Formulation and Quality – Biomolecular
2019 PharmSci 360
The interest in closed system transfer devices (CSTDs) has increased lately due to USP800 , which prescribes the use of CSTDs to ensure occupational safety while handling hazardous drugs. The literature contains publications discussing only the containment properties of CSTDs. However, there are many important functionality aspects relevant to administration. Accordingly, we compared four CSTDs regarding 1) Containment using helium leak test, 2) Visible and subvisible particles using light obscuration and microflow imaging, 3) Extractable volume. Results show that, not all the CSTDs offer complete containment and protection from vapours. Some CSTDs lead to the formation of large number of silicone oil particles. In some cases, visible particles were observed due to stopper fragmentation. Finally, for some CSTDs, up to 1 mL could not be extracted from the vials, significantly affecting dose accuracy. The results will be presented, together with recommendations on assessing the compatibility of CSTDs with drug products.