A procedure is described for the detection and direct enumeration of the number of particles that can potentially be released from wiping materials. The technique involves the use of a scanning electron microscope (SEM) to count the particles from a wiper, first by releasing them in deionized water and then filtering the entirety of the liquid through a submicron membrane filter. To obtain an accurate count, the filtration must produce a normal distribution of particles on the filter, and hence the details of the filtering technique must be performed in a very precise manner. The counting of the particles on the filter is accomplished by scanning a statistically representative number of fields and averaging the number of particles per field. The results can then be checked for statistical precision and accuracy. Our criterion for successful measurement was ± 10% accuracy at a 95% confidence level. We believe that the SEM method described in this article is sensitive enough to quantify very low levels of total particle burden without succumbing to the variability and limitations encountered with other enumeration techniques. Typically, this technique enables the accurate counting of particles of all shapes from below 0.1 μm to hundreds of micrometers. In addition, the SEM technique allows for morphologic identification of particles as well as chemical identification if an energy‐dispersive x‐ray system (EDS) is employed.
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