In recent years, patient-related safety incidences have occurred due to glass syringe misconnections from incompatibility among interfacing components. To combat the issue, in 2013 the FDA created draft guidance: Technical Information … (ISO) Standard 11040-4. The guidance was designed to ensure syringe connection integrity to reduce potential for patient harm. Assessing product risks properly, early and continuously is critical to help ensure patient safety.
Since the release of the draft guidance, several additional ISOs and guidances have been published – such as the Prefilled Syringe User Requirements PDA TR73:2015, Luer ISO standard 80369-7:2016 and Finished Prefilled Syringe ISO 11040-8:2016. These publications outline test strategies and annexes to assess fundamental syringe performance.
Join West packaging and performance experts Daniel Bantz and Jennifer Riter as they explain how fit-for-purpose syringe-based combination product packaging involves holistic consideration and testing for:
- Qualification of packaging components involving drug protection
- Materials compatibility
- Patient safety
- Product performance