A collaboration with pharma contract manufacturer ten23 health fills BD’s new smart, RFID-tagged prefillable syringes to improve traceability from aseptic filling and beyond.
At a Glance
- Pilot tests demonstrate how prefilled syringes can be tracked through manufacturing and distribution.
- Standards-compliant software allows data visibility to multiple supply chain partners.
- Once the smart syringes are introduced, customers will determine how packaging will inform the marketplace.
Mix-ups of prefilled syringes (PFSs) can occur at any stage of the manufacturing process — a mistake that could result in lost productivity, costly recalls, and risk to the patient.
Current traceability solutions for PFSs rely on lot numbers that denote which syringes are used for a specific drug lot, which means there is no tracking of single units for the fill-finish process. In contrast, BD’s iDFill promises to track each individual PFS, not only during distribution but during every step of the manufacturing process. By focusing on individual units instead of batches, the solution is purported to offer greater process visibility and efficiency and allow for quicker identification and tracking of individual units.
The product is still in development and is being tested by BD in partnership with contract development and manufacturing partner ten23 health.
How does it work?
The RFID tag is incorporated into the rigid needle shield (RNS) of the syringe outside of the fluid path, ensuring that it doesn’t come into contact with the drug. The tag, which is compatible with ethylene oxide (EtO) and E-beam sterilization, is sterilized with the syringe/needle presentation. The addition of the tag does not alter the RNS dimensions and maintains compatibility with secondary devices, such as auto-injectors and safety devices.
Each tag is encoded with a unique serial number called the container unique identifier (CUID). This CUID can be scanned at various stages of the manufacturing process, from filling to secondary packaging or any further assembly. By linking the drug code, filling batch, timestamps, and other relevant data with the CUID, the solution provides full container traceability and enables multiple applications, including automated reconciliation, mix-up prevention, and investigation management.
How will iDFill work in practical terms? At the end of BD’s manufacturing line, tagged syringes are placed into a tub and their CUIDs are read and aggregated to the tub/nest Identifier (ID). This aggregation of parent and child ensures tag readability and establishes data integrity and syringe pedigree. At the customer site’s filling line, one reading of the tub/nest ID is enough to associate it with its current drug filling batch; the syringe ID can be cross-checked at each subsequent process step to prevent mix-ups, and additional manufacturing events are expected to be recorded to build a full syringe pedigree. Prior to shipping, the pedigree can be confirmed by its data, showing the product’s movement at every step, continuing to offer data accessibility after the PFS sale and shipment.
According to ten23 health, customers will need to determine how best to call attention to the RFID tag based on the individual product and its intended use. One method is to use graphics on labels or packaging that alert supply chain and healthcare professionals to the presence of the RFID tag on the PFS and guide its use.
Reading and Tracking the Data
Crypto Pharma was selected by ten23 to provide IDFill’s tracking software, which is tailored to customers’ needs and specific pharmaceutical industry requirements. To allow data exchange among various parties, the data architecture adheres to the International Society for Pharmaceutical Engineering’s (ISPE) Good Practice Guide: Unique ID of Glass Primary Containers. Additionally, RFID tag communication follows the globally established GS1 specification and ISO/IEC 18000-63.
RFID-tagged PFS can be read using broadly available RFID readers and various software; however, hardware adaptations might be needed to fulfill regulatory requirements in cleanroom environments.
The cost for iDFill varies, depending on the volume of individual units purchased as well as the investment in ten23 health and associated services for fill-finish operations.
Written by: Kassandra Kania, Freelance Writer