INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • Examine a dual‑mode approach that delivers precise, repeatable detection for both micro‑defects and larger breaches. Strengthen packaging quality and reduce investigation cycles with this platform.

  • The HDK Pinhole Inspector provides high speed inspection for IV Bags and flexible packaging using high voltage leak detection.

  • Used 200 mm Cassel flow thru metal detector, type Shark 2A GF0200. 200 mm diameter aperture, with stainless steel reject system, and digital readout, serial# D180288.03G, built 2018.

  • Ensure compliance with 21 CFR Part 11 and ensure 100% with a cutting-edge technology that inspects up to 400 vials per minute, ranging from 2ml to 100ml.

  • 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.