Romanian Society of Pharmaceutical Sciences

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THE ATP BIOLUMINESCENCE METHOD: AN ALTERNATIVE APPROACH FOR MONITORING CLEANLINESS IN HOSPITAL PHARMACY CLEANROOMS

MATEJA TRŠAN 1*, KATJA SEME 2, STANKO SRČIČ 3

1.Ljubljana University Medical Centre of Pharmacy, Quality Assurance and Quality Control Department, 7 Zaloška Street, SI-1000, Ljubljana, Slovenia
2.University of Ljubljana, Faculty of Medicine, Institute of Microbiology and Immunology , 4 Zaloška Street, SI-1000, Ljubljana, Slovenia
3.University of Ljubljana, Faculty of Pharmacy, Department of Pharmaceutical Technology, 7 Aškerčeva Street, SI-1000, Ljubljana, Slovenia

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The objective of this study was to evaluate the feasibility of a new rapid adenosine triphosphate (ATP) bioluminescence method for monitoring surface hygiene in hospital pharmacy cleanrooms. It was assumed that, despite the low microbial load, the rapid method is sufficiently sensitive for routine use, and, due to its simplicity, useful as a rapid and effective tool for quality control, and also as a tool for detecting change and monitoring trends. A total of 537 surfaces in separate locations were randomly sampled with the traditional Replicate Organism Direct Area Contact (RODAC) imprint method (n = 484) to detect colony form units parallel to LuciPac Pen swabs (n = 992) to detect ATP load. The results were compared to assess correlation and to confirm the usefulness and limitations of the bioluminescent method. The statistical analyses were performed using McNemar’s test, and Cohen’s kappa coefficients of agreement were calculated for each room category. Defined cleanliness thresholds for LAF cabinets were 70 relative high units (RLU), for cleanrooms 140 RLU, and for filters 340 RLU. The results for the bioluminescent method largely confirm the data obtained with the standard culture method, and there was no significant difference in ability to predict unclean surfaces. However, despite the agreement of the results obtained, the analysis did not reveal a correlation between them. We concluded that bioluminescence can be useful as a supplementary method as a real-time surface hygiene monitoring tool to assess a room immediately before use. Faster access to data is an exceptional contribution to the quality and effectiveness of the process, as well as to product and patient safety.