IP Library › Granted Patent US 11,874,256
Granted Patent B2
US 11,874,256 · App. 17/471,449 · Granted Jan 16, 2024

Methods for the evaluation of system inertness

Inventors: Amit Patel (Shrewsbury, MA); Moon Chul Jung (Waltham, MA); Thomas H. Walter (Ashland, MA); Matthew A. Lauber (North Smithfield, RI); Kevin Wyndham (Upton, MA); Mathew DeLano (Needham, MA); Jennifer Simeone (Shrewsbury, MA)
Assignee: Waters Technologies Corporation
G01N30/16G01N30/72G01N30/74G01N30/8637G01N30/06G01N2030/027
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Quick Facts
Patent No.
US 11,874,256
App. No.
17/471,449
Granted
Jan 16, 2024
Kind
B2
Abstract

The present disclosure is directed to methods for evaluating system inertness, such as the inertness of a LC or other fluidic system. Some methods are directed to tests wherein the column has been removed prior to injecting a sample including a positive (e.g., metal reacting moiety) control into the system. Some methods can include: (1) repeatedly injecting the sample into a system, the system comprising: fluidic paths wherein interior surfaces of the fluidic paths define wetted surfaces, and wherein at least a portion of the wetted surfaces of the fluidic flow path are coated with an inert coating, wherein the inert coating is inert to at least one analyte in the sample; (2) detecting a value associated with the positive control; and (3) analyzing values associated with the detected positive control to determine system inertness.

Claims (47)

1. A method for evaluating system inertness, the method comprising:

repeatedly injecting a sample into a system, wherein the sample comprises a positive control; the system comprising: fluidic paths wherein interior surfaces of the fluidic paths define wetted surfaces, and wherein at least a portion of the wetted surfaces of the fluidic flow path are coated with an inert coating, and wherein the inert coating is inert to at least one analyte in the sample;

detecting a value associated with the positive control; and

analyzing the values associated with the detected positive control to determine system inertness.

2. The method for evaluating system inertness of claim 1 , wherein the positive control comprises a metal-sensitive or metal chelating molecule.

3. The method for evaluating system inertness of claim 1 ,

wherein the sample consists of or essentially consists of the positive control, and

wherein the system is without a chromatographic column.

4. The method for evaluating system inertness of claim 1 , wherein the sample further comprises a negative control.

5. The method for evaluating system inertness of claim 4 , further comprising detecting a value associated with the negative control and determining system inertness by comparing the amount of detected positive control to negative control.

6. The method for evaluating system inertness of claim 4 , wherein the positive control and the negative control are structurally similar.

7. The method for evaluating system inertness of claim 4 , the method further comprising detecting the negative control with the detector,

wherein a value associated with the detected positive control is a peak area value,

wherein analyzing the value associated with the detected positive control to determine system inertness comprises comparing the peak area value of the detected positive control with a peak area value of the detected negative control to determine a ratio of the peak area values, and

comparing the determined ratio of the peak area values of the detected positive control and the detected negative control to a reference value.

8. The method for evaluating system inertness of claim 7 , wherein repeatedly injecting the sample into the system comprises injecting the sample at least five times into the system.

9. The method for evaluating system inertness of claim 1 , wherein repeatedly injecting the sample into the system comprises injecting the sample at least five times into the system.

10. A method for evaluating system inertness, the method comprising:

injecting a sample into a system, wherein the sample comprises a positive control;

the system comprising:

a sample injector having a sample injection needle for injecting the sample;

a sample reservoir container in fluid communication with the sample injector;

a detector downstream of the sample injector; and

fluid conduits connecting the sample injector, sample reservoir container, and detector,

wherein interior surfaces of the fluid conduits, sample injector, sample reservoir container, and detector form a fluidic flow path having wetted surfaces, and

wherein at least a portion of the wetted surfaces of the fluidic flow path are coated with an inert coating, and wherein the inert coating is inert to at least one analyte in the sample;

detecting the positive control with the detector; and

analyzing a value associated with the detected positive control to determine system inertness.

11. The method for evaluating system inertness of claim 10 , wherein the positive control comprises a metal-sensitive or metal chelating molecule.

12. The method for evaluating system inertness of claim 10 ,

wherein the sample consists of or essentially of the positive control, and

wherein the system is without a chromatographic column.

13. The method for evaluating system inertness of claim 10 , wherein the sample further comprises a negative control, and wherein injecting the sample comprises injecting the positive control and the negative control.

14. The method for evaluating system inertness of claim 13 , wherein the positive control and the negative control are structurally similar.

15. The method for evaluating system inertness of claim 13 , wherein the detector comprises at least one of a fluorescence detector, UV/Vis absorbance detector, or mass spectrometer.

16. The method for evaluating system inertness of claim 13 , further comprising detecting the negative control and determining system inertness by comparing the amount of detected positive control to negative control.

17. The method for evaluating system inertness of claim 13 , the method further comprising detecting the negative control with the detector,

wherein a value associated with the detected positive control is a peak area value,

wherein analyzing the value associated with the detected positive control to determine system inertness comprises comparing the peak area value of the detected positive control with a peak area value of the detected negative control to determine a ratio of the peak area values, and

comparing the determined ratio of the peak area values of the detected positive control and the detected negative control to a reference value.

18. The method for evaluating system inertness of claim 10 , wherein injecting the sample comprises injecting a negative control and the positive control into the system, and wherein the system is without a chromatographic column.

19. The method for evaluating system inertness of claim 18 , wherein the detector comprises at least one of a fluorescence detector, UV/Vis detector, or mass spectrometer.

20. The method for evaluating system inertness of claim 10 , wherein the sample consists of or essentially of the positive control, the method further comprising multiple injections of the sample into the system.

21. The method for evaluating system inertness of claim 10 , wherein the inert coating comprises siloxane moieties.

22. The method for evaluating system inertness of claim 10 , wherein the inert coating is an alkylsilyl coating.

23. The method for evaluating system inertness of claim 10 , wherein injecting the sample into the system comprises repeatedly injecting the sample into the system.

24. The method for evaluating system inertness of claim 10 , wherein repeatedly injecting the sample into the system comprises injecting the sample at least five times into the system.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 18, 2023
From: PATEL, AMIT; JUNG, MOON CHUL; RZEWUSKI, SUSAN; WALTER, THOMAS H.; LAUBER, MATTHEW A.; WYNDHAM, KEVIN; DELANO, MATHEW; SIMEONE, JENNIFER
To: WATERS TECHNOLOGIES CORPORATION
Reel/Frame 064299/0661 →
Continuity (3)
Provisional Application 63079160 · Sep 16, 2020
Provisional Application 63079156 · Sep 16, 2020
Related Publication 20220082532A1 · Mar 17, 2022