INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • Used Nikka Densok pinhole inspector, model HDB-204V-AS+DL, currently with 2ml change parts, with controls and control computer, with reject, serial# 490, built 2005.

  • The XR75 Pharma X-ray is optimized for the quality control of pharmaceutical, nutraceutical, and cosmetic products in thin opaque packaging materials that cannot be inspected manually or with visual systems. The leakage prevention curtains are designed to leave a 10 mm-clearance that ensures safety and reduces false rejects caused by product jams or changed orientation during conveyance. The system checks for different product integrity issues simultaneously: products trapped in seals, missing, chipped, or broken tablets in blisters, and the presence of foreign contaminants. The high-resolution X-ray images ensure reliable inspection of the small items at belt speed up to 90 m/min.

  • 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.

  • 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.

  • METTLER TOLEDO Safeline pharmaceutical metal detector systems are designed to offer maximum flexibility in process areas. A compact footprint enables systems to be inserted into areas where space is restricted. Robust, low profile, fully rotating castors provide ease of mobility, enabling the system to be used in multiple locations. Flexibility is further enhanced by the ability of the metal detection head to be adjusted easily (without the need for tools) in all three axes to suit any configuration.