Morton D K, Lordi N G, Troutman L H, Ambrosio T J
J Parenter Sci Technol. 1989 May-Jun;43(3):104-8.
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.
对注射用小瓶/瓶盖密封接口进行气体、液体和微生物泄漏测试。气体泄漏通过气泡试验测定，液体泄漏通过铜离子示踪溶液的原子吸收检测，微生物泄漏通过液载微生物悬浮挑战试验验证。将这些方法的泄漏性能与对相同包装系统定量测定的气体泄漏率进行比较。讨论了基于这些结果建立泄漏率规范的问题。
