Formulation and Quality – Biomolecular
Closed system transfer devices (CSTDs) are intended to provide a closed mechanism to transfer a drug from its vial to a syringe during patient administration. These devices are commonly used in oncology pharmacies when preparing hazardous drugs, to prevent their escape into the environment where possible exposure of health care workers and contamination of work areas could occur. Since first appearing on the market these devices have become a regulatory recommendation and may soon become a mandatory guideline for certain drug classes. While many publications point out the effectiveness of CSTD in reducing environmental contamination and surface exposure, publications on CTSD bio-compatibility with drug product are generally lacking. In the current presentation, we present formulations’ compatibility data with five commonly used CSTDs. The effect on formulations’ particulation propensities upon short term CSTD exposure at variable incubation conditions will be reported. CSTDs’ variable hold up volumes will also be addressed.