(493i) Off-the-Shelf Data Loggers Used to Gain Process Understanding Across Pharmaceutical Unit Operations

Process Analytical Technologies (PAT) is often narrowly focused on spectroscopic techniques, which tend to require significant upfront costs and complex data treatments to provide insight into pharmaceutical processes. However, a broader view of PAT as technologies that enable process understanding encompasses a range of monitoring devices, including novel, univariate measurement tools, such as Pyrobuttons^TM. These small, stainless-steel data loggers have enabled temperature and humidity data capture from a range of pharmaceutical processes, such as fluid bed systems and film coaters, with the data stored in an access-controlled, 21-CFR-compliant database, allowing for data traceability. The quick turnaround on data download allows for rapid process changes during development work, which has proven useful for early-phase projects with minimal drug substance available. Application of these monitoring devices to a wide range of unit operations will be demonstrated, with an emphasis on how the data is used to gain process understanding that allows for faster, more knowledgeable product development.