ITW Chemtronics - Cleaning Validation: A Case Study

Our thanks to ITW Chemtronics for allowing us to reprint the following article.
By: Michael Watkins, ITW Chemtronics

Certain Coventry polyester swabs are recommended for use in Cleaning Validation programs for the sampling of surfaces of process equipment used in the production of active pharmaceutical ingredients. Recently a pharmaceutical customer presented us with a special issue involving a competitor's polyester swabs. This issue brought up interesting points related to how polyester swabs are used by the Pharmaceutical Industry, and I would like to discuss this issue in this article.

First, let's do a brief review of the subject of Cleaning Validation as used in the Pharmaceutical Industry. Pharmaceutical manufacturers engaged in producing active pharmaceutical ingredients (APIs), are required by law to have a formal program for insuring that the methods used to clean process equipment between production runs of APIs are effective, verifiable and documented. According to the Active Pharmaceutical Ingredients Committee Working Group, the definition of Cleaning Validation is "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 subsequent product, to a level which is below (a) predetermined level". Such validation of the cleaning procedures may be required by customers, may be a regulatory requirement or an internal company quality control requirement.

If cleaning procedures are inadequate the next batch of product may contain API precursors, by-products or degradation products, the active ingredient, solvents and other materials used in the manufacturing process, micro-organisms, as well as cleaning agents and machine lubricants. The cleaning process used to prevent such contamination from batch to batch must be shown to be effective in controlling carryover of these contaminants from the previous production batch. Validation is achieved by swabbing or rinsing the process equipment and analyzing extracts of the swabs or rinse water for the contaminants of interest...

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