IP Library Granted Patent US 10,670,490
Granted Patent B2
US 10,670,490 · App. 15/824,045 · Granted Jun 2, 2020

Measurement system and method therefore

Inventors: Robert Douglas Burchesky (Westborough, MA); James Molloy (Westborough, MA)
Assignee: GE Healthcare Bio-Sciences Corp.
G01M3/3218C12M23/14C12M41/12C12M41/40G01M3/007G01G17/04
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Quick Facts
Patent No.
US 10,670,490
App. No.
15/824,045
Granted
Jun 2, 2020
Kind
B2
Abstract

The present invention relates to a method for a measurement system configured to test a flexible bio-process bag, the method comprising providing at least one flexible bio-process bag having a volume, wherein the at least one flexible bio-process bag is initially filled with a gas and inflated to a reference pressure (Pu), obtaining a leak model, obtaining baseline information, wherein the baseline information comprises at least a weighed first mass value (m baseline ) and a first time value (t 1 ), obtaining evaluation information, wherein the evaluation information comprises at least a weighed second mass value (m evaluation ) and a second time value (t 2 ), testing the flexible bio-process bag based on the leak model, the baseline information and the evaluation information.

Claims (42)

1. Method for a measurement system configured to test a flexible bio-process bag, the method comprising:

providing at least one flexible bio-process bag having a volume, wherein the at least one flexible bio-process bag is initially filled with a gas and inflated to a reference pressure (P u ),

obtaining a leak model,

obtaining baseline information, wherein the baseline information comprises at least a weighed first mass value (m baseline ) and a first time value (t 1 ),

obtaining evaluation information, wherein the evaluation information comprises at least a weighed second mass value (m evaluation ) and a second time value (t 2 ), and

testing the flexible bio-process bag based on the leak model, the baseline information and the evaluation information,

wherein the leak model is at least indicative of a first leaked mass (Δm model ) dependent on a first time period (Δt model ), the first mass value (m baseline ) is indicative of a first weight of the flexible bio-process bag weighed at a point in time indicated by the first time value (t 1 ), the second mass value (m evaluation ) is indicative of a second weight of the flexible bio-process bag weighed at a subsequent point in time indicated by the second time value (t 2 ), wherein an absolute value of a difference between the second time value (t 2 ) and the first time value (t 1 ) equals the first time period (Δt model ), wherein testing is performed by:

determining a second leaked mass (Δm weighed ) as the absolute value of a difference between the first mass value (m baseline ) and the second mass value (m evaluation ), and

testing the flexible bio-process bag as usable if the second leaked mass (Δm weighed ) is less or equal to the first leaked mass (Δm model ) or

testing the flexible bio-process bag as unusable if the second leaked mass (Δm weighed ) is greater than the first leaked mass (Δm model ).

2. The method according to claim 1 , wherein the leak model indicates the first leaked mass (Δm model ) based on the relation:

Δ m model =k*Δt model +b,

wherein k is a calibration constant and b is a bias constant.

3. The method according to claim 2 , wherein the calibration constant k is determined by performing linear regression on a set of reference data.

4. The method according to claim 3 , wherein the reference data is obtained by weighing a plurality of reference flexible bio-process bags having the predetermined volume, being initially filled with a gas and inflated to a reference pressure (P u ), and having a known mass leak rate.

5. A measurement system configured to test a flexible bio-process bag, the system comprising:

a scale configured to receive at least one flexible bio-process bag and to provide mass values indicative of the weight of the at least one flexible bio-process bag,

a control unit comprising:

a processor, and

a memory, said memory containing instructions executable by said processor, whereby said measurement system is operative to perform the method according to claim 1 .

6. The measurement system according to claim 5 , wherein the scale comprises:

a platform arranged to receive a load to be measured by the scale and extending in a plane,

a receiving arrangement suspended along a normal of the plane extending from a center point of the platform, the receiving arrangement configured to attach to a grip arranged at one end of the flexible bio-process bag.

7. Method for a measurement system configured to test a flexible bio-process bag, the method comprising:

providing at least one flexible bio-process bag having a volume, wherein the at least one flexible bio-process bag is initially filled with a gas and inflated to a reference pressure (P u ),

obtaining a leak model,

obtaining baseline information, wherein the baseline information comprises at least a weighed first mass value (m baseline ) and a first time value (t 1 ),

obtaining evaluation information, wherein the evaluation information comprises at least a weighed second mass value (m evaluation ) and a second time value (t 2 ), and

testing the flexible bio-process bag based on the leak model, the baseline information and the evaluation information, further comprising:

an orifice plate having an orifice of a predetermined diameter (d),

an input valve configured to control the flow of compressed gas from a gas source to an input port of the flexible bio-process bag in response to receiving a first control signal, and

an output valve configured to control the flow of gas from an output port of the flexible bio-process bag to the orifice plate in response to receiving a second control signal.

8. The method according to claim 7 , further comprising a barometer configured to measure air pressure as an air pressure value and send the air pressure value comprised in a third control signal to the control unit.

9. The method according to claim 7 , further comprising a temperature sensor configured to measure ambient temperature as an ambient temperature value and send the ambient temperature comprised in a fourth control signal to the control unit.

10. A measurement system configured to test a flexible bio-process bag, the system comprising:

a scale configured to receive at least one flexible bio-process bag and to provide mass values indicative of the weight of the at least one flexible bio-process bag,

a control unit comprising:

a processor, and

a memory, said memory containing instructions executable by said processor, whereby said measurement system is operative to perform the method according to claim 7 .

11. The measurement system according to claim 10 , wherein the scale comprises:

a platform arranged to receive a load to be measured by the scale and extending in a plane,

a receiving arrangement suspended along a normal of the plane extending from a center point of the platform, the receiving arrangement configured to attach to a grip arranged at one end of the flexible bio-process bag.

Assignments (2)
CHANGE OF NAME Recorded Aug 31, 2020
From: GE HEALTHCARE BIO-SCIENCES CORP.
To: GLOBAL LIFE SCIENCES SOLUTIONS USA LLC
Reel/Frame 053648/0854 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 30, 2017
From: BURCHESKY, ROBERT DOUGLAS; MOLLOY, JAMES
To: GE HEALTHCARE BIO-SCIENCES CORP.
Reel/Frame 044257/0830 →