研究目的
Investigating the applicability of Deep Ultra Violet (DUV) laser-induced fluorescence for cleaning validation in the pharmaceutical industry by detecting trace contamination of organic materials on pharmaceutical process surfaces.
研究成果
DUV laser-induced fluorescence is capable of detecting trace contamination of organic materials on pharmaceutical process surfaces, offering a contactless method that requires no labeling materials. The technique demonstrated detection limits in the order of ≈0.2 μg/cm2 for APIs with low fluorescence efficiency, within a short amount of time, enabling cleaning validation onsite. The method is superior to IR absorption-based methods and can be extended to rinse measurements and the use of an optical fiber probe for cleaning verification of hard to clean areas.
研究不足
The study highlights the need for improving the detector-monochromator combination and using optimized fiber bundles with separate fibers for excitation and collection to further improve collection efficiency and acquisition time. Onsite fluorescence collection mechanisms in terms of the area of sample collection are yet to be developed.
1：Experimental Design and Method Selection:
The study employed a modified spectrometer for offsite bench type prototype analysis of trace samples of API and cleaning detergents with various substrates. DUV laser-induced fluorescence was used for detecting carryover of APIs and detergents onsite.
2：Sample Selection and Data Sources:
Samples included Fluticasone propionate and Paroxetine Hydrochloride Hemihydrate as APIs, and Clean In Process (CIP) 200 detergent. Substrates tested were steel, Hastelloy, pharma grade blue glass, silicone rubber, PTFE, and FEP.
3：List of Experimental Equipment and Materials:
A modified spectrometer from Photon Systems Inc., Ne-Cu hollow cathode laser, Ocean optics QE pro spectrometer, Hamamatsu S7030 back-thinned FFT-CCD, and a custom patch cable for the probe head.
4：Experimental Procedures and Operational Workflow:
Calibration standards were prepared, and fluorescence spectra were collected from stains on various substrates. The specificity and linearity of DUV laser-induced fluorescence were examined.
5：Data Analysis Methods:
The fluorescence spectra were analyzed to determine detection limits and signal to background ratios. Comparisons were made with FTIR absorption techniques.
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