Premier Single-Use Bioprocessing Bags & Bottles Reduce Contamination Risks

BioLink offers a wide range of single-use bioprocess containers covering liquid storage, transport, sampling, mixing, cryopreservation, and final filling. Our disposable bioprocess bags offer many advantages, such as their unique flexibility and safety. Using disposable bioprocess containers can reduce your process risk and increase the efficiency of commercial production. BioLink's single-use bioprocessing containers include 2D single-use bags, 3D single-use bags, RNase free single-use bags, single-use bioprocessing bottles, single-use mixing bags, sterile sampling bags and sterile sampling bottles.

Types of Single-Use Bioprocess Containers

BioHub^® 2D Single-use Storage Bag

BioHub® 2D single-use storage bag are designed for bioprocess needs, suitable for liquid, liquid storage, transport, and cryopreservation. A variety of specifications to choose from, fast delivery.

BioHub® 2D Single-use Storage Bag

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BioHub^® 3D Single-use Storage Bag

BioHub® 3D Single-use Storage Bags are designed for bioprocess needs. It is suitable for buffer storage, media storage, intermediate product storage bulk storage and transport. Flexible, efficient, and safe fluid management options.

BioHub® 3D Single-use Storage Bag

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BioHub^® Single-use Freeze-thaw Bag

BioHub® Single-use Freeze–thaw Bags are designed for the safe and efficient freezing of intermediates, bulk drug substances, and other process fluids in biopharmaceutical R&D and production.

BioHub® Single-use Freeze-thaw Bag

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NovaLinX^® Nuclease-free Single-use Consumables

The best choice for mRNA production, say Goodbye to degradation. Innovative design of RNase-free bioprocess disposable consumables with 100% RNase/DNase inspection and release of products and customer verification.

NovaLinX® Nuclease-free Single-use Consumables

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HemoLinX^® CFT Freezing Bag

HemoLinX® CFT Freezing Bag is designed for safe cryopreservation at ultra-low temperatures, ensuring cell integrity andviability throughout freezing, storage, and thawing. Ideal for single-cycle cryo...

HemoLinX® CFT Freezing Bag

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BioHub^® Single-use Storage Bottle

Reliable material, stable supply. BioHub® Single-use Storage Bottle is available in autoclave and gamma irradiated versions with different caps, eliminating the risk of batch-to-batch or product-to-product cross-contamination.

BioHub® Single-use Storage Bottle

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BioHub^® Storage Bottle Tool Kit

In biopharmaceutical process, the storage of process liquids, especially bulk drug substances, is crucial. To ensure the sealing integrity between the storage bottle and the cap, and to meet PDA No. 9...

BioHub® Storage Bottle Tool Kit

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Certifications of Single-Use Bioprocessing Bags and Bottles

Single use bioprocessing bags eliminate costly cleaning validation and reduce cross-contamination risks, accelerating your time-to-market. BioLink's single-use bags and bottles are validated to meet your compliance and safety requirements. It has passed the following quality control standards:

ISO 10993-4 Hemolysis

ISO 10993-5 Cytotoxicity

ISO 10993-6 Implantation test

ISO 10993-10 Irritation and Sensitization test

USP <85> Bacterial Endotoxins-LAL test

USP <88> Biological reactivity testing, in vivo, class VI

USP <87> Biological reactivity testing, in vitro

USP <661> Pharmacopoeia tests, ch 3.1.5.

Also, BioLink's major bioprocess product, disposable bioprocess bags and bottles, can be used in multiple process steps such as liquid mixing, liquid storage, transport, cryopreservation, sampling, and preparation filling to help customers save validation costs. We have complete chemical compatibility data, extractables testing and physical performance testing and support related audits.

DMF Acknowledgement                                           ISO 9001

FAQs of Single-Use Bioprocessing Bag & Bottle

Q

What are single use bioprocess containers made from?

A

The film is by Renolit. Fabricated using state-of-the-art multilayer co-extrusion technology, the film has ultra-low dissolution and precipitation levels to ensure safety, offering an ideal choice for biopharmaceutical customers.

FAQ

Q

What are the different types of single-use bioprocessing bags and bottles that BioLink offers?

A

BioLink offers a wide range of disposable bioprocess containers covering liquid storage, transport, sampling, and mixing. Disposable bioprocess bags, like 2d biocontainer and 3d biocontainer, are made of multilayer co-extrusion, supporting irradiation sterilization. Bioprocessing bottles are made of PC, supporting autoclave and irradiation sterilization, covering liquid storage, transport, and sampling application.

FAQ

Q

What are the benefits of single-use bioprocess containers?

A

Single-use applied bioprocess containers have the advantages of safety and flexibility. The use of disposable products can greatly reduce the risk of contamination during the process. In addition, single-use containers allow biological manufacturers to schedule their production tasks more flexibly, improve capacity utilization and reduce costs.

Chrom-LinX® Automated Chromatography Column are designed for downstream purification of biopharmaceuticals. They are operated by automated control software (with the BioLink Packing-LinX® column packing workstation), to minimize the cumbersome manual operation of conventional columns. Column packing with the BioLink Slurry-LinX® series slurry tank allows the entire process to remain in a closed environment for most of the time, minimizing the risk of exposure and contamination of the chromatography resin and homogenizing solution.

Chrom-LinX® Automated Chromatography Column have been carefully designed and proven to provide excellent performance with most of the different types of resin. They are compatible with the ChromaX® chromatography resins from BioLink, and perform very well when filled with Chromstar FF and MaXtar series resins of high rigidity and flow rate. The software in the workstation presets the packing method of relevant resins, which can simplify the packing process and improve the production efficiency.

Please be advised that this product is only available for sale and after-sales support in certain regions. For further details, kindly consult with your local sales representative. Thank you for your understanding.

Overview of Chrom-LinX® Automated Chromatography Column

Chrom-LinX® automated large scale chromatography column works in a low-pressure and axial compression mode as a standardized equipment with ID of 450, 600, 800, 1000, 1200 mm and column tube height of 700 mm (1000 mm customizable), making itself suitable for the manufacturing of various types and scales of bioproducts.

The exhaust structure of the columns has been carefully designed and tested to allow for easy exhaust and cleanliness of the column head, reducing cleaning and maintenance steps. The design of the column head distribution plate ensures uniform distribution of liquid flow. The packing process is controlled by software in the column packing workstation, which enables intelligent loading and unloading, as well as automated packing, dismantling and maintenance operations through programming, ensuring the stability and reproducibility of packing. A pre-homogenized resin is pumped into the column through the inlet at the column bottom. The column head is driven upwards by a servo motor, and after pumping in a sufficient amount of homogenate, the column head moves downwards to pack the resin. The speed of the column head can be set by software, and the accuracy of the movement distance can reach 1mm. The height of the column bed can be precisely controlled so that the resin forms a uniform and stable bed structure within the column.

Features of Chrom-LinX® Automated Chromatography Column

Column tube is acrylic structure, clear vision, column bed position visible.

Sanitary design, in line with GMP requirements.

Material safety, in line with the regulatory requirements.

Scientific design, no clean dead corner.

Can be used for a variety of packing.

Specifications of inner diameter: 300, 450, 600, 800, 1000, 1200 mm.

Height range: 550 and 570 mm.

Screen aperture: 10μm and 20μm are optional.

Material of Chrom-LinX® Automated Chromatography Column

Chrom-LinX® Auto Automated Chromatography Columns are made of materials suitable for biopharmaceutical production. The structural materials conform to ASME biological processing equipment standards, and the wetted polymer materials and elastic materials meet the requirements of USP<88> in vivo biological reactivity test and FDA 21 CFR Part 177. All materials contain no ingredients of animal origin and comply with the regulations in EMA/410/01 2nd edition. The parts used are traceable back to the product batch. Wetted parts can withstand most chemical reagents commonly used in chromatography, such as buffers or organic reagents for adsorption, elution, washing and preservation, as well as disinfectant solutions.

Packing-LinX® Column Packing Workstation

The Packing-LinX® Column Loading Workstation enables 21 CFR Part 11 compliant packing operations. Chromatography columns are operated via the touch screen of the workstation. The workstation supports functions including venting, filling, disassembly, and maintenance besides corresponding programs, which can be selected and set by the operator as needed. During the packing process, the equipment will stop automatically when the set compression factor or height is reached, or the operator can stop it manually at any time.

**Please be advised that this product is only available for sale and after-sales support in certain regions. For further details, kindly consult with your local sales representative. Thank you for your understanding.

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

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.

Why Choose Nuclease-free Single-use Bag?

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”.

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).

Specifications of NovaLinX® Nuclease-free Single-use Consumables

**Please be advised that this product is only available for sale and after-sales support in certain regions. For further details, kindly consult with your local sales representative. Thank you for your understanding.

We can offer kinds of RNAse-inhibiting bags for sale. If you are interested, please contact us.

Chrom-LinX® manual chromatography columns are the ideal choice for purification applications. Specifically designed to meet the needs for the chromatography process development in biopharmaceuticals, these columns can be packed with various commonly used media available in the market, including "soft gels"1 like dextran-based agaros, as well as "hard gels" like poly (styrene divinylbenzene) (PS-DVB)2 and hydroxyapatite3. They provide an ideal column platform with high versatility, adaptability and stability. Utilizing the widely adopted rotation compression sealing method in the industry, the simplified design of Chrom-LinX® columns significantly enhances the user experience, and improve the efficiency and success of media packing.

The Chrom-LinX® series columns are designed to optimize the user experience by offering a comprehensive range of optional accessories and spare parts including tubing, valves, consumables, etc. Such a ecosystem empowers users to confidently tackle chromatography processes without any apprehensions about purification challenges.

Please be advised that this product is only available for sale and after-sales support in certain regions. For further details, kindly consult with your local sales representative. Thank you for your understanding.

Features of Chrom-LinX® Manual Compression Industrial Chromatography Column

The SCHOTT borosilicate glass column tubing, with precise column tubing inner diameter and smooth coaxial circumference, ensures meticulous and efficient separation and purification.

The upper and lower sieves of the column are made of USP <88> Class material, and based on the customized plastic sealing process of BioLink. The column is endowed with low flow pressure difference, high liquid dispersion ability, and excellent distribution performance.

Sealing components are made of EPDM material in accordance with USP <88> Class, providing excellent sealing performance with a minimal dead cavity volume.

All parts in contact with the liquid are made of pharmaceutical-grade high-quality stainless steel, offering excellent rigidity and corrosion resistance.

The tubing connection is based on sanitary Tri-Clamp quick fittings, and the sanitary design of the whole flow path ensures the cleanliness of the column.

Optimized screw lifting and O-ring sealing handles for operating sensations make the operation effortless.

The bottom is designed with a side outlet interface for easy connection to valve tubing connector and other components. The micro-slope design ensures efficient liquid drainage, easy cleaning, and no dead corners.

Adaptive column packing reservoirs with a variety of specifications are available to facilitate packing of higher column beds.

*Chrom-LinX 300/X chromatography columns are equipped with distribution plate, with no support screen.

**Chrom-LinX 100/X, 140/X, 200/X chromatography columns are equipped with support screens, with no distribution plate.

Specifications of Chrom-LinX® Manual Compression Chromatography Column

Product Code and Specification Table

**Please be advised that this product is only available for sale and after-sales support in certain regions. For further details, kindly consult with your local sales representative. Thank you for your understanding.

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