PT  - JOURNAL ARTICLE
AU  - Stephen P. Costanzo
AU  - Roya N. Borazjani
AU  - Patrick J. McCormick
TI  - Validation of the Scan RDI for Routine Microbiological Analysis of Process Water
DP  - 2002 Jul 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 206--219
VI  - 56
IP  - 4
4099  - http://journal.pda.org/content/56/4/206.short
4100  - http://journal.pda.org/content/56/4/206.full
SO  - PDA J Pharm Sci Technol2002 Jul 01; 56
AB  - In this report, we review the validation methods and criteria specified in the PDA Technical Report No. 33 “Evaluation, Validation, and Implementation of New Microbiological Testing Methods” against data generated on the Chemunex Scan RDI. For each parameter, we have either reported data obtained in-house or reviewed information and documentation available from the manufacturer of the system. For all specified requirements, the Scan RDI produced data that was within the specifications suggested in the PDA Technical Report or suitable information was obtained from the manufacturer. The results of the study indicate that the Scan RDI can be validated for routine use in a pharmaceutical environment and provide results equivalent to current methods, but in a much shorter time frame.