Polycarbonate 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 duringinoculum transfer.
- Aseptic inoculum transfer to bioreactors
Materials of Construction | |||||
Bottle | Polycarbonate | ||||
Vent Filter |
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Connector | Polypropylene | ||||
Tubing |
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Specifications | |||||
Capacity | 2 litre | ||||
Vent Pore Size | 0.2μm | ||||
Operational | |||||
Max. Operating Temperature | 45 °C | ||||
Sterilization | Gamma irradiated @ 25kGy | ||||
Assurance | |||||
100% Integrity Tested | Polycarbonate Bottle Assembly | ||||
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 | ||||
Biosafety | Passes Bioreactivity test, In-vivo, as per USP <88> for Class VI plastics |
A470XXXXXXXC301 for 2 Liter Inoculum Bottle with | Platinum Cured Silicone Tube. | |
*Please contact for customized drawings for TPE | tubing option. |
Datasheet | Download |