# US 12,109,311 B2 · Lyophilization systems and methods > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,109,311 B2 - Document ID: US12109311B2 - Status: Granted - Kind: B2 - Application number: 17/359,394 - Filed: 2021-06-25 - Published: 2022-03-03 - Granted: 2024-10-08 - Earliest claimed: 2020-08-31 - Assignees: Massachusetts Institute of Technology - Applicants: Massachusetts Institute of Technology - Inventors: Alexander H. Slocum; Bernhardt Levy Trout - Web page: https://patentgrep.com/patent/US12109311B2 ## CPC - A61K 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)} - F26B 3/28: by radiation, e.g. from the sun - F26B 5/042: {for drying articles or discrete batches of material in a continuous or semi-continuous operation, e.g. with locks or other air tight arrangements for charging/discharging} - F26B 5/06: the process involving freezing - F26B 15/14: the objects or batches of materials being carried by trays or racks {or receptacles, which may be connected to endless chains or belts (trays, racks per se F26B25/18; with vertical movement F26B15/22)} - H02N 15/00: Holding or levitation devices using magnetic attraction or repulsion, not otherwise provided for (electric or magnetic devices for holding work on machine tools B23Q3/15 {; monorail vehicle propulsion or suspension B60L13/00}; sliding or levitation devices for railway systems B61B13/08; material handling devices associated with conveyors incorporating devices with electrostatic or magnetic grippers B65G47/92; separating thin or filamentary articles from piles using magnetic force B65H3/16; delivering thin or filamentary articles from magnetic holders by air blast or suction B65H29/24; bearings using magnetic or electric supporting means F16C32/04; relieving bearing loads using magnetic means F16C39/06; magnets H01F7/00; dynamo-electric clutches or brakes H02K49/00 {; electric furnaces with simultaneous levitation and heating H05B6/32}) - B65G 54/02: electrostatic, electric, or magnetic - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - F26B: DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM (drying devices for combines A01D41/133; racks for drying fruit or vegetables A01F25/12; drying foodstuffs A23; drying hair A45D20/00; body-drying implements A47K10/00; drying household articles A47L; drying gases or vapours B01D; chemical or physical processes for dewatering or like separating liquids from solids B01D43/00; centrifugal apparatus B04; drying ceramics C04B33/30; drying yarns or fabrics in association with some other form of treatment D06C; drying frames for laundry without heating or positive air circulation, domestic laundry-or spin-driers, wringing or hot pressing laundry D06F; furnaces, kilns, ovens F27) - H02N: ELECTRIC MACHINES NOT OTHERWISE PROVIDED FOR - B65G: TRANSPORT OR STORAGE DEVICES, e.g. CONVEYORS FOR LOADING OR TIPPING, SHOP CONVEYOR SYSTEMS OR PNEUMATIC TUBE CONVEYORS (packaging B65B; handling thin or filamentary materials, e.g. paper sheets or thread, B65H; cranes B66C; portable mobile or lifting or hauling appliances, e.g. hoists, B66D; devices for lifting or lowering goods for loading or unloading purposes, e.g. fork-lift trucks, B66F9/00; emptying bottles, jars, casks, barrels or similar containers, not otherwise provided for, B67C9/00; delivering or transferring liquids B67D; filling or discharging vessels for liquefied, solidified or compressed gases F17C; pipe-line systems for fluids F17D) ## Abstract System and methods related to lyophilization of pharmaceutical products are disclosed. In some embodiments, vials of product are moved through a system using one or more movers which are electromagnetically levitated and moved through the system without making mechanical contact with each other or the system. Load lock chambers may allow a mover to enter from one process region's environment and then be brought to an environment condition of the next process region to allow materials to be passed through conditioning, nucleation, and/or vacuum drying regions prior to finally exit the system to an unloading zone. The movers may then be cleaned or reloaded with vials to begin the process again with a new load of vials. ## Claims ### Claim 1 A system for lyophilization of pharmaceutical products comprising: at least one mover configured to support one or more containers containing a therapeutic composition; an inlet of the system for receiving the at least one mover; an outlet of the system for outputting the at least one mover from the system; a plurality of chambers disposed between the inlet and outlet, wherein the plurality of chambers includes at least a first chamber configured to perform a nucleation operation on the therapeutic composition and a second chamber disposed downstream of the first chamber configured to perform a vacuum drying operation on the therapeutic composition; and a plurality of stators configured to electromagnetically levitate and move the at least one mover from the inlet, through the plurality of chambers, and to the outlet. ### Claim 2 (depends on 1) The system of claim 1, wherein the plurality of stators are disposed in a substantially continuous surface extending from the inlet through the plurality of chambers to the outlet, and wherein the at least one mover is disposed on the substantially continuous surface. ### Claim 3 (depends on 1) The system of claim 1, further including a third chamber disposed between the inlet and the first chamber, wherein the third chamber is configured to perform a conditioning operation on the therapeutic composition. ### Claim 4 (depends on 1) The system of claim 1, wherein the at least one mover is a plurality of movers, and wherein the plurality of stators is configured to independently control motion of each mover of the plurality of movers. ### Claim 5 (depends on 1) The system of claim 1, further comprising a plurality of load lock chambers configured to isolate an atmosphere within each chamber of the plurality of chambers from an external environment and adjacent chambers. ### Claim 6 (depends on 1) The system of claim 1, further comprising a plurality of radiant heaters configured to heat the one or more containers supported on the at least one mover while the at least one mover is disposed in the second chamber, and wherein the plurality of radiant heaters are independently controllable and are directed towards separate portions of the second chamber. ### Claim 7 (depends on 6) The system of claim 6, further comprising a plurality of sensors configured to sense a temperature of the one or more containers of the therapeutic composition supported on the at least one mover in the separate portions of the second chamber. ### Claim 8 (depends on 1) The system of claim 1, further including a processor configured to perform the steps of: controlling the plurality of stators to move the at least one mover from the inlet into the first chamber; controlling operation of the first chamber and the at least one mover to perform the nucleation operation; controlling the plurality of stators to move the at least one mover from the first chamber to the second chamber; controlling operation of the second chamber and the at least one mover to perform the vacuum drying operation; and controlling the plurality of stators to move the at least one mover from the second chamber to the outlet. ### Claim 9 A method of lyophilizing a therapeutic composition, the method comprising: electromagnetically levitating at least one container including the therapeutic composition; electromagnetically moving the at least one container into a first chamber; performing a nucleation operation on the therapeutic composition in the first chamber; electromagnetically moving the at least one container from the first chamber to a second chamber; performing a vacuum drying operation on the therapeutic composition in the second chamber; and electromagnetically moving the at least one container out of the second chamber. ### Claim 10 (depends on 9) The method of claim 9, further including super cooling a liquid the therapeutic composition is disposed in before electromagnetically moving the at least one container into the first chamber. ### Claim 11 (depends on 9) The method of claim 9, further comprising controlling a temperature of the at least one container and the therapeutic compositions contained therein using radiant heating during the vacuum drying operation. ### Claim 12 (depends on 11) The radiant heating of claim 11, wherein the radiant heating is provided using individual radiant heaters that are independently controlled. ### Claim 13 (depends on 11) The method of claim 11, wherein the at least one container is a plurality of groups of containers supported on a plurality of movers disposed in the second chamber, and wherein a temperature of separate groups of the plurality of groups of containers disposed on separate movers of the plurality of movers are independently controlled using the radiant heating. ### Claim 14 (depends on 9) The method of claim 9, wherein electromagnetically moving the at least one container through the first chamber, into the second chamber, and out of the second chamber includes electromagnetically moving the at least one container over a substantially continuous surface extending between an inlet and an outlet. ### Claim 15 (depends on 9) The method of claim 9, further comprising controlling and isolating an atmosphere within each chamber from an external atmosphere and adjacent chambers. ### Claim 16 A system for lyophilization of pharmaceutical products comprising: at least one mover configured to support one or more containers containing a therapeutic composition; an inlet of the system for receiving the at least one mover; an outlet of the system for outputting the at least one mover from the system; at least one load lock chamber disposed between the inlet and outlet; at least one process chamber disposed downstream of the load lock chamber; a plurality of stators configured to electromagnetically levitate and move the at least one mover from the inlet, through the at least one load lock chamber and the at least one process chamber to the outlet; at least one processor configured to control the stators, the at least one load lock chamber, and the at least one process chamber. ### Claim 17 (depends on 16) The system of claim 16, wherein the at least one processor is configured to perform the steps of: setting an environment of the at least one load lock chamber to an environment of the inlet; opening a first door of the at least one load lock chamber; controlling the plurality of stators to electromagnetically levitate and move the at least one mover into the at least one load lock chamber through the first door; closing the first door of the at least one load lock chamber; setting the environment of the at least one load lock chamber to an environment of the at least one process chamber; opening a second door of the load lock chamber; controlling the plurality of stators to electromagnetically levitate and move the at least one mover into the at least one process chamber through the second door; closing the second door. ### Claim 18 (depends on 17) The system of claim 17, wherein the at least one processor is further configured to perform the steps of: controlling the at least one process chamber to process the therapeutic composition; controlling the plurality of stators to electromagnetically levitate and move the at least one mover from the at least one process chamber to the outlet. ### Claim 19 (depends on 16) The system of claim 16, wherein the plurality of stators are disposed in a substantially continuous surface extending from the inlet through the at least one load lock chamber and the at least one process chamber to the outlet, and wherein the at least one mover is disposed on the substantially continuous surface. ### Claim 20 (depends on 16) The system of claim 16, wherein the at least one mover is a plurality of movers, and wherein the plurality of stators is configured to independently control motion of each mover of the plurality of movers.