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From the early stages of development to commercial production and distribution, maintaining the integrity of container closures is paramount for preserving product sterility and stability. In this blog, we embark on an exploration of complete CCIT services within the pharmaceutical product lifecycle. By understanding the importance of CCIT throughout the lifecycle, we gain insight into its impact on product quality assurance, regulatory compliance, and ultimately, patient safety.

Services Offerings:

CCIT Testing Services

• Feasibility Studies - Initial experimental feasibility studies are the first step in evaluating and selecting the most suitable inspection technology and test method for a specific application. These studies are supported by comprehensive reporting and analysis of test result data.
• Test Method Development Support - Our services in test method development offer documentation and testing assistance, encompassing advanced initial recipe formulation, container qualification, and system suitability testing.
• Stability Testing - This testing service ensures that products maintain container closure integrity either before stability testing or throughout the stability period.
• Recall & Batch Release Testing - Tailored for recalled products, items on hold, and those slated for batch release, this testing service ensures compliance with quality standards.
• Helium Testing Services - Helium Testing Services provides a range of testing solutions including Cold Storage Testing (-80°C to -160°C), Hard Vacuum Method, and 100% Helium Flow Method, all conducted in accordance with ASTM F2391 standards. We specialize in Parenteral Product CCI, blister packs and other applications, including Package Validation testing services.

CCIT Consulting Services

• CCIT Consulting: Ideal for R&D or clinical purposes, PTI will design a plan to assist clients in navigating from component matching to production and manufacturing.
• Sampling Plan Consulting: CCIT helps clients develop and assess their statistical sampling plans to ensure compliance with relevant regulations.
• Package Development Consulting: Our service supports clients in crafting optimal package designs to ensure Container Closure Integrity (CCI). By providing real result data on leak rates of various components, we facilitate comparisons between different designs and package elements.

CCIT Training Services

• Regulatory Requirement Training: General training about regulatory requirements relevant to CCIT. Obtain assistance in navigating USP 1207/Annex 1/ASTM/ISO and standards.
• CCIT Training: Broad training course covering all aspects of general CCI including method comparisons, Maximum allowable leakage limit (MALL), and regulatory guidance.
• Hands-on System Training for all operator levels: beginner and advanced levels.
• Test Recipe Training for distinct applications.
• Application Specific Training: Review the challenges of a particular package or container to find the optimal solution.

CCIT Test Method Development Support

PTI’s CCIT Center of Excellence offers extensive support in developing and validating container closure integrity testing (CCIT) solutions, ensuring clarity and justification within GMP environments. Leveraging scientific principles, PTI creates tailored experimental frameworks for method validation, producing clear reports that detail quantitative test methods, technology solutions, and acceptance criteria. PTI's non-destructive deterministic inspection technologies provide actionable insights, allowing clients to confidently ensure package integrity.

CCIT Helium Testing Services

• Cost-Efficiency – Unlike some testing methods, we can generate leak rate data without the need for a full feasibility study. This not only saves significant time but also eliminates unnecessary expenses.
• Reliable Data – With Helium Leak being a deterministic method, there are no questionable results, as would be the case with probabilistic methods. No operator subjectivity.
• Time Savings – Compared to headspace analysis, helium leak testing can be performed in less than a day as opposed to many days.
• Flexibility – We offer the flexibility to tailor our testing services to your specific needs without the added expense of operating under strict GMP guidelines.

CCIT services employ advanced testing methodologies and technologies to assess the effectiveness of seals and closures in maintaining a sterile barrier. By integrating CCIT into their quality assurance programs, pharmaceutical companies can safeguard product quality, ensure regulatory compliance, and enhance patient safety.