Residue Acceptance Criteria

Question:
Do you have to set residue acceptance criteria for cleaners?

Answer:
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.