Guidelines

Because the freeze drying process is so delicate and complex it is absolutely essential to be able to follow the process in real time. With the recent introduction of SKY this is now possible. Using TrackSense® ProX loggers with Teflon flexible sensors is a unique solution and the live transmission of data from loggers placed inside to Access Point placed outside the chamber is a  trouble free setup providing accurate and instant process control and documentation. The usual number of measuring points during process monitoring could be as high as one sensor placed in a representative sample (vial or tray) per shelf.

For validation of the chamber the usual number of measuring points is 5 for each shelf – one in each corner plus one in center. As freeze dryers often are equipped with 10-15 shelves or more it is essential that the logging hardware and analyzing software can handle data of that magnitude. With a storage capacity of 60.000 data points in each logger and a ValSuite™ software which can handle in excess of 100 channels in each session this is easy to match.