siemens.com/pharma

Creating InnovationsYour partner in the pharmaceutical industry, handling your production process with innovative solutions

Answers for industry.

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Perfectly combined: Active ingredients for your success!

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Decreasing product prices, stagnating demand in traditional markets, missing supplies of

strong-selling active ingredients as well as increasing competition due to expiring patents –

the pharmaceutical industry is facing major challenges. The transformation of risks into

opportunities necessitates a significant reduction of the throughput times of new active

ingredients from development to patent application as well as the setup of innovative

business models for growth markets. At the same time, the added value of existing active

ingredients has to be optimized by means of new dosage forms and application areas.

From the idea to the ready product – as your partner, we accompany you throughout this

process with our comprehensive experience and cross-sector know-how.

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Quality control – throughout the entire process

The direct way to the perfect batchProcess analytical technology – in short PAT – represents the basis for quality by design. It paves the path for real-time prod-uct releases and for an overall improved production process performance. Our SIMATIC SIPAT software solution bundles all PAT-supporting analysis devices and tools in a joint platform. Acquiring all data pertaining to process analysis and control facilitates modeling and valida-tion, supporting perfect compliance with legal regulations.

Consulting for GMPWhether improving existing plants and processes or constructing new plants – all corresponding work has to be carried out with the goal of good manufacturing practice (GMP). The applicable directives of the FDA and EMA are intended to ensure consistent and controlled phar-maceutical production processes in accordance with the quality standards. We support you with comprehensive GMP consulting for all of your engineering and automation projects. This targeted plan-ning creates increased cost efficiency.

The “Pharmaceutical cGMPs for the 21st Century” initiative has led to a rethinking

in the pharmaceutical industry: Accelerate the processes and use quality by design

(QbD) to avoid faulty batches in pharmaceutical production – i.e. the relocation of

previously downstream quality controls into the production process. The dedicated

targets comprise of improved process understanding, continuous quality monitor-

ing and seamless documentation.

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“The Teva ‘Model Based Predictive Control’ initiative is based on the Siemens SIMATIC SIPAT and SBOL & SIMCAControl solution. The outcome will strengthen Teva’s commitment to quality and safety of its products.

Laszlo Simon, technical engineer / project manager at Teva

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Minimized time to market, maximized profitsThe development of new pharmaceuti-cals and active ingredients is very cost-intensive and time-consuming. Efficient facility design, streamlined project run-times, shortened development cycles for new processes and optimized processes all provide major potential for minimizing the time to market. We offer innovative software solutions from process develop-ment right down to design, engineering and realization.

Reduced total cost of ownership through integrated engineeringFurthermore, the pharmaceutical indus-try is seeking solutions for integrated engineering from plant planning to pro-duction in order to ensure the efficient parallelization of workflows. Our COMOS engineering software ensures this consis-tency on the basis of a central database – and closes the gap between planning and operation in combination with the SIMATIC PCS 7 process control system.

The global population, as well as the average life expectancy is growing. Against this back-

ground, the pharmaceutical industry is facing high expectations by patients, health authori-

ties and health insurance companies: New therapies and active ingredients have to provide

verifiable improvements. For pharmaceutical companies, this mainly means that they have to

become more innovative and productive in order to gain faster access to the market.

Ideas mainly need one thing: Rapid effectiveness

yeffectiveness

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We gladly prescribe recipes for cost reduction

Reduced costs through continuous production One thing is for sure: Increased produc-tivity represents a key factor for improved competitiveness in the industry. This particularly applies to the pharmaceutical industry in which continuous capacity utilization is not given due to classical batch processes. In this context, the deci-sive keyword is continuous manufactur-ing. This term refers to the continuous production of pharmaceuticals in com-pact, closed units, involving a high degree of automation and few manual interventions. At the same time, the plants’ setup and cleaning times are reduced. Thus, all in all you can improve the plants’ utilization by more than one third and reduce production costs between 10 and 20 percent in a very short term.

The processes in the pharmaceutical industry are classically executed in consecutive production steps. This

contradicts with the constant need for continuous production capacity. The target lies in the reduction of

production fluctuations and in the generation of higher yields by creating more profitable processes.

“We can prove that process development expenditures can be significantly reduced through continuous production.”

Jan Vugts, managing director, GEA

Continuous benefits In this same context, analytical technolo-gies with corresponding data acquisition and statistical models are necessary to ensure process and quality monitoring and control. This allows for product release in real time. A further advantage: Minimized investment and operating costs, increased energy efficiency and reduced CO2 emissions. Our sophisticated products and scalable solutions support you on the basis of integrated data-based process automation. We also support you with standard-compliant implementation.

Reduced costs through global engineeringAs your global engineering partner, we not only comply with regional standards. Moreover, we share our pharmaceutical know-how on a global basis. This enables us to standardize engineering projects, reduce engineering costs and make your projects more profitable.

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Flexibility thanks to perfectly dosed automation concepts

Active ingredients for your success!Worldwide, a majority of the active ingre-dient plants in existence have realized solutions with Siemens. As a long-stand-ing automation partner of the pharma-ceutical industry, we also offer the suit-able solution for the rest of your plant. Our modular and scalable automation concepts, established on the basis of pharmaceutical standards, complete our comprehensive portfolio ranging from classical process analysis and instrumen-tation, to process control systems, all the way down to software solutions.

This for example comprises an efficient manufacturing execution system (MES) which closes the gap between laboratory and production and facilitates the connec-tion to ERP and corporate IT. This also allows for a considerable reduction of both data complexity and number of interfaces, paperless production is moving within reach.

Excellence for small seriesThe trend towards the production of small series is promoted by progress in the field of pharmaceutical research and development of personalized medicine. The rapid changeover between recipes and process sequences necessitates high plant flexibility. Based on our SIMATIC PCS 7 process control system, we have developed new plant concepts which adjust to the corresponding require-ments – for high product quality, mini-mized complexity as well as maximized productivity. The high degree of our solutions’ standardization allows for improved scalability. The modular soft-ware and hardware architectures facili-tate rapid and flexible process sequence adjustment.

Political and social demands for a diversified product portfolio and the develop-

ment of new therapies for individual patients represent the increased challenges

faced by pharmaceutical manufacturers. This means: Production processes have to

become considerably more flexible. The key lies in the corresponding automation

of plants. Such automation facilitates rapid process conversion and retooling for

the production of various batches.

Flexibility

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Prescription only:Innovative service concepts

The pharmaceutical industry is characterized by a high degree of responsibility and strict

regulations. The defined guidelines of good manufacturing practice (GMP) are applied in

order to ensure product quality, patient safety and data integrity. This calls for a partner

who is familiar with these guidelines and who ensures the plants’ high availability by

means of innovative and GMP-compliant service concepts.

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Services throughout the entire plant lifecycleAs global technology partner for our cus-tomers from the pharmaceutical industry, we offer services for the entire plant life-cycle in special consideration of GMP reg-ulations. From the initial idea, to configu-ration, installation and commissioning, down to the next upgrade – we provide you with a tailored service package matched to your requirements.

Individually combined service componentsWhether you require process consulting, have questions regarding your invest-ments’ financing and risk management or need support with process development, engineering or IT security – you can rely on our help. Also in the form of on-site training measures, technical support and spare parts service. For example, our SIMATIC PCS 7 lifecycle service as well as our turnkey automation concepts ensure high plant availability as well as invest-ment protection, resulting in reduced total cost of ownership. This service offer is valid worldwide – wherever and when-ever you need us.

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The improvement of the health and well-being of patients is the objective of the pharmaceuti-

cal and life science industry. This is why pharmaceutical companies have to take every effort to

meet the highest standards of product quality and safety. Pharmaceutical companies therefore

strive for efficient and sustainable production processes. This goal is not easily attained. After

all, the production of pharmaceuticals in the GMP environment is cost- and resource-intensive –

particularly with regard to energy and water consumption.

Resource savings, sustainable actionsustainable

Efficient productionWhether you are dealing with water, waste or energy – as a long-standing partner of the pharmaceutical industry, we provide you with proven and innova-tive solutions which not only help you to improve your ecobalance, but which also contribute to increased efficiency and competitiveness. This is realized on the basis of a methodical procedure: analysis, concept, implementation and sustainability. You can rely on our support.

Sustainability through predictive solutionsOur solutions are tailored to the require-ments of the pharmaceutical industry: For example, our B.Data energy manage-ment system provides you with transpar-ent energy and water consumption data. This allows for the identification of opti-mization potentials and for a sustainable reduction of energy costs. In connection with SIMATIC PCS 7, plant-level asset management facilitates efficiently increased plant availability.

Creative ideas for the pharmaceutical industry: Convince yourself

Find out more about our role as partner of the pharmaceutical industry, our comprehensive portfolio and our sector know-how.

Find out more:siemens.com/pharma

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The information provided in this brochure containsmerely general descriptions or characteristics ofperformance which in case of actual use do notalways apply as described or which may change asa result of further development of the products. Anobligation to provide the respective characteristicsshall only exist if expressly agreed in the terms ofcontract.All product designations may be trademarks orproduct names of Siemens AG or supplier companieswhose use by third parties for their own purposescould violate the rights of the owners.

Siemens AGIndustry SectorPharmaceutical IndustryGERMANY

Subject to change without prior noticeArticle No.: E20001-A130-T114-X-7600Dispo 4151321/51424 DK.CP.VM.14.XXPH.52.01 WS 03141.Printed in Germany © Siemens AG 2014