LDPE Bottle Assembly
MDI Single Use Assembly for inoculum transfer is a gamma sterilized vented assembly to transfer cell culture to bioreactors.
These assemblies have been designed to provide a closed system to prevent extraneous contamination during inoculum transfer.
- Aseptic inoculum transfer to bioreactors
| Materials of Construction | |||||
| Bottle | LDPE | ||||
| Vent Filter |
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| Connector | Polypropylene | ||||
| Specifications | |||||
| Capacity | 2 litre | ||||
| Vent Pore Size | 0.2μm | ||||
| Operational | |||||
| Max. Operating Temperature | 45 °C | ||||
| Sterilization | Gamma irradiated @ 25kGy | ||||
| Assurance | |||||
| 100% Integrity Tested | Pressure Leak Test | ||||
| Bacterial Endotoxin | Aqueous extracts exhibit < 0.25 EU/ml | ||||
| Fiber Release | Passes test as per USP and comply with USFDA 21 CFR Part 210.3 (b) (6) for fiber release | ||||
| Particle Release | Complies with USP <788> test for particulate matter in injection | ||||
| Endotoxin Testing | Aqueous extract exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) test | ||||
| Sterility | mdi LDPE vented bottle assemblies are sterilized by gamma irradiation to provide a sterility assurance level of 10-6. The sterilization process has been validated as per ISO 11137-2 which includes dose verification, dose mapping, and quarterly dose audits. The sterilization dose of 25 kGy has been substantiated through the careful definition of the test samples, bioburden testing of multiple lots of the selected test samples, calculation of verification dose, and sterility testing. |
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| Biosafety | Passes Bioreactivity test, In-vivo, as per USP <88> for Class VI plastics | ||||
Customization
mdi LDPE vented bottle assemblies can be customized to suit user requirements in terms of tubing, fittings, end connections, bottle sizes, and connectors.
| Datasheet | Download |