Polymeric and elastomeric materials are commonly encountered in medical devices and
packaging systems used to manufacture, store, deliver, and/or administer drug products …

Assessment of extractables and leachables (E&L) released from the pharmaceutical
container closure systems (CCS), single-use polymeric processing materials (PPM), and …

Purpose To develop and justify a Risk Evaluation Matrix for estimating the safety risk
associated with extractables from plastic materials used in pharmaceutical applications and …

Polymeric materials are often used in pharmaceutical packaging, delivery systems, and
manufacturing components. There is continued concern that chemical entities from …

While the ability of packaging systems to contribute leached substances to finished drug
products is well established, increasing interest is being focused on the potential …

The migration of substances from rubber packaging materials into drug products can be
significant with certain packaging materials in contact with organic solvent systems …

The effective management of leachables in pharmaceutical products is a critical aspect of
their development. This can be facilitated if extractables information on the materials used in …

Rubber stoppered glass vial systems are widely used as primary containers for storing and
delivering therapeutic protein products to patients. Addressing concerns and regulatory …

The developers of medical devices evaluate the biocompatibility of their device prior to
FDA's review and subsequent introduction to the market. Chemical characterization …

The plastics used in drug packaging systems and medical devices are composed of
homologous polymers and generally contain additives such as antioxidants, plasticizers and …