Center for Advanced Photonics and Process Analysis (CAPPA) , Cork Institute of Technology , Cork , Ireland.
Anal Chem. 2020 Jan 7;92(1):1447-1454. doi: 10.1021/acs.analchem.9b04658. Epub 2019 Dec 26.
Cleaning verification and validation is a requirement in the pharmaceutical industry. Due to the limited number of mobile devices that do effective and accurate onsite cleaning verification, it is mostly done via lab-based quality control techniques. These techniques, such as high-performance liquid chromatography (HPLC) or total organic carbon, often lead to extending the validation of cleaning by days. The void of more sensitive, accurate, and portable instruments to verify cleaning onsite has to be filled. The article discusses the use of deep ultra violet (DUV) laser-induced fluorescence for detecting carryover of active pharmaceutical ingredients (APIs) and detergents onsite. A modified spectrometer was used as an offsite bench type prototype for analyzing trace samples of API and cleaning detergents with various substrates. Even if the API to be detected has a low fluorescence efficiency, the specificity of the technique allows API traces having concentrations as low as ≈0.20 μg/cm to be identified. The work also shows the possibility of using a probe for validating cleaning of hard to reach areas using DUV laser-induced fluorescence. DUV laser-induced fluorescence of trace API over any polymer/glass substrate has better signal to background ratio (SBR) compared to FTIR absorption techniques. Processing times of DUV laser-induced fluorescence trace detection are shown to be much less than swab based methods.
清洁验证和确认是制药行业的要求。由于能够进行有效且准确的现场清洁验证的移动设备数量有限，因此大多通过基于实验室的质量控制技术来完成。这些技术，如高效液相色谱（HPLC）或总有机碳，通常会导致清洁验证延长数天。需要填补更敏感、准确和便携的仪器来现场验证清洁的空白。本文讨论了使用深紫外（DUV）激光诱导荧光来检测现场残留的活性药物成分（APIs）和清洁剂。改良的分光光度计被用作场外台式原型，用于分析具有各种基质的 API 和清洁清洁剂的痕量样品。即使要检测的 API 荧光效率较低，该技术的特异性也允许识别浓度低至 ≈0.20 μg/cm 的 API 痕迹。该工作还表明，使用 DUV 激光诱导荧光探测难以到达区域的清洁的探头是可行的。与傅里叶变换红外吸收技术相比，DUV 激光诱导荧光在任何聚合物/玻璃基质上对痕量 API 的信号与背景比（SBR）更好。DUV 激光诱导荧光痕量检测的处理时间明显短于基于擦拭的方法。
