(480d) Evaluation of a Pendulum Agitator In Biopharmaceutical Applications

The Chemineer Clean Sweep is a pendulum mixer which applies a side to side mixing motion instead of the traditional rotational motion. This design allows for low volume mixing which is an important requirement for many pharmaceutical applications. In addition, the design utilizes a diaphragm seal eliminating the need for mechanical seals which can cause particulate shedding. This paper presents an evaluation of the Clean Sweep mixer. Cleanability and product quality were assessed under different operating conditions (agitation speeds and mixing volumes). The mixer design, mixing efficiency, ease of disassembly, and scalability parameters were also assessed. Results showed acceptable mixing and cleanability with no product quality effects based on size exclusion chromatography (SEC), filtration studies, particle counting, and turbidity measurements.