The pharmaceutical packaging system is essential to protect medications from potential external influences that could lead to deterioration or contamination during storage and use. CD Formulation offers professional packaging integrity testing services for transdermal formulations.
Ensuring the pharmaceutical packaging system's ability to seal properly is crucial to prevent contamination or damage to the drug throughout its production, storage, and transportation. Testing the integrity of the packaging guarantees that the product stays safe, sterile, and undamaged throughout its shelf life and usage, and confirms that the packaging can withstand various transportation conditions.
Depending on factors such as packaging type, contents, industry regulations, etc., we can provide the following test methods:
The package is submerged in a colored liquid, and any potential leaks can be detected by the appearance of dye on the outside.
The package is placed underwater or in a gas-filled chamber, and escaping bubbles indicate leaks.
The package is placed in a vacuum chamber, and changes in pressure indicate leaks.
Positive pressure or vacuum is applied to the package to evaluate its ability to maintain integrity under pressure.
This involves subjecting the package to internal pressure until it bursts, which helps determine the strength of the package seal.
The package is subjected to simulated transportation conditions (vibration, compression) to evaluate its durability.
Our testing process is as follows (Taking vacuum decay testing as an example):
Fig.1 Flow chart of packaging integrity testing. (CD Formulation)
Technologies | Description |
---|---|
Burst Tester | An instrument that applies pressure until a package bursts, providing data on seal strength and integrity. |
Compression and Vibration Tests | Simulate shipping conditions to assess a package's durability under pressure. |
Environmental Monitoring Systems | Sensors and data loggers monitor environmental factors (temperature, humidity) to ensure packaging materials maintain stability and integrity. |
Technology: Methods to packaging integrity Testing
Journal: Journal of Pharmaceutical Sciences
IF: 3.8
Published: 2023
Results: A new dye ingress test method, suitable for testing at low temperatures, was developed and applied to PFS across a range of deep-frozen temperatures. The technique is versatile and can easily be extended to other common CCS formats over a wide range of temperatures including storage on dry ice (-80°C).
Fig.2 Container closure integrity of the glass PFS evaluated in this work as a function of temperature, via two orthogonal techniques. Dye ingress results are shown as filled circles, and CO2 HGA results are shown as open squares. (Jessica Baseggioa, 2023)
Defects in the sealing integrity of the drug packaging system may cause the drug to be contaminated or result in the loss of the drug's active ingredients, thereby creating drug quality risks. CD Formulation provides you with professional packaging integrity testing for transdermal formulations. If you have any needs, please feel free to contact us and our colleagues will contact you within three working days.
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