Cleanroom Magazine 02-2016

CLEANROOM MAGAZINE MAGAZIN

02 02

spring Frühjahr 2016 2016

Life & Science Life & Science Information Cleanroom Technology Informationen fürfor die Reinraumtechnologie

High Voltage in Hochspannung the Cleanroom im Reinraum Throw sparks and Damit out keinthe Funke überspringt protect sensitive products sensible Produkte schützen

In-Vitro-Fertilisation Künstliche Befruchtung

How doesder theKinderwunsch desire to have children Was hat mit correlate with cleanrooms?

Reinräumen zu tun?

Never Never stop stop thinking thinking

Cleanroom Creative Prize 20162016 Cleanroom Award Award & und Creative Prize

Register now!

3

Dear Readers!

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

EDITORIAL

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 cleanrooms. 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 Frank Duvernell: „I have been convinced for

component, the energy of electrostatic discharge is comparable to lightning

some time that cleanroom technology is a

striking a tree. Respectively, the results are also enormously devastating

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

for integrated switches, instrumentation or small-structured components.

Learn about how lightning strikes can be prevented inside a cleanroom in our cover story.

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

Electrostatic Charges

kind of potential has to be avoided, namely, the

generate High Voltages

cleanroom. Why? Please see right.“ (a)

(b)

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

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 Duvernell Editor

Editorial | CLEANROOM MAGAZINE 2/2016

4

CONTENTS 02/2016

08

08 Title Story: Lightning Strike in the Cleanroom

CONTENTS

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

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

LIFE & BUSINESS Latest 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 Medications 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

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

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

16

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.

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

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

CLEANROOM MAGAZINE 2/2016 | Contents

5

24 When new Life

24

emerges from the Cleanroom

For 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.

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

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

54

36 Behind the Scenes:

On the road with René Hecker

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

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

SCIENCE & TECHNOLOGY Solutions 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 Clean

Cleaning 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.

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

44 New Surfaces for

54 Cleanroom Award 2016:

Cleanroom Technology

Send in your Applications now

Senomed 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.

Until 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.

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

50 What do you do there, …?

Birgit Kriegesmann, responsible for the micro-biological quality controlat Bremer Pharma GmbH in Wartburg, Germany.

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SERVICE

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57 Professional Literature: References for the Cleanroom Industry

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

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Events, Awards, Columns

58 Trade Fairs and Events

52 Laws and Regulations: What it comes down to

60 Imprint

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

When everything is already written down in the regulations, why don’t we have the perfect cleanroom?

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Contents | CLEANROOM MAGAZINE 2/2016

6

Life&Business

LIFE & BUSINESS

The Market in Brief

Cannabis used more frequently for Medical Purposes

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

Approval Debate | Cannabis anti-in-

Generics Market | The market research

flammatory, relieves pain and is far

company Global Data forecasts for

better tolerated thatn morphine and

the Indian pharmaceutical market a

opiates. For pharmaceutical com-

tremendous surge in growth. Market

panies it is nevertheless difficult to

volumes are expected to more than

get approvals for cannabis-based

double from 20 to 55 billion dollars

Samsung will not produce any new

medications. In Germany for

in the next five years. The driver of

products with 3D functions. The

example, it is neither allowed to

this development is the tremendous

reasons for this is the low demand

plant cannabis, to possess nor to be

growth in the generics industry. Ac-

caused by the need to wear 3D glasses

sold. This situation could soon be

cording to Global Data India covers

and the lack of standards for the

changed. The Federal Public Health

20 percent of the worldwide generics

glasses. Another reason is the com-

Ministry is considering putting in

market and is therefore the world’s

petition from the new technologies

the hands of a federal “Cannabis

largest exporter of imitations drugs.

such as ultra HD and virtual reality.

Agency”, the cultivation and sale of

The success of the Indian generics

Industry observers forecast that 3D

cannabis. The plant’s ingredients

televisions will make a comeback as

suit themselves for a wide range of

soon as it becomes possible to build a

medical applications. The spectrum

3D panel which can be used without

ranges from wound medications,

glasses.

the treatment of Multiple Sclerosis to the treatment of neurological illnesses such as the Tourette-Syndrome and ADHS.

The worldwide demand for generics is causing a boom for

Experts expect Approvals for new Medications in 2016

India’s pharmaceutical manufacturers. Photo: arsdigital/ Fotolia

Pharmaceuticals | The Association of

industry is a result of the low produc-

Pharmaceutical Companies doing

tion costs and a worldwide increase

Research in Germany (VfA) believes

in the demand for cheaper medicinal

that in this year several new medi-

products.

cations will be receiving approvals.

Included are two-digit numbers of

3D Television on the Way Out

new pharmaceuticals which aid in the treatment of leukemia, lung cancer and bone marrow cancer.

For medical purposes it is expected the cultivation and sale of cannabis will be allowed. Photo: stokkete/Fotolilo

VR and HD dominate | The Korean

Several of these pharmaceuticals

manufacturers Samsung and LG are

are based on newly developed prin-

pulling out on the much-praised 3D

ciples of operation, for example, the

technology for televisions. LG wants

use of oncolytical viruses which

to halve its production of 3D devices,

attack cancer cells and activate the

CLEANROOM MAGAZINE 2/2016 | The Market in Brief

7 3D-Televisions will see their breakthrough when they can be used without glasses.

And maybe when this kid is big.

journal “Der Ophthalmologe” (The

In another project, a new material

Ophthalmologist), an artificial

was developed which replaces

cornea made out of Tilapia scales

human cartilage. Enriched with a

is currently being tested. The back-

patient’s own cells, the material is

ground of this research is the large

able to support the development of

need for donated corneas which

natural tissue.

until now have been supplied by deceased doners. On the search for alternatives, researchers at the University Hospital for Eye Care Cologne

Hospital Group does away with Doctors’ White Coats

and the University Hospital Leiden

Photo: Sunny studio/Fotolia

are examining a substance which

WHO-Recommendation | The Askle-

comes from the fish’s scales. These

pios Group is the first hospital oper-

are cultured in aquacultures, the

ator which has done away with the

fish’s scales consequently providing a

traditional long sleeved white coat in

base material whose Type 1 collagen

all of its 100 medical facilities. A short

is similar to a human cornea. With

sleeved garment for doctors, the

an experiment on rats, the artificial

so-called tunic, has taken its place,

cornea grew as well as the natural

which in many medical centers is

cornea on other rats.

already the rule. The occasion for

immune system to act against these cells. Additionally, other antibiotics against problem germs (MRSA and others) as well as medications for

Replace Body Parts and improve Treatment of Disease

the treatment of hepatitis C, the treatment of hemophilia A and B,

Stem Cell Research | In Switzerland,

and new vaccines against anthrax

the five-year national research pro-

are expected to reach the market.

gram “Stem Cells and Regenerative

Moreover, more than ten new med-

Medicine” has come to its close. The

ications for the treatment of patients

results which have been recently

with rare diseases are expected to be

presented are very promising. The

approved in 2016.

A Fish could save Those with Eye Disease from becoming Blind

Long sleeved doctor’s coats are often permeated with germs and should be replaced with short sleeved tunics.

Photo: Syda Productions/Fotolia

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

The scales of the Tilapia supply the base material for artificial human corneas. Photo: KonArt/Fotolia

this change is the recommendation The Swiss stem cell research focuses on regenerative

from the Robert Koch Institute and

medicine. Photo: kwanchaift/Fotolia

the World Health Organization

researchers have found out that the

studies that pathogens are more

risk of tumors don’t only come from

frequently found on long sleeved

stem cells but also from immature

coats. Asklepios is the first hospital

intermediate forms. They also dis-

operator which has implemented

covered that the pancreas following

the recommendation. Related to this

the destruction of all insulin pro-

issue, according to a recent survey

ducing cells is able to reproduce new

conducted by Asklepios, 65 percent

cells from closely related cell types.

of the people surveyed are concerned

This discovery could make insulin

about being infected with multi-re-

injections for diabetics unnecessary.

sistant germs in a hospital.

WHO. They have shown in several

The Market in Brief | CLEANROOM MAGAZINE 2/2016

LIFE & BUSINESS

8

CLEANROOM MAGAZINE 2/2016

Mini Sparks with Maxi Damage

9

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

Photo: Cleanroom Media

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.

CLEANROOM MAGAZINE 2/2016

10 PMT Partikel-Messtechnik GmbH.

Amber as a Clothing Brush

LIFE & BUSINESS

The company located in Heimsheim, Germany is specialized in the mon-

The term electrostatic means latent

itoring of clean and sterile rooms as

electricity and comes from the Greek

well as the management of electro-

natural philosopher Thales von Milet

static charges. As Scheibel reports,

(625-546 BC). During his lifetime,

the defective components find their

people in well-to-do homes made use

way to customers and later cause

of the amber phenomenon, which

Indispensable in electronics: tool with ESD symbol.

losses in production which causes

was described by Thales. It is based

Photo: Cleanroom Media

considerable costs in downtime and

on the discovery that an amber stone

replacements. Intact components

which is rubbed on animal fur or on

“A lack of gap will certainly mean

are also vulnerable. “An electrostatic

a piece of cloth is able to attract pieces

that some of the sparks will jump the

discharge at any position along a

of straw or feathers. Larger amber

seam.” With these words the poet Er-

robot-controlled assembly line is

stones were used as clothing brushes

ich Limpach (1899-1965) described in

enough to interfere with the process

because they attracted dust particles

a lyrical form what manufacturers of

regulation in the micro-controllers

when glided along the clothing. The

sensitive components describe with

and to stop the entire assembly line.”

old Greek word for amber is “electron”,

a balled fist: electrostatic discharges.

The mini sparks which are known when combing hair or grabbing a

the origin of the word electricity.

Cleanroom Air no longer offsets Electrostatic Charges

door handle come across as being

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

harmless but in the production of

That mini sparks are able to cause

small and sensitive products they

such maximal damage has diverse

often result in fatal consequences.

reasons. Besides the flooring, table

Electrostatically charged surfaces

For a micro-electronic component

mats, gloves, overalls, brushes and

in cleanrooms are in two respects

for example, the energy of an elec-

tools being used, the air condition-

critical. Firstly, a spark-like discharge

trostatic discharge is comparable to

ing above all is the reason for two

threatens to damage or destroy

lightning striking a tree.

boosting effects: With one effect, the

products. Secondly, charged surfaces

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

“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

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

air conditioning systems reduce the

attract particles. Studies show that a

ion content in the air entering the

heavy load of particles on charged

“The nasty thing about electrostatic

cleanroom and the other effect is

surfaces is able to reduce locally the

discharges is that according to

that this air is no longer able to offset

cleanroom classification up to two

industrial estimates, out of every

the electrostatic charges due to the

steps lower than the ISO classifica-

defect which is detected in produc-

reduced air humidity. Therefore the

tion of the cleanroom.

tion, there are two to five which

materials, products and machines

Moreover particle deposition is not

are detected after delivery” says

in the cleanroom are able to take on

easy to remove from charged sur-

Ricco Scheibel, Sales Manager of

electrostatic charges.

faces. The electrostatic suspension

CLEANROOM MAGAZINE 2/2016 | Electrostatic Discharge

11 of contamination is able to cause in sensitive areas for example in semiconductor cleanrooms or in pharmaceutical 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 protection (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 produces 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

Impressions of the Cleanzone 2015: Between footwear and flooring arise charging voltages when walking.

Thus there will be no uncontrolled

available to the market, the German

discharges have clothing, footwear

ESD Network was founded one year

and flooring - as demonstrated here

ago. Four large companies have joined their ESP lines of business

- have static dissipative properties.

Photo: Cleanroom Media

whereby each company has its own focus and core topic. Andreas Karl GmbH & Co. KG is specialized in ESDsafe work places. Keinath Electronic GmbH offers seminars, workshops, consulting and equipment for the entire ESD sector. Nora Systems

“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

GmbH is a specialist for flooring in ESD protected areas. Wanzl Metallwarenfabrik 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 | CLEANROOM MAGAZINE 2/2016

12 The German ESD Network presented

over a floor between the shoe and

expert Ricco Scheibel. “Firstly all

itself for the first time in May, 2015

flooring material. People are not ex-

electrically condutive components

in Nürnberg, Germany at the SMT,

posed to any danger in this instance

are to be equipped with ground-

Europe’s leading trade fair for system

but electronic components and

ing. Concretely this means: All

integration in micro-electronics. Fur-

devices are. Sitting on ungrounded

personnel are to be grounded with

thermore the newly produced ESD

chairs with rollers as well as wearing

antistatic clothing, this measure

guidebook was presented. “With this

clothing unsuitable in ESD areas can

s u p p o r t e d b y t h e w ea r i n g o f

guidebook, we would like to support

cause people to accumulate charges.

grounding straps on the wrists

companies and specialists in their

So that no uncontrolled discharging

and ankles. Additionally, work

daily work and to sensitize them

takes place, people, clothing, shoes

places are protected by grounding

to the relevance of this topic”, says

and floors have to have electrostatic

table tops, mats and conductive

Andreas F. Karl. The avoidance of

dissipating properties.

flooring.”

LIFE & BUSINESS

damage by electrostatic discharge not only prevents a company from accruing higher costs but also increases customer satisfaction and retention.

Devastating Killer-Events are preventable How is damage caused by elec-

For a micro-electronic component the energy of an electrostatic discharge is comparable to the energy of lightning striking a tree.

Source: Wikipedia

trostatic discharge preventable? „Fundamentally in practice, it is impossible to completely keep static electricity out of production

“In order to suppress particle-at-

Producers of cleanroom needs offer

facilities” says Ricco Scheibel of PMT

traction and ESD-killer events,

a wide range of products. Modern

Partikel-Messtechnik GmbH. Charge

there is a range of pragmatic and

cleanroom clothing reinforced

voltages are generated while walking

effective approaches” says PMT

with conductive carbon fibers for dissipating electrical charges is available which should be worn in

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.

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 overboots, which thanks to anti-static

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

properties no longer electrically charge those who wear them. Other anti-static measures which are recommended 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 socalled insulators that is materials on whose surfaces electrical charges are not able to move. In such cases,

CLEANROOM MAGAZINE 2/2016 | Electrostatic Discharge

13 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 neutralizing 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

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 antistatic 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.

is actually very easy to raise air conductivity 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.

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

As an alternative to air humidification, air ionization has proven itself.

too few. If these ionized air molecules

practically neutralize itself. Several

Ionizers via air flows intensively

come into contact with an electrically

technical ionization processes have

provide the cleanroom with air mol-

charged surface, the ions will change

been established. Depending on the

ecules which have an ion too many or

their polarities and the surface will

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

The moment at which the spark might be dangerous - if no precautions were taken. Photo: gammaburst/Fotolia

Electrostatic Discharge | CLEANROOM MAGAZINE 2/2016

14

“Neutralization by ionization is the method of choice”

LIFE & BUSINESS

Ralf Keinath, the Executive Managing Partner of Keinath Electronic GmbH, comments on the risks to products by electrostatic discharges.

Cleanroom Magazin: In cleanrooms

a spark with our own eyes. Semicon-

as well as possible. The second: To

the constant issue it the ellimination

ductor components are sensitive to

controllably dissipate charges,

of particles and germs. However

even just a few volts!

whereby a gentle discharging is

there isn’t much said or written

meant which is best done with the

about the risks to products by elec-

Cleanroom Magazin: How large are

appropriate room and personnel

trostatic discharges. Why is this?

the damages and product losses due

equipment in the grey rooms. In

to ESD?

cleanrooms, this is conditionally

Ralf Keinath: Well as the name

possible as such equipment present

itself indicates, the demands on

Ralf Keinath: It can be assumed that

contamination issues. Moreover

cleanrooms deal primarily with

15 to 20 percent of all electrical fail-

the metal surface areas which are

cleanliness, either in the sense

ures of semiconductor components

preferred in cleanrooms cannot

of particles and/or in the sense

can be traced back to an ESD event.

be gently discharged as they are

of germs. However, there is also

These values were confirmed by

low-impedance objects. This leads

present the natural phenomenon

different and independent analyses

to the undesired hard discharge

of electrostatic discharge. It is im-

over a period of many years and at

which can cause ESD damage. And

portant to always be aware of this.

several different semiconductor

now for the third method: The

manufacturers.

neutralization of the charges with

Cleanroom Magazin: Is the awareness

neutralization devices. This is in a

of ESD risk lower because it presents a

Cleanroom Magazin: How can

cleanroom as a rule the method of

lower risk than contamination?

cleanroom operators neutralize or

choice!

prevent electrostatic discharges?

Ralf Keinath: The question concern-

Cleanroom Magazin: Is it possible

ing risks has to be differentiated

to build cleanrooms ESD neutral or

from case to case. At first, it must

is this condition only seen after the

be clarified to what extent the prod-

cleanroom is put into operation, if

ucts handled in the cleanroom are

and where it sparks?

electrostatically sensitive.

Ralf Keinath: The latter should be Cleanroom Magazin: Back to my

in any case avoided. If the products

question: Is the awareness of ESD

handled are electrostatically sensi-

risk lower?

tive, than the ESD protection has to be and should be considered in the

Ralf Keinath: I would say: Yes. Everybo-

Ralf Keinath is the Executive Managing Partner of Kein-

dy knows about electrical discharges

ath Electronic GmbH. The company counts as one of the

from everyday life, like the electrical

founding members of the German ESD Network (Deutschen

shock when touching a door handle or

ESD-Netzwerkes). Grafik: kutukupret/Fotolia

the crackling sound when pulling on a sweater. People perceive a discharge

Ralf Keinath: ESD can effectively be

from 3000 volts under this we don’t feel

controlled with three methods. The

anything. From 10,000 volts we can see

first: To avoid electrostatic charging

CLEANROOM MAGAZINE 2/2016 | Electrostatic Discharge

initial planning of a cleanroom. *ESD = electrostatic discharge

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3D-DruckCLEANROOM | MAGAZINE 2/2016

15

16

The next big thing?

Virtual Reality-Devices are expected to replace Smartphones.

Virtual-Reality-Glasses: 20% of Germans are interested in imaginary 3D worlds 14-29 years: 28% 30-49 years 25%

28%

34%

13%

Over 50 years: 13% Other: 34%

25% Source: Bitkom

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

LIFE & BUSINESS

14-29 years: 28%

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

30-49 years 25%

“With modern cleanroom technolOver 50 years: 13% 34%

28%

Other: 34% ogy, modular and flexible solutions

are increasingly in demand. There25%

fore13% the transparent and individual Source: Bitkom planning of cleanrooms for oper-

ators is becoming more and more important”, says Harald Wodtke, To set up a cleanroom today which

in the planning, construction and

Project Manager at bc-technology.

will be built tomorrow? Virtual

qualification of cleanrooms. With

“With the help of VR technology, we

Reality (VR) makes this possible. The

stereo-visualization using CAD

have found a medium which makes

technology generates an artificial

data, the specialists provide for their

it possible for a customer to step into

world on a computer in which the

customers virtual tours through the

his cleanroom also when the project

observer is able to virtually move

planned cleanrooms. Customers are

is only in its conception phase.”

through as if he is actually on site.

able to view machines, devices and equipment from every perspective

Bc-technology GmbH already offers

and – also with ergonomic consid-

for its customers the use of such

erations – play through, reality-true,

virtual 3D worlds for the design of

their individual solutions. Produc-

cleanrooms. The company located in

tion processes are also able to be

Dettingen, Germany is specialized

simulated in real-time.

The Risks are decreasing, The Planning Dependability is increasing These possibilities are providing cleanroom operators major advantages: They are able to determine in virtual reality the optimal utilization of their rooms, to resolve any critical issues before beginning construction and to estimate more realistically the expenditures. Potentials 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

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

CLEANROOM MAGAZINE 2/2016 | Virtual Reality

recent Mobile World Congress in

17 Barcelona, Spain, Europe’s largest Mobile Communication Trade Fair.

From the end of February to the beginning of March, 2016, manufacturers presented their latest solutions and devices for working and playing virtually.

The technological approaches are really 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.

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

It will change every facet of life.” Together with Samsung, Facebook wants

on in life he didn’t want to only look

charging ahead with its VR glasses

to become the market leader in this

at photos and films of her but fully

which are far lighter and therefore

anticipated billion-dollar market. The

immerse himself into these earlier

more comfortable. The trick is: The

New York investment banking and

scenes. Together with Samsung his

Smartphone is not connected to the

securities trading company Goldman

company has developed the Virtu-

glasses but only a connection cable.

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

“Virtual reality will be the next major platform. It will change every facet of life.”

Mark Zuckerberg, CEO Facebook Inc.

Facebook boss Zuckerberg believed early on in the new technology. He has already invested since March,

al-Reality-Glasses Gear VR, which

HTC wants to seize the market from

2014, two billion dollars in the pur-

uses the Smartphone as its display.

the top end and bring to the market

chase of the company Oculus VR

Facebook has piloted its software

in April a highly-praised high-tech

which with its Head-Mounted-Dis-

know-how into the partnership

headset. Apple is also hoping for

play with the name of Oculus Rift is

which has raised eyebrows among

new growth outside of the saturated

considered the forerunner among

market observers. Forrester analyst

Smartphone market and therefore

providers of VR entertainment. The

Juli Ask said when interviewed on

has called into life a top secret di-

glasses give the user the feeling that

n-tv: “The combination of social

vision for Virtual and Augmented

he is really able to move around in

media and communication is the

Reality.

the virtual world.

Killer-App.” According to forecasts from IHS,

The Oculus glasses were developed for especially realistic game enactments however Zuckerberg has long been thinking of further

2016 is expected to bring the Breakthrough for VR Technologies

applications. These range from

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

education to the marketing of real

Facebook and Samsung are however,

million in 2018. By 2020, IHS forecasts

estate and tourism on up to a per-

not the only ones which will make

that 37 million headsets will be sold.

son’s private life. After the birth of

2016 the year for Breakthroughs

The euphoria over the new tech-

his daughter, he realized that later

for the new technologies. LG is

nology does not however include

Virtual Reality | CLEANROOM MAGAZINE 2/2016

LIFE & BUSINESS

18

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

all management boards. Sony for

the small gamer niche, good content

Doctors would have the possibility

example is keeping to its Playstation

material for the mass market is

to digitally simulate risky proce-

VR glasses and is staying out of the

still scarce. Oculus founder Palmer

dures. Architects and city planners

mobile communication market. For

Luckey doesn’t see in the sales of

could create walk-in designs. The

Sony Mobile boss Hiroki Totoki it is

VR glasses a long term sustainable

logistician could be assisted in the

not about putting still another VR

business model. At the first “VR/AR

optimization of goods-storage with

glasses device on the market. He is

Summit” presented by the software

the help of VR glasses. Applications

more concerned with the question

company Unity at the beginning of

have also been devoted to business

where enough good content ma-

February in Los Angeles. California,

communications. The Canadian

terial for the virtual world will be

Luckey stated that money can only be

company Summit Tech for example,

coming from.

made with material content: “It only

has developed a solution with which

counts how often the buyer returns

globally scattered colleagues are

to experience something new.”

able to sit themselves in their host’s

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

conference room during a video The drawing card for the new

conference by using VR glasses and

technology should be in the busi-

are able to look around and see all of

ness applications. For example

the participants.

Thereby the Sony manager has put

pilots could train how to control

a finger in the wound. Apart from

an airplane in a virtual world.

“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

Augmented Reality Highly Interesting for Industry For many industries, it is more interesting the linking of real environments with virtual components which can be merged into the user’s field of vision. This augmented reality 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 procedural steps on the data glasses. The

CLEANROOM MAGAZINE 2/2016 | Virtual Reality

19 Sales of Virtual-Reality glasses 2,2 Million

Sales of Virtual-Reality glasses

2015 2018

20 Million

2,2 Million

2015

20 Million

37 Million

37 Million

2020

2018 2020

Sources: IHS, CCS Insight

Sources: IHS, CCS Insight

Mercedes Benz factory in Bremen

have direct access to information

this world of illusion provides not

has implemented Google Glasses

or need both hands for their tasks.

only the optimization of facilities.

in the construction of automobiles

Cleanroom operators can generate

whereby the tools necessary for

It is imaginable to use such applica-

training environments in which they

the assembly of external parts are

tions in the cleanroom. The textile

are able to prepare new employees

displayed. With these augmented

service and lavatory hygiene provider

for their work in a cleanroom.

reality glasses the tools can be mod-

CWS-boco offers its customers an App

If this is the way it is going, then the

ified and the data immediately sent

for Android and Apple Smartphones

situation has come full circle. Elec-

to the factory in Peking where the

which makes it possible to virtually

tronic systems are able to virtually

tool implementation is just taking

equip a real room with CWS dispens-

resurrect cleanroom worlds from

place. Augmented reality or the

ers. Therefore customers or potential

which they themselves have just

merging of immediate information

customers can see in advance which

emerged.

in real time, is for industry useful

solutions optically and functionally

above all where employees don’t

at best suit their premises. However

Author: Frank Baecke

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innovative – competent – customized

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With us, you see your monitoring from April 5-7, 2016 an entirely new perspective. We transform your cleanroom into the Hall 1, Booth F2.3 «next big thing».

Virtual Reality | CLEANROOM MAGAZINE 2/2016

20

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

Colandis CEO Joachim Ludwig.

LIFE & BUSINESS

Photo: Cleanroom Media

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, Germany, 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? Sometimes 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

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.

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 engineering office. At that point in time,

CLEANROOM MAGAZINE 2/2016 | Portrait

21 he couldn’t imagine that out of this one-man office, the company Colandis 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

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 belongs 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.

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

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

However his efforts paid off. With Ludwig’s support, the company developed new product ranges among them one of the first circuit board

semiconductor industry and was to some extent a competitor for the

The German re-unification came

direct exposure machines. “We could

Dutch lithograph systems manufac-

two years later and the Kombinat

directly go to the circuit board with

turer ASML, at that time known as

Carl Zeiss Jena was divided into

the laser which omitted the round-

ASM. “It was always gripping when

several independent companies.

about film exposure procedure”

we brought our own assemblies into

Joachim Ludwig landed at the

says Ludwig. A further important

operation. For example, we ensured

new Jenoptik Infab GmbH. At this

development was the automation of

constant temperatures of precision

company he took up the initiative

wafer handling and transport into

optics in wafer steppers. There was

to collect information from various

the cleanroom. The terms SMIF and

only a five one-thousandth Kelvin

and diverse sectors of industry. “I vis-

FOUP are well known in the semi-

tolerance and this had to be strictly

ited many congresses and meetings

conductor industry.

maintained” portrays this former as-

and often paid for these trips out of

“At that time, we were in respect to

sembly group/component developer.

my own pocket” recounts Ludwig.

the state of knowledge comparable

CLEANROOM TRAINING

www.reinraum-akademie.de

Portrait | CLEANROOM MAGAZINE 2/2016

22 Two Desks and a Drawing Board

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

Joachim Ludwig, Managing Director Colandis GmbH

At first, the projects were sporadic.

Then came the search for a colleague 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

LIFE & BUSINESS

Colandis GmbH will be celebrating to the Fraunhofer IPA in Stuttgart”

technical ventilation components

its 20th anniversary. “We started

remembers the Colandis owner. At

in sterile environments). Joachim

in Kahla which is nearby Jena in a

the time he was visiting a presenta-

Ludwig is still working today in

40 square meter office. Below the

tion on the optimization of wafer

this and in many other commit-

office was an equally-large garage

steppers at the IPA, he advised the

tees: “I’m the dinosaur there.”

which we could use as a work shop.

referent: “Come on over to Jena,

Two desks and a drawing board

we’re already a step further.” As

were all we had” depicts Joachim

the referent did indeed come to Jena, he was astonished: “You are already two steps ahead!” Prompt-

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

ly, he invited Joachim Ludwig to

Ludwig about his start.

In the garage, which was soon equipped with used work benches

be part of the VDI Guidelines 2083

Then came the hammer. At the end

and surface plates, emerged the

Work Group, in which he was sig-

of 1994, the company management

first company product, a joint de-

nificantly contributing to on page

announced: “We have to dismiss

velopment with Mannesmann-Re-

8, today’s page 9.1 (Suitability of

further employees, but you are

inraumtechnik. The small GbR

operation supplies and equipment

allowed to bring any running

grew quickly. After two years, the

in respect to cleanliness as well as

projects to their finish.” Ludwig

80 square meters in Kahla had be-

sought a dialogue with his boss:

come too cramped. There followed

“We had made the appointment

a move to Jena into an area of 300

for 4.00 p.m. The kids were in the

square meters, which after a half

car. At 5.00 p.m., I still hadn’t been

year also became too small. For the

called in. I called my wife and she

necessary size for his company,

said to me: You have known for a

Joachim Ludwig had already had

long time what you really want to

“a super piece of property in sight”,

do. So, after the conversation with

however the city of Jena put a stone

my boss, I cleaned out my desk and

in his way. They wanted to pass on

as it is known from news reports

the costs for a retaining wall on the

about the USA, marched out of the

property to Cleanroom Technology

company with a full cardboard box

GbR. “I called the mayor of Jena

under my arm.”

about this who immediately offered me an alternative piece of property.

Joachim Ludwig talks about this

A week later, I was able to sign the

setback in his life with crossed

deed of sale” says Ludwig.

arms, but a smile on his face. The crossed arms give the impression as if he retrospectively would like

The Daughter’s Latin Book

to protect himself from the intervention on his professional life.

The new construction in Kahla

However his smile shows: Looking

made it necessary to found a

back, leaving the company was

GmbH. However this had a catch

the right thing to do. A short time

to it. According to a new court deci-

In the days of beginning 1990 / 1991.

later, he was the boss of his own

sion, the GbR could not name itself

Photo: Colandis GmbH

engineering office.

Cleanroom Technology Jena GmbH,

CLEANROOM MAGAZINE 2/2016 | Portrait

23 as the company resided in Kahla.

don’t usually enjoy crime stories

“At this time, my middle daughter

but these I do” raves the 54-year old.

discovered in her Latin book that ‘colandi instumentum’ means approximately filter instrument

Colandis Production Highlights

or filter element.” Thus the idea for the new company name was

Today the company employs 23 peo-

born. Indeed in September, 2001,

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 Ventilation-Filter-Module” he eventually says. “Instead of a standard disposable product, we offer customer-specific solutions which achieve higher prices in Asia because we provide better performance.”

Further highlights of Colandis’ production are x-ray safe mini-environments , a nine-meter high cleanroom with an integrated cable-crane system for an aerospace

QUALIFIZIERUNG WARTUNG STRÖMUNGSVISUALISIERUNG MONITORING

company and above all the com-

MESSTECHNIK

pany’s proprietary portable rent-

KALIBRIERUNG

Colandis CEO Joachim Ludwig celebrates the 20th anni-

al-cleanroom. “We build a 20 square

versary of his company. Photo: Colandis GmbH

meter portable rental-cleanroom

SERVICE

with an ISO Class 5 specification,

BERATUNG

without using any tools in less than Cleanroom Technology Jena GbR

15 minutes, plus two minutes for

became Colandis GmbH.

laying out the flooring” emphasiz-

Joachim Ludwig freely admits that

es Joachim Ludwig. This kind of

he has experienced times in the last

modular installation of a sterile

20 years which he “would rather

environment is unparalleled in the

have done without”. However to

world. Joachim Ludwig glances at

give up was never a question: “The

the clock, the next appointment is

company is my baby!” This admirer

calling. “Oh, one more thing”, he

of Manfred von Ardenne is today

adds while standing up, “Colandis

the possessor of several patents, the

was among the finalists for the

author of numerous publications

Small and Medium-Sized Compa-

as well as a speaker in all corners

nies Award in 2014…”

SCHULUNG

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

of the world. “To enjoy what I do is always first priority” says the

So many highlights, so many rea-

father of two daughters and one

sons to celebrate. Happy Birthday,

son. He also enjoys good hard-rock

Colandis!

music and the crime stories by the Islander Arnaldur Indridason. “I

Author: Frank Baecke

Portrait | CLEANROOM MAGAZINE 2/2016

When New Life emerges from the Cleanroom Couples want to have children. Is not the natural way possible, artificial insemination may be a solution.

Photo: g-stockstudio/shutterstock.com

LIFE & BUSINESS

24

CLEANROOM MAGAZINE 2/2016 | Artificial fertilization

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

How can new life arise in a cleanroom when these environmental conditions should be preventing the growth of cells capable of reproduction? 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

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

commissioned the experts at the Avantalion Consulting Group an

The latter comes across as self-

international expert consulting

evident but in fact, it isn’t. The

service in the areas of Pharmaceu-

Av a n t a l i o n P r o j e c t M a n a g e r

ticals, mechanical engineering and

Claudia Pachl reports that various

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,

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

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

Claudia Pachl, Avantalion Consulting Group

fertilization) and the embryo afterwards placed back into the womb.

The method rapidly spread itself around the world. In Germany, the

automotive financing, The goal of

regulations have to be considered

first test-tube baby was born in 1981,

the project was to obtain the per-

whose diverse work group and ex-

in Erlangen, Germany.

mission in regards to the Medicinal

pert’s interpretations oppose and

Products Act for the Operation of

conflict with each other, which

Practices to fulfill childless couples’

contradict statutory requirements.

desire to have a family. The devel-

These contradictory challenges

opment of a concept was necessary

have to be overcome in order to

which enabled the safe execution of

lead the practice toward obtaining

the demanding processes of han-

an operating license.

dling the germ cells and in addition complying to all regulatory and technical requirements.

Artificial fertilization | CLEANROOM MAGAZINE 2/2016

26 Artificial insemination is always

federal regulations, which require

Wilening, the new Practice for

applied in medicine when a diag-

the use of cleanroom technology,

Fertility in Berlin in March, 2015.

nosis has been submitted which

and the particular needs of working

The doctor looks back on over 20

indicates, for example, a defect in

with human cells in connection

years of experience in artificial

the oviduct, serious limitations in

with the procedures in a doctor’s

insemination. In order to operate

sperm quality, or when only very few eggs are available. “In every case, because of ethical reasons,

“There are more and more invitro-fertilization practices and clinics opening which with the implementation of cleanroom technology are obtaining better results.”

the best-suited environment for the artificial insemination to take place has to be provided.” Says the Avantalion Managing Director and

LIFE & BUSINESS

Partner Claudia Pachl.

Between the Conflicting Priorities of Life and Technology

Claudia Pachl, Avantalion Consulting Group

With the so-called Assisted Reproduction Technique, better known as In-Vitro-Fertilization or artificial

office or clinic have to be dealt with.

the new practice in the Friedrich-

insemination, the practice-opera-

Just how complex these challeng-

straße, he needed a new license

tors face major challenges: In order

es are, the owners of the Berlin

meeting the requirements of the

to properly carry out the procedure

Practice for Fertility Dr. Peet and

Medicinal Products Act which

within the regulatory framework of

Dr. Wilkening could sing out

was applied for at the relevant

artificial insemination, the balanc-

loud. David Peet founded togeth-

State Office for Public Health and

ing act between the fulfillment of

er with his colleague, Dr. Wibke

Social Affairs (LaGeSo).

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

CLEANROOM MAGAZINE 2/2016 | Artificial fertilization

27

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

Laws, Laws and still more Laws

EU-GMP-Guidelines, in other words, Class A. In order for a Class A working

Experts in Disagreement over the Use of Cleanroom Technology

However, there is more. Those who

environment, equipped with special

want to provide Assisted Reproduction

air treatment and air flow regulation

Techniques have to also deal with not

systems, to reduce particulate and

In addition to all this, there are nu-

only the Medicinal Products Act, but

microbial contamination risks to a

merous guidelines and publications

also the Transplantation Law, The

minimum, the adjoining areas have

from associations and scientists

Pharmaceutical and Active Agent

to be constructed to support the ster-

whose recommendations are over-

Production Ordinance, the Industrial

ile conditions inside the cleanroom.

whelmingly contradictory with the

Code as well as the Directives for the

For the treatment and processing of

requirements written down in the

Implementation of Tissues and Cells.

tissues, cleanroom not less than Class

Pharmaceutical and Active Agent

The last two deal with donating, pro-

D is required.

Production Ordinance and reject

curing, testing, processing, conserving,

the use of applicable measures.

storing and distributing human tissues

Moreover the qualification of critical

and cells. Furthermore, the Infections

equipment and devices is required,

“This is principally plausible� ex-

Protection Law and the Embryo Protec-

the validation of critical treatment

plains Claudia Pachl. The built-in

tion Law have to be considered.

and processing procedures is required,

air flows in the Class A areas could

appropriate hygiene measures are

cause changes in the pH values and

The Pharmaceutical and Active Agent

required, traceability procedures are

in the worst case make the germ

Production Ordinance requires for

required, training is required, internal

cells unusable due to cooling effects.

the treatment and processing of

inspections are required, procedural

In addition, the transfer of the

the germ cells the highest degree of

instructions showing standards are

fertilized cells back into the womb,

cleanroom air quality according to

required and much more.

which in nature takes place over a

Artificial fertilization | CLEANROOM MAGAZINE 2/2016

28 authorities in Berlin represent a clear standpoint: The have not

A Small Glossary:

recognized the often-quoted ex-

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 fertilization 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.

LIFE & BUSINESS

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.

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

germ-charged body opening which

technology are obtaining better

cascade which includes monitor-

mustn’t be disinfected, namely the

results although some experts dis-

ing is being required as well as

female vagina, contradicts the

agree with this” observes Claudia

the qualification of the critical

sterility requirements of Class A.

Pachl. “Often it is argued that the

equipment and devices.

Moreover the necessary micro-

Assisted Reproduction Technique

scope, heated table and incubators

has been carried out for many

These environmental conditions

which have to be utilized in the

years under poor environmental

requirements could only be im-

Class A area seem to make the

conditions.” There are, however,

plemented by using cleanroom

situation senseless as the warmth

experts in the world who have the

technology. In this respect, the

emitted, the movement of the

opinion that the use of cleanroom

Ava n t a l i o n Co n s u l t a n t s h av e

microscope and the intervention

technology contribute substantially

been able to support and help and

of the reproduction biologists make

to the increase in pregnancy rates.

have drawn up a concept which

the required air flow relationships impossible to maintain. „Nevertheless, there are more and

fulfills all regulatory demands

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

more in-vitro fertilization prac-

and ensures safe processes when working with germ cells. A particular focus was put on the safe handling of germ cells. “If a

tices and clinics opening which

Independent of the various opin-

wafer is dropped, money is lost.

with the installation of cleanroom

ions and recommendations, the

If a Petri dish with germ cells is

CLEANROOM CLEANING

www.profi-con.com

CLEANROOM MAGAZINE 2/2016 | Artificial fertilization

29 dropped, life is destroyed” emphasizes 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

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.

that the reproduction biologists are able to safely work without limitation among all the technical

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

devices and installations.

This concept was presented before the authorities and it was accepted. Within a very short time, the cleanroom-technical and organizational measures were carried out and implemented so that in November, 2015, the LaGeSo (State Office for Public Health and Social Affairs), following an inspection

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.

of practice rooms and procedures, pregnancy rates have been nega-

been done to protect germ cells and

tively influenced by the cleanroom

patients with the support and im-

equipment. In order to have signif-

plementation of cleanroom-tech-

icant statistics over the possible

nical possibilities” says Claudia

positive influences on pregnancy

Pachl. New life can also emerge

rates due to the implementation of

from cleanrooms. For childless

The first practice results point

cleanroom technology, the data will

couples who long for offspring, this

towards hope: Pregnancy rates

have to be collected over a longer

is indeed good news.

averaged over all age groups from

period of time.

issued the pertinent license.

New Hope for Childless Couples

Author: Frank Baecke. Professional

November, 2015 to February, 2016, come to 41.9 percent. The numbers

“Inherently, the positive feeling re-

and Expert Consultation: Avantalion

show that the germ cells and

mains that everything possible has

Consulting Group, Claudia Pachl

Reinraumbekleidung Dekontamination Sterilisation Am Beckerwald 31 66583 Spiesen-Elversberg Telefon 06821 7930 Telefax 06821 793150 E-Mail: wzb@wzb.de

www.wzb-reinraum.de

Artificial fertilization | CLEANROOM MAGAZINE 2/2016

30

“Cleanroom technology must prevent damage to the germ cells”

LIFE & BUSINESS

Claudia Pachl, managing director and consultant at Avantalion Consulting Group, explains the challenges of building an IVF Laboratory.

Cleanroom Magazine: You have

IVF treatment there. Our task was

think about how we could get elec-

advised a Berlin IVF clinic during

thus to integrate the required clean-

tricity and water in the cleanroom,

the installation of a cleanroom

room technology in such a way that

how to deal with ventilation, install

and accompanied by the grant of

not only fit all legal requirements

the air conditioning and how to in-

permission to Medicines Act. What

but also fit into the daily processes

stall the equipment and appliances.

was the initial situation?

of the clinic.

The cleanroom is about 60 square

Claudia Pachl: The building in which

Cleanroom Magazine: What were the

classes A and D. The main hurdle

the clinic was located had no con-

difficulties?

was to fit in all appliances so that

meters, divided into cleanroom

trolled environment in accordance

the clinic workflow wasn’t impeded.

with GMP standards. Therefore at

Claudia Pachl: Since the cleanroom

If an employee carries open petri

the moment, the authority refused

was to be implemented into an

dishes from one table to another, we

permission, to carry out artificial

already existing structure, we had to

can’t have any edges or raised floors,

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

CLEANROOM MAGAZINE 2/2016 | Artificial fertilization

31 no vibrations or circulating air cur-

increased risk for the cells. We were

rents that damage the germ cells or

then able to determine whether we

cause a shift in Ph of the germ cell

needed a class A and class D range

solution. The latter is incidentally

and how much space and equip-

one of the reasons why some experts

ment was required. The derived

say, one must not expose germ cells

cleanroom concept was discussed

to the conditions of class A.

with the government agency to ensure that we had taken into account

Cleanroom Magazine: Why was

their ideas. This was especially im-

a cleanroom in the Berlin clinic

portant because we could not build

necessary?

a typical A class cleanroom to Annex

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

1 of the EU GMP Guidelines. Rather,

of quality management, qualification, validation and

Claudia Pachl: Because the govern-

we designed our own concept in

cleanroom technology. Photo: Avantalion

ment agency has a different point of

reference to the Annex 1.

view than the experts. For example,

class A cannot be met during an op-

they didn’t allow the exception

Cleanroom Magazine: ‘In reference’,

erative state. We faced several such

clause described in the regulations

What does that mean exactly?

balancing acts between regulations

that experts rely on.

and daily workflow practicality. All Claudia Pachl: For example, we had

in all, a mammoth task. Thankfully,

Cleanroom Magazine: How did you

to change the prescribed airflow

all went well in the end. The gov-

implement these requirements?

speed slightly to find a variation

ernment agency has granted an

that did not damage the germ cells

operation permission for the clinic

Claudia Pachl: We looked closely

when exposed to air, but also main-

after a second walkthrough.

at the workflows in the clinic and

tained the needed preservation.

identified all steps that carry an

Furthermore, the particle limits of a

Author: Frank Baecke

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•

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•

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•

Umfassendes Qualitätsprodukt- und Dienstleistungsportfolio

•

Globales Netzwerk aus Lieferanten und Partnern

VWR International GmbH · basan – the cleanroom division of VWR | Tel. +49 6107 9008-500 | info.basan@eu.vwr.com | vwr.com/cleanroom

Artificial fertilization | CLEANROOM MAGAZINE 2/2016

32

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

LIFE & BUSINESS

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.

From my point of view, cleanroom

Dr. Uli Lösch: As every person

technology would be an important

carries around with him or herself

addition to other measures of

a flora of germs and pathogens are

ensuring hygiene. Together with

transferred via diverse ways such

Doctor of Science (DSc) Uli Lösch

thorough room disinfection, staff

as hand contact, sneezing, etc., a

completed a pharmaceutical study

hand disinfection, appropriate

solitary application of cleanroom

by dissertation at the University

hygiene-clothing, sterile materials

technology is not able to disrupt

Heidelberg. Afterwards he worked for

and an antibiotic patient covering

the infection-chain.

15 years as an Industrial Pharmacist

, all available technical measures

The high velocity of a sneeze, for

in the areas of production and quality

have been taken to effectively

example, is not able to be captured

assurance. Since 2010, Uli Lösch has

prevent infections.

by the installed air flow system.

been employed as the Director of Production in the Hospital Pharmacy of the University Hospital Basel.

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

“Cleanroom technology is to my mind indispensable as an additional measure of protection for patients against microbiological contamination.” Dr. Uli Lösch

Cleanroom Magazin: Would the application of more cleanroom

Cleanroom Magazin: Hospital germs

Furthermore, the many people

technology help prevent most

are in most cases, as was recently

present in a hospital and the speed

cases of hospital germ infections?

shown in Wiesbaden, carried in

of their movements disrupt air

from the outside. Wouldn’t it make

flows and considerably reduce

Dr. Uli Lösch: ABecause of the

more sense to approach the issue

protection measures. Therefore

abundance of germs which people

of pathogen prevention by using

the hospital-wide application of

and thereby patients bring into a

cleanroom technology in the entire

cleanroom technology would not

hospital, cleanroom technology is

hospital and not only in individual

have any great effect. Cleanroom

not able to induce an effect by itself.

departments or in the OP?

technology is able to help in local

CLEANROOM MAGAZINE 2/2016 | Controversy

33 applications, for example in the OP

resistance against antibiotic

Prof. Arnold Brunner: No, because

to safeguard a patient undergoing

therapy and the increasing spread

the probability that an individual

open surgery against additional

of multi-resistant pathogens,

passing on his/her own flora of

germ infections. Cleanroom

it is expedient to install this

bacteria through the air is rela-

technology is in any case standard

technology in an OP. However,

tively small. The focus has to be

equipment in a hospital pharmacy

these costs have to be considered

put more on the transmission of

for the protection of the manufac-

by medical institutions as well as

germs by direct contact, that is,

tured pharmaceutical products.

when calculating package-priced

on measures which prevent the

treatments.

transfer of germs by direct contact

Cleanroom Magazin: What role do

from person to person. In this re-

room ventilation systems play?

spect, a hospital-wide installation

Are they a main source of patient infection or is it more the patient’s

CONTRA: Professor Arnold

own flora of pathogenic organisms

Brunner, university lecturer for

or is the source the OP personnel

building and cleanroom technology

themselves?

at the University Luzern and consultant at Brunner Haustechnik AG

Dr. Uli Lösch: I don’t see the HVAC

in Wallisellen-Zürich, Switzerland.

technology and equipment as being the main source of patient

Cleanroom Magazin: Can the use

infection. If anything, the entry of

of more cleanroom technology

germs into an OP is effectively in-

prevent the majority of hospital

hibited by a regularly maintained

infections?

system equipped with modern filter and air flow technology.

Prof. Arnold Brunner: No. Clean-

Prof. Arnold Brunner is the founder of

Furthermore, the installation of a

room technology is only able to re-

Brunner Haustechnik AG in Wallisellen-

pressure gradient system ensures

duce the risk of hospital infections.

Zürich, Switzerland and is still active as a

that no microbiological organisms

The difference between sterile

consultant. This graduate HLK engineer

contained in outside air are able to

pharmaceutical production and a

is a full-time lecturer for Building and

flow into an OP.

hospital is that the products of the

Cleanroom Technology at the University

pharmaceutical industry emit no

Luzern Department of Technology and

A patient’s own germ flora can

germs. In contrast, the patient is

Architecture as well as the Chairman

be viewed as the main source

not sterile and arguably the major

of the Work Group for Guidelines

of contamination which even

source of germs in a hospital.

SWKI VA 105-01 “Ventilation and Air

disinfection cannot completely

He brings along his own flora of

Conditioning Technology in Rooms

eliminate. For this same reason,

pathogens into the hospital, not

used for Medical Purposes” (Hospital

the hygiene of OP staff is of course

to mention the doctors, nurses

Guidelines) and Swiss Delegate in the

absolutely essential.

and visitors doing the same. From

CEN Norms Work Group TC156 WG18

everywhere bacteria strains are

“Ventilation in Hospitals”. Furthermore

Cleanroom Magazin: Going

imported into the hospital. In

he is a Board Member of the Swiss

back to the main issue here: Is

Germany, this risk has long been

Association of Cleanroom Technology

the application of cleanroom

neglected. The result: There are

SwissCCS/SRRT and on the VDI Specialist

technology in hospitals necessary

more MRSA related deaths in a

Committee for Cleanroom Technology.

and meaningful or is it completely

hospital than traffic deaths.

overstated and unaffordable?

Cleanroom Magazin: If hospital

CONTRA

Dr. Uli Lösch: Cleanroom technol-

germs are imported from the

ogy is to my mind indispensable

outside, doesn’t this mean that

of cleanroom technology would

as an additional measure of

cleanroom technology has to be in-

contribute little.

protection for patients against

stalled in the entire hospital against

In order to prohibit the transfer-

microbiological contamination.

pathogens and not just in individual

ence of germs, hand disinfection,

In view of patients’ growing

departments such as the OP?

the cleaning of contact surfaces,

Controversy | CLEANROOM MAGAZINE 2/2016

34 the changing of clothes and so

observe all hygienic measures

Prof. Arnold Brunner: Cleanroom

on would be far more effective.

and to avoid germ transfer by

technology selectively plays

Cleanliness is a chain of measures

direct contact in order to avoid

an important role, perhaps in

which comes down to every single

hospital infections.

sterile treatments, in isolation

link. If hand disinfection is already

wards or in the OP. In a normal

poor, than all the technical meas-

The ventilation and air condi-

hospital room, normal building

ures taken also become ineffective.

tioning systems function more

technology is enough. Hospitals

to dissipate warm air and odors

are also not qualified under GMP

out of the OP. The same is for

guidelines because the major

Cleanroom Magazin: Which roles do room ventilation and air conditioning systems play? Are they a main source of infections

“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.”

LIFE & BUSINESS

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,

Prof. Arnold Brunner

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

surgical fumes which are formed

source of germs is namely the

be so disinfected that all of the

by cutting with laser beams.

patient, only partially the system

germs are eliminated. Therefore

These fumes are really unhealthy

itself.

when a scalpel makes a cut,

for personnel.

germs are able to enter the body

via the wound. These germs are

Cleanroom Magazin: Let’s get back

then rendered harmless with

to the original point: Is the use

antibiotics. However, the problem

of cleanroom technology in a

is that many germs become re-

hospital necessary and sensible

sistant to antibiotics. Therefore it

or fully over-exaggerated and

is far more important to strictly

unaffordable?

*HVAC: heating, ventilation, air conditioning

Author: Frank Baecke

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CLEANROOM MAGAZINE 2/2016 | Controversy

w w w.r ibe.de

35

PROGRESS

© Kovalenko Inna | Fotolia

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

CLEANROOM MAGAZINE 2/2016

36

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

LIFE & BUSINESS

Photos: Cleanroom Media.

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.

How often are you on the road on

What is important for you when

What kind of music do you enjoy

business? On the average, I am on the

travelling? Of the highest priority for

listening to when travelling? My

road three days a week in Germany

me is to strictly keep appointments

taste in music is diverse. The

where I visit customers and business

with customers, as an appointment

kind of music I enjoy listening to

partners who are looking for meas-

is just that, an appointment. I try to

depends on my mood at the time.

urement equipment solutions for their

plan trips so that I am the least time

I enjoy listening to classical music

cleanrooms. Besides Germany, I reg-

stuck in traffic jams. When I am on

for example Rachmaninow, but

ularly visit the company Novasina in

the road, my car is at the same time

the group Queen also belongs to

Switzerland for meetings and training

my office. A comfortable car with a

repertoire of music.

workshops.

mobile access to the internet enables me to take care of my work. When I

Which countries and regions are

What is your favorite mode of trans-

have to stay somewhere overnight, I

on the list of those you most often

portation? When I visit customers,

am mindful of a comfortable bed in

visit? Our office is located in the

I take with me the sensors from

order to be fit for work the next day.

south of the Netherlands and I am

Novasina and our own cleanroom

This is important if a person wants to

able to reach the German border

displays so that my customers are

get the best out of him or herself.

in only 15 minutes by car. This is

able to experience this equipment

absolutely ideal as I travel quite

“live”. Therefore I prefer to travel by

What should never be forgotten when

a lot and I like to travel through

car. This way I am flexible, quickly at a

travelling? My mobile telephone, my

Germany for my work. Additionally,

customer’s location and have enough

laptop and my products. It is impor-

I am regularly in Switzerland at the

room in the car to pack everything I

tant for my customers that I always be

company Novasina, the producer

need. If no other means of transport

available in order to be able to quickly

of our sensors. As I am the contact

is possible, then I fly.

answer their questions.

person for all our international

CLEANROOM MAGAZINE 2/2016 | On the road with…

37

customers, it often happens that I

How do you unwind at best? Music is

What would be the first thing you

have to travel outside of Germany.

also here my miracle drug. Together

would do if you had the unlimited

Are you able to relax after a day’s

with a good book, this is absolutely

opportunity to do so? II would

the best way to come down.

provide for the political stability

work when travelling on business?

of the entire world as I hold as my

The days are hectic and often long

Which travel destinations do you

life’s motto: The common folk, the

but luckily I am able to come down

favor and why? Germany naturally!

servant and the conqueror alike,

quickly by listening to music. When

Germany is so much larger than the

confess and affirm at all times: The

the weather is nice, mostly in the sum-

Netherlands and offers an incredible

supreme fortune of Earth’s great

mer, I really enjoy riding a motorcycle.

number of possibilities for me and my

populace is solely a person’s caliber

This gives me a wonderful feeling of

company. I am faced again and again

and character.

freedom and an unbelievable amount

with the challenges of offering the best

of energy which makes it so much

solutions to my customers and meeting

easier to cope with stress.

these challenges is for me very fulfilling.

Author: Frank Baecke

EasyMop GMP

®

Reliable cleaning and disinfecting of pharmaceutical cleanrooms

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

On the road with… | CLEANROOM MAGAZINE 2/2016

38

Science & Technology

SCIENCE & TECHNOLOGY

Technology News in brief

The lightest Solar Cell in the World

Pharmaceutical Products cleanly dosed without Filaments and Dripping

Organic Semiconductor | Researchers at the Massachusetts Institute of Tech-

Filling | For the highly precise filling

nology have developed the lightest

in the pharmaceutical industry Visco

solar cell in the world. This flexible

Tec, a specialist for the production,

photovoltaic module is 50 times thin-

dosing, application and extracting

ner than a human hair and generates

of viscous mediums, has developed

six watts per gram. This is in terms of

a solution. The prerequisite for

Pharma-Dispenser from ViscoTec doses viscous products

weight, 400 times more performance

precise dosing is that the filaments

without filaments and dripping. Photo: Visco Tec

than with conventional glass solar

are accurately and cleanly pulled

modules. Additionally, the substrate,

off. This is often not the case with

which plant manufacturers are

semiconductor and top coat no longer

viscous products such as creams,

able to hold to the specifications

have to individually be applied as with

salves or gels. These products pull

of Good Manufacturing Practice

conventional modules, but rather all

long filaments from the dosage

(GMP). These pipe connections suit

three layers ‘grow’ simultaneously by

needle into the packaging or even

themselves for stationary cleaning

vapor deposition. This happens in a

drip. The pharma- dispenser from

(also named Cleaning in Place) by

vacuum chamber at room tempera-

Visco Tec prevents dripping in that

their hygiene-minded construction.

ture. This way the otherwise required

after dosage-injection, the way to the

The flange connections are nearly

next step through the chambers in

gap-free, ruling out to the greatest

the Rotor-Stator-System is blocked

possible extent medium contact

off. Furthermore, the medium is ac-

in the area of the flange gasket.

curately pulled back into the dosage

Belonging to the product program

needle after dosing has been com-

are gaskets and stainless steel parts

pleted. An absolute, clean tear-off

which are able to withstand the high

of the filament is achieved by using

cleaning demands such as the use of

this procedure. The dispenser is also

acids, high temperatures and high

suitable for use in cleanrooms.

medium pressures. The products

The ultra-light solar cell floats even on the surface of a soap bubble. Photo: Joel Jean and Anna Oshero

intermediate treatments and cleanings can be omitted as well as the

Pipe Connections for GMP Requirements

use of solvents and harsh chemicals which with other organic solar cells

Plant Manufacturing | Machine

are needed. As the new solar cells can

and plant manufacturers which

be fixed onto any desired substrate,

work according to GMP guidelines

they could be the basis for the next

need cleanroom-suitable com-

generation of portable, wearable

ponents. Linnemann GmbH has

electronic devices.

developed pipe connections with

CLEANROOM MAGAZINE 2/2016 | Technology News in brief

Small flange connection with stainless steel centering ring and O-ring gasket. Photo: Linnemann GmbH

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

Production of Y-Fittings in Cleanroom Construction

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

Injection Molding | At the Medtec Eu-

isolated environments and together

rope Trade Fair from April 12th to the

with ART Reinraumtechnik (Clean-

14th in Stuttgart, Germany, Arburg

room Technology) has manufactured

will show in an electrical injection

an isolator with an integrated dosage

molding machine the production of

system, an extruder, a conveyor belt

Y fittings in cleanroom construction

and a granulator. The processes of

for the infusion therapy industry. A

powder-mixing on up to the finished

highlight is the lateral injection via a

granulate takes place in a protected and

beverage and cosmetics industries

needle shut off nozzle which results

controlled environment which saves

as well as in related industries.

in a higher surface quality of com-

the setting up of a complete cleanroom.

ponent parts. “The manufacturing

The built-in machines are laid out especially for working with gloves and can be easily disassembled and

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

New Product Generation of Premium Pocket Filters

cleaned by operators. The negative pressure guarantees the compliance

Fine Particle Filter | Camfil has

with GMP Cleanliness Class C speci-

brought a new generation of Premi-

fications. Even the tearing of a glove

um Pocket Filters to the market. They

prevents products from reaching

are called Hi-Flo II XL and provide

outside environments.

besides higher stability a minimum efficiency of a remarkable 54 percent

cell allows itself to be easily docked to a cleanroom. This saves time and

Micro-Biological Air Monitoring easily accomplished

at low energy consumption levels.

This is according to company statements unparalleled in the industry. In the new pocket filters, the prior filter

space in comparison to manufacturing solely in a cleanroom� says

Airborne Germ Collector | MBV AG

medium has been replaced by a mate-

Sven Kitzlinger, Medical Technology

has brought to the market a new

rial which in the filter class F7 reaches

Application Consultant at Arburg.

airborne germ collector with the

the highest energy class A+ according

MAS-100 VF. What the abbreviation

to the new Eurovent Guidelines 2015.

VF indicates is that the device is controlled by volume flow (Volume

The new HI-Flo II XL filters are

Flow). The determination of col-

usable in very diverse applications.

lection volumes, the calibration

The spectrum ranges from standard

as well as the readout of collec-

building ventilation to specific in-

tion and error records is done

dustrial applications on up to pre-fil-

directly via a PC-browser without

tering systems meeting cleanroom

Europe 2016 Y-fittings for the infusion therapy industry.

prior software installation. The

standards.

Photo: Arburg

new device is predestined for

An electrical all-rounder 470 A produces at the Medtec

micro-biological air monitoring The exhibit operates via a covered

in aseptic zones, clean-rooms as

conveyor belt which docks onto the

well as for environmental meas-

cleanroom. Via the conveyor belt,

urements. The MAS-100 VF has

the clean, produced parts are trans-

been validated for ISO 14698 and

ported into the cleanroom while the

guarantees efficient monitoring of

machines and peripheral equipment

micro-biological contamination in

remain outside.

the pharmaceutical, food product,

The new filter series encompasses four models with conical-formed filter pockets of various lengths. Photo: Camfil KG

Technology News in brief | CLEANROOM MAGAZINE 2/2016

40

Keep It Clean

Foto: Fotolia.

SCIENCE & TECHNOLOGY

How component part cleanliness is maintained from Production to Shipping.

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.

CLEANROOM MAGAZINE 2/2016

41

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

While walking with his dog, Klaus

Component Part Cleanliness is as Important as Dimensional Stability

automobile and supplier industries,

friendly component part cleaning

Industrial component part cleaning

practically every business and indus-

technology. As his dog was shaking

has gained increasing importance in

trial sector, companies are having

itself dry after a swim in the lake,

the last years. More and more compa-

to fulfill ever stricter demands on

Döhrer saw the solution right in

nies have taken on the opinion that

component part cleanliness” says

Döhrer came up with the idea. He had received the order to look for an energy-saving and environmentally

the medical technology industry, the aeronautics industry, precision engineering, optics or electronics – in

front of him: Vibration-Cleaning.

This engineer and Managing Director of Vibro-Tec GmbH in Unna, Germany, has developed a process in which the parts to be cleaned are vibrated 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

“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

at the international trade fair for industrial parts and surface cleaning, parts2clean. The trade fair takes

the cleanliness of component parts

Olaf Daebler, General Manager of

place from May 31st to June 2nd, 2016

and surface areas plays an equally

parts2clean at Deutschen Messe AG.

in Stuttgart, Germany.

decisive role in issues such as qual-

This is increasing expenditures for

ity, dimensional stability and the

cleaning substantially. To be on the

absence of defects. “Whether it be the

safe side, things are often dealt with

Technical Cleanliness | CLEANROOM MAGAZINE 2/2016

42 according to the motto: as clean as

Center Leonberg, Germany’s leading

in production processes. Robots are

possible. However, this affects profit-

competence network for industrial

able to feed the component parts into

ability and thereby competitiveness.

component parts and surface area

the cleaning and drying stations.

cleaning. “However, one approach Relief is made possible by a suitable

works mostly only for the processing

A further trend is the targeted clean-

requirements-specified, well-de-

of one, individual component group.

ing of functional surfaces. Instead of

signed cleaning solution which

The one, single solution which al-

cleaning parts completely, only the

allows the cleaning results to be

ways works unfortunately doesn’t

critical sealing or gluing surfaces are

optimized and the expenditures to

exist”.

cleaned. This saves time and money.

SCIENCE & TECHNOLOGY

be reduced. The motto should then

Furthermore, the functional surfac-

read: as clean as possible, as econom-

When choosing an optimally suited

es can be cleaned using just-in-time

ical as possible. Which processes and

cleaning technology, materials,

concepts, whereby the costs for

procedures clean economically will

component geometry, throughput

keeping parts clean after cleaning

be shown at part2clean, as well as

and the kind of soiling (films or par-

or during transport can be omitted.

other solutions in the “Theme Park

ticulate matter) are to be considered.

Precision & Cleanrooms – Cleaning

For mass-produced parts, wet-chem-

under Cleanroom Conditions”.

ical cleaning is recommended. The

Diverse cleaning and analysis pro-

advantages are the high degree of

cesses will be presented which fulfill

throughput and the low percentage

the most demanding cleanliness

of cleaning costs in comparison to

If soiling is to be dependably and

requirements.

overall production costs. More com-

economically removed, the entire

plex parts are cleaned individually

periphery as well as the contaminant

in order to effectively reach drilled

material itself has to be considered,

holes, indentations and channels.

beginning with the cleaning chemi-

Individual part cleaning provides

cals, the manufacturing equipment,

logistical advantages when subse-

the parts-transport system and trans-

“Evolution and innovation take

quent processes require a particular

port bins, the supplied materials and

place continuously in industry”

position of the work piece. Generally,

products on up to the packaging.

observes Christian Siegert, General

the trend toward individual cleaning

Manager of CEC Cleaning Excellence

is preferred because of automation

The one Solution which always works doesn’t exist

The Periphery also influences Component Part Cleanliness

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 complications? 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 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

CLEANROOM MAGAZINE 2/2016 | Technical Cleanliness

The range of cleaning possibilities stretches from solvent cleaning in sterile rooms directly following parts

43 production to CO2-Snow-Jet Cleaning and Plasma Activation on up to Multi-bath Ultrasound Precision

Important Component Part Cleaning Processes

Cleaning in cleanrooms. In order to find the most suitable cleaning procedure, realistic tests should be carried out in the equipment manufacturer’s laboratory.

Looking forward, it can be recommended to carry out cleaning after every mechanical process step in order 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

Wet Chemical Cleaning | The most often used technology in the industry is the cleaning with liquid mediums and solvents. The latter is roughly differentiated into 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 processing technology. Typical processes are injection, immersion, pressure flooding and ultrasound.

Plasma Cleaning | The plasma procedure provides with the use of various reaction 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 treatment of function-surfaces such as seal, coating, glue and laser-welding surfaces. With dry-ice blasting, small ice pellets are used instead of fluid CO2. This procedure 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.

molding into a cleanroom sterile and particle-free, is to implement a grey-room. The cleaning facility then

Cleaning Excellence Center Leonberg

orders. Included here is the contin-

acts as a material lock. Parts can be

says, “In the automobile industry the

ued education and training. What do

brought into the grey-room from the

development in motor technology

employees need? Is it enough to have

production facility and after clean-

has in recent years led to higher

only a sterile room? Which cleaning

ing be taken out on the cleanroom

and higher demands in technical

procedures suit the product? In this

side to be checked and processed.

cleanliness. Even the tiniest particles

respect, the trade fair Cleanzone

Afterwards, the parts can be packed

can lead to failures and defects or a

(November 8-9, 2016, Frankfurt am

under cleanroom conditions and

fingerprint on a circuit board can

Main, Germany) is an ideal place for

now protected from contamination

cause an electrical short.”

industry players to meet. “Visitors

be stored and shipped.

are able to comprehensively inform This is why it is so important to

themselves about new developments

Beyond all the technical solutions,

anchor into the minds of employees

and come into direct contact with

there lies yet another factor which

the awareness of the importance of

manufacturers“, says Siegert.

influences component part cleanli-

technical cleanliness for the entire

ness: employee awareness. Christian

process from purchasing to produc-

Siegert, General Manager of CEC

tion on up to the receipt of customer

Author: Frank Baecke

Technical Cleanliness | CLEANROOM MAGAZINE 2/2016

44

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

CLEANROOM MAGAZINE 2/2016

Photo: Senoplast Klepsch & Co GmbH

SCIENCE & TECHNOLOGY

Among the finalists for the Clean足 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.

45

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

The high barbed-wire fence around

expand with its innovative prod-

In Piesendorf synthetic films from

the factory premises gave it away:

ucts into diverse market niches.

then on were to be produced on an

Something unique is being pro-

Operations are running at full

assembly line in a cleanroom.

duced here. With the military-like

capacity in the factory round the

border, Senoplast Klepsch & Co.

clock which produces in four shifts.

GmbH in Piesendorf, Austria is

Two cleanroom production lines

protecting its most innovative

are already in operation and a third

product from the curiousity of its

is in the planning.

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

with an extremely scratch resistant

Senoplast did without cleanrooms

The clean production environ-

and chemically resistant systhetic

for decades. As a producer of plas-

ment was expected to solve

film which disinfects itself. There

tics in the distribution segment,

two problems. The first

is nothing comparable to it in the

the company offered customers

concerned the rate of

world.

a standard range of products for

rejects which was

industry, supplied Thermoplast

in some years over

mass-made products for various

20 percent due to

industry segments in film and

the uncontrolled

panel formats. However as the

environmental influ-

financial and economical crisis in

ences. “The high rate

2008 involved important customer

of rejects raised the risk

industries, the time had come in

of customer claims” says

which to re-orient away from mass

Marco Grugger, responsible for

production to more demanding,

the process equipment in the Seno-

Auswirkung Auswirkung unkontrollierter unkontrollierter Umgebungseinflüsse Umgebungseinflüsse

10 10 5 0

15 15

10 10

20 20 5

25 25

5

30 30

0 Ausschussrate Ausschussrate ohneohne Reinraumproduktion: Reinraumproduktion: mehrmehr als als

20 % 20 %

0

15 15

5

20 20 25 25 30 30

0

Ausschussrate Ausschussrate nachnach Beginn Beginn der Reinraumproduktion: der Reinraumproduktion: unterunter

2 %2 %

Quelle: Quelle: Senoplast Senoplast Klepsch Klepsch & Co.&GmbH Co. GmbH

specialized products. To realize this

plast Group. “The profitability just

Senoplast produces – unusual for

change in strategy, a cleanroom

wasn’t happening.” With the start

a plastics manufacturer – in clean-

was to be installed in production.

of production in a cleanroom, the

rooms. As the market segment for

When the first experiment began

percentage of rejects fell rapidly to

synthetic films and panels is not

in 2006 during the crisis, it was de-

under two percent.

standard, the company is able to

clared as a strategic company goal:

Surfaces of the Future | CLEANROOM MAGAZINE 2/2016

Photo: Fotolia

competitors. The product deals

46 The second concerned the rise in product quality. Step by step the developers succeeded in improving product properties. “The production environment and the process had to be completely re-designed” says Operations Manager Ernst Rattensperger. Although the cleanroom had been custom made, the process didn’t run smoothly at the beginning. The base material which

SCIENCE & TECHNOLOGY

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

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

Senoplast is now fulfilling the

molecular chemistry, medical tech-

The 200 degree base material glides

quality demands of many former

nology, IT, optics and mechanics.

along a 1.40 meter wide and 20 meter

customers and even surpasses these

Special surfaces play here an im-

long machine. At a particular posi-

demands. The company produces

portant role, not only because they

tion the surface is molecularly ma-

in such a high quality that it is able

are essential for the aesthetics of

nipulated and as a result becomes

to open and extremely demanding

the facility but also because they

harder and more stabile. How this

markets.

take over a variety of tasks acting

works and which material is applied

as a covering for installations, wall

is a company secret.

systems and process surfaces.

It is no secret however that the process demands extremely strict

Suitable for all Particlefree and Micro-biological Clean Environments

control of the environmental con-

For example, hospitals use the material for extensions and interior furnishings and equipment such

ditions. Heat and air flow have to

Since Senomed-Film 2014/2015 en-

as doors, cupboards, wall systems

be controlled and regulated. If the

tered the market, the Austrian fam-

and beds. Research institutes use

temperature changes only a half of

ily company has captured the notice

it for lab furniture, lab cupboards

a degree, no high-gloss, high-tech

of all those industries which need

and walls. Even food product man-

base material will emerge but a

particle-free and micro-biologically

ufacturers are considered as users

material which hurls bubbles.

clean environmental conditions:

for the unique material.

After years of collecting experience

Phamaceutical industry, biology,

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

Where no scratches are found, fewer germs are able to settle in.”

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

CLEANROOM MAGAZINE 2/2016 | Surfaces of the Future

47 steel wool leaves behind no scratches. Where no scratches are formed, fewer germs (colony forming units – CFU) are able to settle in. Additionally: Thanks to its extremely smooth surface, the product is easily cleaned, disinfected and even sterilized with standard materials

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.

and when absolutely necessary with acids or alkaline solutions.

The latter have no effect on the material. Such radical cleaning is

Diverse Properties: The films are scratch and scrub-resistant, chemically resistant, anti-bacterial effective, color-stable and emissions-free. The chemical tolerance refers to acetic acid, hydrogen peroxide, sulfuric acid, hydrochloric acid, acetonitrile, methanol, isopropanol, and many more.

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 microbiological properties: After less than 180 minutes, microbiological activity was no longer detectable.

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 quality color optic, the synthetic film will find a market even in aesthetically demanding home environments.

The Film gives off neither Vapors nor Particles

Problem-free Integration: High-tech components with specialized functions can easily be integrated with the synthetic surfaces.

The material is also emissions-neu-

Interesting Cost Advantages: The wall systems compared with hitherto existing cleanroom materials are very cost-efficient including investment expenditures and operation/maintenance costs.

tral: It neither gives off vapors nor particles. On top of that the synthetic 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 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

correctly configured, colors increase employee concentration,

Surfaces of the Future | CLEANROOM MAGAZINE 2/2016

48 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

SCIENCE & TECHNOLOGY

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-

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

prietary manufacturing systems engineering was responsible for

inter-disciplinary know-how of

without it, especially since random

the construction of the clean-

systems engineering, chemistry,

tests have shown that many less

room-technical processing facility,

physics and process technology.

complex synthetic films gain in

even the palettes for transport to

Therefore Senoplast has succeeded

quality when they are produced in

the interim storage are of its own

to make the cleanroom the com-

a cleanroom.

design and construction. The

pany’s focal point. The company’s

development team possesses an

bosses never again want to do

PT16_175x125_CLEANROOM_MAGAZIN_C4_PHARMA.indd 1

CLEANROOM MAGAZINE 2/2016 | Surfaces of the Future

Author: Professor Gernod Dittel

14.12.15 13:40

49

CLEANROOM AWARD 2016 INNOVATION, SUSTAINABILITY & EFFICIENCY IN THE CLEANROOM

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

9 th NOVEMBER 2016

CREATIVE PRIZE 2016 CREATIVITY & BEAUTY IN THE CLEANROOM

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

9 th NOVEMBER 2016 more informations:

more impressions: CLEANROOM MAGAZINE 2/2016

50

What do you do there, Birgit Kriegesmann?

SCIENCE & TECHNOLOGY

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.

My name is Birgit Kriegesmann.

cleanroom conditions. My tasks in-

in production materials and WFI,

Regarding my profession, I am a

volve monitoring the microbiological

the production and testing of

Biological-Technical Assistent.

issues in the production processes.

growth media, the administration

Since 1999, I have been working

I conduct airborne germ measure-

of culture collections as well as

at Bremer Pharma GmbH in War-

ments in the framework of environ-

the measurement instrument

burg, Germany, in the department

mental monitoring with air samplers

qualification and calibration in

responsible for the microbiological

and sedimentation plates. I also

the microbiological laboratory and

quality control. Bremer Pharma

check surface areas and cleanroom

the validation of microbiological

GmbH is a middle-size company

personnel with direct contact tests

methods.

in the pharmaceutical industry

and afterwards evaluate the growing

and specializes in the production

medium results. Furthermore I am

In 2003, I became qualified as the

of pharmaceutical products both

responsible for the sampling and the

Hygiene Officer and conduct in

in fluid and powder form. These

testing of the water used for injection

this context training courses and

products are for the export and

purposes and for the Aqua purificata

workshops for company employees

domestic markets.

(PW) of the company.

regarding this topic of hygiene.

Sterile and aseptic parenterals have

Additionally, I am responsible for

* sterile preparations which are designated for injection,

to be produced under strictly defined

the testing of bacterial endotoxins

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

infusion or implantation in humans or animals. ** Water for Injection

51

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CLEANROOM MAGAZINE 2/2016

52

What it’s about.

SERVICE

ISO, VDI, GMP – it’s all written down.

Why don’t we then have the perfect cleanroom?

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.

applies only for the air” emphasizes 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-

“Rules guide the wise man. The

the appropriate materials.” Such

room operators should not rely on

idiot obeys them” said Oscar Wilde.

statements leave a lot of room for

air quality measurements.

This Irish writer’s aphorism could be flatly coined for the cleanroom industry, even though Wilde – who

“The regulations are only recommendations. You will never find anything concrete for your situation – it always depends.”

passed away in 1900 – didn’t knew about cleanrooms.

Nevertheless his quote is applicable because the regulations for cleanroom technology often only have contents which guide instead of convenient, easy to follow instruc-

Frank Duvernell, Managing Director profi-con GmbH Contamination Control

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

interpretation. It could also be said

In order to determine surface

wisdom of the cleanroom-practicing

in another way: The regulations

contamination, contact tests are a

man.

contain too many standards. It is not

tried and tested method. With this

specified for example, how often a

method, flat plastic dishes with a

Frank Duvernell, Managing Di-

cleanroom is to be cleaned or how

nutrient medium are pressed onto

rector of the cleanroom cleaning

often employees should be trained.

objects and surfaces to collect any

specialist profi-con GmbH Con-

“When I ask professionals about

micro-organisms possibly present.

tamination Control in Leipzig,

this, they always say: It depends.”

Afterwards the dishes are incubat-

Germany, can shout out loud in this

ed. “After two days I know then if

respect. “What actually stands in

something is growing. After five

the ISO and GMP regulations?” he asks. “For example,: The cleanroom

The Weaknesses of the Measuring Methods

days, I know what it is and how much” says Frank Duvernell. The long incubation time is not the

should be regularly cleaned with But what does it depend on? - Above

only disadvantage with this meth-

all on a risk analysis. The basis for

od. The method is only a random

this analysis is given in the ISO

measurement and cannot be com-

tables with air cleanliness class-

prehensively applied.

es from 9 to 1. “This Regularium

CLEANROOM MAGAZINE 2/2016 | Laws and Regulations

53 The VDI contains a lot, but not everything

of ceilings, walls and floors with

Managing Director. Frequently, the

mops can be done. “Something like

purchasing department decides

this isn’t found in the regulations”

which devices are to be used.

Written down are the particular

explains Duvernell. “It only states

requirements for the cleanliness of

which cleanliness standard has to

Even trickier are the cleaning

the air, work places, surfaces and

be achieved.”

towels. There is a tremendous se-

the personnel in the VDI Guidelines

lection but worldwide, not a single

Series 2083 “Cleanroom Equipment”.

The same applies for cleaning ma-

binding testing procedure. “Every

These guidelines contain a broad

terials. “Where does is state in the

manufacturer can write on his

spectrum of things which are

regulations which cleaning mate-

towel ISO 8/ lint-free” says Frank

allowed in cleanrooms and which

rials are to be used” asks Duvernell.

Duvernell. But what does lint-free

are not allowed, but even though,

“There isn’t anything, worldwide

mean? How much is allowed to

not everything explains Duvernell.

nothing.” In the regulations, it

come out of the towel, in which

“It is fully understandable for ex-

is not specified if isopropanol or

time period, on which surfaces?

ample that cardboard has no place

ethanol should be used. This is

There are no clear statements

in a cleanroom – but where is this

purely a question of the cleanroom

written in the regulations. “It isn’t

written?”

operator’s or cleaning company’s

even written down which towel

experience.

you should choose. This namely

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

depends on…”

A further example is disinfection with hydrogen peroxide. For its use,

Even when choosing cleanroom

according to the regulations, no face

personnel, there are no detailed

mask is necessary up to a six percent

guidelines in the regulations. “The

concentration. “But in practice, a

guideline VDI 2083 Page 15 indeed

cleaning operator gets red eyes after

encompasses cleanroom related

20 minutes with this concentration”

requirements for personnel and

indicates Frank Duvernell. “In other

their clothing, however if jewelry

words: What works and what doesn’t

is allowed in the cleanroom, this

work, you have to try it out – it

isn’t stated” says Frank Duvernell.

depends.”

He gives this advice: “Determine for yourself the criteria which are

profi-con CEO Frank Duvernell. Photo: Cleanroom Media

most appropriate for your clean-

Trying out comes before studying the regulations

room and for your personnel and which bring the best results. The regulations are only recommenda-

This is also the case with cleaning

tions. You will never find anything

thorough cleaning of a cleanroom, it

materials. Nowhere is it written

concrete for your situation – it

is sensible that all fire alarms, sprin-

which device should be used. This

always depends.”

klers, ventilators and so on, have

means only that the devices have to

to be cleaned before the cleaning

be appropriate reports the profi-con

Author: Frank Baecke

Seit 12 Jahren Kompetenz für generative Technologien

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

Rapid.Tech

• Anwendertagung „Neue Technologien“

International Trade Show & Conference for Additive Manufacturing

• Fachforen Wissenschaft, Medizintechnik, Luftfahrt und Werkzeuge

www.rapidtech.de

Titelmotiv: Bremspedal, EOS/Materialise Foto: Andreas Stedtler

Laws and Regulations | CLEANROOM MAGAZINE 2/2016

54

What Cleanroom Technology is revolutionizing

Photo: Nils Brรถer

SERVICE

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

CLEANROOM MAGAZINE 2/2016 | Cleanroom Award and Creative Prize

55 “These robots will revolutionize cleanroom technology” was the opinion of Cleanzone’s audience and went on to choose the air filter monitoring system RobotScan from the company Infrasolution AG as the winner. However: Following the award an award is waiting!

The ReinraumAkademie immediately started accepting applications for the Cleanroom Award and the Creative Prize 2016.

in Frankfurt am Main, Germany. It

the Creative Prize was awarded

was a very good idea to have applied

for the first time in 2015. “In many

for the Award and at the same

companies the tea kitchen is better

time be an exhibitor at Cleanzone.

equipped than the cleanroom”, says

“We will once again be here next

Duvernell. Researchers have long

year – with still a better product”

since proven that colored work

exclaimed Itter to the fair’s visitors

environments help to increase

in the Cleanzone Plaza.

the well-being of employees and therefore also product quality. The

Following tradition, the winner

Creative Prize honors companies

from the previous year presented

which are already taking these

the Award. Yvonne Weis Marketing

factors into consideration.

“We are extremely delighted to

Manager and Representative for

have received this award” said

Initial said during the Award pres-

Infrasolutions Managing Director

entation to Mathias Itter: “It was

Mathias Itter at the Cleanroom

really great for us to have won the

Award ceremony 2015 at Cleanzone

Cleanroom Award. Afterwards we received so many customer inquiries for our Cleanvision Cleanroom Suit that we had to turn down some inquiries because we were just getting too many.”

MED-EL from Austria won the Creative Prize 2015.

Frank Duvernell Managing Di-

Photo: Cleanroom Media

rector of the ReinraumAkademie and founder of the Cleanroom

Applications for the Creative Prize

Awards emphasizes: “With this

and the Cleanroom Award can be

award, we want to bring out new

submitted to the ReinraumAkade-

ideas which are important for the

mie until August 31, 2016.

Infra Solution won the Cleanroom Award 2015, presented

industry to the general public.” To

by Frank Duvernell (right). Photo: Cleanroom Media

additionally serve this purpose,

Author: Frank Baecke

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 applications 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 GmbH Kennwort (Code word) “Cleanroom Award”/ or “Creative Prize” Rosa-Luxemburg-Str. 12-14 04103 Leipzig Tel.: +49 341 98989 302 E-Mail: info@reinraum-akademie.de Web: www.reinraum-akademie.de

Cleanroom Award and Creative Prize | CLEANROOM MAGAZINE 2/2016

56 The Cleanroom Award

The Creative Prize

Awarded will be ideas related to

Awarded will be the most optically

the innovation, sustainability or

and ergonomically creatively de-

energy efficiency in cleanrooms.

signed cleanroom.

Wanted are concepts, products, or

Wanted are concepts and ideas

Also in 2016 the most creative designed cleanroom will

services which distinguish them-

which eliminate the “white noise”

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

selves as trailblazing solutions or

in cleanrooms by using colors, by

are influential in changing the

implementing processes and by

industry.

using colored edges.

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

Creative cleanroom planning not

SERVICE

only relates to the walls but also An expert jury chooses five finalists

Additionally, applications are

the overalls worn by employees

from the total number of applica-

welcome showing concepts which

could be color-coded according to

tions. These five finalists then pres-

use colors to indicate orientation

department or function.

ent their projects at Cleanzone on

and information for example to

November 8 – 9, 2016, in Frankfurt

optically separate adjoining areas.

Author: Frank Baecke

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

Photo: Messe Frankfurt Exhibition GmbH, Sandra Gätke

All Previous Winners of the Cleanroom Award 2012: APMON The 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: BLAUTOUCH The 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-Suit The CleanVision Cleanroom-Suit from the company Textil Service GmbH is a one-piece suit with an integrated hood and an integrated visor. The

CLEANROOM MAGAZINE 2/2016 | Cleanroom Award and Creative Prize

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.

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.

EU Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Concerning the development, manufacture and monitoring of pharmaceutical products, not only the high quality standards are presented, but also the numerous legal guidelines and requirements to be fulfilled. The expanded new edition of the English 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 Medicinal Products for Human and Veterinary Use, Part II Basic Requirements for Active Substances used as Starting Materials, and Part III GMP Related Documents as well as the 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.

Project Management Cleanroom Technology

Master every challenge by using our services.

Process Management Qualification

Benefit from our 360° Pharma Consulting to gain more efficiency, safety and quality. independent · transparent · sustainable Visit us at LOUNGES 2016 · booth K3.8

Quality Management

Validation Computer System Validation

www.avantalion.de

New reference books on the market | CLEANROOM MAGAZINE 2/2016

57

58

14.–17.11.2016 Medica/Compamed Düsseldorf Germany

Graphic: Fotolia

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Trade Fairs and Congresses

08.–09.11.2016 Cleanzone Frankfurt Germany

Berlin

Germany Leipzig Düsseldorf Frankfurt a. Main

12.–14.04.2016 MedTec Europe Stuttgart Germany

Nürnberg

Stuttgart München

20.-23.09.2016 ILMAC Basel Switzerland

Basel Wangen an der Aare

Switzerland Lausanne

13.-14.04.2016 LabInnovations Lausanne Switzerland

CLEANROOM MAGAZINE 2/2016 | Trade Fairs and Congresses

19.–21.04.2016 Powtech mit Partec Nürnberg Germany 10.-13.05.2016 analytica 2016 München Germany 31.05.–02.06.2016 parts 2 clean Stuttgart Germany 21.-23.04.2016 Cleanroom Exhibition & Biotech Euroasia Istanbul Turkey

59

Events at the ReinraumAkademie, Germany and the CleanroomAcademy, Switzerland Reinraum-Expertentage | Cleanroom Experts Days 11.-12.05.2016 | Flexible Cleanroom Design | Leipzig, Germany 07.-08.06.2016 | Cleanroom: Layout, Planning and Construction | Wangen an der Aare, Switzerland 28.-29.09.2016 | Flexible Cleanroom Design and Integration of Production Facilities, Equipment and Furnishings in Cleanrooms | Wangen an der Aare, Switzerland 05.-06.10.2016 | Fundamentals and Optimization in Cleanroom Operations, Cleanroom and Qualification | Leipzig, Germany 23.-24.11.2016 | Optimal Cleanroom Personnel | Leipzig, German 07.-08.12.2016 | Optimization and Qualification of Cleanroom Operations | Wangen an der Aare, Switzerland

BEHAVIOR IN A CLEANROOM 11.04.2016 | One-Day Training Plus | Penzberg, Germany 27.09.2016 | One-Day Training Plus | Wangen an der Aare, Switzerland 02.11.2016 | One-Day Training Plus | Leipzig, Germany

BASICS OF PROFESSIONAL CLEANROOM CLEANING 17.-18.10.2016 | Two-Day-Seminar | Leipzig, Germany

ADDITIONAL EVENTS 28.09.2016 | 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 Center Rosa-Luxemburg-Str. 12-14, D-04103 Leipzig Tel.: +49 341 98989-0, Fax: +49 341 98989-200 info@reinraum-akademie.de, www.reinraum-akademie.de

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

SwissCCS SYMPOSIUM & General Assembly (GA) 2016 20. April 2016 08:30 - 09:00 | registration / coffee & cake 09:00 - 10:00 | General Assembly SwissCCS (SRRT) 10:00 - 17:00 | Symposium NEWS: ISO, VDI, CEN NEWS: 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 Schweiz c/o CleanroomAcademy GmbH Vorstadt 4, 3380 Wangen an der Aare

Events | CLEANROOM MAGAZINE 2/2016

60

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Cleanroom Award

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Monitoring fallender Partikel Monitoring Particle Deposition

Cleanzone

Paris

Attraktives Reiseziel für Technologen Popular destination for technologists

Die Reinraumwelt trifft sich in Frankfurt / The World of cleanroom meets in Frankfurt

Barbara Kanegsberg

Sieglinde Sellemond

Genuss, Kunst und Kultur Indulgence, art and culture

Das Produkt steht im Mittelpunkt / The focus on the product

Dresden

Attraktives Reiseziel für Technologen Popular destination for technologists

Jan Gerbrands Motivation und Leidenschaft Motivation and Passion

Cleanroom Award – Herausforderung an die Branche

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

Cleanroom Award – Challenging the branch

EDITION 1/2014

Keime im Essen Wie die Reinraumtechnik gefährlichen Lebensmittelkeimen den Garaus macht Wenn Milliarden von Geräten dank winzigster Bauteile aus dem Reinraum miteinander kommunizieren

So schätzen Experten die Aussichten der Reinraumbranche ein

Recht und Regularien

Wie Mitarbeiter zu Reinraummitarbeitern werden

Hochspannung im Reinraum

Talententwicklung Ausblick 2016

Der 3D-Druck eröffnet dem Reinraum neue Perspektiven

Internet der Dinge

Vorstoß in die dritte Dimension Approaching the Dimension 3D printing is opening new perspectives for cleanrooms

Experts estimate future prospects in the cleanroom industry How employees become cleanroom operatives

Life & Science Informationen für die Reinraumtechnologie

Life & Science Informationen für die Reinraumtechnologie

CLEANROOM

MAGAZIN

CLEANROOM

2016

Winter

01

2015

Herbst

04

So sieht der Chirurgen-Arbeitsplatz der nächsten Generation aus

Operationssaal der Zukunft

Mitdenkende Stoffe verändern Medizin, Architektur, Mode und Autoindustrie

Smarte Textilien

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

Freude am Gefahrenwerden

ISSN 2364-0405

Regularien Lästige Pflicht OLEDs Die Lichtrevol Krankenhaus Wie Raumtec So nehmen Pol Einfluss auf Ih

Blüh Gefä Kont Life & Science Informationen für die Reinraumt

Sommer 2015

03

Manager Cleanroom Media und Conception Magazine Maja Franke Tel. +49 341 98989 404 maja.franke@cleanroom-media.com Chief Editor Frank Baecke Tel. +49 341 98989 405 frank.baecke@cleanroom-media.com

02

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

Never stop thinking

How does the desire to have children correlate with cleanrooms?

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

2016

EDITION 4/2015

In-Vitro-Fertilisation

Laws & Regulations

Frühjahr

This is what the surgery workstation of the future looks like

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

Throw out the sparks and protect sensitive products

Talent Development

MAGAZIN

Operating Theatre

High Voltage in the Cleanroom

Outlook 2016

Life & Science Informationen für die Reinraumtechnologie

Smart Textiles

CLEANROOM

0 3 | S O M M E R 2 015

02

spring 2016

Life & Science Information for Cleanroom Technology

Life & Science Information for Cleanroom Technology

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

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

CLEANROOM MAGAZINE 2/2016 | Imprint

MAGAZINE

Damit kein Funke überspringt sensible Produkte schützen

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

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

How the vision of autonomous driving is gradually becoming a reality

Internet www.cleanroom-media.com

more informations

CLEANROOM

01

winter 2016

MAGAZINE

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

Imprint CLEANROM MAGAZINE Is issued and published by Cleanroom Media GmbH Rosa-Luxemburg-Straße 12-14 04103 Leipzig Germany

free subscription

CLEANROOM

The Internet of Things

Joy of Being Driven

EDITION 3/2015

04

autumn 2015

Künstliche Befruchtung

09.07.15 12:53

Cleanzone 2015 Die internationale Reinraummesse wird zum Impulsgeber der Branche

EDITION 2/2015

MAGAZINE

Was hat der Kinderwunsch mit Reinräumen zu tun?

Umschlag_2015-03_5mmRuecken_005.indd 1

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

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

summer 2015

Life & Science Information for Cleanroom Technology

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

The influence of pollen and air humidity on your production

0 3 | S O M M E R 2 015

Blossoming Nature Dangerous Contamination

CLEANROOM

03

02

spring 2015

Life & Science Information for Cleanroom Technology

07.12.15 16:38

MAGAZINE

15.03.16 14:05

CLEANROOM

EDITION 1/2015

EDITION 2/2014

Never stop thinking

EDITION 2/2013

Cleanroom Award und Creative Prize 2016

EDITION 1/2013

2015-12-07_Ducklayout_Cover_mit_Schutzlack_CMYK.indd 1

Tirol – High tech in mountain paradise

2016-03-15_Ducklayout_Cover_mit_Schutzlack_CMYK.indd 1

Tirol – Hightech im Bergparadies

EDITION 1/2016

Cleanroom Award & Creative Prize 2016

EDITION 2/2016

Translation Bill Hillman

Circulation 10,000 copies

Authors Frank Baecke Prof. Gernod Dittel Frank Duvernell Claudia Pachl

Printer Löhnert-Druck, Leipzig

Advertisements/Notifications Maja Franke Tel. +49 341 98989 404 maja.franke@cleanroom-media.com Infographics Daniel Read, Cleanroom Media Implementation Wohlfahrt GmbH www.wohlfahrt.net Publication Quarterly

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.

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