Celsius FFT - sartoriusglobal.com · Celsius® FFTp for Plate freezer Celsius ® FFTp has been especially designed to be used with ® plate freezers. It also combines the flexible

Freeze-Thaw Technologies

Single-Use System for Freeze-Thaw OperationCelsius® FFT is constructed from S71 film, a multi-layer co-extruded high gas barrier film containing EVAM (ethylene vinyl acetate copolymer, monomaterial) as fluid contact layer and EVOH (ethyl-ene vinyl alcohol) as gas barrier layer. The shell provides protection to the contents during all processes, proven during extensive characterization under freeze and thaw real process conditions. It makes the assembly robust, reliable, simplifying the handling, storage and shipping of the single-use containers.

Celsius® FFT is a “ready-to-use” sterile container, for freezing and thawing biopharmaceutical solutions in commercially available equipment such as laboratory (walk-in) freezer, cold room, temperature controlled cabinet or water bath.

Description Celsius® FFT combines a unique design of a flexible bag with an integral protective shell. The robustness of this single-use assembly ensures protection, support and ease of handling.

Applications Celsius® FFT is specifically designed for freezing, thawing and long term frozen storage of biopharmaceuticals such as

− Process intermediates − Bulk drug substances − Product in clinical phases (pre, I, II +) − Vaccines − Monoclonal antibodies − Other recombinant proteins

Product Information

Celsius® FFTSingle-use container for flexible freeze-thaw processes

– Single-use

– Proven robustness at low temperature

– Ease-of-use

– Facilitated implementation

– Pre-qualified shippers

– Pre-sterilized, ready-to-use and 100% integrity testing of bag and immediate connection

Benefits

Specifications

Nominal Volume 2 L, 4 L, 6 L and 12 L

Sampling Port Luer® lock

Inlet & Outlet Port MPC Quick Coupling or OPTA connector

Sterilization Gamma Irradiation (25 – 45 kGy)

Materials

Film S71, 360 µm

Product Contact Layer EVA (ethylene vinyl acetate copolymer)

Gas Barrier Layer EVOH (Ethylene Vinyl Alcohol)

Fill and Drain Ports EVA (Ethylene Vinyl acetate copolymer)

Fill, Drain and Sampling C-Flex® 374

MPC Quick Coupling PC (Polycarbonate) with Silicone O-ring

Shell HDPE (High-Density Polyethylene)

Screw Isoplast 101 40% LGF, natural

Nut Nylon 6/6, natural

Shippers – Corrugate product box and dry-ice bunker

– Molded Pur – EPS Crush Zone – DBL Wall Corrugate

Technical Data

Celsius® FFTp for Plate freezerCelsius® FFTp has been especially designed to be used with plate freezers. It also combines the flexible bag with an integral protective shell design. The design is compact and flat to offer a good contact with heat exchange freezer plates.

Celsius® FFT ShippersThe Celsius® FFT Shippers is a robust solution allowing safe shipment of individual or multiple Celsius® FFT to remote locations. The Celsius® FFT shipper has been qualified according to the most restrictive regulations for shipping containers such as ASTM-D4169 Level 1 and ISTA 7D. The shipper provides adequate insula-tion and refrigeration to maintain the Celsius® FFT below –40°C for at least 96 h.

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.

ValidationCelsius® FFT bags have been qualified applying the most complex and innovative test regimes. Biological, 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.

Quality AssuranceSingle-Use Products follow applicable ISO and FDA regulations for Medical Devices. Design, Manufacture and Sterilization processes are conducted under conditions that mirror biopharma-ceutical operations and meet cGMP requirements. A type III drug master file (DMF) has been recorded (applicable for all S71 single-use bags).

Freeze-Thaw Technologies 3

Dimensions L + W + H

Celsius® FFT 2L 38.6 + 32.8 + 12.4 cm | 15.2“ + 12.9“ + 4.9“

Celsius® FFT 4L 43.4 + 42.4 + 12.6 cm | 17.1“ + 16.7“ + 5.0“

Celsius® FFT 6L 57.8 + 42.6 + 11.7 cm | 22.8“ + 16.8“ + 4.6“

Celsius® FFT 12L 69.8 + 53.4 + 13.1 cm | 27.5“ + 21.0“ + 5.23“

Celsius® FFTp 6L 56.6 + 40.4 + 5.1 cm | 22.3“ + 15.9“ + 2.00“

Celsius® FFTp 12L 67.8 + 51.3 + 6.9 cm | 26.7“ + 21.0“ + 2.72“

Shipper; Celsius® FFT 2L 1-unit Shipper 63.5 + 52.8 + 60.4 cm | 25.0” + 20.8” + 23.8”

Shipper; Celsius® FFT 2L 4-unit Shipper 87.0 + 60.0 + 74.3 cm | 34.3” + 23.6” + 29.3”

Shipper; Celsius® FFT 4L 1-unit Shipper 61.5 + 58.9 + 52.8 cm | 24.2“ + 23.2“ + 20.8“





Celsius® FFT (Bag + Shell)

Part Number Description Tubing Port 1 Port 2 Port 3 Qty./BoxFZB212401 Celsius® FFT 4 L

(3T, TPE), 4 L nominal capacity

TPE|Clear C-Flex® 374

a” + b” + 50 cm (20”) and male MPC + sealing cap

4” + a” + 10 cm (4”) + Clear C-Flex® 374 8” + 4” + 50 cm (20”) and female Luer® Lock with plug

a“ + b“ + 50 cm (20“) and male MPC + sealing cap

6

FZB212435 Celsius® FFT 12 L (3T, TPE), 12 L nominal capacity





3

FZB129268 Celsius® FFT 12 L (3T, OPTA, TPE), 12 L nominal capacity


a” + b” x 75 cm (30”) and OPTA male


a“ + b“ + 75 cm (30”) and OPTA male;

3

CELSISUS FFT 4L OR CELSISUS FFT 12L

Ordering Information

Celsius® FFT (Bag + Shell)

Part Number Description Tubing Port 1 Port 2 Qty./BoxFZB114906 Celsius® FFT 2 L

(3T, TPE), 2 L nominal capacity

TPE | Clear C-Flex® 374

a“ + b“ + 38 cm (15”) and male MPC + sealing cap

a“ + b“ + 38 cm (15”) and male MPC + sealing cap + a“ + b“ + 30 cm (12“) + 8“ + 4“ + 50 cm (20“) and female Luer® Lock with plug

6

FZB129267 Celsius® FFT 2 L (3T, OPTA, TPE), 2 L nominal capacity


a“ + b“ + 38 cm (15”) and OPTA male

a“ + b“ + 38 cm (15”) and OPTA male + a“ + b“ + 30 cm (12”) + 8“ + 4“ + 50 cm (20”) and female Luer® Lock with plug

6

FZB212241 Celsius® FFT 6 L (3T, TPE), 6 L nominal capacity

TPE | Clear C-Flex® 374


a“ + b“ + 75 cm (30“) and male MPC + sealing cap + a“ + b“ + 15 cm (6“) + 8“ + 4“ + 75 cm (30“) and female Luer® Lock with plug

6


Celsius® FFTp (Bag + Shell)

Part Number Description Tubing Port 1 Port 2 Qty./BoxFZB114079 Celsius® FFTp 6L (2T,

MPC), for horizontal plate freezer, 6 L nominal capacity

EVA a“ + j“ + 40 mm (1.57“) + a“ + j“ + 150 mm (6“) + male MPC + sealing cap

a“ + j“ + 40 mm (1.57“) + a“ + j“ + 150 mm (6“) + male MPC + sealing cap

6

Part Number Description Tubing Port 1 Port 2 Port 3 Qty./BoxFZB115784 Celsius® FFTp 12L (2T,

MPC), for horizontal plate freezer, 12 L nominal capacity

EVA a“ + j“ + 40 mm (1.57“) + a“ + j“ + 300 mm (12“) + male MPC + sealing cap

a“ + j“ + 40 mm (1.57“) + plug

a“ + j“ + 40 mm (1.57“ ) + a“ + j“ + 300 mm (12“) + female MPC + sealing plug

2

²

X13

X13

X1

CELSIUS® FFT 12L

1

11

1

1

1

1

1

2

3

Celsius® BioPharm Bags

Part Number Description Tubing Port 1 Port 2 Port 3 Qty./BoxFZB212530 Celsius® Biopharm

Bag 4 L (3T, TPE). Fits to FZB212401



4” + a” + 10 cm (4”) + 8” + 4” + 50 cm (20”) and female Luer® Lock with plug


2

FZB212916 Celsius® Biopharm Bag 12 L (3T, TPE). Fits to FZB212435



4” + a” + 10 cm (4”) + 8” + 4” + 50 cm (20”) and female Luer® Lock with plug


10

Part Number Description Tubing Port 1 Port 2 Qty./BoxFZB115991 Celsius® Biopharm

Bag 2 L (3T, TPE). Fits to FZB114906



a” + b” + 38 cm (15”) and male MPC + sealing cap + a” + b” + 30 cm (12”) + 8” + 4” + 50 cm (20”) and female Luer® Lock with plug

10

FZB212521 Celsius® Biopharm Bag 6 L (3T, TPE). Fits to FZB212241



a“ + b“ + 75 cm (30“) and male MPC + sealing cap + a“ + b“ + 15 cm (6“) + 8“ + 4“ + 75 cm (30“) and female Luer® Lock with plug

10


Celsius® FFT Shippers

Part Number DescriptionFTH-SM00103-0006 Shipper; Celsius® FFT 2L 1-unit Shipper

FTH-SM00103-0007 Shipper; Celsius® FFT 2L 4-unit Shipper






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”Uralskaya str. 4, Lit. B199155 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

UkraineLLS “Sartorius 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.Av. Emilio Cavenecia 264 San Isidro15073 Lima, Perú

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.1 Science Park Road, The Capricorn, #05-08A,Singapore Science Park IISingapore 117528

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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C-Flex® is a registered trademark of Saint-Gobain Performance Plastics Corporation.

Documents

Celsius FFT - sartoriusglobal.com · Celsius® FFTp for Plate freezer Celsius ® FFTp has been especially designed to be used with ® plate freezers. It also combines the flexible