PHARMACEUTICAL INSPECTION SOLUTIONS

• Automated Deterministic Inspection Technologies For Complete QC Of Prefilled Syringes

  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.

• Package Quality Solutions For Nutritional Science

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

• Aseptic Container Closure Integrity Testing (CCIT) Systems For Pharmaceutical CDMO's

  Learn how these non-destructive inspection technologies verify container closure system integrity with deterministic quantitative test methods for vials, ampoules, syringes, cartridges and auto-injectors.

• Helium Leak Detection For Bottles

  Bottles come in a wide array of sizes and configurations, reflective of their diverse use in the health sciences industry. Typically, they exhibit a screw top closure threaded onto the bottle mouth, though sealing properties ranges from elastomeric liners, to o-rings, to induction seals and reliance on plastic-to-plastic contact and compression. One specific trend is the increase in need to test sterile bulk containers or sterile API containers. As the industry continues to move toward outsourcing or even insourcing through a network of suppliers or sites, transport of sterile drug product or API is becoming increasingly common. These types of containers are traditionally challenging to test, but can be qualified prior to use or as a proof of concept using helium leak detection.

• Helium Leak Detection Systems For Life Sciences

  Helium leak detection (HeLD) is routinely used and widely accepted for applications that require the utmost leak sensitivity.

• Phase 1, 2, And 3 Clinical Supply
• High Voltage Leak Detection Systems For Glass And BFS Vials
• Pharmaceutical Package Integrity Testing
• Pinhole Inspector For Sampling And Inspection Of Glass And BFS Vials