Injectable portfolio reaches double figures

Each addition follows the same route: formulation and container-closure development, filter compatibility and extractables work, process validation on the commercial line, a full stability programme, and only then commercial release. The route does not shorten with familiarity, though it does become more predictable.

“Adding the tenth product was harder than adding the second. Shared equipment is what makes it so.”

Portfolio growth on a shared aseptic line raises questions a single product does not: campaign sequencing, cleaning validation bracketing across a wider range of actives, and media fills that must represent the most demanding interventions across all of them. Each was addressed before the products were added rather than after.

Every presentation is a 1 ml single-use ampoule, ten to a carton, which keeps downstream handling and serialisation identical across the range.