"Points to consider" in the validation of equipment cleaning procedures

Cleaning validation has received increasing attention by the FDA in recent inspections, yet very little has been published regarding practices within the pharmaceutical industry. This presentation will review several of aspects of the validation of equipment cleaning procedures. A significant portion of the presentation is derived from round table discussions the author has led over the last several years on this subject. Specific areas to be defined include: sampling methods, analytical methods, physical parameters, and of greatest interest, the selection of acceptance criteria. The presentation also includes some additional perspectives on the subject of cleaning validation developed by the author which may prove useful to the practitioner.