Pharmaceutical companies face 4 primary challenges around aseptic filing:

Pharmaceutical companies face 4 primary challenges around asecptic filing images

BD unit level identification, tracking and tracing may help you face these challenges.

woman looking at syringe

How the BD traceability solution is intended to work

Traceability enables unit-level visibility with the potential to log the container’s passage through each manufacturing step, creating a chain of custody record.

Ready-to-fill syringes will incorporate a unique identifier (UID) using radio frequency identification (RFID) technology.

At the end of the BD manufacturing process, tagged syringes are placed into tubs and their UIDs are read and aggregated to the tub/nest ID.

This aggregation of parent and child units ensures tag readability prior to delivery to the customer filling line, establishing both data integrity and syringe pedigree.

When the syringes are loaded onto pharma filling lines, one reading of the tub/nest ID is enough to associate it with its current drug filling batch. Therefore, each unique syringe ID is associated to the product filling batch and drug code.

At each subsequent process step, the syringe ID can be cross-checked to prevent mix-ups and additional manufacturing events are expected to be recorded to build a full syringe pedigree.

Prior to release, the drug’s pedigree can be confirmed based on its movement through the pharmaceutical manufacturing steps.

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Pharmaceutical companies face 4 primary challenges around aseptic filing:

Pharmaceutical companies face 4 primary challenges around asecptic filing images

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Let's have a conversation

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How the BD traceability solution is intended to work

Traceability enables unit-level visibility with the potential to log the container’s passage through each manufacturing step, creating a chain of custody record.

Ready-to-fill syringes will incorporate a unique identifier (UID) using radio frequency identification (RFID) technology.

At the end of the BD manufacturing process, tagged syringes are placed into tubs and their UIDs are read and aggregated to the tub/nest ID.

This aggregation of parent and child units ensures tag readability prior to delivery to the customer filling line, establishing both data integrity and syringe pedigree.

When the syringes are loaded onto pharma filling lines, one reading of the tub/nest ID is enough to associate it with its current drug filling batch. Therefore, each unique syringe ID is associated to the product filling batch and drug code.

At each subsequent process step, the syringe ID can be cross-checked to prevent mix-ups and additional manufacturing events are expected to be recorded to build a full syringe pedigree.

Prior to release, the drug’s pedigree can be confirmed based on its movement through the pharmaceutical manufacturing steps.

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Store Tab

360° rotation knob is effectively sized, contoured and located to enable easy instrument rotation.

360° rotation knob is effectively sized

360° rotation knob is effectively sized

360° rotation knob is effectively sized

More product details

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Drug mix-up prevention

Drug mix-ups are costly in terms of staff time and lost product:1

Colour-coded product identification is limited by the camera’s ability to distinguish between similar colours.

BD syringes, pre-tagged with serial numbers associated with the drug filling batch, ensure product identification throughout the manufacturing process, helping to prevent mix-ups.

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A wide range of evolving use cases

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BD Traceability intended benefits

The BD Traceability solution is intended to offer an optimal balance between the high potential of use cases and the cost of implementation.

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Mature technology

RFID technology already tried and tested in retail, airline, automotive and pharma

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Maintained compatibility

No change in syringe shape will ensure compatibility with secondary devices

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Visual inspection

The barrel will be kept clear for visual inspection

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No rotational step needed

No impact on manufacturing speed

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Reading after assembly

Line of sight is not required, allowing reading through auto-injectors and safety systems

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Mass reading

Enabling reading in tubs, pallets and cartons

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Re-encoding

Enabling option to carry drug information for Point-of-Care use

Let's have a conversation

1. Supporting Becton Dickinson in assessing the opportunity for industrial traceability solutions - Study conducted for Becton, Dickinson and Company

2. Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals – FDA

3. Unique identification of primary containers to drive product traceability and quality – ISPE discussion paper – Feb 2021

4. Leveraging digital and analytics in biopharma operations: Six principles - McKinsey and Company - June 2021

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