MICROBIAL LOAD ASSESSMENT DURING DIRTY EQUIPMENT HOLD TIME STUDY

The objective of this Dirty Equipment Hold Time Study (DEHT) to establish a validated maximum dirty hold time for equipment before cleaning. DEHT study helps us in determining the maximum time equipment can remain uncleaned after production without compromising cleaning effectiveness. The dirty equipment hold time study was carried out for Amlodipine. The study was carried at 96 hours of hold time of dirty Equipments and microbial sampling was done at the end of 96 hours. The Result of visual inspection was found satisfactory and no visible signs of microbial growth was observed. The results of Microbial Sample were found below 100 cfu/25cm2.