Cleaning validation (Part-2)

In the previous issue (Volume IV, No. 35, May 2005), we have covered the basics of guidelines/parameters on cleaning validation and the principles involved therein. Further, we discussed the general and specific consideration regarding equipment and personnel, microbial considerations, types of residues, cleaning agent selection, product consideration, cleaning parameter selection and documentation. This issue focuses on the important sampling techniques, analytical methods used for cleaning evaluations and establishing limits and acceptance criteria.