Non-invasive identification of incoming raw pharmaceutical materials using Spatially Offset Raman Spectroscopy
Non-invasive identification of incoming raw pharmaceutical materials using Spatially Offset Raman Spectroscopy
复制标题
DOI：
10.1016/j.jpba.2012.11.046
复制
发表时间：
2013-03-25
影响因子：
3.4
通讯作者：
Matousek, Pavel
中科院分区：
文献类型：
--
作者：
Bloomfield, Matthew;Andrews, Darren;Matousek, Pavel
提出并演示了一种新的方法来验证通过包装的来料在制药制造。该方法基于空间偏移拉曼光谱（SORS），允许对来货材料进行快速化学特性分析，以满足法规要求，但无需打开包装。这大大增加了进入制药制造链的原料的吞吐量，并消除了侵入性检查方法所需的化学安全采样环境的需要。由于检查是非侵入性的，因此确保了操作人员的安全，并且被检查材料的完整性不会因防止暴露于环境大气和交叉污染而受到损害。这里展示的实验证明了通过一系列常用的包装（包括半透明塑料、纸袋和彩色玻璃瓶）准确识别常见药物材料的能力，通常在10秒内采集时间内，这对于传统的拉曼光谱以及其他光谱学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都适用于这种技术。这证明了这种新的快速验证方法在药品生产中非侵入性材料鉴定的可行性。(c) 2012 Elsevier B.V.版权所有
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 10 s 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. (c) 2012 Elsevier B.V. All rights reserved.