BD iDFill^TM  Individual Prefillable Syringe Identification*

Doctor administering vaccine to young child

Why Traceability of PFS?
How Traceability Works
Use Case
Balancing Benefits and Costs

Primary Challenges Around Aseptic
Filling that Traceability of Primary
Containers can Help Address

Do you recognize any of these challenges? If the answer is
‘yes’, perhaps we can help.

BD iDFill™ Individual Prefillable Syringe Identification ensures syringe traceability throughout every step of the filling process.

Agility Starts With Digital Visibility

Unit-level digital visibility of the primary container is the lifeblood of agile fill/finish operations.

Ready-to-fill syringes will incorporate a Container Unique Identifier (CUID) using Radio Frequency Identification (RFID) technology.
At the end of the BD manufacturing process, tagged syringes are placed into tubs and their CUIDs are read and aggregated to the tub/nest Identifier (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.

BD iDFill™ Individual Prefillable Syringe
Identification in Action

The Benefits of Traceability

De-risk your fill/finish operations and stay flexible in the face of an increasingly challenging environment.

Medical syringes with person writing notes

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.¹

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

Scientists in cleanroom operating machinery

Fast Reconciliation and Line Clearance

BD RFID-tagged syringes are designed to enable automated counting at each manufacturing process entry and exit (filling, visual inspection, assembly, etc). Serial numbers that do not exit a specific process step may be identified and ejected to avoid mix-up.

The solution is intended to allow fast changeovers and accelerated line clearance, improving Overall Equipment Effectiveness (OEE).

Pharmacist organizing medical inventory shelves

Enabling Batch Segregation

BD iDFill^TM Individual Prefillable Syringe Identification aims to provide full digital tracking at unit level during the fill/finish process. This should enable rejected units to be traced back precisely to each step of the fill/finish process. This accuracy should help limit batch segregation to affected units only, which in turn could reduce the costly tendency to oversegregate or dispose of an entire batch due to limited process visibility.

By optimizing investigations and batch segregation, BD iDFill^TM Individual Prefillable Syringe Identification is expected to help maintain continuity of production.

Medical professionals collaborating at laptop in clinic

Accelerated Quality Assurance Investigations

BD iDFill^™Individual Prefillable Syringe Identification is designed to accelerate quality assurance (QA) investigations when process deviations or other issues arise during the fill/finish process.

The availability of syringe traceability data may enable investigators to link issues to the specific containers and batches concerned. If more than one batch of syringes is used to produce a single batch of a finished product, the BD solution should help investigators limit the number of batches requiring investigation.

This could significantly limit the number of batches affected in an expanded-scope investigation.

BD iDFill™ Individual Prefillable Syringe
Identification Benefits

Choose RFID Technology When Agility Counts

BD iDFill Individual Prefillable Syringe Identification offers an optimal balance between the high potential of use cases and the cost of implementation.

BD iDFill™ Individual Prefillable Syringe Identification aims to give you:

Mass Reading

Enabling reading in tubs and ensuring compatibility with fill/finish process speed
Change Management

External container design remains unchanged ensuring compatibility with secondary devices
Visual Inspection

The barrel remains clear for visual inspection
No Rotational Step Required

Ensures compatibility with existing equipment (Retrofit)
Reading After Assembly

Line of sight is not required, allowing reading through autoinjectors and safety systems
Re-encoding

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

ODD article - “RFID-based unit-level
traceability: could it be the key to operational
excellence for fill-finish lines?

Whitepaper - “How can unit-level traceability
of primary packaging improve pharma
operations?”

Explore our products

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BD offers a wide range of safety and shielding systems that feature innovative needle shielding system technology for your injectable drug.

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Self injection systems

BD partners with you to develop self injection systems that enable drug administration across a range of volumes and viscosities, leveraging BD primary container technologies and expertise with a focus on reaching the market faster.

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Plunger Stoppers

With our two stopper processing sites,  we aim to offer security of supply and business continuity for your drug combination  product needs.

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Backstops and plunger rods

As part of our integrated approach to help you develop drug combination products, we offer BD Backstops and BD Plunger Rods in a range of sizes, materials and colors.

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Prefillable syringe systems

Safety and shielding systems

Self injection systems

Plunger Stoppers

Backstops and plunger rods

* BD iDFill Individual Prefillable Syringe Identification is under development and is not a released product; statements contained hereinare forward-looking and are subject to a variety of risks and uncertainties . Actual product may vary.

Supporting Becton Dickinson in assessing the opportunity for industrial traceability solutions - Study conducted for Becton, Dickinson and Company
Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals – FDA
Unique identification of primary containers to drive product traceability and quality – ISPE discussion paper – Feb 2021
2023-01_how-sterile-pharma-manufacturers-can-grow-capacity-without-capital-investment-v3 (v0.1)

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BD iDFill^TM  Individual Prefillable Syringe Identification*

Primary Challenges Around Aseptic
Filling that Traceability of Primary
Containers can Help Address

Do you recognize any of these challenges? If the answer is
‘yes’, perhaps we can help.

Agility Starts With Digital Visibility

Unit-level digital visibility of the primary container is the lifeblood of agile fill/finish operations.

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