Process Equipment

A freeze dryer consist basically of 3 components: sample chamber, condenser and a vacuum pump system. Depending on what should be dried, the sample chamber that is directly connected to the condenser and vacuum pump is designed with appropriate number of shelves which can be moved up and down if closing of vials is requested. This is called the stoppering arrangement. There are essentially two categories of freeze-dryers: batch and continuous dryers.

Batch freeze dryers are designed either for bulk drying where product is distributed onto trays or vial drying where product is dispensed into flasks(vials) using special rubber stoppers with vapour “escape” holes (slots). The benefit of this container is that the product can be easily reconstituted by simply adding liquid. For both systems batch monitoring can be done either by using the E-Val Flex cabled system or TrackSense® wireless loggers. Due to the fact that maintaining a high vacuum is essential for all lyophilization processes, the use of wireless loggers is highly recommended. A configuration with Pro-X loggers, low temperature multi channel flex Teflon sensors in combination with the SKY module and Access Point outside chamber is an ideal solution. Due to the high vacuum (~ 0.005 hPa) none of the available commercial wireless loggers can be used to monitor pressure.

Continuous freeze dryers are designed for vial drying and complete filling, loading and unloading systems which are integrated in the freeze dryer design. This allows full automatic  and sterile manufacturing with in-between batch sterilization (SIP) of  the freeze dryer. This will exclude the use of cabled systems but again Pro-X loggers fitted with low temperature multi channel Teflon flex sensors is recommended. To cover the SIP part of the process, standard multi channel teflon flex sensors are needed. The SKY option can be advantageous if distances are not too big.