Celsius FFT - Sartorius

1 Key Features Integral container with A S71 bag A HDPE protective shell Ready-to-use Pre-assembled Clean, pre-sterilized and QC tested Robust Single-useDescription Celsius FFT is a ready-to-use sterile container,for freezing and thawing biopharmaceuticalsolutions in commercially available equipmentsuch as laboratory (walk-in) freezer, cold room,temperature controlled cabinet or water bath. Celsius FFT combines a unique design of a flexible bag with an integral protective robustness of this single-use assemblyensures protection, support and ease of Celsius FFT is specifically designed for freezing, thawing and long term frozenstorage of biopharmaceuticals such as Process intermediates Bulk drug substances Product in clinical phases (pre, I, II +) Vaccines Single-Use System for Freeze-Thaw OperationCelsius FFT is constructed from S71 film, amulti-layer co-extruded high gas barrier filmcontaining EVAM (ethylene vinyl acetatecopolymer, monomaterial) as fluid contactlayer and EVOH (ethylene vinyl alcohol) as gasbarrier layer.

2 The shell provides protection tothe contents during all processes, making theassembly robust and reliable and simplifyingthe handling, storage and shipping of thesinge-use FFTp for Plate freezerCelsius FFTp has been especially designed tobe used with plate freezers. It also combinesthe flexible bag with an integral protectiveshell design. The design is compact and flat to offer a good contact with heat exchangefreezer FFT ShippersThe Celsius FFT Shippers is a robust solutionallowing safe shipment of individual or multiple Celsius FFT to remote locations. The Celsius FFT shipper has been qualifiedaccording to the most restrictive regulationsfor shipping containers such as ASTM-D4169 Level 1 and ISTA 7D.

3 The shipper providesadequate insulation and refrigeration tomaintain the Celsius FFT below 40 C for at least 96 FFT Single-use container for flexible freeze-thaw processesFreeze-Thaw SystemsSpecificationsMaterialsFilmS71, 360 mProduct Contact Layer EVA (ethylene vinylacetate copolymer)Gas Barrier LayerEVOH (Ethylene VinylAlcohol)Fill and Drain PortsEVA (Ethylene VinylAcetate copolymer) Fill, Drain and Sampling C-Flex 374 MPC Quick CouplingPC (Polycarbonate)with Silicone O-ringShellHDPE (High-DensityPolyethylene)ScrewIsoplast 101 40% LGF,naturalNutNylon 6/6, naturalShippersPolyethylene Stackable TrayMolded PurEPS Crush ZoneDBL Wall CorrugateNominal Volume2 L, 4 L, 6 L and 12 LSampling Port Luer lockInlet & Outlet PortMPC Quick Coupling SterilizationGamma Irradiation(25-45 kGy)2 | S--2055-e11039 Security of SupplySartorius Stedim Biotech has established multiple manufacturing sites with consistentindustrial processes.

4 The expertise of design-ing Single-Use solutions based on collabora-tive supplier management and customerdemand planning assures a state of the artand robust supply chain that can cope withstrong market FFT bags have been qualified applyingthe most complex and innovative testregimes. Biological, chemical and physicaltests combined with extensive extractabletesting provide users of Celsius with datarepresenting the widest range of process fluids in a variety of processing compliance with ISO11137 allows sterilityassurance level validation of 10 6for eachSingle-Use System over its entire shelf AssuranceSingle-Use Products follow applicable ISOand FDA regulations for Medical , Manufacture and Sterilizationprocesses are conducted under conditionsthat mirror biopharmaceutical operations and meet cGMP requirements.

5 A type III drugmaster file (DMF) is on record with the L +W +HCelsius FFT + + "+ "+ " Celsius FFT + + "+ "+ " Celsius FFT + + "+ "+ " Celsius FFT + + "+ "+ " Celsius FFTp + + "+ "+ " Celsius FFTp + + "+ "+ "Shipper; Celsius FFT 4L + + cm1-unit "+ "+ "Shipper; Celsius FFT 4L + + cm4-unit "+ "+ "Shipper; Celsius FFT 6L + + cm1-unit "+ "+ "Shipper; Celsius FFT 6L + + cm4-unit "+ "+ "Shipper; Celsius + + cmFFT 12L 1-unit Shipper "+ "+ "S--2055-e11039 | 31. Celsius FFT (Bag + Shell)Ordering informationPart NumberDescriptionTubingPort 1 Port 2 Port 3 Qty per boxFZB212401 Celsius FFT 4L (3T, TPE)TPE | ClearC-Flex 3743/8" +5/8" +50 cm (20") and male MPC + sealing cap3/8" +5/8" +10 cm (4") +1/8" +1/4" +50 cm (20") and female Luer Lock with plug3/8" +5/8" +50 cm (20") and male MPC + sealing cap6 FZB212435 Celsius FFT 12L(3T, TPE)TPE | ClearC-Flex 3743/8" x 5/8" +50 cm (20")and male MPC + sealing cap3/8" +5/8" +10 cm (4") +Clear C-Flex 374 1/8" +1/4" +50 cm (20")and female Luer Lock with plug3/8" +5/8" +50 cm (20")and male MPC + sealing cap3 CELSISUS FFT 4 LOR CELSISUS FFT 12L4 | S--2055-e110391.

6 Celsius FFT (Bag + Shell)Ordering informationPart NumberDescriptionTubingPort 1 Port 2 Qty per boxFZB114906 Celsius FFT 2L (3T, TPE)TPE | Clear 3/8" +5/8" +50 cm (20") 3/8" +5/8" +50 cm (20") 6C-Flex 374and male MPC + and male MPC + sealing capsealing cap + 3/8" +5/8" +30 cm (12") + 1/8" +1/4" +50 cm (20") and female Luer Lock with plugFZB212241 Celsius FFT 6L (3T, TPE)TPE | Clear3/8" +5/8" +75 cm (30")3/8" +5/8" +75 cm (30")6C-Flex 374and male MPC +and male MPC +sealing capsealing cap + 3/8" +5/8" +15 cm (6") +1/8" +1/4" +75 cm (30") and female Luer Lock with plugS--2055-e11039 | 52. Celsius FFTp (Bag + Shell)Ordering informationPart NumberDescriptionTubingPort 1 Port 2 Qty per boxFZB114079 Celsius FFTp 6L EVA3/8" +15/32" +40 mm 3/8" +15/32" +40 mm6(2T, MPC)( ") + 3/8" +( ") + 3/8" +15/32" +150 mm (6") +15/32" +150 mm (6") + male MPC + sealing capmale MPC + sealing capPart NumberDescriptionTubingPort 1 Port 2 Port 3 Qty per boxFZB115784 Celsius FFTpEVA 3/8" +15/32" +40 mm3/8" +15/32" +40 mm3/8" +15/32" +40 mm212L (MPCx2)( ") + 3/8" +( ") + plug( " ) + 3/8" +15/32" +300 mm (12")15/32" +300 mm (12")+ male MPC + sealing cap+ female MPC + sealing plug X13X13X1 Celsius FFT 12L 11111111236 | S--2055-e110393.

7 Celsius BioPharm BagsOrdering informationPart NumberDescriptionTubingPort 1 Port 2 Port 3 Qty per boxFZB212530 BIOPHARM BAGS71 360 m 4L(3T, TPE)TPE | ClearC-Flex 3743/8" +5/8" +50 cm (20")and male MPC + sealing cap3/8" +5/8" +10 cm (4") +1/8" +1/4" +50 cm (20")and female Luer Lockwith plug3/8" +5/8" +50 cm (20")and male MPC + sealing cap10 FZB212916 BIOPHARM BAGS71 360 m 12L(3T, TPE)TPE | ClearC-Flex 3743/8" +5/8" +50 cm (20")and male MPC + sealing cap3/8" +5/8" +10 cm (4") +1/8" +1/4" +50 cm (20")and female Luer Lockwith plug3/8" +5/8" +50 cm (20")and male MPC + sealing cap10 Part NumberDescriptionTubingPort 1 Port 2 Qty per boxFZB115991 BIOPHARM BAGS71 360 m 2L (3T, TPE)TPE | Clear C-Flex 3743/8" +5/8" +75 cm (30") and male MPC + sealing cap3/8" +5/8" +75 cm (30") and male MPC +sealing cap + 3/8" +5/8" +15 cm (6") + 1/8" +1/4" +75 cm (30") and female Luer Lock with plug10 FZB212521 BIOPHARM BAG S71 360 m 6L (3T, TPE)TPE | Clear C-Flex 3743/8" +5/8" +75 cm (30") and male MPC + sealing cap3/8" +5/8" +75 cm (30") and male MPC +sealing cap + 3/8" +5/8" +15 cm (6") +1/8" +1/4" +75 cm (30") and female Luer Lock with plug104.

8 Celsius FFT ShippersOrdering informationCelsius FFT 1-unit ShipperCelsius FFT 4-unit ShipperS--2055-e11039 | 7 Part numberDescriptionFTH-SM00103-0003 Shipper; Celsius FFT 4L 1-unit ShipperFTH-SM00103-0004 Shipper; Celsius FFT 4L 4-unit ShipperFTH-SM00103-0001 Shipper; Celsius FFT 6L 1-unit ShipperFTH-SM00103-0002 Shipper; Celsius FFT 6L 4-unit ShipperFTH-SM00103-0005 Shipper; Celsius FFT 12L 1-unit ShipperSartorius Stedim Biotech GmbHAugust-Spindler-Strasse 1137079 Goettingen, GermanyPhone + + USA Toll-Free + + + + + + subject to change without notice. Printed and copyrighted by Sartorius Stedim Biotech GmbH. | WPublication No.: S--2055-e11039 Order No.: 85034-535-36 Ver.

9 03 | 2011