PT  - JOURNAL ARTICLE
AU  - Fujishita, Osamu
AU  - Sendo, Toshiaki
AU  - Hisazumi, Ayako
AU  - Otsubo, Kenji
AU  - Aoyama, Toshinobu
AU  - Oishi, Ryozo
TI  - The Evaluation of Sizing Accuracy of Particle Counters for Parenteral Drugs
DP  - 1995 Nov 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 267--271
VI  - 49
IP  - 6
4099  - http://journal.pda.org/content/49/6/267.short
4100  - http://journal.pda.org/content/49/6/267.full
SO  - PDA J Pharm Sci Technol1995 Nov 01; 49
AB  - Our evaluation of electronic liquid-borne particle counter systems has shown that, for accurate measurement of particulate matter in injections, the half count values of voltage thresholds from the particle counter itself should be used in the calibration for the particle sizes being evaluated. The manual method which uses the half count values in the USP XXHI(788) was improved, and the validity of our calibration method was supported by the results based on the ratio test, at 10 µm to those obtained at 15 µm is between 1.5 and 3.5, as per the Seventh Supplement of USP XXII (788). Additionally, computer-based systems with automated calibration routines which solve the approximate Gaussian distribution of calibration particles have advantages. For the proper determination of the sizing accuracy of a particle counter, criteria of the ratio test at 10 µm and 15 µm as per the Seventh Supplement of USP XXII (788) should be applied at all critical particle sizes.