ICF N°3 2021

ANNOXII NO3 2021SUPPLEMENT 

PHARMA SPECIAL EDITION 

RIVISTA 

DELL’ 

INDUSTRIA 

CHIMICA E 

FARMACEUTICA 

POSTE ITALIANE SPA - SPED. IN ABB. POSTALE 

70% - LO/MI - COSTO COPIA €10,00 

www.interprogettied.com 

icf 

 

Competence 

 

= PVS 

Quality Result! 

GxP inside 

PVS srl 

Process Validation Service 

_I_IV_COVER 3_2021_PHARMA.indd 1 31/08/21 17:46

A reliable company for non-conven 

 

 

 

 

TM.I.P. S.r.l. – Termomeccanica Industrial Process 

 

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17:46 _I_IV_COVER 3_2021_PHARMA.indd 2 31/08/21 17:46


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01_03_SUMMARY.indd 1 01/09/21 17:10

RIVISTA 

DELL’ 



_I_IV_COVER 3_2021_PHARMA.indd 1 31/08/21 17:46 

Summary 

RIVISTA 

DELL’ INDUSTRIA 

CHIMICA E 

FARMACEUTICA 


icf 

PHARMA SPECIAL EDITION 

INDUSTRIA 

CHIMICA E 

FARMACEUTICA 

ANNOXII NO3 2021SUPPLEMENT 

Quality * Qualification+Validation 

Competence 

*Efficiency 

= PVS 

icf 

4 

Editorial 

Italian technology ready 

for new pharma scenarios 

10 

Trends 

22 

Technology news 

Quality Result! 

GxP inside 

PVS srl 

Process Validation Service 

6Cover story 

Skills and reliability 

working for the process 

14 

Exhibitions 

18 

Life Science 

Along the path 

to digitalizing life science 

24 

Engineering 

Always close to the needs of 

the pharmaceutical process 

28 

Engineering 

A multidisciplinary approach 

to the process 

Summary 

2 icf RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA 

01_03_SUMMARY.indd 2 01/09/21 17:10

Summary 

NO.3 2021 - SUPPLEMENT 

32 

Machines 

High know-how in solid 

handling technologies 

42 


44 

Instrumentation 

Tailor-made partner for 

thermal validation solution 

50 

Insight 

A new era for the 

industrial research 

36 


38 

Components 

The cutting edge 

of sanitization 

48 


54 


56 

Colophon 

NO.3 2021 - Supplement 

RIVISTA DELL’INDUSTRIA CHIMICA E FARMACEUTICA icf 3 

01_03_SUMMARY.indd 3 01/09/21 17:11

Editorial 

Italian technology ready 

for new pharma scenarios 

The chemical-pharma industry confirms to 

be a leading one for Italian recovery in 

2021, one year and a half after the first 

Covid 19 contagions. In reality, the recovery 

had already started before the pandemic, 

which put further pressure on the 

entire supply chain. During the months of 

restrictions, especially during the first lockdown, drug 

manufacturers exploited the existing plants at full capacity, 

without in reality having time and clarity of 

investing in new technologies. Now, conditions have 

changed and industry is focusing on a range of modernizations 

and expansions that are essential to keep up 

with the growth of demand and to recover the time lost 

during the emergency. Also boosted by European funds 

and the focus on vaccine production, for which Italy 

must become more autonomous, the higher availability 

to invest is creating key opportunities for technological 

providers who are living a phase of transformation, 

above all in digital and Industry 4.0 terms. 

Of course, we are still in a phase of transition and 

it’s difficult to foresee what’ll happen in the next 

few months. Yet vaccine diffusion does well 

in controlling the virus. Fibrillations are not 

lacking, as shown by the evident increase 

in the price of raw materials, caused, almost 

partly by the difficulties of supply chains, 

penalized by months of hiccup closures, in 

restarting with the speed needed to respond 

to the sudden rise in demand 

and just-in-time delivery times. 

Many Italian suppliers proved to be 

ready to new challenges, not just 

due to their proverbial flexibility, 

but also thanks to the strategies 

adopted for a long time, for instance by reinforcing 

warehouses and logistics, capable of serving different 

parts of the world fast or by revamping machinery and 

processes in terms of automation and data management. 

Once again, in emergency times, Italy tries, and 

most of the time succeeds in giving its best. 

by Alessandro Bignami 


04_05_EDITORIAL.indd 4 30/08/21 17:13

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Cover Story 

Skills and reliability 

working for the process 

PVS Group is still growing both 

in terms of orders and staff, also due to 

the training of an expert team, using 

a multidisciplinary approach to intervene 

on site. Thus, PVS Group is a benchmark 

company in the operational management 

of instrumentation in terms of GxP 

validation service. 

Verification 

of temperature 

distribution 

in a lyostat 

The construction of a trust 

relationship with the customer 

is a key factor for PVS 

Group’s growth. The Group’s 

double-digit growth has been 

confirmed year after year since 

its foundation in 2013, even in 

full health emergency. However, the 

pharma industry went on investing 

in new projects, asking suppliers for 

tight response times and full reliability. 

PVS (Process Validation Service) 

could ensure these features excellently 

on the whole range of GxP validation 

and qualification services, including 

Risk Assessment, GAP Analysis 

processes, automation support 

(with extensive expertise on DCS and 

SCADA), instrumentation full management 

(including on-site calibration 

and thermal mapping) and TOC 

analyzer consulting and validation. 

These services require top multidisciplinary 

skills, capacity of adapting 

to different and complex sce- 


06_09_COVER STORY PVS.indd 6 31/08/21 09:42

Cover Story 

Manfredi Musmarra: “We are a 

company with a high level of 

education, but also with a strong 

vocation to work directly on plants” 

narios, as well as a strong presence 

on site, in the factories. That is why 

PVS Group has been focusing on the 

training of expert and close-knit technical 

operators. On average, the 

company staff increases by five people 

per year and today it includes 40 

units, spread in three locations: the 

headquarters in Milan and the operation 

sites in Vicenza and Latina. 

To better understand how PVS Group 

business is evolving in such an important 

age for life science industry, 

we talked with some key company 

managers: Nicolas Livraghi and Fabio 

Salaro from the PVS Operations area, 

Stefano Moltani and Manfredi Musmarra 

from PVS Sales Department. 

How has your business been doing 

in recent months? Have you seen 

an increase in requests compared 

to 2020? 

Stefano Moltani: Very well; the double-digit 

growth that has constantly 

accompanied us since the company 

was established is still going on. 

We are really happy and satisfied this 

growth goes hand in hand with further 

investments, thus adapting our 

company to new demands that come 

not just from consolidated clients, 

but also from new-ones. 

Towards which of your activities 

have demands increased in particular 

and from which types of 

production mainly? 

Manfredi Musmarra: At first glance, 

we may say that requests related to 

new installations have strongly increased, 

but focusing on data, you 

may notice that the totality of our 

services have experienced a progressive 

growth. The aspect of our work 

that has changed the most is associated 

not so much with volumes, but 

with the methods of intervention: 

with much tighter project timelines. 

Clients need to react to market requirements 

in a faster and dynamic 

way and this matches our main 

feature, i.e. to be a company with a 

high level of education (the majority 

of our staff is made up of graduates), 

but also with a strong vocation 

to work directly on plants. This 

means our service ensures top expertise: 

the staff works on site with 

their own instrumentation and respecting 

the required times. 

What about your service range? 

Nicolas Livraghi: The “heart” of our 

range is essentially associated with 

technical services in highly regulated 

environments; thus not just 

pharma, but also cosmetic and food 

industries. We are recognized as a 

specialized technical support team 

that helps company departments, 

not just by integrating activities on 

documentation, but also by physically 

carrying out checks, verifications 

and validations on control systems, 

plants and equipment, especially on 

those of GMP relevance. 

Stefano Moltani: “The double-digit 

growth that has constantly accompanied 

us since the company was established 

is still going on” 

In what direction have your services 

changed over time? 

Fabio Salaro: Over the years (some of 

us have been working in this field for 

over 20 years) we saw needs and demands 

slightly changing. While at the 

beginning the relationship between a 

technician of ours and the customer 

was simply based on the execution of 

a contractual service, today many companies 

aim at a collaboration based 

on trust: one of the main elements of 

our way of working. This had several 

positive effects: it helped us to grow, 

not just in terms of technical evolution 

and in the extension of the fleet of 

tools, but also in terms of awareness of 

our means and predisposition to manage 

more complex scenarios. Over the 

years our experience and the capability 

of working with a multidisciplinary vision 

have increased. Nowadays, working 

in environments that are strongly 

subject to regulatory controls, enables 

us to have a vision also including Regulatory, 

Quality and Production aspects; 

we cannot afford to be mere performers, 

disconnected from the general context 

in which we enter and intervene. 

Manfredi 

Musmarra 

(on the left) 

and Stefano 

Moltani. PVS 

Group Sales 

Department 




Cover Story 

Particle 

counting 

Nicolas Livraghi: “We are a specialized 

technical support team that helps company 

departments, by physically carrying out 

checks, verifications and validations on 

control systems, plants and equipment, 

especially on those of GMP relevance” 

Operator 

with a Nitrogen 

cylinder 

You have long since introduced the 

activity dedicated to TOC analyzers: 

did you perceive the developments 

described above on this 

topic as well? 

Salaro: In general, even in this field, 

the evolution of markets and customer 

demands underwent the same dynamics 

as the services. The world of 

TOC analyzers however features peculiar 

expectations. This equipment 

works continuously and “live” on 

the manufacturing process (as well 

as with analytic functions in Qualipany’s 

in-house organization, pandemic 

did not cause any problem: 

the fact we have three head offices 

in Italy – Milan, Vicenza and Latina 

– boosted us to use more frequently 

the communication systems and 

platforms that we were already been 

using and that enabled us to work remotely 

or to hold remote meetings. 

As far as the provision of services 

outside the company is concerned, 

in addition to complying with the 

set of rules and behaviors required 

by the emergency and by the DPCMs, 

we have further reduced the risk of 

contagion by reorganizing, in agreement 

with customers, the activities 

and teams of technicians, so as to 

operate with the lowest possible 

workforce (mainly with single technicians), 

thus avoiding interpersonal 

contacts, both at the office and 

at work sites. The choice already 

made at the time to have an expert 

staff, with a few juniors, completed 

the success of this operation, alty 

Control areas); therefore TOCs can 

be certainly defined as critical elements 

of the manufacturing process. 

Their malfunction represents an event 

to focus on with special care and fastness. 

In other words, it means to have 

a dedicated division that is always 

working, with key functions with over 

20 years of experience on their special 

technology. Experienced, reliable 

and with a tailor-made approach, this 

is the synthesis of how our service is 

performed. 

How has the pandemic influenced 

your work? 

Moltani: Undoubtedly the last period 

has influenced everybody’s life, 

yet in our company, it has just increased 

the use of technological and 

working devices, we were already 

ready to exploit, since they’ve been 

working for years. In terms of com- 



Cover Story 

Mapping of 

a controlled 

temperature 

warehouse 

lowing us not only to keep our commitments, 

but even to increase orders, 

on which to allocate technicians 

who, albeit in small numbers or 

alone, were still able to carry out the 

projects in perfect autonomy. 

Apart from the tougher lockdown 

periods, will digital platforms continue 

to be of help at least for 

certain operations regarding the 

global validation and qualification 

service? 

Musmarra: We really believe so. Trying 

to find out positive aspects in 

this negative and sad event, we can 

find them in the “discovery” of technological 

supports that may help in 

the management of working activities. 

In the past, the use of these 

media was not so well accepted, also 

due to the typical features of Latin 

people, who prefer a direct, “live” 

relationship with our interlocutors. 

Today, on the contrary, it is normal 

to rely upon alternatives that enable 

to manage remotely activities where 

physical presence is not required. 

What traces will the pandemic 

leave in the pharma industry in 

your opinion and what do you hope 

for the future of your business? 

Livraghi: For our type of business, the 

Fabio Salaro: “Working in environments that are strongly 

subject to regulatory controls, enables us to have a vision 

also including Regulatory, Quality and Production aspects” 

traces were felt indirectly. We are part 

of that portion of the system focusing 

on the control of the production process, 

we are therefore "downstream" 

of the whole research and development 

stage that precedes the production 

of the vaccine. Despite this, we 

witnessed this event and felt its impact 

on our customers' facilities. In 

general, one can only recognize the 

extraordinary effort made: the healthcare 

industry, therefore not only pharmaceuticals, 

but also the world of research, 

medical devices, etc. has 

shown great efficiency, responding to 

the pandemic very fast. For our sector, 

I hope that all this translates into an 

increase in investments aimed at improving 

the structures, both in terms 

of human resources and plant engineering: 

our company has made a contribution 

in this regard and is ready 

to confirm its commitment. l 




Trends 

Bormioli Pharma accelerates on sustainability 

Bormioli Pharma, international 

leader in the production of glass 

and plastic containers for pharmaceutical 

use, announces an ambitious 

but concrete goal: to use 

50% sustainable raw materials, 

such as recycled plastic, bioplastics 

and glass from recycled sources, 

while manufacturing its products 

by 2025. With this commitment, 

the company will triple its 

current 16% use of materials with 

low environmental impact. 

Despite the highly regulated nature 

of the pharmaceutical industry, 

which makes change more complex, 

the sector seems to be ready 

to embrace the challenge of the 

ecological transition: according 

to a survey conducted by Bormioli 

Pharma on its customer base, 

more than 90% of companies in the 

pharmaceutical sector consider the 

quest for new sustainable packaging 

solutions a priority. 

This attention has already translated 

into an increase in sales of 

bottles, closures and accessories 

made from recycled or bio-based 

materials, which reached +50% in 

2020 and +130% in the last three 

years. These are significant results, 

that the company has been able 

to achieve thanks to the ability 

to combine sustainable materials 

with the high quality and safety 

standards required by the industry. 

“Sustainability is quickly entering 

the agendas of pharmaceutical industries 

around the world and, as 

primary packaging manufacturers, 

we feel the responsibility to sustain 

the industry in this transition, 

while supporting the health of people 

and the planet” commented Andrea 

Lodetti, CEO of Bormioli Pharma. 

“We have always invested in 

the research and development of 

concrete sustainable solutions, 

but today we want to make this 

commitment a differentiating element 

of our growth strategy, fixing 

it to medium-term objectives.” 

Thanks to several years of experience 

on sustainable materials, Bormioli 

Pharma can now offer up to 

ten different low-impact product 

ranges. Coming to recycled materials, 

in addition to a progressive increase 

in the share of recycled glass 

in its production, the company is 

able to offer plastic containers obtained 

from polymers from highly 

selected separate waste collection. 

As far as bioplastics are concerned, 

Bormioli Pharma markets containers 

made from residual fibers such as 

sugar cane or corn starch, some of 

which are completely compostable. 

Other solutions are currently being 

developed and tested, such as the 

creation of an innovative plastic 

made from carbon emissions recovery, 

the introduction of eco-design 

guideline that encourage a lower 

use of virgin materials, simplification 

of components and enhanced 

recycling. 

Romaco in Italy: Managing Director Paolo Naldi retires 

After 24 years at the helm of Romaco S.r.l., Paolo Naldi 

is now enjoying wellearned retirement. He was previously 

responsible for running the Romaco Group’s Italian 

production facility in Bologna, home of the Macofar 

and Promatic product brands. Mr. Naldi’s departure 

from the Board of Management marks the end of an era 

which dates back to 1997. A native of Bologna, he began 

his professional career in the late seventies with 

G.N.C. S.r.l., a North Italian manufacturer of 

pharmaceutical machinery. Yet after only a 

few years, Paolo Naldi left again in 1985 to 

set up his own company – Promatic – building 

electronic tablet counting machines. During 

the early nineties, he realigned Promatic’s 

product portfolio, focusing henceforth on the 

production of cartoners, case packers and final 

packaging solutions for the pharmaceutical, 

cosmetic and food industries. His strategy 

paid off: Promatic’s secondary and tertiary packaging 

solutions laid the foundation for today’s leading technologies 

in the global industry. In 1992, Paolo Naldi took 

the decision to sell Promatic to the Romaco Group. He 

was convinced that by integrating his business into such 

a successful global player, he would improve the sales 

prospects for his products and pave the way for stable 

economic growth. Since then, the Promatic cartoners 

have been available as stand-alone machines 

as well as in line with blister and strip packaging 

machines from Noack and Siebler and 

powder and liquid filling machines from Macofar. 

Five years on, in 1997, the Romaco Group 

management appointed Paolo Naldi as Managing 

Director of Romaco S.r.l. with responsibility 

for the Macofar and Promatic product 

brands. It was a role he fulfilled very successfully 

right up until his retirement in 2021. 


10_13_NEWS TREND (ATTUALITA).indd 10 31/08/21 09:45

Trends 

Bayer strengthens drug discovery through acquisition of Vividion 

Bayer AG announced the acquisition 

of Vividion Therapeutics, 

Inc. (Vividion), a US-headquartered 

biopharmaceutical company 

utilizing novel discovery 

technologies to unlock high 

value, traditionally undruggable 

targets with precision 

therapeutics. Vividion’s platform 

is able to produce a variety 

of small molecule therapies 

across indications, with initial 

focus on targets relevant to 

oncology and immunology. Vividion’s 

lead programs include 

multiple precision oncology 

targets and precision immunology 

targets, with ongoing 

efforts on a transcription factor 

NRF2 antagonist for the potential 

treatment of NRF2 mutant 

cancers, as well as NRF2 

activators for various inflammatory 

diseases such as irritable 

bowel disease – among other 

pre-clinical programs. 

Following closing of the acquisition, 

Bayer will own full 

rights to Vividion’s proprietary 

discovery platform, which 

comprises three integrated, 

synergistic components: a 

novel chemoproteomic screening 

technology, an integrated 

data portal, and a proprietary 

chemistry library. The acquisition 

of Vividion strengthens 

Bayer’s small molecule capabilities 

and expands Bayer’s reach 

into new modalities. Under the 

terms of the agreement, Bayer 

will pay an upfront consideration 

of USD 1.5 billion and 

potential success-based milestone 

payments of up to USD 

500 million. 

“This acquisition is a cornerstone 

of our strategy to fuel 

our pipeline with breakthrough 

innovation,” said Stefan Oelrich, 

Member of the Board of 

Management, Bayer AG and 

President of the Bayer’s Pharmaceuticals 

Division. “Vividion’s 

technology is the most 

advanced in the industry, and 

it has demonstrated its ability 

to identify drug candidates 

that can target challenging 

proteins. Together with Bayer’s 

existing know-how, we 

will be able to develop first-inclass 

drug candidates, increasing 

the value of our pipeline. 

We want to provide innovative 

therapies for patients whose 

medical needs are not yet met 

by today’s treatment options.” 

Identification of drug candidates 

for proteins that are 

considered undruggable is a 

great challenge in drug discovery. 

Vividion’s chemoproteomic 

screening platform is 

able to identify previously unknown 

binding pockets on 

well-validated protein targets 

by screening chemical probes 

against the entire human proteome 

to assess selectivity. 

Continuous Process Monitoring of 

Ozone, TOC and Conductivity 

AMI Codes-II O 3 

Colorimetric standard method according to DIN 38408-3, 

no sensitivity loss in absence of ozone. 

AMI LineTOC 

Early trend detection without laboratory measurements. 

Automatic System Suitability Test (SST) and calibration 

at minimized maintenance. 

AMU Pharmacon AMI LineTOC AMI Codes-II O 3 

AMU Pharmacon 

Conductivity transmitter according to USP in a 

standardized design and integrated temperature compensation. 

Swan Analitica Srl ∙ IT-16167 Genova 

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Pharmaceutical Water 

10_13_NEWS TREND (ATTUALITA).indd 11 31/08/21 09:45

Trends 

GSK and Vir Biotechnology announce agreement for COVID-19 treatment 

GlaxoSmithKline plc and Vir Biotechnology, 

Inc. announced they have signed a 

Joint Procurement Agreement with the 

European Commission to supply up to 

220,000 doses of sotrovimab, an investigational 

single dose SARS-CoV-2 monoclonal 

antibody for the treatment of 

adults and adolescents (aged 12 years 

and over and weighing at least 40 kg) 

with COVID-19 who do not require oxygen 

supplementation and who are at 

risk of progressing to severe COVID-19. 

The Joint Procurement Agreement enables 

participating European Union (EU) 

Member States to quickly purchase 

sotrovimab, following local emergency 

authorisation or authorisation at the EU 

level, to treat high-risk patients with 

COVID-19 who may benefit from early 

treatment with sotrovimab. 

This action follows the positive scientific 

opinion issued by the European 

Medicines Agency’s (EMA) Committee 

for Medicinal Products for Human 

Use (CHMP), under Article 5(3) of Regulation 

726/2004, which can be considered 

by the national authorities in 

EU Member States when taking evidence-based 

decisions on the early use 

of the medicine prior to marketing authorisation. 

Sotrovimab is included in the European 

Commission’s portfolio of promising 

candidate therapies as part of its COV- 

ID-19 Therapeutics Strategy. In addition, 

the documentation to support the 

forthcoming marketing authorisation 

application for sotrovimab is under rolling 

regulatory review with the EMA. In 

June, the companies announced confirmatory 

full results for the Phase 3 

COMET-ICE trial, which resulted in a 

79% reduction (adjusted relative risk 

reduction) (p

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10_13_NEWS Rif_Leopardo'21.indd TREND (ATTUALITA).indd 1 13 31/08/21 22/07/21 09:45 

10:03

Exhibitions 

Pharmaceutical and technical knowledge in New York 

International Pharmaceutical Expo 

(Interphex), the premier event 

dedicated to pharmaceutical, biotechnology, 

device innovation, 

technology and technical knowledge 

has opened registration for 

the 2021 show as it makes its return 

to the Javits Center in New 

York City, October 19-21. 

After an almost 2-year absence 

without the ability to hold a live 

event, Interphex is reuniting the 

global pharma, biotech, manufacturing, 

and device development 

industry in New York City at 

the Javits Center. Interphex is the 

event where the newest ideas are 

shared, technology is unveiled, 

and the power of science through 

commercialization comes to life. 

No matter where you are in the 

pharmaceutical supply chain, Interphex 

delivers relevant solutions 

through curated technical education, 

networking and over 550 

global suppliers to source quality 

product and services. 

What to Expect: 

• 3-Day Technical Conference 

Program: Once again, Interphex 

has curated an expert-led conference 

lineup focused on bringing 

industry experts together to share 

expertise and thought-leadership. 

Key focuses for the 2021 

program includes: Process Development, 

Automation, Cell and 

Gene Therapy, Pharma 4.0, Project 

Pivot, and more. 

• Interphex Live Broadcast: Back 

by popular demand—Interphex 

Live presents a moderated panel 

with leading speakers to develop 

a year-round video series, available 

on-demand, 24/7/365. This 

year, Interphex Live sessions will 

be streamed live and broadcasted 

during the show on Reconnex 

365—the year-round repository 

for industry content and supplier 

sourcing. 

• ATS Automation Forum: In- 

Booth Presentations and demos 

around the improvement of automation 

performance presented 

by ATS, each day of the show. 

• Enhanced show planning and 

year-round experience with Reconnex 

365: Leverage Reconnex 

365 to supplement the at-show 

planning process and the power 

of the Interphex community. 

The content hub and supplier 

and product repository allows 

for the ultimate experience with 

Interphex, housing past technical 

conference sessions, leading 

exhibitors, appointment setting 

features to create meetings 

and foster networking, and 

more. Learn more about Reconnex 

365 and be a part of the 

community. 

Cleanzone paused in 2021 

Messe Frankfurt has decided to pause Cleanzone this year. 

The international trade fair for cleanroom and cleanliness 

technology, hygiene and contamination control was originally 

scheduled to be held in Frankfurt am Main on 24 and 

25 November 2021. 

Kerstin Horaczek, Vice President Technology Shows of Messe 

Frankfurt, explains: “We did not take the decision to postpone 

this year’s Cleanzone lightly, particularly in view of 

the fact that we are planning a number of physical events – 

both Messe Frankfurt and guest events – in the second half 

of the year. Nevertheless, the clean-room sector is facing a 

great challenge at present: business in clean-room technology 

is booming. Moreover, due to the pandemic, new fields 

of business, such as vaccine production, are being added. In 

turn, however, this means that the companies’ order books 

are so full that many of them do not have the spare capacity 

needed to organise a trade-fair presentation.” 

Although developments in the immunisation field have 

been extremely good, the pandemic continues to cause 

uncertainty, in particular among many international visitors, 

about attending trade fairs. Cleanzone is a special-interest 

event meaning that this situation is likely to have a 

greater impact on visitor numbers than in the case of bigger 

events. This has impacted negatively on the uncertainty 

of many participants from the sector about taking part 

in Cleanzone 2021. 

Messe Frankfurt will work closely together with the Cleanzone 

Strategy Commission and evaluate the multifarious 

lessons learnt during the pandemic and employ them for future 

editions of Cleanzone. The nine members of the Strategy 

Commission advise the fair and exhibition company 

about general strategic questions relating to clean-room 

technology and provide support for the orientation of the 

event’s content. Together with its partners from the industry, 

Messe Frankfurt will push ahead with the development 

of Cleanzone. 


14_17_NEWS EXIBITIONS.indd 14 31/08/21 09:49


Exhibitions 

Achema in Frankfurt until at least 2027 

Messe Frankfurt and Dechema are extending 

their cooperation. The Frankfurt exhibition 

grounds will remain the venue for 

Achema, World Forum and Leading International 

Trade Fair for the Process Industry, 

until at least 2027. 

As the organiser of Achema, Dechema Ausstellungs-GmbH 

has decided to continue the 

successful partnership with Messe Frankfurt, 

which has already existed for over eight decades. 

Achema has a three-year cycle. The 

event planned for 2021 had to be postponed 

due to the pandemic and will take place from 

4 to 8 April 2022; the following events will 

be held in 2024 and 2027. 

“Achema is one of the largest and most important 

guest events in our portfolio and a 

flagship for Frankfurt as a trade fair location. 

That is why we are very pleased about 

the long-term continuation of this partnership. 

Particularly in the current extraordinarily 

challenging times for the trade fair 

and event industry, we are sending a clear 

signal with this contract extension - a signal 

for the future of high-quality, international 

events and personal encounters”, 

says Uwe Behm, Member of the Board of 

Management of Messe Frankfurt. Dr. Thomas 

Scheuring, Managing Director of Dechema 

Ausstellungs-GmbH, emphasised the optimal 

infrastructure that makes the Frankfurt 

trade fair venue the ideal venue for the 

process industry in the chemical, pharma 

and related industries: “The Frankfurt exhibition 

grounds with its state-of-the-art 

facilities and ideal location are a factor in 

Achema’s success. We very much welcome 

the fact that we will be able to use this 

success factor in the future and continue 

our successful partnership.” 

Achema was initiated in 1920 and has 

been held at the Messe Frankfurt exhibition 

grounds since 1937 and is one of the 

most traditional and international guest 

events in Frankfurt. At the last edition of 

Achema in 2018, around 3,800 exhibitors 

from 55 countries presented products, processes 

and services. 144,628 participants 

from 150 countries travelled to the Main 

at that time. 

AGENDA 

International Chemical Industry Fair 

September 15-17 2021 

Shanghai, China 

en.icif.cn 

OMC 


Ravenna, Italy 

www.omc2019.it 

Chemspec Europe 


Franfkurt, Germany 

www.chemspeceurope.com 

Valve World Americas Expo 

& Conference 

October 13-14 2021 

Houston, Usa 

valveworldexpoamericas.com 

Interphex 


New York, Usa 

www.interphex.com 

Ecomondo 


Rimini, Italy 

www.ecomondo.com 

Key Energy 


Rimini, Italy 

www.keyenergy.it 

Farmaforum 

November 3-4 2021 

Madrid, Spain 

www.farmaforum.es 

CPhI Worldwide 


Milano, Italy 

www.cphi.com 

Pharmtech & Ingredients 


Moscow, Russia 

www.pharmtech-expo.ru 

mcT Petrolchimico 

November 25 2021 

Milano, Italy 

www.mctpetrolchimico.com 

Cosmopack 

March 10-13 2022 

Bologna, Italy 

www.cosmoprof.com 

Cosmoprof Worldwide 

March 10-14 2022 

Bologna, Italy 

www.cosmoprof.com 

Achema 

April 4-8 2022 

Frankfurt, Germany 

www.achema.de 

Packaging Première 

May 24-26 2022 

Milano, Italy 

www.packagingpremiere.it 

SPS Italia 

May 24-26 2022 

Parma, Italy 

www.spsitalia.it 

IVS 

May 25-26 2022 

Bergamo, Italy 

www.industrialvalvesummit.com 

Analytica 

June 21-24 2022 

München, Germany 

www.analytica.de 

Powtech 

August 30 – September 1 2022 

Nürberg, Germany 

www.powtech.de 



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Life science 

Teresa Minero, 

Founder 

& CEO 

of LifeBee 

Along the path 

to digitalizing 

life sciences 

LifeBee - Digitalizing Life Sciences: 

Consulting and Digital Solutions supporting 

Chemical, Biopharmaceutical, Medical, 

Nutraceutical and Cosmetic 

companies along the path towards 

digitalization, proactive compliance 

and business excellence. 

LifeBee was founded in Milan 

18 years ago in April 2004. 

Based in Milan (Italy) with 

a branch in Switzerland (Lugano), 

today it includes over 

50 professional experts with in-depth 

skills related to typical specific of Life 

Science knowledge and associated digitalization; 

counting over 70 international 

companies as valued clients. 

We met Teresa Minero, Founder & CEO 

of LifeBee, sharing with us the proposition 

of the company she founded. 

Minero is one of the Directors of the 

Board of ISPE, leading the Steering 

Committee Pharma 4.0 Global Special 

Interest Group and part of the European 

Leadership Team. 


18_21_ART_LIFEBEE.indd 18 06/09/21 10:34

Life science 

Elvis Graffeo, 

Partner 

at LifeBee, 

Serialization 

& Operation 

BU Lead 

Marco Torciani, 

Partner at 

LifeBee, Quality, 

Regulatory & 

Pharmacovigilance 

BU Lead 

Raffaella Vaiani, 

Partner 

at LifeBee, 

Laboratories 

BU Lead 

Focus on compliance 

“Our main goal is to always excel 

in pharmaceutical processes, meaning 

efficiency, effectiveness, robustness, 

continuous improvement, sustainability 

and compliance. I emphasise 

compliance because our focus is 

on the GxP regulated areas of Production, 

Quality Assurance, Laboratories, 

Logistics, Serialization, Regulatory 

Affairs and Pharmacovigilance. 

Regarding Consulting activities, Life- 

Bee operates through a strict process 

review in terms of Lean and Operational 

Excellence, Process Optimisation, 

GxP Compliance, Data Integrity 

and Digital Innovation. 

We believe that our uniqueness lies 

precisely in working with an integrated 

approach on processes, digitalization 

and compliance, and to do so with 

one eye on short term return in a longterm 

strategy in a step by step approach. 

We do so with a focus on sustainability 

of the projects we propose 

and develop. That is to say, meeting 

the constraints of financial resources 

and structure, formulating a solution 

that is best suited to customer requirements 

based on our experience and 

supported by the innovative thinking 

of our experts. 

I like to define LifeBee approach as 

‘boutique consulting’: we operate like 

seamstresses to tailor our services to 

clients demands as if we were to make 

‘clothing patterns’ when we create a 

strategy and offer consulting, we ‘sew’ 

to carry out System Integration and 

Digital Delivery, using the best ‘fabrics’ 

- market leader software products. 

All consistently tailored to the customer, 

to their needs and budget. 

This distinction has also been recognised 

by Gartner, one of the leading 

market analysts, who in 2018 and 

2019 cited LifeBee, (currently the only 

Italian consulting company, among 

the ‘Vendors in Regulatory Compliance 

- Service and Integration’) for 

serialization in the ‘Gartner for Supply 

Chain Leaders Toolkit’ report”. 

Spanning projects from Consulting 

to Digitalization 

“The projects we carry out are multiple 

and varied, both for Consulting 

and for Digitalization. 

To be precise, we would like to share 

few examples of achieving tangible 

results and meeting time constraints 

in production and laboratories in the 

pharmaceutical factory: 

• reducing review time of a production 

or analytical record batch up 

to 70%; 

• increasing the adherence of quality 

control laboratory responses towards 

the release plan - up to 80%; 

• the reduction of the Cycle Time for 

the analysis of samples - up to 20%. 

On the Consulting side, an important example 

of our projects would be the design 

of a multi-year digital strategy for a 

medium-sized pharmaceutical company. 

In fact, the need to plan for complete 

digital transformation and 4.0 is continuously 

growing. As a result also 

of the ongoing pandemic, Life Science 

companies are beginning to understand 

how digital technologies can 

bring previously unexpected and unknown 

benefits - in which the digital 

maturity of medium-sized Italian companies 

in the sector is certainly not 

homogeneous. We find ourselves with 

extremely innovative circumstances 

and others less innovative. 

An awarded 

company 

LifeBee is the only Italian 

consulting firm mentioned 

consecutively in 2018 

and 2019 by Gartner as 

a “Representative Vendor 

for Service and Integration 

- Serialization”. 

Over the years, LifeBee has 

been awarded for the value 

of its work and the uniqueness of its Proposition; 

only recently it has received recognition 

as “Top Laboratory Automation Solution Provider 

in Europe for 2021” recognised by Pharma 

Tech Outlook, and Teresa Minero has been 

awarded as one of the TOP 25 Healthcare 

Technology CEOs for Europe in July 2021, by 

The Healthcare Technology Report. 



18_21_ART_LIFEBEE.indd 19 31/08/21 09:52

Adver 

Life science 

“Laboratory workflow, 

quality assurance, logistics, 

pharmacovigilance 

and regulatory contain specific 

regulations and a strong impact 

on product quality” 

This depends the vision of the entrepreneur, 

the opportunities that have 

been created, sometimes even in the 

face of rigorous (but forward looking) 

inspection of regulatory bodies that 

have led to change and innovation. 

We are applying our methodology 

to multiple areas, which allows us to 

build a digital roadmap tailored to 

companies which represents a guide 

for different implementation phases, 

establishing priorities and objectives 

to be achieved from the outset. The 

study phase takes a few weeks, while 

the completion of the various digitisation 

projects timelines can vary from 

a duration of 18 months to 2-3 years, 

based on the starting digital maturity, 

allowing tangible results even from 

the early stages of implementation. 

On the aspect of Digitalization, we 

always remind ourselves it has to be 

a “modus operandi” and never the 

ending, I will mention a project that 

we carried out for two plants which 

are part of a large Italian company. 

We began with a shared strategy 

in digitisation and integration between 

automation and factory applications. 

Very different ‘piece of clothing’, 

one Chemical and the other 

Pharmaceutical, they both 

wished to highlight 

the performance data 

of the lines, support 

detailed planning 

and collect 

the critical parameters 

of the production 

lots - which in a 

first phase of the project 

go towards forming 

a report to be attached to 

the batch-report and acceler- 

ate the batch-review process. In the 

final stage of the project, they will 

lead to the creation of entirely electronic 

lot documentation. This is a 

typical example of a fully sustainable 

concrete approach, taken on in successive 

stages with practical benefits 

for the user at each stage. 

Regarding the sector associations, Teresa 

Minero has been an active part of 

ISPE for many years - the largest global 

non-profit association that brings together 

Life Science professionals. 

She is now in the EU Leadership Team 

and a member part of the Steering 

Committee in the Global Board, in 

which she operates as a Pharma 4.0 

leader and reference point. 

“Pharmaceutical, chemical-pharmaceutical, 

biotechnological and medical 

sectors are adjoining sectors, 

with extremely stringent common 

regulations, but also differing management 

needs. A differentiating element, 

for everyone, is to have a patient 

and not just a simple consumer 

at the bottom of the value chain” 

– explains Teresa Minero. 

“Laboratory workflow, quality assurance, 

logistics, pharmacovigilance and 

regulatory contain specific regulations 

and a strong impact on product quality. 

The different rules to be followed 

in case of exporting to multiple countries 

also constitute a commitment in 

terms of managing processes, requiring 

time and cost optimisation. Sense 

of responsibility, practicality combined 

with vision, passion and reliability 

are the strengths of LifeBee” – 

continues Teresa Minero. 

Evolution of Pharma 4.0 

According to Teresa Minero, digitalization 

in the Pharma sector represents 

an important step: “The results 

of a survey we conducted, which 

comprised of more than 400 responses 

from 52 countries, highlighted the 

evolution of the Pharma sector in key 

Industry 4.0. There is a progressive 

shift from a technical to a tactical 

plan and from a tactical to a strategic 

plan. This means that these days 

those who adopt a new technology 

often do so to solve a specific problem. 

Those who choose a broader 

perspective, medium-long term, intend 

to improve processes using the 

enabling technologies of 4.0. Cloud, 

mobile, collaboration platforms are 

now used at a broader scale. Enabling 

technologies such as big data, 

advanced robotics, advanced analytics, 

the internet of things can 

be found in many projects, but are 

not so widespread, probably because 

there are still issues in validating 

systems based on new paradigms. 

Technologies such as artificial 

intelligence, additive manufacturing, 

digital twins, augmented virtual 

reality and block chain are often 

still only being examined”. 

There are many challenges for the future, 

from managing vaccines for the 

ongoing pandemic to improving the 

supply chain and on to regulatory 

harmonisation. 

To this end, LifeBee sets its sights 

once again on foreseeing Life Science 

sector needs and therefore 

adding an extra gear to the digital 

transformation of processes in 

order to bring value to its customers 

with forward thinking projects, 

which guarantee concrete results at 

each step. 

l 


18_21_ART_LIFEBEE.indd 20 31/08/21 09:52

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18_21_ART_LIFEBEE.indd 21 31/08/21 09:52

Technologies 

Sealing systems resistant to chemical aggressions 

Texpack is a manufacturer of packings, 

tapes, twisted ropes, cloths and 

sleeves, for thermal insulation with 

dynamic use, of pumps and valves. It 

produces and markets industrial gaskets 

of different types and sizes, offering 

a complete range of sealing 

systems and products for high temperatures, 

as well as a range of products 

for the maintenance of fireplaces 

and stoves dedicated to the consumer 

market. 

The pharmaceutical sector, as well as 

the chemical sector, revolve around 

two macro themes, namely certifications 

and chemical aggressions. 

Texpack realizes applications for 

these sectors, with the reference 

certifications, which are normally 

FDA and MOCA, as automatic machines, 

such as filling, dosing machines, 

treat products, and therefore 

must comply with the specific legislation 

on materials and objects in 

contact with foods. 

Texpack seals and solutions for the 

pharmaceutical industry are resistant 

to high and low temperatures, 

abrasion and a wide range of aggressive 

chemicals used in sanitation 

and sterilization processes. 

5211 - Jointex Red 

High quality jointing sheet made 

with pigmented, quartz fillers. It 

is an innovative replacement material 

for asbestos seals and conventional 

products in PTFE. 

Its special production process ensures 

that the Jointex® gaskets 

have excellent creep resistance 

and tightness with a wide range of 

temperatures and pressures. Other 

features include excellent chemical 

resistance and good compression 

strength; it offers resistance 

to deformation and does not age. 

9TX - Spiral-Wound Gaskets 

The spiral-wound gaskets are made 

of metal tape with a specially 

shaped profile coupled with a filler 

tape (graphite, ceramic or glass 

fibre, PTFE or mica), both uniformly 

wound with constant 

winding tension. 

The unique metal profile has 

an elastic action that guarantees 

a perfect seal under all fluctuating 

temperature and pressure conditions. 

They can be assembled to a centring 

ring that may be external, internal 

or both. The rings are used 

for precise purpose: the inner ring 

has an antiturbulence function, 

since it usually has an internal diameter 

equal to the internal diameter 

of the flange. It prevents 

the deposition of material in the 

gap between flanges and is normally 

constructed with the same 

material as the spiral, so it protects 

it against corrosion and eliminates 

any flange erosion. The outer 

ring serves as a centering device 

between the bolts, prevents lateral 

expansion of the seal and serves 

as a reference shim for correct assembly. 

4131A - PTFE FDA 

This is a packing composed of pure 

PTFE yarns, which is impregnated 

yarn-by-yarn with PTFE dispersion, 

and formed using a diagonal braiding 

method. It has a low coefficient 

of friction and is resistant to aggression 

by chemical products. 

- Complies with the EC 1935/2004 

standards 

- Complies with the FDA 21CFR177.1550 

standards 

- BAM approved for gaseous oxygen 

and liquid oxygen Nr 2-2019/2012 E 


22_23_NEWS foto texpack.indd 22 31/08/21 09:54

Technologies 

6808GMF - Metaltex MF 

METALTEX® MF is a high-quality-three 

component gasket made 

from flexible natural graphite, 

stainless steel and PTFE. Metaltex 

MF combines the advantages 

of the sealing properties of three 

materials in one product. Owing 

to its expanded graphite core displays 

high long-term stability, and 

adapts well to uneven flanges. 

The reinforcing stainless steel 

sheets ensure the high mechanical 

strength of the gasket. Due 

to the stainless steel/PTFE-foil 

top layers, Metaltex MF separates 

with ease from flanges 

and leaves no residue. Nothing 

sticks to the flanges, whether 

at room temperature or at 300°C. 

There is no time-consuming cleaning 

of the flanges. Maintenance 

time and the risk of scratching the 

flange faces reduces significantly. 

The operator saves time and money 

with every gasket change. Moreover, 

the stainless steel/PTFE-foil 

top layers together with the inner 

eyelet provide excellent sealing 

properties. 

5700C - PTFE envelope gaskets 

for fittings clamp 

Clamp Texpack® gaskets are used 

as sealing elements between two 

stainless steel clamp fittings (ferules) 

sealed with a special collar, 

where no bolts are required. The two 

semi-spheres placed on both surfaces 

of the gasket allow for self-centring 

and perfect coupling with the 

groove present on both “ferules”. 

Clamp gaskets can be made of PT- 

FE, modified PTFE and PTFE with 

rubber insert. They are particularly 

used in laboratory equipment where 

cleaning, hygiene and sterilization 

requirements must be met because 

they ensure easy cleaning and rapid 

replacement of the gasket. 

For further information: www.texpack.it, 

info@texpack.it. 

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22_23_NEWS foto texpack.indd 23 31/08/21 09:54

Engineering 

Always close to the needs 

of the pharmaceutical process 

CSV Life Science has even grown during the health emergency, 

guaranteeing a continuous and complete service for pharma companies. 

The increase in the production capacity, training and strengthening 

of the presence abroad, with a focus on Africa and the Middle East, 

are some of the themes touched on in this interview. 

In the opening 

picture: a HVAC 

system by CSV 

Construction 


CSV Life Science Group over 

the years has developed 

a group of companies and 

highly qualified staff capable 

of providing integrated solutions 

to the pharma industries, extending 

its range of services. In addition 

to the core business - validation, 

designing and facility planning - today 

CSV Life Science Group offers construction, 

containment and brokerage 

services for the active pharmaceutical 

ingredients market as well as process 

plants through its CSV Construction, 

CSV Containment, CSV Active e 

Pharma Hub divisions. At the core of 

the project however the only global 

brand remains, that is CSV Life Science 

Group, a company that currently 

employs in total about 120 internal 

employees, plus external consultants 

and collaborators. In line with the 

growth recorded in 2020, the Group 

hired figures to be placed in strategic 

roles in every business even in 

the middle of the pandemic, from process 

engineering to more operational 

activities, such as those connected 

to validation and worksite management. 

The mission is to continue 

approaching tailoring as much as possible 

to the needs of the clients’ pro- 

cess. These are the premises of this 

meeting, that takes place in the head 

office of via Selvanesco in Milan, with 

the Sales Manager Claudio Fabiano. 

The Group is growing, so much that 

it expanded its personnel even during 

the health emergency. Usually, 

are the new employees already 

highly qualified or do they still 

need to be trained internally? 

Both conditions are possible. Firstly, 

it’s necessary to establish the benchmark 

that identifies a Senior employee. 

We note that on this point the market 

offers various different interpretations. 

CSV is proud of the reputation 


24_27_ART CSV.indd 24 31/08/21 09:56

Engineering 

it managed to establish over years of 

work and we know that this forces us 

to become more and more demanding 

as regards every single individual’s 

professional qualities. Newly hired 

employees are introduced to an organized 

and well defined iter before being 

allowed to act independently. 

CSV Life 

Science Group’s 

service range 

So the Group manages some inhouse 

training courses… 

Yes, along with Elena Disperati, a 

Marketing Assistant, we created the 

dedicated brand CSV Training Academy, 

that is aimed at the multitude 

of professional figures who operate in 

the sector and at international bodies 

and institutions. The pandemic 

didn’t slow down our training activities, 

in fact we got excellent results 

with online training. We still hope 

to be able to restart our face-to-face 

training activities with the right intensity 

soon. 

Did health crisis have negative effects 

on any sectors you focus on or 

even to your own operation? 

A few construction sites had to close 

down temporarily, or at least slow 

down, during the strictest lockdown 

phase, but after that they restarted 

and made up the delay. It should be 

noted that in the markets closest to 

us, the focus is on safety, with the 

adoption of measures, behaviours 

and devices aimed at minimizing the 

risk of contagion. We have involved 

a healthcare professional that takes 

swabs regularly at our locations for 

employees who travel and anyone that 

needs one. After all, we chose to continue 

working out in the field not only 

because some activities require it, 

but also because of our willingness 

to provide full support to our clients. 

Instead, for commercial agreements 

we’ve widely made use of remote 

communication platforms. Our clients 

have appreciated this management of 

movements, because they felt assisted 

even during the periods of harshest 

restrictions. We believe that business 

continuity is a non-negotiable pillar 

of the modern approach to the pharmaceutical 

market. And business continuity 

is basically built on the supplier’s 

responsiveness and the quality 

of the response. It was not by chance 

that at the end of the first wave of the 

pandemic many customers were asking 

their partners for an emergency 

management plan in case the conditions 

of March 2020 reoccurred. We 

prepared ourselves. 

Taking into account the necessity 

of on-site presence, do you believe 

Containment “on the road” 

CSV has started a path along the most important Italian regions 

for the pharmaceutical sector, a real road show that 

involves closely the relevant companies. The intent is to 

shorten the distances that were imposed for a long time by 

the pandemic, in a different and more direct mode compared 

to digital communication platforms. The protagonist 

of the itinerant initiative is the Containment division, that 

in the past years has greatly increased the range of projects 

and products. The Group’s most recent and innovative 

containment solutions will be readily available for comparisons, 

assesments and discussions of their application 

possibilities with companies. 

“Starting in April from Piedmont and Liguria, the tour will 

touch the main regions of Italian pharma, such as Lombardy 

and Lazio, but also Campania and Sicily,” explains 

Elena Disperati, Marketing Assistant. “The event promoter 

is our Product Specialist Roberto Furlan, who brings directly 

our technology to companies, recovering a place for 

meetings and exchanges that the virus took away from us 

for too much time, obviously with all due respect for safety 

protocols.” 

Companies can require a visit by writing to containment@ 

csv-ls.com. 


24_27_ART CSV.indd 25 31/08/21 09:56

Engineering 

Double chamber 

dispensing 

isolator 

manufactured 

by CSV 

Containment 

that digital platforms are useful to 

support validation work? 

Look, during the period of highest 

use of digital platforms, we managed 

to run some Factory Acceptance 

Tests online, for example for some of 

our containment systems for the foreign 

market. Specialised professionals 

developed a digital system for us 

that includes the placement of cameras 

around the plant and in the operator’s 

smartphone, allowing the client 

to observe even the details of its 

operation from their office. In addition, 

we happened to go to important 

Italian machinery suppliers to 

run some FATs for foreign pharmaceutical 

companies, which were unable to 

reach Italy themselves. But these are, 

I must say, exceptional cases. I don’t 

think that online methods will prevail 

for FATs and testing. Obviously these 

methods will become useful in preparatory 

or complementary phases for 

FATs, reducing times and costs. 

Is the pandemic changing the pharmaceutical 

market? 

I find it important that this terrible 

experience has pushed many operators 

and institutions to talk about reshoring 

and hence the return of some 

strategic production lines within the 

borders of the EU. I think that the initial 

confusion caused by the lack of 

goods necessary for the citizens’ safety, 

because of their production elsewhere, 

will boost Europe to take measures, 

even if it won’t be an easy and 

instantaneous shift. The case of the 

masks was particularly striking, but 

I’m also thinking of the importance 

of returning to produce some active 

ingredients and of investing in the development 

of vaccines domestically. 

Speaking of Covid19 vaccines, are 

you involved in the planning of new 

plants? 

Certainly: we’re following the planning 

and fine-tuning of processes that are 

part of various Covid19 vaccine production 

lines in Italy, in the rest of 

Europe and in some African countries 

where the pharmaceutical industry already 

has a high production capacity. 

Do you think that the production 

of vaccines to control the epidemic 

will remain strategic also in the 

coming years? 

Yes, also because the authorities have 

realized the importance of relying on domestic 

production. At the moment nobody 

knows what will happen and when 

and whether Covid will become endemic. 

What is certain is that it is decisive to 

guarantee short response times, something 

which requires having in-house 

know-how. I hope in Italy research investments 

restart in a robust way. 

Is there something to further improve 

in the following months? 

We will continue with internationalization, 

a process that actually has 

already been in progress for years. 

We’re interested in bringing our expertise 

more and more abroad, where 

the solutions and services we offer 

are very much appreciated. Naturally 

every market has different characteristics: 

in some, especially in Europe, 

we’re growing very quickly regarding 

containment systems and process development; 

elsewhere, especially in 

less mature markets, we’re stronger 

in engineering services. The important 

thing for us is to create a widespread 

presence that allows us to re- 

spond promplty to the region’s specific 

requirements, creating opportunities 

for CSV Life Science Group’s 

entire product range. We’re also weaving 

close relationships in some continents, 

for example through the partnership 

with a South African company, 

that provides us important support 

for the whole market, which we 

strongly believe in. 

Other goals? 

We’re investing in production capacity 

by increasing personnel and available 

spaces. Recently we purchased a new 

structure dedicated to production and 

assembly of technologies for flexible 

and rigid containment, providing another 

important growth indicator. The 

area is near Alessandria, where we’ve 

had an isolator production plant for 

years. We’re hiring young local resources: 

some recent additions are a mechanical 

designer and a engineering draftsman. 

Today about 25 people gravitate 

around the Piedmont-based centre dedicated 

to the containment division, bolstered 

by the experts that operate transversally 

between the divisions. 

Has the cancellation and postponement 

of many events in the past 

year and a half caused problems to 

your business? 

It hindered the possibility of deepening 

relationships cultivated over time. 

I consider trade fairs to be a very useful 

moment of encounter, although it’s 

necessary to accurately select them. 

Now we’re focused on Interphex New 

York in October and CPhl Milano in 

November but we’re also thinking of 

Achema Francoforte where we will be 

present in April 2022. 

With certainly different markets and 

target audiences, the aformentioned 

trade fairs are for us the events that 

will show off the actual technological 

innovations dedicated to sectors that 

concern us. 

l 

C 

M 

Y 

CM 

MY 

CY 

CMY 

K 


24_27_ART CSV.indd 26 31/08/21 09:56

C 

M 

Y 

CM 

MY 

CY 

CMY 

K 

Valves and systems to control 

and dose powder and granule flow 

in Pharmaceutical and Chemical industry 

24_27_ART CSV.indd 27 31/08/21 09:56

Engineering 

A multidisciplinary approach 

to the process 

Chemprod accompanies customers from the feasibility study up to detailed 

engineering including assistance in the construction phase. In over 25 

years, Chemprod has become a multidisciplinary engineering company on 

different areas, featuring an important growth in the pharma sector. 


Deeply rooted in Process Engineering, 

Chemprod has developed 

in time several specializations 

that represent the 

skills needed for plant engineering 

and development in different 

technical areas. Engaged on many 

fronts – from oil&gas to petrolchemical 

plants, from fine chemistry to pharma 

plants up to water treatment – for over 

25 years Chemprod has been a partner 

specializing in the process, capable of 

accompanying customers from the feasibility 

study up to detailed engineering 

including assistance in the construction 

phase. In July we met Dario 

Morandi, Chemprod Account and Sales 

Manager. He represents the family’s 

second generation and he manages the 

company together with his father and 

President, Daniele Morandi, who founded 

Chemprod in 1995. 

Dario Morandi, why is it so important 

to focus on a multidisciplinary 

approach? 

First of all because, unavoidably, a plant 

engineering and development require 

skills from different worlds. We start 

from process engineering, that defines 

Dario 

Morandi, 

Chemprod 

Account 

and Sales 

Manager 

how the whole plant should be developed: 

from entrance to exit, from raw 

material to the end product. After this 

engineering stage, process is configured 

and the whole work is planned 

with the key contribution of the other 

disciplines, for instance piping, mechanics, 

the electric section, control instrumentation, 

automation. We started 

over 25 years ago as a process engineering 

company. Over the years, following 

market demands, we have extended our 

expertise in the different disciplines required 

to manage a whole project, enhancing 

above all our know how in the 

instrumentation and piping fields. 

As well as internal skills, did you also 

extend your reference sectors? 

Yes we did it immediately. We thought 


28_31_ART_CHEMPROD.indd 28 31/08/21 09:58

Engineering 

it was strategic to vary the applications 

fields, both to increase our knowledge 

of different markets and not to be damaged 

by periodical crisis some of them 

may go through. 

What about your main clients? 

We work a lot with big engineering companies, 

but also with end users. Pharma 

companies are also very important 

for us and we assist them throughout 

the whole project, from the feasibility 

study up to detailed engineering to 

build the plant. 

Has your presence in the chemical 

and pharma industry been growing 

over the latest years? 

There is no linear trend, it depends on 

market trends. For instance in 2017, 

pharma was a crucial sector for us. On 

the contrary in 2020, it reduced its technological 

investments, on the one side 

to limit the access of external workers 

in its own facilities to comply with anti-contagion 

regulations, and on the 

other because manufacturers fully exploited 

existing lines without having 

time to stop either to expand or to 

modernize them. Yet recently, this situation 

has changed: times and resources 

to start interventions and adapt productions 

broke free. On the other hand, 

today especially engineering companies 

have suffered a decline. 

Pandemic seems to accelerate the 

transformation of a few markets. 

One of our prerogatives is to know how 

to adapt fast to changes in progress, 

as well as to new types of customers 

and activities. Our story, deeply rooted 

“We started over 25 years ago 

as a process engineering company. 

Over the years, following market demands, 

we have extended our expertise 

in the different disciplines required 

to manage a whole project” 

in process engineering, offers us completeness 

and versatility to face problems 

and different applications more 

easily. 

In the last year, what share of your 

business the end users represented? 

About 30%. It is a share we’d like to 

increase, also because working with 

the end user is often creative and fulfilling, 

as against to join engineering 

projects that are already config- 

Endless future: planning and building up our future, today 

Chemprod, that has recently celebrated 25 years of activity, 

collaborates with Cittadellarte – Fondazione Pistoletto, 

adopting Michelangelo Pistoletto’s “Third Paradise” 

symbol. It actually contains a vision of the world including 

the values that have always inspired Chemprod, first 

of all technology and ethics. Within technology, engineering 

eclecticism and flexibility are the company’s strengths. 

Chemprod today deals with plant engineering for many 

industries, including chemistry, with a rigorous approach, 

targeting the most advanced technologies and focusing 

on environment-related issues. Yet Chemprod thinks that 

technology cannot exist without ethics. Thus project quality 

and reliability are its priorities, the effects of a philosophy 

with the person at the center. Even in this critical period 

for economics, Chemprod decided 

to invest on job, safeguarding the employment 

levels and company skills to 

always ensure the best to customers. 

“The Third Paradise is the big legend 

that brings everyone to take personal 

responsibility in the global vision” wrote 

Pistoletto in 2003. “Paradise originates 

from the ancient Persian language and 

means ‘protected garden’. We are the 

gardeners who must protect this planet and care for mankind”. 

Today’s choices are crucial for the future of mankind 

and the world: technology and ethics must find out a 

new synthesis to improve everybody’s life conditions. It’s 

a question of responsibility. These are the vision and the 

values that Chemprod projects on a fast-changing world: 

an ethical, ecological and sustainable approach for a virtuous 

development model, in which creativity and technology 

involve a renewed dimension of life. 

The meaning of Chemprod’s participation and support to 

the activities carried out by Cittadellarte-Fondazione Pistoletto 

lies in the sharing of ideals, in the research of new 

spurs and opportunities to reflect on your job. According 

to Daniele Morandi, Chemprod Founder and President, 

Michelangelo Pistoletto’s Third 

Paradise is a perfect synthesis of the 

challenges we must face in our present, 

the wish and the need to make 

progress building up a better harmony 

between technology and the environment. 

One does not exclude the other 

and the former must not prevail on 

the latter. It has always been our philosophy: 

today more than ever. 



28_31_ART_CHEMPROD.indd 29 31/08/21 09:58

Engineering 

ured by big companies. Taking into account 

the end users’ needs, Chemprod 

can evidently show its identity since 

the very first meeting up to the single 

detail and aspects related to documentation. 

Our standards, for instance, on 

graphic symbols and terms relating to 

the plant are often appreciated and at 

last adopted by the customer itself. 

Moreover working with the user requires 

a constant presence in the facility, 

where we relate with technical 

contractors who dealt with the construction, 

intervening with our specialists 

to correct their errors in the 

assembly stage. 

What problems are you meeting today 

in a plant engineering? 

Delivery times are increasingly reduced, 

but our organization and efficiency enable 

us to respect them. Moreover, a lot 

of effort is needed in the initial phase 

to collect the required documents to 

correctly set up the job. Chemprod is 

very rigorous about that, as well. 

How is ecological and energy transition 

influencing your business? 

In the environmental sector we have 

been engaged for a long time, for instance, 

with projects for wastewater 

treatment, whose demand is constantly 

growing. Yet requests even in the field 

of waste disposal are growing, as well 

as in the reduction of emissions, CO 2 

storage, heat recovery and energy efficiency. 

All of these points today are 

“One of our prerogatives 

is to know how 

to adapt fast to changes 

in progress, as well 

as to new types of 

customers and activities” 

faced in a careful way from the preliminary 

discussion of a project. This is a 

sensitive theme, that also regards the 

image a company aims at offering. 

Did you miss exhibitions and trade 

shows? 

We actually missed human relationships, 

that are key in the relationships 

with markets. Exhibitions boost us to 

create contacts, to innovate, to test 

new partnerships. Otherwise we risk to 

focus only on what is already known. 

What would you like to improve? 

There is always something to improve. 

Aiming at a higher commitment with 

the end users, we’d like to further increase 

the specific weight of a few key 

disciplines, such as piping and go on 

developing skills on software systems 

and the most innovative technologies: 

I’m thinking about laser scanners 

that substituted manual surveys, 

dramatically speeding up times, or 3D 

modelling, that enables to check in 

the engineering phase what will happen 

to the future plant when it comes 

into operation. 

l 


28_31_ART_CHEMPROD.indd 30 31/08/21 09:58 

ICF232

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ICF232x285.indd 28_31_ART_CHEMPROD.indd 1 31 08/07/21 31/08/21 15:29 

09:58

Machines 

High know-how in solid 

handling technologies 

At CPhI Nuova Guseo will present some typical examples 

of its product range, like equipment for mixing and grinding 

and variously configured containment systems. 

Double 

chamber 

isolator for 

weighing 

and bagging 

activities 

In the field of grinding, Nuova 

Guseo boasts decades of experience: 

pre-crusher, hammer 

mills, conical mills for 

calibration activities, jet mills 

for ultrafine grinding, systems that 

can be variously integrated into the 

process lines, and that can be implemented 

in containment systems, 

where the company can combine the 

high know-how both application areas. 

Waiting for CPhI in Milan, that 

will represent the return to “physical 

presence” in a sector event, we 

talked with Gherardo Marchini, Nuova 

Guseo Export Manager. 

What will you be presenting at CPhI 

Milan and what does this event represent 

for you, particularly after the 

long abstinence from events imposed 

by the pandemic? 

With the statement released by the Italian 

government on 16th April 2021, 

tradeshows and exhibitions have been 

given the go-ahead to take place in the 

country starting from 1st July 2021. 

This decision finally gave the green 

light to the organization of the event 

in Milan from 9-11 November 2021. 

CPhI - Chemical Pharmaceutical Ingredients, 

as known, is the International 

Exhibition dedicated to the pharmaceutical 

sector. It is a fixed and itinerant 

event on a global level, for over 

30 years, a reference point for operators 

in the sector not only for pharmaceutical 

products but, in the affiliated 

section P-MEC, also leading platform 

for pharma machinery, equipment and 

technology professionals. 

Exhibitors participate in the CPHI- 

PMEC mainly to maintain relationships 

with already acquired customers, but 

not only that; those who choose to 

exhibit their company also do so to 

generate new contacts and new sales 

opportunities, to present new products, 

to encourage the international 

dimension of the company or to find 

new distributors or agents. For Nuova 

Guseo participation in this event has 

a particular significance, first of all because 

after the period of forced absence 

due to a pandemic we finally return 

to a “physical presence” in a sector 

event. The trade fairs represent an 

important factor in our activities, limited 

editions or media events have a 

very different impact; the direct contacts 

are still crucial in our business. 

In addition to this, I must emphasize 

that for our company, participation in 

the CPHI-PMEC in Milan represents a 

full-blown debut, so we have the clear 

goal of creating a booth where we will 

present some typical examples of our 

product range, like equipment for mixing 

and grinding and variously configured 

containment systems. 

How do you consider the reaction of 

the pharmaceutical industry to the 

health crisis and what do you foresee 

for the next months? 

The pharmaceutical sector is a typically 

anti-cyclical sector that obviously has 


32_35_ART NUOVA GUSEO.indd 32 31/08/21 09:59

Machines 

not been involved in forms of blocking 

of production activity, being, on the 

contrary, one of the priorities for dealing 

with the difficult situation. Therefore, 

it is evident that the sector has 

suffered less than others from the current 

recession, indeed we are probably 

talking about an area in counter-trend 

with the general economic situation, at 

least with regard to specific production 

assets, just think of the important work 

carried out for the realization, experimentation 

and production of vaccines. 

I believe that this will be a trend that 

will not change in the short term, both 

due to the uncertainties related to the 

pandemic evolution and to the awareness 

of the markets for the production 

of the wider sector. 

What are the applications where 

your technologies are being applied 

the most these days? 

In this period we see a constant demand 

for containment systems for the 

most varied applications, where isolation 

technology plays a role of growing 

importance, this is mainly due to 

the well-established trend, especially 

in the chemical and pharmaceutical 

field, to treat substance and/or develop 

molecules with high activity and 

toxicity (API, Active Pharmaceutical 

Ingredients - HPAPI, High Potency Active 

Pharmaceutical Ingredients), this 

in conjunction with the increased attention 

paid to the problem of security 

and protection: for the operator 

as well for the product and its immediate 

environment. We are therefore 

talking about applications to be integrated 

in the primary phase of chemical-pharmaceutical 

production, such 

as for example loading reactors, unloading 

and unloading filter dryers, 

unloading from centrifuges, configurations 

for R&D, for example isolators 

for weighing and dispensing activities 

or kilolabs, in stand-alone or integrated 

with static dryers. Of course, this 

trend has not diminished our presence 

in the field of grinding, where Nuova 

Guseo boasts decades of experience; 

we talk about pre-crusher, hammer 

mills, conical mills for calibration activities, 

jet mills for ultrafine grinding, 

systems that can be variously integrated 

into the process lines, and 

that can be implemented in containment 

systems, where our company can 

combine the high know-how both application 

areas. 

What are currently the biggest requests 

you receive in the milling 

sector? 

Nuova Guseo in the milling sector has 

long represented a consolidated point 

of reference for the chemical-pharmaceutical 

market and beyond, our 

equipment is also widely used in the 

food and cosmetics sectors. The trend 

of requests is usually cyclical for us, 

in the sense that, it being understood 

that requests normally cover the whole 

range of grinding devices in our product 

range, there are years where some 

applications are prominent, milling 

rather than calibration or micronization. 

Currently, the requests are quite 

varied, and concern more or less equally 

all of our solutions in the context of 

comminution. This is probably linked 

to the general trend of the chemical-pharmaceutical 

sector, which is also 

characterized by a growing globality 

of markets interested in our range 

of products, I am referring to countries 

where until 2020 we were only sporadically 

active, for example South America, 

the Far Asia, the Middle East and 

North Africa. 

“In this period we see 

a constant demand 

for containment systems 

for the most varied 

applications, where 

isolation technology 

plays a role 

of growing importance” 

Can you describe some of your most 

innovative equipment and possibly 

some recently completed projects? 

Our goal is customer satisfaction. 

Our strengths are extreme flexibility, 

both in the design and construction 

phase, which allows us to customize 

each model according to the 

customer’s needs; we work together 

with the end user, with a constant 

exchange of information in order to 

correctly identify the characteristics 

of the process to be managed and the 

most suitable solution. Obviously, we 

have a line of “standard” products, 

which however in most cases simply 

represent a starting point in the interaction 

with the customer’s needs; 

each order for us is a unique piece, 

a prototype designed and made to 

Isolator 

integrated 

continuous 

liner supporting 

device 



32_35_ART NUOVA GUSEO.indd 33 31/08/21 10:00

Machines 

On this page, 

clockwise 

from above: 

Micronizer 

model 

Micronette 

M500; 

Hammer mill 

model TB80; 

Cone mill 

model CM200 

measure. An example of the constant 

innovative process that characterizes 

our mission and the high 

degree of customization of our systems 

is represented by the multi-milling 

single-chamber isolator, for calibration 

and milling activities, for an 

OEB 4 containment level. The system 

is connected to an existing suction 

line. Pressure control inside the 

chamber takes place by means of a 

non-electric automatic valve. The 

product loading is carried out by a 

discharging piping line coming from 

a filter dryer, located in a room above 

the one where the multi-milling isolator 

is installed, and interfaced with 

an actuated dosing lobe valve. Inside 

the working chamber is installed a 

switch tasking milling station, consisting 

of two different and, according 

to the process requirements, easily 

interchangeable milling heads: a 

conical mill our model CM 100 and a 

hammer mill our model TB 80, driven 

by a common motorization group, located 

in a housing outside the working 

chamber. The product comes out 

by means of a special continuous liner 

device. Another important realization 

is represented by a two-chamber 

isolator for weighing and bagging 

of highly active solid products. 

The isolator is divided into 2 

sections: the first, pre-arranged for 

the possible future installation of a 

conical calibrator, is equipped with 

a weighing system on load cells integrated 

with a liner bagging system, 

a venting device and a turntable, 

for bags pre-sealing, the product 

is then transferred to the second 

chamber where it is inserted into a 

second liner in order to guarantee the 

required containment level (OEB5). 

I would also like to point out that 

a stand-alone micronization line of 

particular interest is being completed. 

The line consists of a pneumatic 

conveyor for loading the volumetric 

feeder, a micronizer our model Micronette 

M300, a special cyclone separator 

with a vibrating device positioned 

on the lower cone to facilitate 

the flow of sticky products and 

the upper part consisting of a body 

with double gloved door with hermetic 

closure, for access to the internal 

parts and disassembly of the filtering 

elements without direct contact 

of the operator with the treated powders. 

The filter is equipped with a special 

programmable cyclic shaking system. 

The whole line is equipped with 

special devices for carrying out the 

cleaning in place, a weighing system 

“We work together with the end user, 

with a constant exchange of information 

in order to correctly identify the 

characteristics of the process to be managed 

and the most suitable solution” 

is also provided at the discharge from 

the cyclone filter. A peculiarity of this 

system is represented by the fact that 

depending on the characteristics of 

the processing batch and the required 

capacity, it can alternatively host two 

jetmills of different sizes (our models 

M200 and M300). 

On what are you investing more and 

what do you think is important to 

improve in the near future? 

Consistent with our corporate mission, 

our efforts are focusing on the 

commercial communication asset, 

where we have started an action to 

expand our web marketing, including 

the revamping of the website, 

still in progress, creation of landing 

pages, subscription to web portals of 

the sectors of interest and more, at 

the same time we have strengthened 

a fundamental element of our customer 

services, namely remote assistance, 

starting from traditional telephone 

and email support, moving on 

to video chats, without forgetting 

assistance at software level through 

special modules integrated in the 

control systems supplied, we can also 

provide video files relating 

to testing and testing of 

the systems built and training 

for operators. These are 

basic elements in our business, 

which will continue to 

be such even after the pandemic. 

l 

32_35_ART NUOVA GUSEO.indd 34 31/08/21 10:00 

advS

S4 

S 

KNOW-HOW 

TECNOLOGICO 

NEL NOSTRO DNA 

PER I TUOI AMBIENTI 

DI PRODUZIONE E CONTROLLO 

OTTIMIZZIAMO GLI SPAZI 

E LA TECNOLOGIA 

SAPPIAMO COSTRUIRE QUELLO CHE IMMAGINIAMO 

ENGINEERING • CONSTRUCTION • COMMISSIONING • VALIDATION 

S4S S.R.L. 

Via Celotti n°8 - 20814 - VAREDO (MB) 

Tel.1: +39 03621900102 Tel.2: +39 0289080326 

info@s4ssrl.it www.s4ssrl.it 

32_35_ART advS4S_2021_def.indd NUOVA GUSEO.indd 2 35 31/08/21 17/06/21 10:00 

13:58

Technologies 

As safe as ever 

With its high level of reliability 

and quality, R. Stahl ensures 

safety when it comes to explosion 

protection. That’s because 

the leading supplier of products 

and systems for hazardous areas 

offers state-of-the-art solutions 

- perfectly matched to the 

variety of operating conditions 

in hazardous areas. Customers 

and interested parties can find 

these on the new Italian website. 

On r-stahl.com/it/it/, the 

company also offers an e-catalogue 

with selected products 

from the areas of automation, 

installation material, luminaires, 

low-voltage devices, as 

well as HMIs and cameras for 

typical applications. With the 

e-catalogue, the selected products 

can be ordered around the 

clock, every day of the week. For 

many products, dispatch within 

seven days directly from the 

warehouse. With the new website 

r-stahl.com/it/it/, and the 

modern e-catalogue, R. STAHL 

supports all customers and interested 

parties to implement 

time-critical projects in hazardous 

areas quickly and safely. 

For more than 90 years, R. Stahl 

has been setting trends in the 

field of safety solutions for 

hazardous areas. The Waldenburg-based 

company is one of 

the world’s leading suppliers 

of explosion-protected components 

and systems. Its portfolio 

includes products for automation, 

control and distribution, 

installation, operation 

and monitoring, lighting, signaling 

and alerting. Customer-specific 

explosion-protected 

system solutions are fast becoming 

one of R. Stahl’s specialties. 

The perfect combination 

of compatible products 

can be enhanced with an extensive 

range of services, including 

consultation, project and technical 

engineering, and training 

as required. The innumerable 

technological innovations coupled 

with a growing list of patents 

to its name bear testament 

to the company’s product development 

expertise. With international 

certification and approvals, 

R. Stahl’s products can be 

used all over the world. 

Temperature control technology in the fight against Covid-19 

Lauda, worfd market player for constant 

temperature equipment and systems, 

has secured a major order for 

Variocool process thermostats. The 

German subsidiary of a major global 

US company in the biopharmaceutical 

sector has ordered a total of 76 

devices, including accessories, for integration 

in their systems for producing 

the Covid-19 vaccine. The different 

models have a cooling capacity of between 

2 and 10 kW. The Variocool process 

thermostats are factory-certified 

according to CE and NRTL, and therefore 

meet the standards required in Europe 

as well as in North America. Lauda 

redesigned these flexible devices before 

launching them onto the market 

in November 2020. The process thermostats 

have bifrequency and multivoltage 

capability, which means that 

if production is relocated, the thermostats 

can be easily transferred to another 

location and also make project 

planning easier for the cus-tomer. 

The customer uses Lauda devices for 

controlling the temperature of mixers 

and single-use bioreactors required 

to manufacture Covid-19 vaccines. 

Cell cultures are grown at a 

temperature of between 4 and 37 °C 

in reactors with a volume of between 

200 and 2,000 liters. Variocool process 

thermostats are designed to 

maintain a stable temperature within 

an extremely narrow tolerance 

range of ± 0.1 K. 

Last year, Lauda significantly increased 

its production capacity for 

Variocool process thermostats due to 

the high demand, and was therefore 

able to meet the tight delivery deadline. 

“Lauda had already been working 

closely with the Variocool process 

thermostat customer for several years 

even before the major order was secured”, 

explains OEM sales specialist 

Tobias Henning, who is responsible 

for OEM customer support in the bioprocessing 

sector. The Lauda OEM division 

helps customers develop complete 

systems by establishing standards 

in collaboration with the relevant 

development teams, which are then integrated 

into the product configurator 

of the OEM customers at a later stage. 

As a result, the customer also receives 

assistance with documentation, calculations 

and similar tasks. In some cases, 

the OEM division even develops devices 

specifically for customers. “We 

are currently seeing a high degree of 

satisfaction with Lauda on the market 

and want to build on this trust as a basis 

for further expanding our capacity 

to cater for specific customer developments”, 

explains Thorsten Eilers, OEM 

Managing Director at Lauda. 


36_37_news technologies.indd 36 31/08/21 10:07

Technologies 

Pharma separator lines aseptic and pure 

Based on GEA’s decades of expertise 

in the field of mechanical 

separation technology, GEA engineers 

have developed a new, fully 

comprehensive portfolio of plug 

& produce pharma separator systems 

that moves harmoniously and 

perfectly between individual and 

process-related requirements and 

leaves nothing to be desired. 

The separator lines aseptic and 

pure are used in all pharmaceutical 

and biotechnological downstream 

processes. GEA’s aseptic separator 

line offers customers with highly 

hygienic processes gentle processing 

of, for example, human 

and veterinary vaccines, monoclonal 

antibodies (mAb), e-coli, insulin, 

starter cultures and probiotic 

products. The pure line is 

used in applications with 

varying hygienic requirements 

such as nutritional 

supplements, therapeutic 

proteins, pharmaceutical 

extractions, and extracellular 

and intracellular enzyme 

recovery. 

The biopharmaceutical industry 

is united by a common 

denominator. It places 

the highest value on 

uncompromising hygienic 

design, process reliability 

and high yield. However, the detailed 

requirements can vary widely 

depending on process regulations 

and specifications. GEA took this 

requirement profile as an opportu- 

nity to develop a separation 

solution for the biopharmaceutical 

industry that is perfectly adaptable 

in every respect. 

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Components 

Bruno Wolhfarth 

is implementing 

a through 

technological and 

generational renovation. And they launch the 

first pump with a flexible impeller and a drainage 

system for automatic sanitization, particularly 

suitable for pharmaceutical applications. 

The cutting edge 

of sanitization 


Bruno Wolhfarth focuses on increasingly 

automated manufacturing 

processes and patents 

a drainage system that 

makes their flexible impeller 

pumps leap further in quality in regards 

to automatic sanitization. Recently, we 

met Rossella Wolhfarth and Marco Parapetti, 

respectively the second and third 

generation at the head of the company, 

founded in the Sixties by Bruno Wolhfarth, 

in the Sordio-based head office, 

in the province of Lodi. They told us 

how the company has worked at full 

capacity during the entire health emergency, 

triggering at the same time a 

transformation that looks at the principles 

of Industry 4.0, at the training 

of young people, and at the continuous 

increase of production quality. 

What are you focusing on? 

Marco Parapetti: We’re investing in 

technological innovation. We’ll soon 

install a new lathe similar to the present 

one, but with considerably higher 

dimensions and production capabilities. 

This was a non-postponable 

step that will allow us to keep living 

up to our clients’ increasingly high 

production standards. The objective 

is to automate most of the operations 

that used to be done manually. 

It’s a strategy that’s revealing itself 

to be a winning one, especially 

in the light of the fact that the peo- 


38_41_ART_WOHLFARTH.indd 38 01/09/21 13:45

Components 

ple who are capable of operating the 

manual lathes skillfully are gradually 

retiring. We’re finishing a period 

of deep transformation, that projects 

us more and more into the digital 

era and Industry 4.0, but also maintaining 

the historic and knowledgeable 

care of the product, that prefers 

quality over quantity. Engineer Matteo 

Capella, the head of the technical 

office, is providing fundamental 

support on programming and integration 

of the new machinery in the 

key of Industry 4.0. The results are 

proving us right, since all of the pieces 

produced in the last months with 

CAM solutions and the principles of 

Industry 4.0 have shown even higher 

quality compared to the past. 

Are you therefore completely removing 

manual operations? 

Parapetti: The high level of automation 

and precision of the new machining 

centers and the training of 

personnel on software allows us to 

manage even the special orders automatically, 

that nowadays are the 

majority, and the more complex processes. 

Today using CNC machines we 

manage to get the surface finish required 

by the pharmaceutical industry, 

something that was once only 

possible through hand finishing. The 

only processes that will be still done 

by hand are a few particular processes, 

such as certain pharmaceutical 

fittings, or some repairs, or in the 

event that the CNC machine doesn’t 

guarantee the required quality. 

case it’s the most effective method, 

as well as the most appreciated by the 

customers. Anyway, we’ll still keep 

the parallel lathes, that we have recently 

enhanced, in the workshop: 

we want to maintain and transmit to 

young people skills that would otherwise 

risk being lost forever. 

Rossella Wolhfarth: The phase of 

strong renewal we’re living isn’t only 

technological, to tell the truth, 

but also generational, thanks to the 

entrance of young workers, that are 

rapidly growing and learning. Compared 

to only a few years ago, the 

workers’ average age drastically decreased. 

Now we’re looking for an expert 

lathe operator, but it’s not so 

easy to select one that fits our reality: 

we’re small – of course – but at 

the same time we produce high-end 

products with standards and protocols 

on par with those of large companies. 

Standards that our clients 

have been accustomed to for decades. 

How is 2021 going? 

Wolhfarth: The first quarter has 

gone very well. Currently the orders 

are slightly decreasing, but we have 

a lot of ongoing work. It’s a transition 

phase, in which we are all waiting 

to exit the pandemic, but at the 

same time it’s not clear what will 

happen in the markets. Some companies 

still haven’t resumed work at 

full capacity, or are slow to decide. 

Pharmaceutical and food markets are 

still confirmed as driving forces. 

Are your pumps also destined to 

the lines for Covid vaccines? 

Parapetti: We haven’t directly followed 

installations in vaccine pro- 

Rossella 

Wolhfarth e 

Marco Parapetti, 

respectively the 

second and the 

third generation 

at the helm 

of the company 

founded by 

Bruno Wolfarth 

in the Sixties 

The headquarter 

of Bruno 

Wolhfarth in 

Sordio, Lodi 

Can you give us an example? 

Parapetti: Inside the pump body 

there’s an eccentric that presses on 

three impeller blades. It has to be 

very rounded otherwise it would risk 

cutting the impeller, but not too 

rounded, to not reduce the self-priming 

force. That is why it’s a piece that 

we’ve always finished by hand: in this 




Components 

Phase of 

production 

HRS electric 

pump series 

is studied 

for automatic 

washing without 

the need for 

dismantling, 

in harmony 

with automated 

4.0 systems 

duction plants, but it’s possible that 

our solutions have been adopted by 

client construction companies that 

in turn provide complete plants to 

vial manufacturers. 

Wolhfarth: Certainly the production 

of vaccines is giving a strong shock 

to the pharmaceutical industry, so 

much so that – I’m certain – some 

of the resources to be invested will 

be freed up for the filling and packaging 

of other categories of drugs. 

You’ve recently developed a highly 

innovative pump, the HRS model. 

What characteristics does it introduce 

in your production range? 

Wolhfarth: The distinctive and key element 

is suggested by the “H” letter, 

that is added to RS – Rapid Sanitary – 

the previous model’s name. “H” stands 

for Hygienic, to emphasize that the innovative 

content of this pump focuses 

on sanitization. It’s studied in fact for 

automatic washing without the need 

for dismantling, in full harmony with 

fully automated 4.0 systems in which 

it will find itself operating. There are 

some pumps that can be completely 

emptied without dismantling – that’s 

true – but ours is the first flexible impeller 

pump with these features. We 

filed the patent covering the drainage 

system, that is very particular because 

our pumps don’t only handle liquids, 

but also viscous fluids. All of the surfaces 

involved in the transfer of products 

have to also be lapped by the 

washing liquids. 

The letter “H” is also the focus of 

the product’s launch campaign… 

Wolhfarth: We wanted to evoke the 

characteristics of High quality and 

Hyper versatility. And I like to remember 

that the same letter appears 

twice in our family’s surname. 

Now we offer three product ranges 

according to the customer’s requirements: 

Rapid, Rapid Sanitary and Hygienic 

Rapid Sanitary. 

Parapetti: We never reached such levels 

of rugosity: with the HRS we’re 

talking about 0.2 microns, so even 

lower than what is usually required 

by pharmaceutical industries. I would 

like to stress that the same pump utilized 

for the transfer of liquids and 

process fluids is also utilized without 

any modifications even for the 

plant washing operations. Today it’s 

a relatively widespread feature, but 

we were among the first to provide 

it. For the material we chose a highly 

inert silicon, so that it wouldn’t absorb 

the color of the transferred product. 

The prototype was tested at a detergent 

producer, even if the sanitization 

characteristics make HRS ideal 

especially for pharmaceutical and 

food applications. 

Rapid electric 

pump series in 

ATEX execution 

How are your contacts with foreign 

countries? 

Parapetti: We are receiving various 

requests, even from distant countries. 

Recently we supplied an Italian 

pasta maker in Guatemala and a 

plant in Uruguay. These are orders 

that arise without marketing endeavors. 

Simply some local end users 

find our brand on pumps installed 

by installers with which they lost 

contact, and, being satisfied with 

the products, they seek us out. Now 

we would like to be in foreign markets 

more organically, entering into 

agreements with local resellers/installers, 

as we’ve done for decades 

in Belgium and France with excellent 

results. However we need partners 

that are very competent and with 

high attention to service. Our pumps 

are in fact very special and versatile: 

they’re flexible impeller pumps 

but they can execute the functions 

of the most expensive lobe pumps. 

Wolhfarth: We resumed presenting 

in some international trade shows also 

to establish relations abroad. The 

next appointment will be with Achema, 

in Frankfurt from April 4th to 

8th 2022. It will be the occasion to 

present the transformation we’re going 

through and to present the HRS 

pump, currently our spearhead, to 

international markets. l 




Technologies 

State-of-the-art measuring and monitoring 

equipment for perfect water quality 

Swan is one of the world’s 

leading manufacturers of 

online measuring instruments 

and complete solutions 

for the water industry. 

As a company Swan Analytical 

Instruments is fully 

specialized in water analysis 

and develops, produces, 

and sells high quality instruments 

for water quality 

monitoring. The measuring 

instruments are known 

worldwide for their functional 

safety, reliability, and 

ease of use. 

The current product spectrum 

ranges from applications 

for monitoring the 

quality of drinking water 

to feed water, steam and 

condensate in power generation, 

ultrapure water in 

pharmaceutical and semiconductor 

industries, bathing 

water and wastewater. 

All sensors and instruments 

are developed and manufactured 

at the headquarters in 

Switzerland by the 150 employees. 

In-house production of sensors 

is crucial for quality. 

Every step, from the individual 

part to the final production 

of the instruments, is 

subject to strict quality controls. 

No instrument leaves 

the company without final 

tests under real operating 

conditions. 

Thanks to these comprehensive 

control processes, 

the customer’s requirements 

are always met. 

All of the analyzers are delivered 

as fully functional, 

ready-to-use instruments. 

This ensures easy system 

integration as well as user-friendly 

operation and 

maintainability. 

Continuous Process Monitoring 

of TOC, Ozone and 

Conductivity 

Swan Analytical Instruments 

offers continuous 

online monitoring instruments 

for the pharmaceutical 

industry. All instruments 

offer user management, 

instrument qualification 

(IQ, OQ, PQ), audit 

trail (traceability), systematic 

self-monitoring of the 

instrument’s components 

and no loss of data in case 

of power failures. 

AMI LineTOC: The Elegant 

Way of TOC Measuring 

Since its launch in 2011, 

many leading representatives 

of the pharmaceutical 

industry have been 

convinced by the benefits 

of the Swan Analytical Instrument’s 

TOC-Analyzer. 

Swan’s reagent-free AMI 

LineTOC offers early trend 

detection without laboratory 

measurements. Automatic 

System Suitability Test 

(SST) according to USP643 

/ EP 2.2.24 and calibration 

with minimized maintenance. 

IQ OQ PQ documents 

are provided as a hard copy 

or electronically. The analyzer 

can be reviewed at 

regular intervals by an automatic 

function test. The 

user-friendly design of the 

device and the possibility to 

also test grab samples, provide 

additional reassurances 

in operation. The AMI 

LineTOC is also available 

with a removable stainless 

steel enclosure. 

AMI Codes-II O3: Photometric 

Measurements of 

Ozone 

Swan Analytical Instrument 

has developed a photometric 

ozone measuring instrument 

specifically for the 

pharmaceutical sector. 

AMI Codes-II O3 combines 

the advantages of the robust, 

colorimetric standard 

method according to 

DIN-38404-3 from the laboratory 

with online measurement. 

Advantages for 

the user result from the 

low detection limit (1ppb) 

and the long-term stability 

due to the automatic 

zero-point adjustment before 

each measurement. 

Since the measuring method 

does not suffer from a 

loss of sensitivity in the absence 

of ozone for a longer 

period and no run-in time 

is required after maintenance, 

the use of the AMI 

Codes-II O3 directly increases 

process reliability. 

Transmitters and Sensors: 

Making Monitoring Conductivity 

Easier 

Swan Analytical Instruments 

offers AMI and AMU 

transmitters and sensors for 

online conductivity measurements 

with limit alarms 

according to USP and EP. Integrated 

temperature compensation 

is available as 

non-linear function or by 

coefficient. 

For further information: 

www.swan.ch; 

swan@swan.ch. 

N 

so 

c 



Con maschera o senza, i superpoteri rimangono 

SIAMO SEMPRE NOI 

Matteo, sviluppo prototipi. 

Nonostante i cambiamenti attuati nel nostro lavoro e nella nostra organizzazione, le performance della POMPETRAVAINI 

sono invariate. Anche se il volto può essere coperto in parte da una mascherina, sotto c’è sempre la motivazione di 

chi lavora con passione. 

Pompetravaini Spa 

Via per Turbigo, 44 • 20022 Castano Primo (Mi) 

Tel. +39.0331.889000 • Fax +39.0331.889057 

vendite@pompetravaini.it • www.pompetravaini.com 



A tailor-made partner for 

thermal validation solutions 


Ellab Italia is rapidly growing, in line with the ambitious goals 

of the international leading supplier of validation and monitoring 

solutions. At the center of the project, a really complete service: 

from system supply to periodical qualification and maintenance. 

Ellab is an international group 

and leading supplier of thermal 

validation solutions for 

pharma, medical and food 

processing industries. The 

Italian branch relies upon 40 years 

experience that enables it to be a 

benchmark company in the field of 

high precision instrumentation, offering 

top quality thermal process 

validation and monitoring solu- 

tions, especially to pharma industries. 

Ellab Italia comes from a period 

of strong growth, made even 

more tangible by its transfer to the 

Pero-based headquarters, two floor 

featuring a modern design, with 

wide windows conveying brightness 

and airiness to the environment, 

but above all with spaces that are 

three times higher than those left 

last year. The choice of the structure 

is associated with the Group’s 

strong ambitions. In our country, the 

group actually aims to double turnover 

within 2024. We recently visited 

the new building not far from Milan. 

In one of the big rooms on the first 

floor, organized for workshops and 

presentations, we were welcomed 

by Alessandra Ferrari, Italy Country 

Manager and Matteo Noschese, Sales 

Manager. 


44_47_ART_ELLAB.indd 44 06/09/21 10:31


Congratulations for the new head 

office. Was the parent company also 

involved in its research and choice? 

Alessandra Ferrari: As the Italian 

branch, we looked for a place with 

rooms suitable for hosting an accredited 

metrological laboratory, focusing 

not just on the operators’ comfort, 

but also on the need of reorganizing 

and optimizing spaces to improve 

the development of calibration activities. 

Ellab’s top management visited 

the three structures we selected and finally 

they opted for Pero, whose wide 

spaces are prepared for staff increase 

as well as for the activities scheduled 

for next years. The ground floor is fully 

dedicated to the metrological laboratory 

and to the warehouse. Offices 

and training course, product presentation 

and workshop rooms are at the 

first floor. Opening the headquarters to 

clients and partners has always been 

our wish, because we have plenty of 

innovative solutions to show. Unluckily 

Covid 19 hasn’t allowed us to promote 

these meetings as we wished to. 

We hope to recover soon. 

Matteo Noschese: The research of a 

very spacious head office originates 

from the will to develop in Italy as well 

The new headquarters 

of Ellab Italy in Pero (MI) 

the Ellab Academy, i.e. Ellab’s training 

vision combining moments of theoretical 

training with participants’ experience 

sharing. Since we think sharing 

experiences is essential, we’ll propose 

events involving both clients and 

would-be clients. These are stimulating 

moments for all: from the one side we 

describe technological novelties and 

how they work, on the other, every 

participant can witness his/her experience 

and explain how he/she solved a 

certain application, put questions and 

boost new ideas. 

What about the assets of your rich 

growth program? 

Ferrari: First of all, the Group will be 

consolidating the products that have 

become real benchmarks for the pharma 

industry. In particular, in the field 

of thermal validation, where in the last 

few years Ellab has become the leading 

company. 

Noschese: The trust and fame Ellab has 

been building up simplify our task of 

penetrating markets. I should say that 

today the companies themselves are 

looking for our solutions. Next to already 

successful products, the group 

will go on developing new ones through 

a strong commitment in research, to 

which it dedicates 25% of the staff. 

Once you get to the top, you must be 

able to lead the technological evolution 

of the sector, above all in the core 

business of thermal validation. Another 

key asset for our growth lies in completing 

the range with the products of 

the companies we took over. An example 

is the case of Hanwell, belonging 

to Ellab since 2019 and that by chance 

we have been distributing in Italy for 

11 years. The British company enriched 

the group’s range with its monitoring 

systems for environmental parameters 

and since June 1st 2021 it has been 

called Ellab Monitoring Solutions. 

Ferrari: The growth program aims very 

much at enhancing services, as well. To- 

day this is an indispensable factor to 

interact with the pharma market and 

to remain constantly in touch with the 

client. It is no more possible to separate 

product supply from the service. At 

least for those who, like us, come as an 

all-round partner. 

Which are the most required services 

at present? 

Noschese: We are renowned for our 

calibration services, for which we also 

stipulate multi-year contracts to manage 

the customer’s whole instrumentation. 

Yet today we’re increasingly asked 

for the qualification of the systems we 

provide. For example, it happens we 

must supply not just the environment 

monitoring systems, to keep relative 

temperature and humidity in warehouses 

and storage sites under control, but 

we’re often also in charge with the mapping 

service of the environments themselves. 

That is why we provide a consulting 

service before the system supply, 

validation and management, offering 

the user a single and complete solution. 

Alessandra 

Ferrari, Country 

Manager, 

and Matteo 

Noschese, Sales 

Manager 

of Ellab Italy 



44_47_ART_ELLAB.indd 45 01/09/21 17:12


The 

metrological 

laboratory 

is accredited 

by Accredia with 

the LAT128 

Did the pandemic change the pharma 

market? 

Ferrari: The sector recovered very well, I 

should say with a higher growth rhythm 

as against the pre-Covid time. Waiting 

for PNRR and Next Generation EU funding 

is likely to boost pharma companies 

to invest on projects to be ready 

to catch future opportunities. In the 

whole pharma industry, from machine 

providers to the end users, we remark 

a strong increase in demand and production. 

Many companies are upgrading 

their lines, also in view of Covid vaccines 

in the next years. Thus, it is ab- 

solutely strategical that, on this front, 

Italy becomes more and more autonomous. 

How are you responding to this increased 

demand? 

Noschese: We are increasing both sales 

and technical staff. Last October a new 

operator dedicated to installations of 

field systems joined our staff. One more 

specialist was added to the laboratory 

and another one joined the marketing 

area. In a group of 20 employees, hiring 

three people within few months is 

not a trivial matter. This gives a realistic 

idea of how much hour work is growing. 

Ferrari: Soon, more people will be 

needed. In fact our goal is giving a solid 

structure to each division, focusing on 

the management of service, that actually 

includes installation, validation and 

qualification of the supplied system. 

Are the professionals you need easily 

available on the market? 

Ferrari: I should say they aren’t, but 

this is a common problem of highly 

specialized companies. The most 

sought-after figures are not necessarily 

graduates, but specialists and 

young people with an excellent technical 

background. Luckily, there has 

been recently an increasing collaboration 

between schools and companies. 

For instance, we are collaborating with 

Bergamo-based Fondazione ITS per le 

Nuove Tecnologie della Vita, that organizes 

post-diploma courses aimed at 

developing pharma and biotechnological 

skills. Students can carry out their 

internship in Ellab and at the same time 

we evaluate and possibly insert them in 

our staff at the end of the course. 

Technological novelties include the 

LyoPro system. What about its features? 

Noschese: Ellab launched this solution 

at the end of 2020. LyoPro is a wireless 

datalogger revolutionary system, 

expressly designed for accurate measurements 

in freeze dryers featuring automatic 

loading and unloading systems. 

It meets this application’s typi- 

Revolutionize Your Freeze-Drying Process with TrackSense LyoPro 

Freeze Drying, or Lyophilization, has 

become an accepted method of processing 

sensitive products that require 

long term storage at temperatures 

above freezing. There are many 

things to consider in order to ensure 

a high quality and optimal production 

costs for the freeze drying process. 

Ellab, a world leading manufacturer of 

complete thermal validation solutions 

for pharmaceutical, medical, food and 

other industries, offers specific solutions 

for lyophilization needs. The 

company presents TrackSense Lyo- 

Pro, a revolutionary wireless data logger 

specifically designed for accurate 

measurements in freeze dryers with 

vial autoloading systems. 

Freeze Drying is a process whereby 

a product is dried under low temperature 

and vacuum. The water in the 

sample is first frozen to a solid and 

then removed directly by turning the 

ice into vapor. This is done under 

vacuum and without having to pass 

through the liquid phase. The unique 

advantage of Freeze Drying is that the 

samples are kept at low temperatures 

and remain frozen during the entire 

drying process, thereby preserving 

thermo labile components (proteins, 

flavors, colors), all while maintaining 

the original shape and size. The dried 

product can then be stored for long 

periods without the risk of changing 

composition (i.e. enzymatic, genetic) 

or being infected by microorganisms, 

which is all made possible due to the 

lack of water. In other words, Freeze 

Drying is a dehydration technique. 

What makes the Freeze Drying process 

different from other dehydration 

techniques, is that dehydration takes 


44_47_ART_ELLAB.indd 46 06/09/21 10:31


cal requirements: data availability in real 

time, data that are also saved locally 

in case of lack of communication with 

the receiver. Moreover, in line with Industry 

4.0 principles, it can be integrated 

in the machine’s supervision system, 

exchanging data with it through standard 

communication protocols, making 

it ideal to monitor and validate pharma 

lyophilization processes. 

Ferrari: Ellab developed the new system 

working with a pharma company 

equipped with a lyophilization line of 

the last generation, with a totally automatic 

loading. Thus a very compact 

solution was developed, capable of 

adapting to different vial size subject 

to the lyophilization process. 

Any other product that is getting 

important feedbacks? 

Noschese: Continuous monitoring 

systems for temperature, relative humidity 

differential pressure, i.e. the 

most important parameters in the 

pharma industry, are growing exponentially. 

The acquisition of Hanwell 

added know-how about these applications 

within the Group. Today we are 

receiving many requests to monitor 

parameters inside logistic centers and 

warehouses, clean rooms, refrigerators 

and freezers, research laboratories. 

I guess these systems are increasingly 

applied also in the supply 

chain of RNA-based Covid vaccines. 

Noschese: Yes they are and are an 

example of application where control 

and maintenance of the cold chain 

are essential. But this has been valuable 

for a long time for many pharma 

applications. 

Which are the main laboratory activities? 

Ferrari: The metrological laboratory is 

accredited by Accredia with the LAT128 

number for the calibration of temperature, 

relative humidity, pressure, dew 

point measurement instruments, as well 

as electrical quantities in direct current. 

Today we are approaching the goal of 

releasing Accredia certificates even for 

calibrations to be carried out on field, 

a service that is highly required. We are 

also planning to accredit another very 

important parameter for the pharma industry, 

about which however I cannot 

provide more details, by now. 

How did you live the lack of events 

over the last year and a half? 

Ferrari: We are missing the events, I 

must admit. In June we used to leave 

for Rimini-based Simposio AFI. In addition 

to the convention and exhibitions, 

a meeting like Simposio enables 

to share also informal moments that 

are required to consolidate existing relationships 

and to establish new ones. 

We also lost CPhl 2020 that has been 

rescheduled in November in Milan. We 

hope the vaccinal campaign, that is 

going big, enables us to get together 

again during exhibitions. Sometimes, a 

handshake and an eye contact without 

screens in-between is enough to establish 

a relationship with a deeply different 

quality. We must have faith and look 

forward. l 

place while the product is in a frozen 

state and under vacuum. These conditions 

stabilize the product, minimizing 

the effects of oxidation and other degradation 

processes. Freeze Drying has 

become an accepted method of processing 

heat sensitive products that 

require long term storage at temperatures 

above freezing. Freeze Drying is 

widely used in the pharmaceutical- as 

well as other industries. Qualifying the 

freeze dryer is crucial to the quality and 

reliability of the final product. 

Ellab has a lot of well-established solutions 

for the qualification, validation 

and monitoring of freeze dryers. 

Ultimately, the LyoPro data logger is 

what Ellab would recommend for most 

freeze drying setups. It is uniquely designed 

for freeze drying, addressing all 

the challenges this valuable process 

has to offer. The data logger itself can 

be configured to fit the size of the vials 

in question and comes with several 

specially designed fittings to ensure 

trouble-free operation for any vial size. 

Even if the vials are as small as 2R or as 

large as 100R – or anything in between. 

The thermocouple sensor attached 

to LyoPro is easily replaceable with a 

spare, and the very thin tip (0.55 x 0.95 

mm) ensures little to no impact on the 

sample. The complete TrackSense LyoPro 

data logger can also be user-calibrated, 

thereby maintaining the industry 

leading measuring accuracy.Track- 

Sense LyoPro eliminates data gaps 

with its high capacity battery and internal 

memory, providing a complete 

and trustworthy study from start to finish. 

LyoPro can be sterilized at 121°C 

for 30 minutes to ensure clean room 

compliance. 

In addition to its built-in internal memory, 

LyoPro also comes equipped with 

live data. With the TrackSense LyoPro 

Access Point, the user gets a real-time 

view of its Freeze Dryer Lyophilizer 

processes directly to its PC. If needed, 

multiple access points can be connected, 

providing coverage for larger 

areas. For full data integrity, the proprietary 

radio frequency transmission 

protocol ensures data transmissions 

without loss or gaps in data. In the unusual 

situation in which the data transmission 

is interrupted, the LyoPro data 

logger will save the data in its internal 

memory – and once reconnected continue 

its transmission. 



44_47_ART_ELLAB.indd 47 01/09/21 17:12

Technologies 

High oxygen protection in pharmaceutical 

and nutraceutical products 

Airnov Healthcare Packaging, a global 

leader in controlled atmosphere 

packaging, is enabling manufacturers 

of pharmaceutical and nutraceutical 

products to optimize their product 

development cycles through its series 

of oxygen protection and simulation 

solutions. Products in these categories 

are often oxygen sensitive and 

require protective packaging. This includes 

drugs, probiotics, proteins, 

stents, surgical products, devices and 

various dry products. 

To protect such vital commodities, 

Airnov offers two key solutions – Oxynov 

Barrier Bottles and Pharmakeep. 

Oxynov barrier bottles utilize extrusion-blow-molding 

(EBM) technology, 

creating a six-layer bottle with ethylene 

vinyl alcohol (EVOH) that offers 

the highest barrier to oxygen and 

moisture available on the market within 

this packaging category. 

Further, these are rigid bottles do not 

shrink when using oxygen absorbers, 

offering a superior outcome to alternative 

standard LDPE and HDPE bottles. 

Pharmakeep is a two-in-one oxygen 

and moisture absorber, available in 

drop-in canisters and packets. It helps 

to simplify the protection process and 

offers a fast way of absorbing oxygen 

inside the headspace of the packaging 

versus iron oxygen absorbers. Oxygen 

concentrations are reduced from 

20.8% to less than 0.01%, avoiding 

the use of nitrogen flushing. 

Airnov also offers a global evaluation 

tool for oxygen protection through its 

Stablus predictive simulator. Stablus 

helps to reduce time spent on product 

development in relation to the selection 

of appropriate protective solutions. 

“We are encouraging our customers to 

evaluate oxygen protection with Stablus 

at start of their product development 

projects to help optimize oxygen 

protection, taking into account 

the key criteria of a drug product such 

as moisture content, packaging performance, 

and climatic conditions, shelflife” 

commented Stephane Rault, Oxygen 

Absorber Product Manager at 

Airnov. 

“If you’re looking to reduce your development 

time and costs, please contact 

Airnov for a full oxygen protection 

evaluation.” 

Dosing and filling technology 

Smaller portions and larger margins are the trend among 

food companies. This implies that a change of the requirements 

for dosing and filling technology is necessary. The 

latest product in the Hygienic series in the ViscoTec portfolio, 

the vipura-PUMP 10T dosing and filling pump, fits in 

perfectly with this trend. 

The compact design of the vipura-PUMP 10T makes it easy 

to integrate the dosing and filling pump into complete systems: 

The installation space length has been reduced by 

over 25% compared to pumps with the same dosing capacity; 

with a weight reduction of over 60%. At the same time, 

the dosing volume per revolution has been increased. The 

special dosing geometry ensures precise dosing results and 

short cycle times and works non-destructively, even with 

lumpy materials up to 20 mm in diameter. The dosing volumes 

can be flexibly adjusted – from 20 to 200 ml or even 

much higher, depending on the cycle rate. These quantities 

can be precisely dosed and filled, depending on the application, 

and matching the specific requirements. 

Due to its compact size and simple assembly/disassembly 

options, transportation of the vipura-PUMP 10T can be carried 

out by one person alone if required. Cleaning is simple 

and quick via a CIP connection. 

The vipura-PUMP 10T is suitable for dosing and filling various 

materials: For food and pharmaceuticals, as well as 

household products and cosmetics. Common applications 

are, for example, tubular bag filling of chunky sauces or marinades, 

and of pet food or shower gel, detergents, toothpaste, 

creams, etc. 

The benefits: product change is made possible without disassembly; 

one size fits all: for different dosing volumes; 

compact design + hygienic design in stainless steel; short 

cycle times; non-destructive dosing even of lumpy materials; 

transportation and cleaning can be done by 1 person; 

easy integration into existing systems. 




Insight 

A new era for the 

industrial research 

The research-based pharmaceutical industry is providing us 

with great contributions such as increased life expectancy 

and a major control of certain diseases, including cancer. In 

addition, it represents a key asset of the European economy. 

Efpia, European Federation of 

Pharmaceutical Industries 

and Associations, has compiled 

a research paper entitled 

“The Pharmaceutical Industry 

in Figures”. The aim of the 

work is to underline the importance 

and progress of science and technology 

in pharmaceutical industry, wich 

is entering in an exciting new era in 

medicines development. 

The innovative pharmaceutical in- 

dustry aims to turn fundamental research 

into innovative treatments 

that are widely available and accessible 

to patients. Already, the sector 

has contributed to significant 

improvements in patient well-being. 

Today’s European citizens can 

expect to live up to 30 years longer 

than they did a century ago. 

A data says, the research-based 

pharmaceutical industry can play a 

critical role in restoring Europe to 

growth and ensuring future competitiveness 

in an advancing global 

economy. In 2020 it invested an 

estimated € 39,000 million in R&D 

in Europe. To conclude, and according 

to Eurostat research, the pharmaceutical 

industry is the high technology 

sector with the highest added-value 

per person employed, significantly 

higher than the average 

value for high-tech and manufacturing 

industries. 


50_53_ART EFPIA.indd 50 01/09/21 17:16

Insight 

An exciting new era in medicines 

development 

Thanks to advances in science and 

technology, the research-based 

pharmaceutical industry is entering 

an exciting new era in medicines development. 

Some major steps in biopharmaceutical 

research, complimented 

by many smaller steps, have 

allowed for reductions in mortality, 

for instance from HIV/AIDS-related 

causes and a number of cancers. 

High blood pressure and cardiovascular 

diseases can be controlled 

with antihypertensive and cholesterol-lowering 

medicines; knee or hip 

replacements prevent patients from 

immobility; and some cancers can be 

controlled – or even cured – with the 

help of new target treatments European 

citizens can expect not only to 

live longer, but to live better quality 

lives. Yet major hurdles remain, including 

Alzheimer’s, Multiple Sclerosis, 

many cancers, and rare diseases. 

Pharmaceutical industry: a key asset 

to the European economy 

As well as driving medical progress 

by researching, developing and 

bringing new medicines that improve 

health and quality of life for 

patients around the world, the research-based 

pharmaceutical industry 

is a key asset of the European 

economy. It is one of Europe’s top 

performing high-technology sectors. 

The research-based pharmaceutical 

industry can play a critical role in restoring 

Europe to growth and ensuring 

future competitiveness in an advancing 

global economy. In 2020 it 

invested an estimated € 39,000 million 

in R&D in Europe. It directly employs 

some 830,000 people and generates 

about three times more employment 

indirectly – upstream and 

downstream – than it does directly 

(PwC, Economic and societal footprint 

of the pharmaceutical industry 

in Europe, June 2019). However, 

the sector faces real challenges. Besides 

the additional regulatory hurdles 

and escalating R&D costs, the 

sector has been severely hit by the 

impact of fiscal austerity measures 

introduced by governments across 

much of Europe since 2010. 

There is rapid growth in the market 

and research environment in emerging 

economies such as Brazil, China 

and India, leading to a gradual 

migration of economic and research 

activities from Europe to 

these fast-growing markets. During 

the period 2015-2020 the Brazilian, 

Chinese and Indian markets grew by 

11.3%, 4.8% and 10.0% respectively 

compared to an average market 

growth of 5.0% for the top 5 European 

Union markets and 4.9% for 

the US market (source: IQVIA MIDAS, 

April 2021). 

In 2020 North America accounted 

for 49.0% of world pharmaceutical 

sales compared with 23.9% for 

Europe. According to IQVIA (MIDAS 

April 2021), 63.7% of sales of new 

medicines launched during the period 

2015-2020 were on the US market, 

compared with 17.4% on the European 

market (top 5 markets). 

New medicines 

cover all 

new active 

ingredients 

marketed for 

the first time 

on the world 

market during 

the period 2015- 

2020. Source: 

IQVIA (MIDAS 

April 2021) 



50_53_ART EFPIA.indd 51 01/09/21 17:16

Insight 

• The cost of researching and developing 

a new chemical or biological 

entity was estimated at € 1,926 

million ($ 2,558 million in year 2013 

dollars) in 2014 (DiMasi et al, Journal 

of Health Economics, January 

2016); 

• On average, only one to two of 

every 10,000 substances synthesised 

in laboratories will successfully 

pass all stages of development 

required to become a marketable 

medicine. 

In 2019 the pharmaceutical industry 

invested more than € 37,700 

million in R&D in Europe. A decade 

of strong US market dominance led 

to a significant shift of economic 

and research activity towards the 

US during the period 1995-2005. 

Additionally, Europe is now facing 

increasing competition from 

emerging economies: rapid growth 

in the market and research environments 

in countries such as Brazil 

and China are contributing to the 

move of economic and research activities 

to non-European markets. 

The geographical balance of the 

pharmaceutical market – and ultimately 

the R&D base – is likely 

to shift gradually towards emerging 

economies. 

According to EUROSTAT data, the 

pharmaceutical industry is the high 

technology sector with the highest 

added-value per person employed, 

significantly higher than the average 

value for high-tech and manufacturing 

industries. The pharmaceutical 

industry is also the sector 

with the highest ratio of R&D investment 

to net sales. 

According to the 2020 EU Indus- 

Data includes 

Iceland (since 

2017), Croatia, 

Lithuania and 

Turkey (since 2010), 

Bulgaria, Estonia 

and Hungary 

(since 2009), Czech 

Republic (since 

2008), Cyprus 

(since 2007), Latvia, 

Romania & Slovakia 

(since 2005), 

Malta, Poland and 

Slovenia (since 

2004). 

Source: EFPIA 

member 

associations 

(official figures) - 

(e): EFPIA estimate 

The fragmentation of the EU pharmaceutical 

market has resulted in a 

lucrative parallel trade. This benefits 

neither social security nor patients 

and deprives the industry of additional 

resources to fund R&D. Parallel 

trade was estimated to amount to 

€ 5,758 million (value at ex-factory 

prices) in 2019. 

Pharmaceutical industry 

R&D in Europe 

All new medicines introduced into 

the market are the result of lengthy, 

costly and risky research and development 

(R&D) conducted by pharmaceutical 

companies: 

• By the time a medicinal product 

reaches the market, an average of 12- 

13 years will have elapsed since the first 

synthesis of the new active substance; 


50_53_ART EFPIA.indd 52 01/09/21 17:16

Insight 

trial R&D Investment Scoreboard 

the pharmaceutical and biotechnology 

sector amounts to 18.4% 

of total business R&D expenditure 

worldwide. 

Data includes Iceland (since 2017), Greece & Lithuania (since 2013), Bulgaria and Turkey (since 

2012), Poland (since 2010), Czech Republic, Estonia and Hungary (since 2009), Romania (since 

2005) and Slovenia (since 2004) 

Croatia, Cyprus, Latvia, Malta, Serbia, Slovakia: data not available 

Non-weighted average for Europe (average estimate for 25 countries) 

Source: EFPIA member associations 

Source: OECD 

Health Statistics 

2020, May 

2021 – EFPIA 

calculations (nonweighted 

average 

for 26 EU & EFTA 

countries and 

Turkey) 

Employment in the 

pharmaceutical industry 

The research-based pharmaceutical 

industry is one of Europe’s major 

high-technology industrial employers. 

Recent studies in some countries 

showed that the research-based pharmaceutical 

industry generates about 

three times more employment indirectly 

– upstream and downstream 

– than it does directly (PwC, Economic 

and societal footprint of the 

pharmaceutical industry in Europe, 

June 2019). Furthermore, a significant 

proportion of these are valuable 

skilled jobs, for instance in the 

fields of academia or clinical science, 

which can help maintain a high-level 

knowledge base and prevent a European 

“brain drain”. 

The pharmaceutical market 

The world pharmaceutical market 

was worth an estimated € 943,667 

million ($ 1,077,856 million) at 

ex-factory prices in 2020. The North 

American market (USA & Canada) 

remained the world’s largest market 

with a 49.0% share, well ahead 

of Europe, China and Japan. Distribution 

margins, which are generally 

fixed by governments, and VAT rates 

differ significantly from country to 

country in Europe. On average, approximately 

one third of the retail 

price of a medicine reverts to distributors 

(pharmacists and wholesalers) 

and the State. 

In conclusion, medicines constitute 

the smallest part of healthcare 

costs with, on average, 19.1% 

of total health expenditure in Europe 

being spent on pharmaceuticals 

and other medical goods. In 

costly diseases such as cancer and 

rheumatoid arthritis, medicines account 

for even less than 10% of the 

total disease costs. Medicines can 

also generate additional savings, 

for example by substantially reducing 

costs in other areas of healthcare, 

including hospital stays and 

long-term care costs. l 



50_53_ART EFPIA.indd 53 01/09/21 17:16

Technologies 

Print&check machine 

Marchesini Group will be at PCI Days 2021, 

the Polish B2B trade fair dedicated to manufacturers, 

suppliers and businesses operating 

in the pharmaceutical and cosmetic 

industries, which is to be held in Warsaw 

on the 8th and 9th September. 

Marchesini Group will be showcasing the 

print&check machine with integrated 

checkweigher BL-A418 CW (stand B.14): 

this solution for Track and Trace requirements 

is developed by Neri, the division of 

the Group specialised in carton labelling 

and tracking machines. 

The model exhibited, that can process up to 

400 cartons per minute, has a load cell fully 

integrated into the stepper conveyance 

system. This solution is much more compact 

than both the classic one (where the 

weighing unit is coupled in-line) and the version 

of main competitors of the market, who 

offer solutions having weighing units with 

their own independent conveyance system. 

The cartons are fed and accumulated inline 

on the inlet belt to ensure a continuous 

flow of products, even at high speeds. 

A timing device positions and sets the cartons 

apart correctly on the first stabilizing 

belt of the load cell and the vertical 

toothed belts with adjustable opening assure 

the pitch control of the carton during 

the weighing operation. 

The function of the timing device is to set 

the cartons at the correct distance apart; 

its special feature is that it is synchronised 

with the speed of the whole conveyance 

system and there is no need for any size 

change-over adjustments. 

A load cell is fully integrated into the stepper 

conveyance system and is able to check 

the weight of each carton. By integrating 

the load cell into the toothed belt system 

of the BL-A418 CW, it is able to verify the 

position of the cartons at all times: if the 

weight is correct, the product undergoes 

the subsequent processes (serialization and 

marking), then it is sent to the next machine; 

if on the other hand the weight is not 

correct, the subsequent process is skipped 

and the carton is rejected, according to the 

“Fail Safe” operating logic. 

The operation to be performed after checking 

the weight of the cartons is the serialization; 

then, the unique 2D code (Datamatrix) 

and the corresponding human readable 

data are printed on the side flaps and sometimes 

on the upper panel. The unique code 

identifies and makes it possible to track 

each carton. 

A dedicated camera(s) then verifies both the 

codes and the readable data. During these 

phases, the use of the “Fail Safe” operating 

logic means that only “correct” cartons are 

sent to the machine downstream, while the 

others are identified and rejected. 

Innovative monitoring of gas scrubbers by means of sonic velocity 

Environmentally harmful, corrosive or toxic gases are used 

in a large number of industrial processes. To protect people 

and the environment, the treatment of these gases is 

subject to strict regulations, in particular which purification 

criteria a gas scrubber must achieve. 

Ensuring the complete conversion of toxic components 

while using scrubbing liquid efficiently is often a challenge 

for process engineers. The effectiveness of a gas 

scrubber depends on the exact dosage of the scrubbing 

liquid (for example: caustic soda). 

To enable an exact determination of the concentration of 

the scrubbing liquid and the salts, two physical measurands 

have to be combined. Conventional measuring methods 

often map only one measurand and neglect the influence 

of the resulting salts. In addition, in many cases the 

process is monitored in a very time-consuming manner by 

sampling and titration. 

The LiquiSonic® process measuring system analyzes both 

concentrations, that of the washing liquid and that of the 

salt, in real time. This allows exact dosing and adjustment 

of the washing liquid. The washing process thus becomes 

much more efficient and safer. Thanks to the explosion-proof 

inline measuring system, no intervention in 

the process is necessary. The exact concentration of the 

scrubbing liquid and the salt content are available at all 

times. Critical situations in which toxic and environmentally 

harmful gases could escape can be detected at an 

early stage by LiquiSonic and countermeasures can be initiated 

in good time. 

The maintenance-free measuring devices from SensoTech 

GmbH are very durable and can be easily integrated into 

the process control system. The automated documentation 

and various diagnostic tools provide a comprehensive 

analysis of the process and can be used for further 

improvements. LiquiSonic reduces hazards for the environment 

and employees and ensures efficient, time-saving 

process analysis. 


54_55_NEWS_TECHNOLOGIES.indd 54 01/09/21 14:55 

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_I_IV_COVER 3-2019.indd 1 05/09/19 14:17 

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54_55_NEWS_TECHNOLOGIES.indd Pub_interp_232X285_ENG_ross.indd 55 3 01/09/21 31/08/21 14:55 

09:03

In this issue, 

we spoke about... 

ACHEMA ........................................................................ 16 

AIRNOV HEALTHCARE PACKAGING...................................... 48 

BAYER ........................................................................... 11 

BORMIOLI PHARMA ......................................................... 10 

BRUNO WOLHFARTH ...................................... 2 th COVER, 38 

CHEMPROD.............................................................. 15, 28 

CLEANZONE .................................................................... 14 

CO.RA. ..........................................................................27 

CVS LIFE SCIENCE ...................................................... 1, 24 

EFFEBI ..........................................................................41 

EFPIA............................................................................ 50 

ELLAB .................................................................... 13, 44 

ENDRESS+HAUSER ...........................................................5 

FARAVELLI ....................................................................31 

FLUORTECNO .......................................... BACK COVER FLAP 

GEA GROUP .................................................................... 37 

GSK .............................................................................. 12 

INTERPHEX .................................................................... 14 

INTERPROGETTI EDITORI ................................................55 

ITELYUM .......................................................................49 

LAUDA .......................................................................... 36 

LIFEBEEE ....................................................................... 18 

MARCHESINI GROUP........................................................ 54 

MESSE FRANKFURT .....................................................14, 16 

MONTENEGRO ................................................................37 

MOZZANICA&MOZZANICA ...............................................21 

NUOVA GUSEO ......................................................... 17, 32 

POMPETRAVAINI ............................................................43 

PROCESS SERVICE ................................................ 3 rd COVER 

PVS GROUP ............................................... FRONT COVER, 6 

R. STAHL ....................................................................... 36 

ROMACO ........................................................................ 10 

S4S ..............................................................................35 

SANOFI ......................................................................... 12 

SENSOTECH .................................................................... 54 

SWAN ANALITICA .................................................... 11, 42 

TERRANOVA ..................................................................23 

TEXPACK ................................................... BACK COVER, 22 

TMIP ....................................................FRONT COVER FLAP 

TRANSLATE BIO .............................................................. 12 

VIR BIOTECHNOLOGY ....................................................... 12 

VISCOTEC ....................................................................... 48 

VIVIDION THERAPEUTICS ................................................. 11 

icf 

YEARXII 

SUPPLEMENT ISSUE 

NO.3 2021 

MANAGING DIRECTOR: Simone Ghioldi 

REDACTION: Alessandro Bignami (a.bignami@interprogettied.com), 

Eva De Vecchis (e.devecchis@interprogettied.com) 

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

TRANSLATIONS: Elena Marzorati 

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DELL’ INDUSTRIA 

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56_56_COLOPHON.indd 56 01/09/21 16:06

THINKING 

Process Service srl è una società di ingegneria, che dal 1986, opera nell’erogazione 

di servizi di consulenza e progettazione, con una elevata specializzazione negli 

impianti chimici e farmaceutici. Process Service è in grado di accompagnare il cliente 

lungo tutto il corso di un progetto sia nuovo che di revamping. 

Sviluppo del processo e dell’ingegneria di base-Ingegneria di dettaglio-Supporto al 

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Via Alcide De Gasperi 111 20017 Rho (MI) Tel: 02 939 09 272 Fax: +39 02 939 06 328 

info@process-service.it 

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_I_IV_COVER 3_2021_PHARMA.indd 5 31/08/21

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