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System and method for testing closure integrity of a sealed container at cryogenic temperatures

A technology for sealing containers and integrity, which is applied in the field of testing the sealing of sealed containers at cryogenic temperatures, and can solve problems such as endangering the sterility of biological or pharmaceutical products

Pending Publication Date: 2021-07-30
WEST PHARM SERVICES INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As a result, elastomeric seal components may not maintain seal integrity at cryogenic temperatures and may compromise the sterility of biological or pharmaceutical products stored in the container

Method used

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  • System and method for testing closure integrity of a sealed container at cryogenic temperatures
  • System and method for testing closure integrity of a sealed container at cryogenic temperatures
  • System and method for testing closure integrity of a sealed container at cryogenic temperatures

Examples

Experimental program
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Embodiment Construction

[0023] Certain terms are used in the following description for convenience only and not limitation. The words "proximal", "distal", "upward", "downward", "bottom" and "top" in the drawings indicate directions of reference. The words "inwardly" and "outwardly" refer, respectively, to directions toward and away from the geometric center of the device and designated portions thereof according to the present application. The terms "a," "an," and "said" are not limited to one element, but should be understood to mean "at least one" unless the context clearly dictates otherwise. The term includes the above words, their derivatives, and words of similar meaning.

[0024] Referring in detail to the drawings, wherein like numerals refer to like elements throughout the several views, Figure 1-8 Shown is a preferred embodiment of an apparatus and method for testing the closure integrity of a container closed by a closure at cryogenic temperatures.

[0025] As used herein, the term "c...

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PUM

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Abstract

A system for testing the closure integrity of a sealed container at a cryogenic temperature is provided. The system includes a sealed container containing helium having an opening sealed by a closure, a cryogenic storage vessel at least partially filled with a cryogenic fluid at the cryogenic temperature, a hollow tube extending through an opening of the cryogenic storage vessel, a fixture configured to engage the sealed container, and a leak detection unit connected to the hollow tube. The hollow tube has a first end positioned outside of the cryogenic storage vessel and an opposing second end positioned inside the cryogenic storage vessel. The fixture is configured to be removably inserted within the hollow tube through an opening at the first end of the hollow tube, such that the sealed container is positioned at or proximate the second end of the hollow tube.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS [0002] This application claims priority to US Provisional Patent Application No. 62 / 771664, filed November 27, 2018, the disclosure of which is incorporated herein by reference in its entirety. Background technique [0003] The present application relates to an apparatus and method for testing the closure integrity of containers (eg, vials, cartridges, syringes, etc.) at cryogenic temperatures. [0004] The integrity of the seal between the container and closure should be considered when selecting packaging components for biological and pharmaceutical materials. These materials are typically stored in stoppered glass or plastic containers (such as glass or plastic vials or syringes) with elastic closures. For example, these materials include blood, serum, proteins, peptides, stem cells, DNA, and other perishable biological fluids, as well as lyophilized or freeze-dried pharmaceuticals. [0005] Containers must be able to prote...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01M3/22
CPCG01M3/226A61J1/065B01L3/50825A01N1/0268A61J1/1412
Inventor 路易斯·J·布拉斯特詹姆斯·迈考
Owner WEST PHARM SERVICES INC