A system to monitor and control a lyophilization process using a wireless network is disclosed which includes one or more wireless pressure and gas temperature sensors adapted to provide pressure and gas temperature measurements of the ambient environment, a lyophilization chamber, wherein the one or more wireless pressure sensors are distributed in one or more lyophilization vial trays, a vacuum pump, adapted to change the pressure with 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 pressure and temperature within the lyophilization chamber such that the calculated sublimation rate stays within a predetermined envelope.

Devices, systems, and methods used to freeze dry a substance are disclosed. The devices and systems include a freeze dryer including a freeze-drying chamber, heating members, a refrigeration system, a vacuum pump, and a plurality of sensors disposed within the freeze-drying chamber. The freeze-drying methods include four main phases of freeze drying a substance: Phase 1 - Freezing; Phase 2 - Vacuum Freezing; Phase 3 - Sublimation; Phase 3A - Sublimation Verification and Phase 4 - Final Drying. Phase 3 can include cycling the heating members on and off between upper and lower humidity thresholds to increase the temperature of the freeze-drying chamber.

Devices, systems, and methods used to freeze dry a substance are disclosed. The devices and systems include a freeze dryer including a freeze-drying chamber, heating members, a refrigeration system, a vacuum pump, and a plurality of sensors disposed within the freeze-drying chamber. The freeze-drying methods include four main phases of freeze drying a substance: Phase 1 - Freezing; Phase 2 - Vacuum Freezing; Phase 3 - Sublimation; Phase 3A - Sublimation Verification and Phase 4 - Final Drying. Phase 3 can include cycling the heating members on and off between upper and lower humidity thresholds to increase the temperature of the freeze-drying chamber.

A method of preparing a pharmaceutical product in a single multiple chamber flexible bag. A pharmaceutical product is introduced in a liquid state into a first chamber of the flexible bag through a first port. The pharmaceutical product is lyophilized within the first chamber of the flexible bag to provide a lyophilized pharmaceutical product. The flexible bag has a second chamber and the first chamber and the second chamber are separated by a breakable seal. The second chamber further includes a reconstituting solution for reconstituting the lyophilized pharmaceutical product in the first chamber. A user may apply pressure to the flexible bag to break the seal and mix the lyophilized pharmaceutical product and the reconstituting solution to order to administer the pharmaceutical product to a patient.

Provided are a vacuum freeze-drying apparatus and a method capable of continuously performing vacuum freeze-drying in a short time. A vacuum freeze-drying apparatus 1 of this invention having an exhaust path for performing vacuum suction, while a drying device 3 comprises a tubular member 31 provided an inlet portion and an outlet portion formed of a tubular shape, a temperature adjusting means 30a to 30j provided in a plurality of regions formed from the inlet portion toward the outlet portion in a peripheral portion of the tubular member 31 wherein the plurality of regions are at least three or more regions whose temperature is capable of being controlled, for adjusting temperatures of a plurality of regions 40a to 40j in outer surface of the tubular member, a temperature control unit 8 for independently controlling the temperature adjusting means, and a rotating portion 7 for rotating the tubular member 31, wherein the tubular member 31 has a spiral transfer means 31a continuously provided adjacent to an inner wall of the tubular member from the inlet portion toward the outlet portion, and the transfer means 31a transfers the frozen substance sequentially to locations corresponding to the plurality of regions in the tubular member so as to continuously sublimate and dry.

Provided are a vacuum freeze-drying apparatus and a method capable of continuously performing vacuum freeze-drying in a short time. A vacuum freeze-drying apparatus 1 of this invention having an exhaust path for performing vacuum suction, while a drying device 3 comprises a tubular member 31 provided an inlet portion and an outlet portion formed of a tubular shape, a temperature adjusting means 30a to 30j provided in a plurality of regions formed from the inlet portion toward the outlet portion in a peripheral portion of the tubular member 31 wherein the plurality of regions are at least three or more regions whose temperature is capable of being controlled, for adjusting temperatures of a plurality of regions 40a to 40j in outer surface of the tubular member, a temperature control unit 8 for independently controlling the temperature adjusting means, and a rotating portion 7 for rotating the tubular member 31, wherein the tubular member 31 has a spiral transfer means 31a continuously provided adjacent to an inner wall of the tubular member from the inlet portion toward the outlet portion, and the transfer means 31a transfers the frozen substance sequentially to locations corresponding to the plurality of regions in the tubular member so as to continuously sublimate and dry.

Provided herein are methods of producing lyophilized reagents with desired physical characteristics, and the lyophilized reagents produced thereby. In particular, lyophilized combinations of reagents are provided with specific physical geometries that provide optimized use in assays and devices.

Provided herein are methods of producing lyophilized reagents with desired physical characteristics, and the lyophilized reagents produced thereby. In particular, lyophilized combinations of reagents are provided with specific physical geometries that provide optimized use in assays and devices.

The present technology is directed to an apparatus for freeze-drying various items. The apparatus described herein includes a reusable sealable container enabling aseptic handling of bulk processed materials. The multi-use tray enables a sterile sealable enclosure for use throughout the freeze-drying process, including: pre-freeze-drying (e.g., filling, handling, storage, transfer), freeze-drying processing, and/or post-freeze-drying (e.g., handling and storage).

A skin-substitute is constructed by homogenizing an acellular dermal tissue matrix into a slurry, pouring the slurry into a mold, and lyophilizing the slurry.