Test Method Development for Package Testing
A variety of test methods exist to challenge package quality and performance. The objective of a feasibility study is to evaluate if a recommended CCI solution works and establish the optimal test parameters and Limit of Detection (LoD).
For those seeking a turn-key solution, the skilled members of PTI’s Global Technical Services (GTS) team can support advanced test method development. GMP environments require clarity and justification in applying any test method to assure product quality. Advanced method development applies scientific principles for method justification to assure the method is meeting critical objects. Scientific and statistical principles layout a distinct experimental design that can be leveraged for validation in the GMP environment.
PTI’s feasibility studies for container closure integrity and package quality leave clients with a clear report of a quantitative test method to confirm the recommended approach as it relates to a specific package format. Known good test samples, as well as positive control samples with certified defects, are used. The report details the technology solution, specific leak test method, test parameters, test result data and acceptance criteria.
PTI’s mission to provide complete package integrity test solutions begin with a client’s problem statement and conclude with a definitive path to package integrity assurance. Our non-destructive deterministic inspection technologies bring clarity and actionable information to package testing requirements.
Package Test Method Development
PTI provides analytical leak detection services, as well as expertise in package integrity testing equipment and applications. We welcome the Pharmaceutical, Medical Device, Food and Nutrition companies to contact us with their package quality testing issues and challenges.
PTI’s Global Technical Services team also provides the following services:
- Installation and training including validation services for CCI applications
- Service and parts support for PTI test equipment
- Calibration, technical support and overall equipment maintenance
- Experimental, Feasibility Studies, and Test Method Development services
- CCIT and regulatory consulting services - Navigating USP 1207/ASTM/ISO standards