Galante L J, Brinkley M A, Lodder R A
Glaxo, Inc., Research Triangle Park, North Carolina 27709.
Pharm Res. 1992 Mar;9(3):357-64. doi: 10.1023/a:1015843002953.
Aseptic-filling processes are often used with fragile parenteral products that might be destroyed by terminal autoclaving. However, aseptic filling is not as effective as autoclaving in reducing contamination. As a result, time-consuming microbiological methods and turbidimetry are employed currently as product inspection techniques, but these processes can destroy the product and might not detect low levels of contamination. Thus, near-infrared (IR) light scattering was evaluated in this study as a new method for determining low levels of contamination noninvasively and nondestructively. A new parallel mathematical technique was used in conjunction with near-IR spectrophotometry to detect successfully contamination by several species of bacteria through intact glass vials. Using the near-IR method, products can be evaluated without introducing contamination, preserving the sample vial for dispensing or evaluation by another method.
无菌灌装工艺常用于那些可能会被终端高压灭菌破坏的脆弱注射用产品。然而，无菌灌装在减少污染方面不如高压灭菌有效。因此，目前耗时的微生物方法和比浊法被用作产品检测技术，但这些方法可能会破坏产品，而且可能检测不出低水平的污染。因此，本研究评估了近红外（IR）光散射作为一种非侵入性、无损检测低水平污染的新方法。一种新的并行数学技术与近红外分光光度法结合使用，成功地通过完整的玻璃瓶检测到几种细菌的污染。使用近红外方法，可以在不引入污染的情况下对产品进行评估，保留样品瓶以便通过另一种方法进行分发或评估。
