Lyophilizing tray employing reagent cartridge, lyophilizing system employing the same, and method of preparing lyophilized reagent

• US 8,683,712 B2
• Filed: 10/06/2009
• Issued: 04/01/2014
• Est. Priority Date: 10/23/2008
• Status: Active Grant

• Current Assignee: Precision Biosensor Inc.
• Original Assignee: Samsung Electronics Co. Ltd.
• Inventors: Kim, Do-gyoon, Kim, Han-sang, Lee, Jung-nam
• Primary Examiner(s): Rinehart, Kenneth
• Assistant Examiner(s): MCCORMACK, JOHN PATRICK
• Application Number:
  US12/574,206
• Publication Number:
  US 20100101106A1
• Time in Patent Office: 1,638 Days
• Field of Search: 34/92, 341/03, 34192-194, 342/96, 342/84, 342/86, 342/87, 342/03, 342/97, 342/89, 222/526, 222/547, 222/549, 222/539, 222/540, 220/312, 220/345.1, 220/507, 211/126.1, 211/126.5, 211/94.01, 211/71.01, 704/53, 704/54, 206/557, 206/718, 206/561, 206/564, 206/499, 206/379, 249/117, 249/142
• US Class Current: 34/193
• CPC Class Codes: B01L 3/52 Containers specially adapted for storing or dispensing a reagent B01L3/02 takes precedence; containers for medical or pharmaceutical purposes A61J1/00; containers in general B65D; storing or dispensing test elements G01N33/4875; automated reagent dispensing G01N35/1002
• CPC Class Codes: F26B 25/001 Handling, e.g. loading or unloading arrangements
• CPC Class Codes: F26B 5/06 the process involving freezing
• CPC Class Codes: G01N 35/1002 Reagent dispensers

Abstract

A method of manufacturing a lyophilized reagent, including mounting a plurality of reagent cartridges in which a liquid reagent is loaded in a tray including one or more tunnel-shaped first rails having opened end portions in a lengthwise direction and an opening formed in the top of the one or more first rails; closing the opened end portions, placing the tray in a lyophilizer and lyophilizing the liquid reagent according to a lyophilizing program.

Claims

1. A lyophilizing tray comprising:

at least one rail, wherein the rail is a tunnel-shaped through-hole extending in the lengthwise direction of the tray, and the rail includes an opened end portion which is open in a lengthwise direction of the tray and in which a plurality of reagent cartridges are to be mounted, an opened upper portion which is open in a vertical direction and detachment preventative projections configured to directly engage the plurality of reagent cartridges and prevent the reagent cartridges from being detached through the opened upper portion;

an upper wall disposed above the at least one rail and having at least one opening formed therein;

a first stopper which is removably inserted in the opening of the upper wall to close the opening; and

a second stopper which is removably inserted in the end portion of the rail to close the end portion.

2. The lyophilizing tray of claim 1, wherein a space is formed between the upper portion of the rail and the upper wall to allow a gas to flow.

3. The lyophilizing tray of claim 1, wherein the first stopper is movable between a first position which allows input and output of a gas via the opening, and a second position which fully closes the opening.

4. The lyophilizing tray of claim 3, wherein the first stopper includes a vent to allow a flow of gas in the first position.

5. The lyophilizing tray of claim 2, wherein the detachment preventive projections are configured to engage and project over a top surface of the reagent cartridges to prevent the reagent cartridges from being detached through the upper portion.

14. The lyophilizing tray of claim 1, wherein the first rail has an inverted arched cross-section.

6. A lyophilizing system comprising:

a lyophilizing tray comprising at least one first rail, wherein the first rail is a tunnel-shaped through-hole extending in a lengthwise direction of the lyophilizing tray, and the first rail includes an opened end portion which is open in a lengthwise direction of the lyophilizing tray, an opened upper portion which is open in a vertical direction, and detachment preventative projections configured to directly engage a plurality of reagent cartridges and prevent the reagent cartridges from being detached through the opened upper portion;

a loading tray comprising at least one second rail, wherein the second rail is a tunnel-shaped through-hole extending in a lengthwise direction of the loading tray, and the second rail includes an opened upper portion and an opened end portion which is open in a lengthwise direction of the loading tray and in which the plurality of reagent cartridges are mounted, and detachment preventative projections configured to directly engage the plurality of reagent cartridges and prevent the reagent cartridges from being detached through the opened upper portion;

a loader which loads an amount of a liquid reagent in the plurality of reagent cartridges mounted in the second rail of the loading tray; and

a lyophilizer in which the lyophilizing tray is stored, wherein the lyophilizer lyophilizes the liquid reagent loaded in the plurality of reagent cartridges.

7. The lyophilizing system of claim 6, wherein the lyophilizing tray further comprises an upper wall which is disposed above the first rail and has at least one opening formed therein.

8. The lyophilizing system of claim 7, wherein a space is formed between the opened upper portion of the first rail and the upper wall of the lyophilizing tray so as to allow a flow of a gas.

9. The lyophilizing system of claim 7, further comprising:

a first stopper which is removably inserted in the opening of the upper wall of the lyophilizing tray to close the opening; and

a second stopper which is removably inserted in the end portion of the first rail of the lyophilizing tray to close the end portion.

10. The lyophilizing system of claim 9, wherein the first stopper is movable between a first position which allows input and output of a gas via the opening, and a second position which fully closes the opening.

11. The lyophilizing system of claim 10, wherein the lyophilizing tray is stored in the lyophilizer in a state in which the first stopper is in the first position,

wherein the lyophilizer comprises at least one shelf on which the lyophilizing tray is disposed, a fixing plate which is disposed above the shelf, and an actuator which moves the shelf toward the fixing plate,

wherein, after lyophilization is completed by the lyophilizer, the shelf is moved toward the fixing plate so that the first stopper is moved to the second position to close the opening.

12. The lyophilizing system of claim 6, wherein the detachment preventive projections are configured to engage and project over a top surface of the reagent cartridges to prevent the reagent cartridges from being detached through the upper portion.

15. The lyophilizing system of claim 6, wherein the first rail and second rail have an inverted arched cross-section.

13. A method of manufacturing a lyophilized reagent, the method comprising:

mounting a plurality of reagent cartridges into rails of a loading tray, wherein the rails are tunnel-shaped through-holes extending in a lengthwise direction of the loading tray, and the rails include open ends which are open in a lengthwise direction of the rails, an opened upper portion which is open in a vertical direction, and detachment preventative projections configured to directly engage the plurality of reagent cartridges and prevent the reagent cartridges from being detached through the opened upper portion;

loading a liquid reagent into the plurality of reagent cartridges mounted in the rails of the loading tray;

aligning the open ends of the rails of the loading tray with open ends of rails of a lyophilizing tray, wherein the rails of the lyophilizing tray are tunnel-shaped through-holes extending in a lengthwise direction of the lyophilizing tray, and moving the plurality of reagent cartridges into which the liquid reagent is loaded from the rails of the loading tray into the rails of the lyophilizing tray via the opened end portions of the rails of the loading tray and the lyophilizing tray;

closing the open ends of the rails of the lyophilizing tray and placing the lyophilizing tray in a lyophilizer; and

lyophilizing the liquid reagent using the lyophilizer.

16. The method of claim 13, wherein the detachment preventive projections are configured to engage and project over a top surface of the reagent cartridges to prevent the reagent cartridges from being detached through the upper portion.

17. The method of claim 13, wherein the rails of the loading tray and the rails of the lyophilizing tray have inverted arched cross-section.

18. A method of manufacturing a lyophilized reagent, the method comprising:

preparing a tray comprising at least one first rail, and an upper wall disposed above the first rail and including an opening formed therein, wherein the first rail is a tunnel-shaped through-hole extending in a lengthwise direction of the tray, and the first rail includes an opened end portion which is open in the lengthwise direction of the tray, an opened upper portion which is open in a vertical direction, and detachment preventative projections configured to directly engage a plurality of reagent cartridges and prevent the reagent cartridges from being detached through the opened upper portion;

loading a liquid reagent into the plurality of reagent cartridges;

mounting the plurality of reagent cartridges into which the liquid reagent is loaded in the first rail of the tray via the opened end portion of the first rail, and closing the opened end portion;

placing the tray in a lyophilizer and lyophilizing the liquid reagent according to a lyophilizing program; and

removing the tray from the lyophilizer.

19. The method of claim 18, wherein the loading the liquid reagent comprises:

preparing a loading tray comprising at least one second rail, wherein the second rail is a tunnel-shaped through-hole extending in a lengthwise direction of the loading tray and includes an opened upper portion and an opened end portion which is open in a lengthwise direction;

mounting the plurality of reagent cartridges in the second rail of the loading tray via the opened end portion of the second rail; and

loading an amount of the liquid reagent in the plurality of reagent cartridges mounted in the second rail of the loading tray through the opened upper portion of the second rail.

20. The method of claim 19, wherein the mounting the plurality of reagent cartridges into which the liquid reagent is loaded in the first rail of the tray comprises:

arranging the loading tray and the tray so that the end portion of the first rail of the tray and the end portion of the second rail of the loading tray contact each other; and

pushing the plurality of reagent cartridges mounted in the second rail toward the first rail so that the plurality of reagent cartridges are moved from the second rail into the first rail.

21. The method of claim 18, further comprising, after lyophilization is completed, closing the opening of the upper wall of the tray by inserting a stopper in the opening so that the tray is sealed with the plurality of reagent cartridges stored therein, and removing the tray from the lyophilizer.

22. The method of claim 21, further comprising, before the closing the opening of the upper wall of the tray, injecting an inert gas into the tray.

23. The method of claim 21, wherein the lyophilizer comprises a plurality of shelves, and

wherein the placing the tray in the lyophilizer comprises placing the tray on one of the plurality of shelves when the stopper is coupled to the opening so as to allow a flow of a gas through the opening.

24. The method of claim 23, wherein the plurality of shelves are moved to push down the stopper to fully close the opening.

25. The lyophilizing system of claim 24, wherein the first stopper includes a vent to allow a flow of gas in the first position.

26. The method of claim 18, wherein the detachment preventive projections are configured to engage and project over a top surface of the reagent cartridges to prevent the reagent cartridges from being detached through the upper portion.

27. The method of claim 18, wherein the first rail has an inverted arched cross-section.