Allegro™ single-use mixer
High performance, easy-to-use mixers for manual to fully automated solution preparation between 2 and 50 L.
Allegro™ single-use mixer
High performance, easy-to-use mixers for manual to fully automated solution preparation between 2 and 50 L.
Variant
Overview
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
- Low volume 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 Pall.
