ABSTRACT
The goal of process analytical technology is to understand and control the manufacturing process, which is consistent with our current drug quality system: quality cannot be tested into products; it should be built-in or should be by design. The adoption of disposable sensors requires a keen understanding of their need and utilization. Their suitability would be determined by their material properties, sensor manufacturing, process compatibility, performance requirements, control system integration, compatibility with treatments before use, and regulatory requirements. Electrochemical sensors include potentiometric, conductometric, and voltametric sensors. Thick- and thin-film sensors, as well as chemically sensitive field-effect transistors, possess potential as potentiometric disposable sensors in bioprocess control because they can be produced inexpensively and in large quantities. Many bioprocess unit operations are either controlled based on pressure or have significant pressure-related safety issues. Traditional stainless steel reactors are monitored and controlled for pressure, as pressure is used as a means of influencing mass transfer and preventing contamination.
