UA-44035381-1
  • AseptiMix VC Vented Mixer Assemblies

AseptiMix VC Vented Mixer Assemblies

mdi AseptiMix VC are gamma sterilized vented mixer assemblies, suitable for mixing, safe transfer, and storage of biopharmaceutical products and reagents. The assembly does not require any additional hardware and can directly be placed on a magnetic mixer for mixing with a stir bar placed inside

The PVDF stir bar inside the mixer assembly has large chemical compatibility and it ensures the proper mixing of solution without any particle shedding.

These assemblies are fitted with a self-supporting light weight, sterilizing grade 0.2μm PVDF vent filter to prevent ingress of microorganisms during filling and removal of high-value products.

  • Mixing, storage and transfer of cell culture media and buffers
Construction
Dimension

Carboy

CapacityDiameterHeight
10 L249 mm390 mm
20 L285 mm535 mm

Materials of Construction
Carboy Low density polyethylene
Cap High density polyethylene
Inlet Tube Platinum cured silicone
Dip Tube Platinum cured silicone
Vent Filter
Membrane0.2μm hydrophobic PVDF
BodyPolypropylene
Stir Bar PVDF
Assurance
100% Integrity Tested Pressure Leak Test
Toxicity Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics
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 AseptiMix VC vented mixer 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 10 L Bottle AssemblyVCALF83XXXXX301
For 20 L Bottle AssemblyVCALG83XXXXX301
Customization

mdi AseptiMix VC vented mixer assemblies can be customized to suit user requirements in terms of tubing, fittings, end connections, and connectors.

Datasheet Download

Write a review

Note: HTML is not translated!
    Bad           Good