Method For Removal Of Highly Resistant Pseudomonas Aeruginosa/Aeromonas Hydrophila/Burkholderia Cepa

Abstract: Water quality is essential for the manufacturing of pharmaceuticals. Water is act as ingredient of drug product and or cleaning agent of processing equipment and processing area of pharmaceutical industry. Present study was conducted during startup of the water system in Pharmaceutical industry. In routine analysis, pathogen testing is being carried out by using the procedure of Pharmacopiea (EP, USP, JP, IP),and here in this study the method of isolation was being carried out by using selective media such as Cetrimide agar ( Pseudomonas aeruginosa), MacConkey agar (Escherichia coli), Mannitol Salt Agai(staphylococcus aureus) , Xylose Lysine Deoxycholate Agar (Salmonella typi). In this present study characteristic growth was observed most frequently only in Cetrimide agar which was indicated the presence of Pseudomonas aeruginosa. The same contamination was observed throughout the water system, from feed water to final purified water. Further analysis was made only to assess the status of Pseudomonas aeruginosa contamination in all stages of water system. Finally the outcome of isolation and identification indicated Pseudomonas aeruginosa, Burkholderia cepacia and Aeromonas hydrophila existence in bore well water and water purification system which are pathogenic nature. Considering the occurrence of these biofilm forming bacterial species, further study was made to identify the appropriate disinfectant. The identified disinfectant can eradicate biofilm forming bacteria from water system. For this study commercially available disinfectants were selected from reputed manufacturers. Disinfectant efficacy study was performed against the highly resistant gram negative organisms by using three commercial available disinfectants such as sodium hypochlorite (bleach- chlorination), 3% Renaclean and 0.5 % Bacillocid. Chlorination was carried out exclusively with pH adjustment and without pH adjustment. The results of chlorination with pH adjustment study showed that 5 ppm chlorination process at slightly acidic pH 6.5 was efficiently removed Pseudomonas aeruginosa, Burkholderia cepacia and Aeromonas hydrophila. Slightly acidic chlorination process was implemented in water purification system to maintain the free chlorine concentration at low acidic pH. Initially RO subjected for only hot water sanitization and application of chlorination is not feasible due to RO membrane damage by chlorine. Present study concluded that RO system sanitization was demanded both chemical (3% Renaclean) and hot water treatment for complete eradication of pathogens. One more improvement was proposed in water system on the basis of study outcome. Usually in pharm industry purified water loop system and storage tank is not required to keep hot condition. Purified water loop system is to be kept at 60 - 65° C to eradicate the objectionable biofilm organisms. This control was prohibited objectionable Gram negative organisms" entry in the user point of drug manufacturing. In the present study few above said critical changes were introduced in the water system sanitization program for complete eradication of highly resistant Gram negative organisms and so as to assess the treated water quality once again it was subjected for physiochemical parameters and microbial testing as per EPA standards and results met all physicochemical parameter including the absence of all pathogens .Overall conclusion from these results, there was no influence on water quality due to major change in the water sanitization practice. Overall destruction of Pseudomonas aeruginosa, Burkholderia cepacia and Aeromonas hydrophila indicated from entire water purification process in pharmaceutical industry after implementation of these key approaches.

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