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Container Closure Integrity (CCI) testing is a critical component of pharmaceutical and medical device packaging systems. Ensuring packages maintain sterility and prevent contamination throughout their shelf life is essential for product safety and regulatory compliance. Given the diversity of packaging materials, configurations, and product types, selecting the most suitable CCI method requires a thorough and methodical evaluation process. Feasibility studies play a pivotal role in this selection process. They serve as the technical foundation for determining whether a particular inspection technology can effectively detect integrity breaches in a specific package format.

What Feasibility Studies Are and Why They Matter

Feasibility studies in the context of Container Closure Integrity Testing (CCIT) are designed to assess whether a chosen test method is appropriate for the unique characteristics of a given package system. These experimental evaluations determine if the method:

• Can reliably detect relevant defects (e.g., microleaks, seal breaches)
• Is compatible with the materials and geometry of the package
• Meets required sensitivity and resolution thresholds
• Offers practical throughput for production or laboratory settings

Through feasibility studies, manufacturers gain critical insights into a method’s operational performance and limitations before investing in full-scale method development, validation and implementation. These studies help minimize the risk of selecting an ineffective or inefficient testing strategy.

How PTI Conducts Feasibility Evaluations

At PTI, feasibility studies are conducted through structured, data-driven experimentation. Each study includes the following key elements:

• Package Evaluation: Detailed analysis of the packaging system, including material properties, closure mechanisms, and potential leak paths. This stage helps define appropriate test parameters.
• Technology Assessment: Evaluation of various non-destructive CCIT technologies such as vacuum decay, high-voltage leak detection (HVLD), and Airborne Ultrasound. Selection is based on the expected defect type and package configuration.
• Controlled Defect Testing: Introduction of known, calibrated defects into sample packages to challenge the method’s detection capability under controlled conditions.
• Data Collection and Analysis: Comprehensive test data is gathered and analyzed to determine detection limits, repeatability, and method robustness. This step also identifies any sources of false positives or negatives.
• Reporting and Recommendations: A detailed feasibility report is provided, summarizing the findings, identifying the most suitable CCI method(s), and offering guidance for method development or validation phases.

These experimental feasibility studies not only confirm method viability but also serve as a blueprint for further method development and regulatory submission.

Selecting the right Container Closure Integrity (CCI) method is a critical step in ensuring product safety and regulatory compliance. Experimental feasibility studies provide the technical basis for informed decision-making, reducing risk and optimizing test performance. PTI’s structured, data-centric scientific approach to feasibility evaluations ensures that each packaging system is matched with the most appropriate inspection technology. Through careful assessment and validation, manufacturers can confidently advance toward robust and reliable package integrity testing solutions.