Case: Stevanato Group

Correct medication dose with vision technology

For 100% quality control of injection pens, Stevanato Group relies on the SPECTS inspection platform to verify the important steps of the assembly process.

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The challenge

Stevanato Group develops unique assembly systems for the pharmaceutical industry.

Their hormone injector pen assembly machines have a high focus on quality and performance. This requires 100% quality control using vision inspections to verify the important steps of the assembly process.

As the machine supports different pen formats, the inspection system had to support recipe execution. And of course, regulatory compliance - specifically 21 CFR part 11 - was non-negotiable.

The solution

We solved the challenge with SPECTS Assembly, a configuration of our GxP-ready inspection platform that covers the required standard inspections:

  • Mix-up Test
  • 360 inspection
  • Device inspection
  • Label inspection
  • Label on device inspection

The SPECTS platform comes with user management and electronic audit trails, so regulatory compliance is covered out of the box.

Automated GxP data handling with TRACKS
360 inspection
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The outcome

As a result, Stevanato Group can provide their customers with future-proof solutions that are easy to use, flexible in terms of format changeovers and stable in operation, while delivering exceptionally high performance.

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