(769a) In Process Wireless Coating Bed Temperature Monitoring: Application of a Novel Commercial off the Shelf Solution for PAT and Qbd Applications

In order to meet GSKs DFM initiatives and meet requirements set forth by the FDA for process understanding, in depth understanding of critical quality attributes (CQA's) is imperative. One of the most important CQA's that must be controlled and understood in coating applications is the temperature of the product bed. This temperature is very important as overheating can negatively affect product and underheating can cause inadequate drying of the coat, coating quality problems, and substantially longer coating times. Recently a new wireless temperature monitoring technology has been identified by GlaxoSmithKline that will allow direct bed temperature measurement. The CorTemp® temperature probe is a wireless, tablet based temperature probe about the size of a large multi-vitamin. This tablet based temperature probe can be placed directly into the coating bed during the coating process allowing direct measurement of the coating pan bed temperature from the pharmaceutical tablets perspective. The nature of this technology makes it a substantial improvement over any other currently used method of temperature monitoring such as exhaust temperature and infrared guns. In this presentation work is reported showing proof of concept work on temperature monitoring in multiple coaters with the CorTemp® temperature probe. Results from these studies clearly show that the CorTemp® temperature probe is a valid method for real-time monitoring and improving process knowledge in coating applications that can be utilized in the future for process control of these unit operations.