Abstract
Container closure integrity (CCI) testing, along with other engineering and administrative controls, must be incorporated into a holistic approach to ensure overall integrity of a container closure system during the package design and development phases. CCI testing plays an essential role in providing feedback to package design and ultimately demonstrating CCI. To ensure they are suitable for the intended use, the testing methods must be appropriately selected, developed, and validated for the specific drug product-package configuration. This chapter addresses key considerations during packaging design and development phases with focus on CCI testing strategy development and appropriate CCI testing applications. It provides an overview of various commonly used testing technologies and proposes a guideline for method selection, development, and validation.
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© 2013 American Association of Pharmaceutical Scientists
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Li, L. (2013). Advances in Container Closure Integrity Testing. In: Kolhe, P., Shah, M., Rathore, N. (eds) Sterile Product Development. AAPS Advances in the Pharmaceutical Sciences Series, vol 6. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-7978-9_12
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DOI: https://doi.org/10.1007/978-1-4614-7978-9_12
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