INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • Advanced inspection systems ensure packaging integrity, preventing contamination. Gain insight into automated solutions that improve quality, reduce waste, and integrate easily into production lines.

  • Integrated metal detection and checkweigher combine for a powerful critical control point in one space-saving device. Choose from a comprehensive set of metal detectors and dynamic in-line weighing solutions designed for your application.

  • The Thermo Scientific Xpert X-ray Inspection System enables compliance with worldwide HACCP and retailer food safety requirements as well as offering X-ray image analysis for other critical quality verifications.

  • 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.

  • This checkweigher ensures stable transfer and high-accuracy measurement of small containers that can easily topple during conveyance, such as eye lotion bottles, nasal drop vials, and cosmetics containers. The model features a conveyor with three integrated side-grip belts that keep products upright throughout the infeed, weigh table, and outfeed sections. The width of these side-grip belts is easily adjustable to accommodate different product sizes, with a standard range of 20-40 mm and an optional maximum width extension up to 100 mm. This design allows for a processing speed of up to 200 bottles per minute and an accuracy of +/- 0.02 g. The rejector uses a gate-type mechanism, with an optional air jet rejector for products up to 200 g. The system is compliant with federal regulation 21 CFR Part 11 for the integrity of electronic records and signatures, with features such as password authentication, audit trail of operation data, and encryption/decryption of exported data.