#ccitechnologies

Pouches are widely used in pharmaceutical and medical packaging due to their flexibility and efficiency, but ensuring their integrity is essential to maintain product safety. Even microscopic defects in seals or materials can lead to contamination, moisture ingress, or product degradation. Container Closure Integrity Testing (CCIT) provides a reliable solution by detecting leaks using deterministic, non-destructive methods. Technologies such as vacuum decay and airborne ultrasound enable precise and repeatable evaluation of pouch seals. These advanced methods generate quantitative data, helping manufacturers ensure consistent quality, meet regulatory requirements, and maintain the sterile barrier throughout the product lifecycle.

CCIT helps detect package integrity failures that could allow contaminants to enter sterile pharmaceutical products.

Pharmaceutical products rely on robust packaging systems to maintain their intended shelf life, performance, and sterility. Container Closure Integrity Testing (CCIT) helps confirm that these systems remain secure during manufacturing, transport, and storage. Over time, industry standards have evolved and so have the expectations for how package testing is carried out. Traditional approaches—often based on probabilistic methods like dye ingress or microbial challenge—have been widely used but frequently fall short in terms of precision and consistency. Deterministic testing methods have emerged as more consistent and measurable alternatives, offering improved detection and data collection. This shift supports a more structured and repeatable approach to quality control in pharmaceutical packaging.

The Container Closure Integrity testing of blister packages is performed to ensure that the package is properly sealed and that there are no leaks or defects that could compromise the quality of the medication inside. This testing is important because if the package is not properly sealed, moisture and oxygen can enter, potentially degrading the medication and reducing its effectiveness.

Overall, automated Container Closure Integrity testing is an important tool for ensuring the safety and quality of parenteral products, and is increasingly being used by manufacturers to ensure that their products meet regulatory requirements and industry standards.

Biologic product quality control guarantees the efficacy of biological products intended for human use. The safety of human life is ensured by biological product testing, which also enhances the reputation of the company. In general, there is a potential for numerous types of contamination with biological products. A small amount of contamination may ruin an entire batch of products and result in enormous financial and health losses. Hence, maintaining package integrity of biologic products are extremely crucial.

Airborne Ultrasound Technology is a technique for testing the seal quality. It is an ASTM test method F3004 and the Food and Drug Administration (FDA) approved standard for seal quality testing. Such inspections are mainly done to provide improved seal quality inspection of pouches, flexible packages and tray seals. Airborne Ultrasound technology ensures in-depth seal quality analysis and is applicable to multiple packaging materials such as Tyvek, paper, foil, film, aluminum, plastic and poly.