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rnase free bag
rnase free bag
RNAse-inhibiting bags
nuclease free single use bioprocess bags

NovaLinX® Nuclease-free Single-Use Bioprocess Bags

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

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Features Why Rnase-free? Specifications Contact us

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 Bioprocess Bags

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 Manifold Bag

•   Master bag + innovative design of double satellite bags

•   Pre-connection of tubing, with one end of  the main tubing interface for liquid inlet and the other end with an air filter disc for exhaust  and tubing emptying, simplifying operation and reducing contamination risks.

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

•   Imported 9101 film and tubing fittings.

•  Tubing connecting the bags can be disconnected by a sealer.

•   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)



Why Choose Nuclease-Free Single-Use Consumables？

Nuclease-free_Sample.png


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 biological 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 experimental 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 Therapeutic Products”.



Specifications of NovaLinX® Nuclease-free Single-Use Bioprocess Bags

Final A Film Product No.VolumeBag DesignLine 1Line 2Line 3
ARF01LCPPL001 LHanging hole50 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
ARF02LCPPL002 LHanging hole
ARF05LCPPL005 LHanging 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
ARF10LCPPL0010LHanging rod +
Hanging hole
ARF20LCPPL0020 LHanging rod +
Hanging hole
ARF50LCPPL0050 LHanging rod +
Hanging hole
ARF01LHAAL001 LHanging hole50 cm IDl/4"*OD7/16" Platinum 50 Platinum cured silicone tube + AseptiQuik® G Sterile Connector50 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
ARF02LHAAL002 LHanging hole
ARF05LHAAL005 LHanging 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
ARF10LHAAL0010LHanging rod +
Hanging hole
ARF20LHAAL0020 LHanging rod +
Hanging hole
ARF50LHAAL0050 LHanging rod +
Hanging hole
ARF01LX11L001 LHanging hole50 cm ID1/4"*OD7/16" Platinum 50 Platinum cured silicone tube + MPC female connector50 cm ID1/4"*OD7/16" C-Flex TPE tube + MPC male connector30 cm ID1/4"*OD7/16" C-Flex TPE tube + Needleless sampling valve
ARF02LX11 L002 LHanging hole
ARF05LX11L005 LHanging rod +
Hanging hole		50 cm ID3/8"*OD5/8" Platinum 50 Platinum cured silicone tube + MPC female connector50 cm ID3/8"*OD5/8" C-Flex TPE tube+ MPC male connector
ARF10LX11L0010 LHanging rod +
Hanging hole
ARF20LX11L0020 LHanging rod +
Hanging hole
ARF50LX11 L0050 LHanging rod +
Hanging hole
ARF01LXCCL001 LHanging hole50 cm ID1/4"*OD7/16" Platinum 50 Platinum cured silicone tube + TC25 connector50 cm ID1/4"*0D7/16" C-Flex TPE tube + TC25 connector30 cmlD1/4"*OD7/16"
C-Flex TPE tube + Needleless sampling valve
ARF02LXCCL002 LHanging hole
ARF05LXCCL005 LHanging rod +
Hanging hole		50 cm ID3/8"* OD5/8" Platinum 50 Platinum cured silicone tube + TC25 connector50 cm ID3/8"* OD5/8" C-Flex TPE tube + TC25 connector
ARFWLXCCL0010LHanging rod +
Hanging hole
ARF20LXCCL0020 LHanging rod +
Hanging hole
ARF50LXCCL0050 LHanging rod +
Hanging hole



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