2D/ 3D Single Use Storage Bags

US8200 SUIS: 2D/ 3D/ Feeding/ Liner Bag

Bioneau™ Duoning 2D & 3D liquid storage bags are products specially developed for the storage and transfer of liquids in the biopharmaceutical process, which provide complete models, available from 5 mL to 50 L, and specific configurations can be customized according to customer needs. Bag film, DuoFilm-001, is a 7-layer composite biopharmaceutical dedicated film with thickness of 0.3 mm, and the material of liquid contact layer is ULDPE, which has excellent physical and chemical properties and biocompatibility. 2D/ 3Dliquid storage bags ensure that raw materials, product assembly, and sterilization processes fully comply with cGMP and biopharmaceutical operating requirements. The volume range of 2D fluid storage bag is 5 mL – 50 L; the volume range of 3D barrel bag is 38 L – 568 L; the volume range of 3D cubic storage bag is 50 L-3,000 L.

APPLICATIONS

FEATURES

Sterile Filter Capsules

Bioneau™ SUS can be integrated with globally accepted and validated sterile filter capsules of customers choice. Bioneau™ ensure that raw materials, product assembly, and sterilization processes fully comply with cGMP and biopharmaceutical operating requirements with complete control on packaging and traceability through stringent documentation process. Sterile filters ranging from 0.2 micron in varying lengths and end connections sanitary flange or hose barb can be added as per your validated requirements. These Single Use Assemblies with Sterile filters may further be connected to Storage bottles/ Trays/ Transfer Assemblies.

neauFlux™ 2560 Silicone Fluid Transfer Tubing

Bioneau neauFlux™ 2560 Silicone Fluid Transfer Tubing is designed specifically for the most demanding bio-pharmaceutical applications. With its superior flex life characteristics, manufacturing processes can be simplified by reducing potential production downtime due to pump tubing failure. The smooth inner surface of this silicone tubingis designed to help reduce the risk of particle entrapment and microscopic build-up during sensitive fluid transfer. This smooth fluid path also can help to facilitate the complete sanitation of a fluid transfer system. Even in extended use applications, neauFlux™ 2560 Silicone Fluid Transfer Tubing may help to prevent residue build-up, aidingin more efficient cleaning and sterilization processes.

Salient Features

Special formulation promotes long life in pumps Working temperature range -60 °C to +260 °C. Extremely flexible and resilient; hardness value of 60 Shore A
Outstanding compression characteristics
Smooth surfaces offer uniform fluid flow, resistance to bacteria build-up, and consistent pump performance APSPG tubing is USP Class VI approved
Material meets FDA 21 CFR 177.2600 Certified free of animal-derived ingredients
Low volatile grade suitable for pharmaceutical and biomedical applications
Sterilizable/autoclavable available on request Imparts no taste or odor to critical streams Translucent for visual contact with the flow Stocked in sizes from .031" through .500"1.D.
Manufactured and packaged in ISO-certified a Class 10,000 clean room
Sealed in polybags at manufacture for cleanliness Documented lot traceable with identification on bags Documented quality control
Custom lengths, sizes, and packaging available Double bagging available on most sizes
Complete validation package available upon request Laser etching is possible for batch and lot number traceability

Applications

Packaging

Certification

Product Number	ID mm \| Inch(”)	OD mm \| Inch(”)	Wall thickness mm \| Inch(”)	PUMP SIZE	STANDARD LENGTH feet (“)
BN2560NF0157-0475	1.57 0.062″	4.75 0.187″	157 0.062″	#14	50′
BN2560NF	1.57 0.062″	6.35 0.25″	0.79 0.031″	#119	50′
BN2560NF	3.18 0.125″	6.35 0.25″	157 0.062″	#16	50′
BN2560NF318-792	3.18 0.125″	7.92 0.312″	2.36 0.093″	#03, #25	50′
BN2560NF	4.75 0.187″	3.35 0.132″	157 0.062″	#25	50′
BN2560NF	4.75 0.187″	9.93 0.375″	236 0.093″	#15	50′
BN2560NF	4.75 0.187″	11.10 0.437″	3.18 0.125″	—	50′
BN2560NF	6.35 0.25″	9.53 0.375″	157 0.062″	#17	50′
BN2560NF	6.35 0.25″	11.10 0.437″	2.36 0.093″	#24	50′
BN2560NF	6.35 0.25″	12.70 0.5″	3.18 0.125″	#26	50′
BN2560NF	7.92 0.312″	12.70 0.5″	236 0.093″	#35	50′
BN2560NF	9.53 0.375″	14.27 0.562″	236 0.093″	#36	50′
BN2560NF	9.53 0.375″	15.88 0.625″	3.18 0.125″	#73	50′
BN2560NF	9.53 0.375″	19.05 0.75″	157 0.062″	—	50′
BN2560NF	12.70 0.5″	19.05 0.75″	3.18 0.125″	#82	50′
BN2560NF	12.70 0.5″	22.23 0.875″	4.75 0.187″	#88	50′
BN2560NF	15.88 0.625″	22.23 0.875″	318 0.125″	—	50′
BN2560NF	15.88 0.625″	25.40 1.0″	4.75 0.187″	#89	50′
BN2560NF	19.05 0.75″	28.58 1.125″	4.75 0.187″	#191	25′
BN2560NF	19.05 0.75″	31.75 1.25	6.35 0.25″	#90	25′
BN2560NF2540-3493	25.40 1.0″	34.94 1.375″	4.75 0.187″	#92	25′

DuoFilm® Film

The DuoFilm-001® film independently developed by Bioneau Duoning is co-extruded film with 7 layers of PA (polyamide), EVOH (ethylene vinyl alcohol polymer), LDPE (low density polyethylene) and ULDPE (ultra low density polyethylene), the thickness of this film 0.3mm. The outer layer of PA provides strong puncture resistance, strength and stability; the EVOH layer minimizes the diffusion of gas through the film while maintaining very good resistance to flexural cracking; and the liquid contact layer uses ULDPE, provides excellent physical and chemical properties and biocompatibility

Relevant tests

Part of physical parameters of DuoFilm-001®

Test item	Value (after >25 kGy irradiation)	Reference standard
Haz	12.4%	ASTM D-1003
Tensile strength	24.5, MPa	ASTM D-882
Elongation at break	398%	ASTM D-882
Tensile modulus	437, MPa	ASTM D-882
Puncture strength	16.83, N	ASTM D-1306
Oxygen transmission rate	0.012 (cc/100in2·24h)	ASTM D-3985
Water vapor transmission rate	1.608 (g/m2·24h)	ASTM F-1249
Carbon dioxide transmission rate	0.433 (cm3 /m2·24h·0.1MPa)	ASTM F-2476

3D Mixing Bag

The bag body uses the DuoFilm-001® 7-layer co-extruded film independently developed by Bioneau Duoning
2 L-20 L for DuoMix® benchtop mixing system, and 50 L to 3,000 L for DuoMix® floor magnetic mixing system, Provide complete product models: 2 / 5 / 10 / 20 / 50 / 100 / 200 / 500 / 1,000 / 1,500 / 2,000 / 2,500 / 3,000L
Independently packaged with double-layer vacuum bags, with identification on the package, and each batch can be traced and recorded
Can be used with common liquid preparation system on the market, and can be customized and assembled according to customer needs (volume, shape, configuration, inlet and outlet tubing, connector, etc.)
Complete documentation packages of chemical compatibility, E & L, and DNase/RNase-free validation are available on demand
Can be used for buffer, medium preparation, temporally storage, mixing and temperature control of intermediate products, semi-finished product preparation, low pH virus inactivation and other steps

2D/3D Cubic & Cylinder Liquid Storage Bag, Open Liner Bag

Bag body uses the DuoFilm-001® 7-layer co-extruded film independently developed by Bioneau Duoning
Provide 2D storage bag with volume range from 5 ml to 50 L;
Provide 3D liquid storage bag with volume range from 50 L to 3,000 L, and 3D liquid storage bag for collapsible cubic box with volume range for 250 L to 1,000 L. The bags can be used with Bioneau Duoning liquid storage system and collapsible cubic box;
The volume of 2.5D/3D cylindrical liquid storage bag is from 38L to 568 L, which can be used with Bioneau Duoning cylindrical liquid storage system;
The volume of the open liner bag is from 19 L to 568 L, which can be used with the Bioneau Duoning liquid storage system;
The product is independently packaged with double-layer vacuum bags, with identification on the package, and each batch can be traced and recorded;
Can be used with common liquid storage system on the market, and can be customized and assembled according to customer needs (volume, shape, configuration, inlet and outlet tubing, connector, etc.);
Complete documentation packages of chemical compatibility, E & L, and DNase/RNase-free validation are available on demand
Can be used for fraction/sample collection, buffer/medium/stock solution storage and transport and other steps.

Feeding Bag

Bag body uses the DuoFilm-001® 7-layer co-extruded film independently developed by Bioneau Duoning
The feeding port is 3" or 4", and the volume of the feeding bag is from 5- 50 L, which can be used with the Bioneau Duoning feeding system;
The product is independently packaged with double-layer vacuum bags, with identification on the package, and each batch can be traced and recorded;
Customization and assemble are available according to customer needs;
Complete documentation packages of chemical compatibility, E & L, and DNase/RNase-free validation are available on demand;
Can be used for sample and buffer weighing, feeding and transporting steps

Storage System

The liquid storage system is mainly used in processes such as temporary storage and transfer of buffer solutions and intermediates. Duoning liquid storage system includes stainless steel and plastic liquid storage trolleys, collapsible liquid storage cubic boxes, plastic liquid storage drums, plastic trays, bases and other supporting containers. These products can be used with 2D and 3D liquid storage bags independently developed and produced by Lianghei (A Duoning company), which is suitable for different application scenarios from process development to large-scale manufacturing.

Provide complete range of models and specifications, meet the needs of liquid storage of various volumes Particular products can be customized

Product Name	Part No.	Volume	Description
*Stainless Steel Storage Cart, SUS304	BN2560NF01570475	BN2560NF01570475
BN2560NF01570475	BN2560NF01570475	BN2560NF01570475	BN2560NF01570475
BN2560NF01570475	BN2560NF01570475	BN2560NF01570475	BN2560NF01570475
BN2560NF01570475	BN2560NF01570475	BN2560NF01570475	BN2560NF01570475