INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • Developments in non-destructive, deterministic testing technologies that can achieve optimum assurance in container closure for biologics.

  • Used Brevetti vial inspection unit, model A1, speeds up to 360 pcs/hour, currently set up for 53.5 mm diameter 100 mL vails, 8mm - 95 mm diameter x up to 240 mm high vial size range, with integrated robotic arm, (4) inspection units, with vial feed infeed and acceptable exit tables, dual reject stations, with HMI panel, serial# BM242, built 2016.

  • The Food and Drug Administration (FDA), United States Pharmacopeia (USP) and EMA Annex 1 issue strict guidelines for testing the integrity of IV bags and containers closed by fusion. IV bag manufacturers are one among many sterile product manufacturers that must meet these test requirements for container closure integrity.

  • GMP Class 2 containment enclosure designed for the most challenging containment levels during manipulations of High Potent Active Pharmaceutical Ingredients (HPAPI) for compounding activities.

  • Designed for pharmaceutical QC labs, this solution helps protect aseptic conditions, streamline leak and glove testing, reduce maintenance burden, and support compliant operations.