UA-44035381-1
  • AseptiLiner 3D

AseptiLiner 3D

mdi AseptiLiner 3D liners are specially designed for biopharmaceutical processes involving storage and transfer of process intermediates such as post centrifuge slurries and pellets. The easy to seal design using wire ties ensures leak proof storage and transfer.

  • Preparation of media and buffers before filtration
  • Pooling process intermediate solutions
  • Waste collection from downstream purification processes
Construction
Materials of Construction

Film FL- 1Ultra Low Density Polyethylene (ULDPE)
Dimension
AseptiLiner VolumeDrum Size
DiameterDepth
50 Litre43 cm46.5 cm
100 Litre51 cm63.5 cm
200 Litre59 cm91 cm
500 Litre76 cm126 cm
Physical Properties of Film
Tensile Strength >20 N/mm² when tested as per ASTM D-882
Elongation @ Break >280% when tested as per ASTM D-882
Operational
Sterilization Gamma Irradiated @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 50L AseptiLinerAL13HXXXXXXS302
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