Track & Trace - Stevanato Group
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Primary Container Serialization: Value for the pharma industry all along the supply chain

The adoption of global serialization and traceability mandates is driving unprecedented changes in the pharmaceutical industry. The change and investment associated with product serialization have been significant.

But what if you can turn a sunk cost for regulatory compliance into delivering a Return on the Investment for your company?

Stevanato Group devised an innovative solution that wants to answer some important questions that pharma companies have for their fill & finish operations.

Questions:

  • In the filling process: how can I segregate quality issues and reduce filled product wastage? How can I avoid mix-ups of the filled product before labeling and reduce risks in the batch release?
  • In the visual inspection phase: how can I reduce false rejections at the automated inspection, and consequently reduce filled product wastage? Am I able to track rejection data in this process?
  • During the packing process: how can I ensure that each final packaging contains the right filled containers?
  • At secondary packaging serialization stage: how can I limit counterfeiting in case labels and secondary packages are destroyed or modified along the distribution chain?

Answer:

By making each primary container uniquely identified (starting from SG forming operations), Stevanato Group Track & Trace Solution allows the readability of the unique serial number and associated manufacturing data at each step bringing unique benefits, both for glass container producer and pharma companies.
By applying a unique barcode on the glass tubes, the manufactures can track defects of the raw material, segregating not-compliant batches avoiding mix-ups of the empty containers.

 

Track & Trace on Glass Primary Packaging

Stevanato Group has created a solution for the traceability of primary containers that can add significant value for pharma companies to enable them to deliver a return on its existing investments.
In the same way that a secondary pack has a unique identity, Stevanato Group has developed a process that replicates this process for primary glass containers for parental medicines.

All glass syringes, cartridges, and vials are printed with a unique machine-readable code – as unique as a person’s fingerprint.

To simplify implementation and validation, the solution has been designed and tested to be:

  • Being compatible and compliant with existing serialization regulatory requirements and investments to ensure the seamless integration and transfer of data.
  • Delivered from existing manufacturing operations, thus ensuring no impact on the integrity on the glass or integrity of the container.
  • Available across all glass containers: syringes, cartridges, and vials.
  • Integrated with existing pharma manufacturing operations using either bulk glass of pre-sterilized aggregated nested containers.
  • Ensure high-speed processing and readability by using existing off the shelf equipment and readers.
  • Have minimal impact on the existing Fill & Finish operations.
  • Follow all relevant standards and is Regulatory Compliant.

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