IP Library Granted Patent US 12,196,726
Granted Patent B2
US 12,196,726 · App. 17/767,795 · Granted Jan 14, 2025

Testing of filtration device

Inventor: Stephan Menzel (Korschenbroich, DE)
Assignee: Cytiva Sweden AB
G01N30/02G01N2015/084G01N2015/086
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Quick Facts
Patent No.
US 12,196,726
App. No.
17/767,795
Granted
Jan 14, 2025
Kind
B2
Abstract

Disclosed is a system and a method for testing at least one filtration device. The system comprises a chromatography system ( 3 ) comprising at least one pair of inlet and outlet chromatography column connections ( 7 a ), 7 b for at least one chromatography column, and at least one filtration device housing ( 21 ) comprising a filtration device ( 23 ) to be tested, whereby each filtration device housing ( 21 ) is connected to one of the at least one pair of inlet and outlet chromatography column connections ( 7 a, 7 b ) instead of a chromatography column in the chromatography system.

Claims (34)

1. A system for testing at least one filtration device, said system comprising:

a chromatography system comprising at least one pair of inlet and outlet chromatography column connections for at least one chromatography column; and

at least one filtration device housing comprising a filtration device to be tested, whereby the at least one filtration device housing is connected to one of the at least one pair of inlet and outlet chromatography column connections instead of a chromatography column in the chromatography system.

2. The system according to claim 1 , wherein said chromatography system further comprises a sample feed inlet, a pump system for pumping sample feed through connected filtration device housings and pressure sensors configured for measuring pressures at an inlet side and an outlet side of a connected chromatography column.

3. The system according to claim 1 , wherein said filtration device comprises one or more of a depth filter, a sterile filter and a chromatography media.

4. The system according to claim 1 , wherein an effective area of said filtration device is smaller than 3 cm 2 or smaller than 2 cm 2 .

5. The system according to claim 1 , wherein the pump system comprises a pump and a sample loop, wherein said sample loop comprises a housing comprising a pump fluid compartment and a sample feed compartment which are separated from each other by a plunger provided in the housing, wherein said pump fluid compartment comprises a pump fluid inlet which can be connected to the pump and said sample feed compartment comprises a sample feed outlet which is connected to the sample feed inlet of the chromatography system, whereby when the plunger is moved by the pump sample feed provided in the sample feed compartment is pushed out through the sample feed outlet without any contact with the pump fluid.

6. The system according to claim 5 , wherein said sample feed compartment of said sample loop comprises a magnetically driven stirring device.

7. The system according to claim 1 , wherein the system comprises more than one filtration device housings and wherein the chromatography system further comprises one or more valves for controlling the sample feed through the connected filtration device housings one after each other.

8. The system according to claim 7 , wherein said valve can be set in different flow control positions allowing reversing of the flow direction through said connected filtration device housings.

9. The system according to claim 1 , wherein the chromatography system further comprises at least one UV detector configured for measuring UV absorbance of the sample feed after having passed through the filtration device housing.

10. The system according to claim 1 , wherein the chromatography system further comprises a fraction collector for collecting fractions of the sample feed after having passed the at least one filtration device housing.

11. The system according to claim 1 , wherein the filtration device housing comprises a depth filter or a functionalized chromatography media or a combination of those.

12. The system according to claim 1 , wherein the at least one filtration device housing comprises:

a housing part in which the filtration device is provided, whereby the filtration device has an outer circumference which fits closely inside the housing part;

an inlet configured for receiving sample feed into the cylindrical housing part; and

an outlet configured for transferring sample feed out from the cylindrical housing part after having passed through the filtration device.

13. The system according to claim 1 , wherein the chromatography system further comprises an injection valve connected to the sample feed inlet and connectable to a buffer source, whereby said injection valve can be positioned for flushing buffer through the at least one filtration device housing or for providing sample feed through the at least one filtration device housing.

14. A method for testing at least one filtration device, said method comprising:

connecting at least one filtration device housing comprising a filtration device to be tested to the chromatography system at a position intended for a chromatography column in the chromatography system;

pumping sample feed through the at least one filtration device housing; and

measuring pressure in the sample feed before and after the at least one filtration device housing.

15. The method according to claim 14 , further comprising the step of flushing a buffer through the filtration device housing before pumping sample feed through the filtration device housing.

16. The method according to claim 14 , further comprising the step of measuring UV absorption of the sample feed after having passed the at least one filtration device housing.

17. The method according to claim 14 , further comprising the step of sanitizing the chromatography system between different tests of filtration devices.

18. The method according to claim 14 , further comprising the step of fractionating the sample feed after having passed the at least one filtration device housing.

19. The method according to claim 14 , wherein the method is a method for testing filtration devices having an effective area smaller than 3 cm 2 or smaller than 2 cm 2 .

20. A filtration device housing configured for being connectable to a chromatography system where said filtration device housing is configured to be connected to the chromatography system at a chromatography column position, said filtration device housing comprising:

a filtration device to be tested;

an inlet configured for receiving sample feed into the filtration device housing for passing through the filtration device, said inlet being provided with a first connection configured for being connectable to a chromatography system; and

an outlet configured for transferring sample feed out from the filtration device housing after having passed through the filtration device, said outlet being provided with a second connection configured for being connectable to a chromatography system.

21. The filtration device housing according to claim 20 , further comprising a housing part in which the filtration device is provided, whereby the filtration device has an outer circumference which fits closely inside the housing part.

22. The filtration device housing according to claim 20 , wherein the filtration device housing comprises a depth filter, a sterile filter or a functionalized chromatography media or a combination of those.

23. The filtration device housing according to claim 20 , wherein said filtration device has an effective area smaller than 3 cm 2 or smaller than 2 cm 2 .

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 8, 2022
From: MENZEL, STEPHAN
To: GE HEALTHCARE BIO-SCIENCES AB
Reel/Frame 059658/0142 →
CHANGE OF NAME Recorded Apr 8, 2022
From: GE HEALTHCARE BIO-SCIENCES AB
To: CYTIVA SWEDEN AB
Reel/Frame 059658/0154 →
Priority Claims (1)
GB 1915488 · Oct 25, 2019 · national
Continuity (1)
Related Publication 20240085382A1 · Mar 14, 2024
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