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

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Authors

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

Keywords:

Cleaning Validation, Design of Experiments, Hptlc, Swab Sampling.

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Volume 2, Issue 1, 2017 || Articles

How to Cite

Rodríguez-Loaiza, P., Namur, S., & Parra, M. G.- de la. (2017). Application of Design of Experiments (DOE) to the Development and Validation of a Swab Sampling Method for Cleaning Validation. Asian Journal of Chemistry and Pharmaceutical Sciences, 2(1), 16–21. Retrieved from https://ischolar.sscldl.in/index.php/AJPAC/article/view/153796

 

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.

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