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NovaLinX® Nuclease-free Consumables
Brief description

Innovative design of Nuclease-free Single-use Consumables with 100% RNase/DNase inspection and release of products and customer verification.


NovaLinX® Nuclease-free Single-use Consumables mainly include storage bottles, satellite bags, and manifold bags. RNase/DNase testing is optional to prevent the potential introduction of RNase/DNase during drug production.


Deoxyribonuclease (DNase) and ribonuclease (RNase) are a class of hydrolase that can degrade DNA and RNA  molecules by severing the phosphodiester bonds of polynucleotide chains. Nucleases are widely found in the environment, on the surface of materials and consumables. In the production process of biologics, there is also a large potential for residues and contamination of nucleases, including endogenous RNase contamination of bi-ological samples, exogenous contamination of water, buffers, surface of consumables, as well as environmental microorganisms and human beings. Nucleases are often extremely reactive, and small amounts of DNase/RNase contamination can lead to significant DNA/RNA degradation, which can have a significant impact on experimen-tal and manufacturing processes.

With the boom of the biopharmaceutical industry in recent years, more and more bioproducts are being used in disease prevention and treatment. Technologies such as mRNA, cellular and gene therapies, and vaccines based on viral vector modification are gradually gaining widespread use. While anticipating the remarkable effects of these new technologies, the market has also put forward higher requirements for the quality and safety of bioproducts. In order to ensure the safety of bioproducts and the control of impurity residues, numerous relevant regulations and policies have been launched. The “2020 edition of the Pharmacopoeia of the People's Republic of China” specifically mentions the need to control process-related impurities, including nuclease, in the  R&D and production of these biologics in sections “General Instructions on Vaccine for Human Use”, “General  Instructions on Recombinant Monoclonal Antibody Products for Human Use”, “General Instructions on Gene  Therapy Products for Human Use”, and “Technical Guidelines for the Research and Evaluation of Cellular Thera-peutic Products”.

NovaLinX® single-use consumables mainly include storage bottles, satellite bags, and manifold bags. RNase/DNase testing is optional to prevent the potential introduction of RNase/DNase during drug production.



Features of NovaLinX® Nuclease-free Single-use Consumables

Features of Satellite Bag

  • Master bag + innovative design of double satellite bags (enabling 100% individual inspection of RNase/DNase-free bags)

  • Identical material/production environment of the master bag and satellite bags, consistent gamma irradiation after packaging

  • Irradiated satellite bag-1 (QC release): for Nuclease inspection prior to product release

  • Irradiated satellite bag-2 (customer verification): for customer verification and review

  • The extraction ratio of the satellite bag is at the worst case, which represents the Nuclease level of the master bag.

  • Imported 9101 film.

  • The production environment is usually an ISO Class 7 clean workshop for single-use bioprocessing consumables.

  • Environmental monitoring bag (monthly monitoring of production environment Nuclease level.) - produced on the last day of the month on the production line (Worse Case)


Features of Satellite Bag

  • Master bag + innovative design of double satellite bags (enabling 100% individual inspection of RNase/DNase-free bags)

  • Identical material/production environment of the master bag and satellite bags, consistent gamma irradiation after packaging

  • Irradiated satellite bag-1 (QC release): for Nuclease inspection prior to product release

  • Irradiated satellite bag-2 (customer verification): for customer verification and review

  • The extraction ratio of the satellite bag is at the worst case, which represents the Nuclease level of the master bag.

  • Imported 9101 film.

  • The production environment is usually an ISO Class 7 clean workshop for single-use bioprocessing consumables.

  • Environmental monitoring bag (monthly monitoring of production environment Nuclease level.) - produced on the last day of the month on the production line (Worse Case)



Product Model: 1–50 L
Manufacturer nature:Manufacturer
Update time:2025-06-15
Visits:158

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Detailed Introduction

Specifications of NovaLinX® Nuclease-free Single-use Consumables

Final A Film Product No.

Volume

Bag Design

Line 1

Line 2

Line 3

ARF01LCPPL00

1 L

Hanging hole

50 cm  ID1/4"*0D7/16"
C-Flex TPE tube + plug

50 cm  ID1/4"*OD7/16"
C-Flex TPE tube + plug

30 cm  ID1/4"*OD7/16" C-Flex TPE tube +
Needleless sampling valve

ARF02LCPPL00

2 L

Hanging hole

ARF05LCPPL00

5 L

Hanging rod +
Hanging hole

50 cm  ID3/8"*OD5/8"
C-Flex TPE tube + plug

50 cm  ID3/8" * OD5/8"
C-Flex TPE tube + plug

ARF10LCPPL00

10L

Hanging rod +
Hanging hole

ARF20LCPPL00

20 L

Hanging rod +
Hanging hole

ARF50LCPPL00

50 L

Hanging rod +
Hanging hole

ARF01LHAAL00

1 L

Hanging hole

50 cm IDl/4"*OD7/16" Platinum 50 Platinum cured silicone tube + AseptiQuik® G Sterile Connector

50 cm  ID1/4"*OD7/16" Platinum 50 Platinum cured
silicone tube + AseptiQuik® G Sterile Connector

30 cm lD1/4"*OD7/16"
C-FLex TPE tube +
Needleless sampling valve

ARF02LHAAL00

2 L

Hanging hole

ARF05LHAAL00

5 L

Hanging rod +
Hanging hole

50 cm ID3/8"* OD5/8"
Platinum 50 Platinum cured silicone tube + AseptiQuik® G Sterile Connector

50 cm lD3/8"*OD5/8" Platinum 50 Platinum cured silicone tube + AseptiQuik® G Sterile Connector

ARF10LHAAL00

10L

Hanging rod +
Hanging hole

ARF20LHAAL00

20 L

Hanging rod +
Hanging hole

ARF50LHAAL00

50 L

Hanging rod +
Hanging hole

ARF01LX11L00

1 L

Hanging hole

50 cm ID1/4"*OD7/16" Platinum 50 Platinum cured silicone tube + MPC female connector

50 cm ID1/4"*OD7/16" C-Flex TPE tube + MPC male connector

30 cm ID1/4"*OD7/16" C-Flex TPE tube + Needleless sampling valve

ARF02LX11 L00

2 L

Hanging hole

ARF05LX11L00

5 L

Hanging rod +
Hanging hole

50 cm ID3/8"*OD5/8" Platinum 50 Platinum cured silicone tube + MPC female connector

50 cm ID3/8"*OD5/8" C-Flex TPE tube+ MPC male connector

ARF10LX11L00

10 L

Hanging rod +
Hanging hole

ARF20LX11L00

20 L

Hanging rod +
Hanging hole

ARF50LX11 L00

50 L

Hanging rod +
Hanging hole

ARF01LXCCL00

1 L

Hanging hole

50 cm ID1/4"*OD7/16" Platinum 50 Platinum cured silicone tube + TC25 connector

50 cm ID1/4"*0D7/16" C-Flex TPE tube + TC25 connector

30 cmlD1/4"*OD7/16"
C-Flex TPE tube + Needleless sampling valve

ARF02LXCCL00

2 L

Hanging hole

ARF05LXCCL00

5 L

Hanging rod +
Hanging hole

50 cm ID3/8"* OD5/8" Platinum 50 Platinum cured silicone tube + TC25 connector

50 cm ID3/8"* OD5/8" C-Flex TPE tube + TC25 connector

ARFWLXCCL00

10L

Hanging rod +
Hanging hole

ARF20LXCCL00

20 L

Hanging rod +
Hanging hole

ARF50LXCCL00

50 L

Hanging rod +
Hanging hole

Nuclease-free Single-Use Consumables


Single-use storage bottle

Batch inspection

DNase-free/

RNase-free/

Nuclease-free

(DNase-free & RNase-free)


Single-use 2D satellite bag/ manifold bag

Individual/hybrid/batch inspection


Single-use 3D storage bag

Individual/hybrid/batch inspection


Single-use mixing bag

Individual/hybrid/batch inspection


Single-use cell bag/mixing bag

Individual/hybrid/batch inspection


Single-use bioreactor bag

Individual/hybrid/batch inspection



Ordering Information

DNase-free  Cat. No.

RNase-free  Cat. No.

Nuclease-free  Cat. No.

Volume

Product name

Matching type

Package

BTA5ML001D

BTA5ML001R

BTA5ML001N

5 mL

NovaLinX® 5 mL single-use storage bottle

Regular cap

200

BTA20ML001D

BTA20ML001R

BTA20ML001N

20 mL

NovaLinX® 20 mL single-use storage  bottle

200

BTA50ML001D

BTA50ML001R

BTA50ML001N

50 mL

NovaLinX® 50 mL single-use storage  bottle

120

BTA125ML001D

BTA125ML001R

BTA125ML001N

125 mL

NovaLinX® 125 mL single-use storage  bottle

60

BTA250ML001D

BTA250ML001R

BTA250ML001N

250 mL

NovaLinX® 250 mL single-use storage  bottle

40

BTA500ML001D

BTA500ML001R

BTA500ML001N

500 mL

NovaLinX® 500 mL single-use storage  bottle

20

BTA1L001D

BTA1L001R

BTA1L001N

1 L

NovaLinX® 1 L single-use storage bottle

25

BTA2L001D

BTA2L001R

BTA2L001N

2 L

NovaLinX® 2 L single-use storage bottle

16

BTA5ML002D

BTA5ML002R

BTA5ML002N

5 mL

NovaLinX® 5 mL single-use storage bottle

2-port cap

200

BTA20ML002D

BTA20ML002R

BTA20ML002N

20 mL

NovaLinX® 20 mL single-use storage bottle

200

BTA50ML002D

BTA50ML002R

BTA50ML002N

50 mL

NovaLinX® 50 mL single-use storage bottle

120

BTA125ML002D

BTA125ML002R

BTA125ML002N

125 mL

NovaLinX® 125 mL single-use storage bottle

60

BTA250ML002D

BTA250ML002R

BTA250ML002N

250 mL

NovaLinX® 250 mL single-use storage bottle

40

BTA500ML002D

BTA500ML002R

BTA500ML002N

500 mL

NovaLinX® 500 mL single-use storage bottle

20

BTA1L002D

BTA1L002R

BTA1L002N

1 L

NovaLinX® 1 L single-use storage bottle

25

BTA2L002D

BTA2L002R

BTA2L002N

2 L

NovaLinX® 2 L single-use storage bottle

16

BTA5ML003D

BTA5ML003R

BTA5ML003N

5 mL

NovaLinX® 5 mL single-use storage bottle

3-port cap

200

BTA20ML003D

BTA20ML003R

BTA20ML003N

20 mL

NovaLinX® 20 mL single-use storage  bottle

200

BTA50ML003D

BTA50ML003R

BTA50ML003N

50 mL

NovaLinX® 50 mL single-use storage  bottle

120

BTA125ML003D

BTA125ML003R

BTA125ML003N

125 mL

NovaLinX® 125 mL single-use storage  bottle

60

BTA250ML003D

BTA250ML003R

BTA250ML003N

250 mL

NovaLinX® 250 mL single-use storage  bottle

40

BTA500ML003D

BTA500ML003R

BTA500ML003N

500 mL

NovaLinX® 500 mL single-use storage  bottle

20

BTA1L003D

BTA1L003R

BTA1L003N

1 L

NovaLinX® 1 L single-use storage bottle

25

BTA2L003D

BTA2L003R

BTA2L003N

2 L

NovaLinX® 2 L single-use storage bottle

16

DNase-free  Cat. No.

RNase-free  Cat. No.

Nuclease-free  Cat. No.

Volume

Line

BD-X005-S001

BR-X005-S001

BN-X005-S001

5 mL

batch inspection, 5 mL satellite bag

20 cm ID1/8"*OD1/4" platinum cured silicone tubing +  female Luer

10 cm ID1/8"*OD1/4" platinum cured silicone tubing +  female Luer

BD-X010-S001

BR-X010-S001

BN-X010-S001

10 mL

10 mL satellite bagonly for 10mL storage bag

50 mL satellite bagonly for 20mL storage bag

20 cm ID1/8"*OD1/4" platinum cured silicone tubing + female Luer

10 cm ID1/8"*OD1/4" platinum cured silicone tubing + female Luer

10 cm ID1/8"*OD1/4" platinum cured silicone tubing + female Luer

10 cm ID1/8"*OD1/4" platinum cured silicone tubing + needleless sampling

BD-X020-S001

BR-X020-S001

BN-X020-S001

20 mL

BD-X050-S001

BR-X050-S001

BN-X050-S001

50 mL

50mL satellite bag

20 cm ID1/8"*OD1/4" platinum cured silicone tubing +  female Luer

30 cm ID1/8"*OD1/4" platinum cured silicone tubing +  female Luer

30 cm ID1/8"*OD1/4" platinum cured silicone tubing +  female Luer

30 cm ID1/8"*OD1/4" platinum cured silicone tubing +  needleless sampling

BD-X100-S001

BR-X100-S001

BN-X100-S001

100 mL

BD-X250-S001

BR-X250-S001

BN-X250-S001

250 mL

BD-X500-S001

BR-X500-S001

BN-X500-S001

500 mL

BD-0001-S002

BR-0001-S002

BN-0001-S002

1 L

50mL satellite bag

20 cm ID1/8"*OD1/4" C-Flex thermoplastic tubing +  female Luer

30 cm ID1/4" * OD7/16" C-Flex thermoplastic tubing +  plug

30 cm ID1/4" * OD7/16" C-Flex thermoplastic tubing +  plug

20 cm ID1/4"*OD7/16" C-Flex thermoplastic tubing +  needleless sampling

BD-0002-S002

BR-0002-S002

BN-0002-S002

2 L

BD-0005-S002

BR-0005-S002

BN-0005-S002

5 L

50mL satellite bag

20 cm ID1/8"*OD1/4" C-Flex thermoplastic tubing +  female Luer

30 cm ID3/8" * OD5/8" C-Flex thermoplastic tubing + plug

30 cm ID3/8" * OD5/8" C-Flex thermoplastic tubing + plug

20 cm ID1/4"*OD7/16" C-Flex thermoplastic tubing +  needleless sampling

BD-0010-S002

BR-0010-S002

BN-0010-S002

10 L

BD-0020-S002

BR-0020-S002

BN-0020-S002

20 L

BD-0050-S002

BR-0050-S002

BN-0050-S002

50 L

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