Monitoring and controlling bacteria in cleanrooms of pharmaceutical plant model: an in vitro study

This work aims to screen the major species of bacteria distributed in the filling area in one of the new pharmaceutical facilities in the 6th of October city in Egypt and their phylogenic relationship. One hundred percent of collected Gram-positive and Gram-negative isolates of bacteria were sensitive to Levofloxacin. There were five Gram-positive multidrug-resistant (MDR) bacterial isolates and one Gram-negative (MDR) bacterial isolate (three (from personnel), two (from surface), and one (from air)). The five Gram-positive MDR bacterial isolates were resistant to Tobramycin, Gentamicin, Piperacillin, Cefaclor, and Amikacin while the one Gram-negative MDR bacterial isolate was resistant to Ceftazidime, Cefotaxime, Tobramycin, Gentamicin, Piperacillin, Cefoperazone/Sulbactam, Ofloxacin, and Polymixin b. The existence of multidrug-resistant bacteria inside cleanrooms of pharmaceutical plants signifies a life-threatening danger on human through generating contaminated drugs and/or vaccines that undoubtedly harm the consumer's healthiness. The technique of 16SrRNA gene sequencing was used to identify multidrug-resistant bacterial isolates. All tested disinfectants were bactericidal except Dettol that was found to be a bacteriostatic agent and had an anti-biofilm effect. Clorox was the most potent disinfectant that had the least MIC and MBC of 0.0002% and 0.0004%, respectively. Ethanol and Klericide were excellent sanitizing agents. The strongest biofilm formed by Staphylococcus gallinarum strain MN1812 was disrupted by Clorox with a concentration of 0.000098%. Only Dettol with a concentration of 6.3% achieved the highest disruption for the biofilm of Staphylococcus gallinarum strain NM2009. Staphylococcus gallinarum strain MN1812 followed by Bacillus amyloliquefaciens showed the highest adhesion and invasion efficiencies to Caco-cells among the investigated bacterial strains. Klericide and Dettol mixture showed more anti adhesion and invasion effects against Staphylococcus gallinarum strain NM2009 and strain MN1812 and Pseudomonas putida compared to using Klericide alone. Ethanol and Klericide had the least contact time (30 s) against most of the tested bacteria.