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

Pilar Rodríguez-Loaiza,Mario González-De La Parra,Salvador Namur

doi:10.18311/ajcps/2017/8460

Pilar Rodríguez-Loaiza, Mario González-De La Parra + Show 1 more

Open Access

https://doi.org/10.18311/ajcps/2017/8460

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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.

Highlights

Cleaning validation is one of the key elements of the validation program of an active pharmaceutical ingredient (API) manufacturer
The first step consisted of a fractional factorial design where the interest was on detecting the factors with significant influence on the cleaning sampling method from the numerous factors with potential influence
It is important to mention that a full factorial design with seven factors requires 27 = 128 experimental runs; obviously, this amount of experimentation is excessive for a screening step

Summary

Introduction

Cleaning validation is one of the key elements of the validation program of an active pharmaceutical ingredient (API) manufacturer. Cleaning validation in the context of API manufacture may be defined as the process of providing documented evidence that the cleaning methods employed within a facility consistently control potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into the subsequent product to a level which is below predetermined levels[1]. Swab and rinse sampling constitute the two recognized methods for cleaning validation sampling[1,2]. Swabbing or surface sampling is the subject of this article and has following main advantages: physical removal of adherent materials such as insoluble residues and the determination of the worst case condition through the sampling sites that may represent worst case locations on the equipment. Because of the nature of this method which employs physical and chemical forces, there are numerous factors that have to be taken into consideration in the evaluation of a swab sampling method[3]

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