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5: Process capability of data using 25 CFU/25 cm 2

5: Process capability of data using 25 CFU/25 cm 2

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This chapter will discuss microbiology as it pertains to Cleaning Validation. In practice, the primary focus of Cleaning Validation is the removal of chemical residues, either from active ingredients or cleaning agents, and microbiological issues are of an incidental nature. It should be understood that the purpose of cleaning procedures should nev...

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This article will provide a detailed discussion of the science-, risk-, and statistics-based approaches in the American Society for Testing and Material (ASTM) E3106 "Standard Guide for Science Based and Risk Based Cleaning Process Development and Validation".