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Transdermal Formulation Packaging Integrity Testing

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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.

About Transdermal Formulation Packaging Integrity Testing

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.

What Can We Offer

Depending on factors such as packaging type, contents, industry regulations, etc., we can provide the following test methods:

Dye penetration testing

The package is submerged in a colored liquid, and any potential leaks can be detected by the appearance of dye on the outside.

Bubble emission testing

The package is placed underwater or in a gas-filled chamber, and escaping bubbles indicate leaks.

Vacuum decay testing

The package is placed in a vacuum chamber, and changes in pressure indicate leaks.

Pressure and vacuum testing

Positive pressure or vacuum is applied to the package to evaluate its ability to maintain integrity under pressure.

Burst testing

This involves subjecting the package to internal pressure until it bursts, which helps determine the strength of the package seal.

Mechanical stress testing

The package is subjected to simulated transportation conditions (vibration, compression) to evaluate its durability.

Our Workflow for Transdermal Formulation Packaging Integrity Testing

Our testing process is as follows (Taking vacuum decay testing as an example):

Fig.1 Workflow of packaging integrity testing for transdermal formulations.Fig.1 Flow chart of packaging integrity testing. (CD Formulation)

  1. Sample Preparation: Place the packaged sample into a dedicated vacuum testing apparatus.
  2. Vacuum Initiation: Activate the vacuum pump and gradually decrease the pressure within the testing apparatus. Once the initial vacuum is achieved, document the baseline pressure within the test chamber.
  3. Pressure Monitoring: Deactivate the vacuum pump and observe the pressure fluctuations within the test chamber. A rise in pressure suggests that gas within the package is permeating or escaping through a defect in the packaging.
  4. Vacuum Decay Analysis: Evaluate the vacuum decay rate of the package by analyzing the pressure change data collected throughout the test.

Our Technology Platform

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.

Why Choose Us for Transdermal Formulation Packaging Integrity Testing?

  • We have a variety of testing methods, such as vacuum decay test, pressure decay test, etc., and can choose the appropriate testing method according to different packaging materials and products.
  • We have a professional technical team and rich experience, and we can deeply understand the testing requirements of packaging integrity.
  • We are familiar with the characteristics of various packaging materials and containers, as well as the changes in packaging integrity under different environments.

Published Data

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 testing.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.

References

  1. Jessica Baseggioa, Anton Zverev, et al. Container Closure Integrity of a Glass Prefillable Syringe in Deep Frozen Storage Conditions. Journal of Pharmaceutical Sciences. 113 (2024) 1248−1256.
How It Works
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STEP 3
Execute the project with real-time communication, and deliver the final report promptly.
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