Sterility testing of minimally manipulated cord blood products: validation of growth-based automated culture systems.

Background: The St Louis Cord Blood Bank submitted a biologics license application for cord blood (CB) products processed by PrepaCyte-CB (BioE), supported with a validation study of a microbial detection system for product sterility testing (BACTEC-FX, Becton Dickinson). This article provides the validation approach followed to fulfill Food and Drug Administration requirements pertinent to sterility testing method.

Study Design And Methods: System qualification, culture media quality verification, and validation of CB processing by-product (CB-BP) sample as surrogate to final product for sterility testing were followed by studies evaluating method sensitivity, specificity, reproducibility, ruggedness or robustness, and bacteriostatic or fungistatic effect of CB-BP sample.