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Non-contact Laser Interferometer Method to Characterize Tablet Punches: New Methodology to Assess Surface Roughness.

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Tablet punch sticking during drug manufacturing is a critical issue. A new non-destructive laser interferometry method effectively monitors punch surface roughness, identifying unacceptable quality linked to sticking problems.

Keywords:
chrome coatingpharmaceuticalroughnessstickingsurface metrologytablet tooling surface

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Area of Science:

  • Pharmaceutical manufacturing
  • Materials science
  • Surface metrology

Background:

  • Tablet punch sticking is a significant challenge in pharmaceutical production.
  • This issue arises from complex interactions between powder properties, compression force, manufacturing duration, and punch quality.
  • Existing methods for punch assessment are often destructive or insufficient for monitoring over time.

Purpose of the Study:

  • To introduce a novel, non-destructive methodology for evaluating tablet punch surface metrology.
  • To monitor punch quality throughout their operational lifetime.
  • To correlate surface roughness with the occurrence of tablet sticking.

Main Methods:

  • Utilized a non-contact laser interferometer to characterize the surface roughness of commercial S7 steel punches.
  • Employed a profilometer to examine the entire punch surface against the BS_ISO_18804 tooling standard.
  • Developed a 3D-printed holder for efficient punch analysis during manufacturing changeovers.

Main Results:

  • Investigated punches exhibiting sticking issues were found to have unacceptable surface roughness.
  • Specific rough areas on the punch surfaces directly correlated with visually observed sticking.
  • The non-destructive method provided detailed characterization of punch surface topography.

Conclusions:

  • The developed non-destructive methodology offers a reliable way to assess tablet punch surface quality.
  • Monitoring punch roughness can proactively identify potential sticking issues before they impact production.
  • This technique ensures surfaces meet acceptability criteria, especially after coating treatments, enhancing drug product manufacturing.