TY - JOUR T1 - The Evaluation of Sizing Accuracy of Particle Counters for Parenteral Drugs JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 267 LP - 271 VL - 49 IS - 6 AU - Osamu Fujishita AU - Toshiaki Sendo AU - Ayako Hisazumi AU - Kenji Otsubo AU - Toshinobu Aoyama AU - Ryozo Oishi Y1 - 1995/11/01 UR - http://journal.pda.org/content/49/6/267.abstract N2 - 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. ER -