Freezing, drying and/or freeze-drying of product dose units

Patent metadata

Field	Value
Publication number	US-11828535-B2
Application number	US-201917252681-A
Country	US
Kind code	B2
Filing date	Jun 28, 2019
Priority date	Jun 29, 2018
Publication date	Nov 28, 2023
Grant date	Nov 28, 2023

Abstract

A device for holding and monitoring a predetermined dose of a product during a freezing, drying and/or lyophilization process, includes a mold having a receptacle part for containing the predetermined dose of the product in direct contact with the receptacle part, a sensor, contacting the mold or integrated in the mold, for measuring a physical characteristic and/or quantity, and a transmitter for transmitting the measured characteristic and/or quantity in the form of a sensor signal to a control unit for controlling a heating and/or cooling element, integrated in the device, for heating and/or cooling a predetermined dose of product during a freezing, drying and/or lyophilization process, in the lyophilization process. The device relates in further aspects to a system and a method.

First claim

The invention claimed is:

1. A device for holding and monitoring a predetermined dose of a product during a drying, freezing and/or lyophilization process, the device comprising:
a mold adapted for shaping the predetermined dose of the product, having a receptacle part for containing said predetermined dose of the product in direct contact with the receptacle part;
at least one sensor, contacting the mold or integrated in the mold, for measuring a physical characteristic of said predetermined dose and/or a physical quantity affecting said predetermined dose during said process; and
a transmitter for transmitting said measured physical characteristic and/or physical quantity in the form of a sensor signal to a control unit for controlling a heating and/or cooling element in said process;
a heater and/or cooler unit for heating and/or cooling the predetermined dose when contained in the receptacle part;
wherein said heater and/or cooler unit comprises the heating element and/or the cooling element that are controllable by the control unit;
the heater and/or cooler unit being integrated in the mold and in communication with the control unit for controlling said element;
for controlling heat transport to the individual predetermined dose.

2. The device of claim 1 , wherein said mold is adapted for shaping the predetermined dose such that said predetermined dose of the product forms a tablet when said process has been carried out.

3. The device of claim 2 , wherein said mold is adapted for shaping an orally disintegrating tablet, a muco-adhesive tablet or a multilayer tablet.

4. The device of claim 1 , wherein the mold is adapted for providing easy removal of the individual predetermined dose.

5. The device of claim 1 , wherein said heater and/or cooler unit comprises a Peltier element adapted for freezing and/or heating the predetermined dose in the receptacle part.

6. The device of claim 1 , wherein said heater and/or cooler unit comprises an absorber for absorbing heat radiation.

7. The device of claim 1 , wherein said device comprises an ultrasonic vibration generator positioned in contact with the mold or integrated in the mold,
wherein said ultrasonic vibration generator is adapted for controlling nucleation of the product by ultrasonification when freezing the predetermined dose.

8. The device of claim 1 , comprising an insert element for inserting into the predetermined dose when contained in the receptacle part, said insert element comprising at least one elongate structure.

9. The device of claim 1 , further comprising a control unit for controlling a heating and/or cooling element during said drying, freezing and/or lyophilization said process, wherein the transmitter and the control unit are integrated in the mold.

10. A system for freezing, drying and/or freeze-drying at least one predetermined dose of a product, the system comprising:
at least one device in accordance with claim 1 , wherein the system comprises a control unit for receiving at least one sensor signal from the transmitter of said device and for controlling said heating element and/or said cooling element, in which said controlling takes said at least sensor signal into account; or a control unit for controlling a heating and/or cooling element during said drying, freezing and/or lyophilization said process, wherein the transmitter and the control unit are integrated in the mold;
a cooling element for freezing the at least one predetermined dose of the product when contained in the at least one receptacle part of the mold of the at least one device and/or a heating element for heating the at least one predetermined dose of the product when contained in the at least one receptacle part of the mold of the at least one device; and
a vacuum chamber for exposing the at least one predetermined dose to a low pressure environment while heating the at least one predetermined dose using said heating device to desiccate said at least one predetermined dose.

11. The system of claim 10 , wherein said system comprises a vacuum lock for inserting the at least one predetermined dose into and/or removing the at least one predetermined dose from the vacuum chamber.

12. The system of claim 11 , wherein said cooling element is integrated in the vacuum lock.

13. The system of claim 10 , wherein said cooling element comprises a tunnel freezer, and wherein said system is adapted for transporting the at least one device containing the at least one predetermined dose in a liquid state through the tunnel freezer such as to freeze the at least one predetermined dose.

14. The system of claim 10 , wherein said vacuum chamber is a cylindrical chamber, and
wherein said vacuum lock forms a segment of said cylindrical chamber or
wherein said vacuum lock is connected to a segment of the cylindrical chamber.

15. The system of claim 14 , comprising a stationary surface or a rotatable surface,
wherein said vacuum chamber is adapted for rotating over said stationary surface or
wherein said rotatable surface is adapted for rotating in or underneath the vacuum chamber, and
wherein said system is adapted for loading the at least one device in the vacuum chamber by placing the at least one device on the stationary surface or on the rotatable surface via said vacuum lock.

16. The system of claim 10 , comprising a conveyance mechanism for transporting a plurality of devices, said conveyance mechanism forming a loop such as to transport the plurality of devices along a closed loop trajectory.

17. A method for freeze-drying a product in a predetermined dose, the method comprising:
providing the predetermined dose contained in a receptacle part of a mold adapted for shaping the predetermined dose of the product,
freezing the predetermined dose of the product contained in the receptacle part of the mold,
heating the frozen predetermined dose of the product in the receptacle part of the mold while exposing the predetermined dose to a low pressure environment to desiccate the predetermined dose,
measuring a physical characteristic of the predetermined dose and/or a physical quantity affecting the predetermined dose during the step of freezing and/or during the step of heating using a sensor that contacts the mold or that is integrated in the mold, and
controlling at least one parameter of the freezing and/or the heating, wherein said controlling takes the measured physical characteristic and/or physical quantity into account,
wherein freezing and/or heating the predetermined dose of the product in the receptacle part of the mold comprised using a heater and/or cooler unit comprising a heating element and/or a cooling element being integrated in the mold, the heater and/or cooler unit being in communication with a control unit for controlling said heating element and/or a cooling element, for controlling heat transfer properties of the individual predetermined dose.

Assignees

• Univ Gent

Inventors

• De Beer Thomas
• Corver Jozef Antonius Willem Maria
• Vanbillemont Brecht
• Remon Jean Paul

Classifications

• F26B5/06 Primary

  the process involving freezing · CPC title

• F25B21/02

  using Peltier effect; using Nernst-Ettinghausen effect · CPC title

• F26B5/044 Primary

  for drying materials in a batch operation in an enclosure having a plurality of shelves which may be heated (F26B5/045 takes precedence) · CPC title

• F26B25/14

  Chambers, containers, receptacles of simple construction · CPC title

• F26B25/18

  mainly open, e.g. dish, tray, pan {, rack (for drying agricultural produce A01F25/12)} · CPC title