This section describes the calculation of residue acceptance limits used to ensure that cleaning processes reduce product residues to levels that protect patient safety.
1. Purpose and Definition Health-Based Exposure Limits (HBELs) define the maximum daily exposure to a substance that is not expected to cause adverse health effects. In cleaning validation, HBELs establish the scientific basis for acceptable residue levels and control of…
1. Purpose and Definition Maximum Allowable Carryover (MACO) defines the maximum quantity of a product residue that may be carried over from one manufacturing batch to the next without posing a risk to patient safety or product quality. MACO establishes…