INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • Explore the testing process of a completely non-destructive MicroCurrent conductivity test method and the benefits of this non-contact and non-invasive solution for all parenteral and biologic products.

  • Our platform combines our experience and expertise with deep learning models to deliver a bespoke solution that enhances the quality inspection process for every customer.

  • Our Switch 75 comes standard with an integrated de-/renester system, but can also be integrated into your production line via turn table or directly inline. Two inspection carousels allow the inspection of vials and syringes on one machine.

  • Discover a MicroCurrent conductivity test method, HVLDmc, that is completely non-destructive to the container and product. Learn in greater detail about this static test and how defects are detected.

  • 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.