Validation of the Scan RDI for routine microbiological analysis of process water.
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.
Costanzo
Stephen P
SP
Bausch & Lomb, 1400 N. Goodman St., PO Box 30450, Rochester, NY 14603-0450, USA. steve_constanzo@bausch.com
Borazjani
Roya N
RN
McCormick
Patrick J
PJ
D015169:Colony Count, Microbial / Q000379:methods*; D012680:Sensitivity and Specificity; D014871:Water Microbiology; D018508:Water Purification