Standard Flexboy bioprocessing bags - Sartorius

1 Standard Flexboy bioprocessing bags Features Benefits Multiple High security of supply manufacturing sites Fluid Management Systems 100% integrity Process safety and testing of bag integrity and immediate connection All connections Safe and robust extensively qualified Full compliance Highest sterility with ISO11137 assurance level Standard design Most designs available from stock Specifications Bag Chamber Multiple Film Construction, Description Flexibility EVA Fluid Contact Layer Standard Flexboy bioprocessing bags are Standard Flexboy bags are available as designed for the preparation, storage and stand-alone bags and filter & bag assemblies Tubing EVA, TPE. transport of biopharmaceutical solutions, incorporating a variety of filter and bag sizes Fittings Sartopore 2 Gamma intermediates and final bulk products.

2 They allowing easy adaptation to process volume Filter Capsule, Female provide a single-use alternative to traditional and media. Multiple configurations that also Luer Lock, MPC Male glass, stainless steel and rigid plastic carboys integrate thermoweldable TPE tubing Coupling, Mini Triclamp, in a large variety of applications. are provided for flexible incorporation into Needle free sampling your process. Thus, sterile connection and port Applications disconnection devices like the BioWelder and The broad chemical compatibility of Flexboy the BioSealer can be used to allow safe Number of Ports 3. Bags assures the safe processing of a wide connections and disconnections from and to Volumes 50 ml 50 L.

3 Range of biopharmaceutical fluids in a variety another process step. of applications: Sterilization by Gamma Irradiation Buffers and Media sterile Female luer fittings with a needle-free filtration & storage sampling port allow easy and convenient Bulk Harvest sampling, quick connects may be attached Product pooling directly or adapted to a variety of connec- Fraction collection tions and mini triclamps that are constantly Sample collection used in industrial environment assure Bulk intermediate hold maximum flexibility. Final Product transport Easy Implementation Cost reduction and risk reduction Standard Flexboy Bags are available in bag Single-Use Systems used in biopharmaceuti- chamber volumes between 50 ml and 50 L.

4 Cal manufacturing improve process safety as They are supplied sterilized and ready to use. they reduce the risk of cross contamination This allows an easy and convenient process from batch-to-batch and product-to-prod- implementation. A series of associated uct. Cost and time consuming CIP & SIP oper- systems such as Flexboy Trays and Racks ations are minimized. This results not only facilitate an easy bag handling. Sartorius in significant cost savings within the entire Stedim Biotech supports users already at the manufacturing process, but also in the design & implementation phase of a new optimization of capacity utilization. production facility with the most comprehen- sive support program that ensures successful design implementation of Single-Use Manufacturing.

5 SPL2003-e08024 |1. Security of Supply Dimensions Sartorius Stedim Biotech has established multiple manufacturing sites with consistent 50 ml 3 L. industrial processes. The expertise of design- ing Single Use solutions based on collabora- Volume 50 mL 150 mL 250 mL 500 mL 1L 2L 3L. tive supplier management and customer Length (L) mm 134 205 230 241 299 319 381. demand planning assures a state of the art ( ") ( ") ( ") ( ") ( ") ( ") ( "). and robust supply chain that can cope with strong market growth. Width (W) mm 95 85 94 130 155 223 223. ( ") ( ") ( ") ( ") ( ") ( ") ( "). Validation Length inc. 231 302 327 338 396 416 478. Flexboy bags have been qualified applying Tubing (T) mm ( ") ( ") ( ") ( ") ( ") ( ") ( ").

6 The most complex and innovative test Film Surface 143 275 329 452 707 1103 1346. regimes. Biological, chemical and physical Area cm2 ( in2) (42,6 in2) ( in2) ( in2) ( in2) ( in2) ( in2). tests combined with extensive extractable testing provide users of Flexboy with data representing the widest range of process 5 L 50 L. fluids in a variety of processing conditions. Volume 5L 10 L 20 L 50 L. Full compliance with ISO11137 allows sterility Length (L) mm 376 ( ") 621 ( ") 654 ( ") 790 ( "). assurance level validation of 10-6 for each Single Use System over its entire shelf life. Width (W) mm 332 ( ") 300 ( ") 431 ( ") 580 ( "). Length inc. 473 ( ") 718 ( ") 749 ( ") 887 ( "). Quality Assurance Tubing (T) mm Sartorius Stedim Biotech Quality Systems for Film Surface 1929 3528 4826 8106.

7 Single Use Products follow applicable ISO Area cm2 ( in2) ( in2) ( in2) ( in2). and FDA regulations for Medical Devices. Design, Manufacture and Sterilization processes are conducted under conditions that mirror biopharmaceutical operations and meet cGMP requirements. Flexboy bags are tested for compliance to: USP <87>: Biological reactivity tests, in Vitro USP <88>: Biological reactivity tests, in Vivo USP <661>: Tests for plastic USP <788> and : Particulate ISO 11737 : Bioburden ISO 11137 : Sterilization of Medical Devices Rapid Supply The majority of Standard Flexboy storage systems are available from stock. 2| SPL2003-e08024. Ordering Information 1. Standard Flexboy with EVA tubes Standard Flexboy with EVA tubes (50mL to 3L with Luer lock connection).

8 Part number Description Tubing Bag Port 1 Bag Port 2 Bag Port 3 Qty/box FFB102603 Flexboy 50 ml EVA 1/4" + 5/16" + 10 cm (4") 1/4" + 5/16" + 10 cm (4") 3/16" + 1/4" + 5 cm 20. LL male + Cap, pinch clamp LL female + Cap, pinch clamp (1,97 in.) + septum FFB102643 Flexboy 150 ml EVA 1/4" + 5/16" + 10 cm (4") 1/4" + 5/16" + 10 cm (4") 3/16" + 1/4" + 5 cm 20. LL male + Cap, pinch clamp LL female + Cap, pinch clamp (1,97 in.) + septum FFB102670 Flexboy 500 ml EVA 1/4" + 5/16" + 10 cm (4") 1/4" + 5/16" + 10 cm (4") 3/16" + 1/4" + 5 cm 20. LL male + Cap, pinch clamp LL female + Cap, pinch clamp (1,97 in.) + septum FFB103547 Flexboy 1000 ml EVA 1/4" + 5/16" + 10 cm (4") 1/4" + 5/16" + 10 cm (4") 3/16" + 1/4" + 5 cm 20.

9 LL male + Cap, pinch clamp LL female + Cap, pinch clamp (1,97 in.) + septum FFB102812 Flexboy 3000 ml EVA 1/4" + 5/16" + 10 cm (4") 1/4" + 5/16" + 10 cm (4") 3/16" + 1/4" + 5 cm 20. LL male + Cap, pinch clamp LL female + Cap, pinch clamp (1,97 in.) + septum Standard Flexboy with EVA tubes (50mL to 3L with MPC Connection). Part Number Description Tubing Bag Port 1 Bag Port 2 Bag Port 3 Qty/box FFB102640 Flexboy 50 ml EVA 1/4" + 5/16" + 10 cm (4") 1/4" + 5/16" + 10 cm (4") 3/16" + 1/4" + 5 cm 20. MPC male + dust cap, pinch clamp MPC male + dust cap, pinch clamp (1,97 in.) + septum FFB102877 Flexboy 150 ml EVA 1/4" + 5/16" + 10 cm (4") 1/4" + 5/16" + 10 cm (4") 3/16" + 1/4" + 5 cm 20.

10 MPC male + dust cap, pinch clamp MPC male + dust cap, pinch clamp (1,97 in.) + septum FFB103398 Flexboy 500 ml EVA 1/4" + 5/16" + 10 cm (4") 1/4" + 5/16" + 10 cm (4") 3/16" + 1/4" + 5 cm 20. MPC male + dust cap, pinch clamp MPC male + dust cap, pinch clamp (1,97 in.) + septum FFB102606 Flexboy 1000 ml EVA 1/4" + 5/16" + 10 cm (4") 1/4" + 5/16" + 10 cm (4") 3/16" + 1/4" + 5 cm 20. MPC male + dust cap, pinch clamp MPC male + dust cap, pinch clamp (1,97 in.) + septum FFB102704 Flexboy 3000 ml EVA 1/4" + 5/16" + 10 cm (4") 1/4" + 5/16" + 10 cm (4") 3/16" + 1/4" + 5 cm 20. MPC male + dust cap, pinch clamp MPC male + dust cap, pinch clamp (1,97 in.) + septum SPL2003-e08024 |3. Ordering Information Standard Flexboy with EVA tubes (5L to 50L with MPC Connection).