Cleaning Validation: On-Site Trials of SpotView®
نویسنده
چکیده
Background During a series of visits to pharmaceutical and fine chemical plants, a SpotView system was used to develop preliminary calibrations for various APIs, excipients, and cleaning materials. The calibrations were based on sets of spectra collected from standard coupons. In the first case, the calibration was challenged with a set of samples that had been independently prepared, some spiked with an additional contaminant. In two other cases, the calibrations were tested using data collected from reactors before and after cleaning.
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