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.

XELTA 2D 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
  • Storage and transport of drug substance
  • Intermediate and final product sampling

Compliance:

The following tests are conducted for Pharmacopoeial 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 Physicochemical Tests, Extractable Metals, Plastic Additives

Film Properties

• • The film used in XELTA 2D 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 wide range of Pharmaceutical and Biopharmaceutical grade 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

Ordering Information

Disclaimer : All specifications are subject to change. PharmNXT Biotech reserves the right to modify the content. Please contact us while ordering.

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