INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • The PIF-121 Pinhole Inspector offers non-destructive leak testing.

  • 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.

  • 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.

  • Nikka Densok’s micro hole detection machines provide automated, non-destructive inspection of parenteral pharmaceutical containers using advanced High Voltage Leak Detection (HVLD) technology.

  • Explore a range of scalable solutions for the container closure integrity testing of parenterals and biologics that utilizes an innovative and non-destructive inspection technology, MicroCurrent HVLD