Cleaning Validation References For Pharmaceutical Manufacturing And Medical Device

By Jeff Phillips, Director of Science

A cleaning validation involves testing for acceptable residues on pharmaceutical manufacturing or medical device surfaces. The validation involves:

• Residue identification,
• Residue detection method selection,
• Sampling method selection,
• Setting residue acceptance criteria,
• Methods validation and recovery studies, and finally,
• Writing a procedure and training operators.

This procedure is used to document acceptable residues three or more times and then a rational monitoring program to maintain a validated state is put in place. If you are changing any part of your procedure or cleaner, first clean the new way, collect data and then clean the old way before using any equipment while you are in the process of validating the new procedure.