INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • 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.

  • Combined high-precision weighing with advanced x-ray technology for a precise system that meets industry standards and your individual requirements. Easily mix and match the solution to fit your budget.

  • Efficient, customizable, intuitive use

    Advanced bottom inspection of a variety of packages. The system supports customized lighting and can be extended with top cameras for further applications such as seal contamination inspection.

    Effective Bottom Inspection

    Supporting up to 400 ppm, capture the nuances associated with various product shapes or sizes where a larger field of view is required.

    Application Based Design

    Cameras and advanced lighting options help overcome challenging applications where wet, reflective, or uneven surfaces interfere with imaging.

    Intuitive Software

    Powerful CIVCore software offers a range of inspection options for easy setup and configuration.

  • Learn more about a self-contained approach to RTP integrity testing that brings faster verification, repeatable pressure decay results, and easier data handling to isolator and RABS workflows.

  • Bring together contamination control, modular flexibility, leak testing, ergonomic operation, and validation-ready automation to support safer workflows and dependable performance at scale.