Microbial Evaluation of Some Non-sterile Pharmaceutical Preparations Commonly Used in the Egyptian Market

Purpose: To determine the type and incidence of predominant microorganisms in certain non-sterile pharmaceuticals immediately after collection and one year later.Methods: All pharmaceutical samples were subjected to the following examinations: total bacterial count and presence of microbial pathogens, using conventional techniques. Attempts were also made to identify the isolates. The bioburden rate of some of the syrups and oral drops after storage for 0, 6 and 12 months were evaluated in order to assess the effect of storage on microbial contamination level.                                  Results: Microbial load varied among the pharmaceutical preparations with the highest microbial load in suspensions and the lowest in tablets. Bacterial counts ranged from 10 to more than 103 CFU per ml or g. The bacterial count at 6 and 12 months were significantly different from that at 0 month (p < 0.05). The isolated organisms were either of human flora types, essentially Gram-positive bacteria, or airborne fungi.Conclusion: The isolated organisms were either of human flora types, principally, Gram-positive bacteria, or air-borne fungi and the stored preparations lack an effective preservation. Several measures, including equipment automation, monitoring programs and post-marketing surveillanceare required to reduce the level of microbial contamination of non-sterile pharmaceutical products.Keywords: Microbial contamination, Bacteria, Fungi, Non-sterile pharmaceutical

Comparison of methods for the detection of biofilm production in coagulase-negative staphylococci

<p>Abstract</p> <p>Background</p> <p>The ability of biofilm formation seems to play an essential role in the virulence of coagulase-negative staphylococci (CNS). The most clearly characterized component of staphylococcal biofilms is the polysaccharide intercellular adhesin (PIA) encoded by the <it>icaADBC </it>operon. Biofilm production was studied in 80 coagulase-negative staphylococci (CNS) strains isolated from clinical specimens of newborns with infection hospitalized at the Neonatal Unit of the University Hospital, Faculty of Medicine of Botucatu, and in 20 isolates obtained from the nares of healthy individuals without signs of infection. The objective was to compare three phenotypic methods with the detection of the <it>icaA</it>, <it>icaD </it>and <it>icaC </it>genes by PCR.</p> <p>Findings</p> <p>Among the 100 CNS isolates studied, 82% tested positive by PCR, 82% by the tube test, 81% by the TCP assay, and 73% by the CRA method. Using PCR as a reference, the tube test showed the best correlation with detection of the <it>ica </it>genes, presenting high sensitivity and specificity.</p> <p>Conclusions</p> <p>The tube adherence test can be indicated for the routine detection of biofilm production in CNS because of its easy application and low cost and because it guarantees reliable results with excellent sensitivity and specificity.</p