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Authors
Affiliations
1 School of Chemistry, Universidad Nacional Autónoma de México (UNAM), México City, México, MX
2 Fundación Liomont, A.C., Mexico City, Mexico, MX
3 Biokinetics, S.A. de C.V., Mexico City, Mexico, MX
Source
Asian Journal of Chemistry and Pharmaceutical Sciences, Vol 2, No 1 (2017), Pagination: 16-21
Abstract
Cleaning validation is one of the key elements of the validation program of an active pharmaceutical ingredient (API) manufacturer. One of the most important aspects of cleaning validation is the sampling methods. Swabbing or surface sampling is the subject of this article. The application of sequential experimental designs for the efficient development of a swab sampling method, based on a fractional factorial design followed by full factorial design, is illustrated in this article.
Keywords
Cleaning Validation, Design of Experiments, Hptlc, Swab Sampling.
Full Text
References
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