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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 < 0.25 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 |
| File Type | Download |
|---|---|
| Datasheet | Download |
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