RT Journal Article
SR Electronic
T1 Quantitative and Mechanistic Measurements of Container/Closure Integrity. Bubble, Liquid, and Microbial Leakage Tests
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 104
OP 108
VO 43
IS 3
A1 Dana K. Morton
A1 Nicholas G. Lordi
A1 Lydia H. Troutman
A1 Thomas J. Ambrosio
YR 1989
UL http://journal.pda.org/content/43/3/104.abstract
AB The parenteral vial/closure seal interface is tested for leakage of gas, liquids, and microorganisms. Gas leakage is determined using a bubble test, liquid leakage is detected by atomic absorption of a copper ion tracer solution, and microbial leakage is verified using a liquid-borne microbial suspension challenge test. Leakage performance by these methods is compared to gaseous leakage rates quantitatively determined for the same package systems. The establishment of leakage rate specifications based on these results is discussed.