Chemical Residue

Traces of chemicals used during manufacturing or cleaing remaining on equipment surfaces influencing quality

The general term "residue" is defined in PDA Technical Report 29, Points to Consider for Cleaning Validation, as "chemical or microbiological material remaining on equipment surfaces after a cleaning process". A chemical residue is any remaining material on the equipment surface imparted by the production or cleaning process that is not microbial e.g. product residue, impurities, cleaning agents, etc. When determining the cleanliness of equipment after a cleaning process, sampling methods are used to collect chemical residues from the equipment surface and determine if the acceptance criteria (limit from a safety or quality perspective) are met.