Chapter 5 - Package/container closures

Abstract

This chapter starts with the fascinating history of sterile packaging. Understanding the history of sterile packaging and the rationales behind today’s approaches is essential for every packaging engineer. It then provides a review of packaging technologies. Starting with an overview of regulations, terminology, and definitions, it addresses the role of packaging and its functions. It continues with a summary of common container and packaging types and materials as well as considerations for the selection and the development of sterile packaging. Differences regarding packaging between medical devices, pharmaceutical and combination products are highlighted. This continues in the following section which is dedicated to validation principles, with an introduction of key test methods and required sensitivities, with a review of aspects of design and process validation to be considered for successful validation protocols as well as key requirements for process control and monitoring. Packaging and device families and worst-case considerations are reviewed as ways to leverage validation cost, revalidation and change management aspects are also addressed. Finally, examples of validation protocol flow diagrams are provided. A dedicated section addresses power and sample size considerations for testing in the frame of validations and change management processes. The section includes a review of common tests of statistical significance, an overview of equivalence testing and statistical considerations for demonstrating packaging process capability. The authors conclude with a section on new developments and the need for innovation to address the increased complexity of pharmaceuticals and biologics, medical devices, and combination products. Examples of interesting innovative solutions are provided to address new challenges, but also the growing regulatory requirements and the need to reduce the environmental foot print and to fully integrate sustainability aspects.