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 F2338-09(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.
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 of ampoule, cartridge bottles, infusion bottles, prefilled syringes and other pharmaceutical packaging.
Parameters
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 F2338-09(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.
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 of ampoule, cartridge bottles, infusion bottles, prefilled syringes and other pharmaceutical packaging.
| Parameter\Model | C690H | |
|---|---|---|
| Testing Range | um(Reference aperture size USP1207) | 3～8～great leakage |
| Detection Lower Limit | um | ≤3 |
| Resolution | um | 0.1 |
| Repeatability | um | ±1 |
| Pressure Range | kPa | -100～0～＋100 |
| Extended Functions | 21 CFR Part11 | Optional |
| GMP computer system requirements | Optional | |
In conclusion, non-destructive vacuum decay leak testing is an indispensable tool for pharmaceutical and other industries where product integrity is paramount. Its ability to accurately and non-invasively detect leaks makes it a crucial component of quality control and assurance processes, safeguarding product quality and consumer safety.
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