Nichepharm brings the expertise and the capacity to run high-volume sterile ampoule filling for your parenteral project. Four lines fill from 1 to 20 mL, with a combined capacity of around 650 million ampoules a year.
Our ampoule lines run as integrated tunnel lines, from washing through to inspection. Ampoules are washed with Water for Injection and depyrogenated before filling, and only WFI is used across the process. For oxygen-sensitive products, inert-gas purging before and after fill keeps oxygen residual below 1%. We offer aseptic filling and terminal sterilisation, and every line runs under O-RABS with extended laminar air flow maintaining a Grade A critical zone.
Every ampoule is checked by camera-based Automatic Visual Inspection (AVI), capturing each unit through 360° high-resolution imaging to catch particulates, glass defects, sealing defects, and fill-level deviations, with high-voltage leak detection for container closure integrity.
From development through tech transfer and into commercial manufacturing, Nichepharm supports your ampoule formulations at every step, keeping scale-up smooth and compliance in order.
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View detailed specifications for our ampoule formulations.