Single-Time-Point Surface Bioburden Study at 96 Hour Dirty-Hold Time on Amlodipine Manufacturing Equipment in 'Class D' Facility (Non-Sterile)

Shrawan Kr. Singh*
Quest Pharmaceuticals Private Limited, Nepal.
Periodicity:July - December'2025
DOI : https://doi.org/10.26634/djcp.2.2.22824

Abstract

The objective of dirty equipment hold time study (DEHT) was to find the load of microorganism on the equipment's which were used for manufacturing of amlodipine tablets 5 mg in class D (non- sterile) manufacturing facility. Amlodipine tablets contains starch and microcrystalline cellulose as major excipients which may serve as excellent growth medium for growth as well as proliferation of microbes on dirty equipment's. The dirty equipment hold time study was carried out for single product, amlodipine 5mg tablet and hold time of a 96 hours was selected for hold time study on dirty equipment. From 9 equipment's, altogether 18 samples were sampled using sterile swab from 25cm2 on single time point (96 hours) for study purpose. Microbial limit 100 cfu/25cm2 was set as predefined pass/fail limit in analogy to the class D area of environment monitoring in pharmaceutical manufacturing facility. The results of microbial sample were found below 100 cfu/25cm2. Standard deviation of total aerobic microbial count was found to be 20.61(n=9) and total yeast and mold count 0.44 (n=9) respectively. The result of study suggest that the load of microorganism were in predefined limit on amlodipine tablets manufactured dirty equipment in controlled class D Environment. The load of microorganism was found to be very low, this might be due to controlled environment, low water activity on surface of equipment's or low nutrient viability. Further multi time point studies are needed to establish hold time justification.

Keywords

Dirty Equipment, Hold Time, Bioburden, TAMC, TYMC.

How to Cite this Article?

Singh, S. K. (2025). Single-Time-Point Surface Bioburden Study at 96 Hour Dirty-Hold Time on Amlodipine Manufacturing Equipment in 'Class D' Facility (Non-Sterile). Dale View's Journal of Clinical Pharmacology and Pharmacotherapeutics, 2(2), 18-21. https://doi.org/10.26634/djcp.2.2.22824

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