This disclosure relates to equipment utilized to manufacture chemical agents, particularly biopharmaceuticals, using Disposable Containers (DCs).

Method for testing a test piece for the presence of a leak using a foil chamber, wherein the foil chamber has walls having at least one flexible wall region to which a measurement volume adjoins and is arranged on that side of the flexible wall region opposite the foil chamber volume and is hermetically separated from the foil chamber volume, having the following steps: placing the test piece in the foil chamber, closing the foil chamber, evacuating the foil chamber and monitoring the measurement volume during evacuation of the foil chamber, using the result of the monitoring to reach a conclusion regarding the magnitude of a leak, characterized in that a venting valve connecting the measurement volume to the atmosphere is closed when the pressure in the measurement volume is below a predefined threshold value, and is opened as soon as the pressure exceeds the threshold value.

This disclosure relates to equipment utilized to manufacture chemical agents, particularly biopharmaceuticals, using Disposable Containers (DCs).

A leak detection device operable to measure fluid leaks in an element to be tested that is positioned in a first enclosure. In one example, a measuring module is positioned in a second enclosure and connected to the first enclosure and the element to be tested by an aeraulic connection. At least one of the first enclosure and the measuring module are thermally insulated using an insulating material.

Integrity of a flexible bag is verified by a testing system, using helium to detect existence of a possible hole. The bag is preliminary placed in vacuum chamber of a fluid-tightly isolated enclosure. After connecting a port of the bag to a helium feeding pipe and after pre-pressurizing the bag with nitrogen, a test is performed in a vacuum suction mode for a detection area outside the bag in the enclosure. Before starting the test phase, the bag is additionally filled with an amount of helium. A detection detects information representative of helium partial pressure in the internal volume, to allow detection of helium escaping from the bag, by analysis of a helium partial pressure drop. A small amount of nitrogen is sufficient to decrease leak rate mean value, so that uncertainty regarding integrity of some bags decreases.

A method for leak testing includes a leak testing step and a reference leak step. In the leak testing step, a hollow work 20 as a test object is encapsulated in a work capsule 11. A test pressure is supplied to the work capsule 11 through a path 2a connected to the work capsule. A variation of pressure inside the work capsule 11 is detected in a condition in which the path 2a is shut-off, and a judgment is made whether a leakage through the work is generated based on the detected output. In the reference leak step, a reference leak device 30 having a known pinhole 31a is mounted on a work 20′ for reference leakage that is same as the work 20 as the test object. The work 20′ for reference leakage is encapsulated in the work capsule 11. The test pressure is supplied to the work capsule 11 via the path 2a, and a reference leakage is generated in the work 20′ for reference leakage via the reference leak device 30 in a condition in which the path 2a is shut-off. A variation of pressure inside the work capsule 11 accompanying the reference leakage is detected.

Integrity of a flexible bag is verified by a testing system, using helium to detect existence of a possible hole. The flexible bag is preliminary placed in vacuum chamber of a fluid-tightly isolated enclosure. After connecting a port of the bag to a helium feeding pipe, vacuum suction is performed to obtain vacuum outside the bag in the enclosure. Then, a first amount of helium is diffused in the internal volume of the enclosure through a gas permeable wall, to increase helium partial pressure outside the flexible bag. After, in a test phase while said vacuum suction is still performed, the bag is filled with a second amount of helium. A detector detects information representative of helium partial pressure in the internal volume, to allow detection of helium escaping from the bag, by analysis of a helium partial pressure drop.

The application proposes a non-destructive testing method for the sealing degree of the small cigarette box packaging, which includes placing the small cigarette box to be tested in an airtight chamber, using a balance cabin to quickly form a stable negative pressure in the airtight chamber; The pressure change of the sealed chamber is continuously measured until equilibrium, and the data model is analyzed and established by using Darcy's law, Fick's diffusion law and the physical process of molecular kinetic theory. Through the non-destructive testing method for the sealing degree of the small cigarette box packaging of the present invention, the traditional destructive measurement (damaged small box packaging) for measuring the sealing degree of cigarette small box is changed into non-destructive testing; The test results have specific physical meaning; The test time of a single sample is reduced to ⅕ of the time of destructive test.

The invention relates to a film chamber 10 which has a film chamber wall for testing the sealing tightness of a gas-filled test specimen 38, which film chamber wall defines a chamber volume 32 for holding the test specimen 38 and has a first vacuum connection 28 for evacuating the chamber volume 32 by means of a first vacuum pump 30 connected to the first vacuum connection 28, wherein at least a portion of the film chamber wall has a flexible film 12, 14, characterized in that the film 12, 14 has two layers 20, 22 arranged adjacent to each other which surround an evacuable film interspace 26.

A method and system of testing for package leaks by a test system is disclosed. The test system includes a vacuum source and a test chamber in which a package is received for testing. A package is placed in the test chamber, and a vacuum is drawn on the test chamber by the vacuum source. A predetermined pressure level in the test system is detected, and based upon the detection of the predetermined pressure level, the test system determines when to stop drawing the vacuum. The test chamber is isolated from the vacuum source based upon the determination, and subsequently the test system detects the presence or absence of a leak in the package based on pressure measurements in the test chamber. A timer may be used to determine the delay in isolating the test chamber from the vacuum source after detection of the predetermined pressure level.