Process monitoring and control for lyophilization using a wireless sensor network

A system to monitor and control a lyophilization process using a wireless network, comprising:

• one or more wireless pressure and gas temperature sensors, each comprising:
• a housing fluidly coupled to ambient environment of the housing,
• a power supply disposed in the housing,
• an electronics module, electrically coupled to the power supply, the electronics module comprising a microcontroller and a wireless transceiver,
• a pressure sensor coupled to the electronics module and adapted to provide pressure and gas temperature measurements of the ambient environment of the housing;
• a lyophilization chamber having one or more lyophilization vial trays, wherein the one or more wireless pressure and gas temperature sensors are distributed in the one or more lyophilization vial trays;
• a vacuum pump, adapted to change pressure within the lyophilization chamber;
• a heat exchanger adapted to modify temperature within the lyophilization chamber;
• and
• a controller adapted to:
• collect pressure and gas temperature data from the one or more wireless pressure and gas temperature sensors,
• calculate sublimation rate of a product to be lyophilized using the collected pressure and gas temperature data, and
• adjust one or both of the pressure and temperature within the lyophilization chamber such that the calculated sublimation rate stays within a predetermined envelope.