Corrigan Damion K, Cauchi Michael, Piletsky Sergey, Mccrossen Sean
Cranfield Health, Cranfield University, Beds, UK.
PDA J Pharm Sci Technol. 2009 Nov-Dec;63(6):568-74.
Cleaning verification is the process by which pharmaceutical manufacturing equipment is determined as sufficiently clean to allow manufacture to continue. Surface-enhanced Raman spectroscopy (SERS) is a very sensitive spectroscopic technique capable of detection at levels appropriate for cleaning verification. In this paper, commercially available Klarite SERS substrates were employed in order to obtain the necessary enhancement of signal for the identification of chemical species at concentrations of 1 to 10 ng/cm2, which are relevant to cleaning verification. The SERS approach was combined with principal component analysis in the identification of drug compounds recovered from a contaminated steel surface.
清洁验证是确定制药生产设备足够清洁以允许继续生产的过程。表面增强拉曼光谱（SERS）是一种非常灵敏的光谱技术，能够在适合清洁验证的水平进行检测。在本文中，使用市售的Klarite SERS基底，以获得必要的信号增强，用于识别浓度为1至10 ng/cm2的化学物质，这与清洁验证相关。在识别从受污染钢表面回收的药物化合物时，将SERS方法与主成分分析相结合。
