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BioHub 2D Disposable Bioprocess Bags

BioHub 2D Disposable Bioprocess Bags

BioHub® 2d single use systembioprocessing bags are designed for bioprocess needs. As a 2D biocontainer, it is suitable for liquid mixing, storage, transport, and cryopreservation.

Features of BioHub 2D Disposable Bioprocess Bags

100% integrity test of finished products after assembly;

Capacity: 110%;

Liquid recovery rate: 99.9%;

Traceability;

A flexible choice of film options;

Similar materials of construction, extremely low level of extractables and leachables;

High barrier property, optimizing the stability of products in the bag;

High transparency, easy to observe the status of products in the bag;

Animal-derived component-free (ADCF) materials, ensuring safety.

Quality Control of BioHub 2D Disposable Bioprocess Bags

In controlled environments (ISO Class 7 environments).

Following ISO 9001:2015 certified quality system.

Animal-derived component-free (ADCF).

Meets USP <87>, USP <88> Class VI, USP <661>, USP<85>, USP <788>, ISO11737-1, ISO11737-2, and ISO11137 for liquid contact materials.

Document support: Shipped with COQ or COA.

Sterilization: 25–40 KGy of gamma.

Shelf life: 2 years.

Packaging: Double bagged.

Specifications of BioHub® 2D Disposable Bioprocess Bags

BioHub® 2D storage bag adopts ship shape outlet, and the port size includes 1/8 ", 1/4" and 3/8 ". This 2D biocontainer can be connected to sili-cone tubing and Thermoplastic tubing to meet various liquid management requirements.

Part number

Specification

Line 1

Line 2

Line 3 (sampling)

BC-X005-S001

5 ml

10 cm ID1/8"*OD1/4"

NA

NA

Platinum cured silicone tubing + male Luer

BC-X005-S002

5 ml

30 cm ID1/8"*OD1/4"

NA

NA

Thermoplastic tubing + plug

BC-X010-S001

10ml

10 cm ID1/8"*OD1/4"

10 cm ID1/8"*OD1/4"

10 cm ID1/8"*OD1/4"

Platinum cured silicone tubing + female Luer

Platinum cured silicone tubing + maleLuer

Platinum cured silicone tubing +

needleless sampling valve

BC-X010-S002

10ml

30 cm ID1/8"*OD1/4"

30 cm ID1/8"*OD1/4"

10 cm ID1/8"*OD1/4"

Thermoplastic tubing + plug

Thermoplastic tubing + plug

Thermoplastic tubing + needleless

sampling valve

BC-X020-S001

20ml

10 cm ID1/8"*OD1/4"

10 cm ID1/8"*OD1/4"

10 cm ID1/8"*OD1/4"

Platinum cured silicone tubing +

Platinum cured silicone tubing + male

Platinum cured silicone tubing +

female Luer

Luer

needleless sampling valve

BC-X020-S002

20ml

30 cm ID1/8"*OD1/4"

30 cm ID1/8"*OD1/4"

30 cm ID1/8"*OD1/4"

Thermoplastic tubing + plug

Thermoplastic tubing + plug

Thermoplastic tubing + needleless

sampling valve

BC-X050-S001

50ml

30 cm ID1/8"*OD1/4"

30 cm ID1/8"*OD1/4"

30 cm ID1/8"*OD1/4"

Platinum cured silicone tubing + female Luer

Platinum cured silicone tubing + male

Platinum cured silicone tubing +

Luer

needleless sampling valve

BC-X050-S002

50ml

30 cm ID1/8"*OD1/4"

30 cm ID1/8"*OD1/4"

30 cm ID1/8"*OD1/4"

Thermoplastic tubing + plug

Thermoplastic tubing + plug

Thermoplastic tubing + needleless

sampling valve

BC-X100-S001

100ml

30 cm ID1/8"*OD1/4"

30 cm ID1/8"*OD1/4"

30 cm ID1/8"*OD1/4"

Platinum cured silicone tubing +

Platinum cured silicone tubing + male

Platinum cured silicone tubing +

female Luer

Luer

needleless sampling valve

BC-X100-S002

100ml

30 cm ID1/8"*OD1/4"

30 cm ID1/8"*OD1/4"

Thermoplastic tubing + needleless

Thermoplastic tubing + plug

Thermoplastic tubing + plug

sampling valve

BC-X250-S001

250ml

30 cm ID1/8"*OD1/4"

30 cm ID1/8"*OD1/4"

30 cm ID1/8"*OD1/4"

Platinum cured silicone tubing +

Platinum cured silicone tubing + male

Platinum cured silicone tubing +

female Luer

Luer

needleless sampling valve

BC-X250-S002

250ml

30 cm ID1/8"*OD1/4"

30 cm ID1/8"*OD1/4"

30 cm ID1/8"*OD1/4"

Thermoplastic tubing + plug

Thermoplastic tubing + plug

Thermoplastic tubing + needleless sampling valve

BC-X500-S001

500ml

30 cm ID1/8"*OD1/4"

30 cm ID1/8"*OD1/4"

30 cm ID1/8"*OD1/4"

Platinum cured silicone tubing +

Platinum cured silicone tubing + male Luer

Platinum cured silicone tubing +

female Luer

needleless sampling valve

BC-X500-S002

500ml

30 cm ID1/8"*OD1/4"

30 cm ID1/8"*OD1/4"

30 cm ID1/8"*OD1/4"

Thermoplastic tubing + plug

Thermoplastic tubing + plug

Thermoplastic tubing + needleless

sampling valve

BC-0001-S001

1 L

30 cm ID1/4"*OD7/16"

30 cm ID1/4"*OD7/16"

20 cm ID1/4"*OD7/16"

Platinum cured silicone tubing +

Platinum cured silicone tubing + male

Platinum cured silicone tubing +

female MPC connector

MPC connector

needleless sampling valve

BC-0001-S002

1 L

30 cm ID1/4"*OD7/16"

30 cm ID1/4"*OD7/16"

20 cm ID1/4"*OD7/16"

Thermoplastic tubing + plug

Thermoplastic tubing + plug

Thermoplastic tubing + needleless

sampling valve

BC-0002-S001

2 L

30 cm ID1/4"*OD7/16"

30 cm ID1/4"*OD7/16"

20 cm ID1/4"*OD7/16"

Platinum cured silicone tubing +

Platinum cured silicone tubing + male

Platinum cured silicone tubing +

female MPC connector

MPC connector

needleless sampling valve

BC-0002-S002

2 L

30 cm ID1/4"*OD7/16"

30 cm ID1/4"*OD7/16"

20 cm ID1/4"*OD7/16"

Thermoplastic tubing + plug

Thermoplastic tubing + plug

Thermoplastic tubing + needleless

sampling valve

BC-0005-S001

5 L

30 cm ID3/8"*OD5/8"

30 cm ID3/8"*OD5/8"

20 cm ID1/4"*OD7/16"

Platinum cured silicone tubing +

Platinum cured silicone tubing + male

Platinum cured silicone tubing +

female MPC connector

MPC connector

needleless sampling valve

BC-0005-S002

5 L

30 cm ID3/8"*OD5/8"

30 cm ID3/8"*OD5/8"

20 cm ID1/4"*OD7/16"

Thermoplastic tubing + plug

Thermoplastic tubing + plug

Thermoplastic tubing + needleless

sampling valve

BC-0010-S001

10 L

30 cm ID3/8"*OD5/8"

30 cm ID3/8"*OD5/8"

20 cm ID1/4"*OD7/16"

Platinum cured silicone tubing +

Platinum cured silicone tubing + male

Platinum cured silicone tubing +

female MPC connector

MPC connector

needleless sampling valve

BC-0010-S002

10 L

30 cm ID3/8"*OD5/8"

30 cm ID3/8"*OD5/8"

20 cm ID1/4"*OD7/16"

Thermoplastic tubing + plug

Thermoplastic tubing + plug

Thermoplastic tubing + needleless

sampling valve

BC-0020-S001

20 L

30 cm ID3/8"*OD5/8"

30 cm ID3/8"*OD5/8"

20 cm ID1/4"*OD7/16"

Platinum cured silicone tubing +

Platinum cured silicone tubing + male

Platinum cured silicone tubing +

female MPC connector

MPC connector

needleless sampling valve

BC-0020-S002

20 L

30 cm ID3/8"*OD5/8"

30 cm ID3/8"*OD5/8"

20 cm ID1/4"*OD7/16"

Thermoplastic tubing + plug

Thermoplastic tubing + plug

Thermoplastic tubing + needleless

sampling valve

BC-0050-S001

50 L

30 cm ID3/8"*OD5/8"

30 cm ID3/8"*OD5/8"

20 cm ID1/4"*OD7/16"

Platinum cured silicone tubing +

Platinum cured silicone tubing + male

Platinum cured silicone tubing +

female MPC connector

MPC connector

needleless sampling valve

BC-0050-S002

50 L

30 cm ID3/8"*OD5/8"

30 cm ID3/8"*OD5/8"

20 cm ID1/4"*OD7/16"

Thermoplastic tubing + plug

Thermoplastic tubing + plug

Thermoplastic tubing + needleless

sampling valve

Contact Bio-Link experts in your location for more recommendation on bag size and tubing configuration.

2D Storage Bags and Matching Holder Series

Trays for 2D storage bags: Plastic trays

Part number

Tray capacity

Material

Dimensions L*W*H

Weight

Cover

Part number

Cover dimensions

Weight

TRAY0005L001

5 L

PP

300*200*150 mm

Optional

TRAY0005LC

300*200*30 mm

TRAY0010L001

10 L

PP

400*300*150 mm

Optional

TRAY0010LC

400*300*30 mm

TRAY0020L001

20 L

PP

600*400*150 mm

Optional

TRAY0020LC

600*400*30 mm

Trays for 2D storage bags: Stainless steel trays

Part number

Tray capacity

Material

Dimensions (L*W*H)

Weight

Cover

TRAY0005L002

5 L

SS 304L

480*270*80 mm

6 kg

Standard

TRAY0010L002

10 L

SS 304L

600*370*120 mm

8 kg

Standard

TRAY0020L002

20 L

SS 304L

760*460*160 mm

11 kg

Standard

TRAY0050L002

50 L

SS 304L

910*644*200 mm

18 kg

Standard

Cryopreservation cases for 2D storage bags

Part number

Match bag

Case dimensions including outer package

Weight

Package

CASE050ML001

BioHub Series standard 50 mL bag

290*185 mm

10/box

CASE100ML001

BioHub Series standard 100 mL bag

320*210 mm

10/box

CASE250ML001

BioHub Series standard 250 mL bag

370*235 mm

10/box

CASE500ML001

BioHub Series standard 500 mL bag

400*255 mm

10/box

CASE0001L001

BioHub Series standard 1 L bag

606*406*100 mm

5/box

CASE0002L001

BioHub Series standard 2 L bag

606*406*100 mm

5/box

CASE0005L001

BioHub Series standard 5 L bag

700*500*120 mm

5/box

CASE0010L001

BioHub Series standard 10 L bag

1000*600*120 mm

6 kg

5/box

CASE0020L001

BioHub Series standard 20 L bag

1000*600*120 mm

7 kg

5/box

*Cryopreservation cases for other types of bags are available. Contact Bio-Link experts in your location for details.

BioHub® Film

The films of BioHub® disposable bioprocess bags are from Renolit----the world's top film supplier. The biopharmaceutical-dedicated film is manufactured by the advanced multi-layer co-extruded technology, adequate certificates of material quality and validation documents are provided. Its physiochemical intensity, gamma irradiation tolerance, extractable level, and biological safety all meet the strictest standard of biopharmaceutical industry.

Features

Similar materials of construction, extremely low level of extractables and leachables;

High barrier property, optimizing the stability of products in the bag;

High transparency, easy to observe the status of products in the bag;

Animal-derived component-free (ADCF) materials, ensuring safety.

Film features

Physical properties

Unit

Test value (before/after irradiation)

Reference standard

Haze

%

7/7

ASTM D-1003

Clarity

%

97/97

ASTM D-1003

Transmittance

%

93/93

ASTM D-1003

Tensile strength

MPa

14/13

ASTM D-882

Elongation at break

%

280/300

ASTM D-882

Modulus of elasticity

MPa

370/350

ASTM D-882

Density

g/cm³

ASTM D-792

Moisture vapor transmission rate (MVTR)

g/(m² .day)

ASTM F-1249

Oxygen permeability

cm³/(m² .day.bar)

< 0.05/ < 0.05(23 ℃ , 0%RH)

ASTM D-3985

Carbon dioxide permeability

cm³/(m² .day.bar)

< 0.2/ < 0.2(23 ℃ , 0%RH)

ASTM F-2476

Biocompatibility (irradiation dose > 45 kGy)

Hemolysis

ISO 10993-4

PASS

Cytotoxicity

ISO 10993-5

PASS

Implantation test

ISO 10993-6

PASS

Sensitization test

ISO 10993-10

PASS

Acute systemic toxicity test

ISO 10993-11

PASS

Class VI plastic USP

USP<88>

PASS

Biocompatibility

USP<87>

PASS

Contact Bio-Link experts in your location for more information on films and products.

Quality assurance system

The Bio-Link single-use product manufacturing factory has been certified by ISO9001:2015 and ISO13485:2016.



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