Formulation and Quality – Biomolecular
2019 PharmSci 360
Standard open-system methods for transferring drugs during preparation and administration can put health care practitioners in danger when handling a hazardous drug. An open system can lead to escape of the hazardous drug through release of liquid or vapor droplets or through an accidental needle stick. A Closed System Transfer Device (CSTD) is a drug-transfer device that is specifically designed to prohibit both contamination from the surroundings and escape of the hazardous drug. These systems come in a variety of forms with a multitude of product-contact components, which must be demonstrated to be compatible with the drug product. This presentation will focus on particulate observations for a monoclonal antibody using visual inspection, micro flow imaging and Archimedes techniques after exposure to different CSTDs. The presentation will also include mitigation strategies to minimize potential drug product impact due to leachables, such as silicone oil, from these devices.