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Abstract:  Compounded medicinal products should be prepared using an appropriate quality-assurance system. Cleaning and disinfection, as part of this system, are important to avoid cross-contamination of the preparations, reduce the bioburden levels in products, and avoid hazardous drugs residues or toxic chemical exposure of the staff workers. However, manual cleaning is difficult to standardize. Automated robotic cleaning devices are currently available and designed for domestic use only. To fill this gap, a laboratory automated robotic cleaning device (RVC1, FagronLab, The Netherlands) was specially developed to clean and sanitize laboratories of compounding pharmacies and other production facilities of primary healthcare establishments. The objective of this study was to evaluate the efficacy of an automated robotic cleaning device (robotic vacuum cleaner) for compounding pharmacies and other production facilities of primary healthcare establishments. A set of 6 experiments was conducted to evaluate the efficacy of the cleaning procedure using the automated robotic cleaning device. All experiments were conducted at the end of a regular daily routine in the laboratory to simulate a genuine cleaning procedure. Tests were performed both with no forced contamination (to imitate the regular use of the device) and with forced contamination (to mimic unexpected, non-regular contamination, such as in the case of accidents). Total aerobic microbial count and the total combined yeasts and molds count were determined, as well as pathogens identification and the concentration of thiamine hydrochloride and progesterone active pharmaceutical ingredients (deliberately spread on the floor surface for the tests). In real-conditions, both two-step and single-step were adequate to clean the areas and reduce microbiological contamination to non-detected levels, and only the cleaning cycle without the mopping accessory was also suitable (in the two-step cleaning). The same can be seen for the forced-contamination condition, except for the use of the cleaning cycle without the mopping. In terms of chemical contamination, both high and low water-soluble active pharmaceutical ingredients were reduced (completely and 932-fold, respectively) in the single-step cleaning. The RVC1 automated robotic cleaning device showed the necessary microbiological and chemical efficacy to be used in the cleaning routine of compounding pharmacies, both in a singlestep cleaning (brushing, ultraviolet light, and mopping simultaneously) or in a double-step cleaning (brushing and ultraviolet light first, mopping second). It is then recommended to always use the mopping accessory and the ultraviolet light on. The RVC1 can be a valuable add-on method to standardize cleaning.

Related Keywords: quality assurance, drug safety, pharmacy laboratory cleaning standards, disinfection, sanitization, environmental contamination, automated robotic cleaning devices, robotic vacuum cleaner, mopping, ultraviolet light, good manufacturing practices, employee contamination, chemical exposures, HEPA air filter, microbiological contamination

Related Categories: ENVIRONMENTAL , PEER-REVIEWED, TECHNOLOGY, QUALITY CONTROL

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