RT Journal Article
SR Electronic
T1 Quantitative and Mechanistic Measurements of Parenteral Vial Container/Closure Integrity. Leakage Quantitation
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 88
OP 97
VO 43
IS 2
A1 Dana K. Morton
A1 Nicholas G. Lordi
A1 Thomas J. Ambrosio
YR 1989
UL http://journal.pda.org/content/43/2/88.abstract
AB Leakage across the parenteral vial/closure seal interface is quantitatively measured in terms of mass of gas per unit time using a differential pressure method of leakage measurement. With this test system, uncoated, Purcoat® coated, and film coated closures are compared for their ability to seal nondefective and defective vial surfaces. Correlations are made between closure sealing performance and rubber viscoelasticity, closure coating material type and thickness, and crimped vial residual seal force.