The XELTA 3D bags are designed for large-scale applications where systems are required to be reliable, flexible and easy to install. Manufactured from premium film Validated for use in the Biopharmaceutical and Pharmaceutical manufacturing processes. The XELTA 3D bags bring together state-of-the-art design features that improve the robustness of single-use systems. This brings considerable advantages in terms of ease of use and product recovery when dealing with large fluid volumes.

The XELTA 3D bags are designed for reliable, flexible, and easy-to-install large-scale applications in biopharmaceutical and pharmaceutical manufacturing processes. They offer state-of-the-art design features that improve single-use system robustness and ease of use. With various types and specifications available, these bags are suitable for storage, transport, filtering, and mixing of biopharmaceutical liquids. They comply with pharmacopeia standards and undergo extensive testing to ensure quality and biocompatibility. The specialized film used in the bags provides good resistance to chemicals and solvents and has excellent clarity, tensile strength, and permeability properties. Gamma irradiation is recommended for sterilization.

XELTA 3D bags have been designed for safe processing and storage of a wide range of biopharmaceutical liquids in a variety of applications such as:

Storage and transport of buffer and media Transport of cell harvest suspension Purified component collection Filtering and storing of intermediates Appropriate liquid-liquid mixing process7 Storage and transport of drug substance

 

DOWNLOAD DATASHEET (PDF)

TECHNICAL INFORMATION

The XELTA 3D bags are designed for reliable, flexible, and easy-to-install large-scale applications in biopharmaceutical and pharmaceutical manufacturing processes. They offer state-of-the-art design features that improve single-use system robustness and ease of use. With various types and specifications available, these bags are suitable for storage, transport, filtering, and mixing of biopharmaceutical liquids. They comply with pharmacopeia standards and undergo extensive testing to ensure quality and biocompatibility. The specialized film used in the bags provides good resistance to chemicals and solvents and has excellent clarity, tensile strength, and permeability properties. Gamma irradiation is recommended for sterilization.

XELTA 3D bags have been designed for safe processing and storage of a wide range of biopharmaceutical liquids in a variety of applications such as:

Storage and transport of buffer and media
Transport of cell harvest suspension
Purified component collection
Filtering and storing of intermediates
Appropriate liquid-liquid mixing process
Storage and transport of drug substance

1) Compliance:
The following tests are conducted for Pharmacopoeia compliance and Bio-compatibility.
USP <85> Bacterial Endotoxins – LAL test
USP <87> Biological Reactivity Test in-vitro
USP <88> Biological reactivity testing, in-vivo, Class VI European Pharmacopoeia tests 3.1.5
USP <661.1> Polyethylene Physiochemical Tests, Extractable Metals, Plastic Additives

2) Film Properties
The film used in XELTA 3D bags is specialized for biopharmaceutical and pharmaceutical processes.

The thickness of the film is 0.325mm
The recommended sterilization method is Gamma Irradiation. The dose for gamma sterilization is 25-50 KGy
Good resistance to many chemicals
Good resistance to polar solvents (alcohols, esters, etc)
Water pH compatibility – 2.5 to 11
Clarity – ASTM D-1003
Tensile Strength at break – ASTM D-882
O2 permeability – ASTM D-3985
CO2 permeability – ASTM F-2476

 

 

Coming Soon!

 

 

GET YOUR DATA SHEET NOW! JUST FILL OUT THE QUICK FORM TO DOWNLOAD.

    For further specifications and ordering information

    MORE SOLUTIONS

    NXTtff

    The NXT TFF system by PharmNXT Biotech is a system that’s perfect for running fully automated UF/DF processes at high capacity. It can handle any volume between 20L and 500L (200 g to 2.5 kg), and the compact system, has a low hold-up volume and the capacity to accommodate cassettes with surface area ranging from 0.5 to 2.5 m2

    Chromatography Resins (Purolite)

    The purification of commercially-available monoclonal antibodies (mAbs) on the market today is typically performed in three chromatography steps. Purolite offer industry-leading solutions for each step. 
    Protein A Affinity Chromatography
    A Protein A affinity resin is utilized as an initial antibody capture step. Praesto Protein A resins deliver exceptionally high purity (>99%) and yield in a single, efficient step.
    Cation Exchange Chromatography
    A Sulphopropyl- (SP) functionalized cation exchange resin in ‘bind and elute’ mode is used to remove aggregates and HCP (Host Cell Proteins).
    Anion Exchange Chromatography
    A Quarternary Amine (Q) functionalized anion exchange resin is used in ‘flow-through’ mode to remove trace contaminates and ensure sufficient viral clearance.

    NXTmfilt

    Single-use technology continues to be adopted for many areas of bioprocessing. The use of automation provides additional benefits in manufacturing such as consistency in product quality, reduced labor costs, and reduction of operator errors.

    For further process consultancy or sales and service related queries