(493i) Off-the-Shelf Data Loggers Used to Gain Process Understanding Across Pharmaceutical Unit Operations
AIChE Annual Meeting
2009
2009 Annual Meeting
Food, Pharmaceutical & Bioengineering Division
Poster Session: Pharmaceutical Engineering
Wednesday, November 11, 2009 - 6:00pm to 8:00pm
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 PyrobuttonsTM. 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.