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Today, there is no individual identification of primary glass containers for parenteral use. If a problem is identified during a process step, manufacturers are unable to define exactly which products may have been impacted. As a result, they adopt either an “over segregation” or “full batch write-off" policy. This can have significant financial impact from lost or missed revenue and lead to drug shortages in the market.
A survey published by PDA[1] indicated that 68% of respondents had considered using marked containers. The potential use-cases ranged from mix-up avoidance of filled containers to reject tracking in automated inspection processes.
[1] 2019 PDA Traceability of Primary Packaging Survey – Published January 2020.
Stevanato Group offers the option of developing uniquely coded containers, as part of its drug containment solutions, improving production efficiency and quality by providing insight into each process. This data could help drive more detailed root cause analysis, corrective actions, and adjustments to product design and process optimization, addressing key industry needs and solutions across pharmaceutical manufacturing.
The glass container traceability solution marks each primary container with a unique identity. This machine readable 2D barcode allows each container to be tracked at every manufacturing process - from forming through to filing and automated inspection. Manufacturing data at each step delivers significant process and quality benefits for both the glass container producer and pharma companies.
Stevanato Group traceability can be applied across different glass primary packaging formats and manufacturing configurations.
Applicable to all glass containers: syringes, cartridges and vials
It could be delivered through existing glass manufacturing operations ensuring no impact on the integrity of the glass or integrity of the container
Applicable to either bulk or pre-sterilized Ready-to-Use (RTU) containers
Compatible with traditional pharmaceutical sterilization operations
High-speed processing and readability using existing off-the-shelf equipment and readers
Minimal impact on existing fill and finish operations
Follows all regulatory compliance mandates and relevant product/process standards
Providing interoperability with existing serialization investments to ensure the seamless integration and transfer of data
The individual identification of primary containers in filling, inspection, and packaging operations has been validated across the industry.
Prevent mix-ups and quality issues in time with container segregation
Avoid batch mix-up before labeling
Reject cause tracking
Reduce risk of counterfeiting and tampering