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.

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

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

Film Properties

• • The film used in XELTA 3D bags is specialized for biopharmaceutical and pharmaceutical processes.
  • 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

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XELTA 2D

The XELTA 2D bags have been designed for crucial applications where systems are required to be reliable, flexible, and easy to install. Manufactured from premium film and with a film thickness of 0.325mm the XELTA 2D bags are validated for use in the biopharmaceutical and pharmaceutical manufacturing processes. The XELTA 2D 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 biopharmaceutical fluids.

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NXTstor

NXTstor is a stainless steel container designed for safe and robust storage of biopharmaceutical fluids using XELTA 3D single-use bags. This unit has a wide range of bag sizes, making it suitable for many applications. NXTstor units are available in four volumes: 100L, 200L, 500L and 500L. NXTstor is available in both the option Jacketed and Non-Jacketed for temperature-sensitive applications.

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XELTA Mix

The XELTA Mix bags are available in various types and specifications starting from 50L, 100L, 200L, 650L and 1000L and can be used independently for the preparation of buffer, media, intermediate or drug substance mixing.

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