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Deep UV Laser-Induced Fluorescence for Pharmaceutical Cleaning Validation.

Krishnakumar Chullipalliyalil1, Liam Lewis1, Michael A P McAuliffe1

  • 1Center for Advanced Photonics and Process Analysis (CAPPA) , Cork Institute of Technology , Cork , Ireland.

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|December 12, 2019
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Summary

Deep ultra violet (DUV) laser-induced fluorescence offers sensitive, onsite cleaning verification for pharmaceuticals. This technique rapidly detects active pharmaceutical ingredient (API) traces, improving validation times compared to traditional lab methods.

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Science
  • Spectroscopy

Background:

  • Pharmaceutical cleaning verification is essential but often relies on slow, lab-based methods like HPLC.
  • Current onsite verification tools lack sensitivity and portability, delaying cleaning validation.
  • There is a need for advanced, rapid, and accurate onsite cleaning detection technologies.

Purpose of the Study:

  • To introduce and evaluate deep ultra violet (DUV) laser-induced fluorescence for onsite pharmaceutical cleaning verification.
  • To assess the sensitivity and specificity of DUV laser-induced fluorescence for detecting active pharmaceutical ingredient (API) and detergent residues.
  • To demonstrate the potential for portable DUV systems to streamline cleaning validation processes.

Main Methods:

  • A modified spectrometer was utilized as an offsite bench prototype to analyze trace samples.
  • Deep ultra violet (DUV) laser-induced fluorescence was employed to detect API and detergent carryover on various substrates.
  • A probe-based system was explored for accessing difficult-to-reach areas.

Main Results:

  • DUV laser-induced fluorescence successfully identified API traces as low as approximately 0.20 μg/cm².
  • The technique demonstrated superior signal-to-background ratio (SBR) over FTIR absorption methods for trace API detection on polymer/glass.
  • Processing times for DUV laser-induced fluorescence detection were significantly shorter than traditional swab-based methods.

Conclusions:

  • DUV laser-induced fluorescence is a sensitive and specific method for onsite pharmaceutical cleaning verification.
  • This technology offers a faster alternative to conventional lab-based techniques, reducing cleaning validation timelines.
  • The development of portable DUV systems holds promise for improving efficiency and accuracy in pharmaceutical manufacturing quality control.