Explains the scientific basis for cleaning validation limits, including health-based exposure limits, PDE and ADE concepts, maximum allowable carryover calculations, equipment-surface allocation, and development of practical swab, rinse, and visual acceptance criteria.
Health-based exposure limits (HBELs) provide the toxicological basis for determining how much unintended exposure to a pharmaceutical substance can be considered acceptable. In cleaning validation, the HBEL is used to establish a patient-safety-based starting point for controlling carryover from a…
Maximum Allowable Carryover (MACO) defines the maximum quantity of residue from a previously manufactured product that may theoretically carry into a subsequently manufactured product without causing the patient receiving the subsequent product to exceed the established health-based exposure limit for…
Cleaning-validation acceptance criteria convert patient-safety, product-quality, and process-control requirements into measurable limits that can be applied during validation and routine cleaning verification. A defensible program does not begin with an arbitrary swab number. It begins with a scientifically justified basis…