Use of Commercial Data Loggers to Develop Process Understanding in Pharmaceutical Unit Operations
Tóm tắt
Due to the growing emphasis on quality by design during pharmaceutical development, accurate process data collection has become even more crucial. While process analytical technology has emphasized complex spectroscopic techniques, univariate measurements can provide data to develop further process understanding, such as assessing the impact of operating conditions on downstream product attributes or spatially mapping the equipment environment for building detailed process models. Since pharmaceutical scientists have historically had little ability to influence equipment manufacturers on the number, type, or location of sensors intended to measure processing conditions, additional univariate measurements have been obtained using robust temperature/humidity sensors in a number of unit operations. The small size of the sensors allows them to be placed anywhere they are not subject to mechanical damage, while the 21-CFR-11-compliant database provides for traceability for regulatory submissions. This work presents data from fixed-location and portable sensors for two widely used pieces of pharmaceutical equipment, film coaters and fluid bed systems. Portable sensors are also demonstrated as a viable means to obtain process data not available by fixed-location sensors, such as the tablet bed of a film coater. These sensors have been used for a range of process scales, from early-stage products with minimal drug substance to commercial-scale production.
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