The revised EU Annex 1 contains new requirements for ensuring the container closure integrity (CCI) of sterile pharmaceutical products, causing pharmaceutical companies to reassess their CCI policies for compliance.
CCI testing plays an important role in maintaining the sterility and stability of sterile injectable products. Recent regulatory guidance and requirements are influencing changes in industry best practices for CCI testing. Emphasis is being put on implementing validated deterministic CCI testing methods and generating science-based CCI data.
Lighthouse Instruments offers solutions for CCI testing activities based on non-destructive laser-based headspace analysis. These solutions can be applied to various activities throughout the product life cycle in development, manufacturing, and quality control.