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Integrated Solutions for biomanufacturing processes
Serv
ices
Qua
lifica
tion
Man
ufac
turi
ng
Desi
gn
Cons
ulti
ng
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 its 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.
CustomersResponsibility
SartoriusResponsibility
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 1000s 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 its 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 were 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.
Spec
ifica
tions
sub
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ithou
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in G
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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 737934212 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 dellAntella, 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 70Polgono 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 AndrSo PauloCep 09110-001
Phone +55.11.4451.6226Fax +55.11.4451.4369
MexicoSartorius de Mxico S.A. de C.V.Circuito Circunvalacin Poniente No. 149Ciudad Satlite53100 Naucalpan, Estado de Mxico
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, Yuan 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. 233234 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, 811Kita 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