Container Closure Integrity Testing (CCIT)

Ensure product sterility and compliance with RSSL’s CCIT services aligned to USP & EP requirements

 

 

We support the pharmaceutical industry in maintaining the highest standards of sterility and product quality with our Container Closure Integrity Testing (CCIT) services.

 

Ensuring a container’s closure system remains intact is critical within a stability study for maintaining a sterile barrier throughout a product’s shelf life. A compromised container can allow air, moisture or microorganisms to enter, which can affect drug efficacy, safety and compliance.

 

A key quality assurance process, Container Closure Integrity Testing evaluates whether packaging systems can maintain sterility under real-world handling and storage conditions. This includes ensuring packaging integrity during transportation and storage, verifying package changes or component compatibility or root cause investigations in quality incidents

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Regulatory authorities, including the European Pharmacopoeia (EP 3.2.9) and the United States Pharmacopeia (USP <1207>) recognise several CCIT methods as acceptable approaches to assessing container integrity. These include vacuum decay, pressure decay, high voltage leak detection (HVLD) and dye ingress testing, which is the primary method we offer at RSSL.

Expertise in Dye Ingress Testing

 

RSSL specialises in Dye Ingress Testing, a robust and validated method for detecting potential breaches in sealed pharmaceutical containers. This technique is suitable for a wide range of primary packaging formats such as ampoules, vials, syringes and blister packs. The method is referenced in both EP 3.2.9 under the ‘Self-Sealing Test’ and USP <1207> making it a widely accepted approach for sterile product assurance. 

 

Following the vacuum cycles, our methodology includes full UV-Visible spectroscopy spectral scans from 400 nm to 750 nm, using validated software to identify peak absorbance and quantify dye presence with high sensitivity. 

UV-Visible Absorbance of Methylene Blue

Our spectrophotometric analysis is sensitive down to parts per million (ppm) levels of methylene blue, ensuring accurate and reproducible results. This quantitative approach provides an objective measure of integrity, unlike purely visual tests.

 

Methylene blue at various concentrations

Our CCIT service combines regulatory expertise, robust validation and scientific precision to help clients maintain confidence in their packaging systems. All testing is conducted in accordance with EP and USP guidelines, ensuring full regulatory compliance. Our methods are validated for reliability and sensitivity, providing quantitative results through advanced UV-Vis spectroscopic analysis.

 

With deep technical expertise and tailored support, RSSL delivers clear, strong data to support product quality, sterility and shelf life.

 

Trusted CCIT testing with RSSL

Whether you’re preparing a regulatory submission, investigating a packaging failure, or validating packaging for a new product, RSSL is here to help 

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