Method and device for conducting an integrity test on a flexible test container

Patent metadata

Field	Value
Publication number	US-10088381-B2
Application number	US-201615063621-A
Country	US
Kind code	B2
Filing date	Mar 8, 2016
Priority date	Jan 15, 2016
Publication date	Oct 2, 2018
Grant date	Oct 2, 2018

Abstract

A method for conducting an integrity test on a flexible test container ( 1 ) includes arranging the test container ( 1 ) in an examination container ( 5 ) that is sealable in a fluid-tight manner, providing negative pressure in the interior of the sealed examination container ( 5 ), filling examination fluid into the test container ( 1 ) arranged in the examination container ( 5 ), detecting examination fluid present in the interior of the examination container ( 5 ), and providing negative pressure in the test container ( 1 ) arranged in the examination container ( 5 ) prior to filling the examination fluid. Prior to filling the examination fluid, the negative pressure in the test container ( 1 ) is lower than the negative pressure in the interior of the examination container ( 5 ), and the pressure difference between the negative pressure in the test container ( 1 ) and the negative pressure in the interior of the sealed examination container ( 5 ) is more than 0 mbar and a maximum of 100 mbar.

First claim

What is claimed is:

1. A method for conducting an integrity test on a flexible test container ( 1 ), comprising:
arranging the test container ( 1 ) in an interior of an examination container ( 5 ) that is sealable in a fluid-tight manner;
providing negative pressure in the interior of the sealed examination container ( 5 );
providing negative pressure in the test container ( 1 ) arranged in the examination container ( 5 ), the negative pressure in the test container ( 1 ) being provided before and during the step of providing negative pressure in the interior of the sealed examination container ( 5 ), the negative pressure in the test container ( 1 ) being lower than the negative pressure in the interior of the examination container ( 5 ) and being selected so that a pressure difference between the negative pressure in the test container ( 1 ) and the negative pressure in the interior of the sealed examination container ( 5 ) is more than 0 mbar and a maximum of 100 mbar;
filling examination fluid into the test container ( 1 ) arranged in the examination container ( 5 ); and
detecting whether any of the examination fluid is present in the interior of the examination container ( 5 ).

2. The method of claim 1 , wherein the step of providing negative pressure in the test container ( 1 ) is carried out prior to filling the examination fluid into the examination container ( 5 ) so that the negative pressure in the test container ( 1 ) is 0 mbar to 10 mbar lower than the negative pressure provided in the examination container ( 5 ).

3. The method of claim 1 , wherein the step of providing negative pressure in the test container ( 1 ) and the step of providing negative pressure in the interior of the examination container ( 5 ) are carried out substantially at the same time, wherein during the provision of the two negative pressures, the negative pressure in the test container ( 1 ) is maintained continuously lower than the negative pressure in the interior of the sealed examination container ( 5 ).

4. The method of claim 1 , wherein during the steps of providing the negative pressures in the test container ( 1 ) and in the examination container ( 5 ), the level of the negative pressure in the test container ( 1 ) is matched to the level of the negative pressure in the examination container ( 5 ).

5. The method of claim 4 , wherein during the steps of providing the negative pressures in the test container ( 1 ) and in the examination container ( 5 ), at least temporary pressure compensation takes place between the interior of the test container ( 1 ) and the interior of the examination container ( 5 ).

6. The method of claim 4 , wherein the matching between the negative pressure in the interior of the test container ( 1 ) and the negative pressure in the interior of the examination container ( 5 ) comprises
matching between an examination container pump ( 4 ) for pumping off the interior of the sealed examination container ( 5 ) and a test container pump ( 6 ) for pumping off the interior of the test container ( 1 ), and/or
operating an isolation valve (V 7 ).

7. The method of claim 1 , wherein the step of filling the examination fluid into the test container ( 1 ) comprises filling examination fluid from a preloaded examination fluid source ( 3 ).

8. The method of claim 1 , further comprising terminating the method as soon as the examination fluid concentration in the examination container ( 5 ) exceeds a predetermined leak limit (Limit3_LeakRate) and rating the test container ( 1 ) as being defective.

9. The method of claim 1 , further comprising flushing the interior of the examination container ( 5 ) after examination fluid has been detected in the examination container ( 5 ).

10. The method of claim 1 , further comprising setting a background concentration of examination fluid in the examination container ( 5 ).

11. A method for conducting an integrity test on a flexible test container ( 1 ), comprising:
arranging the test container ( 1 ) in an interior of an examination container ( 5 ) that is sealable in a fluid-tight manner;
providing negative pressure in the interior of the sealed examination container ( 5 );
providing negative pressure in the test container ( 1 ) arranged in the examination container ( 5 ), the negative pressure in the test container ( 1 ) be lower than the negative pressure in the interior of the examination container ( 5 ) and being selected so that a pressure difference between the negative pressure in the test container ( 1 ) and the negative pressure in the interior of the sealed examination container ( 5 ) is more than 0 mbar and a maximum of 100 mbar;
filling examination fluid into the test container ( 1 ) arranged in the examination container ( 5 );
detecting whether any of the examination fluid is present in the interior of the examination container ( 5 ); and
increasing an examination fluid background concentration in the examination container ( 5 ) when a background leak rate (LeakRate) in the examination container ( 5 ) falls below a predetermined leak limit (Limit2_LeakRate).

12. The method of claim 11 , wherein the step of providing the negative pressure in the test container ( 1 ) is carried out before and during the step of providing negative pressure in the interior of the examination container ( 5 ).

13. A method for conducting an integrity test on a flexible test container ( 1 ), comprising:
arranging the test container ( 1 ) in an interior of an examination container ( 5 ) that is sealable in a fluid-tight manner;
providing negative pressure in the interior of the sealed examination container ( 5 );
providing negative pressure in the test container ( 1 ) arranged in the examination container ( 5 ), the negative pressure in the test container ( 1 ) be lower than the negative pressure in the interior of the examination container ( 5 ) and being selected so that a pressure difference between the negative pressure in the test container ( 1 ) and the negative pressure in the interior of the sealed examination container ( 5 ) is more than 0 mbar and a maximum of 100 mbar;
filling examination fluid into the test container ( 1 ) arranged in the examination container ( 5 ); and
detecting whether any of the examination fluid is present in the interior of the examination container ( 5 ), wherein the negative pressure in the test container ( 1 ) is provided via a supply line (L 1 ), via which the examination fluid is filled into the test container.

14. A test device ( 10 ; 20 ) for conducting an integrity test on a flexible test container ( 1 ), comprising:
an examination container ( 5 ) that is sealable in a fluid-tight manner, in which the test container ( 1 ) is arrangeable;
an examination container pump ( 4 ) for pumping off the interior of the sealed examination container ( 5 ) to achieve a negative pressure;
an examination fluid source ( 3 ), from which examination fluid can be filled into the test container ( 1 ) arranged in the examination container ( 5 );
an isolation valve (V 7 ) between the interior of the test container ( 1 ) and the interior of the examination container ( 5 );
an examination fluid detector ( 2 ) for detecting examination fluid in the interior of the examination container ( 5 ); and
a pump connection, via which the interior of the test container arranged in the examination container ( 5 ) can be pumped off such that the negative pressure in the test container ( 1 ) is lower than the negative pressure in the interior of the sealed examination container ( 5 ), wherein the pressure difference between the negative pressure in the test container ( 1 ) and the negative

Assignees

• Sartorius Stedim Biotech Gmbh
• Sartorius Stedium Biotech Gmbh

Inventors

• Hogreve Marc

Classifications

• G01M3/3218 Primary

  for flexible or elastic containers · CPC title

• G01M3/229

  removably mounted in a test cell · CPC title

• G01M3/04 Primary

  by detecting the presence of fluid at the leakage point · CPC title

• G01M3/227

  for flexible or elastic containers · CPC title

• G01M3/027 Primary

  Details with respect to the testing of elastic elements, e.g. gloves, condoms · CPC title