AseptiMix™ MI Mini
Biopharmaceutical process involves a very wide range of process fluids. A critical requirement is mixing of many of these fluids within the isolators such as vaccines with adjuvants, nano suspensions and small batches of high value drug products.
Specially designed MDI AseptiMix™ MI Mini 3D mixer bags provide validated and reliable mixing solutions for these biopharmaceutical process requirements.
These single use disposable pre-sterilized mini mixer systems can be used to mix very small volumes starting from 400 mL.
Custom designed to suit user specific process applications
- Works with very low volumes (400 mL)
- Sanitary flange powder port for powder-to liquid mixing
- 2″ powder port available for 1L and 2L bags
- 2″ or 3″ powder port options available for 5L to 20L bags
- Easy inlet and outlet quick connections
- 100% integrity tested with pressure leak test
MDI AseptiMix™ MI Mini mixer bags are used for critical biopharmaceutical process steps involving mixing and transfer of drug product formulations such as:
- Antibody drug conjugates (ADCs)
- Orphan durgs
- Vaccines with adjuvants
- Nano suspensions
| Materials of Construction | |||||||||||||||||||||||||
| Impeller | Polypropylene | ||||||||||||||||||||||||
| Bag Film | AseptiFlex-I | ||||||||||||||||||||||||
| Tubing | Platinum cured silicone | ||||||||||||||||||||||||
| Dimensions | |||||||||||||||||||||||||
| Bag Size |
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| Assurance | |||||||||||||||||||||||||
| 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 Mini 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.
| File Type | Download |
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| Datasheet | Download |
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