Device and method for container closure integrity testing
AssigneeLonza Ltd.
InventorsRoman Mathaes, Anja Matter, Sarah Pelaez, Hanns-Christian Mahler, Atanas Koulov, Benjamin Zucol, Martin Vogt, Lorenz Hochwallner
Life of this patent
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Abstract
Devices and methods for container closure integrity testing by leak testing, in particular of pharmaceutical containers, which are composed of two parts, the container itself, which shows an opening, and a closure system that is used to close this opening of the container, such as a lid; and their application in quality control.
Claims26
A device for testing the integrity of a closure system of a container, the container having a top portion comprising a main opening and a bottom portion, wherein the main opening is closed by the closure system, the device comprising
- (a) a casing having a wall forming a chamber into which at least the top portion of the container is insertable;
- b) sealing means adapted to seal at least a portion of the chamber against the container if the container or the top portion thereof is inserted;
- the sealing means divide the device and the chamber into an upstream portion, which is above the sealing means and where the top portion is located, and into a downstream portion, which is below the sealing means and where the bottom portion is located;
- (c) an outlet in the wall of the casing of the upstream portion of the chamber for allowing an efflux of a gas from the upstream portion of the chamber;
- characterized in that the device comprises positioning means for preventing contact between a top end of the closure system and a top part of the wall of the device when the top portion of the container is inserted into the chamber of the device;
- wherein the positioning means and sealing means are two separate means and the positioning means are located in the upstream portion of the chamber.
A method for testing the integrity of a closure system closing a container, wherein the container includes a top portion comprising a main opening and a bottom portion, wherein the main opening is closed by the closure system, a device for testing the integrity of a closure system comprising:
- (a) a casing having a wall forming a chamber into which at least the top portion of the container is insertable;
- b) sealing means adapted to seal at least a portion of the chamber against the container if the container or the top portion thereof is inserted;
- the sealing means divide the device and the chamber into an upstream portion, which is above the sealing means and where the top portion is located, and into a downstream portion, which is below the sealing means and where the bottom portion is located;
- (c) an outlet in the wall of the casing of the upstream portion of the chamber for allowing an efflux of a gas from the upstream portion of the chamber;
- characterized in that the device comprises positioning means for preventing contact between a top end of the closure system and the top part of the wall of the device when the top portion of the container is inserted into the chamber of the device;
- wherein the positioning means and sealing means are two separate means and the positioning means are located in the upstream portion of the chamber,
- wherein the method comprises the steps of:
- providing the container closed with the closure system,
- (a) placing the closure system of the container into a chamber of a container closure integrity test device and sealing the wall of the chamber against the container,
- wherein the container is or can be filled for the test with a testing gas, and
- wherein the closure system is prevented from contact with the wall of the chamber by the positioning means;
- (b) generating a pressure difference between the inside of the container and the inside of the sealed chamber;
- (c) detecting the testing gas that passes the closure system.
Dependencies are inferred from the claim text.