A Single Adulteration Limit for Clesning Validation in a Pharmaceutical Pilot-Plant Environment

摘要

A well run cleaning-validation program requires a significant amount of planning and resources. Planning takes into account the size, configuration, and complexity of the manufacturing equipment; the physical properties of the soils encountered, which directly affect the cleaning procedure used; the detergent to clean the equipment; the type of swab or rinse sampling to capture residue levels; the analytical test methods to determine residue levels; the periodic monitoring of the system to ensure ongoing compliance; change control to address new residues and equipment; ap-propriate documentation; and training for personnel cleaning equipment and performing validation challenges. Required resources include equipment downtime for the validation, raw materials for the formulations tested, analytical instrumentation for analysis, detergents for cleaning, solvents for testing, and personnel to perform the validation.