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