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Particulate Contamination

Definition

Particulate contamination describes the unintended presence of extraneous, mobile and undissolved particles in a parenteral solution [1;2].

These particles can be of various size, defining them as detectable by visual inspection (in general ≥ 50 µm) sub-visible inspection with a range of 2-50 µm in size in general.

Especially the sub-visible sized particles demand specific analytical tests for their detection.

References:

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1 Werner PB, Winter G. (2015) Particle contamination of parenteralia and in-line filtration of proteinaceous drugs. Int J Pharm: S0378-5173(15)30349-5. doi: 10.1016/j.ijpharm.2015.10.082. [Epub ahead of print]

2 Doessegger L, Mahler HC, Szczesny P, Rockstroh H, Kallmeyer G, Langenkamp A, Herrmann J, Famulare J. (2012) The potential clinical relevance of visible particles in parenteral drugs. J Pharm Sci; 101(8): 2635-44

To read the abstract go to the literature page.