28.09.2020 Views

ICF N° 4 Settembre/Ottobre 2020 Supplemento

ICF - Rivista dell'Industria Chimica e Farmaceutica è la rivista di Interprogetti che, oltre ad offrire un quadro esaustivo sullo stato dell'arte dei due settori di riferimento, rappresenta uno strumento di lavoro qualificato, attraverso una presentazione completa dell'innovazione tecnologica ad essi dedicata.

ICF - Rivista dell'Industria Chimica e Farmaceutica è la rivista di Interprogetti che, oltre ad offrire un quadro esaustivo sullo stato dell'arte dei due settori di riferimento, rappresenta uno strumento di lavoro qualificato, attraverso una presentazione completa dell'innovazione tecnologica ad essi dedicata.

SHOW MORE
SHOW LESS

You also want an ePaper? Increase the reach of your titles

YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.

Construction<br />

Via Selvanesco, 75 - 20142 Milano<br />

tel. +39 02.27.43.931 - fax +39 02.27.43.93.20<br />

info@csv-ls.com www.csv-ls.com


www.ellab.it<br />

RIVISTA<br />

DELL’<br />

POSTE ITALIANE SPA - SPED. IN ABB. POSTALE<br />

70% - LO/MI - COSTO COPIA €10,00<br />

_I_IV_COVER_4-<strong>2020</strong><br />

UnMondoServizio'20-05-20.indd PHARMA.indd<br />

2 1<br />

22/07/20 11/09/20<br />

12:00<br />

08:54<br />

Summary<br />

RIVISTA<br />

DELL’ INDUSTRIA<br />

CHIMICA E<br />

FARMACEUTICA<br />

www.interprogettied.com<br />

icf<br />

PHARMA SPECIAL ISSUE<br />

INDUSTRIA<br />

CHIMICA E<br />

FARMACEUTICA<br />

YEARXI NO4 SEPTEMBER/OCTOBER<strong>2020</strong>SUPPLEMENT<br />

icf<br />

6<br />

Editorial<br />

Science, a necessary<br />

asset<br />

12<br />

Technical news<br />

Products for medical<br />

and pharmaceutical<br />

applications<br />

20<br />

Trends<br />

Where personalized<br />

medicine is already<br />

effective<br />

THE solutions for your Validation & Monitoring needs<br />

Everything is hardbefore it gets easy!<br />

8Cover story<br />

A strategic supplier<br />

for the pharma industry<br />

16<br />

Trends<br />

2.0 therapeutic support:<br />

the storytelling<br />

in the pharma industry<br />

26<br />

Safety<br />

On the trail<br />

of the future<br />

Summary<br />

2 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA


Summary<br />

NO.4 SEPT/OCT <strong>2020</strong> SUPPLEMENT<br />

30<br />

Machines<br />

Contained milling process:<br />

an integrated know how<br />

36<br />

Technical news<br />

Flexible solution<br />

for serialization<br />

38<br />

Instrumentation<br />

Reliable measured values,<br />

from lab to process<br />

47<br />

Technical news<br />

IMA Group accelerates<br />

digital innovation<br />

34<br />

Instrumentation<br />

New Directions in the TOC<br />

Measurements<br />

37<br />

Technical news<br />

High quality stills<br />

with the GFL Technology<br />

quality mark<br />

42<br />

Packaging<br />

Pharmaceutical packaging:<br />

high tech for our health<br />

48<br />

Colophon<br />

“The current emergency showed us even more clearly the importance<br />

of technological and IT infrastructures: we are very satisfied about<br />

the success of remote inspections we were subjected to by Accredia,<br />

the body designated by the Italian Government to certify the competence<br />

of the accredited calibration laboratories”.<br />

Alessandra Ferrari, Ellab Srl Business Manager, page 10.<br />

September/October <strong>2020</strong><br />

RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA icf 3


usiness & quality continuity<br />

GxP inside


Editorial<br />

Science, a necessary asset<br />

The trend to polarization that has characterized<br />

our Western societies for years<br />

has been reflected in the ways of dealing<br />

with the health emergency. This<br />

could be remarked first of all in some<br />

irrational and extremist behaviours,<br />

culminating in the denial marches that<br />

cannot be justified by our prolonged psychological<br />

stress and by the serious economic problems that<br />

involved large sections of the population. On the<br />

opposite side, let’s point out that some media and<br />

institutions gave different examples of confused<br />

and aggressive communication, aiming at frightening<br />

people, more than informing them. Polarisation<br />

and frontal collisions, as some recent politics taught<br />

us, try to simplify the language to such an extent<br />

to provide an univocal and superficial version of the<br />

events. Bypassing either instrumentally or because<br />

of ignorance the big complexity of our time and<br />

reality, thus feeding anti-scientific and anti-industrial<br />

prejudices. This doesn’t mean that every interpretation<br />

of facts can be based on data or<br />

pure rationality. Understanding something<br />

about human events looking away from the<br />

contradictions that characterize it, is impossible.<br />

Not everything can be measured<br />

and scientists themselves repeat us they<br />

have no absolute truths. In short,<br />

there are no indisputable dogmas.<br />

However this does not authorize us<br />

to let our guard down against irrational<br />

drifts that risk to become<br />

dangerous for public health, economy<br />

and even civil cohabitation.<br />

Let’s hope that this extreme experience, that can be<br />

probably compared to last century’s big wars, may<br />

help us in the long term to think about the limits<br />

and the need of science to build up a future putting<br />

in the middle of our development social, environmental<br />

and economic sustainability.<br />

<br />

by Alessandro Bignami<br />

6 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA


THIS PAGE IS INTENTIONALLY LEFT BLANK<br />

quality speed<br />

reliability<br />

<br />

www.pompetravaini.com<br />

I L<br />

V E R O<br />

4 . 0<br />

a<br />

G E N E R A Z I O N E<br />

Pompetravaini Spa www.pompetravaini.com


Cover Story<br />

A strategic supplier<br />

for the pharma industry<br />

In order to ensure production during the coronavirus<br />

emergency, pharma companies increased their demand<br />

for quick calibrations and measuring equipment.<br />

Ellab Srl proves to be a reliable, skilled, future-oriented<br />

supplier who is ready to meet any need with promptness<br />

and flexibility. We talked about it with Alessandra Ferrari,<br />

the company business manager.<br />

by Eva De Vecchis<br />

In the picture:<br />

Alessandra<br />

Ferrari,<br />

Ellab Srl<br />

Business<br />

Manager<br />

Since 1977, Ellab Srl has<br />

been providing products<br />

and services ensuring and<br />

implementing the operational<br />

efficiency of production<br />

processes in the life science<br />

industry. The company offers a<br />

complete range of process and laboratory<br />

systems and tools to measure<br />

and monitor temperature, relative<br />

humidity, HVAC parameters,<br />

as well as solutions for thermal processes<br />

validation. The company is<br />

part of Ellab Group, Danish world<br />

leader in this field. Ellab Srl moreover<br />

relies upon a LAT <strong>N°</strong> 128 calibration<br />

laboratory accredited by<br />

Accredia and offers several services<br />

including the rental of measurement<br />

instruments. Pharma companies<br />

find in Ellab Srl a reference<br />

supplier of high precision instruments<br />

and a solid support to solve<br />

measurement, calibration and<br />

validation-related problems. We<br />

talked about all this, in early April<br />

during the coronavirus emergency,<br />

with Alessandra Ferrari, Ellab Srl<br />

Business Manager.<br />

How the demand from pharma<br />

companies that must face the<br />

coronavirus challenge has<br />

changed?<br />

As we all know, drug production<br />

is certainly included in<br />

the list of essential commodities<br />

for people’s life<br />

and health. Even more during<br />

the covid19 emergency,<br />

pharma companies had to go<br />

on being operational to meet<br />

the needs of those who need<br />

care. Ellab Srl never stops offering<br />

its constant commitment to ensure<br />

a total customer-satisfaction. Our<br />

calibration services ensure the appropriate<br />

operation of measurement<br />

instruments that, for pharma<br />

companies, are of key importance.<br />

In this period, the need of equipment<br />

hire has strongly grown, as<br />

well as the demand for a very fast<br />

calibration service.<br />

8 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA


The company<br />

relies on a LAT<br />

n. 128 calibration<br />

laboratory,<br />

accredited<br />

by Accredia<br />

Cover Story<br />

How did you manage, from an organizational<br />

point of view, the<br />

sanitary emergency?<br />

Our company as well had to face<br />

a delicate situation, requiring an<br />

aware, but at the same time positive<br />

approach. With a sense of responsibility,<br />

we managed to be fully<br />

operational. We put in place all<br />

the measures indicated by the authorities<br />

to work safely: as to office<br />

activities, we relied upon the<br />

home office; in the laboratory, we<br />

offered the staff the necessary personal<br />

protection equipment and we<br />

introduced shifts in order to keep<br />

employees at least one meter away<br />

from one another.<br />

September/October <strong>2020</strong><br />

RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA icf 9


Cover Story<br />

A product<br />

by Hanwell,<br />

the British<br />

manufacturer<br />

of environmental<br />

monitoring<br />

technology,<br />

that has been<br />

recently taken<br />

over by Ellab<br />

Group<br />

bration laboratories. We had no<br />

reports of non-compliance of any<br />

kind, which makes us proud. We’ll<br />

go on investing on training and<br />

communication activities: in the<br />

face of a phenomenon that upsets<br />

interpersonal contacts, it is<br />

key for the brands to start initiatives<br />

to be closer to their customers.<br />

In the new headquarters<br />

we planned a meeting room to be<br />

used also for training courses: refresher<br />

courses will be focused not<br />

only on the tools we are selling,<br />

but also on the different technical<br />

subjects concerning our world: I<br />

think for instance about validations<br />

and environmental monitoring.<br />

This will bring users<br />

to focus on the features<br />

of the products we provide,<br />

but also to get<br />

to know our company<br />

better.<br />

Due to this pandemic,<br />

events and exhibitions<br />

were cancelled, but for us,<br />

they were fixed appointments, including<br />

the AFI Symposium and<br />

the CPhI exhibition.<br />

What about the novelties?<br />

Our novelties regard<br />

freeze drying processes:<br />

by the way Ellab is launching<br />

some prototypes to be<br />

tested at client companies.<br />

They are very small data loggers,<br />

equipped with wireless transmission,<br />

that are used to follow the<br />

temperature profile throughout the<br />

freeze drying process, with the option<br />

to get data in real time. These<br />

are customised solutions for each<br />

What can we learn from this situation<br />

for the future?<br />

I think this situation will leave the<br />

awareness we always have to improve<br />

and will give the chance to<br />

focus on structural problems. Today<br />

work is underway for a new<br />

headquarters: it is a building three<br />

times the size we occupy now, with<br />

a laboratory that would enable us<br />

to work at full power, also avoiding<br />

to alternate employees presence<br />

on the workplace.<br />

The current emergency showed<br />

us even more clearly the importance<br />

of technological and IT infrastructures:<br />

we are very satisfied<br />

about the success of remote<br />

inspections we were subjected to<br />

by Accredia, the body designated<br />

by the Italian Government<br />

to certify the competence<br />

of the accredited calicustomer,<br />

and they perfectly fit to<br />

any format. This occurs above all<br />

because in pharma companies, especially<br />

in freeze drying processes,<br />

the loading of the liostats is carried<br />

out automatically, without the<br />

intervention of operators.<br />

Moreover, we have recently made<br />

available Sterisense, a tool to run<br />

electronically the Bowie Dick test<br />

that is useful to easily check the<br />

autoclave is working correctly. Further<br />

new products will result from<br />

Ellab’s acquisition of Hanwell, a<br />

British manufacturer of environmental<br />

parameter wireless monitoring<br />

systems for whom we were<br />

already distributors in Italy, as<br />

well as from Ellab’s acquisition<br />

of a 30 employees-company specialised<br />

in validation services. The<br />

group, even in this difficult moment,<br />

is investing very much on<br />

calibration services on-site, both<br />

in Europe and in the USA. <br />

10 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA


STAINLESS STEEL PUMPS AND FILTERS<br />

HYGIENIC<br />

DESIGN<br />

for an easy cleaning.<br />

SAFETY<br />

<br />

suitable for the use in<br />

contact with foods.<br />

ENDURANCE<br />

<br />

<br />

NO CAST PART, NO WELDINGS.<br />

“RAPID” PUMPS<br />

Sanitary - Self priming.<br />

Both for liquid and for<br />

thick products<br />

(Creams and Sauces).<br />

“FARMINOX”<br />

FILTERS<br />

Packingless plate filters.<br />

Working through<br />

paperboard filter-sheets.<br />

V. Cavour, 31 - 26858 Sordio (LO) - Italy - Tel. +39 02 9810153 - Fax. +39 02 98260169<br />

info@wolhfarth.it - www.wolhfarth.it


Technical news<br />

Push your immune system and energy with API Iron salts<br />

Dr. Paul Lohmann®, one of the world’s<br />

leading producers of iron salts as<br />

APIs, now presents two new references<br />

with characteristics that make<br />

them very well tolerated in the intestine<br />

and optimally absorbed by our<br />

body, for a full of energy and important<br />

support to the immune system.<br />

Normally iron salts can cause gastrointestinal<br />

side effects. Ferrous Bisglycinate<br />

is an organic Iron Salt with<br />

an excellent bioavailability. The absorption<br />

rate in the intestine is up to<br />

five times higher than for the benchmark<br />

Ferrous Sulfate. Iron Salts usually evoke gastro-intestinal side<br />

effects, but Ferrous Bisglycinate significantly decreases the occurrence<br />

of these side effects due to the chelate structure of this fully<br />

reacted Mineral.<br />

Dr. Paul Lohmann is the worldwide first manufacturer of Ferrous Bisglycinate<br />

as an Active Pharmaceutical Ingredient (API) including<br />

available regulatory documentation (DMF) to support the customers<br />

with a novel Iron active in pharmaceuticals and OTC products.<br />

The other new reference that has become part of the Dr. Paul<br />

Lohmann range is an API grade iron<br />

polymaltose complex, accompanied<br />

by all the regulatory documentation<br />

(DMF / ASMF) required for for the<br />

registration of a medicinal drug at<br />

the health authorities.<br />

Iron polymaltose complexes are<br />

mainly used for the treatment of<br />

iron deficiency anemia; some studies<br />

also suggest its application as a<br />

phosphate binder for the treatment<br />

of hyperphosphataemia. In general,<br />

they are appreciated for high bioavailability<br />

as well as for its high<br />

patient compliance due to less side effects related to the upper<br />

gastrointestinal tract.<br />

The products normally present on the market are characterized<br />

by high dustiness, a feature which complicate the production of<br />

pharmaceuticals. Dr. Paul Lohmann has developed a free-flowing<br />

and low-dust quality, perfectly suitable to produce tablets, capsules<br />

and syrups.<br />

API grade iron salts by Dr Paul Lohmann are distributed in Italy by<br />

Faravelli Pharma Division. For info: pharma@faravelli.it<br />

Products for medical and pharmaceutical applications<br />

Having been operating in the field of automation<br />

for more than 35 years, Gimatic Srl<br />

can today boast many successes in the<br />

pneumatic market, the same field in which<br />

it started to develop its first Handling<br />

products.<br />

Over the years, thanks to the evolution<br />

of technologies, Gimatic has expanded its<br />

range of products creating three new divisions:<br />

Plastic, Sensors and Mechatronics.<br />

The Mechatronics division is based on the<br />

use of the electricity as it is more suitable<br />

for medical and pharmaceutical applications<br />

than the pneumatic one.<br />

Gimatic put its electric gripper to the test<br />

and receives excellent results from the IPA<br />

Fraunhofer Institute of Stuttgard for the<br />

fields above mentioned.<br />

The MPPM-GMP-KIT is surely the Gimatic<br />

crown jewel. It is composed by an electric<br />

parallel gripper (MPPM1606) and a silicone<br />

cover. It is suitable for use in environment<br />

with low content of suspended particles.<br />

The gripper in the kit is a 2 jaw selfcentering<br />

parallel actuator, with plug and<br />

play and no electricity consumption when<br />

the gripper is engaged. It also has an excellent<br />

weight-dimension-force trade off.<br />

Mechatronics products are easy to use. This<br />

is due to the fact that the electric actuator<br />

does not require any programming because<br />

the electronic control has been expertly<br />

integrated inside the body. The weight of<br />

the compact grippers ranges from only 390<br />

grams to 890 grams, depending on the dimensions.<br />

They can be used on both sides<br />

and they grip both from the inside to the<br />

outside and vice versa.<br />

The actuators conform to European recommendations<br />

(CE) and the packaging is realized<br />

in line with the existing environmental<br />

disposal directives.<br />

Maintaining the same flexibility, Gimatic<br />

wishes to offer its costumers the unique<br />

opportunity to realise their ideas and expand<br />

the functions of existing technology<br />

by integrating additional components, such<br />

as a camera or sensors.<br />

12 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA


Technical news<br />

Vacuum Drying Revolution<br />

Moving the frontier of innovation<br />

forward every day. This has always<br />

been Italvacuum’s mission, one<br />

of the leading manufacturers in<br />

the world of Vacuum pumps and<br />

Vacuum dryers for Pharmaceutical,<br />

Chemical, Fine Chemical and<br />

food industries. Now, forget convetional<br />

horizontal vacuum dryers:<br />

Planex® System is the cutting<br />

edge innovation designed<br />

and manufactured by Italvacuum.<br />

This patented machine introduces<br />

a real revolution in vacuum<br />

drying and is conquering all<br />

over the world the most demanding<br />

operators, guaranteeing results<br />

unthinkable until now with<br />

conventional systems.<br />

What makes Planex System so special?<br />

His eccentric agitator<br />

with two independent<br />

movements,<br />

able to rotate<br />

simultaneously<br />

on its own axis and<br />

tangentially to the<br />

drying chamber. The<br />

solution for drying wet<br />

dust from filtration or centrifugation,<br />

which is particularly suitable<br />

for the production of Active Pharmaceuticals<br />

Ingredients (APIs),<br />

Fine Chemicals and Intermediates.<br />

The combined double rotation of<br />

the stirrer and its small size, in relation<br />

to the diameter of the drying<br />

chamber, guarantee the perfect<br />

handling of the entire batch<br />

and allow to use at least three<br />

times less energy than traditional<br />

dryers. This means reducing the<br />

mechanical and thermal stress on<br />

the product to be dried by three<br />

times and guarantees the maximum<br />

respect of treated products,<br />

including the most delicate and<br />

Eccentric agitator with two<br />

indipendedent movements<br />

thermolabile materials. The Planex<br />

System meets the requirements of<br />

FDA and cGMP standards and can<br />

be manufactured according to AT-<br />

EX, UL, PED and ASME standards.<br />

The design of the system’s application<br />

software includes a program<br />

(Stop & Swing) that automatically<br />

manages the “settable<br />

pendulum” movement of the agitator<br />

shaft, ensuring continuous<br />

mixing of the product during the<br />

drying cycle and also allow an effective<br />

treatment of small batches.<br />

Minimum hold-up because<br />

the movements of the agitator<br />

blades, managed by a specific<br />

software, transport all the product<br />

residue into the discharge.<br />

Continuous Process Monitoring of Ozone,<br />

TOC and Conductivity<br />

AMI Codes-II O 3<br />

Colorimetric standard method according to DIN 38408-3,<br />

no sensitivity loss in absence of ozone.<br />

AMI LineTOC<br />

Early trend detection without laboratory measurements.<br />

Automatic System Suitability Test (SST) and calibration<br />

at minimized maintenance.<br />

AMU Pharmacon<br />

AMI LineTOC<br />

AMI Codes-II O 3<br />

AMU Pharmacon<br />

Conductivity transmitter according to USP in a<br />

standardized design and integrated temperature compensation.<br />

Swan Analitica Srl ∙ IT-16166 Genova<br />

www.swan.ch ∙ swan@swananalitica.it<br />

Pharmaceutical Water<br />

Ad_Pharmapalette_194x121.indd 1 30.06.<strong>2020</strong> 16:30:08


Technical news<br />

More than 50 years of process equipment<br />

Delta Costruzioni Meccaniche is an OEM with<br />

extensive experience in pressure vessels and<br />

machines for fine chemical and API production.<br />

Delta is especially known for: systems<br />

for liquid-solid separation (Nutsche filters<br />

or Nutsche filter dryers); systems for vacuum<br />

drying (paddle, conical vacuum dryers);<br />

reactors/tanks for chemical synthesis; heat<br />

exchangers.<br />

Its philosophy is based on four main points:<br />

design starting from the process; in-house<br />

development and construction; total customization;<br />

build with the highest quality.<br />

Delta’s history began in 1968 when the goal<br />

was to supply the growing Italian equipment<br />

market -for-chemical companies and<br />

to focus on simple pressure process vessels<br />

(tanks, reactors, heat exchangers, etc.).<br />

During the 1970s, Delta started to develop<br />

more complex systems in order to fulfill customers’<br />

needs. In particular, following API<br />

(Active Pharmaceutical Ingredients) producers,<br />

attention was directed towards equipment<br />

for: liquid/solid separation Nutsche filter<br />

dryers (DNFD); vacuum drying.<br />

This equipment was first installed on the<br />

following dates: 1986 (DNFD Delta Nutsche<br />

Filter Dryer); 1987 (DVRF Delta Horizontal<br />

Vacuum Dryer); 1995 (DCHD Delta Conical<br />

Helix Dryer).<br />

The 1990s were years of growth linked to<br />

internationalization. South Korea, China,<br />

Eastern Europe, Egypt, Israel, and the USA<br />

are some of the countries where Delta delivered<br />

its machines during this period. To continue<br />

to strengthen its worldwide presence,<br />

Delta became part of Polaris Group in 2009.<br />

Today, Delta continues its growth, providing<br />

effective and reliable added value to customers<br />

through its products.<br />

Drying, filtration, and washing are production<br />

steps that are normally handled by<br />

multiple machines. The DNFD Delta Nutsche<br />

Filter Dryer surpasses this traditional concept<br />

by combining operations and offering<br />

a more consolidated and flexible approach<br />

to the chemical process.<br />

The DNFD Delta Nutsche Filter Dryer is a<br />

batch machine that can perform multiple<br />

operations: filtration; washing; vacuum drying;<br />

automatic discharge of dried product.<br />

The intrinsic flexibility and versatility of the<br />

DNFD Delta Nutsche Filter Dryer offers several<br />

advantages: by having the integration of<br />

multiple production steps in one machine;<br />

the filtration and drying processes can be<br />

optimized together, leading to better results<br />

in terms of product quality; high-potency<br />

products are more easily managed<br />

when using a single machine for several<br />

operations. Material transfers are reduced.<br />

Because of its ability to combine multiple<br />

process steps, the DNFD Nutsche Filter Dryer<br />

can be applied in many industries, such as:<br />

API production; fine chemicals; plastics; dietary<br />

supplements/fragrances; chemical intermediates;<br />

precious metals/metals recycling;<br />

catalysts.<br />

Marchesini Group acquired three companies<br />

Marchesini Group closed 2019 with a consolidated turnover of<br />

441 million Euro, a repeat of the excellent performance in 2018.<br />

During the current year, the Marchesini Group has continued its<br />

production activities as steadily as possible, despite the sharp<br />

slowdown in the Italian and international economy caused by<br />

the Covid-19 pandemic. Notably, between February and June more<br />

than 50 virtual tests were carried out, which made it possible to<br />

respect the machine delivery times and maintain a stable economic<br />

outlook for the company. In the same period, a series of initiatives<br />

worth 500,000 Euro were also launched to ensure employee<br />

health, including sanitation measures, serological tests, safety<br />

devices, additional insurance and home educators and babysitters.<br />

Investments required for safety in the workplace were accompanied<br />

by those to develop two new stake holdings and an acquisition<br />

in the Italian mechanical and automation supply chain.<br />

The first company in which Marchesini has a stake is the Pianoro-based<br />

Carlo Corazza Srl, a historic brand that specialises<br />

in precision machining and special processes, with which<br />

Marchesini boasts a solid partnership. Founded in the ’70s, Carlo<br />

Corazza has developed over time and currently employs 23 people,<br />

with a turnover of 2 million Euro.<br />

Marchesini has also acquired a stake in FVM Srl, a Tuscan artisan<br />

manufacturing company (Monteriggioni, Siena) that has<br />

been producing small automatic machines and components for<br />

the pharmaceutical, diagnostic, cosmetic and food sectors since<br />

1992. With its entry into the Marchesini Group, FVM - which employs<br />

seven people and has a turnover of 800,000 Euro - will<br />

consolidate its existing collaboration with the Corima Division of<br />

the Marchesini Group, one of the world’s leading manufacturers<br />

of packaging for drugs such as vaccines and anti-cancer drugs.<br />

Auteco Sistemi Srl, a software company in Lombardy (Pavia)<br />

that was founded in 1985 and develops solutions in the field<br />

of automation, process control and workflow digitalisation, has<br />

joined the Group.<br />

14 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA


September/October <strong>2020</strong>


Trends<br />

2.0 therapeutic support:<br />

the storytelling<br />

in the pharma industry<br />

Producing entertainment contents,<br />

in addition to information<br />

contents, is becoming increasingly<br />

important in the pharma world.<br />

Pharma companies focus on<br />

emotions to create empathy<br />

with patients and support them<br />

in the therapy. Along this line,<br />

the Medicom (Medical Comedy)<br />

educational TV series dedicated<br />

to prevention were developed.<br />

by Elena Marzorati<br />

“Life is a little<br />

bit like a journey<br />

against the tide,<br />

above all during<br />

the illness. But<br />

now that I’m<br />

well, I can say I<br />

really know my<br />

skin”. Susanna,<br />

influencer<br />

affected<br />

by chronic<br />

spontaneous<br />

urticaria<br />

Consumers evolution into<br />

more informed and aware<br />

subjects caused a transformation<br />

also in brand communication,<br />

requiring a<br />

higher effort to conquer their trust.<br />

For today’s companies, in fact, a unidirectional<br />

promotional communication<br />

of their products is no longer<br />

enough, but it is essential to involve<br />

their consumers differently, also producing<br />

contents capable of informing<br />

and entertaining them. This is<br />

one of the main tasks of storytelling,<br />

since it tells a story or it offers an<br />

entertainment experience that enables<br />

the consumer to identify himself<br />

and discover a product’s usefulness.<br />

If these trends involve one of<br />

the most risky and conservative industries,<br />

such as the pharma one, the<br />

challenge doubles since the need for<br />

more specific and profiled contents<br />

matches with a higher and more conscious<br />

communication ethics. Nevertheless<br />

branded content also arrived<br />

at the pharma industry, abroad<br />

it already exists in different shapes<br />

whose common denominator is the<br />

widespread use of storytelling. Starting<br />

from Novartis, that created the<br />

“Living like you” digital review to be<br />

closer to multiple sclerosis patients,<br />

up to Merck’s “Blue or Pink. A trip to<br />

fertility” documentary, to promote<br />

fertility therapies. And what about<br />

Italy? We’ll talk about it today with<br />

someone who has been dealing for<br />

many years with developing mini-fictions<br />

for some Italian divisions of big<br />

pharma companies, in which the key<br />

players are first of all the patients.<br />

16 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA


Trends<br />

Here is an expert in branded content<br />

and entertainment: Dario Nuzzo.<br />

Why does storytelling work so well<br />

also in the pharma industry?<br />

I’d say it works so well above all in<br />

the pharma industry. When it comes<br />

to health, a higher relationship of<br />

trust comes into play among doctor,<br />

drug and patient, thus for a pharma<br />

company it is essential to connect to<br />

its own emotions to create empathy.<br />

On the set<br />

of the “On<br />

Susanna’s skin”<br />

web series,<br />

ranking first at<br />

Mediastars – the<br />

technical adv<br />

award – in the<br />

ethical-social<br />

category<br />

corporate<br />

identity section<br />

What are risks and advantages with<br />

using a branded content in this field?<br />

When a new concept is created, I<br />

speak from my experience, we always<br />

try to catch the ideal mindset<br />

of those who suffer from a specific<br />

pathology, by understanding his/her<br />

daily problems. Once the project is<br />

over, then, a big content analysis is<br />

also required since every single word<br />

might represent an important educational<br />

content. The healthy content<br />

has changed: it is not only intended<br />

as the absence of illness, but more<br />

in general, its management coincides<br />

with the research of wellbeing.<br />

What do you mean?<br />

In every story, a change of characters<br />

through a growth takes place. That is<br />

why the BC, as well as representing<br />

for the patient a direct identification<br />

testimony, also allows for an indirect<br />

education to good practices offering<br />

wellbeing advices in many fields. An<br />

example is the web series we produced<br />

for Novartis that was recently<br />

awarded by Mediastars, the advertising<br />

technical award. “On Susanna’s<br />

skin” is an insight into the life of an<br />

influencer and into her complex daily<br />

relationship with chronic spontaneous<br />

urticaria, a little known pathology<br />

which weakens in many everyday<br />

situations. That is why every episode<br />

was accompanied by support<br />

tutorials.<br />

Therefore, does it make sense to<br />

imagine a further video development<br />

about therapeutic support?<br />

Yes, of course! In Italy, online service<br />

users are growing, including<br />

doctors and patients, who are more<br />

inclined to interact in a virtual way.<br />

I think that, after what has recently<br />

occurred with Covid 19, it is more<br />

than ever the moment to use videos<br />

as prevention, therapeutic support<br />

and also training platform. Companies<br />

will increasingly have to integrate<br />

the drug supply with disclosure<br />

and therapy support services.<br />

For instance, at the end of last<br />

year for Novo Nordisk, we developed<br />

some videos on diabetes with insulin<br />

therapy treatment, for which<br />

specialist doctors were interviewed<br />

about various aspects of the pathology,<br />

for the duration of a ride by<br />

car. There are also some more videos<br />

testifying patients that cohabit<br />

every day with diabetes, as well<br />

as a webcast with all of the specialists<br />

involved. For Daiichi Sankyo,<br />

I’m presently working on an<br />

awareness project on hypercholesterolemia,<br />

quite a difficult challenge<br />

for a very special target. In<br />

the field of scientific training, I’m<br />

developing a project I’m very fond<br />

of: making ECM course much more<br />

interactive, by creating augmented<br />

reality contents, for example.<br />

Which further evolutions can we<br />

expect in the chemical-pharma<br />

and cosmetic industry?<br />

So many, because every company is<br />

increasingly becoming also the editor<br />

of its contents. Thus, we’ll assist<br />

in the future to the birth of entertainment<br />

formats and integrated<br />

communication platforms dedicated<br />

to therapeutic support. Roche, for<br />

instance, has already dedicated an<br />

online portal to diabetes, while our<br />

company, with Servier Italy, expressly<br />

created a sketchcom about therapeutic<br />

practice. It is the first time<br />

that a pharma company becomes the<br />

producer of an educational comic TV<br />

series wholly dedicated to prevention.<br />

We called this new genre “Medicom”,<br />

standing for Medical Comedy.<br />

We are presently working for Novo<br />

Nordisk on a web series about dia-<br />

Dario Nuzzo<br />

is a freelancer<br />

author and<br />

journalist<br />

specialising in<br />

branded content<br />

and branded<br />

entertainment<br />

in the chemicalpharma<br />

field www.<br />

darionuzzo.<br />

com/pharma<br />

September/October <strong>2020</strong><br />

RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA icf 17


Trends<br />

On the set<br />

of “Chronic<br />

impatients”,<br />

the educational<br />

sketchcom<br />

produced<br />

for Servier Italy<br />

A shoot from<br />

LeniCup fields,<br />

the 11-a<br />

side under<br />

13 football<br />

tournament<br />

organised by<br />

Polisportive<br />

Giovanili<br />

Salesiane and<br />

supported<br />

by Eg SpA with<br />

Lenirit brand<br />

betes that is entirely set in a digital<br />

context, also to cope with the Covid-19-related<br />

problems on sets.<br />

Then, cosmetics as well is developing<br />

products that increasingly include a<br />

“digital extension”: I wrote about it<br />

on Grazia magazine in the wellbeing<br />

section with the article “The face of<br />

the future”, little time ago.<br />

Thus, also the pharma industry will<br />

produce entertainment in some<br />

ways…<br />

It may seem strange, but certainly<br />

yes! Branded entertainment is the<br />

next frontier. And it won’t be only<br />

an interactive experience at an<br />

exhibition stand to impress visitors,<br />

but something directly involving<br />

people. I know EG SpA supported,<br />

with the Lenirit brand a whole<br />

football tournament organized with<br />

Polisportive Giovanili Salesiane to<br />

raise awareness to first aid and fair<br />

play values. In 2010 I had a very<br />

successful test experience with Euticals,<br />

developing Favolé, an awareness<br />

project for Lombardy-based<br />

schools. Who knows what else<br />

awaits us tomorrow.<br />

From what I read, you are fond of<br />

educational entertainment. For instance,<br />

if I say Pinocchio?<br />

With Pinocchio I have a challenging<br />

but very satisfying relationship,<br />

that has been lasting for 12 years<br />

now. I started collaborating with<br />

Collodi Foundation, the body dealing<br />

with the protection of the work,<br />

in 2008 and since then we’ve developed<br />

many projects also involving<br />

design companies, schools and<br />

brands. The latest-one last year: I<br />

designed an immersive path at Collodi<br />

park, the Pinocchio’s park, where<br />

you can relive the tale in a digital<br />

mode. In the pharma world instead,<br />

Pinocchio already engaged himself<br />

to raise awareness about good eye<br />

hygiene practices with an educational<br />

project developed for Bausch&Lomb<br />

“Occhio Pinocchio, Viaggio<br />

nel paese di BeiOcchi”.<br />

In your past, there is also the children’s<br />

TV…<br />

Yes. I started by creating a format<br />

for children, Mukko Pallino, on local<br />

broadcasters and then I had the luck<br />

to look after musical animated videos<br />

of great classics for children, such<br />

as “Le tagliatelle di nonna Pina”, “44<br />

gatti”, “Il gatto puzzolone” that had<br />

millions visualizations on YouTube,<br />

until working at Mediaset as author<br />

and host. But this is another story.<br />

Let’s make a practical example.<br />

What about requiring such a project?<br />

Do companies go directly to<br />

you?<br />

In reality, companies express a “sentiment”<br />

to their agencies, i.e. they<br />

aim at moving their patients focusing<br />

on different subjects that are<br />

strictly connected to the pathology<br />

to be treated. And that’s where<br />

I come in. The agency usually contacts<br />

me and after all relevant analysis,<br />

I write down the first concepts<br />

that then become scripts, screenplays<br />

and storyboards, always keeping<br />

in touch with the pharma company.<br />

According to you, the branded<br />

content in the pharma industry is<br />

without risks.<br />

On the contrary, behind the writing<br />

of every work, there is the huge spectrum<br />

of ethical communication, as it<br />

should be. Moreover I often collaborate<br />

with the International University<br />

research group Family and Media,<br />

subsequently ethics in communication<br />

for me, as well as a creed, is<br />

a responsibility. In the branded content<br />

web series for the pharma industry,<br />

you’ll never find specific products,<br />

but everybody works to increasingly<br />

approach the patient’s psychological<br />

condition, trying to offer him<br />

all the tools he needs to appropriately<br />

manage his pathology. <br />

18 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA


Trends<br />

Where personalized medicine<br />

is already effective<br />

In modern medicine, tailor-made therapies<br />

are becoming increasingly important.<br />

Tangible successes are already evident in HIV<br />

and cancer. According to vfa (Verband der<br />

forschenden Pharma-Unternehmen – the German<br />

association of research-based pharmaceutical<br />

companies), some 67 drugs are currently being<br />

used in a “personalized” manner in Germany.<br />

Photo by Messe<br />

München GmbH<br />

medicine<br />

is the medicine of the<br />

future,” says Dr. Richard<br />

Mitreiter, Head of<br />

“Personalized<br />

Department at the<br />

German Aerospace Center (DLR), Project<br />

Management Health for the Federal<br />

Ministry of Education and Research<br />

(BMBF). The ongoing rapid technological<br />

development in life sciences, biomedicine<br />

and information technology<br />

has opened up fascinating perspectives<br />

for the development of novel treatment<br />

approaches that are optimized for individuals<br />

and specific patient groups.<br />

“The challenge of the coming decade<br />

is to develop sustainable solutions for<br />

clinical practice and marketable product<br />

innovations from the many-faceted<br />

results of research. This also includes<br />

finding suitable models for reimbursement<br />

in the healthcare system<br />

and developing the regulatory framework<br />

further,” explains Mitreiter. “Since<br />

2013, the Federal Ministry of Education<br />

and Research – the BMBF – has invested<br />

some 360 million euros from project<br />

funding and significant amounts<br />

from institutional funding into personalized<br />

medicine, and will continue to<br />

support this.”<br />

Diagnosis and therapy in tandem<br />

“Personalized medicine has advanced<br />

rapidly in recent years. The prerequisite<br />

for this was the mapping and decoding<br />

of the genome,” asserts Dr. Martin Walger,<br />

Managing Director of the German Diagnostics<br />

Industry Association (VDGH).<br />

The decoding of the human genome and<br />

the resulting possibilities of modern ge-<br />

20 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA


Trends<br />

netic diagnostics have significantly accelerated<br />

this trend. Standardized therapy<br />

concepts have so far often been<br />

aimed at overall patient groups, without<br />

taking into account the health status<br />

of each individual and his or her<br />

physical condition, and without differentiation<br />

according to age and sex. Accordingly,<br />

drugs and therapies for identical<br />

diseases would show differing degrees<br />

of efficiency, ranging from highly<br />

efficient to completely ineffective.<br />

Hence, today’s medical research focuses<br />

on the development of new types<br />

of individual-oriented diagnostic procedures<br />

and innovative drugs for bespoke<br />

treatment approaches.<br />

Oncological patients in particular benefit<br />

from the fact that companion diagnostics<br />

provide important information<br />

before and during treatment: this information<br />

enables a tailored therapy approach<br />

and shows whether a drug is or<br />

is not suitable and effective. “Molecular<br />

genetic methods such as next-generation<br />

sequencing (NGS) technologies<br />

can now be used to create comprehensive<br />

tumor profiles or even entire genome<br />

sequencings in a short time,” explains<br />

Walger. For this reason, individualized<br />

or “personalized” treatment<br />

methods are already being successfully<br />

used today in diagnostics and therapy<br />

for breast and colon cancer. In the case<br />

of colorectal cancer, for example, a genetic<br />

test on a tissue sample from the<br />

tumor can now be used to determine<br />

exactly which drugs are suitable for a<br />

particular patient, and which are not.<br />

Personalized therapies also yield treatment<br />

successes in the case of HIV-induced<br />

immunodeficiency and certain<br />

infectious diseases such as hepatitis.<br />

Modern diagnostics not only provides<br />

the pre-tests necessary for successful<br />

application of personalized medicine,<br />

but also enables increasingly better<br />

differential diagnosis. Today, six genotypes<br />

of hepatitis C viruses can already<br />

be distinguished in the laboratory.<br />

Use in oncology<br />

Personalized medicine has had its<br />

greatest successes so far in oncology,<br />

where personalization is of particular<br />

importance for efficient treatment.<br />

Cancer cells arise through mutations.<br />

However, not all cancers are the same.<br />

In tumor tissues from different patients<br />

with the same type of cancer, the mutations<br />

found are yet not necessarily the<br />

same. However, whether certain therapies<br />

are effective or not depends on<br />

the mutations. Immunoglobulins such<br />

as the monoclonal antibodies cetuximab<br />

(trade name Erbitux; Eli Lilly, Bristol-Myers<br />

Squibb, Merck) or panitumumab<br />

(trade name Vectibix; Amgen)<br />

can be effective in advanced colorectal<br />

cancer only if the KRAS gene has not<br />

mutated yet. A genetic test can now be<br />

used to determine by taking a tissue<br />

sample from the tumor whether or not<br />

the drugs are effective for the particular<br />

patient. Thanks to tissue diagnostics,<br />

tumors and metastases can be precisely<br />

identified in oncology, which enables<br />

more precise monitoring and opens up<br />

prospects for tailored treatment.<br />

Knowledge of the genetic data enables<br />

earlier and more precise diagnosis,<br />

more effective prevention, and optimized<br />

treatment. Here it is important<br />

to elucidate and understand the<br />

processes in the body. In this way, the<br />

mechanisms of action of relevant drugs<br />

can be specifically determined in order<br />

to develop tailor-made therapies. Successes<br />

with personalized therapy approaches<br />

have been achieved in breast,<br />

colon and lung cancer, as well as in rare<br />

malignant tumor diseases such as mantle<br />

cell lymphoma.<br />

Breast cancer patients whose tumor<br />

cells overexpress the special growth<br />

factor receptor HER2 can be treated<br />

with anti-HER2 therapy (trade names<br />

Herceptin, Perjeta; Roche) based on<br />

the active ingredients trastuzumab or<br />

pertuzumab.<br />

Certain lung cancers can also be treated<br />

with targeted drugs. For example, in<br />

some non-small cell lung tumors, the<br />

active ingredient erlotinib (trade name<br />

Tarceva; Roche) can be used to inhibit<br />

the EGFR gene, which shows specific<br />

mutations in lung cancer. The ALK mutation<br />

that is frequently found in nonsmall<br />

cell lung cancer can likewise be<br />

treated with the targeted drug alectinib<br />

(trade name Alecensa; Roche).<br />

The battle against Parkinson’s and<br />

Alzheimer’s diseases<br />

In addition to the wide application<br />

range of personalized medicine in personalized<br />

cancer therapy, personalized<br />

High-tech<br />

lab: Analytical<br />

technology is<br />

an important<br />

source of<br />

impulses for<br />

the tailor-made<br />

development<br />

of active<br />

substances.<br />

(Photo by<br />

Messe München<br />

GmbH)<br />

September/October <strong>2020</strong><br />

RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA icf 21


Trends<br />

Photo by EBM+<br />

diagnosis is also used against Parkinson’s<br />

and Alzheimer’s diseases, as well<br />

as in the field of intestinal microbiology<br />

and personalized hearing support.<br />

The therapeutic options for Parkinson’s<br />

disease address the causal chain in order<br />

to detect causally involved molecular<br />

defects on the one hand, and to<br />

study pathological -synuclein species<br />

and their propagation on the other.<br />

-synuclein (encoded by the SNCA<br />

gene) is a transport protein in the brain<br />

that regulates the release of dopamine.<br />

Mutations in the SNCA gene are responsible<br />

for certain inheritable forms of<br />

Parkinson’s disease. The drugs available<br />

today can only protect the dopaminergic<br />

nerve cells from damage and<br />

thus halt the progression of the disease.<br />

Hopes are pinned on research into the<br />

antioxidant coenzyme Q10, which may<br />

be of particular benefit to patients with<br />

impaired mitochondrial function.<br />

Research into new anti-Alzheimer drugs<br />

also enjoys high priority in the pharmaceutical<br />

industry. However, the success<br />

rate is sobering. Nevertheless, the<br />

important finding has been made that<br />

treatment with drugs for slowing down<br />

or prevention must be started very early.<br />

This has become possible because<br />

both -amyloid and tau fibrils, two different<br />

protein compounds characteristic<br />

of Alzheimer’s disease, can now be<br />

detected using non-invasive imaging<br />

techniques. These two protein deposits<br />

disturb communication in and between<br />

the nerve cells to such an extent<br />

that the nerve cells die. This<br />

is because Alzheimer’s disease<br />

alters degradation of<br />

the amyloid precursor protein<br />

found in the organism.<br />

The -amyloid proteins thus produced<br />

in the course of the disease accumulate<br />

as toxic oligomers and lump<br />

together to form insoluble deposits between<br />

the nerve cells. These so-called<br />

-amyloid plaques, also known as<br />

Alzheimer plaques, can then no longer<br />

be broken down by the body.<br />

The tau protein in turn helps to form<br />

microtubules in healthy cells and is<br />

thus responsible for the stability and<br />

nutrient supply of the cells. In Alzheimer’s<br />

disease, the tau protein is chemically<br />

altered so that it is deposited in<br />

the form of fibers, the so-called tau fibrils.<br />

As a result, the diseased nerve<br />

cells lose their shape and function until<br />

they decay. Drugs with active ingredients<br />

such as aducanumab (Biogen),<br />

solanezumab (Eli Lilly) or gantenerumab<br />

(Roche), which are designed to prevent<br />

and reduce formation of plaques,<br />

are in the test phase and await marketing<br />

authorization. Therapeutic active<br />

vaccines to be administered concomitantly<br />

with the actual treatment<br />

are also in the trial phase in the fight<br />

against Alzheimer’s disease.<br />

Predicting strokes<br />

“Predictive stroke modeling enables<br />

person-related prediction of strokes,<br />

since it integrates multidisciplinary<br />

sources such as genomics, biochemistry,<br />

social issues, lifestyle, sex, or the<br />

working environment,” explains VDGH<br />

Managing Director Walger. “One recent<br />

achievement is the liquid-biopsy<br />

method.” The latter enables detection<br />

of circulating tumor cells or tumor<br />

DNA in the blood. This requires highly<br />

sensitive detection methods such as<br />

advanced polymerase chain reaction<br />

(PCR) and next-generation sequencing<br />

(NGS) technologies. “In the next few<br />

years, liquid biopsies are likely to become<br />

more and more important alongside<br />

conventional biopsies, i.e. sampling<br />

of tissue and its histopathological<br />

examination, also because they are<br />

less invasive for the patient,” says Walger.<br />

Liquid biopsies can be used for early<br />

detection of tumors in screening, for<br />

therapy monitoring, or for estimating<br />

an individual risk of metastasis.<br />

Bioanalysis as stimulator<br />

Pivotal for these medical successes are<br />

high-resolution analysis as well as biotechnological<br />

and chemical research.<br />

Biotechnological advances in particular<br />

are important for novel developments<br />

in the drug discovery field of<br />

pharmaceutical research and point-ofcare<br />

diagnostics.<br />

Efficient development of highly effective<br />

substances is possible only in high-tech<br />

laboratories with powerful automated<br />

analysis systems and high-throughput<br />

sequencing. Analytical technology<br />

is an important source of impulses for<br />

the tailor-made development of active<br />

substances. Target-oriented studies of<br />

drug interactions and target binding of<br />

active ingredients would not be possible<br />

without automated procedures such<br />

as high-throughput screening and biotechnological<br />

methods.<br />

Modern analysis and molecular genetics<br />

methods make it possible to elucidate<br />

genetic and biological processes,<br />

demystify molecular structures and<br />

switch points, and understand the<br />

mechanisms of gene expression in order<br />

to successfully apply targeted individualized,<br />

tailor-made therapeutic<br />

concepts. A key role is played by disease-specific<br />

biomarkers that provide<br />

scientists with meaningful information<br />

about the type, molecular cause, and<br />

status of the disease. “The diagnostics<br />

industry is cooperating closely with the<br />

pharmaceutical industry on research in-<br />

22 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA


Trends<br />

to biomarkers and the development of<br />

corresponding tests, which are a prerequisite<br />

for personalized medicine,”<br />

adds VDGH Managing Director Walger.<br />

As a result, targeted therapies can<br />

be initiated for various types of cancer,<br />

such as breast, colon or lung cancer,<br />

and for HIV, significantly increasing<br />

the success of treatment.<br />

Personalized gene therapies, regenerative<br />

medicine, tissue engineering and<br />

bioprinting likewise open up new paths<br />

in tissue and organ research. Functional<br />

organ structures from so-called biofabrication<br />

for intelligent therapies are<br />

based on the use of tailor-made biomaterials<br />

such as functional peptides, and<br />

allow novel individual treatment methods.<br />

It is thus possible to grow certain<br />

cell cultures and tissue structures<br />

in culture and nutrient media for use<br />

as implants in orthopedic, plastic and<br />

cardiovascular surgery. Human in-vitro<br />

models based on human cells, in particular<br />

from the human liver, are already<br />

being developed by Hepacult.<br />

The potential of personalized<br />

medicine<br />

The member surveys of the VDGH show<br />

that personalized medicine has gained<br />

importance for more and more companies<br />

in the in-vitro diagnostics (IVD) industry.<br />

While in 2016 there were about<br />

27 percent of the IVD companies surveyed<br />

active in this field, the share<br />

had grown to more than 61 percent by<br />

2019, and the trend is still upwards.<br />

“Researchers predict that in the future<br />

most types of cancer will be diagnosable<br />

at an early stage thanks to genetic<br />

blood tests,” says Walger. “A prerequisite<br />

for this is development of validated<br />

biomarkers with high sensitivity<br />

in order to be able to detect the<br />

disease in the pre-symptomatic stage.<br />

This is one of the tasks and challenges<br />

the life science and diagnostics industries<br />

are working on. On the therapeutic<br />

side, developments in immunoncology,<br />

cell therapy and gene therapy are decisive<br />

fields in which a great deal is already<br />

happening today and will be even<br />

more so in the next five to eight years.”<br />

According to the VDGH, progress has<br />

been made in recent years in the reimbursement<br />

of companion diagnostics<br />

by statutory health insurance. “If<br />

use of a medicinal product requires prior<br />

testing, a remuneration figure for the<br />

test procedure must be agreed upon in<br />

due time. This automatism promotes<br />

implementation of personalized medicine<br />

outside the inpatient setting,” explains<br />

Walger.<br />

Digitization and data management<br />

are a key to success<br />

Computer-aided drug design and<br />

next-generation ultra-high-throughput<br />

methods generate gigantic amounts of<br />

data very quickly. Here, digitization creates<br />

the necessary basis for meaningful<br />

evaluations and efficient data management<br />

for biobanks, peptide libraries,<br />

or patient data. Further successes<br />

in personalized medicine will crucially<br />

depend on digitization. Innovative<br />

and fast technologies that enable ever<br />

more precise diagnostics in ever shorter<br />

times generate enormous quantities<br />

of data that need to be stored, analyzed<br />

and intelligently merged. “With<br />

each data set, the understanding of diseases<br />

improves, patterns can be recognized,<br />

and indications for new treatment<br />

strategies can be derived. This<br />

means an enormous transfer effort. Intelligent<br />

information and data management<br />

- and this also includes the possibility<br />

of using data from care reality<br />

- are the prerequisite for this,” according<br />

to Walger.<br />

Laboratory<br />

equipment at<br />

the analytica:<br />

Effective<br />

and precise<br />

diagnostics<br />

is ultimately<br />

the crucial<br />

prerequisite for<br />

more treatment<br />

successes<br />

in personalized<br />

medicine<br />

(Photo by<br />

Messe München<br />

GmbH)<br />

September/October <strong>2020</strong><br />

RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA icf 23


Trends<br />

Next-generation technologies<br />

at analytica<br />

Next-generation technologies from biological<br />

and genetic research, diagnostics<br />

and analysis are the pacemakers<br />

for Personalized Medicine. The latest<br />

trends from these areas will be<br />

presented to the experts at analytica<br />

<strong>2020</strong>. The trade fair comprehensively<br />

presents cutting-edge technologies<br />

and future-oriented methods. To discuss<br />

their experiences, international<br />

experts and the global players meet in<br />

Munich, where the know-how of the industry<br />

and the latest state of the art will<br />

be exemplified.<br />

The user is presented with well-structured<br />

and comprehensive practical<br />

system solutions, which allow shorter<br />

analysis and test times as well as<br />

better interpretation possibilities of<br />

the measurement results and central<br />

availability of meaningful data<br />

to be achieved. New diagnostic possibilities<br />

and individual therapies are<br />

possible only through novel molecular<br />

genetic methods, as presented at<br />

analytica. Effective and precise diagnostics<br />

is ultimately the crucial prerequisite<br />

for more treatment successes<br />

in personalized medicine. <br />

Source: analytica - Messe München<br />

Analytica <strong>2020</strong> gets a digital extension<br />

With the new format analytica virtual,<br />

the world’s leading trade fair for laboratory<br />

technology, analysis and biotechnology<br />

also enables those exhibitors<br />

and visitors to participate who<br />

due to travel restrictions cannot come<br />

to Munich. In addition, parts of<br />

the analytica supporting program will<br />

be available in digital form. analytica<br />

virtual will supplement the classic a-<br />

nalytica in Munich (October 19 to 22),<br />

but will be open for one day longer.<br />

With this complementary offering, a-<br />

nalytica underscores its importance<br />

as the most important platform for the<br />

industry: Even in the year of the corona<br />

crisis, it will present the decisive<br />

innovations to a global audience and<br />

facilitate exchange between experts.<br />

“It is our aspiration to host the most<br />

important platform for the laboratory<br />

industry worldwide. We are<br />

pleased that even in these difficult<br />

times we can offer our customers<br />

the trade fair experience that is optimal<br />

for them – either on-site in Munich<br />

or virtually via our new digital<br />

platform,” says Dr. Reinhard Pfeiffer,<br />

Deputy Chairman of the Management<br />

Board of Messe München.<br />

As part of analytica, analytica virtual<br />

will be an online trade fair with<br />

virtual exhibition booths. There, visitors<br />

can view product presentations,<br />

Photo by Messe München GmbH<br />

download flyers, and contact the respective<br />

exhibitor directly via a text,<br />

audio and video chat function. The<br />

virtual trade fair will be open 24 hours<br />

a day from October 19 to 23, <strong>2020</strong>.<br />

Product novelties and product innovations<br />

from all fields of laboratory and<br />

analytical technology for the target industries<br />

of chemistry, biotech, pharmaceuticals<br />

and foodstuffs are going<br />

to be presented. In addition, webinars<br />

and parts of the classic analytica supporting<br />

program are to be made available<br />

via the platform. Important events<br />

will be repeated at different times of<br />

the day to reach interested parties in<br />

distant time zones as well. One of a-<br />

nalytica’s highlights, the special show<br />

Digital Transformation, will be present<br />

both in Munich and at analytica virtual.<br />

The show illustrates the state of laboratory<br />

automation in a presentation<br />

that is unique in the world.<br />

Messe München is hosting analytica<br />

virtual in collaboration with Lumitos<br />

AG. “I am very pleased that<br />

Messe München and Lumitos a-<br />

re combining their many years of<br />

experience in specialist trade fairs<br />

and B2B online portals in the context<br />

of analytica virtual. This creates<br />

an unprecedented trade fair experience<br />

for visitors and exhibitors<br />

from all over the world, with completely<br />

new opportunities and outreach,”<br />

says Lumitos’s Managing<br />

Director Stefan Knecht.<br />

Concomitantly with analytica virtual,<br />

the classic analytica will take place<br />

at the exhibition grounds in Munich<br />

from October 19 to 22. In order to<br />

ensure the safety of all participants,<br />

Messe München is implementing a<br />

protection and hygiene concept a-<br />

dopted by the Bavarian state government,<br />

which is based on rules that<br />

currently also apply in many areas of<br />

daily life (supermarkets, catering). In<br />

China, Messe München has already<br />

demonstrated that even in the times<br />

of COVID-19 safe, attractive and e-<br />

conomically successful industry platforms<br />

are possible: On the first weekend<br />

of July it successfully hosted<br />

four major trade fairs in Shanghai.<br />

LASER World of PHOTONICS CHI-<br />

NA alone registered 57,135 visitors<br />

from the field and 819 exhibitors.<br />

24 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA


QUALITY SYSTEM CERTIFICATION<br />

Gaskets for flanges<br />

5211 Jointex ® red<br />

High quality jointing<br />

sheet made with pigmented,<br />

quartz fillers.<br />

5212 Jointex ® blue<br />

High quality jointing<br />

sheet made of PTFE<br />

with pigmented glass<br />

sphere fillers.<br />

5213 Jointex ® white<br />

High quality sheet jointing<br />

made of modified<br />

PTFE filled by 25% with<br />

glass fibres.<br />

5214 Jointex ® micro<br />

High quality sheet jointing<br />

made of modified<br />

PTFE filled with micro<br />

spheres microspheres<br />

of glass.<br />

5215 Jointex ® black<br />

High quality joint made<br />

of modified PTFE containing<br />

2% of a special<br />

carbon mix.<br />

5700 FEP O-Ring in FEP<br />

The Texpack ® PTFE O-Rings, also called<br />

toroidal seals, consist of a moulded<br />

vulcanized round section ring.<br />

5500 Texlon ® self-adhesive<br />

soft tape<br />

A self-modelling gasket tape made of<br />

soft and flexible non-sintered expanded<br />

100% PTFE.<br />

Ask for the new<br />

catalogue<br />

GASKETS<br />

to our<br />

customer service<br />

ISO 9001<br />

Texpack ® srl - unipersonale - Via Galileo Galilei, 24 - 25030 Adro (BS) Italia<br />

Tel. +39 030 7480168 - Fax +39 030 7480201 - info@texpack.it - www.texpack.it


Safety<br />

On the trail of the future<br />

The expansion on the<br />

emerging markets. The<br />

reinforcement of the<br />

partnership with IMA,<br />

for inspection, track&trace<br />

and smart data management.<br />

The TrackMyHealth platform<br />

to support companies in the<br />

post-Covid19 challenge.<br />

The software AVionics for<br />

the maximum efficiency<br />

of the production processes.<br />

The <strong>2020</strong> of Antares Vision<br />

is full of enthusiastic results<br />

and encouraging goals.<br />

For Antares Vision <strong>2020</strong> – quoted<br />

at AIM Italia and global<br />

leader in the complete<br />

process of protecting products<br />

throughout their life-cycle<br />

by delivering quality control inspection<br />

systems, track&trace solutions<br />

for the control of the supply<br />

chain, smart data management for<br />

production efficiency and consumer<br />

involvement in all the most demanding<br />

industries, including the pharma,<br />

biomedical devices, food and beverage,<br />

cosmetics and fashion – started<br />

with a very ambitious goal: focusing<br />

on the expansion on emerging<br />

markets, such as Brazil, Russia,<br />

China, India, South America and<br />

South Eastern Asia, geographical areas<br />

where in 2019, the company already<br />

based various headquarters to<br />

expand its business.<br />

Inspection systems: the collaboration<br />

with IMA consolidated<br />

Antares Vision is increasingly aiming<br />

at global markets and has just inau-<br />

gurated a partnership with IMA, one<br />

of the Italian world packaging leaders,<br />

with which Antares Vision has<br />

been collaborating for over 20 years,<br />

starting when it still had a different<br />

name. Based in Bologna, Ima,<br />

in fact, confirmed the collaboration<br />

with Antares through a 5-year agreement<br />

for implementation of innovative<br />

solutions through a unique and<br />

complete platform to integrate the<br />

supply of inspection systems with<br />

smart data track&trace and management<br />

along the whole supply chain.<br />

The agreement with IMA will allow<br />

Antares to penetrate new sectors<br />

more quickly, consistently with its<br />

mission to export its high-value offering<br />

into high-potential sectors,<br />

beyond pharmaceuticals. Two global<br />

leaders promoting the digitization<br />

of the supply chain, with the applications<br />

of the future: from automation,<br />

to interconnection, through to<br />

smart data management, to guarantee<br />

Trustparency® – the transparency<br />

that generates trust.<br />

26 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA


Safety<br />

Better skills in serialization software<br />

systems<br />

The acquisition on 10th April <strong>2020</strong> of<br />

Tradecity d.o.o., a company founded<br />

in Zagabria (Croatia) in 2017 and specialized<br />

in the software management<br />

of advanced traceability processes<br />

(serialization) falls within the framework<br />

of the strategy of extending Antares<br />

Vision’s geographical presence<br />

also in Eastern Europe –to strengthen<br />

internal resources for the development<br />

of traceability and serialization<br />

software solutions, dedicated to all<br />

the different players in the pharmaceutical<br />

supply chain (distributors,<br />

CMOs, 3PLs, …), up to the regulatory<br />

bodies, thereby enhancing data<br />

management and interconnection.<br />

Safer companies and commercial<br />

services with TrackMyHealth<br />

During Covid19 sanitary emergency,<br />

that starting from China engulfed the<br />

whole world, the Brescia-based company<br />

not only by birth, but also by<br />

character, has certainly not shied<br />

away from its responsibilities, and<br />

exploiting its know-how in digital<br />

health, launched the TrackMyHealth<br />

platform to help companies and commercial<br />

services to face Phase 2 and<br />

3 in full safety. “In this process of<br />

drug and treatment dispensing renewal<br />

that also aims at reducing the<br />

huge costs of health management –<br />

Emidio Zorzella, Antares Vision President<br />

and CEO comments – we offered<br />

this portal very quickly: its purpose is<br />

to facilitate phase 2 and 3 to recover<br />

the ordinary life as soon as possible.<br />

The portal’s primary purpose is to<br />

check the body temperature of people<br />

entering a big building, including<br />

theaters, malls and so on through a<br />

thermal imaging camera and without<br />

the need of a person appointed to do<br />

so. It is a kind of “electronic steward”<br />

considering that, as well as temperature,<br />

it also checks people wearing<br />

the mask and behaviours that take into<br />

account social distancing. In practice<br />

the portal interfaces with the video<br />

surveillance systems that are already<br />

present in the buildings, as well<br />

as with systems equipped with automatic<br />

badges”. In a period of profound<br />

upheavals that unavoidably have led<br />

to a change in our way of living and<br />

intending sociality, the Antares Vision’s<br />

TrackMyHealth platform represents<br />

a sort of guarantor of transparency<br />

and trust towards citizens.<br />

Innovation and sustainability<br />

Yet, Antares Vision’s innovation,<br />

that has always represented a company<br />

value, is also focusing on environmental,<br />

economic and social sustainability<br />

with a medium-long term<br />

strategy aiming at ensuring the transparency<br />

of information along product<br />

distribution channel, for people’s<br />

safety and every product consumed,<br />

through systems that show information<br />

about product origin, with all<br />

due respect for sustainability. That is<br />

why, the company prepared programs<br />

to improve the energy efficiency of<br />

its facilities, as well as a growing<br />

use of renewable energies, eliminating<br />

the use of plastic as much as possible<br />

even in the offices (the company's<br />

participation to the #plasticfree<br />

campaign dates back to 2019, as well<br />

as to the #iosonoambiente project<br />

promoted by the Ministry of Environment<br />

with the elimination of disposable<br />

plastic bottles in favor of stainless<br />

steel bottles and the subsequent<br />

reduction of over 3,000 water bottles<br />

per month in the Travagliato-based<br />

headquarters). Paper was eliminated<br />

as well (for instance by digitalizing<br />

all of the documents including<br />

plant manuals). A platform for sorted<br />

refuse collection was activated,<br />

too. Within this framework, BNL recognized<br />

to Antares Vision’s sustainability<br />

program a special support of<br />

2 million euros to go on investing<br />

in projects and initiatives improving<br />

the company’s sustainable approach.<br />

Artificial intelligence<br />

The CEO specifically talks about the<br />

development plan envisaged for the<br />

next few years to focus on the renewed<br />

release of AVionics, the software<br />

that, through data collection,<br />

processing and management, even<br />

through AI algorithms, allows to get<br />

valuable information in real time,<br />

about the line, the plant and the<br />

company. The data intelligence landscape<br />

system works through a system<br />

of modules capable of collecting different<br />

types of data (from lines, ma-<br />

Massimo<br />

Bonardi (on<br />

the left) and<br />

Emidio Zorzella,<br />

Antares Vision<br />

co-founders<br />

Serialization<br />

of pharma<br />

products<br />

September/October <strong>2020</strong><br />

RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA icf 27


Safety<br />

Exploiting<br />

production<br />

smart data,<br />

Avionics<br />

software<br />

optimizes<br />

process<br />

efficiency<br />

in real time<br />

chinery, quality control) and to interconnect<br />

different equipment and<br />

machinery, as well as to be integrated<br />

into MES, ERP or other production<br />

management systems, for the purpose<br />

of monitoring performances and maximizing<br />

the results of a plant, manufacturing<br />

processes, and production<br />

skills thanks to an overall management<br />

of the generated data. AVionics<br />

monitors production status, instant<br />

and accumulated speed, overall<br />

equipment efficiency and camera<br />

performances. Its ergonomic dashboard<br />

reports the performances of<br />

all OEE production parameters in real-time.<br />

“Our data management solutions<br />

operate in real time alongside<br />

the production and quality processes<br />

and provide information on useful<br />

values to help guide future businesses<br />

- says Emidio Zorzella, CEO of<br />

Antares Vision –. A future, which is<br />

now marked by the digital transformation,<br />

with companies where all the<br />

relevant data are interconnected, aggregated,<br />

analyzed and used proactively,<br />

within a smart ecosystem. A<br />

data analysis that opens up unique<br />

opportunities and allows companies<br />

to be highly competitive, providing<br />

the best picture of market demands<br />

and maximizing business opportunities.<br />

A true production intelligence<br />

that offers a significant advantage to<br />

decision-makers thanks to the digitalization<br />

of their business, optimizing<br />

costs, improving quality, accelerating<br />

innovation and redefining the<br />

customer experience”.<br />

AVionics consists of five modules<br />

that can be implemented independently<br />

or in combination with<br />

each other to better collect and interpret<br />

data, with different purposes<br />

for each module.<br />

AVionics Performance: monitors<br />

productivity performance and KPIs,<br />

analyses and plans trends, is able to<br />

identify the best performance at line,<br />

plant and company level;<br />

AVionics Quality: collects data from<br />

quality controls through a statistical<br />

check of processes based on their<br />

quality and variability, capable of<br />

constructing models and trends in<br />

order to create predictive analyses;<br />

AVionics Manager: controls and optimises<br />

the entire production process<br />

(from the line or from the control<br />

room) thanks to a centralised storage<br />

that allows an exchange of input<br />

and output data and to make decisions<br />

based on occurring events;<br />

AVionics Maintenance: helps to improve<br />

performance by directing predictive<br />

and preventive system technical<br />

maintenance;<br />

AVionics Sustainability: collects electricity<br />

consumption data and specific<br />

parameters related to the environmental<br />

impact in order to reduce consumption,<br />

waste, improve ROI, document<br />

and improve the environmental<br />

profile of products.<br />

Thanks to AVionics, Antares Vision is<br />

able to design and implement new additional<br />

and tailor-made functionalities<br />

for all five modules. Furthermore,<br />

through artificial intelligence algorithms<br />

based on machine-learning processes,<br />

it can further enhance system<br />

accuracy and reliability over time. AVionics,<br />

in addition to the ease of installation<br />

and integrated connectivity that<br />

allows the software to adapt to existing<br />

systems on the production lines without<br />

affecting validation procedures and<br />

performance, therefore provides multiple<br />

benefits:<br />

• constant monitoring of the performance<br />

of processes and KPIs on all levels<br />

(lines, plants, company) through<br />

customizable and user-friendly dashboards,<br />

to achieve a constant and<br />

complete control in real time.<br />

• strategic support to coordinate<br />

all the production departments with<br />

targeted actions in real time, to plan<br />

and improve current and future activities,<br />

based on trends and history.<br />

• a continuous improvement through<br />

artificial intelligence that grants access<br />

to the information needed to<br />

quickly make decisions in order to<br />

keep production planning efficient;<br />

• a sustainable technology that helps<br />

companies reduce consumption and<br />

waste in order to increase ROI and<br />

improve the environmental impact of<br />

production.<br />

<br />

28 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA


Machines<br />

Contained milling process:<br />

an integrated know how<br />

Nuova Guseo’s containment systems are capable of combining<br />

the special attention paid to the needs of protection,<br />

with the high ergonomic level for the operator, concepts that<br />

characterize the configurations in the various areas of application.<br />

by Gherardo Marchini, Export Manager, Nuova Guseo<br />

High containment<br />

multi-chamber<br />

isolator for<br />

calibration and<br />

micronization<br />

activities<br />

The isolation technology in<br />

recent years is playing a role<br />

of growing importance, this<br />

is mainly due to the well-established<br />

trend, especially<br />

in the chemical and pharmaceutical<br />

field, to treat substance and/or develop<br />

molecules with high activity and<br />

toxicity (API, Active Pharmaceutical<br />

Ingredient - HPAPI, High Potency Active<br />

Pharmaceutical Ingredient), this<br />

in conjunction with the increased attention<br />

paid to the problem of security<br />

and protection: for the operator<br />

as well for the product and its immediate<br />

environment.<br />

There is no single standard for establishing<br />

the level of exposure to the<br />

substance acceptable to the operator;<br />

the most internationally used index<br />

are the OEL (Occupational Exposure<br />

Limit) and the OEB (Occupational<br />

Exposure Band).<br />

The index OEL defines the average<br />

concentration (g/m 3 ) of a substance<br />

measured for 8 hours in the air<br />

breathed by an operator in the work<br />

environment. Therefore the term<br />

"containment" refers to the process<br />

of input of a biological agent (i.e.<br />

active medicinal products, pathogens)<br />

or of another substance within<br />

a defined area.<br />

The index OEB (1, 2, 3, 4, 5) is assigned<br />

on the basis of the toxicity of<br />

a given substance in a pure state in<br />

order to a classification of the plants.<br />

Each OEB level corresponds to a range<br />

of OEL values, the so-called “containment<br />

pyramid” summarizes the various<br />

exposure levels and the associated<br />

risk, thanks to which it is possible<br />

to identify the most appropriate<br />

preventive measures and select devices<br />

and manufacturing processes more<br />

suitable for a given product.<br />

The design and manufacturing criteria<br />

of the Nuova Guseo isolators, in compliance<br />

with the international reference<br />

standards, provide for:<br />

• high degree of internal finish in<br />

order to avoid the accumulation of<br />

treated substances while the control<br />

of air flows minimizes the contact of<br />

the product with the internal surface<br />

of the processing chambers; all this in<br />

order to facilitate cleaning operations<br />

when changing the product;<br />

• internal washing devices with relative<br />

draining bottom in which the<br />

30 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA


Machines<br />

contaminated liquid is conveyed;<br />

• ergonomic design for easy access to<br />

all internal surfaces and to the work<br />

areas in relation to the process performed<br />

in them (possibility of performing<br />

ergonomic tests on simulacrum<br />

- mock up test);<br />

• use of glove ports, of variable shape<br />

and size, made of different materials,<br />

suitable for easy replacement of the<br />

gloves maintaining the integrity of<br />

the system;<br />

• use of gloves of different sizes and<br />

materials in relation to operational<br />

needs, the characteristics of the<br />

washing solvents used and the product<br />

to be handled;<br />

• use of high efficiency filters of different<br />

types (screwed, push-through,<br />

push-push, bag in bag out), which<br />

can be replaced in safe conditions for<br />

the operator;<br />

• prearrangement for the installation/integration<br />

of product transfer<br />

systems, process tools and discharge<br />

of waste material (continuous liner,<br />

RTP, split valve, etc.);<br />

• appropriate instrumentation and<br />

alarm signaling according to operational<br />

and safety requirements;<br />

• variously implementable control<br />

systems; from the basic configurations<br />

for controlling the internal negative<br />

pressure regime and any interlocks,<br />

up to the more sophisticated<br />

solutions with PLC and GAMP 5 - CFR<br />

21 compliant software;<br />

• safety tests: leak test as per ISO<br />

10648-2, helium test.<br />

Nuova Guseo’s containment systems<br />

are capable of combining the special<br />

attention paid to the needs of<br />

protection, with the high ergonomic<br />

level for the operator, concepts<br />

that characterize our configurations<br />

in the various areas of application,<br />

such as: loading and unloading of reactors<br />

and filters dryers, centrifugal<br />

discharge, laboratory analytical ac-<br />

tivities, weighing and dispensing and<br />

much more.<br />

In this context the consolidated knowhow,<br />

both in the milling and containment<br />

sectors, has enabled Nuova Guseo<br />

to fully understand the critical<br />

process safety aspects and problems<br />

related to the need to avoid environmental<br />

contamination by managing a<br />

milling process in a contained way,<br />

offering to the market perfectly integrated<br />

process solutions.<br />

We pay now particular attention to<br />

some examples of realized configurations<br />

that combine this integrated<br />

know-how in strict compliance with<br />

current Good Manufacturing Practices,<br />

and operating by important pharmaceutical<br />

companies around the world.<br />

Example of particular interest is represented<br />

by a multi-chamber isolator,<br />

for calibration and micronization activities,<br />

configured for a containment<br />

level in band 5 (OEB5).<br />

The system consists of a material inlet<br />

pre-chamber, a central chamber<br />

where the jetmill (our model M200),<br />

is housed connected with a screw<br />

feeder in a wall mounted configuration<br />

(motorization group outside the<br />

working chamber), increasing in thus<br />

the operating space within the same.<br />

The central chamber is connected to<br />

a double stage gas-solid separation<br />

chamber, with a bag filter “octopus”<br />

type in the upper section - equipped<br />

with pneumatic shaking for an effective<br />

product recovery action - and a<br />

lower section, with a double continuous<br />

liner system for the bagging and<br />

outlet of the processed product, ensuring<br />

the high containment performance<br />

required.<br />

The chambers work with different<br />

negative pressure setting, and the<br />

operating logic is highly automated<br />

and managed by PLC, the isolator is<br />

also inertized by nitrogen, with constant<br />

monitoring of the oxygen content<br />

present in the work chambers,<br />

in compliance with the project's AT-<br />

EX requirements.<br />

An aspect of particular interest is represented<br />

by the integration, in the<br />

central chamber, of a second milling<br />

device, a conical mill (our model<br />

Conical Mill CM<br />

100 and Jetmill<br />

M200 in isolator<br />

Multistage<br />

isolator with<br />

possibility<br />

to install<br />

a Jetmill M200<br />

and M300<br />

September/October <strong>2020</strong><br />

RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA icf 31


Machines<br />

Detail of the<br />

double stage<br />

gas-solid<br />

separation<br />

chamber<br />

Single-chamber<br />

isolator<br />

with switch<br />

tasking milling<br />

station<br />

CM100), also in a wall mounted configuration,<br />

used for the calibration of<br />

batches of product with inhomogeneous<br />

starting particle size, in order to<br />

optimize the subsequent phase of micronization<br />

by means of the jetmill.<br />

Another configuration for contained<br />

micronization activities (OEB 5 level)<br />

is always represented by a mul-<br />

ti-chamber isolator composed of a<br />

central processing chamber where the<br />

jetmill will be installed, connected<br />

with a screw feeder in a wall mounted<br />

configuration and a two-stage solid<br />

gas separation chamber. In this case,<br />

the product is entered through a suitable<br />

continuous liner device.<br />

Also in this configuration the lower<br />

section of the gas solid separation<br />

chamber is equipped with a double<br />

continuous liner system for the bagging<br />

and outlet of the processed product;<br />

the discharging cone is equipped<br />

with in-line sampler, in order to allow<br />

analytical checks on the product<br />

during processing. The peculiarity<br />

of this system is represented by<br />

the fact that the isolator, depending<br />

on the characteristics of the processing<br />

batch and the required capacity,<br />

can alternatively host two jetmills of<br />

different sizes (our models M200 and<br />

M300) within the appropriate housing<br />

in the working chamber, consequently<br />

the upper part of the solid<br />

gas separation chamber is configured<br />

to be able to install “octopus” filtration<br />

systems, with different filtering<br />

surfaces in relation to the size of<br />

the used jetmill.<br />

An example of the constant<br />

innovative process that characterizes<br />

our mission and the<br />

high degree of customization<br />

of our systems is represented<br />

by the multi-milling single-chamber<br />

isolator, for calibration<br />

and milling activities<br />

(OEB4 level).<br />

The system is in passive<br />

configuration, it<br />

means that it is not<br />

equipped with an autonomous<br />

ventilation<br />

system but is connected<br />

to an existing suction<br />

line. Pressure control<br />

inside the chamber<br />

takes place by means<br />

of a non-electric automatic valve. The<br />

product loading is carried out by a discharging<br />

piping line coming from a filter<br />

dryer, located in a room above the<br />

one where the multi-milling isolator is<br />

installed, and interfaced with an actuated<br />

dosing lobe valve.<br />

Inside the working chamber is installed<br />

a switch tasking milling station,<br />

consisting of two different and<br />

– according to the process requirements<br />

– easily interchangeable milling<br />

heads: a conical mill our model<br />

CM 100 and a hammer mill our model<br />

TB 80, driven by a common motorization<br />

group, located in a housing<br />

outside the working chamber. The<br />

product comes out by means of a special<br />

continuous liner device. The unit<br />

is also equipped with a pressurizable<br />

tank, side mounted, for the cleaning<br />

fluids.<br />

The functioning of the system is<br />

managed by means of a control system<br />

with PLC and GAMP 5 compliant<br />

software.<br />

Access to the internal devices after<br />

the decontamination activities is<br />

guaranteed by a wide opening front<br />

view, if the batch coming from the<br />

above filter dryer does not need to be<br />

milled, but simply bagged in protected<br />

conditions, the milling unit can be<br />

removed and replaced by a dedicated<br />

piping with relevant devices; further<br />

proof of the extreme operational flexibility<br />

of the proposed system.<br />

This equipment has been successfully<br />

subjected to the test SMEPAC (Standardized<br />

Measurement of Equipment<br />

Particulate Airborne Concentration),<br />

guideline issued by the ISPE (International<br />

Society for Pharmaceutical Engineering’s),<br />

for its particulate containment<br />

performance.<br />

The proven experience of the Nuova<br />

Guseo technical staff is explicit in<br />

combining the need for protection for<br />

the operator with the quality of the<br />

process carried out.<br />

<br />

32 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA


LINKEDIN / FACEBOOK / TWITTER / INSTAGRAM / YOUTUBE<br />

The Best ingredients for a reactive life<br />

#FaravelliIndustrialDivision<br />

ADDITIVI PER FERTILIZZANTI E FORMULATI FITOFARMACI / AUSILIARI PER LA DETERGENZA / TRATTAMENTO ACQUE /<br />

AUSILIARI PER INDUSTRIA TESSILE E CONCIARIA / ADDITIVI PER MATERIALI COSTRUZIONE E PER CERAMICA /<br />

ADDITIVI PER PITTURE, VERNICI ED INCHIOSTRI / ADDITIVI PER INDUSTRIA DEI LUBRIFICANTI E DEI GRASSI /<br />

ADDITIVI PER INDUSTRIA GALVANICA E DEL TRATTAMENTO DEI METALLI / ADDITIVI PER L’INDUSTRIA CARTARIA /<br />

MATERIE PRIME PER INDUSTRIA CHIMICA E CHIMICA-FARMACEUTICA / ADDITIVI PER MATERIE PLASTICHE<br />

VIA MEDARDO ROSSO, 8 - 20159 MILANO - WWW.FARAVELLI.IT - CHEMIE@FARAVELLI.IT


Instrumentation<br />

New Directions<br />

in the TOC Measurement<br />

In this report, the capabilities and limitations of direct UV oxidation<br />

are described, as well as the technical changes which were made on the<br />

Swan AMI LineTOC measuring device for improving the power of the UV<br />

reactor and thereby also the precision of the measuring device.<br />

2.1 Presentation of the Measurement<br />

Procedure<br />

After the first conductivity measureby<br />

Roger Schmid, Swan Analytical Instruments AG<br />

Figure 1:<br />

Schematic<br />

diagram of<br />

direct UV<br />

oxidation<br />

The quality specification for<br />

the water which is used in<br />

the production is especially<br />

high in the pharmaceutical<br />

industry. In order to guarantee<br />

the quality of the ultrapure water<br />

at all times, an increasing number of<br />

drug manufacturers are implementing<br />

an automated and continuous<br />

monitoring of the treatment plants<br />

and the ultrapure water circuits.<br />

Total Organic Carbon (TOC) serves as<br />

a gauge for the organic contamination<br />

in the water. Various procedures<br />

exist for oxidizing the organic carbon<br />

present and measuring the resultant<br />

carbon dioxide. Swan Analytical<br />

Instruments has been using the direct<br />

UV oxidation method from the<br />

outset. In this report, the capabilities<br />

and limitations of direct UV oxidation<br />

are described, as well as the<br />

technical changes which were made<br />

on the AMI LineTOC measuring device<br />

for improving the power of the<br />

UV reactor and thereby also the precision<br />

of the measuring device.<br />

1. Introduction<br />

The following methods for TOC determination<br />

are mainly found on the<br />

market today:<br />

Figure 1<br />

• Thermal decomposition with NDIR<br />

detection<br />

• UV-Persulphate decomposition<br />

with NDIR detection<br />

• UV-Persulphate decomposition<br />

with conductivity detection<br />

• Direct UV oxidation with conductivity<br />

detection<br />

Each of these procedures relies on the<br />

oxidation of the organic carbon that<br />

is present in the water and the subsequent<br />

measurement of the carbon<br />

dioxide produced by the oxidation.<br />

Each method has its specific pros and<br />

cons, depending on how the oxidation<br />

and measurement is technically<br />

implemented.<br />

2. Direct UV Oxidation<br />

Direct UV oxidation can be deployed<br />

for ultrapure water applications in<br />

the pharmaceutical industry, as the<br />

possible organic contamination only<br />

occurs in very small concentrations.<br />

However, prerequisite for the complete<br />

oxidation of the present organic<br />

carbon via UV radiation is an optimized<br />

UV reactor and the presence of<br />

the required measuring environment.<br />

34 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA


Instrumentation<br />

ment (Total inorganic Carbon; TIC) the<br />

sample enters the UV reactor whereby<br />

the organic carbon present in the water<br />

is oxidized and routed to the second<br />

conductivity measurement (Total<br />

Carbon; TC). From the conductivity<br />

difference between the two sensors,<br />

the TOC content is calculated according<br />

to the following formula:<br />

TOC = TC - TIC<br />

Figure 2<br />

Like every other method, the direct<br />

UV oxidation also has its inherent<br />

drawbacks:<br />

• Limited measuring range < 2 µS/<br />

cm at 20 °C / < 1 ppm TOC<br />

• Thermal effects influence the<br />

measurement<br />

• Insufficient reproducibility of the<br />

UV oxidation<br />

To avoid these drawbacks or minimize<br />

them, the following goals were<br />

focused on during the further de-<br />

velopment of the measuring device:<br />

• Stabilization of the thermal conditions<br />

in the device<br />

• Increased radiation density during<br />

oxidation<br />

• Optimization of the sample flow in<br />

the system<br />

2.2 Stabilization of Thermal Conditions<br />

Temperature has a significant influence<br />

on the conductivity measurement<br />

during direct UV oxidation.<br />

Correlating to the energy output<br />

of the UV lamp, the temperature<br />

of the water sample is heated<br />

by more than 10°C depending on<br />

the design. The temperature difference<br />

between the two conductivity<br />

sensors must be compensated. However,<br />

the compensation only constitutes<br />

an approximation. A heat exchanger<br />

is therefore upstream of the<br />

reactor to keep the differential as<br />

small as possible.<br />

With this measure, the temperature<br />

difference between the two measurements<br />

can be kept below 0.2 °C.<br />

This measure is especially effective<br />

for samples with low TOC values.<br />

2.3 Increase of Radiation Density During<br />

Oxidation<br />

The UV lamps used today (low pressure<br />

Hg quartz lamps) have a narrow<br />

temperature range in which they produce<br />

full power. The range is usually<br />

between 40 to 50°C. An operational<br />

temperature change of 10°C can<br />

result in a power loss of up to 20%.<br />

Figure 3<br />

It is therefore very important to keep<br />

the temperature of the lamp in the<br />

optimal range. Additional heating<br />

cartridges (C) or cooling units (depending<br />

on the application) enable<br />

very precise control of a target temperature<br />

of 42°C. This achieves maximum<br />

radiation intensity and thereby<br />

optimal and uniform oxidation.<br />

2.4 Optimization of the Sample Flow<br />

In the classical arrangement of the<br />

UV lamps and sample flow, the sample<br />

is directed around a light source.<br />

Scattering loss and reflections cannot<br />

really be avoided. Furthermore,<br />

accumulation of deposits on the directly<br />

irradiated side (and thereby<br />

a reduction of the radiation density)<br />

cannot be ruled out during longterm<br />

operation.<br />

Only through the direct pairing of<br />

the UV lamp and sample can these<br />

side effects be avoided. In the newly<br />

developed UV reactor, the sample<br />

is directed along the lamp. The maximum<br />

distance to the lamp is 8 mm<br />

and the thickness is only 0.5 mm.<br />

The closed design prevents scattering<br />

loss and the production of ozone.<br />

3. Pharmaceutical Application<br />

Devices which are deployed in pharmaceutical<br />

applications must pass a<br />

verification test (System Suitability<br />

Test; SST) in accordance with the<br />

standard Pharmacopoeia (USP 643 /<br />

EP 2.2.24). The UV lamps currently<br />

used for devices with direct UV<br />

oxidation have a service-life of 6<br />

Figure 2:<br />

Reactor with a<br />

heat exchanger<br />

and a heating<br />

cartridge<br />

A: Inlet Block;<br />

B: Heat<br />

Exchanger;<br />

C: Heating<br />

Cartridge;<br />

D & E:<br />

Conductivity<br />

Sensors;<br />

F: UV Reactor<br />

Figure 3:<br />

Cross section<br />

of a UV reactor<br />

September/October <strong>2020</strong><br />

RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA icf 35


Instrumentation<br />

Figure 4:<br />

AMI LineTOC<br />

analyser<br />

months. Each replacement requires<br />

a mandatory SST, thus at least two<br />

tests are needed per year.<br />

3.1 The Function Test as Assistant<br />

In addition to the time-consuming<br />

SST, there is also the need for regular<br />

inspections of the measurement device.<br />

Therefore, the AMI LineTOC has<br />

an automatic function test. The testing<br />

procedure is adapted to the wellknown<br />

SST and allows for the validation<br />

of the measuring device at user<br />

definable intervals. Highly concentrated<br />

solutions are used (sucrose<br />

and benzoquinone) which are stable<br />

up to 3 months. The solutions are diluted<br />

with the sample water at the<br />

time of the test, via the installed<br />

peristaltic pump. The basic functions<br />

of the instrument can thereby<br />

be easily checked without exterior<br />

intervention or modification.<br />

4. Conclusion<br />

Emphasis was placed on three areas<br />

during the further development of<br />

the TOC analyser. The stabilisation of<br />

the thermal conditions, the increase<br />

of the radiation density during oxidation<br />

and the optimisation of the<br />

material flow in the system. The introduced<br />

technical solutions have<br />

demonstrably improved the precision<br />

and accuracy of the direct UV<br />

oxidation. Furthermore, during the<br />

development the specific requirements<br />

of the pharmaceutical industry<br />

concerning the specifications of<br />

the calibration and verification were<br />

taken into account.<br />

All these technical innovations are<br />

contained in the presented measuring<br />

device, the AMI LineTOC, by<br />

Swan. The modern TOC analyser that<br />

is also ready to cope with the demands<br />

of the future.<br />

<br />

Technical news<br />

Flexible solution for serialization<br />

Laetus presents current solutions for the entire<br />

supply chain on the Internet, from inline<br />

quality control to the end customers’ engagement.<br />

Alongside the Modular X series, many<br />

further innovations are presented in the areas<br />

of vision inspection, device management,<br />

aggregation and Track & Trace. At each virtual<br />

station, a short film can be watched, explaining<br />

the respective system.<br />

The Modular X series is the first fully modular<br />

serialization system on the market. It<br />

convinces with its unique flexibility regarding<br />

the packaging sizes to be processed. The<br />

Modular X 1000-MV forms the basis, marking<br />

and verifying up to 400 folding boxes per minute<br />

with barcodes or plain text, depending<br />

on product size and quality. At belt speeds of<br />

up to 60 metres per minute, a mechanically<br />

forced guidance ensures that the secondary<br />

packaging with a maximum size of 120 x 100<br />

x 200 mm is precisely processed. The compact<br />

GMP design allows for easy operation, cleaning<br />

and maintenance.<br />

Format changes are fully automated and<br />

therefore reproducible, and they can be carried<br />

out in less than 60 seconds. This reduces<br />

refitting times and hazards of operator errors<br />

to a minimum, and it enables companies<br />

to react quickly to changing market requirements<br />

at any time while operating at a constantly<br />

high production output. The optionally<br />

available Tamper Evident module Modular X<br />

1000-TL furthermore applies up to 400 Tamper<br />

Evident labels per minute on two sides. The<br />

labels are applied at four possible positions<br />

(front or rear opening, top or bottom respectively)<br />

with an accuracy of 1 mm, which is also<br />

checked automatically. The electronically controlled<br />

high-speed ejection makes sure that<br />

incorrectly marked products are discharged.<br />

36 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA


Technical news<br />

High-quality stills with the ‘GFL Technology’ quality mark<br />

Lauda, the world market leader<br />

for constant temperature equipment<br />

and systems for precise<br />

temperature generation, has extended<br />

its laboratory technology<br />

product range with the Lauda<br />

Puridest stills product line.<br />

The devices with the ‘GFL Technology’<br />

quality mark produce an<br />

ultra-pure, low-gas, sterile and<br />

pyrogen-free distillate with very<br />

low conductivity. Puridest stills<br />

are used in bacteriological and<br />

medical sample preparation and<br />

also in the preparation of cell<br />

and tissue cultures. They are also<br />

used for cleaning and sterilization<br />

processes, buffer solutions<br />

and microbiological and<br />

analytical applications. The distillate<br />

complies with the DAB<br />

regulations and the specifications<br />

of international pharmacopoeias.<br />

Lauda Puridest stills also<br />

distill raw water of lower quality,<br />

separate pollutants, and reliably<br />

kill germs such as bacteria<br />

and viruses.<br />

Lauda Puridest stills are available<br />

throughout the world in four<br />

high-performance product lines<br />

with 14 single- or two-stage<br />

model variants in the form of<br />

stainless steel or glass stills. Depending<br />

on the model, the devices<br />

are equipped with a storage<br />

tank and produce 2 to 12 liters of<br />

distillate per hour with conductivities<br />

down to below 1.6 µS/<br />

cm. Apart from their reliability<br />

and extremely long service life,<br />

Lauda Puridest stills are characterized<br />

by their simple handling<br />

in the daily work in the laboratory.<br />

The stills are extremely easy<br />

to commission and operate. The<br />

ultra-pure water can be extracted<br />

directly after connection to the<br />

raw water and power supply. The<br />

devices are maintenance-free,<br />

because the glass stills automatically<br />

remove pollutants.<br />

Decades of experience and technical<br />

development have set the<br />

standard: Lauda Puridest stills<br />

are developed and manufactured<br />

by Lauda-GFL. The company<br />

has been a member of the Lauda<br />

group since December 31st,<br />

2018 and is known throughout<br />

the world as a premium manufacturer<br />

of reliable laboratory technology.<br />

The use of the “GFL Technology”<br />

quality mark means that<br />

Lauda is continuing the tradition<br />

of the GFL brand, which has been<br />

renowned for its quality and reliability<br />

in laboratories worldwide<br />

for more than 50 years.<br />

GF Piping Systems<br />

SYGEF ECTFE<br />

Estremamente affidabile<br />

Il sistema SYGEF ECTFE garantisce una elevata resistenza e<br />

sicurezza anche in condizioni estreme.<br />

www.gfps.com/ectfe<br />

Georg Fischer Spa<br />

Via E. Villoresi 2/4<br />

IT-20864 Agrate Brianza (MB)<br />

T +39 02 92186.1<br />

www.gfps.com/it


Instrumentation<br />

Reliable measured values,<br />

from lab to process<br />

The multiparameter handheld<br />

instrument from Endress+Hauser<br />

provides values you can trust<br />

and enables easy and reliable<br />

control and verification.<br />

by Bo Ottersten, Business Development Manager,<br />

Laboratory Portfolio, Endress+Hauser<br />

On-line measured values<br />

commonly need verification<br />

by grab sample analysis<br />

in the laboratory. This<br />

is a challenge for many operators<br />

and laboratory workers due<br />

to measurement discrepancies that<br />

arise from different sensors, variable<br />

algorithms or varying ambient conditions.<br />

The multiparameter handheld<br />

instrument from Endress+Hauser<br />

provides values you can trust and<br />

enables easy and reliable control and<br />

verification. Whether it’s done in the<br />

lab or in the field at the sampling<br />

point, the Liquiline Mobile CML18<br />

can be used in a wide range of applications<br />

and it fits in any shirt pocket.<br />

The Liquiline Mobile CML18 handheld<br />

instrument measures pH, ORP, conductivity<br />

and dissolved oxygen – four<br />

parameters in just one device. It utilizes<br />

reliable Memosens technology<br />

that converts all sensor signals to robust<br />

digital signals that are not affected<br />

by moisture or other environmental<br />

influences, ensuring 100% data<br />

integrity. In addition, the Mem-<br />

osens technology makes switching<br />

between different sensors easy. After<br />

replacing the sensor, the device<br />

immediately detects which sensor is<br />

connected, automatically loads the<br />

saved sensor data and displays the<br />

correct measured value. Operation of<br />

the portable instrument is easy and<br />

intuitive using the SmartBlue app on<br />

a smartphone or tablet. All measured<br />

values and sensor data are transferred<br />

via a secure Bluetooth connection<br />

that transforms and encrypts all data.<br />

The high security protection level of<br />

this connection has been confirmed<br />

by a renowned German institute. The<br />

Liquiline Mobile CML18 - Multiparameter<br />

handheld device for pH, ORP,<br />

conductivity, dissolved oxygen<br />

SmartBlue app provides a convenient<br />

way to configure or adjust the device<br />

and read out sensor values and measured<br />

values. It also makes these values<br />

available for Industry 4.0 applications.<br />

Liquiline Mobile CML18 features<br />

all the properties of a flexible<br />

all-round device, suitable for a wide<br />

range of applications in sample analysis<br />

or temporary measurement.<br />

38 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA


Instrumentation<br />

Robust grab sample measurement<br />

directly at the sampling point<br />

Laboratory and maintenance staff in<br />

process industries commonly need to<br />

verify their on-line analytical measurement<br />

values. Typically, this is done<br />

by grab sample measurement. Samples<br />

can be measured directly at the<br />

sampling point using a portable instrument.<br />

However, many handheld<br />

and laboratory instruments are sensitive<br />

to harsh process environments<br />

and cannot handle high humidity<br />

without signal loss. This can lead to<br />

incorrect measured values and the<br />

operators do not know which values<br />

they can trust. Thanks to its robust<br />

Memosens technology, Liquiline Mobile<br />

provides reliable measured values<br />

even under harsh ambient conditions<br />

and supports operators in quickly taking<br />

required measurements and keeping<br />

the process running under optimized<br />

conditions.<br />

When grab samples are measured at<br />

the sampling point, the values must<br />

be documented in one way or another.<br />

A paper and a pen have been<br />

traditionally used, but this is hardly<br />

comfortable or useful. It is better<br />

to use the internal memory inside<br />

the portable device. Liquiline Mobile<br />

has a memory for grab samples taken<br />

in the field. The operator simply<br />

needs to press the store button<br />

and choose the predefined location.<br />

Time, date, location and measured<br />

values are securely saved. The stored<br />

values can then be easily transferred<br />

to a smartphone via the SmartBlue<br />

app and shared.<br />

Consistent grab sample measurement<br />

in the laboratory<br />

Another method of grab sample<br />

measurement is bringing a sample<br />

from the measuring point to a laboratory<br />

or maintenance shop. The<br />

challenge of this kind of monitoring<br />

is that samples are often not stable<br />

over time; the sample changes its<br />

values between the time it was taken<br />

at the sampling point and when<br />

it is analyzed in the laboratory, and<br />

the sample temperature can influence<br />

the sample values. In addition,<br />

the use of different measuring technologies<br />

in the lab can often result<br />

in deviations between the lab<br />

measurement and the measurement<br />

recorded in the process. With the<br />

Liquiline Mobile CML18, the identical<br />

Memosens sensors that are used<br />

in the process can also be used in<br />

the lab. This guarantees consistency<br />

of data between lab and process<br />

measurements. In cases requiring a<br />

particularly fast response time, the<br />

new robust lab pH sensor, the Memosens<br />

CPL51E, is the ideal choice. It<br />

uses the same Memosens technology<br />

as the process sensors but is optimized<br />

for a fast response time in<br />

sample analysis and laboratory applications<br />

that do not require a high<br />

degree of temperature – and pressure<br />

– resistance.<br />

Occasional or temporary measurement<br />

at process points with no online<br />

measuring device<br />

Ensuring the quality of products and<br />

processes also requires monitoring<br />

in places where no on-line measurement<br />

is installed. In these cases, grab<br />

sample analysis is often done in<br />

the laboratory, again with a high risk<br />

that sample values change due to<br />

temperature or contamination. The<br />

compact Liquiline Mobile and the robust<br />

Memosens sensors are suitable<br />

for random measurements in the process<br />

because they are easy to carry<br />

to any point in the plant and are not<br />

affected by wet ambient conditions.<br />

If a certain point in the process<br />

needs to be monitored over a specific<br />

time, customers can easily set up<br />

a temporary measurement with Liquiline<br />

Mobile, as the integrated data<br />

logger can store 10,000 measured<br />

values with a date and time stamp.<br />

Afterwards, the data can be quickly<br />

transferred to a mobile device via<br />

the SmartBlue app and exported into<br />

a computer as a CSV file.<br />

Conclusion<br />

The Liquiline Mobile CML18 multiparameter<br />

instrument is the perfect tool<br />

for anyone who wants to have values<br />

they can trust, in the laboratory<br />

or at the sampling point. It is robust<br />

like a field device and brings identical<br />

sensor technology and measurement<br />

algorithms from the process to the<br />

laboratory, eliminating all uncertainties<br />

and discrepancies in measured<br />

values caused by different measuring<br />

technologies. Thanks to its compact<br />

design and easy operation via<br />

the SmartBlue app, Liquiline Mobile<br />

CML18 can be applied wherever and<br />

whenever it is needed. <br />

From the<br />

left: robust<br />

grab sample<br />

measurement<br />

directly at<br />

the sampling<br />

point;<br />

temporary<br />

measuring<br />

point thanks<br />

to integrated<br />

data logger<br />

September/October <strong>2020</strong><br />

RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA icf 39


Instrumentation<br />

In a strong position to address the challenges of the corona crisis<br />

Endress+Hauser performed well across all fields of activity,<br />

industries and regions in 2019. The Group created hundreds<br />

of new jobs, invested record amounts and improved<br />

in the area of sustainability. According to CEO Matthias<br />

Altendorf, the family company is thus in a strong position<br />

to address the challenges of the corona crisis.<br />

“2019 was a solid year for Endress+Hauser,” emphasized<br />

Matthias Altendorf. “Growth was broad-based and balanced.”<br />

The measurement and automation technology specialist<br />

for process and laboratory applications increased<br />

net sales by 8.0 percent to 2.652 billion euros, despite a<br />

weakening economy. During the annual media conference<br />

on financial statements in Basel, the CEO explained<br />

that instead of large-scale orders, this growth was driven<br />

by smaller and medium-sized projects.<br />

Focus on innovation and sustainability<br />

According to the CEO, this success is also tied to the<br />

company’s undiminished innovative spirit. In 2019 Endress+Hauser<br />

filed 318 patent applications and invested<br />

7.6 percent of sales in research and development. More<br />

than 1,100 people are working on new products, solutions<br />

and services. By the end of 2019 Endress+Hauser<br />

had 14,328 employees worldwide. 400 new jobs have been<br />

created within one year.<br />

The company also made progress in the area of sustainability.<br />

In the annual EcoVadis audit, Endress+Hauser a-<br />

chieved 72 points, 4 more than in 2018, placing it in the<br />

top 2 percent of the comparison group. By switching to<br />

green electricity in production, the Group was able to reduce<br />

CO 2<br />

emissions by more than one-third. New buildings<br />

meet the highest environmental standards. Endress+Hauser<br />

is currently constructing a new energy self-sufficient<br />

customer experience and training center in Canada.<br />

USA still the largest market; China overtakes Germany<br />

In 2019, Asia provided strong growth impulses. Europe<br />

performed well and South America recorded excellent<br />

growth. North America fell behind expectations, however,<br />

while the business in Africa and the Middle East declined.<br />

China overtook Germany based on sales volume and<br />

just trails the US, which continues to be the largest sales<br />

market for Endress+Hauser. According to Chief Financial<br />

Officer Luc Schultheiss, the Group companies were able<br />

to gain market share.<br />

40 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA<br />

Digital intimacy bridges the physical distance<br />

Endress+Hauser started <strong>2020</strong> with a further increase in incoming<br />

orders. However, the coronavirus pandemic makes<br />

it massively more difficult to achieve the original goals.<br />

“Although we are still unable to predict the economic<br />

impacts of the crisis, we and our customers will certainly<br />

feel the effects,” underlined CEO Matthias Altendorf. The<br />

Group responded early to the spread of the virus and u-<br />

sed all means at its disposal to protect people’s health and<br />

continue to offer customers solid support.<br />

“We bridge the physical distance through digital and emotional<br />

proximity,” said Matthias Altendorf. The CEO has<br />

been driving digitization at Endress+Hauser for years – in<br />

the product and services areas, as well as in customer interaction<br />

and internal collaboration. At peak periods, up<br />

to 10,000 employees are currently working from home.<br />

Customers can use the website to order instruments or<br />

track orders, and an online tool enables remote support<br />

aided by video.<br />

Group aims to safeguard employment<br />

“Our everyday heroes are those working in production, logistics<br />

and service, or under difficult conditions from home<br />

or in the office,” said Matthias Altendorf. Through hard<br />

work, the company has been successful in ensuring the<br />

availability of materials, keeping the logistics chains intact<br />

and supporting customers in all respects. “The Group’s<br />

plants are operating, and Endress+Hauser is still able to<br />

deliver.” The CEO therefore believes that the company is<br />

well prepared for difficult times.<br />

“We have always run a sound business and as a company<br />

we are very well positioned,” said Matthias Altendorf. “We<br />

will do everything we can to safeguard jobs and bring Endress+Hauser<br />

through this crisis. This will benefit customers,<br />

employees and shareholders.” The shareholder family<br />

supports this course and accepts a decline in profits,<br />

said Supervisory Board President Dr Klaus Endress. “We<br />

would like to have as many people as possible on board<br />

when the wind shifts and things pick up again.”


I N D U S T R Y 4 . 0<br />

COLLABORATIVO, CERTIFICATO,<br />

PLUG & PLAY<br />

Soluzioni per robot collaborativi<br />

anche per ambienti sterili<br />

La gamma Mechatronics di Gimatic si arricchisce della<br />

compatibilità in applicazioni collaborative con Universal<br />

Robots®.<br />

Il nuovo kit permette di collegare la gamma di pinze<br />

elettriche direttamente al polso del robot senza bisogno<br />

di ulteriori accessori.<br />

La cover di protezione e il sistema di presa adattativo<br />

garantiscono la protezione dell’operatore. Le dita di<br />

presa, fornite in una configurazione standard, sono<br />

rimovibili e personalizzabili.<br />

Inoltre, grazie all’esclusivo sistema CAPBOX, le pinze di<br />

qualsiasi taglia, sono comandate direttamente dal polso<br />

del robot senza cavi e costose ed ingombranti protezioni<br />

lungo il braccio dello stesso.<br />

WWW.GIMATIC.COM


Packaging<br />

Tests in stateof-the-art<br />

clean<br />

rooms and<br />

laboratories<br />

help recognise<br />

risks at an early<br />

stage and thus<br />

accelerate<br />

the approval<br />

of medicines.<br />

Photo: Harro<br />

Höfliger<br />

Pharmaceutical packaging:<br />

high tech for our health<br />

Growing drug development requirements result<br />

in a parallel increase in systems and machine<br />

technology demands in the field of packaging<br />

and bottling medicines.<br />

by Melanie Streich<br />

Chronic diseases are more<br />

widespread than ever before.<br />

In industrial nations and,<br />

increasingly, in developing<br />

countries as well, they are<br />

among the most common and economically<br />

relevant health problems.<br />

The health sector’s global economic<br />

factor is accordingly high, and si-<br />

42 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA


Packaging<br />

multaneously acts as leverage for<br />

the pharmaceutical industry, which<br />

invests a comparably high share of<br />

its revenue in research and development<br />

(R&D).<br />

In light of global demographic<br />

changes, the industry’s development<br />

opportunities are excellent.<br />

People are living longer and more<br />

health-conscious lives – which further<br />

increases the high-tech sector’s<br />

growth outlook. Growing drug<br />

development requirements result in<br />

a parallel increase in systems and<br />

machine technology demands in the<br />

field of packaging and bottling medicines.<br />

“Today, pharmaceutical companies<br />

need integrated solutions.<br />

Machines provide the foundation<br />

for these. An extensive service offer<br />

and digital solutions in particular<br />

are gaining in importance,” explains<br />

Norbert Gruber, Chairman of<br />

the Executive Board at Uhlmann,<br />

which provides systems for packaging<br />

pharmaceuticals in blister packs,<br />

bottles and boxes. The German family<br />

business, which has more than<br />

2,300 employees around the world,<br />

has accordingly positioned itself as<br />

an innovative and digitalised company<br />

at interpack, the world’s leading<br />

trade fair for the packaging and<br />

associated process industries.<br />

The trade fair, that will take place<br />

from 25 February to 3 March 2021<br />

due to corona virus crisis, presents<br />

further cutting-edge solutions that<br />

the industry has to offer. As a focal<br />

point for pharmaceutical packaging,<br />

Halls 15 to 17 offer visitors the opportunity<br />

to find out more about innovative<br />

packaging and process developments<br />

for this specific industry.<br />

The other halls also showcase corresponding<br />

solutions: The approximately<br />

1,000 companies with exhibits<br />

on Industry 4.0, digitalisation, automation,<br />

personalisation, track and<br />

trace and many other interesting top-<br />

ics from the field of pharmaceuticals<br />

represent a significant share of the<br />

around 3,000 exhibitors at interpack.<br />

Pharmaceutical market forecast<br />

According to figures released by market<br />

research company IQVIA, global<br />

expenditures for pharmaceuticals are<br />

expected to increase to 1,43 trillion<br />

US dollars by 2022. In comparison:<br />

In 2006, expenditures amounted to<br />

658 billion US dollars. The highest<br />

amount is spent on cancer medication<br />

and biopharmaceuticals.<br />

The reasons for this increase in market<br />

growth are quite apparent: Demographic<br />

change with a rise in older<br />

patients and increasing urbanisation<br />

with a growing middle class are<br />

the determining market factors for<br />

the pharmaceutical sector and the<br />

associated process and packaging industries.<br />

The future of biopharmaceuticals<br />

Whilst in pharmerging countries,<br />

more and more people are gaining<br />

access to traditional medicines such<br />

as painkillers and antibiotics, industrial<br />

nations are increasingly employing<br />

new, complex active ingredients<br />

and innovative treatments.<br />

In the pharmaceutical sector, biotechnology<br />

is considered a key technology<br />

in the global fight against severe<br />

diseases such as cancer and autoimmune<br />

diseases. Their share in<br />

the medical market has almost doubled<br />

in the past ten years and has<br />

thus become a decisive factor for the<br />

process and packaging industry.<br />

More and<br />

more Uhlmann<br />

solutions<br />

are made of<br />

bits and bytes<br />

instead of steel<br />

and safety<br />

glass.<br />

Photo: Uhlmann<br />

Medical<br />

packaging<br />

has to protect<br />

highly sensitive<br />

products<br />

from external<br />

influences.<br />

Photo:<br />

Marchesini<br />

Group<br />

September/October <strong>2020</strong><br />

RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA icf 43


Packaging<br />

Optima’s CSPE<br />

process helps<br />

pharmaceutical<br />

companies<br />

launch their<br />

newly developed<br />

products as<br />

quickly as<br />

possible.<br />

Photo: Optima<br />

Sophisticated processing<br />

Highly effective medicine is accompanied<br />

by considerable demands on<br />

packaging and processing technologies,<br />

particularly with regard to bottling<br />

and packaging solutions. When<br />

manufacturing biotech medicines,<br />

avoiding contamination is essential.<br />

Special containment solutions<br />

aim to prevent said contamination.<br />

Isolators are one such example. Liquid<br />

medicines can be processed under<br />

sterile conditions in vials. Prefilled<br />

syringes also contribute to an<br />

increase in safety. They help prevent<br />

dosage errors and also eliminate<br />

contamination when changing<br />

needles. In the hectic daily life of<br />

practices and clinics, pre-filled syringes<br />

and pens also save precious<br />

time. Authenticity checks performed<br />

on complex purification processes<br />

using combined sensor technology<br />

and mathematical models ensure<br />

that quality controls can be performed<br />

much more quickly with increased<br />

process accuracy.<br />

Pharmaceuticals and packaging:<br />

True team play<br />

When manufacturers launch new<br />

pharmaceuticals, they depend on the<br />

market and technology competence<br />

of machine, systems and packaging<br />

manufacturers and processors. Time<br />

limits on patent protection require<br />

fast and flexible solutions that have<br />

to guarantee scale-ups from small<br />

laboratory amounts to high volumes<br />

in larger plants.<br />

Optima is a single-source provider<br />

of packaging machines and bottling<br />

and production systems. To ensure<br />

that newly developed products can<br />

be launched as quickly as possible,<br />

Optima uses the CSPE method, which<br />

will be one of the company’s central<br />

topics at interpack. This method reduces<br />

delivery times and significantly<br />

accelerates the commissioning of<br />

pharmaceutical systems. “In light of<br />

increased development periods and<br />

costs on the one hand and increasingly<br />

tough international competition<br />

on the other, the time between<br />

concluding the approval phase and<br />

launching the product has to be<br />

kept as short as possible,” explains<br />

Gerhard Breu, Chairman of Optima’s<br />

Pharma division.<br />

At the same time, companies require<br />

reliable packaging machines<br />

and bottling systems that are easy to<br />

use and clean, and that can be retrofit<br />

without great effort. Pharmaceutical<br />

service provider Harro Höflinger<br />

provides support in the early stages.<br />

His clean rooms and laboratories<br />

can depict extensive processes in a<br />

controlled environment, whilst test<br />

setups allow clients to check critical<br />

steps in advance. “Our clients<br />

increasingly ask to test their own<br />

substances and critical conditioning<br />

products on machines designed by<br />

Harro Höflinger. Our clean rooms and<br />

laboratories are the perfect place to<br />

implement these tests. They allow us<br />

to recognise and minimise risks at an<br />

early stage – the basis for quick and<br />

safe scale-ups to commercial manufacture,”<br />

explains Stefan Mayer, Senior<br />

Director Process Services.<br />

Protection against counterfeiting<br />

In the pharmaceutical field in particular,<br />

strict legal provisions and<br />

guidelines apply that are of extreme<br />

importance for all parties involved in<br />

the process and that at the same time<br />

mean tremendous investments for the<br />

affected companies. Since February<br />

2019, prescription medicine in the EU<br />

has to be equipped with tamper-proof<br />

seals that ensure that the packaging<br />

has not been opened.<br />

Serialisation on the packaging is<br />

now also a legal requirement. All affected<br />

packaging has to be equipped<br />

44 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA


Packaging<br />

with a two-dimensional datamatrix<br />

code that uniquely identifies the<br />

medicine and confirms its authenticity.<br />

This code contains information<br />

on the batch number, the expiration<br />

date, the serial number and<br />

the national reimbursement number.<br />

These new regulations have far-reaching<br />

consequences. In individual cases,<br />

production facilities have to be<br />

expanded, constructed or modified<br />

to accommodate new serialisation<br />

units. The expansion of the IT infrastructure<br />

in particular is a true feat<br />

of strength for many companies and<br />

is associated with high costs.<br />

Körber Medipak Systems offers extensive<br />

solutions that protect patients<br />

against counterfeit medicine.<br />

Pre-serialised folding boxes with<br />

tamper-evident seals and targeted<br />

system solutions put a stop to counterfeit<br />

medicines in the legal value<br />

chain, as packages now visibly and<br />

unambiguously show whether they<br />

have been opened or not.<br />

The silver generation<br />

By 2050, global population will reach<br />

9.7 billion people; a mere 50 years<br />

later, this number is expected to increase<br />

to 10.9 billion, according to<br />

the most recent UN global population<br />

forecasts released in June 2019.<br />

In 2050, every sixth person in the<br />

world will be over 65, with a total of<br />

426 million people over the age of 80.<br />

This equates to triple the 2019 numbers,<br />

with 143 million people over 80.<br />

These demographic changes also<br />

mean a rise in diseases that increasingly<br />

occur with age. These include<br />

diabetes, rheumatism, multiple<br />

sclerosis as well as dementia<br />

and Alzheimer’s disease. The affected<br />

patients require particular administration<br />

methods, depending<br />

on the type of complaint and symptoms.<br />

Pre-filled syringes and auto injectors<br />

help people with limited mobility<br />

regularly administer their medicine<br />

themselves.<br />

The packaging industry offers smart<br />

packaging for patients whose sight<br />

and hearing are dwindling or who<br />

are losing their finger strength and<br />

motor skills. One of these innovations<br />

was created by pharmaceutical<br />

technology provider Romaco Siebler.<br />

In cooperation with foil experts Huhtamaki,<br />

Romaco Siebler developed<br />

Push Packs, which are equipped with<br />

special, accessible features and allow<br />

patients to easily push tablets<br />

out of the foil. “Push Packs are an affordable<br />

alternative to cold-formed<br />

aluminium-aluminium blister packs<br />

(AI/AI blister packs). As the packaging<br />

foils are a lot thinner, they<br />

require less material. This reduces<br />

packaging costs in direct comparison<br />

by up to 60 percent,” calculates<br />

Jörg Pieper, CEO at Romaco Holding.<br />

Tailor-made medicine<br />

Personalised medicine will change<br />

the global health system considerably<br />

in the years to come. Studies<br />

have shown that more than 70 percent<br />

of all pharmaceuticals currently<br />

in development have been customised<br />

to meet the needs of specific patient<br />

groups. In cancer therapy, individual<br />

medicine is already common<br />

and is to supplement standard therapies<br />

in future. Scale-out solutions for<br />

machines and equipment enable the<br />

production of smaller batch sizes.<br />

Here, existing equipment is copied<br />

exactly for other locations. This re-<br />

quires clearly defined processes and<br />

machine technology with a high degree<br />

of automation.<br />

More and more pharmaceutical manufacturers<br />

require flexible bottling<br />

and packaging systems that allow<br />

them to work on small batches with<br />

maximum efficiency. Bausch+Ströbel<br />

has a compact solution in their portfolio:<br />

the modular VarioSys production<br />

system is also suitable for application<br />

in laboratories with small<br />

batch sizes. “Flexibility is the first<br />

priority in all our designs. We achieve<br />

this by quick and easy module changes<br />

on the one hand and short cycle<br />

times when sterilising the isolator<br />

on the other,” explains Heiko<br />

Schwarz, who is responsible for the<br />

development of VarioSys in product<br />

management at Bausch+Ströbel.<br />

Print your own tablets<br />

Tablets fresh off the 3D printer are no<br />

longer a dream of the future. Spritam,<br />

a printed epilepsy treatment, was the<br />

first medicine to be approved by the<br />

Food and Drug Administration (FDA)<br />

in 2015. 3D printing processes allow<br />

manufacturers to adapt products exactly<br />

to patient needs whilst reducing<br />

time and cost factors in production,<br />

as machine components no longer<br />

need retrofitting.<br />

Compared to conventional tablet<br />

presses, printed pills can also be<br />

equipped with a more porous surface,<br />

which helps them dissolve more<br />

quickly and without additional liquid<br />

intake. They can also be equipped<br />

Tamper-evident<br />

seals keep<br />

patients safe<br />

and secure.<br />

Photo: Rondo<br />

AG, a Körber<br />

Medipak<br />

Systems<br />

company<br />

September/October <strong>2020</strong><br />

RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA icf 45


Packaging<br />

with more active ingredients. This<br />

particularly benefits patients who<br />

have difficulty swallowing and who<br />

depend on various tablets. However,<br />

experts say it will be quite some time<br />

before patients can print their own<br />

prescription medicine, with an individual<br />

formula put together by their<br />

doctor, in the comfort of their own<br />

home. The current fields of application<br />

are limited exclusively to highly<br />

specialised, individual medicine.<br />

Child-proof,<br />

suitable for<br />

senior citizens<br />

and sustainable.<br />

Patients can easily<br />

push tablets out<br />

of the Push Packs<br />

by Romaco Siebler<br />

and Huhtamaki.<br />

Photo: Romaco<br />

Siebler<br />

Convenience and safety<br />

Personalised medicine is a field that<br />

particularly affects the hospital and<br />

care sector. To ensure that patients receive<br />

the right drug cocktails whilst relieving<br />

carers of the task of putting the<br />

necessary medicine together, tablets<br />

may be blister-packed ready for use.<br />

Blister pack machines in chemists<br />

and blister packaging centres pack<br />

the patient’s individual tablet mix in<br />

an airtight and hygienic strip of sacs<br />

and simultaneously ensure that the<br />

individual doses are labelled and delivered<br />

in the right order. This prevents<br />

wrong dosages and ensures<br />

that patients do not take the wrong<br />

tablets by mistake.<br />

Cost pressure and systems efficiency<br />

Despite all the positive market developments<br />

in the pharmaceutical sector, we<br />

must not forget that even though the<br />

industry is growing, the health care systems<br />

in several countries are subjected<br />

to tremendous cost pressure. Mandatory<br />

discounts, price limits and reimbursement<br />

models often force manufactures<br />

to lower their costs per package. Machine<br />

and systems manufacturers have<br />

to work on improving overall equipment<br />

efficiency. In Industry 4.0’s future, this<br />

means using integrated systems with reliable<br />

availability and a continually high<br />

product quality. This is the only way to<br />

ensure that providers can keep up with<br />

a dynamic market in the long run. <br />

46 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA


Technical news<br />

IMA Group accelerates digital innovation<br />

IMA Group continues to consolidate<br />

its digital innovation<br />

strategy with increasingly advanced<br />

and customer-oriented<br />

services. The round table organized<br />

in July in partnership with<br />

PTC was an opportunity to share<br />

the latest IMA digital solutions<br />

aimed at optimizing the production<br />

of the Group’s customers.<br />

Within the web events,<br />

IMA experts presented the latest<br />

innovations born from the<br />

collaboration with PTC with a<br />

focus on IIoT (Industrial Internet<br />

of Things), thus re-launching<br />

the message of a necessary,<br />

increasingly coordinated and<br />

uniform innovation to maintain<br />

industrial leadership in a<br />

highly competitive sector such<br />

as manufacturing.<br />

Among the offered services, the<br />

APP developed with PTC on a<br />

ThingWork basis is meant to facilitate<br />

customers in real-time<br />

monitoring of the operating<br />

conditions of the lines. Thanks<br />

to the accessible data of this<br />

simple and intuitive APP, the<br />

end user has an active and fully<br />

autonomous involvement in<br />

the decision-making processes<br />

to make changes and adjustments<br />

directly on the systems.<br />

Among the numerous advantages<br />

that the APP guarantees<br />

there is a natural increase in<br />

OEE (Overall Equipment Effectiveness)<br />

that can be reached in<br />

a short time. The possibility of<br />

translating effectively the KPIs<br />

plants into measurable values<br />

then allows a deepening of the<br />

loss analysis and opens up the<br />

opportunity of deepening the<br />

details regarding inefficiencies,<br />

downtime, average intervention<br />

times to make all the necessary<br />

corrective actions and restore<br />

full efficiency of flows.<br />

“The scalability and the opening<br />

of the developed APP allow<br />

the end-user the access to<br />

the entire set of real-time information<br />

generated by the machines<br />

using a wide range of<br />

devices – tablets, smartdevices,<br />

notebooks etc. – and regardless<br />

of where the customer<br />

is located”, said Martina<br />

Stefanon, AMS Business<br />

Development Director at IMA<br />

Group during the recent online<br />

event. “Only the most precise<br />

and detailed knowledge of its<br />

own production assets makes<br />

an improvement of process efficiency<br />

possible. And this can<br />

only be done by understanding<br />

their status, that is, by analyzing<br />

and using the data they<br />

generate, in order to increase<br />

uptime and consequently optimize<br />

costs and margins”.<br />

The developed APP integrates<br />

with the services offered by<br />

the IMA Digital Room, a control<br />

center that constantly monitors<br />

the production of the customer’s<br />

machines or installed base,<br />

remotely. Inside the Digital<br />

Room, a team of expert engineers<br />

available 24/7 monitors<br />

the operating conditions of the<br />

plants by taking into consideration<br />

both KPIs and value parameters<br />

to anticipate and report<br />

potential future malfunctions<br />

to customers, in order to<br />

set corrective actions and make<br />

the production more efficient.<br />

The protection of data and information<br />

from hackers or malware<br />

attacks on the network<br />

is fundamental in the IOT sector.<br />

“IMA recently launched<br />

A4Gate,” explained Pier Luigi<br />

Vanti, ICT Corporate Director at<br />

IMA Group, “an integrated hardware/software<br />

solution that allows<br />

the users to control the<br />

data transmission from a machine/source<br />

inside the plant to<br />

the outside, ensuring full information<br />

confidentiality and preventing<br />

cyber threats”. The developed<br />

product fully supports<br />

features related to the IoT Edge<br />

& IoT Data Collector, IoT Remote<br />

Access Control and 24/7<br />

connection to the Digital Room,<br />

all in maximum security and allotment<br />

from external penetration<br />

attempts.<br />

The growth of projects aimed at<br />

monitoring production trends<br />

and protecting the data generated<br />

within the plants is the<br />

natural evolution of the IMA<br />

Digital initiative. The parallel<br />

agreement signed with Antares<br />

Vision at the beginning of June<br />

is also part of the project’s development<br />

plans. The ongoing<br />

collaboration inherent in the<br />

supply of inspection systems is<br />

consolidated in a partnership<br />

extended to the most innovative<br />

Antares Vision solutions for<br />

product traceability and for the<br />

smart data management.<br />

The new five-year agreement<br />

with Antares Vision sees the<br />

synergistic development and<br />

implementation of innovative<br />

solutions in the context of specific<br />

projects, new businesses<br />

and products, with the aim of<br />

not only consolidating and potentiating<br />

technological leadership<br />

but also offering new<br />

application and business potential<br />

to their customers.<br />

September/October <strong>2020</strong><br />

RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA icf 47


In this issue,<br />

we spoke about...<br />

ANALYTICA .................................................................... 20<br />

ANTARES VISION ...........................................................26<br />

BAUSCH & LOMB............................................................. 16<br />

BAUSCH+STRÖBEL ........................................................... 42<br />

BEA TECHNOLOGIES .......................................................15<br />

BRUNO WOLHFARTH ......................................................11<br />

CO.RA ................................................................... 4A COP.<br />

CVS LIFE SCIENCE ............................................................1<br />

D&D ENTERTAINMENT DI DARIO NUZZO ...........................16<br />

DELTA COSTRUZIONI MECCANICHE ..................................... 14<br />

EG ................................................................................ 16<br />

ELLAB ...............................................................1A COP., 8<br />

ENDRESS+HAUSER ........................................................... 38<br />

EUTICALS ...................................................................... 16<br />

FARAVELLI ....................................................................33<br />

FLUORTECNO .......................................... BATTENTE 1A COP.<br />

GEORG FISCHER .............................................................37<br />

GIMATIC ................................................................. 12, 41<br />

IBSA FARMACEUTICI ......................................................19<br />

IMA .........................................................................26, 47<br />

INTERPACK .................................................................... 42<br />

IQVIA .......................................................................... 43<br />

IRON SALTS .................................................................... 12<br />

ITALVACUUM .................................................................. 13<br />

LAETUS ......................................................................... 36<br />

LAUDA .......................................................................... 37<br />

LENIRIT......................................................................... 16<br />

LUMITOS ....................................................................... 24<br />

MARCHESINI GROUP...................................................14, 42<br />

MERCK .......................................................................... 16<br />

NOVARTIS ...................................................................... 16<br />

NOVO NORDISK ............................................................... 17<br />

NUOVA GUSEO ................................................................ 30<br />

OMAC ................................................................... 3A COP.<br />

OPTIMA ......................................................................... 42<br />

POMPETRAVAINI ..............................................................7<br />

PRECISION FLUID CONTROLS ..........................................29<br />

PTC ............................................................................... 47<br />

PVS .............................................................................4-5<br />

ROMACO SIEBLER ............................................................ 45<br />

RONDO AG ..................................................................... 42<br />

SALVATORE ROBUSCHI .......................................... 2A COP.<br />

SERVIER ITALIA .............................................................. 17<br />

SWAN ANALITICA .................................................... 13, 34<br />

TEXPACK .......................................................................25<br />

TMIP ..................................................... BATTENTE 4A COP.<br />

TRADECITY D.O.O. ........................................................... 27<br />

UHLMANN ..................................................................... 42<br />

RIVISTA<br />

DELL’ INDUSTRIA<br />

CHIMICA E<br />

FARMACEUTICA<br />

SUPPLEMENT<br />

ISSUE NO.4<br />

SEPT/OCT<strong>2020</strong><br />

icfYEARXI<br />

MANAGING DIRECTOR: Simone Ghioldi<br />

REDACTION: Alessandro Bignami (a.bignami@interprogettied.com),<br />

Eva De Vecchis (e.devecchis@interprogettied.com)<br />

CONTRIBUTORS: Gherardo Marchini, Bo Ottersten, Roger Schmid, Melanie Streich<br />

GRAPHIC LAYOUT: Studio Grafico Page Vincenzo De Rosa, Simona Viapiana - www.studiopage.it<br />

TRANSLATIONS: Elena Marzorati<br />

INTERPROGETTI EDITORI S.R.L.<br />

Via Statale 39 - 23888 La Valletta Brianza (LC)<br />

Redazione, vendite e abbonamenti<br />

Tel./fax +39 039 5153705<br />

www.interprogettied.com<br />

SALES DIRECTOR: Marika Poltresi<br />

SALES: Simone Ghioldi (vendite@interprogettied.com)<br />

ADMINISTRATION: amministrazione@interprogettied.com<br />

© Copyright Interprogetti Editori Srl<br />

The columns and news are realised by the editorial team. All rights reserved – All reproduction,<br />

even partial, of published material without the publisher’s consent is strictly prohibited.<br />

SUBSCRIPTION RATES:<br />

Italy: ordinary mail delivery EUR 45.00, COD delivery EUR 48.00<br />

International: ordinary mail delivery EUR 60.00, express delivery within Europe EUR 70.00<br />

Express delivery to Africa, America, Asia: EUR 85.00<br />

Express delivery to Oceania: EUR 100.00<br />

Single copy: EUR 10.00<br />

The VAT on subscription prices as well as on the price of single copies is paid by the publisher<br />

pursuant to article 74, sub-section 1, point C of the Italian DPR n. 633 of 26th Oct 1972<br />

and subsequent amendments and additions. It is therefore not possible to issue invoices.<br />

Registered at the Court of Milan on 7 May 2010 no. 259<br />

Managing Director: Simone Ghioldi<br />

Print concluded on 14 th September <strong>2020</strong> at Aziende Grafiche Printing S.r.l.<br />

Via Milano, 5 - 20068 Peschiera Borromeo (MI)<br />

Information to be given to the data subject - art. 13, legislative decree 30th June 2003, no. 196. Personal data are<br />

processed, with or without the help of electronic means, by Interprogetti Editori S.r.l. - Via Statale 39 - 23888 La<br />

Valletta Brianza (LC), Italy, to send you the magazine requested and for the operations connected. The processing of<br />

data will be carried out by the persons who have been committed by the controller the task of performing the processing<br />

operations connected with recording, modification, processing of personal data and printing, fulfilment and<br />

delivery of magazines, commercial and fiscal issues, accounting and call center activity. With reference to art. 7, Italian<br />

legislative decree 196/2003, you have the right to access to your data, modify, update or cancel data or to object<br />

to their processing for direct marketing purposes, by writing to the controller, and ask for the list of data processors.<br />

Publisher’s information to public – art. 13, legislative decree 30th June 2003, no. 196. With reference to Italian<br />

Personal Data Protection Code and art. 2, point 2 of Code of Conduct for the processing of personal data in the<br />

exercise of journalistic activities, Interprogetti Editori S.r.l. informs that the place where personal data, images and<br />

photos are kept is La Valletta Brianza (Italy). Data can be used by journalists, free-lance journalists, persons in the<br />

role of trainee journalists and persons who carry out processing for the publication or occasional circulation of<br />

essays, articles and other intellectual works for the purpose of the exercise of their journalistic or similar activities.<br />

The processing of data will be carried out by the persons mentioned above and by persons in charge of printing<br />

and publishing activities. With reference to art. 7, Italian legislative decree 196/2003, you have the right of access<br />

to your data, modify, update or cancel data or to object to their, by writing to Interprogetti Srl, and ask for the list of<br />

data processors. It is understood that the provisions concerning professional secrecy in the journalistic profession<br />

shall be left unprejudiced as related to the source of the information if a data subject requests to be informed of<br />

the source of the personal data processed by journalists.<br />

48 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!