Double sterilisation in pharmaceuticals: The impact of Annex 1 on component strategy
By Datwyler
Since the revision of EU GMP Annex 1, what was once a clear choice between aseptic processing and terminal sterilisation is now shifting towards a hybrid approach, changing how companies evaluate sterilisation methods for primary packaging components. This report examines the latest sterilisation trends and the impact of Annex 1’s revision, discussing how the industry is shifting towards a ‘double sterilisation’ model to provide the highest level of sterility assurance for high-value products.