BD iDFill™ - Individual Prefillable Syringe Identification

The fill/finish stage in pharmaceutical manufacturing is increasingly becoming a bottleneck for many companies. A McKinsey report states, “The world will need more sterile products than manufacturers have or can build capacity for.” Simultaneously, health authorities and regulators are intensifying their demands for greater traceability in the manufacturing process to drive a step change in quality. It is becoming increasingly critical to find solutions to improve the Overall Equipment Efficiency (OEE) of existing equipment while meeting these escalating demands of health authorities. Our innovative solution addresses this dual challenge of expanding fill/finish capacity while meeting growing quality and regulatory requirements. This pioneering approach uses Container Unique Identifiers (CUID) to provide unit-by-unit accountability for each container in the fill-finish processes. Thanks to this precise visibility, manufacturers can automate some of the time-consuming operations to unlock capacity while improving their quality standards thanks to an enhanced traceability. We are developing an RFID-based solution for traceability branded BD iDFIll™ Individual Prefillable Syringe Identification. Each of our prefillable syringes will contain an RFID tag encoded with a unique serial number (CUID). The CUID can be read at the entry and exit of each fill/finish process step, from the filling to the packaging. The drug code, filling batch, timestamps and other relevant data can be associated to the CUID, creating full traceability and enabling multiple use cases ranging from automated reconciliation to mix-up prevention. This also can provide precise segregation and can accelerate investigations in case of deviation. Moving the scrutiny from the batch to the dose unit level will bring an additional layer of process visibility that will help build mature quality systems able to better prevent deviations.