Container Closure Integrity: Meeting the New EU GMP Annex 1 Container Closure Requirements

Implement a deterministic analytical method for container closure integrity testing; Methods based on laser-based headspace analysis enable the generation of robust science-based packaging data during the product life cycle as required by the new Annex 1; And the execution of packaging studies which demonstrate the achievement and maintenance of good container closure, and enable the design of an appropriate testing strategy.

“These requirements have triggered new best industry practices in the area of container closure integrity.” Derek Duncan, PhD, Director Product Lines, Lighthouse Instruments