Rackson J T, Zellhofer M J, Birmingham P H
Am J Hosp Pharm. 1984 Oct;41(10):2071-3.
The effects of typewriting on labels of two unit dose packages with respect to moisture permeability were examined. Using an electric typewriter, a standard label format was imprinted on two different types of class A unit dose packages: (1) a heat-sealed paper-backed foil and cellofilm strip pouch, and (2) a copolyester and polyethylene multiple-cup blister with a heat-sealed paper-backed foil and cellofilm cover. The labels were typed at various typing-element impact settings. The official USP test for water permeation was then performed on typed packages and untyped control packages. The original untyped packages were confirmed to be USP class A quality. The packages for which successively harder impact settings were used showed a corresponding increase in moisture permeability. This resulted in a lowering of USP package ratings from class A to class B and D, some of which would be unsuitable for use in any unit dose system under current FDA repackaging standards. Typing directly onto the label of a unit dose package before it is sealed will most likely damage the package and possibly make it unfit for use. Pharmacists who must type labels for the unit dose packages studied should use the lowest possible typewriter impact setting and test for damage using the USP moisture-permeation test.
研究了打字对两种单位剂量包装标签透湿性的影响。使用电动打字机,在两种不同类型的A类单位剂量包装上打印标准标签格式:(1)热封纸背箔和玻璃纸带状袋,以及(2)带有热封纸背箔和玻璃纸盖的共聚酯和聚乙烯多层杯泡罩包装。标签在不同的打字元件冲击设置下打印。然后对打印后的包装和未打印的对照包装进行美国药典(USP)官方的水渗透测试。确认原始未打印的包装符合USP A类质量标准。使用的冲击设置依次增大的包装,其透湿性相应增加。这导致USP包装等级从A类降至B类和D类,其中一些包装按照当前美国食品药品监督管理局(FDA)的重新包装标准,在任何单位剂量系统中都不适于使用。在单位剂量包装密封前直接在标签上打字很可能会损坏包装,甚至可能使其无法使用。必须为所研究的单位剂量包装打印标签的药剂师应使用尽可能低的打字机冲击设置,并通过USP透湿性测试来检测是否有损坏。