An approach for the evaluation of closed system drug-transfer devices for transfer accuracy, particle release, and...

A Closed System Drug-Transfer Device (CSTD) is designed to prevent hazardous drugs from escaping their containers, thereby effectively safeguarding healthcare professionals from potential exposure. However, variations among CSTD designs may affect dose accuracy and overall quality of the drug product. This article proposes a standardized approach for evaluating CSTDs irrespective of product type. It addresses three critical attributes: transfer volume accuracy through residual hold-up volume measurements, device-related particle generation after exposure to drug surrogate solution, and standardized provision of comprehensive material-of-construction (MoC) data for all drug-contact components. The approach includes volume transfer across multiple vial sizes using a surfactant-containing surrogate solution at different viscosities to quantify dosing accuracy and residual loss after simulated use. The process also incorporates standardized particle analysis including USP 〈788〉 to detect subvisible particles shed by the device(s) after simulated use. A comprehensive and uniform MoC overview is also recommended to evaluate compatibility and monitor material modifications. The adoption of such a standardized approach by CSTD manufacturers would provide pharmaceutical companies with critical data to inform overfill requirements and compatibility assessments. Furthermore, it may potentially decrease the necessity for drug product-specific studies. Similarly, it may allow healthcare practitioners to enhance their compounding and administration practices by integrating CSTD performance data into their decision-making processes. In summary, adopting this harmonized evaluation framework for CSTDs would streamline device evaluation and integration in clinical practice, while safeguarding drug product quality and patient safety.