INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • The Thermo Scientific™ Global VersaWeigh™ and Global Versa GP checkweighers are designed to improve accuracy and reliability, decreasing maintenance, product giveaway and total cost of ownership. Our global manufacturing and service teams enable a high level of solutions and service support wherever you do business.

  • The pharmaceutical industry continues to bring breakthroughs in the field of new drugs and drug delivery systems amidst the increased scrutiny of the regulators. The packaging acts as the primary sterile barrier in drug delivery systems that safeguard the drug product through its life cycle. The efficiency of the primary sterile barrier and the functional components are of utmost importance to patient safety.

  • Our Bench Vision Unit has been developed to provide maximum flexibility, with the same software and component design as our automatic visual inspection equipment used on production lines throughout the world.

    • Container range: ampoules, vials, cartridges, syringes
    • Inspected products: water-like, viscous, suspensions
  • The HDK pinhole inspector provides 100% inspection for IV Bags with non-destructive leak testing.

  • As the governing regulatory document of the European Medicines Agency (EMA), EU GMP Annex 1 discusses a full host of concepts related to manufacture of sterile medicinal products. In contrast to guidance documents issued by the FDA, EU GMP Annex 1 is interpreted as law, requiring strict adherence to the regulatory expectations contained, numerous of which allude to container closure integrity testing. In fact, current proposed and ongoing revisions increase the expectations of scrutiny on package integrity.