(615g) Application of Commercially Available Data Loggers to Gain Process Understanding Across Pharmaceutical Development Processes

The increased emphasis on QbD during pharmaceutical development has created a need for a range of technologies that can be used to obtain process understanding data. Process Analytical Technologies (PAT) is often considered synonymous with 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. Use of these calibrated sensors also gives a way to assess the need for validated measurement solutions on process equipment prior to significant capital outlay.

These simple devices have provided information across all phases of development, from early stage work with minimal drug substance to trouble-shooting exercises for commercial-scale products. Application to numerous unit operations will be shown, with an emphasis on how the data is used to gain process understanding that allows for faster, more knowledgeable product development. Pyrobuttons provide a relatively affordable and rapid means of building process understanding across a wide range of pharmaceutical processes.