OPTIMIZING SANITIZATION AND ACCESS CONTROL: LESSONS FROM A CLEANING VALIDATION STUDY

Background: Cleaning Validation studies is an important aspect in pharmaceutical studies to identify and correct potential problems previously unsuspected, which could compromise the safety, or quality of subsequent batches of product produced within the equipment. Methods The study was designed as experimental study and conducted between January-June 2025.The study was conducted on Clobetasol 0.05% cream manufacturing equipments. Total 36 samples from 3 consecutive batches were included in the study. Swabbing technique was used to find microbial load on equipment under the study. Total aerobic Microbial Count (TAMC) 100 cfu/ 100 cm 2 and Total Yeast and Mould Count 10cfu/ 100 cm 2 was set as pass limit during cleaning validation study. Different contamination variables were studied during cleaning validation study.Statical analysis was done using Standard deviation on obtained data. Result: The mean value of cleaning validation study for Total aerobic Microbial count and Total yeast and mould count was found to be 8.38 and 0.55 for all three batches of used equipments respectively. Standard deviation was found to be 6.08 and 0.511. Conclusion:Several contamination variables like sanitizationtechnique, frequency of fumigation, access control in area, Microbial load over lint free clot used for mopping was coined during study and after mitigating such contamination variables the study result was found satisfactory.Changed technique like change from chemical method of sterilization to moist heat sterilization of templates , use of lint-free cloths soaked in 70% IPA provided better control, Increased fumigation frequency and limited access in area acts as major preventive measures for contamination Control.