Asian Journal of Chemistry and Pharmaceutical Sciences

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Application of Design of Experiments (DOE) to the Development and Validation of a Swab Sampling Method for Cleaning Validation


Affiliations
1 School of Chemistry, Universidad Nacional Autónoma de México (UNAM), México City, México, Mexico
2 Fundación Liomont, A.C., Mexico City, Mexico, Mexico
3 Biokinetics, S.A. de C.V., Mexico City, Mexico, Mexico
 

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.
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  • Application of Design of Experiments (DOE) to the Development and Validation of a Swab Sampling Method for Cleaning Validation

Abstract Views: 472  |  PDF Views: 220

Authors

Pilar Rodríguez-Loaiza
School of Chemistry, Universidad Nacional Autónoma de México (UNAM), México City, México, Mexico
Salvador Namur
Fundación Liomont, A.C., Mexico City, Mexico, Mexico
Mario González-de la Parra
Biokinetics, S.A. de C.V., Mexico City, Mexico, Mexico

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.

References