• AseptiMix™ MI 3D Single Use Mixer Bags

AseptiMix™ MI 3D Single Use Mixer Bags

MDI AseptiMix™ MI 3D mixer bags provide validated and reliable mixing solutions for biopharmaceutical process requirements such as mixing of

  • Cell culture media
  • Process intermediates
  • Sterile buffers with wide ranging pH
  • Formulations

MDI AseptiMix™ MI single use mixer bags are designed for uniform and fast mixing. The impeller is located inside the AseptiMix™ MI mixer bags which is rotated with the help of a magnetic drive. These are available for volumes upto 1000 liters.

Powder Ports

The AseptiMix™ MI mixer bag is also available with 4” and 8” sanitary flange powder ports for powder-to-liquid mixing.

  • Custom designed to suit user specific process applications
  • Impeller for uniform and easy mixing
  • Available with 4” and 8” sanitary flange powder port for powder-to-liquid mixing
  • Easy inlet and outlet quick connections
  • High barrier properties for protection of product molecule, product pool and media components
  • 100% integrity tested
  • Powder to liquid mixing
  • Liquid to liquid mixing
Materials of Construction
Impeller Polypropylene
Bag Film AseptiFlex-D film type FBG-1

Thermoplastic Elastomer
Platinum cured silicone
Bacterial Endotoxin Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test as per USP <85>
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 injections
Extractables with WFI Does not affect the quality of Water for Injection (passes tests as per USP <661>)
Sterilization Gamma Sterilizable upto 50 kGy
Sterility The gamma sterilization process has been validated as per ISO 11137 to ensure a sterility assurance level(SAL) of 10-6
Biosafety Passes the Biological Reactivity Tests, In Vivo for Class VI plastics as described in USP <88>.

These AseptiMix™ MI mixing systems can be customized to suit user requirements regarding tubing sizes, type of inlet ports, sampling ports, and position and type of drain ports. A technical feasibility of the required design is established based on available components and an initial drawing is proposed. Products prototyping and final approval leads to customized mixer bag realization.

Datasheet Download

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AseptiMix™ MI is made from AseptiFlex™-D film offering multiple advantages such as:

  • Uniform and fast mixing
  • Customized to user requirements
  • Very low extractable profile for low ‘Product’ risk