Setting Residue Acceptance Criteria

Q. Do you have to set residue acceptance criteria for cleaners?

A. Yes. For pharmaceutical and medical device manufacturing it is required that there be set residue acceptance levels for potential residues such as the active drug, excipients, degradation products, cleaning agents, bioburden and endotoxins. These levels are determined based on potential pharmacological, safety, toxicity, stability, and contamination effects on the next product using that surface or equipment. Limits are typically set for visual, chemical, and microbiological residues.

For more information on residue acceptance criteria, visit http://www.alconox.com/static/section_top/gen_cleanval.asp.

For additional technical information on cleaning validation, please Download our Pharmaceutical and Medical Device Cleaning Validation References PDF.

And if you have a question for our experts about critical cleaning, please visit Ask Alconox or Click HERE to access our free critical cleaning tools all in one place.