Assessment of the Risk in Pharmaceutical Facility to the Human Health Based on the Ecological Surface Quality of Bacteria in the Clean Area

Abstract

In the view of many recalls of different pharmaceutical dosage forms withdrawn from the market as reported worldwide, a continuous microbiological environmental monitoring (EM) programs for bioburden in clean area should be established to identify their potential impact on the manufactured medicinal products. One of the most important criteria of observations is the surface microbe – herein focus on bacterial ecology - cleanliness monitoring. Surfaces can be direct or indirect source of the contamination of the final medicinal products. Random surface samples using contact plates were taken aseptically from  the newly established pharmaceutical plant as a part from total EM and assessment program in clean rooms for drug manufacturing. After incubation of the samples a process of isolation and identification was conducted using Gram-stain and miniaturized BBL™ Crystal™ enteric/non- fermenter (E/NF) and Gram-positive (GP) miniaturized biochemical identification system. Data were interpreted and analyzed, showing that identified bacteria were belonging to Staphylococcaceae, Bacillaceae, Actinomycetaceae, Dermacoccaceae and Micrococcaceae contribution to more than 60% from the total samples. Only 8% of the total samples (2% Gram-positive bacilli and 6% Gram-negative rods) were not identified by the commercial identification system. However, there was different colonial morphology observed for the same identified bacteria, which are represented, by Arcanobacterium pyogenes, Bacillus circulans, B. cereus, Micrococcus lylae and Kytococcus sedentarius from different surface samples. A simple quantitative risk index was applied showing significant health risk in the manufacturing environment of some bacterial families over others in order different from their ecological distribution in the pharmaceutical facility.