Environmental Monitoring in a Class D Pharmaceutical Facility: Microbial Load and Hygiene Practices, a Risk-Based Cross-Sectional Study

Abstract

Background: Environmental monitoring is a crucial current Good Manufacturing Practice (cGMP) tool for assessing the status of the working environment in a Pharmaceutical Manufacturing Facility.

Methods: The test was conducted between May 20 and 25, 2025. 90 mm Diameter Settle Plates methods, 4 hours exposure under dynamic conditions, were used as a test method to study the microbial load in controlled and classified areas. The finger dab test was used to assess hygiene and sanitization practices in the plant. The non-viable count was excluded from the study due to limitations, including a lack of facilities for conducting the tests.

Result: The result of the environmental monitoring test was below 100 colony-forming units (CFU) in the rooms. The mean value of Total Aerobic Microbial Count and Total Yeast and Mold Count shows a higher microbial count at the Near Return air loop. The p-value of Total aerobic microbial count and Total Yeast and Mold Count was found to be 0.8685 and 0.8716, respectively. The result is not significant at p<0.05. The result of the Finger dab test was below 100 CFU/5 fingerprints in both hands and complies with the internal action limit.

Conclusion: The result of the study suggests that the higher load of organisms was found at the “near return loop area”. The result of the Finger dab test was satisfactory according to the in-house limit (100 CFU). The result can serve as a basis for selecting a sample spot for regular Environmental Monitoring in a Manufacturing Facility.