Explaining Container Closure Integrity Testing

What Is Container Closure Integrity Testing for Blister Packs?

CCIT, or Container Closure Integrity Testing, ensures that tablets and capsules remain in pristine condition throughout its shelf life. By using advanced testing techniques, CCIT expertly identifies any leaks, defects, or weak seals in blister packs that could potentially compromise the quality and safety of your medication. With a focus on preventing contamination and moisture ingress, CCIT helps detect issues such as faulty seals, cavity defects, material problems, or even machine settings.

What Are the Different Leak Test Methods for Blister Packs?

Blister packs play a crucial role in keeping medications safe, efficient, and fully protected. To ensure that they meet the highest quality standards, pharmaceutical manufacturers use a variety of leak testing methods:

Dye Ingress Testing

Dye ingress testing is a widely used method for detecting defects in blister packs. By immersing blister packs in a solution of blue dye and water and subjecting them to a vacuum, this technique helps identify any hidden flaws. After applying a vacuum, any defective pockets in the packs absorb the blue dye, making them stand out during inspection. While it’s inexpensive and easy to perform, it’s important to note that dye ingress testing is subjective, time-consuming, and destructive.

Tracer Gas (Vacuum Mode)

Using mass spectrometers, this method can accurately measure the rate of leakage of tracer gasses such as hydrogen or helium. Here’s how it works: test samples are filled with the tracer gas and sealed in a vacuum chamber. As the chamber is emptied, any gas that is leaking is pulled through the analyzer. Although sensitive, this method can be cost prohibitive.

Vacuum Deflection

Vacuum deflection by laser measurement technology scans the surface of blister packs before and after vacuum application. By precisely measuring the deflection or difference in height of the foil in each cavity, it can detect any potential issues. When there are no holes present, the foil reacts by moving and causing deflection. Large holes result in minimal deflection as the pressure equalizes. However, small holes exhibit initial expansion under vacuum. As the vacuum is reduced, any increased collapse indicates the presence of a small hole, where air gradually escapes and equalizes the pressure inside the pocket. This highly accurate method is non-destructive, deterministic, and cost effective.

There are a variety of other non-destructive testing (NDT) methods that outperform traditional, destructive methods for pharmaceutical packaging.

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What Regulatory Compliance Should Be Considered for Container Closure Integrity Testing?

Good Manufacturing Practice (GMP) emphasizes the importance of leak detection procedures for manufacturers. Not only do they provide peace of mind regarding the integrity of the packaging, but they also ensure product stability and shelf life.

Two ASTM standard test methods can be used for leak detection: ASTM F3169-16 and ASTM F2391-22.

ASTM F3169-16 uses the vacuum deflection method with laser measurement. It assesses non-porous blister packs sealed with flexible materials, such as polymer or foil. This method is ideal for thermoformed polymer or cold-formed aluminum trays containing tablets or capsules in individual blister pockets.

On the other hand, ASTM F2391-22 uses helium as the tracer gas for leak testing cold-formed aluminum blister packs. By following these industry standards, you can maintain the integrity of your products and ensure consistent quality for their customers.

Why Should You Consider Non-Destructive Leak Testing?

Traditional leak testing methods for blister packaging can result in unnecessary waste and destruction of products. But now, non-destructive leak testing is gaining momentum, offering a more sustainable and efficient solution. With non-destructive testing, packs that pass the test can be returned to the production line or the product can be recovered and repackaged. This means less waste and significant cost savings, especially for manufacturers of expensive drugs such as oncology medications. By switching to non-destructive methods, you can also reduce your environmental impact. This greener choice minimizes product waste, eliminates the need for incineration, and avoids potential contamination risks associated with traditional testing methods.

What Is the Standard Acceptable Leak Size for CCIT of Blister Packs?

Various factors, such as the type of product and packaging material, influence the acceptable leak size. Regulatory bodies like the FDA and EMA emphasize the importance of demonstrating packaging integrity and using leak test methods that are sensitive enough to detect potential defects that could compromise product quality and safety. Each pharmaceutical manufacturer sets their own standards for leak size based on their unique products and packaging materials. Rigorous testing and validation procedures are conducted to determine the necessary sensitivity level of the chosen leak test method, ensuring that it can detect any leaks that may affect the product’s integrity.

Key Takeaways

Explore the significance of Container Closure Integrity Testing in the pharmaceutical packaging sector.

At Ascend Packaging Systems, we recognize the importance of ensuring the safety and effectiveness of prefilled syringes and other pharmaceutical products. Our state-of-the-art machinery, such as the Sepha Multi-Q HD and Sepha VisionScan 3D, utilizes advanced technology to detect leaks as small as 1 micron or 5 microns respectively. These NDT methods provide reliable and consistent results, ensuring the integrity of your packaging. Contact us today to learn more about NDT methods.