


On the road with… |

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

EasyMop GMP®

Reliable cleaning and disinfecting ofpharmaceutical cleanrooms

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Science & TechnologyTechnology News in brief

The lightest Solar Cell in the World

Organic Semiconductor | Researchers at the Massachusetts Institute of Tech-nology have developed the lightest solar cell in the world. This flexible photovoltaic module is 50 times thin-ner than a human hair and generates six watts per gram. This is in terms of weight, 400 times more performance than with conventional glass solar modules. Additionally, the substrate, semiconductor and top coat no longer have to individually be applied as with conventional modules, but rather all three layers ‘grow’ simultaneously by vapor deposition. This happens in a vacuum chamber at room tempera-ture. This way the otherwise required

intermediate treatments and clean-ings can be omitted as well as the use of solvents and harsh chemicals which with other organic solar cells are needed. As the new solar cells can be fixed onto any desired substrate, they could be the basis for the next generation of portable, wearable electronic devices.

Pharmaceutical Products cleanly dosed without Filaments and Dripping

Filling | For the highly precise filling in the pharmaceutical industry Visco Tec, a specialist for the production, dosing, application and extracting of viscous mediums, has developed a solution. The prerequisite for precise dosing is that the filaments are accurately and cleanly pulled off. This is often not the case with viscous products such as creams, salves or gels. These products pull long filaments from the dosage needle into the packaging or even drip. The pharma- dispenser from Visco Tec prevents dripping in that after dosage-injection, the way to the next step through the chambers in the Rotor-Stator-System is blocked off. Furthermore, the medium is ac-curately pulled back into the dosage needle after dosing has been com-pleted. An absolute, clean tear-off of the filament is achieved by using this procedure. The dispenser is also suitable for use in cleanrooms.

Pipe Connections for GMP Requirements

Plant Manufacturing | Machine and plant manufacturers which work according to GMP guidelines need cleanroom-suitable com-ponents. Linnemann GmbH has developed pipe connections with

which plant manufacturers are able to hold to the specifications of Good Manufacturing Practice (GMP). These pipe connections suit themselves for stationary cleaning (also named Cleaning in Place) by their hygiene-minded construction. The flange connections are nearly gap-free, ruling out to the greatest possible extent medium contact in the area of the flange gasket. Belonging to the product program are gaskets and stainless steel parts which are able to withstand the high cleaning demands such as the use of acids, high temperatures and high medium pressures. The products

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| Technology News in brief

Pharma-Dispenser from ViscoTec doses viscous products

without filaments and dripping. Photo: Visco Tec

The ultra-light solar cell floats even on the surface of a

soap bubble. Photo: Joel Jean and Anna Oshero

Small flange connection with stainless steel centering

ring and O-ring gasket. Photo: Linnemann GmbH

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are pre-destined for the chemical, food product and pharmaceutical industries.

Production of Y-Fittings in Cleanroom Construction

Injection Molding | At the Medtec Eu-rope Trade Fair from April 12th to the 14th in Stuttgart, Germany, Arburg will show in an electrical injection molding machine the production of Y fittings in cleanroom construction for the infusion therapy industry. A highlight is the lateral injection via a needle shut off nozzle which results in a higher surface quality of com-ponent parts. “The manufacturing

cell allows itself to be easily docked to a cleanroom. This saves time and space in comparison to manufac-turing solely in a cleanroom” says Sven Kitzlinger, Medical Technology Application Consultant at Arburg.

The exhibit operates via a covered conveyor belt which docks onto the cleanroom. Via the conveyor belt, the clean, produced parts are trans-ported into the cleanroom while the machines and peripheral equipment remain outside.

Granulate Production in High ContainmentGranulate fertigen im High Containment

Powder Mixture | Three-Tec GmbH has reacted to the increasing demand for a granulate production process in isolated environments and together with ART Reinraumtechnik (Clean-room Technology) has manufactured an isolator with an integrated dosage system, an extruder, a conveyor belt and a granulator. The processes of powder-mixing on up to the finished granulate takes place in a protected and controlled environment which saves the setting up of a complete cleanroom. The built-in machines are laid out especially for working with gloves and can be easily disassembled and cleaned by operators. The negative pressure guarantees the compliance with GMP Cleanliness Class C speci-fications. Even the tearing of a glove prevents products from reaching outside environments.

Micro-Biological Air Monitoring easily accomplished

Airborne Germ Collector | MBV AG has brought to the market a new airborne germ collector with the MAS-100 VF. What the abbreviation VF indicates is that the device is controlled by volume flow (Volume Flow). The determination of col-lection volumes, the calibration as well as the readout of collec-tion and error records is done directly via a PC-browser without prior software installation. The new device is predestined for micro-biological air monitoring in aseptic zones, clean-rooms as well as for environmental meas-urements. The MAS-100 VF has been validated for ISO 14698 and guarantees efficient monitoring of micro-biological contamination in the pharmaceutical, food product,

beverage and cosmetics industries as well as in related industries.

New Product Generation of Premium Pocket Filters

Fine Particle Filter | Camfil has brought a new generation of Premi-um Pocket Filters to the market. They are called Hi-Flo II XL and provide besides higher stability a minimum efficiency of a remarkable 54 percent at low energy consumption levels. This is according to company state-ments unparalleled in the industry. In the new pocket filters, the prior filter medium has been replaced by a mate-rial which in the filter class F7 reaches the highest energy class A+ according to the new Eurovent Guidelines 2015.

The new HI-Flo II XL filters are usable in very diverse applications. The spectrum ranges from standard building ventilation to specific in-dustrial applications on up to pre-fil-tering systems meeting cleanroom standards.

Technology News in brief |

Airborne Germ Collector for efficient air monitoring. Photo: MBV AG

An electrical all-rounder 470 A produces at the Medtec

Europe 2016 Y-fittings for the infusion therapy industry.

Photo: Arburg

The new filter series encompasses four models with

conical-formed filter pockets of various lengths. Photo:

Camfil KG

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Cleaning procedures decisively influence production quality but also expenditures. This is why production and shipping processes should be not just as clean as possible but as clean

as necessary and as most economically designed as possible. How this can be accomplished will be shown at the trade fair ‘part2clean’ at the end of May, 2016 in Stuttgart, Germany.

Keep It CleanHow component part cleanliness is maintained from Production to Shipping.

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While walking with his dog, Klaus Döhrer came up with the idea. He had received the order to look for an energy-saving and environmentally friendly component part cleaning technology. As his dog was shaking itself dry after a swim in the lake, Döhrer saw the solution right in front of him: Vibration-Cleaning.

This engineer and Managing Di-rector of Vibro-Tec GmbH in Unna, Germany, has developed a process in which the parts to be cleaned are vi-brated in such a way that oils, cooling lubricant substances and chips are slung away and vacuumed up.

Innovative cleaning solutions of this kind will be standing in focus at the international trade fair for industrial parts and surface clean-ing, parts2clean. The trade fair takes place from May 31st to June 2nd, 2016 in Stuttgart, Germany.

Component Part Cleanliness is as Important as Dimensional Stability

Industrial component part cleaning has gained increasing importance in the last years. More and more compa-nies have taken on the opinion that

the cleanliness of component parts and surface areas plays an equally decisive role in issues such as qual-ity, dimensional stability and the absence of defects. “Whether it be the

automobile and supplier industries, the medical technology industry, the aeronautics industry, precision engineering, optics or electronics – in practically every business and indus-trial sector, companies are having to fulfill ever stricter demands on component part cleanliness” says

Olaf Daebler, General Manager of parts2clean at Deutschen Messe AG. This is increasing expenditures for cleaning substantially. To be on the safe side, things are often dealt with

“Even the smallest particles are able to lead to failures and defects or a fingerprint on a circuit board can

cause an electrical short.” Christian Siegert, General Manager

of CEC Cleaning Excellence Center Leonberg

Technical Cleanliness |

Above: cleaning a satellite component. Left side: ultrasonic cleaning. Photos: Fraunhofer IPA

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according to the motto: as clean as possible. However, this affects profit-ability and thereby competitiveness.

Relief is made possible by a suitable requirements-specified, well-de-signed cleaning solution which allows the cleaning results to be optimized and the expenditures to be reduced. The motto should then read: as clean as possible, as econom-ical as possible. Which processes and procedures clean economically will be shown at part2clean, as well as other solutions in the “Theme Park Precision & Cleanrooms – Cleaning under Cleanroom Conditions”. Diverse cleaning and analysis pro-cesses will be presented which fulfill the most demanding cleanliness requirements.

The one Solution which always works doesn’t exist

“Evolution and innovation take place continuously in industry” observes Christian Siegert, General Manager of CEC Cleaning Excellence

Center Leonberg, Germany’s leading competence network for industrial component parts and surface area cleaning. “However, one approach works mostly only for the processing of one, individual component group. The one, single solution which al-ways works unfortunately doesn’t exist”.

When choosing an optimally suited cleaning technology, materials, component geometry, throughput and the kind of soiling (films or par-ticulate matter) are to be considered. For mass-produced parts, wet-chem-ical cleaning is recommended. The advantages are the high degree of throughput and the low percentage of cleaning costs in comparison to overall production costs. More com-plex parts are cleaned individually in order to effectively reach drilled holes, indentations and channels. Individual part cleaning provides logistical advantages when subse-quent processes require a particular position of the work piece. Generally, the trend toward individual cleaning is preferred because of automation

in production processes. Robots are able to feed the component parts into the cleaning and drying stations.

A further trend is the targeted clean-ing of functional surfaces. Instead of cleaning parts completely, only the critical sealing or gluing surfaces are cleaned. This saves time and money. Furthermore, the functional surfac-es can be cleaned using just-in-time concepts, whereby the costs for keeping parts clean after cleaning or during transport can be omitted.

The Periphery also influences Component Part Cleanliness

If soiling is to be dependably and economically removed, the entire periphery as well as the contaminant material itself has to be considered, beginning with the cleaning chemi-cals, the manufacturing equipment, the parts-transport system and trans-port bins, the supplied materials and products on up to the packaging.

The following criteria play roles in the optimal sequencing oft he cleaning process: Which materials are to be processed? At which step in production are the parts dirtied? Does this contamination have to be immediately removed in order to rule out any adverse affects in the next processing step? Does the processing involve any auxiliary materials whose intermixture could lead to cleaning complica-tions? Does the risk exist of parts made of differing materials causing cross-contamination?

A cleaning solution can be developed coming from the answers to the above questions, which is optimized both in regards to results and costs. The range of cleaning possibilities stretches from solvent cleaning in sterile rooms directly following parts

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| Technical Cleanliness

The sterilization and aseptic packaging of parts often requires clean rooms and personnel. But many companies can

not have the entire process chain for logistical and economic reasons. A new method of Fraunhofer IFAM can now arise

molded parts sterile in the package. Photo: Fraunhofer IFAM

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production to CO2-Snow-Jet Clean-ing and Plasma Activation on up to Multi-bath Ultrasound Precision Cleaning in cleanrooms. In order to find the most suitable cleaning procedure, realistic tests should be carried out in the equipment man-ufacturer’s laboratory. Looking forward, it can be recom-mended to carry out cleaning after every mechanical process step in or-der to remove chips and cutting oils. Therefore a mixing of the differing cutting oils is prevented which can lead to more difficult cleaning issues.Especially important is the reliable elimination of films and residues from medical-technical products which are used on or inside people as particles, burrs or oil films on implants and instruments present health hazards. Cleaning costs can be reduced when component parts and component groups are designed to be easily cleaned.

When the Cleaning Facility becomes a Material Lock

A time-saving possibility to bring parts which have been milled or lathed or parts produced by injection molding into a cleanroom sterile and particle-free, is to implement a grey-room. The cleaning facility then acts as a material lock. Parts can be brought into the grey-room from the production facility and after clean-ing be taken out on the cleanroom side to be checked and processed. Afterwards, the parts can be packed under cleanroom conditions and now protected from contamination be stored and shipped.

Beyond all the technical solutions, there lies yet another factor which influences component part cleanli-ness: employee awareness. Christian Siegert, General Manager of CEC

Cleaning Excellence Center Leonberg says, “In the automobile industry the development in motor technology has in recent years led to higher and higher demands in technical cleanliness. Even the tiniest particles can lead to failures and defects or a fingerprint on a circuit board can cause an electrical short.”

This is why it is so important to anchor into the minds of employees the awareness of the importance of technical cleanliness for the entire process from purchasing to produc-tion on up to the receipt of customer

orders. Included here is the contin-ued education and training. What do employees need? Is it enough to have only a sterile room? Which cleaning procedures suit the product? In this respect, the trade fair Cleanzone (November 8-9, 2016, Frankfurt am Main, Germany) is an ideal place for industry players to meet. “Visitors are able to comprehensively inform themselves about new developments and come into direct contact with manufacturers“, says Siegert.


Technical Cleanliness |

Important Component Part Cleaning Processes

Wet Chemical Cleaning | The most often used technology in the industry is the

cleaning with liquid mediums and solvents. The latter is roughly differentiated in-

to halogenated hydrocarbons (CHC) and polarized solvents. The cleaning results

are determined by the choice taken by the person doing the cleaning. In order to

obtain the desired result in a short time, the effects of the cleaning medium, in

all cleaning procedures, are supported by diverse strongly-acting physical pro-

cessing technology. Typical processes are injection, immersion, pressure flood-

ing and ultrasound.

Plasma Cleaning | The plasma procedure provides with the use of various reac-

tion gases a wide spectrum of applications with piece and bulk goods of every kind

made of synthetic materials, metals, glass and ceramic. This procedure improves

the adhesion of glues and coatings. Moreover it makes possible the generation

of the so-called Easy-to-Clean surfaces such as the surfaces which protect the

parts from contamination during production. Plasma procedures are relevant

prior to coil coating in the medical technology sector, the electronics, optics and

the micro-systems technology sectors.

CO2-Snow Blasting | With this technology, fluid CO2 together with pressurized air

is accelerated through jet nozzles at supersonic velocity. The CO2 snow removes

oil and particle contamination, dry and without leaving behind any residues from

practically all materials. This procedure suits itself also for the targeted treat-

ment of function-surfaces such as seal, coating, glue and laser-welding surfac-

es. With dry-ice blasting, small ice pellets are used instead of fluid CO2. This pro-

cedure suits itself for the cleaning of forms, tools and machines. Super critical

carbon dioxide uses the physical properties between the fluid and gas-forming

phases. In this condition, CO2 has very small viscosity. Therefore, oils and fats

can be removed even from the tiniest gaps and cracks.

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Among the finalists for the Clean-room Award 2015 was Senoplast

Klepsch & Co. GmbH in Austria. The company develops using Senomed

a chemically resistant, scrub resistant and anti-bacterial film

for surfaces in cleanrooms and air locks. The film has the potential

to replace existing materials.

New Surfaces for Cleanroom Technology An innovative synthetic film makes it possible to design totally new cleanroom work places.

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The high barbed-wire fence around the factory premises gave it away: Something unique is being pro-duced here. With the military-like border, Senoplast Klepsch & Co. GmbH in Piesendorf, Austria is protecting its most innovative product from the curiousity of its competitors. The product deals with an extremely scratch resistant and chemically resistant systhetic film which disinfects itself. There is nothing comparable to it in the world.

Senoplast produces – unusual for a plastics manufacturer – in clean-rooms. As the market segment for synthetic films and panels is not standard, the company is able to

expand with its innovative prod-ucts into diverse market niches. Operations are running at full capacity in the factory round the clock which produces in four shifts. Two cleanroom production lines are already in operation and a third is in the planning.

Senoplast did without cleanrooms for decades. As a producer of plas-tics in the distribution segment, the company offered customers a standard range of products for industry, supplied Thermoplast mass-made products for various industry segments in film and panel formats. However as the financial and economical crisis in 2008 involved important customer industries, the time had come in which to re-orient away from mass production to more demanding, specialized products. To realize this change in strategy, a cleanroom was to be installed in production. When the first experiment began in 2006 during the crisis, it was de-clared as a strategic company goal:

In Piesendorf synthetic films from then on were to be produced on an assembly line in a cleanroom.

Thanks to Cleanroom Production the Percentage of Rejects fell by Two Percent

The clean production environ-ment was expected to solve two problems. The first concerned the rate of rejects which was in some years over 20 percent due to t h e u n c o n t r o l l e d environmental influ-ences. “The high rate of rejects raised the risk of customer claims” says Marco Grugger, responsible for the process equipment in the Seno-plast Group. “The profitability just wasn’t happening.” With the start of production in a cleanroom, the percentage of rejects fell rapidly to under two percent.

Surfaces of the Future |

Doubly protected in cleanrooms as well as with entrance-safety and visually-dense facades: Senoplast synthetic film production in Piesendorf, Austria. Photo: Senoplast Klepsch & Co. GmbH

durch anschließende Desinfektion

auf 84 bis 99,9%

Auswirkung unkontrollierter Umgebungseinflüsse

5

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20

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300

5

1015

20

25

300

Ausschussrate ohne Reinraumproduktion: mehr als

Ausschussrate nach Beginn der Reinraumproduktion: unter 20 % 2 %

Quelle: Senoplast Klepsch & Co. GmbH

durch anschließende Desinfektion

auf 84 bis 99,9%

Auswirkung unkontrollierter Umgebungseinflüsse

5

1015

20

25

300

5

1015

20

25

300

Ausschussrate ohne Reinraumproduktion: mehr als

Ausschussrate nach Beginn der Reinraumproduktion: unter 20 % 2 %

Quelle: Senoplast Klepsch & Co. GmbH

Phot

o: F

otol

ia

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The second concerned the rise in product quality. Step by step the developers succeeded in improving product properties. “The produc-tion environment and the process had to be completely re-designed” says Operations Manager Ernst Rattensperger. Although the clean-room had been custom made, the process didn’t run smoothly at the beginning. The base material which is transported into the extruder is indeed a mixture of standard plastics however the catch didn’t reside with the raw materials but with the processing.

The molecular Manipulation of the Surfaces hardens the Synthetic Material

The 200 degree base material glides along a 1.40 meter wide and 20 meter long machine. At a particular posi-tion the surface is molecularly ma-nipulated and as a result becomes harder and more stabile. How this works and which material is applied is a company secret.

It is no secret however that the process demands extremely strict control of the environmental con-ditions. Heat and air flow have to be controlled and regulated. If the temperature changes only a half of a degree, no high-gloss, high-tech base material will emerge but a material which hurls bubbles.After years of collecting experience

Senoplast is now fulfilling the quality demands of many former customers and even surpasses these demands. The company produces in such a high quality that it is able to open and extremely demanding markets.

Suitable for all Particle-free and Micro-biological Clean Environments

Since Senomed-Film 2014/2015 en-tered the market, the Austrian fam-ily company has captured the notice of all those industries which need particle-free and micro-biologically clean environmental conditions: Phamaceutical industry, biology,

molecular chemistry, medical tech-nology, IT, optics and mechanics. Special surfaces play here an im-portant role, not only because they are essential for the aesthetics of the facility but also because they take over a variety of tasks acting as a covering for installations, wall systems and process surfaces.

For example, hospitals use the ma-terial for extensions and interior furnishings and equipment such as doors, cupboards, wall systems and beds. Research institutes use it for lab furniture, lab cupboards and walls. Even food product man-ufacturers are considered as users for the unique material.

Easy to clean, to disinfect and to sterilize

That the synthetic material suits itself to be used in aseptic, that is in germ-free environments is due to its properties above all on one: The material’s surface possesses a very high degree of hardness. This makes it scrub-resistant in fact

| Surfaces of the Future

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“The film is scrub-resistant, even steel wool leaves behind no scratches. Where no scratches are found,

fewer germs are able to settle in.”

Hospitals and Laboratories can easily use the new f ilm. Foto: sudok1/Fotolia

47


steel wool leaves behind no scratch-es. Where no scratches are formed, fewer germs (colony forming units – CFU) are able to settle in. Addi-tionally: Thanks to its extremely smooth surface, the product is easily cleaned, disinfected and even sterilized with standard materials and when absolutely necessary with acids or alkaline solutions.

The latter have no effect on the material. Such radical cleaning is not often necessary as the surface neutralizes itself as tests with the most prevalent germs have shown. Testers took contact samples from contaminated surfaces in certified labs at defined time periods. The samples confirmed the microbio-logical properties: After less than 180 minutes, microbiological activ-ity was no longer detectable.

The Film gives off neither Vapors nor Particles

The material is also emissions-neu-tral: It neither gives off vapors nor particles. On top of that the syn-thetic material is so stable that only heat and extreme physical impact

is able to destroy it. In a nutshell, the new material offers the positive characteristics of glass, ceramic or metal without giving up any of its synthetic advantages.

With this many-sided product the Austrian company has unlocked a niche which is unique in the world. The innovative synthetic surfaces suit themselves above all for the use in aseptic areas. They are also suitable for making work places more pleasant thanks to their diverse properties for color design and configuration. When correctly configured, colors in-crease employee concentration,

Surfaces of the Future |

These are the Advantages of Senomed Synthetic Film

Cleanroom Suitability: The film has passed all relevant tests and is approved for

cleanrooms classified with ISO Classes 1 to 9 as well as for cleanrooms with GMP

classification A to D.

Diverse Properties: The films are scratch and scrub-resistant, chemically resist-

ant, anti-bacterial effective, color-stable and emissions-free. The chemical toler-

ance refers to acetic acid, hydrogen peroxide, sulfuric acid, hydrochloric acid, ace-

tonitrile, methanol, isopropanol, and many more.

Easy to work with: The film can be applied to any stable and smooth sub-surface.

The synthetic substrate combination can easily be drilled, screwed and re-worked.

After installation, polishing is seldom necessary as is the use of solvents.

Color Diversity: The synthetic is currently available from the factory in 50 colors

and diverse metallic versions. New colors are always technically conceivable,

which in contrast to other base materials, is not expensive. Thanks to its high qual-

ity color optic, the synthetic film will find a market even in aesthetically demand-

ing home environments.

Problem-free Integration: High-tech components with specialized functions can

easily be integrated with the synthetic surfaces.

Interesting Cost Advantages: The wall systems compared with hitherto existing

cleanroom materials are very cost-efficient including investment expenditures and

operation/maintenance costs.

Previously in a Blue Man (Boiler suit), today in overalls: Factory employees keep to strict hygiene and work behavior

requirements. Photo: Senoplast Klepsch & Co. GmbH

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PT16_175x125_CLEANROOM_MAGAZIN_C4_PHARMA.indd 1 14.12.15 13:40

prevent accidents, improve safety and reduce the number of sick days (Cleanroom Magazine reported on the effects of color and design in cleanrooms in the issue 03/2015).

Even Less Comples Films are gaining in Quality in Cleanrooms

Even today, Senoplast is preparing a major budget for research and development, is cooperating with universities and has a particularly distinctive product range. Its pro-prietary manufacturing systems engineering was responsible for the construction of the clean-room-technical processing facility, even the palettes for transport to the interim storage are of its own design and construction. The development team possesses an

inter-disciplinary know-how of systems engineering, chemistry, physics and process technology. Therefore Senoplast has succeeded to make the cleanroom the com-pany’s focal point. The company’s bosses never again want to do

without it, especially since random tests have shown that many less complex synthetic films gain in quality when they are produced in a cleanroom.

Author: Professor Gernod Dittel

| Surfaces of the Future

Process control in the clean room: The film running in the endless process from tape. Photo: Senoplast Klepsch & Co. GmbH

49


CLEANROOM AWARD 2016

APPLY NOW! DEADLINE 31 AUGUST 2016winners presentation at the cleanzone

CREATIVE PRIZE 2016

CREATIVITY & BEAUTY IN THE CLEANROOM

INNOVATION, SUSTAINABILITY & EFFICIENCY IN THE CLEANROOM

winners presentation at the cleanzone9 NOVEMBER 2016

more informations: more impressions:

st

APPLY NOW! DEADLINE 31 AUGUST 2016st

th

9 NOVEMBER 2016th

50

CLEANROOM MAGAZINE 2/2016 | What do you do there, … ?

My name is Birgit Kriegesmann. Regarding my profession, I am a Biological-Technical Assistent. Since 1999, I have been working at Bremer Pharma GmbH in War-burg, Germany, in the department responsible for the microbiological quality control. Bremer Pharma GmbH is a middle-size company in the pharmaceutical industry and specializes in the production of pharmaceutical products both in fluid and powder form. These products are for the export and domestic markets.

Sterile and aseptic parenterals have to be produced under strictly defined

cleanroom conditions. My tasks in-volve monitoring the microbiological issues in the production processes. I conduct airborne germ measure-ments in the framework of environ-mental monitoring with air samplers and sedimentation plates. I also check surface areas and cleanroom personnel with direct contact tests and afterwards evaluate the growing medium results. Furthermore I am responsible for the sampling and the testing of the water used for injection purposes and for the Aqua purificata (PW) of the company.

Additionally, I am responsible for the testing of bacterial endotoxins

in production materials and WFI, the production and testing of growth media, the administration of culture collections as well as the measurement instrument qualification and calibration in the microbiological laboratory and the validation of microbiological methods.

In 2003, I became qualified as the Hygiene Officer and conduct in this context training courses and workshops for company employees regarding this topic of hygiene.

* sterile preparations which are designated for injection,

infusion or implantation in humans or animals.

** Water for Injection

What do you do there, Birgit Kriegesmann?Brief profiles of the cleanroom industry

Birgit Kriegesmann works as a Biological-Technical Assistent at Bremer Pharma GmbH in Warburg, Germany and conducts in the context of microbiological monitoring, airborne germ

measurements in sterile-filling cleanrooms. Photo: Bremer Pharma GmbH.

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51


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52


SERV

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“Rules guide the wise man. The idiot obeys them” said Oscar Wilde. This Irish writer’s aphorism could be flatly coined for the cleanroom industry, even though Wilde – who passed away in 1900 – didn’t knew about cleanrooms.

Nevertheless his quote is applicable because the regulations for clean-room technology often only have contents which guide instead of convenient, easy to follow instruc-tions. Those who read the rules and regulations quickly notices that a lot of content is not specified to the smallest detail but requires the wisdom of the cleanroom-practicing man.

Frank Duvernell, Managing Di-rector of the cleanroom cleaning specialist profi-con GmbH Con-tamination Control in Leipzig, Germany, can shout out loud in this respect. “What actually stands in the ISO and GMP regulations?” he asks. “For example,: The cleanroom should be regularly cleaned with

the appropriate materials.” Such statements leave a lot of room for

interpretation. It could also be said in another way: The regulations contain too many standards. It is not specified for example, how often a cleanroom is to be cleaned or how often employees should be trained. “When I ask professionals about this, they always say: It depends.”

The Weaknesses of the Measuring Methods

But what does it depend on? - Above all on a risk analysis. The basis for this analysis is given in the ISO tables with air cleanliness class-es from 9 to 1. “This Regularium

applies only for the air” empha-sizes Frank Duvernell. “When you measure the particle concentration of your cleanroom, than you still don’t know what is lying on your surface areas.” Therefore clean-room operators should not rely on air quality measurements.

In order to determine surface contamination, contact tests are a tried and tested method. With this method, flat plastic dishes with a nutrient medium are pressed onto objects and surfaces to collect any micro-organisms possibly present. Afterwards the dishes are incubat-ed. “After two days I know then if something is growing. After five days, I know what it is and how much” says Frank Duvernell. The long incubation time is not the only disadvantage with this meth-od. The method is only a random measurement and cannot be com-prehensively applied.

What it’s about.ISO, VDI, GMP – it’s all written down. Why don’t we then have the perfect cleanroom?

| Laws and Regulations

The regulations for cleanroom technology neither contain planning details for a turn-key cleanroom concept nor exact requirements for practical operations. They more describe the requirements of safe cleanroom operation and are to be taken as a code of practice for correct implementation.

“The regulations are only recommendations. You will never

find anything concrete for your situation – it always depends.”

Frank Duvernell, Managing Director profi-con GmbH Contamination Control

53


profi-con CEO Frank Duvernell. Photo: Cleanroom Media

The VDI contains a lot, but not everything

Written down are the particular requirements for the cleanliness of the air, work places, surfaces and the personnel in the VDI Guidelines Series 2083 “Cleanroom Equipment”. These guidelines contain a broad spectrum of things which are allowed in cleanrooms and which are not allowed, but even though, not everything explains Duvernell. “It is fully understandable for ex-ample that cardboard has no place in a cleanroom – but where is this written?”

The profi-con Managing Director further points out that with the

thorough cleaning of a cleanroom, it is sensible that all fire alarms, sprin-klers, ventilators and so on, have to be cleaned before the cleaning

of ceilings, walls and floors with mops can be done. “Something like this isn’t found in the regulations” explains Duvernell. “It only states which cleanliness standard has to be achieved.”

The same applies for cleaning ma-terials. “Where does is state in the regulations which cleaning mate-rials are to be used” asks Duvernell. “There isn’t anything, worldwide nothing.” In the regulations, it is not specified if isopropanol or ethanol should be used. This is purely a question of the cleanroom operator’s or cleaning company’s experience.

A further example is disinfection with hydrogen peroxide. For its use, according to the regulations, no face mask is necessary up to a six percent concentration. “But in practice, a cleaning operator gets red eyes after 20 minutes with this concentration” indicates Frank Duvernell. “In other words: What works and what doesn’t work, you have to try it out – it depends.”

Trying out comes before studying the regulations

This is also the case with cleaning materials. Nowhere is it written which device should be used. This means only that the devices have to be appropriate reports the profi-con

Managing Director. Frequently, the purchasing department decides which devices are to be used.

Even trickier are the cleaning towels. There is a tremendous se-lection but worldwide, not a single binding testing procedure. “Every manufacturer can write on his towel ISO 8/ lint-free” says Frank Duvernell. But what does lint-free mean? How much is allowed to come out of the towel, in which time period, on which surfaces? There are no clear statements written in the regulations. “It isn’t even written down which towel you should choose. This namely depends on…”

Even when choosing cleanroom personnel, there are no detailed guidelines in the regulations. “The guideline VDI 2083 Page 15 indeed encompasses cleanroom related requirements for personnel and their clothing, however if jewelry is allowed in the cleanroom, this isn’t stated” says Frank Duvernell.He gives this advice: “Determine for yourself the criteria which are most appropriate for your clean-room and for your personnel and which bring the best results. The regulations are only recommenda-tions. You will never find anything concrete for your situation – it always depends.”


Laws and Regulations |

Rapid.TechInternational Trade Show & Conference for Additive Manufacturing

www.rapidtech.de

• Fachmesse und Kongress

• Anwendertagung „Neue Technologien“

• Fachforen Wissenschaft, Medizintechnik, Luftfahrt und Werkzeuge

Seit 12 JahrenKompetenz für generative Technologien

14. – 16. Juni 2016, Messe Erfurt

Titelmotiv: Bremspedal, EOS/MaterialiseFoto: Andreas Stedtler

54


What Cleanroom Technology is revolutionizing Until August 31th, 2016, innovation highlights for the Cleanroom Award and the Creative Prize can be submitted.

Phot

o: N

ils B

röer

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| Cleanroom Award and Creative PrizeCLEANROOM MAGAZINE 2/2016

55


“These robots will revolutionize clean-room technology” was the opinion of Cleanzone’s audience and went on to choose the air filter monitoring system RobotScan from the company Infraso-lution AG as the winner. However: Fol-lowing the award an award is waiting! The ReinraumAkademie immediate-ly started accepting applications for the Cleanroom Award and the Crea-tive Prize 2016.

“We are extremely delighted to have received this award” said Infrasolutions Managing Director Mathias Itter at the Cleanroom Award ceremony 2015 at Cleanzone

in Frankfurt am Main, Germany. It was a very good idea to have applied for the Award and at the same time be an exhibitor at Cleanzone. “We will once again be here next year – with still a better product” exclaimed Itter to the fair’s visitors in the Cleanzone Plaza.

Following tradition, the winner from the previous year presented the Award. Yvonne Weis Marketing Manager and Representative for Initial said during the Award pres-entation to Mathias Itter: “It was really great for us to have won the Cleanroom Award. Afterwards we received so many customer inquir-ies for our Cleanvision Cleanroom Suit that we had to turn down some inquiries because we were just getting too many.”

Frank Duvernell Managing Di-rector of the ReinraumAkademie and founder of the Cleanroom Awards emphasizes: “With this award, we want to bring out new ideas which are important for the industry to the general public.” To additionally serve this purpose,

the Creative Prize was awarded for the first time in 2015. “In many companies the tea kitchen is better equipped than the cleanroom”, says Duvernell. Researchers have long since proven that colored work environments help to increase the well-being of employees and therefore also product quality. The Creative Prize honors companies which are already taking these factors into consideration.

Applications for the Creative Prize and the Cleanroom Award can be submitted to the ReinraumAkade-mie until August 31, 2016.


Cleanroom Award and Creative Prize |

Applications for the Cleanroom Award and the Creative Prize 2016

What ideas are being looked for?All interesting ideas regarding the

topics of innovation, sustainability

and energy efficiency in cleanrooms

can be submitted. They should

differ from conventional ideas and

processes and present more than just

a marginal improvement to existing

products or services. The concepts

have to be thoroughly worked out and

cannot be fragmentally submitted.

Until when can applica-tions be submitted?Submission deadline for applications is

August 31, 2016. Valid for participation

are companies, institutions, scientific

facilities and individual persons.

Where can applications be sent?Please send applications for the

Cleanroom Award 2016 and the Creative

Prize 2016 to the following address:

ReinraumAkademie GmbHKennwort (Code word) “Cleanroom

Award”/ or “Creative Prize”

Rosa-Luxemburg-Str. 12-14

04103 Leipzig

Tel.: +49 341 98989 302

E-Mail: [email protected]

Web: www.reinraum-akademie.de

Infra Solution won the Cleanroom Award 2015, presented

by Frank Duvernell (right). Photo: Cleanroom Media

MED-EL from Austria won the Creative Prize 2015.


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| Cleanroom Award and Creative Prize

All Previous Winners of the Cleanroom Award

2012: APMONThe Dutch company Technology of

Sense won in 2012 with APMON the

very first Cleanroom Award. This

measurement instrument monitors all

particles in a room which could fall onto

products and sounds an alarm when

safety limits have been exceeded.

2013: BLAUTOUCHThe Portuguese company Laborial

S.A. developed with Blautouch a

laboratory table with an interactive

surface for GMP cleanrooms. The

Touchsystem has been installed under

a glass surface and makes possible

the use of computers which have

been placed outside of the room.

2014: CleanVision Cleanroom-SuitThe CleanVision Cleanroom-Suit from

the company Textil Service GmbH is

a one-piece suit with an integrated

hood and an integrated visor. The

closed design predestines itself for

the use in sterile environments.

2015: RobotScan Flex The German company InfraSolutions AG

developed with RobotScan Flex a solution

for robot-supported air filter monitoring.

The measurements are able to be done

with fewer personnel and with much

more precision and speed than by hand.

The Cleanroom Award

Awarded will be ideas related to the innovation, sustainability or energy efficiency in cleanrooms.

Wanted are concepts, products, or services which distinguish them-selves as trailblazing solutions or are influential in changing the industry.

An expert jury chooses five finalists from the total number of applica-tions. These five finalists then pres-ent their projects at Cleanzone on November 8 – 9, 2016, in Frankfurt am Main, Germany.

Which of the five finalists wins the ReinraumAkademie’s 3000 Euro Cleanroom Award prize is determined by Cleanzone’s visitors by ballot.

The Creative Prize

Awarded will be the most optically and ergonomically creatively de-signed cleanroom.

Wanted are concepts and ideas which eliminate the “white noise” in cleanrooms by using colors, by implementing processes and by using colored edges.

Additionally, applications are welcome showing concepts which use colors to indicate orientation and information for example to optically separate adjoining areas.

Creative cleanroom planning not only relates to the walls but also the overalls worn by employees could be color-coded according to department or function.


The Creative Prize was awarded in 2015 for the first time and designed by the Swiss artist Beat Toniolo.

Photo: Messe Frankfurt Exhibition GmbH, Sandra Gätke

Also in 2016 the most creative designed cleanroom will

get an award. The Creative Prize will be every year fresh

created by an artist. Photo: Daniel Read, Cleanroom Media

57


Cleanroom Knowledge to glean The editorial office of Cleanroom Magazin regularly scans new publications which are relevant to the cleanroom. These books – newly published – we would like to present.

New reference books on the market |

EU Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use

Concerning the development, manufacture and monitoring of pharmaceuticalproducts, not only the high quality standards are presented, but also the numerouslegal guidelines and requirements to be fulfilled. The expanded new edition of theEnglish edition of the EU Guide offers the latest legislative text up to October, 2015.The book contains the three main parts, Part 1 Basic Requirements for MedicinalProducts for Human and Veterinary Use, Part II Basic Requirements for ActiveSubstances used as Starting Materials, and Part III GMP Related Documents as well asthe Annex 1 to 19.

“EU Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use”, G. Auterhoff and S. Throm, ECV Editio Cantor Publisher, 8, updated and expanded edition 2016, 325 pages, Brochure. ISBN 13:978-3-87193-431-5. Price: 72.76 Euros.

www.avantalion.de

Quality Management

Cleanroom Technology

Qualifi cation

Validation

Computer System Validation

Process Management

Project Management

Master every challenge

by using our services.

Benefi t from our 360° Pharma Consulting

to gain more effi ciency, safety and quality.

Visit us atLOUNGES 2016 · booth K3.8

independent · transparent · sustainable

58


58

GermanyLeipzig

Trade Fairs and Congresses

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| Trade Fairs and Congresses

Berlin

München

Stuttgart

13.-14.04.2016LabInnovations Lausanne Switzerland

14.–17.11.2016Medica/CompamedDüsseldorfGermany

19.–21.04.2016Powtech mit PartecNürnbergGermany

10.-13.05.2016analytica 2016MünchenGermany

21.-23.04.2016Cleanroom Exhibition & Biotech EuroasiaIstanbulTurkey

20.-23.09.2016ILMACBaselSwitzerland

31.05.–02.06.2016parts 2 cleanStuttgartGermany

12.–14.04.2016MedTec EuropeStuttgartGermany

08.–09.11.2016CleanzoneFrankfurtGermany

Basel

Switzerland

Lausanne

Nürnberg


Wangen an der Aare

Düsseldorf

Frankfurt a. Main

Grap

hic:

Fot

olia

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SwissCCS SYMPOSIUM & General Assembly (GA) 2016

20. April 201608:30 - 09:00 | registration / coffee & cake09:00 - 10:00 | General Assembly SwissCCS (SRRT)10:00 - 17:00 | Symposium

NEWS: ISO, VDI, CENNEWS: SwissCCS Experts groups: Engineering, microbiology / qualification and operation / behavior in the cleanroom.

After that Symposium with:"Requirements for purest high-tech packaging"

17:00 - 20:00 | Net-working with Apéro ( r.s.v.p.)

Cleanroom Experience Competence Centre Schweizc/o CleanroomAcademy GmbH Vorstadt 4, 3380 Wangen an der Aare

Events at the ReinraumAkademie, Germanyand the CleanroomAcademy, SwitzerlandReinraum-Expertentage | Cleanroom Experts Days11.-12.05.2016 | Flexible Cleanroom Design | Leipzig, Germany07.-08.06.2016 | Cleanroom: Layout, Planning and Construction | Wangen an der Aare, Switzerland28.-29.09.2016 | Flexible Cleanroom Design and 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, German07.-08.12.2016 | Optimization and Qualification of Cleanroom Operations | Wangen an der Aare, Switzerland

BEHAVIOR IN A CLEANROOM11.04.2016 | 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 CLEANING17.-18.10.2016 | Two-Day-Seminar | Leipzig, Germany

ADDITIONAL EVENTS28.09.2016 | Swiss Cleanroom Industry’s Autumnal Reception | Wangen an der Aare, Switzerland 05.10.2016 | Cleanroom Industry’s Autumnal Reception | Leipzig, Germany

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

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

Events |

60


Order your free subscription www.cleanroom-media.com

Next issue | Juli, 2016

SERV

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| Imprint

Imprint CLEANROM MAGAZINEIs issued and published byCleanroom Media GmbHRosa-Luxemburg-Straße 12-1404103 LeipzigGermany

Internetwww.cleanroom-media.com

Managing director Frank Duvernell, V.i.S.d.P.

Manager Cleanroom Media und Conception Magazine Maja FrankeTel. +49 341 98989 [email protected]

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

Translation Bill Hillman

AuthorsFrank BaeckeProf. Gernod DittelFrank DuvernellClaudia Pachl

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

InfographicsDaniel Read, Cleanroom Media

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.

E D I T I O N 1 / 2 0 1 5

free subscription

more informations

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 2 / 2 0 1 5

CLEANROOMLife & ScienceInformationen für die Reinraumtechnologie MAGAZIN

CLEANROOMMAGAZINE

Life & Science Information for Cleanroom Technology

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

Frühjahr 2015

Blühende NaturGefährliche Kontamination So nehmen Pollen und Luftfeuchtigkeit Einfl uss auf Ihre Produktion

ISSN 2364-0405

02

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

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 E D I T I O N 2 / 2 0 1 6

A D V E R T I S I N G R A T E S / 2 0 1 6

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

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

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

CLE

AN

RO

OM

MA

GA

ZIN

03 |

SO

MM

ER 2

015

03summer

2015

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

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

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

CLE

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2015

Umschlag_2015-03_5mmRuecken_005.indd 109.07.15 12:53

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

CLEANROOMLife & ScienceInformationen für die Reinraumtechnologie MAGAZIN

Keime im Essen Wie die Reinraumtechnik gefährlichen Lebensmittelkeimen den Garaus macht

Cleanzone 2015 Die internationale Reinraummesse wird zum Impulsgeber der Branche

Herbst 2015

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

04CLEANROOM

Life & 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 erö� net dem Reinraum neue Perspektiven

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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



Hochspannung im Reinraum Damit kein Funke überspringt - sensible Produkte schützen

Frühjahr 2016

02

Life & ScienceInformationen für die Reinraumtechnologie MAGAZIN

CLEANROOM

CLEANROOMMAGAZINE


spring 2016

02



