Table 3.

Concentration of nanoparticles of sizes between 60-1000 nm (10⁸/mL) in IVIG solution centrifuged at various g forces and exposed to either freeze thawing, agitation or agitation in the presence of polysorbate 20

	45 minutes @2,350g	45 minutes @30,000g	3 hours @112,000g
Control	25.43 ± 1.56	0.47 ± 0.007	0.23 ± 0.20
Freeze-Thawing	19.90 ± 0.569	2.85 ± 2.68	1.50 ± 0.595
Agitation
0 hr	10.04 ± 7.0	0.47 ± 0.14	0.07 ± 1.27
0.75 hr	8.92 ± 2.82	2.89 ± 1.03	0.80 ± 0.45
1.5 hr	8.73 ± 1.33	4.87 ± 1.09	2.85 ± 0.65
2 hr	8.55 ± 2.02	5.66 ± 0.57	3.01 ± 0.85
4 hr	6.85 ± 2.31	7.08 ± 0.71	5.82 ± 1.64
6 hr	8.01 ± 1.54	7.48 ± 1.54	6.76 ± 1.49
8 hr	8.13 ± 3.39	7.48 ± 2.07	6.03 ± 1.43
Agitation with Tween 20	n/aa	Not determinedb	Not determinedb

^*Measurement error represents standard deviation from measurement of three independent samples

^aParticle levels above the limit of quantitation of the instrument (ca 10⁹ particles/mL).

^bSamples not tested for this treatment