The authors present a simple way to qualify a swab-sampling procedure for its ability to recover residues of a small-molecule API from cleaned equipment surfaces. Spiking studies were specifically designed to assess the impact of sampling parameter variability on swab recoveries. The qualification characteristics included accuracy, precision, linearity, and robustness. An eight-run Plackett-Burman design was used to assess the procedure’s robustness. Click Here For Complete Article Text
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