Container Closure Integrity (CCI) Development Services

914.337.2005

Initial Recipe Creation (IRC) Recipe Optimization

Initial method parameters to aid as a starting point for test method development.

Comprehensive report and consultation call for analysis review

In this phase, PTI begins by performing measurements on both positive and negative control samples using various recipe parameters. These measurements are analyzed to determine if there is sufficient separation between the control groups. Based on this evaluation, an initial reject reference or pass/fail acceptance criteria is established.

These parameters and the corresponding reject reference form the foundation for further optimization in method development. All findings, including statistical analysis and conclusions, are documented in a detailed final report and reviewed during a consultation call with the client.

Test Method Development

Method development support in accordance with PTI-supplied USP <1207> protocol.

System suitability testing.

Testing and analysis of statistically significant sample populations to produce reliable, repeatable, and robust test methods.

Comprehensive report and consultation call for analysis review.

This stage focuses on refining the test method to ensure it is capable of detecting packaging defects at the required sensitivity level. Method development is conducted using PTI’s instruments at our headquarters in Hawthorne, NY, or in St-Prex, Switzerland. Additional testing can also be performed on-site at the client facility if required.

The process includes system suitability testing and the use of statistically significant sample sets to develop a robust and repeatable method. The objective is to establish the limit of detection and create a validated approach for future package integrity assessments. A final report and client consultation conclude this phase, providing clarity on test performance and development outcomes.

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Test Method Validation Support

Method validation support in accordance with PTI-supplied USP <1207> protocol

System suitability testing

On-site execution support with a PTI engineer

Consultation calls for execution review

Following the successful completion of test method development, PTI offers end-to-end support for method validation to ensure your container closure integrity (CCI) method meets regulatory and quality standards. A validation protocol template, compliant with USP <1207.1>, is provided. This protocol outlines a structured approach to executing the validation and serves as a working document for recording and documenting each stage of the process. It enables a standardized and efficient execution of validation activities while maintaining traceability.

The method validation process is designed to thoroughly evaluate critical performance characteristics, including accuracy, precision, intermediate precision, specificity, detection limit, quantitation limit, range, and robustness. Execution is supported on-site by a qualified PTI engineer to ensure proper implementation. After completion, a consultation call is held to review the results, address any findings, and finalize documentation.

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PTI Equipment Support & CCIT Application Support

914.337.2005