RT Journal Article
SR Electronic
T1 Validation of Elastomeric Closures for Parenteral Use: An Overview
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 286
OP 294
VO 34
IS 4
A1 Richard T. Wood
YR 1980
UL http://journal.pda.org/content/34/4/286.abstract
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.