What is it about?
This research focused on identifying and determining the distribution of bacterial contamination in non-sterile pharmaceutical raw materials and final products over a one-year period in a newly established pharmaceutical firm. Samples that showed suspect results or were out-of-specification were subjected to identification using miniaturized biochemical systems. The study found that over 60% of the total bacterial isolates belonged to three main families: Bacillaceae (24.53%), Enterobacteriaceae (18.86%), and Micrococcaceae (16.98%). Crucially, the work introduced a novel quantitative approach to Microbiological Risk Assessment (QMRA) tailored for final medicinal dosage forms, which is an area that lacks defined risk analysis in the pharmaceutical field. This new approach uses a simplified risk index (RI) formula that incorporates the viable microbial count, the microbial fraction of the contaminant, the maximum single dose, the infective dose (ID), and the product's antimicrobial power.
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Why is it important?
The control of bacterial contamination is a critical aspect of drug manufacturing due to the serious risks posed to patients' health and possibly their lives. This study is important because it provides a quantitative tool to assess the hazard, showing that Enterobacteriaceae followed by Burkholderiaceae contributed to more than 80% of the major hazard that could be delivered to patients through drugs, thereby guiding prioritization efforts. The calculated Risk Index (RI) can serve as a milestone for pharmaceutical companies to set safety goals, identify major contamination sources, and ultimately improve the microbiological safety of their products.
Perspectives
Perspectives of the study include the strong affirmation that microbial identification is crucial for anticipating the impact of bioburden and setting appropriate corrective and preventive actions. Furthermore, the work advocates for a risk-based quality management system, reinforcing the concept that products with high water activity and lack of antimicrobial properties that support microbial growth should not be marketed due to the high health risk they pose. Finally, the perspective that water activity is a key determinant in microbial survival and proliferation is reinforced, showing that Gram-negative bacilli require higher moisture contents than Gram-positive bacteria.
Independent Researcher & Consultant Mostafa Essam Eissa
Read the Original
This page is a summary of: Distribution of bacterial contamination in non-sterile pharmaceutical materials and assessment of its risk to the health of the final consumers quantitatively, Beni-Suef University Journal of Basic and Applied Sciences, September 2016, Springer Science + Business Media,
DOI: 10.1016/j.bjbas.2016.08.005.
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