Description
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.
