UA-44035381-1
  • PETG Bottle Assembly

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 High-density polyethylene (HDPE)
Inlet Tube Thermoplastic Elastomer (TPE)
Bottle
CapacityDiameterHeight*
125 mL53 mm104 mm
250 mL59 mm142 mm
500 mL73 mm174 mm
1000 mL92 mm213 mm
2000 mL116 mm266 mm

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.

For Standard PETG Bottle Assemblies
For 50 mL Bottle AssemblyVBAPS38XTXXX301
For 60 mL Bottle AssemblyVBAPR38XTXXX301
For 125 mL Bottle AssemblyVBAPP38XTXXX301
For 250 mL Bottle AssemblyVBAPB38XTXXX301
For 500 mL Bottle AssemblyVBAPV38XTXXX301
For 1000 mL Bottle AssemblyVBAPC38XTXXX301
For 2000 mL Bottle AssemblyVBAPD53XTXXX301
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

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