Characterization of Silicone from Closed System Transfer Devices and its Migration into Pharmaceutical Drug Products.

Closed System Transfer Devices (CSTDs) are increasingly used in healthcare settings to facilitate compounding of hazardous drugs but increasingly also therapeutic proteins. However, their use may significantly impact the quality of the sterile product. For example, contamination of the product solution may occur by leaching of silicone or particulates from the CSTDs.

Impact of the Design of Different Infusion Containers on the Dosing Accuracy of a Therapeutic Drug Product.

Residual volumes of infusion solutions vary greatly due to container and dimensional variances. Manufacturers use overfill to compensate, but the exact amounts vary significantly. This variability in overfill - when carrier solutions are used to dilute other parenteral preparations - may lead to variable concentrations and dosing, hence, potential risk for patients.

A Survey on Handling and Administration of Therapeutic Protein Products in German and Swiss Hospitals.

Protein products in hospitals often have to be compounded before administration to the patient. This may comprise reconstitution of lyophilizates, dilution, storage, and transport. However, the operations for compounding and administration in the hospital may lead to changes in product quality and possibly even impact patient safety.