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Labthink Instruments Co., Ltd.
A Non-Destructive Vacuum Decay Method for Testing the Integrity of Lyophilized Drug Vials

A Non-Destructive Vacuum Decay Method for Testing the Integrity of Lyophilized Drug Vials

Product catalog summary

Introduction
Lyophilized drugs, or freeze-dried drugs, are essential for long-term storage and transportation, especially in remote or developing areas. Ensuring the integrity of the vials containing these drugs is crucial to prevent contamination and ensure safety.

Vacuum Decay Method
The vacuum decay method is a non-destructive testing technique used to assess the integrity of lyophilized drug vials. It involves placing the package in a vacuum chamber and detecting leaks by measuring pressure changes caused by gas or vapor escape. This method is standardized under ASTM F2338-09(2020).

Sensitivity and Applications
The method can detect leaks as small as 5 μm in rigid packages, making it highly sensitive and suitable for applications where even minor leaks can have significant consequences. It is applicable for various pharmaceutical packaging types, including vials, ampoules, cartridge bottles, infusion bottles, and prefilled syringes.

Labthink C690H Nondestructive Package Leak Detector
This device is based on the vacuum decay method and adheres to ASTM F2338 standards. It is designed for batch sealing leak detection and trace leakage detection in pharmaceutical packaging, ensuring product integrity and consumer safety.

Conclusion
Non-destructive vacuum decay leak testing is vital for maintaining product integrity in the pharmaceutical industry. Its accuracy and non-invasive nature make it an essential part of quality control and assurance processes, protecting both product quality and consumer safety.

Catalog excerpts

A Non-Destructive Vacuum Decay Method for Testing the Integrity of Lyophilized Drug Vials-1

Labthink Instruments Co., Ltd. [email protected] +86-531-85068566 A Non-Destructive Vacuum Decay Method for Testing the Integrity of Lyophilized Drug Vials Lyophilized drugs, also known as freeze-dried drugs, are medicines that have been preserved by removing water from them through a process called freeze-drying. They are often used in situations where long-term storage or transportation is necessary, such as in remote areas or developing countries. One of the challenges of using lyophilized drugs is ensuring that the vials they are packaged in remain intact. If the vials are damaged, the drug inside can become contaminated, which can lead to serious health problems. To address this issue, a promising non-destructive vacuum decay method commonly applied for testing the integrity of lyophilized drug vials. The vacuum decay test is a non-destructive method that measures the change in pressure within an evacuated chamber containing the test package. The essential non-destructive vacuum decay leak testing method and its applications are standardized in ASTM F233809(2020). In essence, the package is placed in a vacuum chamber, and any leaks are detected by the escape of gas or vapor from the package, causing a rise in pressure within the chamber.

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A Non-Destructive Vacuum Decay Method for Testing the Integrity of Lyophilized Drug Vials-2

Labthink Instruments Co., Ltd. [email protected] +86-531-85068566 The test can detect leaks of varying sizes, depending on the package type, with the ability to identify holes as small as 5 μm in rigid packages. This sensitivity is crucial for applications where even minute leaks can have significant consequences. Labthink C690H Nondestructive Package Leak Detector is based on the testing principle of the vacuum decay method, designed and manufactured according to ASTM F2338 and other standards. It is professionally suitable for batch sealing leak detection of vials, and trace leakage detection...

Open the catalog to page 2

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