INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • Pharmaceutical Metal detectors identify small particles of stainless steel, ferrous, and non-ferrous metals that can enter the workflow from the manufacturing process, or raw materials.

  • The pharmaceutical industry continues to lead industries in terms of quality requirements and the value of data. The shift to more automated processes is less about the cost of human capital, but more about the pursuit of quality. The European Medicines Agency (EMA) updated Annex 1, driving for 100% inspection on fused containers and appropriate quality test measures for applications based on level of risk. The United States Pharmacopeia (USP) revamped Chapter 1207 on container closure integrity (CCI) to be prescriptive of deterministic technologies and encourages a deeper understanding of a container’s CCI requirements. The FDA continues to drive a ‘quality culture’ agenda versus a ‘compliance culture’, and the FDA has been explicitly targeting data integrity as a campaign for assuring quality. Every regulatory and guidance body is driving towards more reliable and accurate test methods.

  • The HDI Pinhole Inspector from Nikka Densok offers 100% inspection for BFS vial card production.

  • V35- Advanced, automatic, high-throughput

     Sophisticated 360° inspection of round containers. Get a complete picture of every package with six-camera configuration for maximum inspection.

    Breakthrough Design

    Unique six-camera configuration captures a 360° view of each product for 100% inspection of label design and packages up to 230 mm in diameter.

    Automate Product Changeovers

    Cameras adjust automatically to support a range of field-of-view-requirements on a variety of product sizes, enabling easier product changeovers.

    High-Speed Configuration

    Installs on new or existing production lines with speeds up to 1,000 ppm for minimal disruption to current processes.

  • 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.