PETG Bottle Assembly
MDI gamma sterilized Vented Bottle Assemblies are suitable for the safe transfer, sampling, and storage of biopharmaceutical products and reagents.
These assemblies are fitted with a self supporting lightweight, sterilizing grade 0.2μm PVDF vent filter to prevent ingress of microorganisms during filling and removal of high value products. The unique bottle cap design allows easy opening without rotating the tubing and vent connections.
- Storage and transfer of Cell culture media
- Aseptic sampling
- Sterile filling and transfer
| Materials of Construction | |||||||||||||||||||
| Cap | Polypropylene | ||||||||||||||||||
| Inlet Tube | Thermoplastic Elastomer (TPE) | ||||||||||||||||||
| Bottle |
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| Dip Tube | Platinum Cured Silicone (PCS) | ||||||||||||||||||
| Assurance | |||||||||||||||||||
| 100% Integrity Tested | Pressure Leak Test | ||||||||||||||||||
| Toxicity | Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics | ||||||||||||||||||
| Fiber Release | Passes test as per USP and comply with USFDA Title 21 CFR Part 210.3(b)(6) for fiber release | ||||||||||||||||||
| Particle Release | Complies with USP <788> test for particulate matter in injections | ||||||||||||||||||
| Endotoxin Testing | Aqueous extracts exhibit <0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test as per USP <85> | ||||||||||||||||||
| Extractables | Passes NVR test as per USP <661> | ||||||||||||||||||
| Sterility | mdi PETG 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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For Standard PETG Bottle Assemblies
| For 50 mL Bottle Assembly | VBAPS24XTXXX301 |
| For 60 mL Bottle Assembly | VBAPR22XTXXX301 |
| For 125 mL Bottle Assembly | VBAPP38XTXXX301 |
| For 250 mL Bottle Assembly | VBAPB38XTXXX301 |
| For 500 mL Bottle Assembly | VBAPV38XTXXX301 |
| For 1000 mL Bottle Assembly | VBAPC38XTXXX301 |
| For 2000 mL Bottle Assembly | VBAPD53XTXXX301 |
Customization
mdi PETG vented bottle assemblies can be customized to suit user requirements in terms of tubing, fittings, end connections, bottle sizes and connectors.
| Datasheet | Download |