INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • 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.

  • 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.

  • Safeguard your cleanroom environment with secure material transfer solutions. Interlocking pass boxes prevent cross-contamination and maintain critical sterility during item transit.

  • 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.

  • 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.