Glass Primary Container Traceability - Stevanato Group
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Glass Primary Container Traceability - Stevanato Group
Glass container traceability system for the individual identification of ampoules, vials, cartridges and syringes, to boost efficiency in pharma manufacturing.
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Glass Primary Container Traceability

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.

The option of uniquely coded containers would improve 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.

The benefits of having a unique code in filling, inspection and packaging operations has been validated across the industry. A recent 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.

The glass container traceability solution marks each primary container with a unique identity. This machine readable 2D barcode code allows each container to be tracked at every manufacturing process - from forming through to filing and automated inspection. The addition of manufacturing data at each step delivers significant process and quality benefits for both the glass container producer and pharma companies.

[1] 2019 PDA Traceability of Primary Packaging Survey – Published January 2020

Benefits

318 Track Trace

Available across all glass containers: syringes, cartridges and vials

81 Optimized Process

Delivered through existing glass manufacturing operations ensuring no impact on the integrity of the glass or integrity of the container

50 Nesting & Tubbing

Available as either bulk glass or as pre-sterilized Ready-to-Use (RTU) nested containers

52 Sterilization

Passes all pharmaceutical sterilization operations

61 Serialization

High-speed processing and readability using existing off-the-shelf equipment and readers

54 Filling Syringe Ok

Minimal impact on existing Fill & Finish operations

25 Regulatory Expertise

Follows all regulatory compliance mandates and relevant product/process standards

217A Data Management

Providing interoperability with existing serialization investments to ensure the seamless integration and transfer of data

Benefits

Container Traceability
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