Selection of containers and closure systems for injectable products.
Factors related to the choice of appropriate container and closure systems for injectable drug products are discussed. The primary packaging system of an injectable product must ensure that the contents are protected against both loss from and entry into the system. Additionally, there must be no physicochemical incompatibility between the system and its contents. Containers in current use are either glass or plastic. Glass, a noncrystalline mixture of oxides, is reasonably resistant to chemical degradation, but its components will leach into solutions under appropriate conditions. Plastics commonly used include vinyls (polyvinyl chloride and ethylene vinyl acetate) and olefins (polyethylene and polypropylene). Various additives to these plastics will also leach into solutions under appropriate conditions. The final component of primary packaging systems is the closure, which is often rubber. Rubber, being natural in origin, contains many compounds in variable quantities, and these may leach into solutions. Three types of evaluations should determine which components are chosen for a packaging system. Functional evaluations assess sterilizability, puncture-reseal capability, and system integrity. Physicochemical screening tests for closures and plastic formulations measure the extent of leaching. Biologic screening tests are used to assess toxicity. An appropriate expiration date can be assigned after these screening tests are completed and stability data are obtained. Similar factors must be assessed by pharmaceutical scientists and hospital pharmacists in choosing packaging materials for injectable products.
D055598:Chemical Phenomena; D002627:Chemistry, Physical; D004349:Drug Packaging / Q000592:standards*; D004355:Drug Stability; D005898:Glass; D007267:Injections / Q000592:standards*