Non-invasive identification of incoming raw pharmaceutical materials using Spatially Offset Raman Spectroscopy

被引:52
作者
Bloomfield, Matthew [1 ]
Andrews, Darren [1 ]
Loeffen, Paul [1 ]
Tombling, Craig [1 ]
York, Tim [1 ]
Matousek, Pavel [1 ,2 ]
机构
[1] Cobalt Light Syst Ltd, Oxford OX11 0QR, England
[2] STEC Rutherford Appleton Lab, Cent Laser Facil, Oxford OX11 0QX, England
关键词
Spatially Offset Raman Spectroscopy; Raw material analysis; Pharmaceutical formulations; Quality control; Non-invasive analysis;
D O I
10.1016/j.jpba.2012.11.046
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
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.
引用
收藏
页码:65 / 69
页数:5
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