TY - JOUR 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 SP - 104 LP - 108 VL - 43 IS - 3 AU - Dana K. Morton AU - Nicholas G. Lordi AU - Lydia H. Troutman AU - Thomas J. Ambrosio Y1 - 1989/05/01 UR - http://journal.pda.org/content/43/3/104.abstract N2 - 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. ER -