Raman Microscopic Applications in the Biopharmaceutical Industry: In Situ Identification of Foreign Particulates Inside Glass Containers with Aqueous Formulated Solutions
Raman Microscopic Applications in the Biopharmaceutical Industry: In Situ Identification of Foreign Particulates Inside Glass Containers with Aqueous Formulated Solutions
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DOI：
10.1366/000370209788701026
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发表时间：
2009-07-01
影响因子：
3.5
通讯作者：
Torraca, Gianpiero
中科院分区：
文献类型：
--
作者：
Cao, Xiaolin;Wen, Zai-Qing;Torraca, Gianpiero
颗粒鉴定是生物制药行业质量控制和保证的重要分析程序。快速、可靠地识别微粒有助于评估颗粒污染的性质及其对内部和外部标准规定的产品质量的影响。拉曼显微镜是一种可用于识别微粒的显微光谱技术，具有原位检测的优点。在本文中，我们证明可见激光拉曼显微镜对于识别玻璃容器（例如玻璃注射器、小瓶和试管）内的微粒特别有用，这些玻璃容器通常用作水性制剂药物的容器。这些例子包括识别预装玻璃注射器内的液滴状颗粒、玻璃试管内的纤维颗粒和玻璃瓶内的白色颗粒；所有这些例子通常都需要其他技术进行具有挑战性或耗时的样本操作。拉曼显微技术由于能够进行原位检测而被证明能够解决这些具有挑战性的微粒鉴定。特别是在微滴识别的例子中，拉曼显微技术是快速、成功的颗粒检测的唯一选择。对于所有三种鉴定，拉曼原位检测显着加速了颗粒分析，并避免了由于没有或最少的样品操作而导致潜在的样品二次污染或损失。
Particle identification is an important analytical procedure for quality control and assurance in the biopharmaceutical industry. Rapid and reliable identification of micro-particles helps in evaluating the nature of particle contamination and its consequences on the product quality regulated by internal and external standards. Raman microscopy is one of the microspectroscopic techniques that can be used to identify micro-particles with the advantage of in situ detection. In this paper we demonstrate that a visible laser Raman microscope was particularly useful to identify micro-particles that were inside glass containers such as glass syringes, vials, and test tubes, which are commonly used as containers for aqueous formulated drugs. The examples include the identifications of a droplet-like particle inside a pre-filled glass syringe, a fibrous particle inside a glass test tube, and a white particle inside a glass vial; all of these examples usually demand challenging or time-consuming sample manipulation for other techniques. The Raman microscopic technique was shown to be able to solve these challenging micro-particle identifications due to its ability to carry out detection in situ. Particularly in the example of micro-droplet identification, the Raman microscopic technique was the only choice for a fast and successful particle detection. For all three identifications, Raman in situ detection has significantly accelerated particle analysis and avoided potential sample secondary contamination or losses owing to none or minimal sample manipulation.