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Container Closure Integrity Testing

Ensuring the integrity and safety of your pharmaceutical containers
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The crucial role of Container Closure Integrity Testing (CCIT) for patient safety

To ensure patient safety, maintaining the sterility and stability of drug products is a critical task for drug containment solutions. Container Closure Integrity (CCI) is essential in preserving the efficacy of a drug and preventing contamination. Effective CCI testing verifies that the final product is safe and effective when injected into a patient.

SCHOTT Pharma's services for CCIT assist customers in testing various containment systems to assess their suitability for specific applications, as well as compiling data for drug application submissions. We support data generation in compliance with global standards and authority requirements. Related methods and acceptance criteria ensure that pharmaceutical products can be trusted and approved for the market. With headspace analysis and dye penetration, we provide quantitative insights while adhering to traditional CCIT methods.

Headspace analysis – quantitative insights to CCI performance

Our Container Closure Integrity Testing (CCIT) employs a state-of-the-art approach, combining advanced equipment and precise analytical methods. We use a CCI test vessel in tandem with a headspace gas analyzer. Accommodating a wide range of container types and sizes, this setup is highly versatile and designed to expedite gas ingress in the presence of any container defects.

The core of our testing method is laser-based analysis. This method accurately measures changes in the headspace gas composition or pressure due to gas ingress, offering a highly sensitive and precise assessment of container integrity. This quantitative approach enables a time-resolved performance evaluation of the container’s closure system.

Our CCIT method is adaptable to various product specifications and container types, and applies validated mathematical models to determine the rate of gas ingress. This enables us to develop a customized and efficient CCIT protocol tailored to each specific product’s requirements.

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Dye penetration test: This test is meticulously designed to detect microscopic leaks in container seals, which are pivotal to maintaining the integrity and safety of pharmaceutical products. Utilizing specialized dyes, this method is capable of revealing the smallest of breaches in seals. The dye’s distinct visibility under specific conditions allows for the precise and reliable detection of the most minute leaks, assuring the integrity of the seal and the safety and efficacy of the product within the container.

CCIT services for product integrity and safety

By choosing CCIT services from SCHOTT Pharma, you will benefit from robust testing methods that provide evidence about the integrity and safety of your pharmaceutical products. The reliability and precision of our results combined with our commitment to regulatory adherence will help you maintain the highest standards of product quality and safety, ultimately contributing to the well-being of patients. Tailored to specific needs, our comprehensive solutions ensure that every aspect of container closure integrity is thoroughly assessed and validated.

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Reliable results – We provide transparent and detailed testing process documentation, including accurate and conclusive outcomes.

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Regulatory adherence – Our testing methods are designed to meet global regulatory standards, including FDA requirements.

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Comprehensive solutions – We offer a mix of traditional and advanced methods, tailored to each client’s unique testing needs.

Container Closure Integrity Testing: How to proceed

SCHOTT Pharma's service team of specialists offers support and advice about your pharmaceutical packaging challenge. We provide guidance and a complete process that will take you from initial request to effective solution.
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1. Get in touch

Tell us about your current needs using the contact form below or phone us directly (see number in contact information).

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2. Receive a study proposal

Based on your information, our scientific experts will advise you and create a customized study proposal that conforms to the latest regulatory guidelines.

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3. Quotation and sample requirements

Based on your feedback, we will provide a quotation, comprising a detailed study protocol and instructions for sample selection, packaging, and submission.

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4. Sample submission

You then send the samples to our laboratories with a completed submission form, proforma invoice, and material safety data sheet.

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Matthias Bicker

Matthias Bicker

Scientific Advisor Pharma Services

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