The widespread adoption of global serialization and traceability mandates to ensure product integrity and protect patient safety is driving unprecedented changes in the pharmaceutical industry. The evolution and investment associated with product serialization have been significant.
The critical challenge for the industry is, how to deliver a Return on Investment through operational benefits for their organization, considering these additional costs for regulatory compliance.
Stevanato Group understands this need and has created a solution for the traceability of primary containers, which can add significant value for pharma companies, enabling them to deliver a measurable return on their existing investments.
In the same way that secondary packaging has a unique identity, Stevanato Group has developed a process that replicates this process for any primary glass container for parenteral medicines. All glass syringes, cartridges, and vials will be printed with a unique machine-readable code; which is as individual as a person’s fingerprint. This unique identity delivers an extensive range of internal and external benefits.
Following extensive research with Stevanato Group customers, the following key business case metrics have been defined:
- Reducing the risk of discarding filled drug product through efficient batch segregation in the case of quality issues.
- Avoiding batch mix-ups of filled containers inside pharma operations
- Automating reconciliation on filling lines at the container level.
- Tracking rejects causes within automated inspection processes in order to reduce rejections of filled products
- Overall improvement of manufacturing processes and efficiency (e.g., OEE, TCO, etc.).
- Improved clinical trial monitoring at the individual patient level.
To simplify implementation and validation, the solution has been designed and tested to be:
- Compliant with current international serialization regulatory requirements and investments to ensure seamless integration and data transfer.
- Deliverable through existing manufacturing operations, thus ensuring no impact on the integrity of the glass or the container.
- Compatible across all glass containers: syringes, cartridges, and vials.
- Integrated with existing pharma manufacturing operations using either bulk glass or pre-sterilised aggregated nested containers.
- Capable of high-speed processing and readability using existing off-the-shelf equipment and readers.
- Streamlined for existing Fill & Finish
To encourage industry adoption, Stevanato Group is actively engaged with a consortium of large pharma organizations and external third parties, to facilitate the creation of a standard that can be applied and utilized to ensure commonality across different vendors.