Celsius FFT - sartoriusglobal.com · Celsius® FFTp for Plate freezer Celsius ® FFTp has been...
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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“
Shipper; Celsius® FFT 4L 4-unit Shipper 110.5 + 64.3 + 79.2 cm | 43.5“ + 25.3“ + 31.2“
Shipper; Celsius® FFT 6L 1-unit Shipper 74.4 + 59.2 + 42.7 cm | 29.3“ + 23.3“ + 16.8“
Shipper; Celsius® FFT 6L 4-unit Shipper 112.1 + 78.3 + 72.5 cm | 44.1“ + 30.8“ + 28.6“
Shipper; Celsius® FFT 12L 1-unit Shipper 90.7 + 74.9 + 51.6 cm | 35.7“ + 29.5“ + 20.3“
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
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
3
FZB129268 Celsius® FFT 12 L (3T, OPTA, TPE), 12 L nominal capacity
TPE|Clear C-Flex® 374
a” + b” x 75 cm (30”) and OPTA male
4” + a” + 10 cm (4”) + Clear C-Flex® 374 8” + 4” + 50 cm (20”) and female Luer® Lock with plug
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
TPE|Clear C-Flex® 374
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“ + 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
Freeze-Thaw Technologies 5
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
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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
TPE|Clear C-Flex® 374
a” + b” + 50 cm (20”) and male MPC + sealing cap
4” + a” + 10 cm (4”) + 8” + 4” + 50 cm (20”) and female Luer® Lock with plug
a” + b” + 50 cm (20”) and male MPC + sealing cap
2
FZB212916 Celsius® Biopharm Bag 12 L (3T, TPE). Fits to FZB212435
TPE|Clear C-Flex® 374
a” + b” + 50 cm (20”) and male MPC + sealing cap
4” + a” + 10 cm (4”) + 8” + 4” + 50 cm (20”) and female Luer® Lock with plug
a“ + b“ + 50 cm (20“) and male MPC + sealing cap
10
Part Number Description Tubing Port 1 Port 2 Qty./BoxFZB115991 Celsius® Biopharm
Bag 2 L (3T, TPE). Fits to FZB114906
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
10
FZB212521 Celsius® Biopharm Bag 6 L (3T, TPE). Fits to FZB212241
TPE|Clear C-Flex® 374
a” + b” + 75 cm (30”) and male MPC + sealing cap
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
Freeze-Thaw Technologies 7
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
FTH-SM00103-0003 Shipper; Celsius® FFT 4L 1-unit Shipper
FTH-SM00103-0004 Shipper; Celsius® FFT 4L 4-unit Shipper
FTH-SM00103-0001 Shipper; Celsius® FFT 6L 1-unit Shipper
FTH-SM00103-0002 Shipper; Celsius® FFT 6L 4-unit Shipper
FTH-SM00103-0005 Shipper; Celsius® FFT 12L 1-unit Shipper
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C-Flex® is a registered trademark of Saint-Gobain Performance Plastics Corporation.