Endress+Hauser Magazine www.endress.com/life-sciences Issue 5/2015

life sciences

A pulse ahead

Improve quality, compliance and cost control

08 Ease standardizationBiopharmax insulin plant in China

14 Operational ExcellenceImproved calibration management at UCB Ireland

Imprint

Pubisher Endress+Hauser Consult AG Kägenstrasse 2, 4153 Reinach, Switzerland

Editors Klaus Köhler, Samuel UrbainDate of publication June 2015Reprint Any printing - even in parts - is forbidden without prior permission. This document remains the property of the company.

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Ease standardization 4 Added value

through automationGTec relies on digital Memosens protocol

6 Complete package for cosmeticsMeasurement, energy monitoring and calibration for Beiersdorf in Mexico

8 The multiple virtues of standardizationBiopharmax implemented a fully automated insulin manufacturing facility

11 Focused on efficient processesMerck Serono standardizes process instrumentation

12 Significantly reducing costsStandardization reduces the complexity of operations

13 Shorten engineering time

Operational excellence14 Improving calibration processes

UCB Pharma uses calibration management software

15 Paperless calibrationIssues for calibration and paper base systems are history

16 Advantages are crystal clearSchott seeks help from outside to carry out on-site calibration

19 Accredited calibration expertiseMinimization 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 Operational excellenceWherever you produce, we are by your side to increase efficiency while maintain the required GMP level.

4 Ease standardizationStandardize with the largest offering of instruments to minimize project complexity, operational costs and plant downtime.

20 Product highlightsEasy operation and calibration: innovation and performance for temperature, pH and dissolved oxygen devices

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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 KöhlerGlobal Industry Manager Life Sciences

Trustful answersEditorial

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.

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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 automationWater treatment in regulated industry: GTec relies on conductivity measurements from the digital Memosens protocol in reverse osmosis plants.

Philipp GarbersIndustry Manager

Life SciencesGermany

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

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 cosmeticsMeasurement, energy monitoring and calibration: The engineering company M+W commissioned Endress+Hauser instrumentation with a service package in a Mexican manufacturing facility of Beiersdorf.

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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 atwww.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 skincare 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.

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Philipp GarbersIndustry Manager

Life SciencesGermany

Analysis and Coriolis mass flow meters in the system at Beiersdorf in Mexico.

7Ease standardization

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The multiple virtues of standardizationBiopharmax 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

“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

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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

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Samuel UrbainCommunication 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.

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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.

Focused on efficient processesMerck 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.

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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 costsStandardization 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/plantbuilders 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 GarbersIndustry Manager

Life SciencesGermany

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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 timeWhen 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 traceabilityWhether 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 cyclePlant 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 atwww.endress.com/lifecyclemanagement

Improving calibration processesUCB 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.

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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 atwww.compucalcalibrations.com

Christophe RocheGeneral 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 calibrationWith 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.

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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 clearGlass 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.

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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

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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

SpokesmanEndress+Hauser Group

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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 sideConfiguration, calibration and maintenance

Tools of choice

life sciences

Thomas KaufmannProduct 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 standardsThe 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 atwww.endress.com/calibration

Accredited calibration expertiseMinimization 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

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.

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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.

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Digital sensors in biotechnologyWith 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

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 GarbersIndustry Manager

Life SciencesGermany

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.

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21Product highlights

More information atwww.endress.com/lifecyclemanagement

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.

QuickSensspeed:Foreffectivemonitoringand flawlesscontrol 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

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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

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 atwww.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 MaribeIndustry Manager

France

23Product highlights

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, Metrologistat 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.

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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

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25Solution highlights

In the service of beautyA cosmetic manufacturer ordered complex vacuum processing units from FrymaKoruma. Endress+Hauser provided the dosing units.

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

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 sourceMarkus 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 atwww.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 SettelmeyerProduct 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

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