Galante L J, Brinkley M A, Drennen J K, Lodder R A
Glaxo, Inc., Research Triangle Park, North Carolina 27709.
Anal Chem. 1990 Dec 1;62(23):2514-21. doi: 10.1021/ac00222a601.
Biotechnology and pharmaceutical research have created a number of new and potentially life-saving drugs. Many of these drugs are formulated as injectable products. Some drug products do not survive autoclaving or other means of terminal sterilization. An aseptic filling process is typically used to sterilize such products, but it is less reliable than autoclaving, making detection of unsterile units even more essential. Invasive microbiological methods and turbidimetry are currently employed as inspection techniques. These processes are time-consuming, destroy product, and may not detect low levels of contamination. Near-IR light scattering is proposed as a new method of determining low levels of contamination noninvasively and nondestructively. The method is used successfully in the current study to detect contamination by a species of yeast, mold, and bacteria in intact plastic infusion bags at levels as low as three colony-forming units per milliliter for yeast. By use of the near-IR method, each injectable unit can be evaluated with its integrity maintained, allowing the product to be dispensed or evaluated by another analytical method.
生物技术和制药研究已研发出许多新型且可能挽救生命的药物。这些药物大多被制成注射剂产品。有些药品无法耐受高压灭菌或其他最终灭菌方式。通常采用无菌灌装工艺对这类产品进行灭菌，但该工艺不如高压灭菌可靠，因此检测未灭菌单元就显得更为重要。目前，侵入性微生物检测方法和比浊法被用作检测技术。这些方法耗时、会破坏产品，而且可能检测不出低水平的污染。近红外光散射被提议作为一种非侵入性、无损检测低水平污染的新方法。在本研究中，该方法成功用于检测完整塑料输液袋中酵母、霉菌和细菌的污染情况，酵母的检测下限低至每毫升三个菌落形成单位。通过使用近红外方法，每个注射单元都能在保持完整性的情况下进行评估，从而使产品能够通过另一种分析方法进行分发或评估。
