Solutions for End
to End Bioprocessing
with IntegratedAutomation

Maximize Your Process Efficiency
At Sartorius Stedim Biotech Integrated Solutions weprovide a unique implementation methodology for yourbioprocess using single-use technologies wherever
possible and hybrid solutions as appropriate for your typeand scale of process. Our teams develop the layout,
workflow and design of your bioprocess equipment based
upon your process needs.

Parallel to your process design, we also consider the needand importance of state of the art automation systems tomaximize process efficiency and minimize risk.
At Integrated Solutions, we engineer, design, andimplement flexible automation platforms and management
information systems to match your industrial needs.

Sartorius Core Competences

Customer Single Use Process
Siemens Core Competences

Sartorius and Siemens: Partners for Your Success------

Intuitive Systems Tailored to your Process
Possibilities for Process Optimization throughFlexible Configurations
Faster Time to Market
Decreased Engineering Effort through Quality of Design
Expedited Project Execution
Accelerated and Reliable Start of Production
Lower Initial Investment
Precise Cost Determination and Allocation in Early
Design Phases of production

The Sartorius conceptual design approach combines
hardware, software and consumables in a unique way toensure full functionality, best-in-class supply chain,serviceability and hence enables single-use commercialmanufacturing.

By working in close corporation with Siemens, we areable to provide core competencies in both bioprocess
and automation engineering. This is the key to successfor your next Biomanufacturing facility.

“Keeping up with the dexterous industrial trends, thestate of the art equipment provided by Sartorius, coupledwith our process centric approach and partnership with
Siemens allows us to deliver the most optimized solutions
to meet the heterogeneous needs of the clients.”
Michael Koch
Head of Integrated Solutions Sartorius Stedim Biotech

Conceptual Design –Automation Concept
The Sartorius Integrated Solutions conceptual design
services describe the engineering philosophy for entire
single-use processes. Well defined sequences of predefined unit operations are combined to the entire processlines. These platform processes will support present andfuture progress in biopharmaceutical development andproduction in order to shorten the time-to-market byminimising engineering efforts and installation work.

We GuaranteeHigh Quality
High Investment reliability
Short Leadtime

Conceptual DesignUSP

MP | BPDSP

Customer Single Use Process

With our individual conceptual design studies, Sartorius offers tailored solutions which meet individual customer
process requirements. The customers can concentrate on their core competences, and Sartorius offers the process
know-how. From the definition of the process up to the integration into customer IT infrastructures, Sartorius provides
the solution – the “all-around carefree package”. Conceptual Design shortens the realization time supporting faster time
to market.

Development Lifecycle ModelTo ensure our projects meet customer and cGMP requirements, a rigorous development lifecycle model is followed:
starting from day one through to all engineering design, manufacturing and qualification test phases.

Responsibilityof Customer

Responsibilityof Sartorius

User Requirement
Specification

Process
Qualification

Functional
Specification

Operational
Qualification

DesignSpecification-

Project Definition
Decomposition
ofcustomer
processrequirements
Creation ofsystemspecifications

Installation
Qualification-

Assembling ofProcess Equipment

Project Qualification
Full level of IQ | OQ
procedures – Fully
documented in test
reportstimeIn accordance withcGMP requirements

Find out moreFor more information on our Integrated Solutions Platforms, please visit:www.sartorius.com/integrated-solutions

Automation: The Backbone for Successful
Project Execution and Smart Bioprocessing
Besides equipment, automation and integration into acontrol infrastructure are fundamental to a successfulproject execution. The goal is flexibility in automation.
Sartorius single-use equipment can easily be integrated
into a distributed control system (DCS), respectively intoa manufacturing execution system (MES). This open
system architecture covering the entire production
process ensures an efficient interaction of all automation
components. This is supported by consistent datamanagement, global standard compliancy and uniform
software interfaces.

Our preferred automation solution is based on Siemens
technologies. Siemens ensures continuity and reliability
regarding availability and support throughout the complete
life cycle of the plant.
In addition to the openness of an integrated systemarchitecture, this holistic automation approach paves theway for intelligent bioprocessing by means of Multivariate
Data Analytics (MVDA) and real-time data acquisition andmonitoring of your bioprocesses. Siemens SIMATIC PCS 7
works together with MVDA software packages provided bySartorius Stedim Data Analytics.

DCS System Architecture for a fully integrated SU Process Line

Sartorius and Siemens:
Partners for yourSuccess“The turn-key solution offered by the Sartorius | SiemensPartnership enables pharmaceutical manufacturers toaccelerate their digital transformation journey by leveraging
highly efficient manufacturing equipment by Sartorius aswell as state-of-the-art automation and digitalization
technologies by Siemens.”
Christian Korner
Corporate Account Manager Siemens AG

The use of industrial standards in automation guarantees
stable systems with minimized risk and faster time toproduction within the predicted cost frame.
The implementation of a Distributed Control System (DCS),
like Siemens SIMATIC PCS 7, fulfills today‘s requirementsof biopharmaceutical industries, like plant-wide recipe
control, full electronical batch reporting (eBR), review byexception (RBE) and plant-wide visualization.
The advantages of the Sartorius – Siemens automation
approach includes a seamless scalable solution, from
fulfillment of basic GMP requirements via batch
management up to paperless manufacturing.

Sartorius Core Competence
Leading provider for end-to-end
bioprocess solutions from concept
to realization.
Siemens Core Competence
Leading provider of industrial
automation solutions.

Sartorius Process Equipment Assemblies (PEA) can beeasily drag-and-dropped into Simatic PCS 7, creating an
integrated bioprocess line. This not only decreases
engineering effort and implementation time, but also
provides the flexibility to change and add PEA’s ondemand. Additionally, there is no risk to open an
engineering change management process (ECM) for
pre-qualified PEA’s.
Both Sartorius and Siemens share a proven track recordand provide full level local support and remote
maintenance access as well as personalized service
packages and maintenance contracts.

-----

Customer Benefits
Decreased Risk
Increased Quality
Flexibility
Security of Investment
Faster Time to Market
Maximum Productivity

Germany
Sartorius Stedim Biotech GmbH
August-Spindler-Strasse 1137079 Goettingen
Phone +49 551 308 0USA
Sartorius Stedim North America Inc.
565 Johnson Avenue
Bohemia, NY 11716
Toll-Free +1 800 368 7178

F or further contacts, visit
www.sartorius.com

Specifications subject to change without notice.
© 2022 Sartorius Stedim Biotech GmbH, August-Spindler-Strasse 11, 37079 Goettingen, Germany
Status: 09 | 02 | 2022