AseptiMix™ MB
MDI AseptiMix™ MB single use mixer bags are designed for uniform and fast mixing of
- Cell culture media
- Process fluids
- Buffers
- Reagents
- Formulations
The polypropylene stir bar located inside the MDI AseptiMix™ MB mixer bags is rotated with the help of magnetic mixer placed on the trolley base of magnetic mixer systems.
- Custom designed to suit user specific process applications
- Polypropylene stir bar for uniform and easy mixing
- Available with 50 mm 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 with pressure leak test
- Robust and flexible with high burst strength
MDI AseptiMix™ MB systems are used for critical biopharmaceutical process steps such as:
Mixing and transfer of
- Cell culture media
- Buffers
- Formulations
AseptiMix™ MB is made from AseptiFlex™-D film offering multiple advantages such as:
- Very low extractable profile for low ‘Product’ risk
- Higher strength and flexibility
| Materials of Construction | |
| Bag Film | AseptiFlex™-D film type FBG-1 |
| Stir Bar | Polypropylene |
| Tubing | Thermoplastic Elastomer Platinum cured silicone |
| Specifications | |
| 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 |
| Bacterial Endotoxin | Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test as per USP <85> |
| Biosafety | Passes the Biological Reactivity Tests, In Vivo for Class VI plastics as described in USP <88>. |
| 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>) |
| Description | Catalog No |
| BioMixer™ MB Hardware Trolley | BMBHTXXXXXXXX01 |
| 200L Cylindrical Drum for BioMixer™ MB | PEDXJMBXXXXXX01 |
| BioMixer™ MB Drive Unit 110V | BMBHDAXXXXXXX01 |
| BioMixer™ MB Drive Unit 230V | BMBHDBXXXXXXX01 |
| File Type | Download |
|---|---|
| Datasheet | Download |
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