Integrated Solutions for biomanufacturing processes

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Sartorius Stedim Biotech - the partner of choice for next generation biomanufacturing

Sartorius Stedim Biotech engineering consultants provide design services that ease the application of single use, hybrid or fully stainless steel technology into new or existing facilities.

V-Model

The qualification of process equipment is a very important task prior to process validation. The V-Model illustrates the different steps and documents which are utilized to fulfill the regulatory requirements.

Single use systems and compo-nents are now well established in modern manufacturingprocesses.

Consequently, the security of supply of those product contact assemblies is one of the major issues. Sartorius Stedim Biotech addresses this

concern with our configurable, pre-designed Flexact® platform technologies. The components of this platform technology are standardized and in stock. Sartorius Stedim Biotech consultants can help with developing a User Requirement Specification which results in a process design with minimal or no customization of it’s components, allowing short delivery times while maintain-ing a high degree of flexibility. The platform technologies are designed to meet a defined process performance. Trained personnel will assist you during

performance qualification. The cooperation and partner-ship between the supplier of product contact assemblies and the end user is of paramount importance when single use components are used. Sartorius Stedim Biotech is fully capable of fulfilling the expectations as engineering and manufacturing of all critical components and assemblies as well as of engi-neered, customized single use, hybrid or reusable systems are made in our own workshops.

Customer‘sResponsibility

Sartorius‘Responsibility

UserRequirementSpecification

ProcessQualification

OperationalQualification

FunctionalSpecification

InstallationQualification

DesignSpecification

AssemblingofProcessEquipment

3D general arrangement of a Biotech production facility.

Hybrid fermentation system using bags for media supply.

Operational Qualification using standardized protocols during Site acceptance test.

Operator training increases efficiency and safety during your manufacturing process.

Process simulation program for customer specific cost modeling of a single use process.

Integrated solutions. From the URS to the final qualification.

Platform concepts for defined biotech processes are available out of the

box, enabling you to evaluate cost, equipment and utility consumption during the pre conceptual phase of your project.

Competence from pre conceptual phase to detailed engineering

and facility design is given by the experience gained in more than four decades of technological leadership

in engineering and single use product development.

Design

ConsultingDedicated project management, experienced lead engineers and certified workshop

personnel as well as our own QA personnel accompany-ing the project during all phases of the execution are the key factors which led to 1000‘s of successfully executed projects.

Manufacturing sites in all areas of the world ensure the highest possible

level of security of supply for re-useable and single use components and systems.

Manufacturing

Our own QA personnel accompany each project from the start to ensure

continuity and easy IQ | OQ later on. Most of the Installation Tests are already performed during the Factory Acceptance Test to reduce time and cost.

Powerful simulation tools are used to 100 % pretest all DCS functions according

to the Functional Specification allowing a more ef-ficient execution of the Factory Acceptance Test.

Performance Qualification is supported by our application specialists ensuring

that you get the most out of the equipment and to identify further potential for process optimization.

Qualification

Our full servicing concept for instruments and equipment covers not just FAT, Installa-

tion and SAT but also provides preventive maintenance plans and service contracts.

Confidence® Validation Service includes extractables and leachables studies

as well as Physio-Chemical studies on single-use components which come in contact with your product, making sure that your process is in full regulatory compliance.

Expand® seminars, workshops and courses are integrated into the

Sartorius Stedim Biotech service program. They cover all different areas from operator training to hands on Cell Cultivation and Microbiology trainings.

Services

Discover® Application Support A team of specialists is at your service to support you

in your process development tasks, ranging from feasi-bility trials to full plant surveys.

Process simulation Cost calculation and process simulation programs

allow you to evaluate the impact of different technol-ogies on your specific process and expansion plans.

A biopharmaceutical manufacturing concept is more than the sum of it‘s elements.

Sartorius Stedim Biotech is capable to supply fully single use, hybrid or traditional stainless steel systems which are „fit for purpose“ and not just fulfilling a URS. Our thorough under-standing of the biopharmaceutical manufacturing processes and of our customers specific needs, enables us to add value into the design of engineered solutions, adding cost efficiency and security to our customers manufacturing processes. Our world wide supply chain concept, with manufacturing sites all over the world, makes us the supplier with the highest level of security of supply for reusable and single use systems and components.

As a „full solution provider“ we‘re bringing together one of the broadest portfolios of single use components and services with our unique engineering and manufacturing capabilities, allowing us to provide fully integrated process solutions to the biopharmaceutical market.

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Sales and Service ContactsFor further contacts, visit www.sartorius-stedim.com

EuropeGermanySartorius Stedim Biotech GmbHAugust-Spindler-Strasse 1137079 Goettingen

Phone +49.551.308.0Fax +49.551.308.3289

www.sartorius-stedim.com

Sartorius Stedim Systems GmbH Schwarzenberger Weg 73–7934212 Melsungen

Phone +49.5661.71.3400Fax +49.5661.71.3702

www.sartorius-stedim.com

FranceSartorius Stedim Biotech S.A.ZI Les PaludsAvenue de Jouques – BP 105113781 Aubagne Cedex

Phone +33.442.845600Fax +33.442.845619

Sartorius Stedim France SAS ZI Les PaludsAvenue de Jouques – CS 7105813781 Aubagne Cedex

Phone +33.442.845600Fax +33.442.846545

AustriaSartorius Stedim Austria GmbHFranzosengraben 12A-1030 Vienna

Phone +43.1.7965763.18Fax +43.1.796576344

BelgiumSartorius Stedim Belgium N.V.Leuvensesteenweg, 248/B1800 Vilvoorde

Phone +32.2.756.06.80Fax +32.2.756.06.81

DenmarkSartorius Stedim Nordic A/SHoerskaetten 6D, 1.DK-2630 Taastrup

Phone +45.7023.4400Fax +45.4630.4030

ItalySartorius Stedim Italy S.p.A.Via dell’Antella, 76/A50012 Antella-Bagno a Ripoli (FI)

Phone +39.055.63.40.41Fax +39.055.63.40.526

NetherlandsSartorius Stedim Netherlands B.V.Edisonbaan 243439 MN Nieuwegein

Phone +31.30.6025080Fax +31.30.6025099

SpainSartorius Stedim Spain SAC/Isabel Colbrand 10,Oficina 70Polígono Industrial de Fuencarral28050 Madrid

Phone +34.90.2110935Fax +34.91.3589623

SwitzerlandSartorius Stedim Switzerland GmbHLerzenstrasse 218953 Dietikon

Phone +41.44.741.05.00Fax +41.44.741.05.09

U.K.Sartorius Stedim UK LimitedLongmead Business ParkBlenheim Road, EpsomSurrey KT19 9 QQ

Phone +44.1372.737159Fax +44.1372.726171

AmericaUSASartorius Stedim North America Inc.5 Orville DriveBohemia, NY 11716

Toll-Free +1.800.368.7178Fax +1.631.254.4253

Sartorius Stedim SUS Inc.1910 Mark CourtConcord, CA 94520

Phone +1.925.689.6650Toll Free +1.800.914.6644Fax +1.925.689.6988

Sartorius Stedim Systems Inc.201 South Ingram Mill RoadSpringfield, MO 65802

Phone +1.417.873.9636Fax +1.417.873.9275

ArgentinaSartorius Argentina S.A.Int. A. Avalos 4251B1605ECS MunroBuenos Aires

Phone +54.11.4721.0505Fax +54.11.4762.2333

BrazilSartorius do Brasil LtdaAv. Dom Pedro I, 241Bairro Vila PiresSanto AndréSão PauloCep 09110-001

Phone +55.11.4451.6226Fax +55.11.4451.4369

MexicoSartorius de México S.A. de C.V.Circuito Circunvalación Poniente No. 149Ciudad Satélite53100 Naucalpan, Estado de México

Phone +52.5555.62.1102Fax +52.5555.62.2942

Asia|PacificAustraliaSartorius Stedim Australia Pty. Ltd.Unit 5, 7-11 Rodeo DriveDandenong South Vic 3175

Phone +61.3.8762.1800Fax +61.3.8762.1828

ChinaSartorius Stedim BeijingRepresentative OfficeNo. 33, Yu’an Road,Airport Industrial Zone B, Shunyi DistrictBeijing 101300

Phone +86.10.80426516Fax +86.10.80426580

Sartorius Stedim ShanghaiRepresantative OfficeRoom 618, Tower 1, German Centre,Shanghai, PRC., 201203

Phone +86.21.28986393Fax +86.21.28986392.11

Sartorius Stedim Guangzhou OfficeRoom 704, Broadway Plaza,No. 233–234 Dong Feng West RoadGuangzhou 510180

Phone +86.20.8351.7921Fax +86.20.8351.7931

IndiaSartorius Stedim India Pvt. Ltd.#69/2-69/3, JakkasandraKunigal Road, Nelamangala TqBangalore – 562 123

Phone +91.80.4350.5361Fax +91.80.4350.5253

JapanSartorius Stedim Japan K.K.KY Building, 8–11Kita Shinagawa 1-chomeShinagawa-kuTokyo 140-0001

Phone +81.3.3740.5407Fax +81.3.3740.5406

MalaysiaSartorius Stedim Malaysia Sdn. Bhd.Lot L3-E-3B, Enterprise 4Technology Park MalaysiaBukit Jalil57000 Kuala Lumpur

Phone +60.3.8996.0622Fax +60.3.8996.0755

SingaporeSartorius Stedim Singapore Pte. Ltd.10, Science Park Road, The Alpha#02-25, Singapore Science Park 2Singapore 117684

Phone +65.6872.3966Fax +65.6778.2494