Allegro™ single-use mixer

Mixing is a critical operation within many biopharmaceutical processes for applications ranging from buffer and media preparation, in-process unit operations such as low pH viral inactivation, to final formulation. The Allegro™ 50 L single-use mixer is part of the expanding range of Allegro products and services providing integrated process solutions throughout the drug production process. The Allegro mixers combine critical requirements for single-use technologies, such as extreme ease-of-use, with established engineering design principles and criteria for robust mixer design to deliver the ultimate in mixing performance.

The Allegro 50 L mixer is designed to provide exceptional mixing performance for a wide range of applications from upstream through downstream process to formulation and filling. Due to its efficient mixing and high turn-down ratio, this mixer is especially suited to small volume formulation applications where fast, reproducible results are required. Potential applications include:

• Upstream media preparation for cell culture
• Downstream pH adjustment, virus inactivation and buffer preparation
• Final formulation mixing

Single-use mixers are also available in larger sizes – contact your Cytiva representative for more info.

Validation

As part of our rigorous approach to product validation, a wide range of tests have been conducted in addition to the general performance tests to prove the robustness of the Allegro 50 L mixer. A summary of key validation tests is provided below:

• Biological safety (USP<87> and <88>)
• Physico-chemical tests (USP<661>)
• Particulate matter in Injections (USP <788>)
• USP<85> LAL endotoxin (compared to limit for WFI)
• Extractables testing (water and ethanol)
• Gamma resistance<788>)
• Leak tests
• Drainage/product recovery
• Tubing connection robustness
• Shelf life studies

Full details of product validation in the form of a comprehensive validation guide can be requested from Cytiva.