Achieving PAT Goals with Process Analytics Equipment
Pharmaceutical manufacturers need to focus on quality and cost efficiency. Traditionally, the pharmaceutical industry evaluates quality on samples tested in the laboratory. The FDA has encouraged the industry to implement in-line tools as described in the PAT initiative, with the goal being to better understand and control the manufacturing process.
This white paper focuses on a new technology used to assist the measurement of pH and dissolved oxygen in bioreactors, as well as in product purification and downstream processing. pH and dissolved oxygen measurement are classical tools. Intelligent Sensor Management (ISM), a break-through improvement to these measurement parameters, offers diagnostic tools that aid optimization of the lifetime, performance and reliability of process analytical equipment. It is much better to predict problems before they happen, than to have to respond rapidly because a sensor has failed in service. Intelligent Sensor Management means higher process safety, higher productivity and less downtime.