Transportation of particles through tubing between the sample inlet and the optics of a particle counter has often been at the forefront of discussion regarding the truth of readings. With the release of the 2009 EC GMP Annex 1 the issue of particle loss of large particles has been elevated such that a better understanding and measurement of those losses is warranted. When the validation implications of losses due to various forces are reviewed, the absolute certainty of a result is always in question. So what are these forces? What are the losses? What are acceptable results? The goal of this paper is to address several of these issues and provide a better understanding of the problem.
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