The cleaning process should be validated by which method?

• A. Air sampling
• B. Wipe sampling
• C. Visual inspection
• D. Pressure testing

Answer: (B)

Cleaning process validation hinges on obtaining objective data about surface residues. Wipe sampling directly collects material from surfaces after cleaning and the residue is quantified with an analytical method, giving a measurable level that can be compared to predefined acceptance criteria. This makes it the most appropriate way to confirm that hazardous drug residues have been reduced to an acceptable level. Visual inspection is subjective and cannot detect trace amounts of contamination; air sampling focuses on contamination in the air rather than on surfaces; and pressure testing checks system integrity rather than residue removal. Therefore, wipe sampling is the proper method for validating a cleaning process.