Method of providing inline sterile freeze drying of a product in trays accommodated in a trolley, system for carrying out the method, and use of the method

• US 9,863,700 B2
• Filed: 11/30/2015
• Issued: 01/09/2018
• Est. Priority Date: 05/29/2013
• Status: Active Grant

• Current Assignee: GEA Process Engineering Incorporated (GEA Group AG)
• Original Assignee: GEA Process Engineering Incorporated (GEA Group AG)
• Inventors: Pedersen, Morten Woldsted, Grnborg, Christian
• Primary Examiner(s): Gravini, Stephen M
• Application Number:
  US14/954,022
• Publication Number:
  US 20160076810A1
• Time in Patent Office: 771 Days
• Field of Search: 34284, 34287, 34 92
• CPC Class Codes: F26B 25/001 Handling, e.g. loading or unloading arrangements
• CPC Class Codes: F26B 5/06 the process involving freezing

Abstract

For providing inline sterile freeze drying of a product containing solid matter and a solvent, such as water, in a plurality of trays accommodated in at least one trolley, a system comprises a filling station having an inlet end and an outlet end, or a docking station, a freeze storage, a freeze dryer unit, an emptying station having an inlet end and an outlet end, or a docking station, a plurality of trays adapted to be accommodated in at least one trolley. A cleaning and sterilizing unit is provided between the outlet end of the emptying station and the inlet end of the filling station.

Claims

1. A method of providing inline sterile freeze drying of a product containing solid matter and a solvent, which comprises:

i. filling the product into a plurality of trays accommodated in at least one trolley in a filling station;

ii. reducing a temperature of the product;

iii. bringing the product to a pressure and a temperature below a triple point of the solvent in a freeze dryer unit;

iv. maintaining lowered pressure and thereby provide a freeze dried product by removing the solvent as vapor in the freeze dryer unit;

v. bringing the freeze dried product to a temperature and pressure above the triple point;

vi. emptying the product from the plurality of trays;

vii. sterilizing the at least one trolley with the plurality of trays; and

viii. bringing the at least one trolley with the plurality of trays to the filling station.

2. The method according to claim 1, which further comprises cooling the at least one trolley with the plurality of trays before step i.

3. The method according to claim 1, which further comprises bringing the at least one trolley with the plurality of trays to a freeze storage after step i.

4. The method according to claim 2, which further comprises cooling the at least one trolley with the plurality of trays in a freeze storage before step i.

5. The method according to claim 3, which further comprises bringing the at least one trolley with the plurality of trays to a supplemental freeze storage before step i.

6. The method according to claim 1, which further comprises sterilizing the filling station before step i.

7. The method according to claim 1, which further comprises sterilizing the freeze dryer unit before one of step iii. and step iv.

8. The method according to claim 5, which further comprises sterilizing at least one of a freeze storage and the supplemental freeze storage before step i.

9. The method according to claim 1, which further comprises carrying out steps i. to viii. in a clean-room.

10. The method according to claim 1, which further comprises carrying out freeze drying in the freeze drying unit at a pressure of between at least one of:

0.1-0.25 mbar; and

0.1-0.2 mbar.

11. The method according to claim 1, which further comprises carrying out freeze drying in the freeze drying unit at a mean sublimation rate equal to or above 0.5 kg/m²/h.

12. The method according claim 1, which further comprises carrying out step vii. in a cleaning and sterilizing unit.

13. A system for carrying out the method according to claim 1, comprising:

a filling station having an inlet end and an outlet end;

a freeze storage;

a freeze dryer unit;

an emptying station having an inlet end and an outlet end;

at least one trolley;

a plurality of trays shaped to be accommodated in the at least one trolley; and

a cleaning and sterilizing unit operatively connected between the outlet end of the emptying station and the inlet end of the filling station.

14. The system according to claim 13, wherein:

the freeze storage has an outlet end; and

the freeze dryer unit has;

an inlet end operatively connected with the outlet end of the freeze storage; and

an outlet end operatively connected with the inlet end of the emptying station.

15. The system according to claim 14, wherein the outlet end of the freeze storage is selectively connected to the inlet end of the filling station.

16. The system according to claim 13, further comprising a supplemental freeze storage between the cleaning and sterilizing unit and the filling station.

17. The system according to claim 13, further comprising a trolley storage between the outlet end of the emptying station and the cleaning and sterilizing unit.

18. The system according to claim 13, wherein the cleaning and sterilizing unit has:

an inlet end operatively connected with the outlet end of the emptying station; and

an outlet end.

19. The system according to claim 18, wherein:

the trolley storage has an outlet end; and

the inlet end of the cleaning and sterilizing unit is operatively connected with the outlet end of the trolley storage.

20. The system according to claim 18, wherein the outlet end of the cleaning and sterilizing unit is operatively connected with the inlet end of the filling station.

21. The system according to claim 18, wherein:

the supplemental freeze storage has an inlet end; and

the outlet end of the cleaning and sterilizing unit is operatively connected with the inlet end of the supplemental freeze storage.

22. The system according to claim 13, wherein the cleaning and sterilizing unit is sized to accommodate one of:

between one and six trolleys; and

between two and four trolleys.

23. The system according to claim 13, wherein the freeze dryer unit is sized to accommodate one of:

between one and six trolleys; and

between two and four trolleys.

24. The system according to claim 13, wherein the freeze storage is sized to accommodate one of:

between one and six trolleys; and

between two and four trolleys.

25. The system according to claim 13, wherein:

a pass-through section of the system is defined between a first line and a second line extending on either side of the freeze dryer unit and the cleaning and sterilizing unit;

a filling section is defined between the second line and a third line; and

an emptying section is defined between the first line and a fourth line.

26. The system according to claim 25, wherein the pass-through section, the filling section and the emptying section are located in a clean-room.

27. The method according to claim 1, wherein the product is selected from probiotic bacteria, lactic bacteria, whey derivatives, yeast bacteria, and/or bacterial cultures.

28. The system according to claim 13, wherein:

the filling station comprises a docking station; and

the emptying station comprises a docking station.

29. The method according to claim 1, wherein the solvent is water.