RT Journal Article
SR Electronic
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
FD Parenteral Drug Association (PDA)
SP 267
OP 271
VO 49
IS 6
A1 Fujishita, Osamu
A1 Sendo, Toshiaki
A1 Hisazumi, Ayako
A1 Otsubo, Kenji
A1 Aoyama, Toshinobu
A1 Oishi, Ryozo
YR 1995
UL http://journal.pda.org/content/49/6/267.abstract
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.