Biopharmaceutical processing involves a wide range of process fluids, with many critical mixing operations required within isolators. Applications such as vaccines with adjuvants, nano suspensions, and small batches of high-value drug products require reliable mixing solutions, particularly where process integrity, sterility, endotoxins, biosafety, extractables, and particle or fiber release are important considerations.
The MDI AseptiMix™ MI Mini has been specially designed to provide a validated and reliable single-use mixing solution for these requirements. These disposable, pre-sterilized mini mixer systems are designed for very small volumes starting from 400 mL.
The system uses a magnetic drive to rotate an impeller fixed inside the mixer bag, providing the mixing action without requiring direct mechanical contact with the impeller. The mixer bag is also available with a sanitary flange powder port for powder-to-liquid mixing.
Key Applications
MDI AseptiMix™ MI Mini mixer bags are used for critical biopharmaceutical process steps involving mixing and transfer of drug product formulations, including:
- Antibody drug conjugates (ADCs)
- Orphan drugs
- Vaccines with adjuvants
- Nano suspensions
The mixer systems can support both liquid-to-liquid and powder-to-liquid mixing, with configurations customized according to user requirements.
Designed for Small-Volume Processing
AseptiMix™ MI Mini mixer bags are manufactured using AseptiFlex™-I, a multilayered polyethylene film designed for bioprocess applications. The film is physically tough and chemically inert, while its multilayer construction provides barriers to oxygen, carbon dioxide, and moisture. Its contact layer is ultra-low-density polyethylene without additives.
The mixer bags are available in 1 L, 2 L, 5 L, 10 L, and 20 L sizes. Powder port configurations include a 2-inch port for 1 L and 2 L bags, and 2-inch or 3-inch options for 5 L to 20 L bags.
Validation and Quality Considerations
For biopharmaceutical manufacturing, the performance and characterization of single-use components are critical considerations.
AseptiMix™ MI Mini mixer bags are produced in validated ISO Class 7 facilities under an ISO 9001 quality management system. Each lot is supported by manufacturing records providing traceability of raw materials, equipment, personnel, process controls, and quality-control data.
The mixer systems are validated for key quality attributes including:
- 100% integrity testing
- Pressure and temperature endurance
- Burst pressure
- Bioburden <1,000 cfu/bag
- Bacterial endotoxin <0.25 EU/mL
- Biosafety according to USP <88> Class VI
- Fiber release testing
- Particle release according to USP <788>
- Extractables with WFI according to USP <661>
- Gamma sterilization up to 50 kGy
- Sterility assurance level of 10⁻⁶ according to ISO 11137
Configured to Your Process
AseptiMix™ MI Mini systems can be customized according to requirements for tubing sizes, inlet ports, sampling ports, and drain ports. MDI establishes technical feasibility based on factors such as pressure, temperature, system complexity, and component compatibility before developing the customized design.
The system can also be integrated with prequalified components including membrane capsule filters, connectors, tubing, and fittings.
Explore Compact Single-Use Mixing with AseptiMix™ MI Mini
Looking for a compact single-use mixing solution for small-volume biopharmaceutical processing? Explore how AseptiMix™ MI Mini can be configured for your mixing and powder-to-liquid requirements.
Explore AseptiMix™ MI Mini Documentation