Fluid Management Connectionssartorius-stedim.ir/images/pdf/fluid management/f l u i d m a n a g e...

259F l u i d M a n a g e m e n t

Connections ________________________ 260

Flexboy® Bags _______________________ 264

Flexel® 3D Bags _____________________ 276

Palletank® ___________________________ 304

Instruments _________________________ 314

Single-Use Mixing __________________ 318

Freeze-Thaw Systems _______________ 354

Aseptic Transfer System ____________ 380

Configurable Solutions – FlexAct® BP __________________________ 394 FlexAct® MP _________________________ 418

260 Connections

Description The Opta® SFT Sterile Connector is a single-use device that allows a sterile connection between two separate, pre-sterilized compo-nents in biopharmaceutical manufacturing processes. Opta® SFT Sterile Connectors are quick and easy to use, and are backed by extensive validation work and 100% in house integrity testing.

The Opta® SFT-D is available as individual device for end-user assembly with TPE tubing and autoclave sterilization.

Ultra Safe Hose Barb Design The dimensions of Opta® SFT-I hose barbs have been specifically designed to assure the robustness and the integrity of the engage-ment between hose barb and various types of tubing. This is a key requirement for sterile fluid transfer in critical biopharmaceutical applications. Special tools in manufacturing guarantee the proper attachment to any type of tubing. Thus the Opta® SFT-I Sterile Connec-tor is supplied with Flexel® 3D and Flexboy® bags as part of integrated Sartorius Stedim Biotech Fluid Management assemblies. The Opta® SFT-I is also available as individual device for end-user assembly with silicone tubing and autoclave sterilization.

Ready to Autoclave or Gamma sterilised transfer sets with Opta® SFT-I are also available to ensure the counter connection to customers process equipment.

Features & Benefits

Male and female connector couplings sealed with sterilizing grade membrane

Allows for sterile fluid transfer in non classified & classified environments

Male and female connector couplings

Allows for “error proofing” of designs to prevent mistaken connections.

Sterilizable by Gamma irradiation & Autoclave

Flexible implementa-tion of Hybrid single-use and multiple use technologies.

100% integrity tested Highest security

Claimed size equivalent to tubing ID size

No flow restriction

3-step operation Easy, Robust, Repeat-able Operation

All hose barb con-nections intensively qualified (SFT-I only)

Safe and robust tubing connections

Fully integrated supply chain for Opta® SFT-I incorporating single- use assemblies from Sartorius Stedim Biotech

Streamlined supply chain, high security of supply

Opta® SFTSterile Connector to be Integrated Into Sartorius Stedim Biotech Fluid Management Assemblies (Opta® SFT-I) and Also Available as Individual Device for End-User Assembly with Silicone Tubing (SFT-I) or TPE Tubing (SFT-D) and Autoclave Sterilization

Single-Use Technology


Specifications

Materials for Male and Female Coupling

Connector body & collar

Polycarbonate

Seal Santoprene

Membrane Hydrophobic polyethersulfone

Protective cap Polypropylene

Connections

Small connector body 4”, 3/8” and 1” Hose Barb

Large connector body 1“ and 3“ Hose Barb

Pressure Resistance

Max. operating pressure

3 bar (43.5 psi) at 40°C (104°F)

Sterilization Methods

Gamma irradiation < 50 kGy

Autoclaving 20 minutes at 121°C (250°F)

Simple & Fast Operation Principle The Opta® SFT Sterile Connector consists of a female and a male coupling body that once assembled create the sterile fluid path via an easy 3-step operation. The removal of the protective plastic caps attached to each coupling prepares for assembly. After sliding the male and female coupling heads together, the sterile barrier membrane is pulled out to create the sterile fluid path. Finally, the locking collar is screwed into place. The Opta® SFT Sterile Connector is now ready for the sterile fluid transfer.

Operating Sequences

1. Remove protective cap and connect the Opta® SFT male and female connectors – correct connection validated by a click

2. Remove membranes

3. Screw the collar – correct screwing validated by a click

Transfer fluid

262 Connections

IntegrationAll Opta® SFT-I connectors can be integrated into custom Sartorius Stedim Biotech assembly including a full range of additional disposable components.

Opta® SFT-I are pre-assembled to bags, filters and tubing and then Gamma sterilised to offer a ready to use solution. They can also be assembled on tubing and filtration sets without Gamma sterilisation to offer ready to autoclave solutions to end users when autoclaving is required in the process.

100% Integrity TestedAll Opta® SFT Sterile Connectors are 100% integrity tested to assure the highest quality for critical applications like sterile fluid transfer.

QualificationOpta® SFT Sterile Connector has been qualified applying the most stringent and innovative test regimes. Biological, chemical and physical tests combined with extensive extractable testing provide users of Opta® SFT sterile connectors with data representing a variety of processing conditions. Full com-pliance with ISO11137 allows for a validated claim of sterility on all Sartorius Stedim Biotech single-use products with a sterility assurance level of 10-6 over the shelf life.

Opta® SFT Sterile Connectors are tested for compliance to:

– USP : Bacterial Endotoxin testing

– USP : Biological reactivity tests, in Vitro

– USP : Biological reactivity tests, in Vivo

– USP : Tests for plastic

– USP : pH and conductivity

– USP and E.P. 2.9.19: Particulate

– ISO 11737: Bioburden

– ISO 11137: Sterilization of Medical Devices

Details on methodologies and equipment used as well as further tests performed are available in the Validation Guide.

Gamma sterilised

Gamma sterilised

Customer process

Ready to autoclave

Gamma sterilised Gamma sterilised


Sterile Fluid Transfer ValidationOpta® SFT Sterile Connectors has been validated to provide a sterile fluid transfer path under worst case conditions. In order to provide the assurance that the Opta® SFT can provide a sterile fluid path in your process, a comprehensive validation, including immer-sion of the male and female connector bodies in a bacterial suspension prior to connection, followed by the transfer and subsequent incubation of growth promotion medium has been performed. Complete details of this validation are available in our validation guide.

ApplicationsOpta® SFT Sterile Connectors are used to create a sterile fluid path between two pre-sterilized components in classified as well as non classified production environments. All operations in Up – and Downstream Process-ing that are using single-use or hybrid equip-ment can benefit from the Opta® SFT Sterile Connector from Sartorius Stedim Biotech.

Quality AssuranceSartorius Stedim Biotech Quality Systems for Single-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.

Security of SupplySartorius Stedim Biotech has established multiple manufacturing sites with consistentindustrial processes for its fully integrated disposable assemblies. 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.

Ordering Information

Part Number to be Specified in FMT Assembly Specifications

Description

640MS014M OPTA® SFT-I Sterile Connector, 1/4” Hose Barb, Male Small Connector Body

640FS014M OPTA® SFT-I Sterile Connector, 1/4” Hose Barb, Female Small Connector Body





640ML012M OPTA® SFT-I Sterile Connector, 1/2” Hose Barb, Male, Large Connector Body

640FL012M OPTA® SFT-I Sterile Connector,1/2” Hose Barb, Female, Large Connector Body

640ML034M OPTA® SFT-I Sterile Connector, 3/4” Hose Barb, Male, Large Connector Body

640FL034M OPTA® SFT-I Sterile Connector, 3/4“ Hose Barb, Female, Large Connector Body

Product Code Description Pack Size640MS014M---D OPTA® SFT-I Sterile Connector, 1/4“ Hose Barb, Male 10

Small Connector Body, For assembly with silicone tubing.640FS014M---D OPTA® SFT-I Sterile Connector, 1/4“ Hose Barb, Female 10

Small Connector Body, For assembly with silicone tubing.640MS038M---D OPTA® SFT-I Sterile Connector, 3/8“ Hose Barb, Male 10


Small Connector Body, For assembly with silicone tubing.640MS012M---D OPTA® SFT-I Sterile Connector, 1/2“ Hose Barb, Male 10


Small Connector Body, For assembly with silicone tubing.640ML012M---D OPTA® SFT-I Sterile Connector, 1/2“ Hose Barb, Male, 10

Large Connector Body, For assembly with silicone tubing. 640FL012M---D OPTA® SFT-I Sterile Connector, 1/2“ Hose Barb, Female, 10

Small Connector Body, For assembly with silicone tubing.640ML034M---D OPTA® SFT-I Sterile Connector, 3/4“ Hose Barb, Male, 10

Large Connector Body, For assembly with silicone tubing. 640FL034M---D OPTA® SFT-I Sterile Connector, 3/4“ Hose Barb, Female, 10

Small Connector Body, For assembly with silicone tubing.641MS014M---D OPTA® SFT-D Sterile Connector, Male Small Connector 10

Body, 1/4“ Hose Barb, For assembly with TPE tubing641FS014M---D OPTA® SFT-D Sterile Connector, Female Small Connector 10

Body, 1/4“ Hose Barb, For assembly with TPE tubing641MS038M---D OPTA® SFT-D Sterile Connector, Male Small Connector 10


Body, 3/8“ Hose Barb, For assembly with TPE tubing641MS012M---D OPTA® SFT-D Sterile Connector, Male Small Connector 10


Body, 1/2“ Hose Barb, For assembly with TPE tubing

264 Flexboy® Bags

DescriptionStandard Flexboy® Bioprocessing bags are designed for the preparation, storage and transport of biopharmaceutical solutions, intermediates and final bulk products. They provide a single-use alternative to traditional glass, stainless steel and rigid plastic carboys in a large variety of applications.

ApplicationsThe broad chemical compatibility of Flexboy® Bags assures the safe processing of a wide range of biopharmaceutical fluids in a variety of applications:

– Buffers and Media sterile filtration & storage

– Bulk Harvest

– Product pooling

– Fraction collection

– Sample collection

– Bulk intermediate hold

– Final Product transport

Cost Reduction and Risk ReductionSingle-Use Systems used in biopharmaceuti-cal manufacturing improve process safety as they reduce the risk of cross contamination from batch-to-batch and product-to-prod-uct. Cost and time consuming CIP & SIP oper-ations are minimized. This results not only in significant cost savings within the entire manufacturing process, but also in the optimization of capacity utilization.

FlexibilityStandard Flexboy® bags are available as stand-alone bags and filter & bag assemblies incorporating a variety of filter and bag sizes allowing easy adaptation to process volume and media. Multiple configurations that also integrate thermoweldable TPE tubing are provided for flexible incorporation into your process. Thus, sterile connection and disconnection devices like the BioWelder® and the BioSealer® can be used to allow safe connections and disconnections from and to another process step.

Female luer fittings with a needle-free sampling port allow easy and convenient sampling, quick connects may be attached directly or adapted to a variety of connec-tions and mini triclamps that are constantly used in industrial environment assure maximum flexibility.

Easy ImplementationStandard Flexboy® Bags are available in bag chamber volumes between 5 mL and 50 L. They are supplied sterilized and ready to use. This allows an easy and convenient process implementation. A series of associated systems such as Flexboy® Trays and Racks facilitate an easy bag handling. Sartorius Stedim Biotech supports users already at the design & implementation phase of a new production facility with the most comprehen-sive support program that ensures successful design implementation of Single-Use Manufacturing.

Features Benefits

Multiple High security of supply manufacturing sites

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

Standard Flexboy® Bioprocessing Bags



Specifications

Bag Chamber Multiple Film Construction, EVA Fluid Contact Layer

Tubing EVA, TPE

Fittings Female Luer Lock, MPC Male Coupling, Mini Triclamp, Needle free sampling port

Filters Sartopore® 2 Gamma Filter Capsule

Number of Ports 3 (except for 5 mL: 1 Port)

Volumes 5 mL –50 L

Sterilization by Gamma Irradiation

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

ValidationFlexboy® 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 Flexboy® 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 AssuranceSartorius Stedim Biotech Quality Systems for Single-Use Products follow applicable ISO and FDA regulations for Medical Devices. Design, Manufacture and Sterilization pro-cesses are conducted under conditions that mirror biopharmaceutical operations and meet cGMP requirements. Flexboy® bags are tested for compliance to:






– ISO 11137: Sterilization of Medical Devices Rapid SupplyThe majority of Standard Flexboy® storage systems are available from stock.

266 Flexboy® Bags

Dimensions 5 mL – 3 L Volume 5 mL 50 mL 150 mL 250 mL 500 mL 1 L 2 L 3 LLength (L) mm 70 134 205 230 241 299 319 381 (2.76“) (5.28“) (8.07“) (9.06“) (9.49“) (11.77“) (12.56“) (15.00“)

Width (W) mm 59 95 85 94 130 155 223 223 (2.32“) (3.74“) (3.35“) (3.70“) (5.12“) (6.10“) (8.78“) (8.78“)

Length inc. 110 231 302 327 338 396 416 478 Tubing (T) mm (4.33“) (9.09“) (11.89“) (12.88“) (13.31“) (15.59“) (16.39“) (18.82“)

Film Surface 21 143 275 329 452 707 1103 1346 Area cm2 (3.3 in²) (22.2 in2) (42,6 in2) (51.0 in2) (70.0 in2) (109.6 in2) (171.0 in2) (208.7 in2)

5 L – 50 L Volume 5 L 10 L 20 L 50 LLength (L) mm 376 (14.80“) 621 (24.45“) 654 (25.75“) 790 (31.10“)

Width (W) mm 332 (13.07“) 300 (11.81“) 431 (16.97“) 580 (22.83“)

Length inc. 473 (18.62“) 718 (28.27“) 749 (29.57“) 887 (34.92“) Tubing (T) mm

Film Surface 1929 3528 4826 8106 Area cm2 (299.0 in2) (546.9 in2) (748.0 in2) (1256.4 in2)


Ordering Information 1. Standard Flexboy® with EVA Tubes 1.1. Standard Flexboy® with EVA Tubes (5 mL with Luer® Lock Connection) (All Countries Except USA and Canada)

Part Number Description Tubing Bag Port 1 Bag Port 2 Bag Port 3 Qty/BoxFFB115270 Flexboy® 5 mL EVA 3/16“ + 1/4“ + 5 cm (2“) NA NA 100 Female LL + plug, slide clamp

1.2. Standard Flexboy® with EVA Tubes (50 mL to 3 L with Luer Lock Connection)

Part Number Description Tubing Bag Port 1 Bag Port 2 Bag Port 3 Qty/BoxFFB102603 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



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 1.3. Standard Flexboy® with EVA Tubes (50 mL to 3 L with Luer Lock Connection) (USA and Canada) Part Number Description Tubing Bag Port 1 Bag Port 2 Bag Port 3 Qty/BoxFFB207567 Flexboy® 50 ml EVA 1/4“ + 5/16“ + 10 cm (4“) 1/4“ + 5/16“ + 10 cm (4“) 3/16“ + 1/4“ + 5 cm 50 LL male + Cap, pinch clamp LL female + Cap, pinch clamp (1,97 in.) + septum







268 Flexboy® Bags

Ordering Information (All Countries)

1.4. Standard Flexboy® with EVA Tubes (50 mL to 3 L with MPC Connection)

Part Number Description Tubing Bag Port 1 Bag Port 2 Bag Port 3 Qty/BoxFFB102640 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 MPC male + dust cap, pinch clamp MPC male + dust cap, pinch clamp (1,97 in.) + septum





Ordering Information 1.5. Standard Flexboy® with EVA Tubes (5 L to 50 L with MPC Connection) (All Countries Except USA and Canada)

Part Number Description Tubing Bag Port 1 Bag Port 2 Bag Port 3 Qty/BoxFFB102025 Flexboy® 5 liter EVA 3/8‘‘ + 15/32‘‘ + 10 cm (4“) 3/8‘‘ + 15/32‘‘ + 10 cm (4“) 3/16“ + 1/4“ + 5 cm 20 MPC Male + dust cap, slide clamp MPC Male + dust cap, slide clamp (1,97 in.) + septum

FFB101974 Flexboy® 10 liter EVA 3/8‘‘ + 15/32‘‘ + 10 cm (4“) 3/8‘‘ + 15/32‘‘ + 10 cm (4“) 3/16“ + 1/4“ + 5 cm 20 MPC Male + dust cap, slide clamp MPC Male + dust cap, slide clamp (1,97 in.) + septum



1.6. Standard Flexboy® with EVA Tubes (5 L to 50 L with MPC Connection) (USA and Canada) Part Number Description Tubing Bag Port 1 Bag Port 2 Bag Port 3 Qty/BoxFFB207582 Flexboy® 5 liter EVA 3/8‘‘ + 15/32‘‘ + 10 cm (4“) 3/8‘‘ + 15/32‘‘ + 10 cm (4“) 3/16“ + 1/4“ + 5 cm 20 MPC Male + dust cap, slide clamp MPC Male + dust cap, slide clamp (1,97 in.) + septum




270 Flexboy® Bags

Ordering Information (All Countries) 2. Standard Flexboy® with TPE Tubes 2.1.Standard Flexboy® with TPE Tubes (150 mL)

Part Number Description Tubing Bag Port 1 Bag Port 2 Bag Port 3 Qty/BoxFFB110898 Flexboy® 150 ml EVA 1/8“ + 1/4“ + 50 cm (20“) 1/8“ + 1/4“ + 50 cm (20“) EVA port tube 50 + Clear C-Flex 374 LL female LL female + slide clamp + needle free sampling port, + needle free sampling port, + LL female dust cap, pinch clamp dust cap, pinch clamp + needle free sampling port, dust cap

2.2. Standard Flexboy® with TPE Tubes (1 L to 3 L)

Part Number Description Tubing Bag Port 1 Bag Port 2 Bag Port 3 Qty/BoxFFB110900 Flexboy® 1000 ml EVA 1/4‘‘ + 7/16‘‘ + 50 cm (20“) 1/4“ + 7/16“ + 50 cm (20“) 1/8“ + 1/4“ + 50 cm (20“) 20 + Clear C-Flex 374 3/4“ Triclamp, MPC Male + sealing cap, LL female pinch clamp pinch clamp + needle free sampling port, pinch clamp

FFB110902 Flexboy® 3000 ml EVA 1/4‘‘ + 7/16‘‘ + 50 cm (20“) 1/4“ + 7/16“ + 50 cm (20“) 1/8“ + 1/4“ + 50 cm (20“) 20 + Clear C-Flex 374 3/4“ Triclamp, MPC Male + sealing cap, LL female pinch clamp pinch clamp + needle free sampling port, pinch clamp


Ordering Information (All Countries) 2.3. Standard Flexboy® with TPE Tubes (5 L to 50 L)

Part Number Description Tubing Bag Port 1 Bag Port 2 Bag Port 3 Qty/BoxFFB110904 Flexboy® 5 liter EVA 3/8“ + 5/8“ + 50 cm (20“) 3/8‘‘ + 5/8‘‘ + 50 cm (20“) 1/8“ + 1/4“ + 50 cm (20“) 20 + Clear C-Flex 374 3/4“ Triclamp, MPC Male + sealing cap, LL female pinch clamp pinch clamp + needle free sampling port, pinch clamp

FFB110905 Flexboy® 10 liter EVA 3/8“ + 5/8“ + 50 cm (20“) 3/8‘‘ + 5/8‘‘ + 50 cm (20“) 1/8“ + 1/4“ + 50 cm (20“) 20 + Clear C-Flex 374 3/4“ Triclamp, MPC Male + sealing cap, LL female pinch clamp pinch clamp + needle free sampling port, pinch clamp



272 Flexboy® Bags


3. Standard Flexboy® with TPE Tubes & Sartopore® 2 Gamma Capsules

3.1. Standard Flexboy® with TPE Tubes (1 L to 3 L)

Part Number Description Tubing Bag Port 1 Bag Port 2 Bag Port 3 Qty/BoxFFB110908 Flexboy® 1000 ml EVA 1/4“ + 7/16“ + 50 cm (20“) 1/4‘‘ + 7/16‘‘ + 50 cm (20“) 1/8“ + 1/4“ + 50 cm (20“) 20 + Clear C-Flex 374 5441307H4G-OO, 3/4“ Triclamp, LL female Sartopore 2, 0.2 μm, pinch clamp + needle free sampling port, filter inlet: pinch clamp 1/4“ stepped Hose Barb filter outlet: 1/4“ stepped Hose Barb; 150 cm2, pinch clamp

FFB110909 Flexboy® 3000 ml EVA 1/4“ + 7/16“ + 50 cm (20“) 1/4‘‘ + 7/16‘‘ + 50 cm (20“) 1/8“ + 1/4“ + 50 cm (20“) 20 + Clear C-Flex 374 5441307H4G-OO, 3/4“ Triclamp, LL female Sartopore 2, 0.2 μm, pinch clamp + needle free sampling port, filter inlet: pinch clamp 1/4“ stepped Hose Barb filter outlet: 1/4“ stepped Hose Barb; 150 cm2, pinch clamp



3.2.Standard Flexboy® with TPE Tubes (5 L to 50 L)

Part Number Description Tubing Bag Port 1 Bag Port 2 Bag Port 3 Qty/BoxFFB110910 Flexboy® 5 liter EVA 3/8‘‘ + 5/8‘‘ + 50 cm (20“) 3/8“ + 5/8“ + 50 cm (20“) 1/8“ + 1/4“ + 50 cm (20“) 20 + Clear C-Flex 374 5441307H5G-OO, 3/4“ Triclamp, LL female Sartopore 2, 0.2 μm, pinch clamp + needle free sampling port, filter inlet: pinch clamp 1/4“ stepped Hose Barb filter outlet: 1/4“ stepped Hose Barb; 300 cm2, pinch clamp

FFB110911 Flexboy® 10 liter EVA 3/8‘‘ + 5/8‘‘ + 50 cm (20“) 3/8“ + 5/8“ + 50 cm (20“) 1/8“ + 1/4“ + 50 cm (20“) 20 + Clear C-Flex 374 5441307H5G-OO, 3/4“ Triclamp, LL female Sartopore 2, 0.2 μm, pinch clamp + needle free sampling port, filter inlet: pinch clamp 1/4“ stepped Hose Barb filter outlet: 1/4“ stepped Hose Barb; 300 cm2, pinch clamp

FFB110912 Flexboy® 20 liter EVA 3/8‘‘ + 5/8‘‘ + 50 cm (20“) 3/8“ + 5/8“ + 50 cm (20“) 1/8“ + 1/4“ + 50 cm (20“) 10 + Clear C-Flex 374 5441307H5G-OO, 3/4“ Triclamp, LL female Sartopore 2, 0.2 μm, pinch clamp + needle free sampling port, filter inlet: pinch clamp 1/4“ stepped Hose Barb filter outlet: 1/4“ stepped Hose Barb; 300 cm2, pinch clamp

FFB110913 Flexboy® 50 liter EVA 1/2‘‘ + 3/4‘‘ + 50 cm (20“) 3/8“ + 5/8“ + 50 cm (20“) 1/8“ + 1/4“ + 50 cm (20“) 10 + Clear C-Flex 374 5441307H7G-SM, 3/4“ Triclamp, LL female Sartopore 2, 0.2 μm, pinch clamp + needle free sampling port, filter inlet: pinch clamp

1.5“ Sanitary flange filter outlet: 5/8“ Hose Barb;500 cm2, pinch clamp

FFB110915 Flexboy® 50 liter EVA 1/2‘‘ + 3/4‘‘ + 50 cm (20“) 3/8“ + 5/8“ + 50 cm (20“) 1/8“ + 1/4“ + 50 cm (20“) 10 + Clear C-Flex 374 5441358K7G-SM, 3/4“ Triclamp, LL female Sartopore 2, 0.1 μm, pinch clamp + needle free sampling port, filter inlet: pinch clamp

1.5“ Sanitary flangefilter outlet: 5/8“ Hose Barb;500 cm2, pinch clamp

274 Flexboy® Bags

DescriptionThe Flexboy® Tray and Rack Systems are designed to facilitate handling of both individual and manifold Flexboy® Single-Use Bioprocessing Bags (5 L–20 L) within bio-pharmaceutical manufacturing processes.

ApplicationsThe Flexboy® Tray and Rack Systems are designed to support Flexboy bags for the safe processing & transfer of a wide range of biopharmaceutical fluids in applications such as:

– Buffer and Media storage

– Bulk harvest

– Product pooling



– Bulk intermediate hold

– Final product transport

FlexibilityThe modular Tray and Rack System offers the possibility to expand the system according to process needs. Swivel wheels integrated in the rack allow individual or manifold Flexboy® bags to be easily moved around the facility.

Additional rack systems focused on specific application demands are available upon request.

SafetySmooth finish and integrated handles make the system both user friendly and safe. This allows reliable stacking of additional modules by maintaining highest safety levels. Technology Integration SupportSartorius Stedim Biotech supports users already at the design & implementation phase of a new production facility with the most comprehensive support program that ensures successful design implementation and validation of Single-Use Manufacturing.

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

Quality Assurance The Flexboy® Tray and Rack Systems are designed, developed and manufactured in accordance with a ISO 9001 certified Quality Management System. They undergo extensive testing before shipping.

Available from StockFlexboy® Tray and Rack Systems are available from stock.

Flexboy® Tray and Rack System


Specifications

Specifications Tray & Lid

Material Stainless Steel 304L

Surface Finish Bead Blasted

Volumes 5 L, 10 L and 20 L Dimensions

5 L 475+330+117 mm (18.7“+12.9“+4.6“)

10 L 760+330+117 mm (29.9“+12.9“+4.6“)

20 L 770+404+170 mm (30“+15.9“+6.7“)

Weight of Tray|bag & Lid (Bag filled to nominal volume)

5 L 8.6 kg

10 L 15.7 kg

20 L 28.6 kg

Base Module 1 Additional Module 2 Full System

Material Stainless steel 304 Stainless steel 304 Stainless steel 304

Surface finish Blast Blast Blast

Weight 30.5 kg 26 kg 82.5 kg

Flexboy® tray 2 places for 20 L 4 places for 20 L 10 places for 20 L compartments Trays or 4 places for Trays or 8 places for Trays or 20 places for 5 or 10 L Trays 5 or 10 L Trays 5 or 10 L Trays

Peristaltic pumps Yes – Dimension: No Yes – Dimension: Compartment 887+775+300 mm 887+775+300 mm (34.9“+30.5“+11.8“) (34.9“+30.5“+11.8“)

Wheels 4 swivel wheels – 4 swivel wheels (two with brakes) (two with brakes)

Additional features Built in wheels – Full = 1 base + 2 (non autoclavable) additional modules

Ordering Information Order Code Description

Flexboy® Racks

FFA102707 Flexboy® Rack|Base Module 1

FFA102714 Flexboy® Rack|Module 2 Flexboy® Trays

FFA102705 Flexboy® Tray + Lid 5 L



Please note: Custom versions are available upon request.

Base module 1H: 772 mm+L: 887 mm+W: 775 mm (30.4“+34.9“+30.5“)

Module 2H: 640 mm+L: 887 mm+W: 775 mm (25.2“+34.9“+30.5“)

Full versionH: 1980 mm+L: 887 mm+W: 775 mm (77.9“+34.9“+30.5“)

276 Flexel® 3D Bags

Description Flexel® 3D standard bags are designed for processing, storage and transport of large volume biopharmaceutical solutions in Sartorius Stedim Biotech’s proven Palletank® containers. They provide a single-use alterna-tive to traditional stainless steel vessels in a large variety of applications.

Cost Reduction and Risk ReductionSingle-use systems used in biopharmaceutical manufacturing improve process safety as they reduce the risk of cross contamination from batch-to-batch and product-to-product. Costly and time consuming CIP & SIP opera-tions are minimized. This results not only in significant cost savings within the entire manufacturing process, but also in the optimization of capacity utilization.

ApplicationsThe multi-layer film construction of different materials provides a strong structure with low gas permeability and high chemical resistance for the safe processing of a wide range of biopharmaceutical fluids in a variety of applications such as:

– Buffers and media filtration & storage

– Bulk harvest

– Product pooling



– Bulk intermediate filtration & hold

– Final product storage and transport

FlexibilityStandard Flexel® 3D bags are available as stand-alone bags with silicone tubing, stand-alone bags with C-Flex tubing and filter & bag assemblies incorporating a variety of filter and bag sizes allowing easy adoption to process volume and media. Multiple configu-rations that also integrate thermoweldable TPE tubing are provided for flexible incor-poration into your process. Thus, sterile con-nection and disconnection devices like the BioWelder® and the BioSealer® can be used to allow safe connections and disconnections from and to another process step.

Female luer fittings with a needle free sampling port may be used for easy and convenient sampling, quick connects may be attached directly or adapted to a variety of connections and tri-clamps that are widely used in a production environment assure maximum flexibility.

Fast OperationThe new defined range of standard Flexel® 3D bag systems incorporates 1,000 L standard bag solutions that enable the user to empty the bags quickly through a 3” ID tubing.

Features Benefits

Multiple manu- High security of supply facturing sites




Designed to fit Market leading Palletank® space saving bag

containment system

3” ID bottom drain Quick transfer of process fluid

Various bag & filter High flexibilitysizes

Standard Flexel® 3D Bioprocessing Bags for Palletank®



Specifications

Standard Flexel® 3D for Palletank®

Bag Chamber Multiple layer film construction, including EVOH gas barrier layer ULDPE contact layer

Tubing Silicone, TPE

Fittings MPX Couplings, Female Luer Lock, MPC Male Coupling, Triclamp, Needle-less sampling port

Filters Sartopore® 2 Gamma Filter Capsule

Volumes 100 L–1,000 L

Number of Ports Standard silicone: 100 L–1,000 L: 3 (2 top, 1 bottom)

Standard TPE: 100 L–1,000 L: 4 (3 top, 1 bottom)

Standard TPE & Sartopore® 2: 100 L–1,000 L: 4 (3 top, 1 bottom)


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

Validation Flexel® bags have been qualified applying the most comprehensive and innovative test regimes. Biological, chemical and physical tests combined with extensive extractable testings provide users of Flexel® 3D bags with data representing the widest range of process fluids in a variety of processing conditions.

Full compliance with ISO11137 allows for a validated claim of sterility on all Sartorius Stedim Biotech single-use products with a sterility assurance level of 10-6 over the shelf life.

Quality AssuranceSartorius Stedim Biotech Quality Systems for Single-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. Flexel® 3D bags for Palletank® are tested for compliance to:







Supply ChainThe majority of standard Flexel® 3D bags for Palletank® systems are available from stock.


Ordering Information (All Countries Except USA and Canada)

1. Standard Flexel® 3D Bags with Silicone Tubes

Standard Flexel® 3D bags with silicone tubes (100 L to 500 L) Standard Flexel® 3D bags with silicone tubes (1,000 L)

Part Number Description Tubing Top Port 1 Top Port 2 Bottom Port 1 Qty/BoxFXB103341 Flexel® 100 L Silicone 1/2“ + 11/16“ + 0.5 m (20“) 1/2“ + 11/16“ + 0.5 m (20“) 1/2“ + 11/16“ + 0.5 m (20“) 5 for Palletank® 1/2“ MPX male + sealing cap 1/2“ MPX male + sealing cap 1/2“ MPX male – Silicone + sealing cap

FXB103364 Flexel® 200 L Silicone 1/2“ + 11/16“ + 0.5 m (20“) 1/2“ + 11/16“ + 0.5 m (20“) 1/2“ + 11/16“ + 0.5 m (20“) 5 for Palletank® 1/2“ MPX male + sealing cap 1/2“ MPX male + sealing cap 1/2“ MPX male – Silicone + sealing cap

FXB103376 Flexel® 500 L Silicone 1/2“ + 11/16“ + 0.5 m (20“) 1/2“ + 11/16“ + 0.5 m (20“) 1/2“ + 11/16“ + 0.5 m (20“) 5 for Palletank® 1/2“ MPX male + sealing cap 1/2“ MPX male + sealing cap 1/2“ MPX male – Silicone + sealing cap

Part Number Description Tubing Top Port 1 Top Port 2 Bottom Port 1 Bottom Port 2 Qty/BoxFXB103426 Flexel® 1000 L Silicone 1/2“ + 11/16“ + 1.5 m 1/2“ + 11/16“ + 1.5 m 1/2“ + 11/16“ + 1 m Plug 5 for Palletank® (60“) (60“) (40“) – Silicone 1/2“ MPX male 1/2“ MPX male 1/2“ MPX male + sealing cap + sealing cap + sealing cap


Ordering Information (USA and Canada)

1. Standard Flexel® 3D Bags with Silicone Tubes

Standard Flexel® 3D bags with silicone tubes (100 L to 500 L) Standard Flexel® 3D bags with silicone tubes (1,000 L)

Part Number Description Tubing Top Port 1 Top Port 2 Bottom Port 1 Qty/BoxFXB207591 Flexel® 100 L Silicone 1/2“ + 11/16“ + 1.5 m (60“), 1/2“ + 11/16“ + 1.5 m (60“), 1/2“ + 11/16“ + 1 m (40“) 10 for Palletank® 1/2“ MPX female + sealing plug 1/2“ MPX female + sealing plug 1/2“ MPX male with GammaTag™ + sealing cap

FXB207592 Flexel® 200 L Silicone 1/2“ + 11/16“ +1.5 m (60“), 1/2“ + 11/16“ + 1.5 m (60“), 1/2“ + 11/16“ + 1 m (40“), 10 for Palletank® 1/2“ MPX female + sealing plug 1/2“ MPX female + sealing plug 1/2“ MPX male with GammaTag™ + sealing cap

FXB207593 Flexel® 500 L Silicone 1/2“ + 11/16“ + 1.5 m (60“), 1/2“ + 11/16“ + 1.5 m (60“), 1/2“ + 11/16“ + 1 m (40“), 3 for Palletank® 1/2“ MPX female + sealing plug 1/2“ MPX female + sealing plug 1/2“ MPX male with GammaTag™ + sealing cap

Part Number Description Tubing Top Port 1 Top Port 2 Bottom Port 1 Bottom Port 2 Qty/BoxFXB207595 Flexel® 1000 L Silicone 1/2“ + 11/16“ + 1.5 m 1/2“ + 11/16“ + 1.5 m 1/2“ + 11/16“ + 1 m 1/2“ + 11/16“ + 1 m 5 for Palletank® (60“) (60“) (40“) (40“) – Silicone 1/2“ MPX female 1/2“ MPX male 1/2“ MPX male 1/2“ MPX male + sealing plug + sealing plug + sealing cap + sealing cap

1

2

Bottom port

11

1

1

1

1

1

2

Bottom port 1Bottom port 2

11

1

1

1

1

1

1



2. Standard Flexel® 3D Bags with TPE Tubes

Standard Flexel® 3D bags with TPE tubes (100 L to 500 L) Standard Flexel® 3D bags with TPE tubes (1,000 L) Standard Flexel® 3D bags with TPE tubes High Flow Rate(1,000 L)

Part Number Description Tubing Top Port 1 Top Port 2 Top Port 3 Bottom Port 1 Qty/BoxFXB110925 Flexel® 100 L Silicone 1/2“ + 3/4“ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m 1/2“ + 3/4“ + 1.5 m 4 for Palletank® + Clear C-Flex® (60“) (60“) (40“) (60“) – PTE 374 1/2“ MPX male 1–1/2“ Tri-Clamp LL female + needle free 1–1/2“ Tri-Clamp + sealing cap sampling port

FXB110927 Flexel® 200 L Silicone 1/2“ + 3/4“ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m 1/2“ + 3/4“ + 1.5 m 2 for Palletank® + Clear C-Flex® (60“) (60“) (40“) (60“) – TPE 374 1/2“ MPX male 1–1/2“ Tri-Clamp LL female + needle free 1–1/2“ Tri-Clamp + sealing cap sampling port



FXB111157 Flexel® 1,000 L Silicone 1/2“ + 3/4“ + 1.5 m 3/4“ + 1-1/8“ + 1.5 m 1/8“ + 1/4“ + 1.1 m 3/4“ + 1-1/8“ + 1.5 m 2 for Palletank® + Clear C-Flex® (60“) (60“) (40“) (60“) – HIGH FLOW 374 1/2“ MPX male silicone LL female + needle free silicone – TPE + sealing cap 1-1/2“ Tri-Clamp sampling port 1-1/2“ Tri-Clamp



3. Standard Flexel® 3D Bags with TPE Tubes and Sartopore® 2 Gamma MidiCaps

Standard Flexel® 3D bags with TPE tubes and Standard Flexel® 3D bags with TPE tubes and Standard Flexel® 3D bags with TPE tubes and Sartopore® 2 Gamma MidiCaps (100 L to 500 L) Sartopore® 2 Gamma MaxiCaps (1,000 L) Sartopore® 2 Gamma MaxiCaps - High Flow rate (1,000 L)

Standard Flexel® 3D Bags with TPE Tubes and Sartopore® 2 Gamma MidiCaps, 0.2 μm (100 L to 500 L)

Part Number Description Tubing Top Port 1 Top Port 2 Top Port 3 Bottom Port 1 Qty/BoxFXB110962 Flexel® 100 L Silicone 1/2“ + 3/4“ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m 1/2“ + 3/4“ + 1.5 m 3 for Palletank® + Clear C-Flex® (60“) (60“) (40“) (60“) – TPE 374 Sartopore® 2 Gamma, 1–1/2“ Tri-Clamp LL female + needle free 1–1/2“ Tri-Clamp – Sartopore® 2 MidiCaps size 8, sampling port – Gamma 0.2 μm, filter inlet 1.5“ sanitary flange 1,000 cm2

FXB110964 Flexel® 200 L Silicone 1/2“ + 3/4“ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m 1/2“ + 3/4“ + 1.5 m 2 for Palletank® + Clear C-Flex® (60“) (60“) (40“) (60“) – TPE 374 Sartopore® 2 Gamma, 1–1/2“ Tri-Clamp LL female + needle free 1–1/2“ Tri-Clamp – Sartopore® 2 MidiCaps size 9, sampling port – Gamma 0.2 μm, filter inlet 1.5“ sanitary flange 2,000 cm2



Ordering Information (All Countries) Standard Flexel® 3D Bags with TPE Tubes and Sartopore® 2 Gamma MidiCaps, 0.1 μm (100 L to 500 L) Part Number Description Tubing Top Port 1 Top Port 2 Top Port 3 Bottom Port 1 Qty/BoxFXB110975 Flexel® 100 L Silicone 1/2“ + 3/4“ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m 1/2“ + 3/4“ + 1.5 m 3 for Palletank® + Clear C-Flex® (60“) (60“) (40“) (60“) – TPE 374 Sartopore® 2 Gamma, 1–1/2“ Tri-Clamp LL female + needle free 1–1/2“ Tri-Clamp – Sartopore® 2 MidiCaps size 8, sampling port – Gamma 0.1 μm, filter inlet 1.5“ sanitary flange 1,000 cm2



Standard Flexel® 3D Bags with TPE Tubes and Sartopore® 2 Gamma MaxiCaps, 0.2 and 0.1 μm (1,000 L) Part Number Description Tubing Top Port 1 Top Port 2 Top Port 3 Bottom Port 1 Qty/BoxFXB110967 Flexel® 1,000 L Silicone 1/2“ + 3/4“ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m 1/2“ + 3/4“ + 1.5 m 1 for Palletank® + Clear C-Flex® (60“) (60“) (40“) (60“) – TPE 374 Sartopore® 2 Gamma, 1–1/2“ Tri-Clamp LL female + needle free 1–1/2“ Tri-Clamp – Sartopore® 2 MaxiCaps size 2, sampling port – Gamma 0.2 μm, filter inlet 1.5“ sanitary flange 1.2 m2

FXB110978 Flexel® 1,000 L Silicone 1/2“ + 3/4“ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m 1/2“ + 3/4“ + 1.5 m 1 for Palletank® + Clear C-Flex® (60“) (60“) (40“) (60“) – TPE 374 Sartopore® 2 Gamma, 1–1/2“ Tri-Clamp LL female + needle free 1–1/2“ Tri-Clamp – Sartopore® 2 MaxiCaps size 2, sampling port – Gamma 0.1 μm, filter inlet 1.5“ sanitary flange 1.2 m2


Ordering Information (All Countries) Standard Flexel® 3D Bags with TPE Tubes and Sartopore® 2 Gamma MaxiCaps (1,000 L - High Flow Rate) Part Number Description Tubing Top Port 1 Top Port 2 Top Port 3 Bottom Port 1 Qty/BoxFXB111153 Flexel® 1,000 L Silicone 1/2“ + 3/4“ + 1.5 m 3/4“ + 1-1/8“ + 1.5 m 1/8“ + 1/4“ + 1.1 m 3/4“ + 1-1/8“ + 1.5 m 1 for Palletank® + Clear C-Flex® (60“) (60“) (40“) (60“) HIGH FLOW 374 Sartopore® 2 Gamma, silicone LL female + needle free silicone – TPE MaxiCaps size 2, 1-1/2“ Tri-Clamp sampling port 1-1/2“ Tri-Clamp – Sartopore® 2 0.2 μm, filter inlet 1.5“ – Gamma sanitary flange 1.2 m2

FXB111154 Flexel® 1,000 L Silicone 1/2“ + 3/4“ + 1.5 m 3/4“ + 1“ + 1.5 m 1/8“ + 1/4“ + 1.1 m 3/4“ + 1“ + 1.5 m 1 for Palletank® + Clear C-Flex® (60“) (60“) (40“) (60“) HIGH FLOW 374 Sartopore® 2 Gamma, 1–1/2“ Tri-Clamp LL female + needle free 1–1/2“ Tri-Clamp – TPE MaxiCaps size 2, sampling port Silicone – Sartopore® 2 0.1 μm, filter inlet 1.5“ – Gamma sanitary flange 1.2 m2


DescriptionFlexel®3D standard bags are designed for processing, storage and transport of large volume biopharmaceutical solutions in drums. They provide a single-use alternative to traditional stainless steel vessels in a large variety of applications.

Cost Reduction and Risk ReductionSingle-use Systems used in biopharmaceutical manufacturing improve process safety as they reduce the risk of cross contamination from batch-to-batch and product-to-product. Costly and time consuming CIP & SIP opera-tions are minimized. This results not only in significant cost savings within the entire manufacturing process, but also in the optimization of capacity utilization.

ApplicationsThe multi-layer film construction of different materials provides a strong structure with low gas permeability and high chemical resistance for the safe processing of a wide range of biopharmaceutical fluids in a variety of appli-cations such as:

– Buffers and Media filtration & storage

– Bulk harvest

– Product pooling




– Final product storage and transport

FlexibilityStandard Flexel® bags for drums are available as stand-alone bags with Silicone tubing, stand-alone bags with C-Flex tubing and Fil-ter & Bag assemblies incorporating a variety of filter and bag sizes allowing easy adoption to process volume and media. Multiple con-figurations that also integrate thermoweld-able TPE tubing are provided for flexible incorporation into your process. Thus, sterile connection and disconnection devices like the BioWelder® and the BioSealer® can be used to allow safe connections and disconnections from and to another process step.

Female luer fittings with a needle free sampling port may be used for easy and convenient sampling, quick connects may be attached directly or adapted to a variety of connections and tri-clamps that are widely used in a production environment assure maximum flexibility.

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

Features Benefits

Multiple High security of supply manufacturing sites




Various bag & High flexibility filter sizes

Standard Flexel® 3D Bioprocessing Bags for Drums



Specifications

Standard Flexel®3D for Drum

Bag Chamber Multiple layer film construction, including EVOH gas barrier layer, ULDPE Contact Layer


Fittings MPX Couplings, Female Luer Lock, MPC Male Coupling, Triclamp, Needle free sampling port

Filters Sartopore® 2 Gamma Capsule

Volumes 50 L – 560 L


Validation Flexel® bags have been qualified applying the most comprehensive and innovative test regimes. Biological, chemical and physical tests combined with extensive extractable testing provide users of Flexel® with data representing the widest range of process fluids in a variety of processing conditions.


Quality AssuranceSartorius Stedim Biotech Quality Systems for Single-Use Products follow applicable ISO and FDA regulations for Medical Devices. Design, Manufacture and Sterilization processes are conducted under conditions that mirror bio-pharmaceutical operations and meet cGMP requirements.

Flexel® 3D bags are tested for compliance to:






– ISO 11137: Sterilization of Medical devices

Supply ChainThe majority of Standard Flexel® 3D bags for drum systems are available from stock.


Ordering Information 1. Standard Flexel® 3D Bags for Drum with Silicone Tubes (All Countries Except USA and Canada) Part Number Description Tubing Top Port 1 Top Port 2 Top Port 3 Top Port 4 Qty/BoxFXB103162 Flexel® 50 L for Drum Silicone 1/2“ + 11/16“ + 0.5 m (20“) 1/2“ + 11/16“ + 0.5 m (20“) Plug Plug 5 – Silicone 1/2“ MPX male + sealing cap 1/2“ MPX male + sealing cap

FXB102464 Flexel® 100 L for Drum Silicone 1/2“ + 11/16“ + 0.5 m (20“) 1/2“ + 11/16“ + 0.5 m (20“) Plug Plug 5 – Silicone 1/2“ MPX male + sealing cap 1/2“ MPX male + sealing cap





FXB102508 Flexel® 1,000 L for Drum Silicone 1/2“ + 11/16“ + 0.5 m (20“) 1/2“ + 11/16“ + 0.5 m (20“) Plug Plug 5 – Silicone 1/2“ MPX male + sealing cap 1/2“ MPX male + sealing cap


Ordering Information (USA and Canada) 1. Standard Flexel® 3D Bags for Drum with Silicone Tubes Part Number Description Tubing Top Port 1 Top Port 2 Top Port 3 Top Port 4 Qty/BoxFXB207614 Flexel® 50 L for drum Silicone 1/2“ + 3/4“ + 0.75 m (30“), 1/2“ + 3/4“ + 0.75 m (30“), 1/8“ + 1/4“ + 0.45 Plug 10 - Silicone 1/2“ MPX male + sealing cap 1/2“ MPX female + sealing plug (30“) TPE, sealing plug

FXB207615 Flexel® 100 L for drum Silicone 1/2“ + 3/4“ + 0.75 m (30“), 1/2“ + 3/4“ + 0.75 m (30“), 1/8“ + 1/4“ + 0.45 Plug 10 - Silicone 1/2“ MPX male + sealing cap 1/2“ MPX female + sealing plug (30“) TPE, sealing plug



1

2

3


Ordering Information (All Countries) 2. Standard Flexel® 3D Bags for Drum with Silicone & TPE Tubes 2.1. Standard Flexel® 3D Bags for Drum with Silicone & TPE Tubes with Side Bottom Drain Part Number Description Tubing Top Port 1 Top Port 2 Top Port 3 Bottom Port 1 Qty/BoxFXB110917 Flexel® 50 L for Drum Silicone 1/2“ + 3/4“ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m (40“) 1/2“ + 3/4“ + 1.5 m 5 – TPE + Clear C-Flex® (60“) (60“) LL female (60“) 374 1/2“ MPX male 1-1/2“ Tri-Clamp + needle free 1-1/2“ Tri-Clamp + sealing cap sampling port

FXB110919 Flexel® 100 L for Drum Silicone 1/2“ + 3/4“ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m (40“) 1/2“ + 3/4“ + 1.5 m 5 – TPE + Clear C-Flex® (60“) (60“) LL female (60“) 374 1/2“ MPX male 1-1/2“ Tri-Clamp + needle free 1-1/2“ Tri-Clamp + sealing cap sampling port

FXB110920 Flexel® 200 L for Drum Silicone 1/2“ + 3/4“ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m (40“) 1/2“ + 3/4“ + 1.5 m. 5 – TPE + Clear C-Flex® (60“) (60“) LL female (60“) 374 1/2“ MPX male 1-1/2“ Tri-Clamp + needle free 1-1/2“ Tri-Clamp + sealing cap sampling port





Ordering Information (All Countries) 2.2. Standard Flexel® 3D Bags for Drum with Silicone & TPE Tubes Part Number Description Tubing Top Port 1 Top Port 2 Top Port 3 Bottom Port 1 Qty/BoxFXB110922 Flexel® 50 L for Drum Silicone 1/2“ + 3/4“ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m No bottom drain 5 – TPE + Clear C-Flex® 374 (60“) (60“) (40“) 1/2“ MPX male 1-1/2“ Tri-Clamp LL female + sealing cap + needle free sampling port

FXB110923 Flexel® 100 L for Drum Silicone 1/2“ + 3/4“ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m No bottom drain 5 – TPE + Clear C-Flex® 374 (60“) (60“) (40“) 1/2“ MPX male 1-1/2“ Tri-Clamp LL female + sealing cap + needle free sampling port

FXB110924 Flexel® 200 L for Drum Silicone 1/2“ + 3/4“ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m No bottom drain 5 – TPE + Clear C-Flex® 374 (60“) (60“) (40“) 1/2“ MPX male 1-1/2“ Tri-Clamp LL female + sealing cap + needle free sampling port


Ordering Information (All Countries) 3. Standard Flexel® 3D Bags for Drum with Silicone & TPE Tubes & Sartopore® 2 Gamma MidiCaps 3.1. Standard Flexel® 3D Bags for Drum with Silicone & TPE Tubes with Side Bottom Drain & Sartopore® 2 Gamma MidiCaps 0.2 μm (50 L to 370 L) Part Number Description Tubing Top Port 1 Top Port 2 Top Port 3 Bottom Port 1 Qty/BoxFXB110954 Flexel® 50 L for Drum Silicone 1/2‘‘ + 3/4‘‘ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m 1/2“ + 3/4“ + 1.5 m 5 – TPE + Clear C-Flex® (60“) (60“) (40“) (60“) – Sartopore® 2 Gamma 374 Sartopore® 2 Gamma, 1-1/2“ Tri-Clamp LL female 1-1/2“ Tri-Clamp MidiCaps size 7, + needle free 0.2 μm; filter inlet 1.5“ sampling port sanitary flange 500 cm2

FXB110958 Flexel® 100 L for Drum Silicone 1/2‘‘ + 3/4‘‘ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m 1/2“ + 3/4“ + 1.5 m 5 – TPE + Clear C-Flex® (60“) (60“) (40“) (60“) – Sartopore® 2 Gamma 374 Sartopore® 2 Gamma, 1-1/2“ Tri-Clamp LL female 1-1/2“ Tri-Clamp MidiCaps size 8, + needle free 0.2 μm; filter inlet 1.5“ sampling port sanitary flange 1000 cm2

FXB110960 Flexel® 200 L for Drum Silicone 1/2‘‘ + 3/4‘‘ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m 1/2“ + 3/4“ + 1.5 m 5 – TPE + Clear C-Flex® (60“) (60“) (40“) (60“) – Sartopore® 2 Gamma 374 Sartopore® 2 Gamma, 1-1/2“ Tri-Clamp LL female 1-1/2“ Tri-Clamp MidiCaps size 9, + needle free 0.2 μm; filter inlet 1.5“ sampling port sanitary flange 2000 cm2


Ordering Information (All Countries) 3.1. Standard Flexel® 3D Bags for Drum with Silicone & TPE Tubes with Side Bottom Drain & Sartopore® 2 Gamma MidiCaps 0.2 μm (50 L to 370 L) Part Number Description Tubing Top Port 1 Top Port 2 Top Port 3 Bottom Port 1 Qty/BoxFXB111629 Flexel® 300 L for Drum Silicone 1/2“ + 3/4“ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m 1/2“ + 3/4“ + 1.5 m 2 – TPE + Clear C-Flex® 374 (60“) (60“) (40“) (60“) – Sartopore® 2 Gamma filter inlet 1.5“ 1-1/2“ Tri-Clamp LL female 1-1/2“ Tri-Clamp sanitary flange + needle free Sartopore® 2 Gamma, sampling port MidiCaps size 9, 0.2 μm, 2000 cm2

FXB111633 Flexel® 370 L for Drum Silicone 1/2“ + 3/4“ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m 1/2“ + 3/4“ + 1.5 m 2 – TPE + Clear C-Flex® 374 (60“) (60“) (40“) (60“) – Sartopore® 2 Gamma filter inlet 1.5“ 1-1/2“ Tri-Clamp LL female 1-1/2“ Tri-Clamp sanitary flange + needle free Sartopore® 2 Gamma, sampling port MidiCaps size 9, 0.2 μm, 2000 cm2 3.2. Standard Flexel® 3D Bags for Drum with Silicone & TPE Tubes with Side Bottom Drain & Sartopore® 2 Gamma MidiCaps 0.1 μm (50 L to 370 L) Part Number Description Tubing Top Port 1 Top Port 2 Top Port 3 Bottom Port 1 Qty/BoxFXB110969 Flexel® 50 L for Drum Silicone 1/2‘‘ + 3/4‘‘ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m 1/2“ + 3/4“ + 1.5 m 5 – TPE + Clear C-Flex® 374 (60“) (60“) (40“) (60“) – Sartopore® 2 Gamma filter inlet 1.5“ 1-1/2“ Tri-Clamp LL female 1-1/2“ Tri-Clamp sanitary flange + needle free Sartopore® 2 Gamma, sampling port MidiCaps size 7, 0.1 μm, 500 cm2

FXB110971 Flexel® 100 L for Drum Silicone 1/2“ + 3/4“ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m 1/2“ + 3/4“ + 1.5 m 5 – TPE + Clear C-Flex® 374 (60“) (60“) (40“) (60“) – Sartopore® 2 Gamma filter inlet 1.5“ 1-1/2“ Tri-Clamp LL female 1-1/2“ Tri-Clamp sanitary flange + needle free Sartopore® 2 Gamma, sampling port MidiCaps size 8, 0.1 μm, 1000 cm2





Ordering Information (All Countries) 3.3. Standard Flexel® 3D Bags for Drum with Silicone & TPE Tubes & Sartopore® 2 Gamma MidiCaps 0.2 μm (50 L to 200 L) Part Number Description Tubing Top Port 1 Top Port 2 Top Port 3 Bottom Port 1 Qty/BoxFXB110955 Flexel® 50L Silicone 1/2‘‘ + 3/4‘‘ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m No bottom drain 5 – TPE + Clear C-Flex® 374 (60“) (60“) (40“) – Sartopore® 2 Gamma Sartopore® 2 Gamma, 1-1/2“ Tri-Clamp LL female MidiCaps size 7, + needle free 0.2 μm; sampling port filter inlet 1.5“ sanitary flange 500 cm2

FXB110959 Flexel® 100L Silicone 1/2‘‘ + 3/4‘‘ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m No bottom drain 5 – TPE + Clear C-Flex® 374 (60“) (60“) (40“) – Sartopore® 2 Gamma Sartopore® 2 Gamma, 1-1/2“ Tri-Clamp LL female MidiCaps size 8, + needle free 0.2 μm; sampling port filter inlet 1.5“ sanitary flange 1000 cm2

FXB110961 Flexel® 200L Silicone 1/2‘‘ + 3/4‘‘ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m No bottom drain 5 – TPE + Clear C-Flex® 374 (60“) (60“) (40“) – Sartopore® 2 Gamma Sartopore® 2 Gamma, 1-1/2“ Tri-Clamp LL female MidiCaps size 9, + needle free 0.2 μm; sampling port filter inlet 1.5“ sanitary flange 2000 cm2


Ordering Information (All Countries) 3.3. Standard Flexel® 3D Bags for Drum with Silicone & TPE Tubes & Sartopore® 2 Gamma MidiCaps 0.1 μm (50 L to 200 L) Part Number Description Tubing Top Port 1 Top Port 2 Top Port 3 Bottom Port 1 Qty/BoxFXB110970 Flexel® 50L Silicone 1/2‘‘ + 3/4‘‘ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m No bottom drain 5 – TPE + Clear C-Flex® 374 (60“) (60“) (40“) – Sartopore® 2 Gamma Sartopore® 2 Gamma, 1-1/2“ Tri-Clamp LL female MidiCaps size 7, + needle free

0.1 μm; sampling port filter inlet 1.5“ sanitary flange 500 cm2

FXB110972 Flexel® 100L Silicone 1/2“ + 3/4“ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m No bottom drain 5 – TPE + Clear C-Flex® 374 (60“) (60“) (40“) – Sartopore® 2 Gamma Sartopore® 2 Gamma, 1-1/2“ Tri-Clamp LL female

MidiCaps size 8, + needle free 0.1 μm; sampling port filter inlet 1.5“ sanitary flange 1000 cm2

FXB110974 Flexel® 200L Silicone 1/2“ + 3/4“ + 1.5 m 1/2“ + 3/4“ + 1.5 m 1/8“ + 1/4“ + 1.1 m No bottom drain 5 – TPE + Clear C-Flex® 374 (60“) (60“) (40“) – Sartopore® 2 Gamma Sartopore® 2 Gamma, 1-1/2“ Tri-Clamp LL female

MidiCaps size 9, + needle free 0.1 μm; sampling port filter inlet 1.5“ sanitary flange 2000 cm2


Ordering Information (All Countries) 4. Standard Flexel® Tank Liners for Drum 4.1. Standard Sterile Flexel® Tank Liners for Drum with Side Bottom Drain Part Number Description Tubing Bottom Port 1 Qty/BoxFXB110931 Flexel® 30 L liner – TPE Silicone + Clear C-Flex® 374 1/2“ + 3/4“ + 1.5 m (60“) 10 1-1/2“ Tri-Clamp

FXB110934 Flexel® 50 L liner – TPE Silicone + Clear C-Flex® 374 1/2“ + 3/4“ + 1.5 m (60“) 10 1-1/2“ Tri-Clamp






FXB110940 Flexel® 1,000 L liner – TPE Silicone + Clear C-Flex® 374 1/2“ + 3/4“ + 1.5 m (60“) 5 1-1/2“ Tri-Clamp


Ordering Information (All Countries Except USA and Canada) 4.2. Standard Flexel® Tank Liners for Drum Part Number Description Sterility Qty/BoxFXB102120 Flexel® 50 L liner Non sterile 20

FXB102116 Flexel® 100 L liner Non sterile 20





FXB111118 Flexel® 30 L liner Sterile 10







Ordering Information (USA and Canada) 4.2. Standard Flexel® Tank Liners for Drum Part Number Description Sterility Qty/BoxFXB207551 Flexel® 50 L liner Non sterile 20







FXB207558 Flexel® 1,000 L liner Non sterile 10








FXB207084 Flexel® 1,000 L liner Sterile 10


DescriptionStandard Scalable Flexel® 3D Bioprocessing Bags are designed for processing and storage of small volume biopharmaceutical solutions. They provide a single-use alternative to tradi-tional glass, stainless steel and rigid plastic carboys in a large variety of applications.With a volume range of 5 L to 50 L, the Standard Scalable Flexel® 3D Bags are rou-tinely used in bioresearch, process develop-ment and in small volume biomanufacturing. These bags are manufactured with very high quality standards for applications requiring remarkable levels of robustness, reliability and security.

Scaling-up operations to very large volume (up to 3000 L) is straightforward starting with Scalable Flexel® 3D Bags as they are manufactured with the same S40 film, same 3D bag technology and same port technology as the very large volume Flexel® 3D Bags.Standard Scalable Flexel® 3D Bags are available with an extensive range of accessories (trays, racks, Palletank, reusable handle, BioWelder®, BioSealer®, GammaTag®) for a rapid and functional deployment of a complete single-use engineered liquid handling and storage solutions in your process.

Cost Reduction and Risk ReductionSingle-use systems used in biopharmaceutical manufacturing improve process safety as they reduce the risk of cross contamination from batch-to-batch and product-to-product. Costly and time consuming CIP & SIP opera-tions are minimized. This results not only in significant cost savings within the entire manufacturing process, but also in the optimization of capacity utilization.

ApplicationsStandard Scalable Flexel® 3D Bioprocessing Bags are constructed from S40, a multi-layer film that provides a strong structure with low gas permeability and high chemical resistance for the safe processing of a wide range of biopharmaceutical fluids in a variety of appli-cations.

Typical applications requiring robust container storage include:

– Buffers and cell culture media filtration and storage

– Product harvest

– Product pooling


– Viral inactivation & filtration


– Final product storage

Features Benefits

Multiple manu- High security of supply facturing sites




Various bag size High flexibility

Designed to fit Space saving standard tray containment systems and Palletank®

Scalable S40 film Process scalability with the same product contact materials from 5 L to 3000 L

Standard Scalable Flexel® 3D Bioprocessing Bags



FlexibilityStandard Scalable Flexel® 3D Bags are avail-able for a fast implementation in a customer process, using pre-defined bag configurations.The bag configurations may be readily cus-tomized to optimize the integration into a specific application and process using pre-qualified and off the shelf OPUS components. Sartorius Stedim Biotech supports user design with a comprehensive support program that ensures successful design implementation of Single-Use Manufacturing.

Easy ImplementationStandard Scalable Flexel® 3D Bags are avail-able with volume of 5 L, 10 L, 20 L and 50 L. They are supplied sterilized and ready to use for easy and convenient process implementa-tion. A 50 L configuration with thermoweld-able TPE tubing is provided for flexible incor-poration into your process. Sterile connection and disconnection devices like the BioWelder® and the BioSealer® can be used to allow safe connections and disconnections from and to another process step.

A series of associated systems such as reusable handle, plastic and stainless steel Trays, Racks and Palletanks® facilitates bag handling, transportation and storage. 50 L Flexel® 3D Bag assembly is equipped with a GammaTag® RFID tag that enables the user to reliably read and write all relevant product, process and lifecycle information directly on the Sartorius Stedim Biotech single-use system, providing instantaneous data recall.

Security of SupplySartorius Stedim Biotech has established multiple manufacturing sites with consistent industrial processes. The expertise of design-ing single-use solutions combined with collaborative supplier management and customer demand planning assures a state of the art product supported by a robust supply chain that can cope with strong market growth.

ValidationStandard Scalable Flexel® 3D Bags have been qualified applying the most comprehensive and innovative test regimes. Biological, chemical and physical tests combined with extensive extractable testing provide users of Standard Scalable Flexel® 3D Bags with data representing a wide range of process fluids in a variety of processing conditions.


Quality AssuranceSartorius Stedim Biotech Quality Systems for single-use products follow applicable ISO and FDA regulations. Design, Manufacture and Sterilization processes are conducted under conditions that mirror biopharmaceutical operations and meet cGMP requirements. Standard Scalable Flexel® 3D Bags are tested for compliance to:




– USP and E.P. 2.9.19: Particulate matters in injections

– USP and E.P.2.6.14: Bacterial endotoxins



Supply ChainThe majority of Standard Scalable Flexel® 3D Bag systems are available from stock.


Specifications

1. Standard Scalable Flexel® 3D Bags

Bag Chamber Multiple layer film construction, including EVOH gas barrier layer and a PE contact layer

Tubing Silicone, TPEFittings MPC and MPX Male & Female Couplings, Female Luer Lock,

Needle-less sampling portVolumes 5 L, 10 L, 20 L and 50 L Number of Ports 3 ports (5 L, 10 L & 20 L) 3 top ports and 3 bottom ports (50 L)Sterilization By Gamma irradiation

2. Reusable Handle

Description Removable handle for Flexel® 3D 5-10-20 LMaterial of Silicone|PA Coated Steel Construction

3. Plastic Trays

Material of Construction PolypropyleneTray Capacity 5 L, 10 L and 20 LLids available for 5 L, 10 LStackable Yes

Dimensions5 L 400 + 300 + 175 mm – (15.8 + 11.8 + 6.9”)10 L 600 + 400 + 175 mm – (23.63 + 15.8 + 6.9”)20 L 1000 + 400 + 214 mm – (39.4 + 11.8 + 8.4”)

Weight of Tray|Bag & Lid (Bag filled to nominal volume)5 L 6.2 Kg – 13.7 lbs10 L 12.4 Kg – 27.3 lbs20 L 24.1 Kg – 53.0 lbs

4. Stainless Steel Trays

Material 304L Stainless SteelSurface Finish Bead BlastedTray Capacity 5 L (for Flexel® 3D 5 L) 10 L (for Flexel® 3D 10 L & 20 L)Lid available for 5 L, 10 L

Dimensions5 L 475 + 330 + 117 mm – (18.7“ + 12.9“ + 4.6“)10 L 760 + 330 + 117 mm – (29.9“ + 12.9“ + 4.6“)

Weight of Tray|Bag & Lid (Bag filled to nominal volume)5 L 8.6 Kg (18.9 lbs)10 L 15.7 Kg (34.5 lbs)20 L in 10 L Tray 25.7 Kg (56.5 lbs)


5. Rack System

(Please consult the Flexboy® Tray and Rack System Datasheet)

Base Module 1 Additional Module 2 Full SystemMaterial 304 Stainless Steel 304 Stainless Steel 304 Stainless Steel Surface Finish Bead Blasted Bead Blasted Bead BlastedWeight 30.5 Kg (67.1 Lbs) 26 Kg (57.2 Lbs) 82.5 Kg (181.5 Lbs)Stainless Steel Tray 4 Places for 5 or 10 L 8 Places for 5 or 10 L 20 Places for 5 or 10 L Compartments Stainless Steel Trays – Stainless Steel Trays – Stainless Steel Trays – (2 Places for 20 L (4 Places for 20 L (10 Places for 20 L Stainless Steel Trays) Stainless Steel Trays) Stainless Steel Trays)Plastic Tray 2 Places for 20 L Plastic Trays or 4 Places for 20 L Plastic Trays or 10 Places for 20 L Plastic Trays or Compartments 2 Places for 10 L Plastic Trays or 4 Places for 10 L Plastic Trays or 10 Places for 10 L Plastic Trays or 4 Places for 5 L Plastic Trays 8 Places for 5 L Plastic Trays 20 Places for 5 L Plastic Trays Peristaltic Pumps Yes – Dimensions: No Yes – Dimensions: Compartment 887 + 775 + 300 mm 887 + 775 + 300 mm (34.9“ + 30.5“ + 11.8“) (34.9“ + 30.5“ + 11.8“)Wheels 4 Swivel Wheels – 4 Swivel Wheels (Two With Brakes) (Two With Brakes)Additional Features Built In Wheels – Full = 1 Base + (Non Autoclavable) 2 Additional Modules

6. Palletank® for Storage

Description Palletank® 50 L for storage stackableBag Volume 50 LConstruction Material 304L Stainless SteelSurface Finishing Bead BlastedDimensions (Approx.) 490 + 490 + 750 mm (19.3 + 19.3 + 29.5”)Sliding Gate 1Stackability (static) Yes (3)Weight (Approx.) 24 kg (52.8 lb)

Accessories

Description Dolly for Palletank 50 L for storageWeight (Approx.) 7 kg (15.4 lb)


Ordering Information

1. Scalable Flexel® 3D Bioprocessing Bags

Part Number Description Tubing Bag Port 1 Bag Port 2 Bag Port 3 Bag Port 4 Qty/BoxFXB112850 STD Flexel® 5 L Silicone 3/8’’ + 5/8’’ + 150 mm (6’’) 1/4’’ + 3/8’’ + 100 mm (4’’) Plug 3/8’’ + 5/8’’ + 150 mm (6’’) 12 3/8’’ MPC female + plug LL female + plug 3/8’’ MPC male + cap

FXB112852 STD Flexel® 10 L Silicone 3/8’’ + 5/8’’ + 150 mm (6’’) 1/4’’ + 3/8’’ + 100 mm (4’’) Plug 3/8’’ + 5/8’’ + 150 mm (6’’) 12 3/8’’ MPC female + plug LL female + plug 3/8’’ MPC male + cap

FXB112853 STD Flexel® 20 L Silicone 3/8’’ + 5/8’’ + 150 mm (6’’) 1/4’’ + 3/8’’ + 100 mm (4’’) Plug 3/8’’ + 5/8’’ + 150 mm (6’’) 12 3/8’’ MPC female + plug LL female + plug 3/8’’ MPC male + cap

Part Number Description Tubing Top Port 1 Top Port 2 Top Port 3 Top Port 4 Qty/BoxFXB113153 STD Flexel® Silicone & 1/4” + 3/8” + 10 cm (4”) + 1/2” + 3/4” + 50 cm (20”) + 1/2” + 3/4” + 50 cm (20”) + Plug 4 Cubical 50 L Clear male MPC + female MPX + male MPX + C-Flex® 374 sealing cap sealing cap sealing cap

Bottom Port 1 Bottom Port 2 Bottom Port 3 Bottom Port 4 1/4” + 3/8” + 10 cm (4”) + 1/2” + 3/4” + 50 cm (20”) + 1/2” + 3/4” + 50 cm (20”) + Plug LL female + GammaTag™ + male MPX + needle free sampling port female MPX + sealing cap sealing cap


2. Reusable Handle

Part Number Description Qty/BoxFXA113036 Removable Handle For Flexel® 3D 5–10–20 L 3

3. Plastic Trays

Part Number Description Qty/BoxFFA113141 Plastic Tray Flexel® |Flexboy® 5 L + Lid 1FFA113142 Plastic Tray Flexel® |Flexboy® 10 L - 20 L + Lid 1FFA113143 Plastic Tray Flexel® 20 L 1

4. Stainless Steel Trays

Part Number Description Qty/BoxFFA102705 Flexboy® Tray + Lid 5 L 1FFA102715 Flexboy® Tray + Lid 10 L 1

5. Rack System

Part Number Description Qty/BoxFFA102707 Flexboy® Rack|Base Module 1 1FFA102714 Flexboy® Rack|Module 2 1

6. Palletank® for Storage 50 L

Part Number Description Qty/BoxFXC113946 Std Palletank® Storage 50 L (Stackable) 1FXA113988 Std Palletank® Accessory Dolly 50 L (Storage) 1


DescriptionFlexel® 3D Bioprocessing Bags are designed for processing, storage and transport of large volume biopharmaceutical solutions in drum and Palletank®. They provide a single-use alternative to traditional stainless steel vessels in a large variety of applications. Normal process validation and in process control of the manufacturing provides a high degree of reliability of Flexel® 3D Bioprocessing Bags.

For critical storage and processing appli-cations that require a higher degree of assurance, the integrity of each Flexel® 3D Bioprocessing Bag can be controlled with an optional test performed at Sartorius Stedim Biotech manufacturing plant.

Integrity TestingLarge volume, single-use Flexel® 3D Bags are increasingly used for the handling, storage and transport of high value products, such as bulk drug substances and vaccines. For these applications, an in-process bag chamber integrity test can be performed during manufacturing at Sartorius Stedim Biotech. This in-process physical control, in combina-tion with the microbial challenge validation study is essential to provide the highest assur-ance level of the bag integrity. This optional test is performed on customer request for customized bag configurations.

The integrity test method is derived from ASTM F2095: “Standard Leak Test for Nonporous Flexible Packages with Restraining Plates”. A pressure decay leak test is used to detect small channel defects in the seals or pinholes in the walls of the flexible bag.

The test method is non destructive and com-patible with a 100% on-line implementation in Sartorius Stedim Biotech grade C clean rooms. The in-process test is performed on sealed bag chambers after the welding of the bag port and before assembly with the fill and drain lines.

Features & Benefits

Applicable to Flexel® 3D Bags for Drum and Palletank® (50 L – 200 L)

Covers most common volume bags for critical applications.

Non destructive testing

Safe and robust 100% testing is performed

High resolution, reproducibility, repeatability

High assurance level of the bag chamber integrity

Rapid, online testing 100% testing

Validated High assurance level of bag integrity

Traceable Documented batch record and certificate of release

Integrity Testing of Flexel® 3DBioprocessing Bags for Drum and for Palletank®


Specifications

Integrity Tested Flexel® 3D Bags for Drum

Bag Chamber S40 multiple layer film construction, including EVOH gas barrier layer, and a PE contact layer

Volumes 50 L, 100 L & 200 L

Port tubing Top port: 4 + port tubing with a 1” hose barb in position 1 Bottom port: No port


Integrity Tested Flexel® 3D Bags for Palletank®

Bag Chamber S40 multiple layer film construction, including EVOH gas barrier layer, and a PE contact layer

Volumes 100 L & 200 L

Port tubing Top port: 4 + port tubing with a 1” hose barb in position 1 Bottom port: 1 port tubing


ApplicationsFlexel® 3D Bioprocessing Bags are constructed from S40, a multi-layer film that provides a strong structure with low gas permeability and high chemical resistance for the safe processing of a wide range of biopharmaceu-tical fluids in a variety of applications. Typical applications requiring a 100% in-process integrity testing include:


– Bulk drug substance storage and transport

– Final fill and finish operations

The integrity of large volume sterile single-use bags is of paramount importance for the handling and storage of biopharmaceutical products. The single-use container must act as an effective barrier to microorganism to insure the sterility of the stored solutions. The integrity testing performed during the manufacturing of Flexel® 3D Bioprocessing Bags considerably increases the security and safety of single-use biopharmaceutical processes.

Security of Supply

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