Discover our Freezing Capabilities: Celsius Product...

Discover our Freezing Capabilities:Celsius® Product Lines

Overview of the Freezing and Thawing Operations Sartorius Stedim Biotech offers comprehensive solutions, using either patented freeze-thaw technologies or conventional freezers, for the handling, storage, transfer and shipping of biophar-maceuticals.

Total Solution Provider

in Freezing Solutions

The Celsius® CFT systems use a proprietary heat transfer techno–logy to solidify aqueous solutions,scalable from process development to commercial scale production products.

The Celsius® FFT single-use assem-blies are designed to provide the freezing container used in conven-tional freezer. The associated logistics for frozen storage and shipping of biopharmaceuticals is also available.

Celsius® FFT(Volumes: 2 L, 4 L, 6 L and 12 L)

Celsius® ShippableStorage Module (SSM)

Celsius® SSM Shipper

Storage & Logistics

Freezing & storage in conventional freezer

Controlled Thawing Operation

Celsius® Fill Station FS16-S1

Celsius® FT100Celsius® FT16

Celsius® Logistics

Celsius® FT100Celsius® FT16

Celsius® Controlled Freeze Thaw (CFT)

Celsius® Flexible Freeze Thaw (FFT)

Filling Operation

Controlled Freezing Operation

Celsius® FFT Shippers

Celsius®-Pak(Volumes: 30 mL, 100 mL, 1 L, 2 L, 8.3 L and 16.6 L)

We Provide Our Support in Your Freezing Operations

Security of SupplySartorius Stedim Biotech has established multiple manufacturing sites with consistent industrial processes. The expertise of designing Single-Use solutions based on collaborative supplier management and customer demand planning assures a state of the art and robust supply chain that can cope with strong market growth.

Quality AssuranceSingle-Use Products follow applicable ISO and FDA regulations for Medical Devices. Design, Manufacture and Sterilization processes are conducted under conditions that mirror biopharmaceutical operations and meet cGMP requirements.

A type III drug master file (DMF) is on record with the FDA.

ValidationCelsius® Bags have been qualified applying the most complex and innovative test regimes. Bio-logical, chemical and physical tests combined with extensive extractable testing provide users of Celsius® with data representing the widest range of process fluids in a variety of processing conditions.

Full compliance with ISO11137 allows sterility assurance level validation of 10–6 for each Single-Use System over its entire shelf life.

Application SupportContract Development StudiesThe purpose of Sartorius Stedim Biotech’s feasibility studies is to assess the characteristics (quality, viability, robustness) of a drug substance product sample (provided by the Customer) when using Sartorius Stedim Biotech Laboratory Scale Freeze and Thaw technologies.

The studies are designed to replicate the freeze | hold | thaw profiles of the Production Scale Controlled Freeze-Thaw Systems.

Feasibility studies include freeze-thaw cycling and frozen storage studies.

We also understands that biological entities have their own intrinsic characteristics that call for the development of product specific studies. Our applications group will work with clients to develop studies that will address the unique requirements of their biological entity.

Celsius® S3 Overview

The Celsius® S3 is the only laboratory instrument to evaluate the Freeze and Thaw processes of new drug candidates in single-use containers.

This tool allows generation of consistent samples library useful for evaluating stability, storage conditions and formulations.

Samples frozen in the Celsius® S3 system may be stored at different temperatures to investigate the drug substance stability, using final scale-like conditions.

consistent samples library useful for evaluating stability, storage conditions and formulations.

Celsius® CFT Celsius® FFT

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 GmbHSchwarzenberger Weg 73–7934212 Melsungen

Phone +49.5661.71.3400Fax +49.5661.71.3702


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

Phone +33.442.845600Fax +33.442.845619

Sartorius Stedim France SASZI 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 4251 B1605ECS Munro Buenos Aires

Phone +54.11.4721.0505 Fax +54.11.4762.2333

BrazilSartorius do Brasil LtdaAv. Dom Pedro I, 241Bairro Vila Pires Santo André São 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, 8–11 Kita 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 Sp

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Phone +49.551.308.0Fax +49.551.308.3289



Phone +49.5661.71.3400Fax +49.5661.71.3702



Phone +33.442.845600Fax +33.442.845619


Phone +33.442.845600Fax +33.442.846545


Phone +43.1.7965763.18Fax +43.1.796576344


Phone +32.2.756.06.80Fax +32.2.756.06.81


Phone +45.7023.4400Fax +45.4630.4030


Phone +39.055.63.40.41Fax +39.055.63.40.526


Phone +31.30.6025080Fax +31.30.6025099


Phone +34.90.2110935Fax +34.91.3589623


Phone +41.44.741.05.00Fax +41.44.741.05.09


Phone +44.1372.737159Fax +44.1372.726171


Toll-Free +1.800.368.7178Fax +1.631.254.4253




Phone +1.417.873.9636Fax +1.417.873.9275


Phone +54.11.4721.0505 Fax +54.11.4762.2333


Phone +55.11.4451.6226Fax +55.11.4451.4369


Phone +52.5555.62.1102Fax +52.5555.62.2942


Phone +61.3.8762.1800Fax +61.3.8762.1828


Phone +86.10.80426516Fax +86.10.80426580


Phone +86.21.28986393Fax +86.21.28986392.11


Phone +86.20.8351.7921Fax +86.20.8351.7931


Phone +91.80.4350.5361Fax +91.80.4350.5253


Phone +81.3.3740.5407Fax +81.3.3740.5406


Phone +60.3.8996.0622Fax +60.3.8996.0755


Phone +65.6872.3966Fax +65.6778.2494 Sp

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Phone +49.551.308.0Fax +49.551.308.3289



Phone +49.5661.71.3400Fax +49.5661.71.3702



Phone +33.442.845600Fax +33.442.845619


Phone +33.442.845600Fax +33.442.846545


Phone +43.1.7965763.18Fax +43.1.796576344


Phone +32.2.756.06.80Fax +32.2.756.06.81


Phone +45.7023.4400Fax +45.4630.4030


Phone +39.055.63.40.41Fax +39.055.63.40.526


Phone +31.30.6025080Fax +31.30.6025099


Phone +34.90.2110935Fax +34.91.3589623


Phone +41.44.741.05.00Fax +41.44.741.05.09


Phone +44.1372.737159Fax +44.1372.726171


Toll-Free +1.800.368.7178Fax +1.631.254.4253




Phone +1.417.873.9636Fax +1.417.873.9275


Phone +54.11.4721.0505 Fax +54.11.4762.2333


Phone +55.11.4451.6226Fax +55.11.4451.4369


Phone +52.5555.62.1102Fax +52.5555.62.2942


Phone +61.3.8762.1800Fax +61.3.8762.1828


Phone +86.10.80426516Fax +86.10.80426580


Phone +86.21.28986393Fax +86.21.28986392.11


Phone +86.20.8351.7921Fax +86.20.8351.7931


Phone +91.80.4350.5361Fax +91.80.4350.5253


Phone +81.3.3740.5407Fax +81.3.3740.5406


Phone +60.3.8996.0622Fax +60.3.8996.0755


Phone +65.6872.3966Fax +65.6778.2494 Sp

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Phone +49.551.308.0Fax +49.551.308.3289



Phone +49.5661.71.3400Fax +49.5661.71.3702



Phone +33.442.845600Fax +33.442.845619


Phone +33.442.845600Fax +33.442.846545


Phone +43.1.7965763.18Fax +43.1.796576344


Phone +32.2.756.06.80Fax +32.2.756.06.81


Phone +45.7023.4400Fax +45.4630.4030


Phone +39.055.63.40.41Fax +39.055.63.40.526


Phone +31.30.6025080Fax +31.30.6025099


Phone +34.90.2110935Fax +34.91.3589623


Phone +41.44.741.05.00Fax +41.44.741.05.09


Phone +44.1372.737159Fax +44.1372.726171


Toll-Free +1.800.368.7178Fax +1.631.254.4253




Phone +1.417.873.9636Fax +1.417.873.9275


Phone +54.11.4721.0505 Fax +54.11.4762.2333


Phone +55.11.4451.6226Fax +55.11.4451.4369


Phone +52.5555.62.1102Fax +52.5555.62.2942


Phone +61.3.8762.1800Fax +61.3.8762.1828


Phone +86.10.80426516Fax +86.10.80426580


Phone +86.21.28986393Fax +86.21.28986392.11


Phone +86.20.8351.7921Fax +86.20.8351.7931


Phone +91.80.4350.5361Fax +91.80.4350.5253


Phone +81.3.3740.5407Fax +81.3.3740.5406


Phone +60.3.8996.0622Fax +60.3.8996.0755


Phone +65.6872.3966Fax +65.6778.2494 Sp

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Phone +49.551.308.0Fax +49.551.308.3289



Phone +49.5661.71.3400Fax +49.5661.71.3702



Phone +33.442.845600Fax +33.442.845619


Phone +33.442.845600Fax +33.442.846545


Phone +43.1.7965763.18Fax +43.1.796576344


Phone +32.2.756.06.80Fax +32.2.756.06.81


Phone +45.7023.4400Fax +45.4630.4030


Phone +39.055.63.40.41Fax +39.055.63.40.526


Phone +31.30.6025080Fax +31.30.6025099


Phone +34.90.2110935Fax +34.91.3589623


Phone +41.44.741.05.00Fax +41.44.741.05.09


Phone +44.1372.737159Fax +44.1372.726171


Toll-Free +1.800.368.7178Fax +1.631.254.4253




Phone +1.417.873.9636Fax +1.417.873.9275


Phone +54.11.4721.0505 Fax +54.11.4762.2333


Phone +55.11.4451.6226Fax +55.11.4451.4369


Phone +52.5555.62.1102Fax +52.5555.62.2942


Phone +61.3.8762.1800Fax +61.3.8762.1828


Phone +86.10.80426516Fax +86.10.80426580


Phone +86.21.28986393Fax +86.21.28986392.11


Phone +86.20.8351.7921Fax +86.20.8351.7931


Phone +91.80.4350.5361Fax +91.80.4350.5253


Phone +81.3.3740.5407Fax +81.3.3740.5406


Phone +60.3.8996.0622Fax +60.3.8996.0755


Phone +65.6872.3966Fax +65.6778.2494 Sp

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Specifications subject to change without notice. Printed in Germany on paper that has been bleached without any use of chlorine. W/sart-000 · G.Publication No.: S--1512-e10071 Order No.: 85032-537-54 Ver. 07 | 2010

Discover our Freezing Capabilities: Celsius Product...

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