Our Facility

Sterile operations are designed around the current EU GMP Annex 1 standard, built to meet the requirements of international regulatory authorities.

Every line integrates high-speed filling with automated inspection, with vial filling to 24,000 units per hour across a 2–100 ml range, and flexible nested filling of ready-to-use vials, syringes, and cartridges on a single line. Volumetric filling holds ±0.5–1% dosing accuracy, and for oxygen-sensitive products, inert-gas purging before and after fill keeps oxygen residual below 1%.

Camera-based systems inspect each unit through 360° high-resolution imaging, detecting particulates, glass defects, and fill-level deviations. High-voltage leak detection identifies micropores down to 0.2 μm for container closure integrity.

Our vial lines offer containment to OEL 5, with O-RABS and isolator options, so highly potent compounds can be filled safely alongside our standard sterile portfolio.

Water For Injection is generated on site by vapour-compression distillation and used exclusively across every manufacturing line, down to the final rinse in ampoule washing. Sanitary design throughout, with no dead legs, and vacuum particle extraction at capping.

All filling lines run under open Restricted Access Barrier Systems, maintaining aseptic conditions across the fill.