Cobalt Light Systems Limited, The Electron Building, Fermi Avenue, Harwell, Oxford OX11 0QR, United Kingdom.
J Pharm Biomed Anal. 2013 Mar 25;76:65-9. doi: 10.1016/j.jpba.2012.11.046. Epub 2012 Dec 16.
A new approach to verification of incoming raw materials through packaging in pharmaceutical manufacturing is proposed and demonstrated. The method is based around Spatially Offset Raman Spectroscopy (SORS) and permits a rapid chemical identity analysis of incoming materials to satisfy regulatory requirements but without the need to open the packaging. This dramatically increases the throughput of incoming raw materials into the pharmaceutical manufacturing chain and eliminates the need for a chemically safe sampling environment required for invasive inspection methods. Since the inspection is non-invasive the safety of the operators is ensured and the integrity of inspected material is not compromised by preventing exposure to the ambient atmosphere and cross contamination. The experiments presented here demonstrate the ability to accurately identify common pharmaceutical materials, typically in under 10s acquisition time, through a range of frequently used packaging, including translucent plastic and paper sacks and coloured glass bottles, which can be challenging for conventional Raman spectroscopy as well as other optical spectroscopy methods. With the exception of metallic containers and cardboard drums all the tested packaging materials proved to be amenable to this technique. This demonstrates the viability of this new rapid verification method for non-invasive materials identification in pharmaceutical manufacture.
提出并展示了一种在制药生产中通过包装来验证来料的新方法。该方法基于空间偏移拉曼光谱（SORS），可快速对来料进行化学物质身份分析，以满足监管要求，而无需打开包装。这极大地提高了制药生产链中来料的吞吐量，并消除了对侵入性检查方法所需的化学安全采样环境的需求。由于检查是非侵入性的，因此可以确保操作人员的安全，并且不会通过防止暴露于环境大气和交叉污染来破坏受检材料的完整性。这里呈现的实验证明了通过一系列常用包装（包括半透明塑料和纸袋以及彩色玻璃瓶），在通常不到 10 秒的采集时间内准确识别常见药物材料的能力，这对于常规拉曼光谱以及其他光谱方法来说是具有挑战性的。除了金属容器和纸板桶外，所有经过测试的包装材料均适用于该技术。这证明了这种新的快速非侵入性材料识别验证方法在制药生产中的可行性。
