E+H Life Sciences Magazine May 2015

1. Endress+Hauser Magazine www.endress.com/life-sciences Issue 5/2015
life sciences
A pulse ahead
Improve quality,
compliance
and cost control
08 Ease standardization
Biopharmax insulin plant
in China
14 Operational Excellence
Improved calibration
management at UCB Ireland

2. Imprint
Pubisher Endress+Hauser Consult AG
Kägenstrasse 2, 4153 Reinach, Switzerland
Editors Klaus Köhler, Samuel Urbain
Date of publication June 2015
Reprint Any printing - even in parts - is forbidden without prior
permission. This document remains the property of the company.
2
Ease standardization
4 Added value
through automation
GTec relies on digital
Memosens protocol
6 Complete package for cosmetics
Measurement, energy
monitoring and calibration
for Beiersdorf in Mexico
8 The multiple virtues
of standardization
Biopharmax implemented
a fully automated insulin
manufacturing facility
11 Focused on efficient processes
Merck Serono standardizes
process instrumentation
12 Significantly reducing costs
Standardization reduces the
complexity of operations
13 Shorten engineering time
Operational excellence
14 Improving calibration processes
UCB Pharma uses calibration
management software
15 Paperless calibration
Issues for calibration and paper
base systems are history
16 Advantages are crystal clear
Schott seeks help from outside
to carry out on-site calibration
19 Accredited calibration expertise
Minimization of downtime and
prevention of plant shutdowns
Product highlights
20 Digital sensors in biotechnology
Sartorius Stedim Biotech relies
on innovative technologies
22 New TM411 thermometers:
Innovations and performance
24 Fast and easy for a better quality
at Chr. Hansen
Solution highlights
25 In the service of beauty
Endress+Hauser provides dosing
units for complex vacuum
processing units
14 Operationalexcellence
Wherever you produce, we are by
your side to increase efficiency while
maintain the required GMP level.
4 Ease standardization
Standardize with the largest offering
of instruments to minimize project
complexity, operational costs and
plant downtime.
20 Product highlights
Easy operation and calibration:
innovation and performance for
temperature, pH and dissolved oxygen
devices
life sciences

3. 3
Doing more with less is still the quintessence of operational excellence
in the life sciences industry. By capitalizing on innovation and new
technologies, the ultimate goal is to bring down operational costs
while maintaining product quality and increasing productivity.
This is good news: Manufacturing in life sciences has reached a
higher level of maturity!
Reported batch losses are decreasing! Some of the reasons are
due to less errors caused by human interaction due to better trained
personnel, better understanding of the manufacturing processes and
their limits, and PAT slowly sneaking into manufacturing. Process
control has reached a higher level due to the availability of innovative
and better adopted sensors and analyzers.
However, some aspects are still considered critical. Do suppliers
know about the life sciences processes and regulations? What about
our suppliers’ understanding of compliance? How can I mitigate the
risk associated with each innovation and improvement applied to the
manufacturing environment?
This 5th
issue of the “life sciences” magazine will provide you
trustful answers that show how Endress+Hauser can help you
improve life sciences processes no matter if you are successfully
operating, engineering or supplying to a manufacturing plant in
pharmaceuticals, biopharmaceuticals or cosmetics.
I hope you enjoy reading.
Yours,
Klaus Köhler
Global Industry Manager Life Sciences
Trustful answers
Editorial

4. The company GTec GmbH is based
in Winsen an der Luhe in Lower Saxony
in Germany and was founded in 2001.
It has more than thirty years’
experience in water treatment.
In addition to the high quality of the
water treatment plants, customers
also value the 24-hour service.
The solution Intelligent Memosens
sensors provide increased benefits for
customers:
• Calibration under laboratory
conditions, irrespective of the
measurement location, for more
accurate process management.
• Increased operating life and reduced
calibration costs enable savings of up
to 40%.
• Inductive transmission of the
digitized measured data, resistant
to environmental influences such as
Electromagnetic Compatibility (EMC)
and moisture.
• Effective, reliable documentation
of the calibration data and process-
related data using Memobase
software.
Read page 23 for more information.
4 life sciences

5. Today, water with various levels of purity is required in the
pharmaceutical and cosmetics industries, and also in medical
technology. Current pharmacopoeias define limit values,
depending on the application, for conductivity, total organic
carbon (TOC), bacterial count, certain ions and endotoxins,
and adherence to these limit values must be achieved,
demonstrated and documented. GTec GmbH, a leading
supplier of innovative water treatment plants, offers many
years of experience in the design, planning and production
of plants and plant systems for the pharmaceutical industry.
For the company, customer focus is increasingly shifting
towards plant efficiency. In water treatment plants, it can
be defined by the “water conversion factor”. The WCF sets
the quantity of permeate in proportion to the drinking water
used. Using innovative technologies, GTec was able to launch
plants with a WCF of up to 90%.
The company achieves a particularly high level of
automation in its plants. This provides additional benefits
for the operator. For example, in a reverse osmosis plant
the conductivity is measured at six points and the signals
are processed on a multi-channel transmitter. To do this,
the water experts rely on analysis measuring points from
the digital Memosens protocol. GTec project engineer
Andreas Stangenberg explains various aspects of the plant
technology.
The market for pharmaceutical water generation is
highly competitive. How do you differentiate yourself
from the competition?
Andreas Stangenberg: We stand for high standards
generally. “Low-cost technology” is not something you
get with us. Our plant technology frequently exceeds our
customers’ actual requirements. For example, we were able
to achieve conductivity values of less than 0.075 µS/cm. That
is considerably less than the limit value of 1.3 µS/cm actually
required. We were even able to achieve this merely by using
reverse osmosis membranes, which are considerably more
robust than EDI plants (electro-deionization), for example.
We also offer our customers a special service: If required,
we can remotely monitor an existing plant online. This is
where the high degree of automation and instrumentation
in our plants comes into effect. It is only possible to carry out
remote monitoring such as this efficiently if measurements
are also taken at other points, between the individual
process stages. Our customers value this service, because
they are convinced that, as a specialist, GTec is best placed
to assess its plants. Other factors driving differentiation are
true technical innovations. For example, with our “HPW
pharma LOOP” we have created a distribution system for
pharmaceutical water which has fully automated point-
of-use management and which does not require storage
containers and pumping stations. This saves space and costs
for the plant operator. The price of this plant provision must
be appropriate, but increasingly it is of secondary importance
compared to the long-term view of operating costs.
What benefits do you see in the collaboration
with Endress+Hauser?
Stangenberg: We see Endress+Hauser as a particularly
versatile supplier capable of handling important
measurement parameters completely and reliably. We have
a contact person for all instrumentation questions. That is
important to us. Endress+Hauser provides a high level of
quality and the number of equipment failures is significantly
lower compared with other suppliers. Another point to
mention is the high level of acceptance among customers.
Endress+Hauser is very well established.
Added value
through automation
Water treatment in regulated industry: GTec relies on conductivity
measurements from the digital Memosens protocol in reverse osmosis plants.
Philipp Garbers
Industry Manager
Life Sciences
Germany
HPW pharma RO is the largest reverse osmosis plant built by GTec to
date. It generates 12.5 m3
/h of permeate with a water conversion
factor (WCF) of up to 90%.
5Ease standardization

6. Nivea, Labello, Hansaplast ... the
brands of cosmetics group Beiersdorf
are known worldwide. Recently,
the company has built a new
production facility in Mexico for
the production of cosmetic products
for the North American and Latin
American markets. After an efficient
construction time of less than two
years, the new plant, strategically
located about 350 kilometers
northwest of Mexico City in the state
of Guanajuato, began operation in
July 2014. With a production volume
of about 280 million cosmetic products
and 45,000 tons of product annually,
the new factory is the second largest
within the global Beiersdorf production
network after Hamburg in Germany.
As a general contractor for
the building of this production
facility, M+W Group operated with
its subsidiaries M+W High Tech
Projects Mexico and M+W Process
Industries GmbH, in the search for a
competent full-service provider for
the instrumentation, the choice fell
on Endress+Hauser. It was agreed
for a package of nearly 300 stations
in the fields of flow, temperature,
pressure, analysis and level, with
rounded smart scale energy solutions
for the collection, documentation and
optimization of energy flows, as well
as various calibration services on site.
Global and local support Metrological
instrumentation was produced in the
Endress+Hauser works in Germany,
Switzerland, France and Italy, supplied
to M+W in Stuttgart and shipped with
other materials to Mexico. The wiring
and installation were carried out on-site.
The installed equipment base is very
strong, calibrated by experts of the
Complete package for cosmetics
Measurement, energy monitoring and calibration: The engineering company
M+W commissioned Endress+Hauser instrumentation with a service package
in a Mexican manufacturing facility of Beiersdorf.
6 life sciences

7. 100 employee strong Endress+Hauser
sales and service organization in Mexico.
Monitoring earns points Beiersdorf
strives for important LEED points for
a platinum status certification. The
Leadership in Energy & Environmental
Design, a system for classifying
sustainable buildings, from the United
States Green Building Council, was
created in 1998. It defines a set
of standards for environmentally
friendly, resource-efficient and
sustainable construction. The energy
monitoring system e-Sight can help.
More information at
www.endress.com/esight
M+W Group, with headquarters
in Stuttgart, Germany, is one of
the leading global companies
in the field of high-tech
engineering, procurement and
construction. From concept
development to turnkey
solutions, the Group manages
projects of all sizes for many
industries. Founded in 1912,
the company is recognized
today as a market leader in
several segments, such as the
semiconductor and photovoltaic
industries. M+W Group employs
around 8,500 employees.
Beiersdorf AG is among the
world’s leading suppliers of
innovative and high-quality skin
care products and has over
130 years of experience in this
market segment. The cosmetic
company, headquartered in
Hamburg, employs about
16,500 workers around the
globe. NIVEA is the heart of the
internationally successful brand
portfolio of Beiersdorf AG,
which also includes Eucerin,
La Prairie, Labello, 8x4 and
Hansaplast. With the affiliate
tesa SE, Beiersdorf supplies
industry, crafts, and consumers
with self-adhesive products and
system solutions.
©Beiersdorf
Philipp Garbers
Industry Manager
Life Sciences
Germany
Analysis and Coriolis mass flow meters in the system at Beiersdorf in Mexico.
7Ease standardization

8. 8 life sciences
The multiple virtues of standardization
Biopharmax designed and implemented a fully automated and monitored
insulin manufacturing facility in China. Cooperation with Endress+Hauser
resulted in higher productivity and lower maintenance and calibration costs.
In order to manufacture insulin for
the Chinese market, a local company
engaged with Biopharmax to
establish the plant on a turnkey basis,
design, construction, commissioning
and validation in accordance to
USFDA, EMEA and CFDA regulatory
requirements.
Biopharmax designed and built
a fully automated facility, including
an insulin technology that was
procured from a third party, based on
recombinant e-coli fermentation.
Full automation The control of the
entire facility is managed from a
centralized control room. The HMI
control unit is in charge of the entire
functionality. This automation results
in lower operating costs and less
failure. All relevant manufacturing
and environmental parameters are
seamlessly monitored. Per regulatory
requirements, data (SQL; events, audit
trail) is kept, secured for a long period
of time.
Multinational project “We managed
to build a state-of-the-art
manufacturing facility by handling
all scale up tasks and the challenges
of the complexity caused by a
large multinational project team”,
explains Sarel Chen Tov, CEO at
Biopharmax LTD.The compliance to
the regulatory requirements from
USFDA, EMEA and CFDA is assured
and – very important – the time frame
was perfectly met.”
However managing such a project
is no easy task. “A project of this size
requires a seamless cooperation of
several sub-contractors and suppliers
from a wide range of disciplines.
Choosing skilled workforce, educating
them with the project requirements
and building a team that can efficiently
execute high quality work has been
successfully mastered. Keeping to
international standards and sustain
regulatory compliance was a must.”
350 people involved Working in
an international environment with
suppliers from all over the world
requires a special approach to bridge
any culture and language barriers.
On one hand, we are utilizing an
international workforce on the
engineering and project management
team, including local as well as
Asian staff. On the other hand, with
solid local support, we work with
international equipment providers
what enables to bridge over the gaps
and to effectively communicate the
work processes. Eventually over 100
of Biopharmax engineers of different
nationalities and more than 250

9. “Endress+Hauser stands for reliability,
accuracy and stability in the
instrumentation area. We trusted in
the highly qualified and available
project service to assure the best fit
and quality for each application.
In addition, fast delivery and global
support made it an easy choice.”
Sarel Chen Tov, CEO at Biopharmax Group
9
sub-contractor workforce joined hands
to complete the project successfully.
Outstanding challenges “A major
engineering challenge came as the
project called for scale up from R&D
scale at 100 liters to a production
scale of 5,000 liters”, says Chen Tov.
“Another layer of complexity that
was added to the project was the
technology transfer between two
very distant countries around the
globe. Meeting this challenge meant
a very close cooperation between the
Biopharmax engineering team and
technology providers in understanding
the most delicate nuances of the
process. Utilizing the expertise of
Endress+Hauser helped to choose
the equipment that best suited to
the process and assured best control,
high accuracy, and lowest possible
maintenance and calibration effort.”
Expertise Endress+Hauser provided
the majority of measurement
instruments – more than 350 pieces
for flow, temperature, pressure,
conductivity, chlorine and level.
“The project objective was to build
Established for 40 years, Biopharmax is a global design and construction
provider of manufacturing facilities and systems, specialized on
biopharmaceutical industry.
Biopharmax undertakes turnkey projects from URS (User Requirement
Specification), concept stage through implementation to successful
validation. The company’s mission is to design, build and validate
pharmaceutical facilities of the highest level.
Process design and technology transfer Biopharmax brings not only
knowledge and experience in the engineering area but is also involved with
a variety of technologies in the pharma field. Biopharmax’s outstanding
strength is in process design and implantation including technology transfer.
Biopharmax’s ability to complete turnkey project, to implement technology
transfer and to guaranty regulatory compliance – such as USFDA, CFDA,
EMEA – provides ultimate solution for the client.
Biopharmax has designed and constructed over 100 facilities in
14 countries around the globe and actively present in Europe, USA, China,
India and Middle East.
Ease standardization
…

10. Samuel Urbain
Communication Manager
Life Sciences
Endress+Hauser provided the majority of the measurement instruments, all in all around 350 pieces for flow, temperature, pressure, conductivity,
chlorine, pressure and level.
10 life sciences
a fully automated and monitored
facility. Reliable instruments play
a very important role to reach this
target and in maximizing plant
availability. Endress+Hauser provided
not only high-quality instruments
but also professional expertise in all
applications in the Biotech plants
and a professional documentation
service which complied with FDA
cGMP. Please let me mention the
excellent support by Endress+Hauser
to build a world leading plant which
exceeded our expectations by far.” The
project has been completed with yield
significantly higher than expected and
purity above 99%. Close coordination
with the equipment manufacturers
has proven an unmatched success.
Standardization “We have chosen
Endress+Hauser because in this project,
the highest standards were required”
declares Chen Tov. “Endress+Hauser
stands for reliability, accuracy and
stability in instrumentation. We
trusted in the highly qualified and
available Endress+Hauser project
service team to assure the best fit
and quality for each application.
The high level GMP documentations
and certificates required in
biopharmaceutical industry assure
compliance. In addition fast delivery
and global support made it an easy
choice. The standardization on one
supplier and the high quality of the
products result in little maintenance
and low calibration costs for the
end-user. Last but not least, we
found out that it was easy to the
international equipment suppliers to
stand to the project requirement for
instrumentation standardization as
they use Endress+Hauser instruments
to begin with.”
The project
The 7,500 m2
facility
was built including:
• inculcation and
fermentation train
• upstream separation
and isolation equipment
• downstream purification
systems
• critical systems and
plant utilities
• grade C, B and A cleanrooms
• QC laboratories
• warehouse, technical areas
and offices.
Overall, more than 100 systems
were installed.

11. Focused on efficient processes
Merck Serono standardizes its process measurement technology early,
thus achieving a high level of efficiency in internal processes.
Merck Serono’s biotechnological
production is located in Switzerland,
at the Aubonne and Corsier-sur-Vevey
sites at Lake Geneva. Around
320 people are employed at Aubonne,
where engineering and calibration
services are combined under one
roof. The manageable size of the
site promotes open communication
between the departments; interfaces
are reduced and internal processes
optimized. In automation engineering,
the open discussion between planners
and subsequent operating staff about
metrological specifications is of
significant importance.
In Aubonne, the advantages of
standardized measuring instrumen-
tation was also recognized early on.
Today, roughly 90% of the measuring
instruments are standardized across
all the sites. This results in a reduction
in the complexity and this significant
advantages for any work that needs
to be carried out as part of calibration
and maintenance. Merck Serono trusts
Endress+Hauser as its main supplier for
the most important level, temperature,
pressure, flow rate and analysis process
Today, Merck Serono, the biopharma branch of the Merck Group, employs
15,600 people globally. The headquarters of the Merck Group is at the
company’s traditional home in Darmstadt, Germany. Merck currently has
about 39,000 employees worldwide. Its products are sold in 150 countries.
©Endress+Hauser
11Ease standardization

12. parameters. In order to reduce the
number of suppliers, there is a focus
on just a few partners for metrology.
In-house expertise Risk-based
calibration management makes
it possible to concentrate on the
essential quality-related measurement
parameters while fulfilling the
calibration requirement in accordance
with the applicable GMP regulations.
The parameters to be calibrated are
all calibrated on-site in Aubonne and
divided into three classes for this
purpose: “Class A” (regularly calibrated
on-site), “Class B” (initial calibration
performed only following installation)
and “Class C” (not calibrated on-site).
Merck Serono relies on its
specialists in the technical service
division to provide a high level of
continuity in carrying out this work.
All calibration services can be carried
out without using external suppliers.
Therefore, process and calibration
expertise remains in-house, and it is
not necessary to train and coordinate
external calibration suppliers. “Over
the years, we have optimized our risk-
based calibration management. With
more than 3,600 measuring points in
service, we have been able to focus our
calibration work on the quality-related
30% of these measuring points,”
explains Shahid Malik, Supervisor
of Validation & Metrology Services.
With the optimization of internal
processes, the standardization of the
high level measuring instrumentation
and process efficiency was achieved
as a result. He sees Merck Serono’s
Aubonne site as being equipped for
the future.
“The historical development of the Aubonne site has prompted us to accelerate
the standardization of metrology as part of a drive to reduce the number of
suppliers. Endress+Hauser has proved itself to be a very reliable partner.”
Bruno Walcher, Engineering Project Manager at Merck Serono
Significantly reduce
your operating costs
Standardization of measurement
instrumentation can reduce complexity
during operations.
Modern manufacturing plants in the life sciences industry have a
modular design, the modules of which are supplied by skid/plant
builders and OEMs from around the globe. Standardizing the
measurement instruments offers a huge potential for cost savings
throughout the entire life cycle, encompassing both the engineering
and the operational phase.
Interview with Philipp Garbers, Industry Manager Life Sciences
in Germany.
How can standardization be so beneficial to the life sciences
industry?
Philipp Garbers: The continually increasing diversity in automation
technology means that new projects are becoming increasingly complex.
This diversity needs to be carefully managed during the engineering
phase in order to minimize the complexity in the operational phase.
By way of example, one customer recently reported to me that the
installed base of temperature assemblies in a newly built facility
consisted of over 30 different varieties. The reason for this was that in
Philipp Garbers
Industry Manager
Life Sciences
Germany
©Endress+Hauser
12 life sciences

13. the absence of any device standardization, each supplier on the project
had implemented his own standards, resulting in the wide variety of
devices supplied. Such situations are not uncommon and can lead to
numerous problems during the installation and operational phase of a
facility. For example, during installation one sensor type required the
use of thermally conductive paste whilst other types did not. Each sensor
had its own unique calibration procedure reducing the ability to adopt
a standard calibration procedure, leading to unnecessary complexity.
In addition, the number of critical devices that needed to be kept in
stock was significantly higher, which resulted in further unnecessary
costs. Finally, lack of standardization amongst the installed devices
increased the training requirements for the maintenance personnel.
Pharmaceutical manufacturing processes, particularly biotechnology have
a modular design, which often means that individual unit operations are
implemented by a number of different suppliers. If insufficient attention
is given to the standardization of instrumentation during the engineering
phase, the results are likely to manifest themselves in the type of diversity
described above, which will lead to considerable extra work for the
personnel operating the facility, not to mention additional cost.
How does Endress+Hauser provide active support?
Garbers: With products designed specifically for use in the life sciences
industry, Endress+Hauser is able to provide devices to suit all of the key
process parameters. These devices are supported by a global network
of qualified application, calibration, maintenance and engineering
personnel, all familiar with working in GMP environments. Our global
presence and extensive project capabilities help us to implement life
science projects in an environment in which plant builders from around
the globe supply one end-customer. We support both the end user and
the plant builders locally and globally as required by the project.
Can you give us an example?
Garbers: One of our customers is constructing a new biopharmaceutical
manufacturing facility in South-East Asia. The scope of supply consists
of fermentation skids, chromatography and filtration skids, buffer
preparation and hold skids, and utilities packages for water and steam.
Before sending requests for quotations (RFQ) to the various skid/
plant builders, the customer worked out a standard instrument list
with Endress+Hauser. This standard was supplied to the vendors along
with the RFQ, with Endress+Hauser providing support to all involved
parties throughout the quotation process and beyond. This dramatically
reduced the diversity and complexity of the devices supplied on this
project. Furthermore, the data for the entire installed base was made
available via the Endress+Hauser W@M portal. This, in turn will bring
advantages when analyzing the criticality of measuring points during
the qualification and operation phases of the facilities.
Have you already put this into practice?
Garbers: Working in partnership with the plant engineering and
construction departments on major projects, we have coordinated a
number of large international projects for life sciences customers. The
number of installed devices ranges between 3,000 and 25,000 and the
effort required to ensure standardization is maintained on such global
projects is substantial. Many customers have already recognized and
benefited from the significant advantages this approach delivers.
Which prerequisites must be in place at the customer?
Garbers: As a precondition the end user should recognize that
standardization efforts during the project phase offer significant
potential to reduce both capital expenditure and operational costs.
If engineering, quality assurance and plant operation are focused on
total cost of ownership, then capital expenditure can be minimized
and future operating costs significantly reduced.
13Ease standardization
Shorten
engineering time
When engineering or re-engineering
process applications, the time needed
to define the right measurement
devices can be substantial. We help
you shorten engineering time with
various state-of-the-art tools, keeping
your project on-time and on-budget.
Engineering with full traceability
Whether you are engaged in detailed
engineering, creating isometric
drawings or writing a bill of material,
you can rely on Endress+Hauser’s
device data. Using our online tools,
you can select and size the best-fit
instrument and configure it according
to your application. A product order
code is generated and based upon order
code, device CAD models and drawings
are made available which can be used
for planning and documentation.
Access to engineering data
throughout the entire life cycle
Plant data is generated from the first
day of planning. Throughout your
project, all data is documented and
securely stored for all subsequent
processes. W@M Engineering is
designed to transfer the defined
parameters of the instruments to the
subsequent phases and processes
offering complete asset information
throughout the entire life cycle of
your plant.
Benefits
• Reduced time for detailed
instrument engineering
• Open interface to integrate the data
into customer systems
• Smooth handover to the next
project steps
More information at
www.endress.com/
lifecyclemanagement

14. Improving calibration processes
UCB Pharma, Ireland uses CompuCal calibration management software
from Endress+Hauser to improve quality and efficiency while lowering
calibration costs.
Calibration is an essential element
of any instrumentation maintenance
program. However, sometimes
calibration operations can be long;
paper based processes are prone to
transcription errors and are time-
consuming. By planning the process
and adding the right tools, efficiency
and quality can be improved and costs
lowered substantially.
Electronic records Shannon-
based pharmaceutical firm, UCB
Manufacturing Ireland, uses
CompuCal to manage its calibration
program. CompuCal has been
employed at the Shannon site since
2007 and prior to this the plant
was using a manual/Excel system to
manage calibrations. lt was required
that the system need to be 21 CFR
Part 11 compliant and able to use
electronic records.
The site upgrade in 2006
increased the calibration workload
significantly and to manage the
additional workload, the site
leadership recognized the need
for an electronic calibration
management system. The key
drivers for selecting CompuCal
to manage the implementation
were not only the functionality of
the software but also CompuCal’s
ability and resources to provide a
turnkey solution with installation,
configuration, data migration and
full validation.
UCB manufactures active
pharmaceutical ingredients
(APis) for a number of
indications including
cardiovascular.
©UCB
14 life sciences

15. Full validated system CompuCal’s
team was flexible, professional and
operated as part of the UCB team,
ensuring the project was delivered
within time and budget, and was able
to adapt to the validation approach
at UCB.
CompuCal delivered a fully
validated system that was up and
running with minimal impact on the
site operations. The migration of
data was handled very efficiently and
validated by CompuCal. Calibrations
are now recorded electronically with
a paper copy of calibration record also
retained.
In the manufacturing environment
of API, plant critical instrumentation,
for example temperature and
pressure, needs to be calibrated on
a regular basis. CompuCal manages
this schedule and ensures that UCB
calibrates the instruments to the
right standards at the right time.
CompuCal produces compliant
calibration certificates ensuring
UCB is compliant with their own
standard and those of the US and
European agencies. During audits
and regulatory inspections, the
calibration records are accessed
from the electronic record within
CompuCal or from the paper copy of
the calibration record.
Quality of life science products
are somehow dependent on the
functionality of the critical process
devices, thus these instruments need to
be calibrated and maintained regularly.
Maintaining calibration and related
records can be time consuming, costly
and stressful work, in ensuring and
proving these instruments meet
industry standards and regulations
during an audit.
CompuCal approach CompuCal
ensures the input of the data is quick
and easy while reducing the risk
of human error. The history of an
instrument can be viewed easily and
the engineer can see when the last
calibration or maintenance check was
done on any particular instrument.
The information stored in the software
system can be easily accessed at the
time of an audit, and Crystal Reports
generates calibration and maintenance
certificates in real time, ensuring you
are ‘Always Ready For An Audit’.
If an instrument depicts a deviation,
an automated email alert is sent to the
plant manager, thus allowing them
to schedule an engineer to attend
to the instrument immediately. The
added advantage that calibration
management software gives to the
plant manager is they are always
aware of what is happening on-site,
even if they are not on-site.
Always compliant Increased
enforcement by the FDA means plant
engineers and managers need to
ensure they remain 100% compliant.
CompuCal calibration management
software can facilitate this and ensure
that you stay compliant.
The key benefits of using CompuCal in
the life sciences sector are:
• Regulatory compliance
to FDA regulations
• 21 CFR part 11 compliance
• Eliminate costly manual entry errors
• Receive automated failure and
out-of-tolerance email notifications
• Reduce operating costs
• Paperless solution
• Always ready for an audit
More information at
www.compucalcalibrations.com
Christophe Roche
General Manager
Ireland
By your side for calibration
Located in the same building
than the CompuCal teams,
Endress+Hauser subsidiary
ensures accredited calibration in
Ireland for various parameters
such as level, pressure, flow
(soon ISO 17025), analytics
parameters. Calibration
management is also part of the
services provided to support
Irish life sciences customers.
Paperless calibration
With CompuCal, there are no issues
with calibration and paper base systems.
If an instrument depicts a deviation, an automated email alert is sent to the plant manager.
15Operational excellence

16. 16 life sciences
The constant humming of machines fills the hall. The
whirring of gas flames can be heard intermittently. Glass
tubes are heated, worked and allowed to cool, gradually
cut to size and then shaped. Several inspection steps later,
syringes, cartridges (such as those used in insulin pens) and
vials leave the production lines and are carefully packaged.
The Schott Pharmaceutical Systems production facility in
St. Gallen, Switzerland specializes in packaging for
injectable medicines.
The plants produce several million units annually.
“Our facility is involved in mass production which is subject
to the most stringent standards” explains Maintenance
Manager Andreas Maissen. The syringes must even be
sterile on delivery to the customer so they are cleaned
Advantages are crystal clear
Glass specialist Schott is subject to strict regulations as a supplier to the life
sciences industry. To guarantee the quality of its products, the company seeks
help from an outside supplier to carry out on-site calibration of its measuring
technologies.
A clean-cut affair: Glass specialist Schott produces packaging for the pharmaceutical industry. Sterile products account for an increasing part
of production.

17. 17Operational excellence
and packaged in a cleanroom. The system that treats
the ultrapure water required – referred to as water for
injection – is one of the core components within the
facility’s infrastructure.
Andreas Maissen says “Of course we must monitor
the atmosphere in the cleanrooms as well as the quality
of the water and record this information”. The facility is
certified in accordance with an extensive set of standards
and complies with US guidelines on good manufacturing
practice (cGMP – Current Good Manufacturing Practice).
This also has an impact on maintenance: “We are now
much more sensitive to the different parameters than
previously.”
Highest demands Processing the glass tubes also requires
a considerable level of precision: “The hot forming process
can cause stresses in the glass” explains René Zeidler, who
works as a maintenance engineer. “The glass bodies must
be allowed to cool slowly to ensure they relax properly.”
The exact temperatures in the process are defined by means
of appropriate limit and tolerance values. “Ultimately,
our main goal is to deliver on the quality commitments
made to the customer. We achieve this through regular
calibration of critical measuring points.” Schott has been
able to rely on Endress+Hauser for support in performing
these calibrations for eight years now. “It started with the
request for a conductivity sensor” says Thomas Gelencsér
who is responsible for service projects in the Swiss sales
team. “Today, the calibration contract covers 450 measuring
points for temperature, conductivity, pH value and pressure.”
“The calibration contract has allowed us to improve
internal capacity and make better use of our resources.”
Andreas Maissen, Maintenance Manager at Schott Pharmaceutical Systems in St. Gallen, Switzerland.
Schott has become a very important customer and
Endress+Hauser an invaluable service partner.
Time pressure In the summer when the rest of Schott’s
production team heads off on holidays, Andreas Maissen
and his team face some of the hottest days in the
production plant. Systems are shut down for roughly two
weeks. The maintenance manager packs all scheduled and
predictable inspection work into an intensive program.
“Our time frames are incredibly tight as we need to be able
to start systems in good time and test them.”
A large number of external service providers are onsite
during this phase. “There are usually five experts working
on the job and we try to bring in the same people wherever
possible” says Endress+Hauser service specialist Thomas
Gelencsér. Not only do they possess the technical knowhow
for their tasks, they also have the appropriate training in
Sensitive infrastructure: Maintenance engineer René Zeidler checks
a pressure measuring instrument on the water treatment system.
how to work on a pharmaceutical production line. René
Zeidler holds this experienced team in high regard: “It
is a major advantage when the technicians are familiar
with our operation and how the systems work.” Schott’s
maintenance team has great praise for the commitment
©SchottAG

18. Expertise in glass With its headquarters in Mainz,
Germany, Schott AG is part of the Carl-Zeiss
Foundation. The international, technology-based
group boasts more than 125 years of experience
in the area of specialty glasses and materials. The
Schott Pharmaceutical Systems division is one of the
world’s leading suppliers of primary packaging for the
pharmaceutical industry. More than 600 production
lines in 13 countries worldwide produce more
than 9 billion syringes, vials, ampoules, cartridges
and special articles of tubing glass and plastic.
The production facility in St. Gallen in Eastern
Switzerland employs roughly 520 people. This site
has developed into a center of excellence within the
group for syringes and cartridges and is responsible
for developing products, processes and systems.
The global business in syringes is also managed
from this center.Martin Raab
Spokesman
Endress+Hauser Group
18
©SchottAG
of Endress+Hauser’s service technicians as well as their
flexibility. “They work completely independently” says
Andreas Maissen. “If there is a problem anywhere, they
approach us immediately to find a solution.” Generally,
however, the Schott team is only required to validate and
sign the calibration reports. The maintenance manager
is more than impressed “The calibration contract with
Endress+Hauser has allowed us to improve internal
capacity as we can make better use of our resources during
this hectic period.
Words and actions Thomas Gelencsér is fully aware that
trust is the cornerstone of service contracts such as the one
with Schott. The service expert emphasizes “The customer
can rely on us to bring our extensive expertise in the area of
calibration and measurement instrumentation to the table”.
Oftentimes, Endress+Hauser technicians identify ways
to optimize processes. “For example, we helped Schott
to change over to sensors that can be precalibrated for
temperature measurements. This reduces complexity
significantly if a thermometer needs to be replaced
at some point.” In addition, Schott has been using
Endress+Hauser’s W@M portal for five years now. This
browser-based application offers access to device information
so that manuals, certificates and inspection reports are
merely a mouse-click away. “We have recorded all of the
measuring devices installed in the facility, including third-
party instruments” explains Thomas Gelencsér. Andreas
Maissen is very enthusiastic about use of the portal: “It saves
us many a search for documents on a daily basis.”
Worldwide, Endress+Hauser employs more than 1,000
service personnel who draw on decades of experience in a
wide range of industrial applications. All over the world,
this team offers comprehensive services in accordance
with unified standards. Needless to say, all services
comply with quality, health and safety requirements in
the relevant sector. The services offered have a three-tier
structure. Customer service engineers offer instant help in
emergencies. They are always present for technical support,
diagnostic work and repairs wherever and whenever
customers need it. In addition, a broad range of customized
solutions are available from engineering, commissioning
and calibration, to maintenance and training. Finally,
Endress+Hauser also provides assistance in optimizing
systems and processes. It offers advice on matters of
maintenance and measurement instrumentation and can
carry out maintenance and calibration tasks. This leads to
cost and risk reduction and improved quality.
Endress+Hauser offers software and hardware solutions to
help customers manage device configuration, maintenance
and calibration. W@M Life Cycle Management provides
online access to device information and documents over
the entire life cycle of a plant. This data can also be
accessed directly using the company’s own ERP system if
desired. Endress+Hauser supplies specific software tools
for parameter configuration and measurement instrument
diagnosis. The computer program CompuCal, for example
(see pages 14 to 15), allows users to automate and
optimize processes when performing and documenting
calibrations. Furthermore, building on their own world-
class rigs, Endress+Hauser has developed mobile units for
flow calibration. Customers can choose from a particularly
compact rig or a mobile flow laboratory. Both enable high-
quality, repeatable and traceable onsite calibrations.
Services
Always by your side
Configuration, calibration and maintenance
Tools of choice
life sciences

19. Thomas Kaufmann
Product Manager Services
Germany
19
The initial calibration of critical
measuring points in the production of
active ingredients is an integral part
of qualifying new facilities as part
of the installation or performance
qualification. During ongoing operation,
recalibration occurs at defined intervals
for continuous quality assurance. The
EU Guide to Good Manufacturing
Practice for Medicinal Products
stipulates in section 3.41: “Measuring,
weighing, recording and control
equipment should be calibrated and
checked at defined intervals. Adequate
records of such tests should be
maintained.”
What this means concretely is
that critical measuring devices must
be checked with respect to specified
tolerances under current operating
conditions. Typical parameters that are
calibrated include flow, temperature,
pressure, level, limit detection,
agitator speeds, mass, density and
analytical parameters such as pH value,
conductivity and dissolved oxygen.
All parameters To minimize
downtime and prevent plant
shutdowns the calibration service
of Endress+Hauser can perform all
calibrations on-site. Compared to
the typical procedure, users have to
interrupt their processes only briefly.
This does away with time-consuming
uninstallation, packaging, sending in
and installation of the devices.
Another plus: The result of
calibrating a device that is installed
and under process conditions is
substantially more conclusive
and accurate. The measuring
uncertainty information gained by
the on-site calibration enables easy
calculation of the total deviation
and a clear statement of quality for
the process. In particular, small and
mid-size companies benefit from the
calibration services, because they do
not have to staff their own test lab
with corresponding test equipment
personnel. Consequently, this also does
away with the internal testing effort
for one’s own equipment. Depending
on the system topology, the calibration
teams can calibrate many measuring
points in a short time. This promises
additional cost advantages.
In accordance with standards
The on-site calibration service of
Endress+Hauser is accredited in
several countries in accordance with
ISO/IEC 17025 for a wide variety of
parameters (and A2LA in the USA).
This includes measured variables such
as temperature, pressure and flow.
In particular, the accreditation
for flow represents a novelty; here
Endress+Hauser is the first accredited
calibration service provider in the
region of Germany, Austria and
Switzerland. ISO calibration certificates
can be issued for additional parameters
and usually suffice in the good
manufacturing practice environment.
The customer benefits from this
In general, collaboration with an
accredited service provider comes
with multiple advantages: All of
the equipment used and all of the
calibration results can be seamlessly
traced to national and international
standards. Thus users can completely
rely on the correctness of the
calibration results.
In addition, accreditation often
makes laborious auditing of suppliers
unnecessary, which is positively
reflected on the cost side. One more
thing: Accreditation is also always
synonymous with an implemented
continuous improvement process.
More information at
www.endress.com/calibration
Accredited calibration expertise
Minimization of downtime and prevention of plant shutdowns
thanks to the on-site calibration service of Endress+Hauser.
Technician with calibration rig: On-site calibration saves time and costs.
Operational excellence

20. Biopharmaceutical medications have to go down a long road of
development before they are ready to be put on the market. The
length of time from identification of the active ingredient and clinical
phases to approval by the authorities for release on the market is
now between 8 and 14 years. To be able to deliver the required
active ingredient quantities in the respective phase, the process must
first be developed in the laboratory. For this purpose, biotechnology
frequently uses bioreactors/fermenters with glass culture vessels
having process volumes up to five liters. A choice is made between
either singular (a bioreactor with a control station) or multiparallel
operating systems (parallel operation of multiple bioreactors).
Reproducible results The development of cell culture or microbial
processes in the laboratory is the first step in the process-engineering
scale-up, which is ultimately finalized in large bioreactors with single-
use technology (≤2,000 liters) or stainless steel (≤20,000 liters) on
a production scale. In scale-up, the automation plays a large role to
enable reproducible results and processes that can be validated. In
aerobic bioprocesses, the pH and pO2
parameters are primarily of
Sartorius Stedim Biotech supplies
products and services for
development, quality assurance
and production processes in
the biopharmaceutical industry.
With integrated solutions
for fermentation, filtration,
reprocessing, storage and
transport of fluids, as well as
for the laboratory, the company
provides its customers with
support for reliable, fast and
economical development and
manufacturing of biotech
medications.
©SartoriusAG
Memosens sensors for pH (CPS71D) and dissolved oxygen pO2
(COS22D) in the cover of the autoclavable Biostat A® bioreactor. The digital signal
transmission to the transmitter takes place free of wear via inductive connections, without metallic contacts.
20
Digital sensors in biotechnology
With the new Biostat A® bioreactor system, Sartorius Stedim Biotech is
relying on innovative technologies that make for reliable process control
and easy operation.
life sciences

21. special significance. Once qualified, this quality-related
instrumentation is frequently transferred into the next
phase in the scale-up and then finally ends up in the
production scale in successful clinical development.
For the introduction of the new Biostat A® bioreactor
system, Sartorius Stedim Biotech relies on innovative
technologies that are simultaneously reliable and made
for easy operation. The Biostat A® was created as an
entry-level system for research and development, but also
for university education, to be operated in the laboratory
without special supply devices. The ability to operate it
using a laptop, tablet and smartphone enables timely and
clear process control and visualization.
Innovative logging The simple operation concept also
carries through in the choice of sensors. Here the company
relies on Memosens technology from Endress+Hauser for
pH and pO2
. Memosens is an innovative protocol in which
transmission between sensor and transmitter is only digital.
With Memosens technology, the calibration data (serial
number, calibration points, slope, date, time, probe history,
etc.) is saved directly in the head of the sensor instead of in
the transmitter, as it used to be. Once connected according
to the plug-and-play principle, the sensor and calibration
data is transmitted to the transmitter and the sensor is
automatically detected via the inductive cable connection.
Simplified calibration This provides enormous
advantages, because the sensors can be precalibrated
using software based on Memobase on a computer or
other transmitter, for example, in the quality lab. This
way the calibration can be greatly simplified particularly
in multiparallel applications with multiple sensors. With
the Memobase Plus calibration and documentation tool,
four sensors can be simultaneously calibrated to be used
subsequently in the bioreactor. Thus, the software enables
serial-number-specific display of the calibration history
of a sensor and allows for its diagnostics. For example,
the sensor-specific data, the slope history, as well as the
calibration and measurement reports can be called up at
any time. The question of whether a sensor can still be used
or should be disposed of can now be answered based on
facts from the displayed history.
Philipp Garbers
Industry Manager
Life Sciences
Germany
With its simple operation concept, the new Biostat A® is primarily
aimed at users in the field of university education and research and
development.
Memobase Plus enables versatile and convenient access to sensor-specific
data such as slope history, and calibration and measurement reports.
©SartoriusAG
21Product highlights
More information at
www.endress.com/lifecyclemanagement

22. The life sciences industry is subject to increasingly stringent
requirements in terms of regulation and metrology. At
the same time, cost efficiency remains a priority. In this
context, Endress+Hauser has developed a new line of
sensors designed to optimize manufacturing yields while
also maintaining maximum process safety.
Designed for aseptic environments With over 50 types of
aseptic process connections, the new TM411 thermometer
can be adapted for any process. Its construction completely
from steel means that it has superb corrosion resistance.
Its new, more compact housing is suitable for cleaning with
high-pressure jets (IP69K). This housing is 3A and EHEDG
certified and has minimum retention areas to ensure
optimum cleanability and hygiene levels.
QuickNeck tool-free disassembly: For simplified
maintenance and metrology Another benefit of the
TM411 thermometer is its instant tool-free insert extraction
feature which uses the unique, patented QuickNeck system.
It no longer requires superhuman strength to loosen (by a
quarter turn) and separate the pocket from the other part
of the thermometer. Thanks to the assisted opening, it is
no longer necessary to disconnect the terminal head during
calibration, which therefore eliminates the risk of incorrect
reconnection. This simplification saves 15 to 20 minutes
on each calibration. In this way, a considerable return on
investment can be expected during calibration campaigns. For
example, on a unit with 100 measuring points, a 25% return
on investment can be achieved in just 12 months. In addition,
as it is no longer necessary to empty the process, production
shutdowns are avoided and the risk of contamination
eliminated because the process remains permanently closed.
In summary, thanks to QuickNeck, you can benefit from
reduced maintenance work and a reduction in metrology costs.
QuickSens speed: For effective monitoring and flawless
control of fast temperature changes To monitor
temperature changes reliably, it is essential to use a
thermometer with exceptional performance: Very low
measurement uncertainties, a fast response time and simple
metrology monitoring. The new TM411 thermometer
satisfies all these requirements. A new insert technology
called QuickSens provides the fastest response time on the
market (T90: 0.75 s). In fact, this time is 10 times faster
than those achieved by conventional technologies. These
inserts can also be connected to a protector in order to
22
New TM411 thermometers:
Innovations and performance
The new range of TM411 thermometers for hygienic processes complies
with all international standards (ASME/BPE, FDA) and provides unparalleled
technical and metrological performance.
life sciences

23. malfunctions on the inserts, which lead to untimely
production shutdowns and heavier maintenance work. The
Endress+Hauser solution is the new, patented StrongSens
insert technology. The insert’s special construction gives it
maximum robustness, which makes it almost indestructible
by the vibrations generated by the process. This insert
can therefore resist acceleration of up to 60 g, which is
30 times higher than that required by international standard
CEIC60751. This new technology therefore improves process
safety and quality through increased insert durability.
More information at
www.endress.com/TM411
improve the availability of installations, and without any
negative effect on the measuring performance.
QuickSens technology uses a sensitive, thin-film Pt100
element which is welded directly on the end of the insert
and provides improved heat transfer. Therefore, the
immersion lengths can be reduced to 20 mm for improved
stability and more accurate measurement. This insert is
therefore ideal for measuring the temperature on small
tubes, as well as for critical processes such as sterilization,
in which it is necessary to accurately monitor temperature
changes. In conclusion, complete control of the temperature
enables control of the overall process to be optimized and
therefore the quality of the final product to be improved.
StrongSens structure: For improved process safety
Currently, those in the industry may be confronted by
the problem of vibrations caused by the harsh process
conditions. These vibrations are often the cause of frequent
Laurence Maribe
Industry Manager
France
23Product highlights

24. Chr. Hansen is a global bioscience
company that develops natural
ingredient solutions for the
food, nutritional, pharmaceutical
and agricultural industries.
One of its main production
facilities is situated at Avedoere
Holme, south of Copenhagen
in Denmark.
Both accurate temperature control
and fast response to temperature
changes are vital for the efficient
and safe production of bacterial
cultures. During the UHT (Ultra
High Temperature) treatment, the
temperature must be kept above
139°C (282°F), otherwise in the
worst-case scenario, the production
batch might have to be destroyed.
Tommy Mikkelsen, Metrologist
at Chr. Hansen, Avedoere Holme,
Denmark, conducted extensive testing
of the iTHERM TM411 temperature
sensor with convincing results. Its
very short response time allows
continuous process monitoring and
enables a constant temperature to be
maintained within a very small range.
The tests also showed that the
predictable negative impact of the
thermowell on the overall accuracy was
hardly detectable. Thus the multiple
recalibrations which are required for
this critical device can be performed
without interrupting the process.
“When the sensor is
mounted in the
thermowell, you don’t
need to stop the process
during calibration,
which means saving a
CIP cleaning of the UHT.”
Tommy Mikkelsen, Metrologist
Unmatched response time Tommy
Mikkelsen has conducted response
time tests with different generations
of temperature sensors which
revealed that the latest model with
iTHERM QuickSens technology could
reduce response times by more than
50% compared to older sensors!
For Chr. Hansen, this means a
measurable quality improvement for
the whole process.
Recalibration made easy Using
thermowells offers a significant
advantage: during recalibrations
the process can be kept closed as
the thermowell remains in the plant
while the sensor itself is removed for
calibration. Removing the sensor for
recalibration is easy: the QuickNeck
allows the tool-free removal of the
entire upper part of the sensor from
the thermowell with just one twist.
No need to open the housing or to
disconnect any wires – it is simple,
safe and fast.
The results
• Plant availability is increased.
• The new temperature sensor
ensures higher process safety.
• No additional CIP cleaning
procedure is required after a
recalibration.
• The solution contributes to the
reduction of maintenance costs.
iTHERM TM411 in process (3D animation).
24 life sciences
Fast and easy for better quality
By switching to the iTHERM TM411 temperature sensor, Chr. Hansen’s
Danish site successfully improved temperature monitoring, which is critical
to the UHT treatment. Furthermore, the process remains closed during
recalibrations.

25. ©AnnaSubbotina-fotolia.com
A vacuum process system is used to produce creams,
lotions, gels, ointments, toothpaste and all manner of
other kinds of dispersions. The planning and design of
this type of system requires a great deal of experience and
the use of high-quality materials and components. Typical
requirements of the operators are minimizing process and
cleaning times, optimal heat exchange, gentle processing
of the ingredients, product hygiene from start to finish,
aseptic machine design and easy, menu-guided operation
with integrated recipe management.
Project in Brazil FrymaKoruma is one of the leading
international companies offering materials processing
machines and processing installations. In 2011,
FrymaKoruma received an order from a major Brazilian
cosmetics manufacturer for six complete vacuum process
systems. Each of these systems features a capacity of
10,000 liters and has an additional dosing unit for exact
metering of the raw materials needed to manufacture
the cosmetic products. The entire project was to be
implemented in accordance with GMP guidelines.
FrymaKoruma turned to Endress+Hauser to deliver the
complete dosing units. The many years of experience that
the Center of Competence (CoC) for Life Sciences Industry
has in the GMP area and flow measuring and the many
references for implementing dosing control systems in
pharmaceutical applications persuaded FrymaKoruma.
Dinex vacuum process system from FrymaKoruma with minimized
process and cleaning times
CourtesyofFrymaKoruma
25Solution highlights
In the service
of beauty
A cosmetic manufacturer ordered
complex vacuum processing units
from FrymaKoruma. Endress+Hauser
provided the dosing units.

26. The companies agreed that, as a first step, four of the six
dosing control systems would be delivered.
The following requirements from the end customer had
to be fulfilled by Endress+Hauser in close coordination with
FrymaKoruma: The dosing units work with autonomous
dosing control systems, based on the specifications of
the vacuum control system’s higher-level control system.
Metering of two times two components simultaneously, at
an accuracy of less than 0.6%, is to be implemented. The
level of accuracy attained is to be monitored at all times.
The opening and closing times of the valves are to be
optimized automatically and the effects of valve wear are to
be equalized accordingly. Metering takes place directly into
the homogenizing chamber of the vacuum process system.
Innovative concept for the dosing units Each of the four
dosing units to be delivered includes the measuring system,
dosing valves, controller and piping and is split up over two
skids. The dosing units were prepared for integration into
the FrymaKoruma vacuum process system and tested as
part of a Factory Acceptance Test (FAT) before delivery to
FrymaKoruma.
Due to the number of components to be metered, each
dosing unit was fitted with a total of nine Endress+Hauser
Dosimass flowmeters. Tri-Clamp process connections
are provided for later coupling of the Dosimass to the
circular manifolds that feed the individual raw materials
to the machines. The stainless steel control cabinet with
the programmable logic controller is located between the
two skids of one dosing unit. The controller measures the
metered quantities of the individual product components
via counting pulses of the respective Dosimass and sends
control commands for opening or closing to the dosing
valves. The dosing control automatically monitors the
accuracy attained in the metering process and adapts the
opening and closing times of the valves automatically. An
additional control cabinet contains the pneumatic system
for actuating the diaphragm valves.
Comprehensive control concept In addition to the dosing
controls and the machine control of the vacuum process
system, there is also a higher-level process control system
already installed at the end customer’s facility. As a result,
the data exchange between the dosing controls and the
machine control and, in parallel, between the control system
and the machine control must be coordinated and ensured.
Endress+Hauser created a function description to define
which types of data are exchanged with the machine control.
This takes the following aspects into consideration: enabling
or disabling each individual dosing line, selecting manual or
automatic function, specifying the amount to be metered,
inspecting each individual metering operation, CIP cleaning.
Complete, high-precision dosing units with integrated controller and Dosimass flowmeters.
26 life sciences

27. Data is exchanged via the Ethernet interfaces of the
controllers. Both the dosing controls and the machine control
use Simatic S7-315-2PN/DP programmable logic controllers.
Optimal support can be provided to the end customer via the
remote maintenance access to the controls.
Highly accurate flow measuring technology Dosimass
mass flowmeters are installed in the dosing units. The
compact geometry of the Dosimass means it only requires a
little space – a great advantage, particularly for these types
of metering tasks. Other advantages are the high accuracy
and robustness of this mass flowmeter. Of course, CIP and
SIP cleaning of the device are possible. Still other benefits of
the Coriolis measuring system used are that no inlet/outlet
runs are necessary, it works independently of the physical
fluid properties and is maintenance-free.
Tried-and-tested diaphragm valves The valves used
have an important effect on the dosing accuracy and
reproducibility of the recipe. In planning and designing the
dosing units, Endress+Hauser made use of tried-and-tested
components and selected a Gemü 660 diaphragm valve for
each dosing line. Each diaphragm valve is installed below the
Dosimass by means of Tri-Clamp process connections and is
actuated pneumatically. The Gemü 660 is a compact, low-
maintenance design with stainless steel drive, a valve body
made of 316L stainless steel and a visual position indicator.
High-precision complete solution from a single source
Markus Wohlgemuth, Project Manager at Endress+Hauser
Metso AG, gives a positive assessment saying, “It was
important to FrymaKoruma to receive a functional and
high-precision dispensing solution from a single source.
The critical factor was having a partner that takes
over responsibility for the complete solution (project
management, hardware and software engineering,
function, qualification and accuracy). Our many years
of experience in dosing solutions meant we could offer
the ideal match for the required application. Of course,
we also support FrymaKoruma in integrating our system
documentation into the plant documentation.”
Samuel Mettler, FrymaKoruma Project Manager, has
this to say about the partnership with Endress+Hauser
Metso AG: “Particularly when planning and implementing
large-scale projects, it is of vital importance that we be able
to depend on our suppliers. In designing vacuum process
systems with a capacity of 10,000 liters, every technical
detail has to be right. In addition to a well-developed
mechanical process, exact control of the recipe is a must.
We have had very good experiences with Endress+Hauser
dosing systems in the past, and our current cooperative
projects also confirm that assessment. Endress+Hauser
delivers the quality and performance we need.”
More information at
www.endress.com/dosimass
Dosimass provides highly accurate dosing quantities with short
dosing times.
FrymaKoruma is Based in Rheinfelden, Switzerland
and Neuenburg, Germany. With 145 employees,
the company is one of the leading global suppliers
of process engineering machines, vacuum process
systems and industrial grinders. Their machines
are used to produce pharmaceuticals, cosmetics,
food and chemicals. Customers in more than
180 countries employ over 23,000 of the company’s
solutions, with approximately 350 new machines
being added each year.
Rüdiger Settelmeyer
Product Manager
Process Automation
“Particularly when planning
and implementing large-scale
projects, it is of vital importance
that we are able to rely on our
suppliers. Endress+Hauser
delivers the quality and
performance we need.”
Samuel Mettler, Project Manager at FrymaKoruma
27Solution highlights

28. CM01073L/29/EN/01.15
All issues are available electronically at
www.endress.com/life_sciences
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www.endress.com/worldwide
Holding
Endress+Hauser Consult AG
Kaegenstrasse 2
4153 Reinach
Switzerland
Tel +41 61 715 7700
Fax +41 61 715 2888
info@holding.endress.com
www.endress.com