liners 3d, 3d liners, Single Use System, SUS, AL16, AL15, AL14, AL13
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- 1 | Ultra Low Density Polyethylene (ULDPE) |
|
| Dimension |
| AseptiLiner Volume | Drum Size | | Diameter | Depth | | 50 Litre | 43 cm | 46.5 cm | | 100 Litre | 51 cm | 63.5 cm | | 200 Litre | 59 cm | 91 cm | | 500 Litre | 76 cm | 126 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 < 0.25 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 50L AseptiLiner™ | AL13HXXXXXXS302 |
| For 100L AseptiLiner™ | AL14IXXXXXXS302 |
| For 200L AseptiLiner™ | AL15JXXXXXXS302 |
| For 500L AseptiLiner™ | AL16KXXXXXXS302 |
