Container Closure Integrity Testing Workshop Overview

This document is a guide for the Container Closure Integrity Testing Workshop, specifically the Slovenia Edition, which is scheduled for October 12, 2023. The workshop aims to assist participants in understanding the updated EU GMP Annex 1 regulations that mandate stricter standards for container closure integrity (CCI) in sterile pharmaceutical products. It outlines the objectives of the workshop, which include providing knowledge and tools necessary for developing a customized CCI testing strategy that spans the entire product life cycle. The workshop features technical presentations from CCI application experts, industry case studies, and laboratory demonstrations to provide practical insights and hands-on experience. Key learnings include understanding the new regulations, learning from case studies on various container configurations, and recognizing the importance of detecting temporary leaks. The target audience includes packaging engineers, formulation scientists, and quality assurance staff involved in parenteral development and manufacturing.