All three lots of RM 8671 were shown to be consistent with one another, as well as to the PS 8670 material with respect to total particle content (within ±3SD). This indicates that the fill finish sequence did not significantly introduce particulates in the size range ≥ 2 μm and that consistent production of future lots can be expected. Table S13 does, however, show a potential trend of increasing particle content with increasing lot number. Trending of additional lots of material may be useful in the future to discern if this is indeed a trend or within typical lot-to-lot variability.