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Success Stories

AVI Vial Machine for Lyophilized Drugs

A leading pharma company based in Europe engaged Stevanato Group to develop a best-in-class solution for inspecting all quality aspects of its lyophilized drug product with reduced false rejection rates.

The challenge

Although inspecting for known or probable defects in lyophilized drugs is challenging enough, the real challenge is avoiding falsely detected contamination in acceptable products due to variations of the product itself. Correctly lyophilized drugs present as cake and have variable characteristics in the container, including:

  • A cracked, shrunken mass, able to move around in the vial
  • Product as powder present on sides and bottom of the vial
  • Shiny surfaces on the cake
  • Significant freeze-drying at the edges
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The solution

Through our extensive experience, Stevanato Group understood that lighting and image capturing techniques were the key to more accurate and precise automated inspection of lyophilized products. We were able to successfully:

  • Inspect for glass particles on top of the cake, embedded in the surface or hidden by product dust in the vial
  • Distinguish between variation and defects more accurately
  • Establish test sets that help the system learn to more accurately distinguish glass particles from cracks and product defects from cosmetic issues with the container

As a result, our equipment solution significantly lowered false rejects, for all defects by 50% from FAT to site production.

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Visual Inspection

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