Dirty-hold time effect on the cleaning process efficiency

摘要

The paper evaluated the efficiency of a standard cleaning procedure of the process equipment after production of antihypertensive with the active component Losartan Potassium for different lengths of time between completion of production and the start of the treatment process-so called dirty-hold time. It has been found that the cleaning process is appropriately designed and efficient. The concentration of losartan in swabs from the equipments was in all cases within the limits of acceptance criteria. However, the washing process was in all cases sufficiently effective to meet the eligibility criteria, significant effect of the time of weaning of the contaminated equipment on the efficiency of the washing process was found. At studied dirty hold time horizon (0-4 days) there was a progressive deterioration of the efficiency of the cleaning process. It was found that the influence of the nature of the residual material on the cleaning process has minor effect then the length of the dirty hold time. Laboratory experiments provide comparable results for both wet and dry contamination of the surface.