Sometimes I am asked about cleaning validation for packaging equipment, and the thought behind the question appears to be that this is not a critical cleaning process and therefore doesn’t require cleaning validation. While it is true that effective cleaning of some packaging equipment may be much easier to achieve, it is not necessarily true that the effectiveness of such cleaning is non-critical.
Before I discuss the topic, let’s make sure of some definitions. By packaging equipment I am referring to primary packaging equipment, usually of a finished drug product. That includes such examples as liquids being filled into vials and then capped, and tablets being filled into bottles and then capped.
Journal:
Cleaning Memo for MARCH 2005
