solutions for end to end bioprocessing with integrated automation · in addition to the openness of...

Solutions for End to End Bioprocessing with Integrated Automation

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At Sartorius Stedim Biotech Integrated Solutions we provide a unique imple-mentation methodology for your bioprocess using single-use technologies wherever possible and hybrid solutions as appropriate for your type & 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 need and importance of state of the art automation systems to maximize process efficiency and minimize risk. At Integrated Solutions, we engineer, design, and implement flexible automation platforms and management information systems to match your industrial needs.

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

Customer Single Use Process

Siemens Core Competences

Sartorius Core Competences

Sartorius and Siemens: Partners for your Success

l Intuitive Systems Tailored to your Process

l Possibilities for Process Optimization through Flexible Configurations

l Faster Time to Market

l Decreased Engineering Effort through Quality of Design

l Expedited Project Execution

l Accelerated and Reliable Start of Production

l Lower Initial Investment

l Precise Cost Determination and Allocation in Early Design Phases of production

Maximize Your Process Efficiency

The Sartorius New Automation Platform combines hardware, software and consumables in a unique way to ensure full functionality, best-in-class supply chain, serviceability and hence enables single-use commercial manufacturing.

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Integrated Solutions is designing and implementing process solutions for the biopharmaceutical industry under consideration of time-to-market, quality and cost targets. Process Automation is a key element to reach these targets. The collaboration between Sartorius and Siemens supports our customers to manage the challenges of the future. Dr. Thorsten Peuker, Vice President Integrated Solutions, Sartorius Stedim Biotech

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The Sartorius Integrated Solutions approach “Process4Success®” describes the engineering philosophy for entire single-use processes. Well defined sequences of pre-defined unit operations are combined to the entire process lines. These platform processes will support present and future progress in biopharmaceutical development and production in order to shorten the time-to-market by minimising engineering efforts and installation work.

Process4Success® guarantees

h High Quality

h High Investment reliability

h Short Leadtime

USPMP/BP DSP

Process4Success®

Fill & Finish

Customer Single Use Process

Process4Success® – The Sartorius Process Platform

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With Process4Success® (P4S), Sartorius does not only offer the platform, but furthermore a customised solution which meets individual customer requirements. The customers can concentrate on their core competences, and Sartorius offers the process know-how and relieves the customer. From the definition of the process up to the integration into customer IT infrastructures, Sartorius provides the solution – the “all-around carefree package”. Process4Success® shortens the realization time supporting faster time to market.

Development lifecycle model

To 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.

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

User Requirement Specification

Process Qualification

Functional Specification

Operational Qualification

Design Specification

Installation Qualification

Assembling of Process Equipment

Responsibility of Customer

Responsibility of Sartorius

time

Project Qualification

- Full level of IQ | OQ procedures – Fully documented in test reports

- In accordance with cGMP requirements

Project Definition

- Decomposition of customer process requirements

- Creation of system specifications

Datum / Date Name

BearbeiterDrawn

GeprüftChecked

Ind. Änderung /Revision Dat ./Date Name Ursprung /Origin

Document -Nr./Document -no. Format /Size

A0

Artikel -Nr./Article -no. Blatt/Sheet

1/1Ers . f./Repl . for Ers . d./Repl . by

Für diese Zeichnung behalten wir uns alle Rechte vor / This drawing is the property of Sartorius Stedim Biotech

Stat . -

Customer /Kunde

Profibus

Control Network

Discrete I /O

Server PC

Operator Station

Switch

DCUController

Instrument

Balance

SolenoidValves

PLC -CPU

RemoteI/O

Dong -A NetworkVFD

Laptop

Touch Panel 19"

WinCC

OS

hPrinter

CELL CULTURE - BRX

10 AI02 AO08 DI40 DO

CPU :317 -22,0 MB + 8MB

Picd 1

12 AI08 AO08 DI08 DO04 EM16 Ph00 Op

BR 2060500 L Seed Bioreactor

Managed Switch


CH 1080Depth Filtration

CPU :317 -22,0 MB + 8MB


CPU :317 -22,0 MB + 8MB

Picd 1


BR 20702000 L Production

Bioreactor

CPU :317 -22,0 MB + 8MB

HARVEST

BR 204020L Seed Bioreactor

CPU :317 -22,0 MB + 8MB


DCS Operator Station

Picd 1



Bioreactor

CPU :317 -22,0 MB + 8MB


Managed Switch

Picd 1




CPU :317 -22,0 MB + 8MB


CPU :317 -22,0 MB + 8MB

Picd 1



Bioreactor

CPU :317 -22,0 MB + 8MB

BR 104020L Seed Bioreactor

CPU :317 -22,0 MB + 8MB



Picd 1



Bioreactor

CPU :317 -22,0 MB + 8MB

Managed Switch

CELL CULTURE - MEDIA

Managed Switch

CPU :317 -21,0 MB + 8MB


MP 9020400 L Media Mixing

System

MP 901020L Media Mixing

System

OPC


CPU :317 -21,0 MB + 8MB


System


CPU :317 -21,0 MB + 8MB


System


Managed Switch


CPU :317 -21,0 MB + 8MB

UD 1160UF /DF Skid

FO 1170Formulations

Skid



CPU :317 -21,0 MB + 8MB

CR 1130CEX Chromo

Skid

CR 1090Protein A Chromo

Skid

VR 1150 Virus Filtration

Skid

CR 1140AEX Chromo

SkidVI 1100Virus Inactivation

Skid

OPC

OPC


CPU :317 -21,0 MB + 8MB


CPU :317 -21,0 MB + 8MB

Picd 1

CPU :317 -21,0 MB + 8MB



PURIFICATION – PRE VIRAL PURIFICATION – POST VIRAL

Managed Switch

CH 1080Clarified Harvest

OS Server redundantEngineering Station

Managed Switch

Printer

Historian

Batch RecipesPCS 7 CL 7 PCS 7 CL 8 PCS 7 CL 9

Managed Switch

PCS 7 AS 410

UPS /DST2000 l

SERVER ROOM / CONTROL ROOM

SimApi

Simca -Client

Simca -Online Server

Batch Server redundant

VIRTUAL MACHINE SERVER DATA ANALYTICS

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Besides equipment, automation and integration into an MES infrastructure are fundamental to a successful project execution. The goal is flexibility in automation.

Sartorius single-use equipment can easily be integrated into a distributed control system (DCS). This open system architecture covering the entire production process ensures an efficient interaction of all automation components. This is supported by consistent data management, 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 system architecture, this holistic automation approach paves the way for intelligent bioprocessing by means of Multivariate Data Analytics (MVDA) and real-time data acquisition and monitoring of your bioprocesses. Siemens SIMATIC PCS 7 works together with MVDA software packages provided by Sartorius Stedim Data Analytics (formerly Umetrics) , a world leader in MVDA technology.

Automation: The Backbone for Successful Project Execution and Smart Bioprocessing

DCS System Architecture for a fully integrated SU Process Line

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Leading provider for end-to-end bioprocess solutions from concept to realization.

Siemens Core Competence

Sartorius Core Competence

Leading provider of industrial automation solutions.

l Decreased Risk

l Increased Quality

l Flexibility

l Security of Investment

l Faster Time to Market

l Maximum Productivity

Customer Benefits

The use of industrial standards in automation guarantees stable systems with minimized risk and faster time to production within the predicted cost frame.

The implementation of a Distributed Control System (DCS), like Siemens SIMATIC PCS 7, fulfills today‘s requirements of biopharmaceutical industries, like plant-wide recipe control, full electronical batch reporting (eBR), review by exception (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 package units (PU) can be easily 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 PU’s on demand. Additionally, there is no risk to open an engineering change management process (ECM) for pre-qualified PU’s.

Both Sartorius and Siemens share a proven track record and provide full level local support and remote maintenance access as well as personalized service packages and maintenance contracts.

Sartorius and Siemens:Partners for your Success

The partnership between Sartorius and Siemens guarantees a highly qualitive and proven automation solution incl. MES based on gobal standards. Our deep familiarity with the Sartorius products allows us to develop dedicated standards for automation. This proven concept assures fast track project execution and thus early start of production. Hannspeter Pachel, Senior Consultant Account Development, Siemens AG

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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

Sartorius Stedim Systems GmbHRobert-Bosch-Strasse 5 – 7 34302 Guxhagen

Phone +49.5665.407.0Fax +49.5665.407.2200

FranceSartorius Stedim FMT S.A.S.ZI des PaludsAvenue de Jouques – CS 9105113781 Aubagne Cedex

Phone +33.442.845600Fax +33.442.845619

Sartorius Stedim France SASZI des PaludsAvenue de Jouques – CS 7105813781 Aubagne Cedex

Phone +33.442.845600Fax +33.442.846545

AustriaSartorius Stedim Austria GmbHModecenterstrasse 221030 Vienna

Phone +43.1.7965763.18Fax +43.1.796576344

BelgiumSartorius Stedim Belgium N.V.Rue Colonel Bourg 1051030 Bruxelles

Phone +32.2.756.06.80Fax +32.2.756.06.81

HungarySartorius Stedim Hungária Kft.Kagyló u. 52092 Budakeszi

Phone +36.23.457.227Fax +36.23.457.147

ItalySartorius Stedim Italy S.r.l.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.

Phone +31.30.60.25.080Fax +31.30.60.25.099

[email protected]

PolandSartorius Stedim Poland Sp. z o.o.ul. Wrzesinska 7062-025 Kostrzyn

Phone +48.61.647.38.40Fax +48.61.879.25.04

Russian FederationLLC “Sartorius Stedim RUS”Vasilyevsky Island5th line 70, Lit. A199178 St. Petersburg

Phone +7.812.327.53.27Fax +7.812.327.53.23

SpainSartorius Stedim Spain, S.A.U.Avda. de la Industria, 32Edificio PAYMA28108 Alcobendas (Madrid)

Phone +34.913.586.098Fax +34.913.589.623

SwitzerlandSartorius Stedim Switzerland AGRingstrasse 24 a8317 Tagelswangen

Phone +41.52.354.36.36Fax +41.52.354.36.46

U.K.Sartorius Stedim UK Ltd.Longmead Business CentreBlenheim Road, EpsomSurrey KT19 9 QQ

Phone +44.1372.737159Fax +44.1372.726171

UkraineLLC “Sartorius Stedim RUS”Post Box 440 “B”01001 Kiev, Ukraine

Phone +380.44.411.4918Fax +380.50.623.3162

AmericasUSASartorius Stedim North America Inc.5 Orville Drive, Suite 200Bohemia, NY 11716

Toll-Free +1.800.368.7178Fax +1.631.254.4253

ArgentinaSartorius Argentina S.A. Int. A. Ávalos 4251 B1605ECS Munro Buenos Aires

Phone +54.11.4721.0505 Fax +54.11.4762.2333

BrazilSartorius do Brasil Ltda Avenida Senador Vergueiro 2962 São Bernardo do Campo CEP 09600-000 - SP- Brasil

Phone +55.11.4362.8900Fax +55.11.4362.8901

MexicoSartorius de México, S.A. de C.V.Libramiento Norte de Tepotzotlan s/n,Colonia Barrio Tlacateco,Municipio de Tepotzotlan,Estado de México,C.P. 54605

Phone +52.55.5562.1102Fax +52.55.5562.2942

[email protected]

PeruSartorius Peru S.A.C.Avenue Alberto del Campo 411 Floor 12 – The Office15076 – San Isidro, Lima

Phone +51.1.441 0158 Fax +51.1.422 6100

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 Biotech (Beijing) Co. Ltd.No. 33 Yu’an RoadAirport Industrial Park Zone BShunyi District, Beijing 101300

Phone +86.10.80426516Fax +86.10.80426580

Sartorius Stedim (Shanghai) Trading Co., Ltd.3rd Floor, North Wing, Tower 1No. 4560 Jinke RoadZhangjiang Hi-Tech Park Pudong DistrictShanghai 201210, P.R. China

Phone +86.21.6878.2300Fax +86.21.6878.2882

Sartorius Stedim Biotech (Beijing) Co. Ltd.Guangzhou Representative OfficeUnit K, Building 23Huihua Commerce & Trade BuildingNo. 80 Xianlie Middle RoadGuangzhou 510070

Phone +86.20.37618687 | 37618651Fax +86.20.37619051

IndiaSartorius Stedim India Pvt. Ltd.#69/2-69/3, NH 48, JakkasandraNelamangala Tq562 123 Bangalore, India

Phone +91.80.4350.5250Fax +91.80.4350.5253

JapanSartorius Stedim Japan K.K.4th Fl., Daiwa Shinagawa North Bldg.8-11, Kita-Shinagawa 1-chomeShinagawa-ku, Tokyo, 140-0001 Japan

Phone +81.3.4331.4300Fax +81.3.4331.4301

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

Phone +60.3.8996.0622Fax +60.3.8996.0755

SingaporeSartorius Stedim Singapore Pte. Ltd.10 Science Park Rd The Alpha #02-13/14Singapore Science Park IISingapore 117684

Phone +65.6872.3966Fax +65.6778.2494

South KoreaSartorius Korea Biotech Co., Ltd.8th Floor, Solid Space B/D, PanGyoYeok-Ro 220, BunDang-GuSeongNam-Si, GyeongGi-Do, 463-400

Phone +82.31.622.5700Fax +82.31.622.5799

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www.sartorius.com/en/integrated-solutions

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

solutions for end to end bioprocessing with integrated automation · in addition to the openness of...

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