INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • The most current model, the Seal Integrity Monitoring System (SIMS) 1915+, is the ideal choice for your helium-based leak detection system. Compared to conventional vacuum bubble and dye penetration test methods, packages can be quantitatively tested using helium as the tracer gas that ensures higher levels of accuracy. Such an approach allows a comparison between multiple packaging materials and forms production line settings and stability storage conditions, supporting the entire lifecycle.

  • 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 Thermo Scientific™ Versa Flex and Versa Flex GP checkweighers are designed to improve accuracy and reliability, decreasing maintenance and product giveaway. Our global manufacturing and service teams enable a high level of solutions and service support wherever you do business.

  • High productivity rate using advanced inspection technologies. CVT inspection machines promise to deliver high-speed, high-performance inspection of a wide range of drugs. Thanks to its patented imaging technology, it provides reliable inspection results on difficult products such as foaming liquids, suspensions and viscous products such as insulin or hyaluronic acid.

  • With our Switch 350, you benefit from the advantages of two machine concepts: We have combined the modularity, handling options, and technologies of our well-proven standard platforms with the flexibility of our small batch inspection machine to run syringes and vials on one and the same machine – with nesting system for syringes and vials alike.