Innovation - From Mining to Pharmaceutical Manufacturing - The Inspiring Role of the Theory of Sampling (TOS)
DOI: 10.62178/sst.004.004
Abstract
TOS has guided the author in addressing multiple challenges in the sampling and analysis of the powder blends that are compressed into the tablets that many patients ingest. Real time measurements of pharmaceutical manufacturing processes are possible through near infrared and Raman spectroscopy. These real-time measurements form part of a systematic effort called Process Analytical Technology (PAT) designed to guarantee the quality of pharmaceutical products. In PAT sampling is performed through spectroscopic methods. Sampling errors have been identified in real time PAT measurements. This report also presents a two-fold composite sampling approach developed to improve the accuracy of the real-time spectroscopic methods. Pharmaceutical processes include 1-D lot transformations just like processes in mining and other industries. Variograms can be used to evaluate the sources of sampling and analytical errors in near infrared and Raman spectroscopic methods, even though the true mass of the sample analyzed is not known. Variographic analysis is practically custom made for continuous manufacturing of pharmaceutical formulations, providing valuable information. As part of innovation initiatives, the author has been involved in intensive customer discovery efforts for the development of new sampling technology. The Stream Sampler Kit, inspired by the Theory of Sampling, is now commercially available for pharmaceutical processes.
Published in Issue 4 · December 2025
Citing this article
Romañach, R. J. (2025). Innovation - From Mining to Pharmaceutical Manufacturing - The Inspiring Role of the Theory of Sampling (TOS). Sampling Science & Technology, December 2025(4), 19-40. https://doi.org/10.62178/sst.004.004
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