Abstract

ESTIMATION OF MICROBIAL CONTAMINATION IN VARIOUS ACTIVE PHARMACEUTICAL INGREDIENTS AND EXCIPIENTS

Nighat Razvi, Riaz Awan, Baqir Shyum Naqvi, Fakhsheena Anjum*, Zohaib Hussain and Sadaf Farooqi

ABSTRACT

Objective: This study was conducted to estimate the presence of microbial contaminants in samples of various raw materials used for the preparation of different pharmaceutical products. Methodology: A total of 269 samples of 32 different raw materials (both active pharmaceutical ingredients and excipients) were subjected to total viable count and test for existence of pathogens using standard conventional techniques. Results: Microbial load varied among the APIs (active pharmaceutical ingredients) and the excipients; 35.97% excipients were found contaminated whereas 13.75% active pharmaceutical ingredients showed microbial contamination after evaluation. Fungal contamination was found less than that of bacteria (15.7 % in active while 35.8% in excipients) in the samples tested. In general, bacterial contamination was less than 2 x 10² cfu/ml in the samples tested and gram positive bacilli were accounted for contamination of majority of the samples. Also Aspergillus spp. and P. notatum were the major fungal contaminants found in the tested materials. Conclusion: The microbiological quality of the tested samples was in general satisfactory except for some cases. It is by and large desirable to have information regarding microbial content of all pharmaceutical products, whether sterile or non-sterile. Considerations must also be given to their proper handling and storage.

Keywords: bacterial contamination, fungal contamination, microbiological testing, microbial load.