Polonini Hudson, Dijkers Eli Cf, Ferreira Anderson O, da Silva Sharlene L, Araújo Paulo Victor C, Koulouridas Savvas
Fagron BV, Rotterdam, The Netherlands.
Ortofarma Analytical Services, Matias Barbosa, MG, Brazil.
Int J Pharm Compd. 2020 Sep-Oct;24(5):426-433.
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.
复方药品应使用适当的质量保证体系进行配制。作为该体系的一部分，清洁和消毒对于避免制剂的交叉污染、降低产品中的生物负荷水平以及避免工作人员接触危险药物残留或有毒化学物质至关重要。然而，手工清洁难以标准化。目前有自动化机器人清洁设备，但其仅设计用于家庭用途。为填补这一空白，专门开发了一种实验室自动化机器人清洁设备（RVC1，荷兰法格龙实验室），用于清洁和消毒复方药房的实验室以及基层医疗机构的其他生产设施。本研究的目的是评估一种自动化机器人清洁设备（机器人吸尘器）对复方药房和基层医疗机构其他生产设施的清洁效果。进行了一组6项实验，以评估使用该自动化机器人清洁设备的清洁程序的效果。所有实验均在实验室日常工作结束时进行，以模拟真实的清洁程序。测试在无强制污染（以模拟设备的常规使用）和有强制污染（以模拟意外的、非常规的污染，如事故情况）两种情况下进行。测定了总需氧微生物计数、酵母和霉菌总数，以及病原体鉴定和故意撒在地面用于测试的盐酸硫胺和黄体酮活性药物成分的浓度。在实际情况下，两步法和单步法都足以清洁区域并将微生物污染降低到未检测到的水平，并且在两步清洁中仅不使用拖地附件的清洁周期也是合适的。在强制污染条件下也是如此，只是不使用拖地的清洁周期除外。在化学污染方面，单步清洁可降低高水溶性和低水溶性活性药物成分（分别完全降低和降低932倍）。RVC1自动化机器人清洁设备在单步清洁（同时刷洗、紫外线照射和拖地）或两步清洁（先刷洗和紫外线照射，后拖地）中均显示出在复方药房清洁程序中使用所需的微生物和化学清洁效果。因此建议始终使用拖地附件并开启紫外线灯。RVC1可以成为一种有价值的标准化清洁附加方法。
