Rapid freezing, storage, transport, and thawing system for containers of biopharmaceutical products

Patent metadata

Field	Value
Publication number	US-12078403-B2
Application number	US-202217651672-A
Country	US
Kind code	B2
Filing date	Feb 18, 2022
Priority date	Oct 5, 2018
Publication date	Sep 3, 2024
Grant date	Sep 3, 2024

Abstract

Disclosed is a system for freezing, storing, transporting, and thawing biopharmaceutical product, comprising a stationary equipment and one or more movable pallets, each pallet configured to carry one or more container units, each containing biopharmaceutical product, the stationary equipment comprising a gas circulating unit configured to cause a circulation of cold gas and/or warm gas, from a pull inlet toward a blow outlet, wherein there is provided at least a first side plenum having one or more gas conveying channel therein, configured to be fluidly coupled to the blow outlet of the gas circulating unit, the first side plenum having a plurality of outlet ports directed toward an interior volume of the pallet, wherein the gas circulates substantially in a horizontal direction in the interior volume of the pallet, and wherein a shaking arrangement is provided.

First claim

The invention claimed is:

1. A system for freezing, storing, transporting, and thawing biopharmaceutical product, the system comprising a stationary equipment and one or more movable pallets, each pallet being configured to carry one or more container units, each containing biopharmaceutical product, the stationary equipment comprising an enclosure delimiting an inner area and an outer area, the inner area being configured to receive one pallet therein,
the stationary equipment comprising a gas circulating unit configured to cause a circulation of cold gas or warm gas, from a pull inlet toward a blow outlet,
wherein a largest dimension of the container unit extends substantially in a horizontal direction
whereby the cold gas or warm gas is caused to circulate substantially in the horizontal direction in an interior volume of the pallet, so as to make a horizontal gas flow substantially parallel to said horizontal direction and which maximizes the thermal transfer surface area, such that the horizontal gas flow flows along a top and bottom surface of the container units
wherein the system comprises a shaker device comprising one or more strength members and a drivetrain, wherein the shaker device is configured to support and shake a pallet present on the shaker device, wherein the drivetrain is configured to impart a periodic orbital movement in a vertical plane to the one or more strength members,
wherein the drivetrain comprises a motor located in the outer area, one or more drive gears located in the outer area, and one or more drive shafts located at least partly in the inner area, wherein the drive shaft is in interaction with the one or more strength members.

2. The system according to claim 1 , wherein the periodic movement is an orbital movement.

3. The system according to claim 1 , wherein the shaker device comprises two drive shafts ( 51 , 52 ).

4. The system according to claim 3 , wherein each drive shaft is supported and held by two journal bearings ( 91 , 92 , 93 , 95 ).

5. The system according to claim 1 , wherein the drive shaft comprises a first portion and a third portion having a first stationary axis, and a second portion having a second axis offset with regard to the first axis.

6. The system according to claim 5 , wherein the second axis (Y 2 ) is spaced from the first axis (Y 1 ) by an offset distance (EC 1 ) comprised between 10 mm and 25 mm.

7. The system according to claim 1 , wherein there are provided two strength members, parallel to each other, perpendicular to a pallet introduction direction.

8. The system according to claim 1 , wherein there is provided a receiving frame ( 100 ) comprising two strength members and two cross members ( 153 , 154 ).

9. The system according to claim 8 , wherein there are provided a clamping device to hold the pallet on the receiving frame.

10. The system according to claim 8 , wherein the shaker device is configured to receive and support a pallet exhibiting a weight of at least 300 Kg.

11. The system according to claim 1 , wherein the drivetrain is configured to impart a rotation speed to the drive shaft, said rotation speed being comprised between 40 rpm and 120 rpm.

12. The system according to claim 1 , wherein the stationary equipment comprises a blower, and a heat exchanger.

13. The system according to claim 1 , wherein the pallet exhibits a footprint of substantially 800 mm×1200 mm.

14. The system according to claim 8 , wherein the receiving frame comprises at least four pads to support the pallet.

15. The system according to claim 8 , wherein the receiving frame comprises six pads to support the pallet.

16. The system according to claim 3 , wherein there are provided two bevel gears, each interposed between the motor and a drive shaft, wherein each of the two drive shafts and each bevel are driven by a single motor.

17. The system according to claim 16 , wherein each of the two drive shafts is driven at a same rotation speed.

18. The system according to claim 16 , wherein the single motor is coupled to a reduction gear having an output shaft interposed between the two bevel gears, the single motor having a vertical axis, the output shaft exhibiting a horizontal axis and driving the bevel gears.

19. The system according to claim 3 , wherein each of the two drive shafts extends over a length of at least 2 meters.

20. The system according to claim 1 , wherein the shaker device exhibits an overall height (H 2 ) less than 200 mm.

21. The system according to claim 1 , wherein the container units are formed as bag assemblies, each bag assembly comprising a single-use flexible bag and a protective packaging, each single-use flexible bag containing biopharmaceutical product.

22. The system according to claim 1 , wherein said periodic movement is at least partly in a vertical plane.

23. The system according to claim 22 , wherein said shaker device has a receiving frame comprising said one or more strength members and wherein a clearance is provided below said receiving frame regarding a bottom wall or the ground to allow movement of said receiving frame under shaking conditions, notably movement along a vertical direction.

24. The system according to claim 1 , wherein said shaker device can engage with a base of the pallet and said periodic movement is imparted to the whole pallet.

Assignees

• Sartorius Stedim North America Inc

Inventors

• Cutting Jonathan
• Sanchez Marc

Classifications

• B65D2519/00776

  Accessories for manipulating the pallet · CPC title

• B65D19/00

  Pallets or like platforms, with or without side walls, for supporting loads to be lifted or lowered · CPC title

• B01F31/265

  the vibrations being caused by an unbalanced rotating member · CPC title

• F25D2331/801

  Bags · CPC title

• F25D25/00

  Charging, supporting, and discharging the articles to be cooled · CPC title