UA-44035381-1
  • AseptiLiner 3D Liners with Drain Port

AseptiLiner 3D Liners with Drain Port

mdi AseptiLiner 3D liners with drain port are specially designed for biopharmaceutical processes involving preparation and transfer of buffers, media and process intermediates.

These liners are made from robust multilayered film FL-2 with a polyethylene contact layer.

  • Preparation of media and buffers before filtration
  • Pooling process intermediate solutions
  • Waste collection from downstream purification processes
Physical Properties of Film
Film Multilayered film type FL-2
Tube Platinum Cured Silicone
Tensile Strength >25 N/mm² when tested as per ASTM D-882
Thickness 200µm
Elongation @ Break >400% when tested as per ASTM D-882
Gelbo Flex Test No pinholes after Flex durability test as per ASTM F 392
Tube Length 18 inch
Drain Port 1/2” HB male quick connector with female plug
Operational
Sterilization GammaIrradiated @25 kGy
Assurance
Bacterial Endotoxin Aqueous extracts exhibit < 0.125 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test as per USP<85>
Bioburden Bioburden level is < 1000 cfu/liner as perISO 117371: 2018
Fiber Release Passes microscopic test for fibers
Particle Release The filtrate complies with USP <788> test for particulate matter in injections
Extractables with WFI Does not affect the quality of Water for injection (passes test as per USP)
Biosafety

Passes the Biological Reactivity Tests, In Vivo for Class VI plastics as described in USP<88>.

Passes the Biological Reactivity Tests, In Vitro for Cytotoxicity as described in USP<87>.

For 50 L AseptiLinerAL07HXXXXXXS302
For 100 L AseptiLinerAL08IXXXXXXS302
For 200 L AseptiLinerAL11JXXXXXXS302
For 500 L AseptiLinerAL09KXXXXXXS302
For 1000 L AseptiLinerAL10MXXXXXXS302

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