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 AseptiLiner | AL07HXXXXXXS302 |
| For 100 L AseptiLiner | AL08IXXXXXXS302 |
| For 200 L AseptiLiner | AL11JXXXXXXS302 |
| For 500 L AseptiLiner | AL09KXXXXXXS302 |
| For 1000 L AseptiLiner | AL10MXXXXXXS302 |
| Datasheet | Download |