INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • A helium based test method for verifying the integrity of a blister card holding drug product has been proven to be the most effective approach due to the extreme sensitivity offered. The test method relies on detecting helium sealed in the package system as it escapes through micro-channels in the package. A test sequence begins by placing the package in the test fixture and a vacuum is quickly drawn. The resulting pressure differential causes helium to escape through potential holes or cracks in the package.

  • Helium leak detection (HeLD) is routinely used and widely accepted for applications that require the utmost leak sensitivity. This brochure explains how Helium enables the discovery of extremely small microleaks that other leak testing methods cannot detect and what applications it can be used for.

  • 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.

  • Discover a versatile system for vial sizes from 2 mL to 20 mL that is compliant with 21 CFR Part 11 and is integrated with patented handling to ensure smooth, non-destructive inspection at 240 pieces per minute.

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