IMAGE ANALYSIS
The primary result reported by image analysis is a number distribution since the
particles are inspected one at a time. Setting specifications based on the number
distribution
is acceptable, but this is the one example where conversion to another
basis (i.e. volume) is both acceptable and often preferred. As long as a sufficient
number of particles are inspected to fully define the distribution, then the conversion
from number to volume does not introduce unknown errors into the result. The
pharmaceutical industry discussed the subject at a meeting
organized by the AAPS
(ref. 6) and concluded that results are preferably reported as volume distributions.
Particle size distribution specifications based on the image analysis technique often
include the mean, D10, D50, and D90 values. Care should be taken to avoid basing
specifications on the number-based mean since this value may not track process
changes such as milling or agglomeration (ref. 12).
Conversion from number to
volume distribution can be performed with high accuracy by specifying the typical
particle shape (spherical, cylindrical, ellipsoidal, tetragonal, etc.).
Particle shape parameters such as roundness, aspect ratio, and compactness are
used to describe particle morphology. Specifications
for shape parameters are
typically reported using just the number-based mean value, so this is recommended
for setting specifications.
CONCLUSIONS
The task of setting a particle size specification for a material requires knowledge
of which technique will be used for the analysis and how size affects product
performance. Sources of error must be investigated and
incorporated into the final
specification. Be aware that, in general, different particle sizing techniques will
produce different results for a variety of reasons including: the physical property
being
measured, the algorithm used, the basis of the distribution (number, volume,
etc.) and the dynamic range of the instrument. Therefore, a specification based on
using laser diffraction is not easily compared to expectations from other techniques
such as particle counting or sieving. One exception to this
rule is the ability of
dymanic image analysis to match sieve results.
Attempting to reproduce PSD results to investigate whether a material is indeed
within a stated specification requires detailed knowledge of how the measurement
was acquired including variables such as the refractive index, sampling procedure,
sample
preparation, amount and power of ultrasound, etc. This detailed information
is almost never part of a published specification and would require additional
communications between the multiple parties involved.
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