PT - JOURNAL ARTICLE AU - Wood, Richard T. TI - Validation of Elastomeric Closures for Parenteral Use: An Overview DP - 1980 Jul 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - 286--294 VI - 34 IP - 4 4099 - http://journal.pda.org/content/34/4/286.short 4100 - http://journal.pda.org/content/34/4/286.full SO - PDA J Pharm Sci Technol1980 Jul 01; 34 AB - Validation and qualification of eiastomeric closures are complex operations involving the coordinated efforts of both the pharmaceutical manufacturer and the closure manufacturer. Validation begins with selection of the elastomer formulation and concludes with the final packaging performance testing of the product/container/closure system. A review of the physical, chemical, functional, and stability testing requirements is presented.