Impact of RFID-Enabled Unit-Level Traceability on Resource Utilization and Quality Assurance in Prefilled Syringe Production
Author(s)
Matthias Borms, PharmD1, Yacine Haddadi, PharmD2, adeline tournebize, MS2, Herve Soukiassian, MS2, Thomas Hiltbrand, MSc3, Julia D. Lucaci, PharmD, MS4, Emilien Folzer, PhD5.
1Becton Dickinson, Le Pont de Claix, France, 2Becton Dickinson, le Pont de Claix, France, 3Crypto Pharma, Basel, Switzerland, 4Becton Dickinson, Chicago, IL, USA, 5Ten23 health AG, Basel, Switzerland.
1Becton Dickinson, Le Pont de Claix, France, 2Becton Dickinson, le Pont de Claix, France, 3Crypto Pharma, Basel, Switzerland, 4Becton Dickinson, Chicago, IL, USA, 5Ten23 health AG, Basel, Switzerland.
OBJECTIVES: The visual inspection in pharmaceutical manufacturing often becomes a capacity bottleneck. We evaluated whether unit-level radio-frequency identification (RFID) traceability for prefilled syringes can relieve this constraint by cutting documentation time, satisfying tighter compliance demands, and strengthening quality assurance during manual visual inspection as a last step of fill-finish operations. The study compares the conventional paper-based workflow with an RFID-assisted process, reporting quantitative time and labor savings, quality assurance, and operator feedback on usability.
METHODS: This prospective crossover pilot study was conducted at ten23 health, a contract development and manufacturing organization, following the current good manufacturing practice (cGMP). Four operators of varied seniority inspected in total more than 2 000 prefilled syringes - with critical, major, minor, and cosmetic defects - using two workflows in randomized sequence: the conventional paper-based process and an RFID-enabled unit-level traceability process. For every syringe, we captured the inspection time and documentation time. The time used for manual reconciliation and batch-record finalization was recorded as well. The operators then completed a brief usability and satisfaction survey.
RESULTS: The RFID unit-level process reduced average documentation time per syringe from 35 s to 15 s (−57%). Inspection time was not influenced by the documentation method and remained similar between the conventional paper-based and RFID-assisted workflows. Eliminating batch-record preparation and defect-calculation steps further shortened defect recording by 57%, manual reconciliation by 70%, documentation finalization by 60%, and batch record review (performed by production and quality assurance) by 98 %, yielding an overall paperwork reduction of up to 85%. All operators found the RFID workflow straightforward, felt less fatigued, and believed it lowered the risk of errors.
CONCLUSIONS: This study shows that RFID-enabled unit-level traceability achieved a six-fold reduction in documentation workload, freeing operator time and delivering clear gains in fill-and-finish efficiency and could lower risk of errors.
METHODS: This prospective crossover pilot study was conducted at ten23 health, a contract development and manufacturing organization, following the current good manufacturing practice (cGMP). Four operators of varied seniority inspected in total more than 2 000 prefilled syringes - with critical, major, minor, and cosmetic defects - using two workflows in randomized sequence: the conventional paper-based process and an RFID-enabled unit-level traceability process. For every syringe, we captured the inspection time and documentation time. The time used for manual reconciliation and batch-record finalization was recorded as well. The operators then completed a brief usability and satisfaction survey.
RESULTS: The RFID unit-level process reduced average documentation time per syringe from 35 s to 15 s (−57%). Inspection time was not influenced by the documentation method and remained similar between the conventional paper-based and RFID-assisted workflows. Eliminating batch-record preparation and defect-calculation steps further shortened defect recording by 57%, manual reconciliation by 70%, documentation finalization by 60%, and batch record review (performed by production and quality assurance) by 98 %, yielding an overall paperwork reduction of up to 85%. All operators found the RFID workflow straightforward, felt less fatigued, and believed it lowered the risk of errors.
CONCLUSIONS: This study shows that RFID-enabled unit-level traceability achieved a six-fold reduction in documentation workload, freeing operator time and delivering clear gains in fill-and-finish efficiency and could lower risk of errors.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
MT28
Topic
Health Service Delivery & Process of Care, Medical Technologies, Organizational Practices
Disease
No Additional Disease & Conditions/Specialized Treatment Areas