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Single-use 2D liquid storage bags for bioprocess provide customized services

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Single-use 2D liquid storage bags for bioprocess used for biopharmaceutical antibody production, vaccine production, biotechnology, cell gene therapy, CGT gene therapy, cell therapy, CDMO
Single-use 2D liquid storage bags for bioprocess provide customized services

The products are manufactured in a clean room in accordance with ISO 14644 CLASS 7 standard and comply with the requirements of ISO 13485:2016 medical devices quality management system, ISO 9001:2015 quality management system and GMP related regulations, and are strictly controlled in all aspects from design and development, material selection, manufacturing to finished product inspection and release. Our products have established corporate standards according to USP, FDA, ISO, ASTM, Chp, Ep, YBB, etc. and are verified by qualified third-party testing laboratories, and the verification results are in compliance with Chp, YBB, USP<661>, USP<665>, USP<85>, USP87>, USP<88> Class Vl, USP<788>, ISO<1099>, and ISO<1099>. 788>, ISO<10993>SO<11137>, ASTM 1980-16, FDA CFR 177.2600, European Pharmacopoeia 3.1.9 standard requirements. We can provide complete system validation documents and technical support services to meet the needs of drug registration.

Single-use 2D liquid storage bags for bioprocess provide customized services

Single-use bags for biological processes, commonly known as single-use bioreactor bags, are specialized containers designed for the cultivation of cells or microorganisms in bioprocessing applications. These bags are used in the production of biopharmaceuticals, vaccines, and other biologically derived products. The term "single-use" implies that these bags are disposable after a single batch or use, reducing the risk of cross-contamination and eliminating the need for extensive cleaning and sterilization processes associated with traditional stainless-steel bioreactors.

Key Features of Single-Use Bags for Biological Processes:

  1. Material Compatibility: The bags are typically made from biocompatible and sterile materials such as polyethylene or other polymers that do not interfere with the growth of cells or the production of biological products.

  2. Sterility: Single-use bags must maintain a high level of sterility to ensure the integrity of the biological process. They are often gamma-irradiated or treated with other methods to achieve and maintain sterility.

  3. Scalability: Single-use bioreactor bags come in various sizes to accommodate different volumes, allowing for scalability in bioprocessing operations.

  4. Ports and Connectors: These bags include ports for the addition of nutrients, sampling, and harvesting of the cultured cells or products. The bags are equipped with connectors for integration with other components of the bioprocessing system.

  5. Mixing Systems: Some single-use bioreactor bags come with integrated mixing systems, such as magnetic stirrers or rocking motion, to ensure homogenous cell growth and product expression.

Advantages:

  1. Reduced Cleaning Validation: Eliminates the need for extensive cleaning and validation processes associated with traditional stainless-steel bioreactors.

  2. Flexibility: Allows for quick and easy changeovers between different batches or products.

  3. Cost-Efficiency: Reduces capital and operating costs associated with cleaning, sterilization, and maintenance of traditional bioreactors.

  4. Minimized Cross-Contamination Risk: With single-use bags, the risk of cross-contamination between batches is significantly reduced.

Applications:

Single-use bags for biological processes are used in a variety of bioprocessing applications, including:

  1. Biopharmaceutical Production: Cultivation of mammalian cells for the production of monoclonal antibodies, recombinant proteins, and other biopharmaceuticals.

  2. Vaccine Production: Growth of virus or bacteria cultures for vaccine production.

  3. Stem Cell Culture: Expansion and cultivation of stem cells for regenerative medicine applications.

  4. Microbial Fermentation: Cultivation of microorganisms for the production of enzymes, antibiotics, and other microbial-derived products.

The single-use bags for biological processes provide a flexible and cost-effective solution for bioprocessing applications, offering advantages in terms of scalability, sterility, and minimizing the risk of cross-contamination.

Introduction:

In the whole biological process, the storage and transportation of liquid is also very important. We can provide a complete system of transportation and storage solutions to support the needs of liquid handling in the production process, to meet the requirements of transportation and loading and unloading, with 2D and 3D storage bags ranging from 5 mL to 2500 L, as well as supporting containers and transport equipment.

The single-use bags produced are mainly made of 0.325 mm five-layer co-extruded film. With good physical strength, chemical compatibility and biological compatibility, the film is suitable for 2D and 3D storage bags and can meet the storage and transport needs of various solutions in the biopharmaceutical process. In addition, we can also provide a complete set of transfer tools, such as round plastic drums, folding plastic square boxes, plastic pallets and  material transfer trucks, etc.

*2D fluid storage bags are mainly applicated in industries of biopharmaceutical, laboratory, clinical diagnosis etc.

*The bag has a multi-layer membrane structure, and good performance in physical strength, chemical compatibility and biocompatibility.

*Operating temperature -80 to +45°C

*Customization for pipes of various size available to scale with different needs.

*2D liquid storage bag is of volume 5ML-50L, for liquid over 50L is 3D storage bag recommended.

*Gamma ray irradiation sterilization (25-40kGy)


Application:

·Storage and transport of the buffer and culture medium.

·Upper and down stream sample collection.

·Collection and transport of the cell harvesting solution.

·Purified fraction collection.

·Temporary storage and transportation of intermediate goods

·Multiple batches of products or liquid materials are combined

·Harvest, storage and transport of the stock solution.

·Transportation of the final products.

Characteristic:

Single-use 2D liquid storage bags for bioprocess provide customized services·Membrane material has good physical strength, chemical compatibility and biocompatibility.

·High transparency of membrane material, which is conducive to auxiliary process judgment.

·It can meet the storage and transport of various solutions in the biopharmaceutical process.

·Various sizes and pipelines can be flexibly customized according to customer needs.

We provide various customized services (OEM&ODM) to global buyers, informing us of the requirements for bioprocess single use bags or other equipment, such as pipeline materials, length, diameter, clamp types, usage or photos of the products currently in use. You can also inquire with us based on the standard model numbers listed below.

Standard bag order information:

Single-use 2D liquid storage bags for bioprocess provide customized servicesSingle-use 2D liquid storage bags for bioprocess provide customized servicesSingle-use 2D liquid storage bags for bioprocess provide customized servicesSingle-use 2D liquid storage bags for bioprocess provide customized services


Single-use 2D liquid storage bags for bioprocess provide customized servicesSingle-use 2D liquid storage bags for bioprocess provide customized services


Single-use 2D liquid storage bags for bioprocess provide customized services


Partial products categories: Bioprocess single-use bagsAtomic absorption spectrometer(AAS)Ultraviolet and Visible spectrophotometer(UV-VIS Spectrophotometer) , Life science instrumentsHeating instruments, etc.


We look forward to more communication with you. Please contact us for inquiryinfo@newmeen.com

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