Environmental contamination, product contamination and workers exposure using a robotic system for antineoplastic drug preparation

Environmental contamination, product contamination and workers exposure using a robotic system for antineoplastic drug preparation
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DOI:
10.1177/1078155214522840
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发表时间:
2015-04-01
影响因子:
1.3
通讯作者:
Kassoul, Nassima
Kassoul, Nassima
中科院分区:
医学4区
文献类型:
--
作者:
Sessink, Paul J. M.;Leclercq, Gisele M.;Kassoul, Nassima

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使用机器人系统CytoCare制备环磷酰胺静脉输液袋后,测量环境污染、产品污染和技术人员暴露。在CytoCare内,在洁净室环境中,从小瓶中采集擦拭样品,并制备静脉输液袋(包括输液港),并分析环磷酰胺污染。还在环境空气中以及技术人员用于处理药物的手和手套上测量了环磷酰胺污染。通过分析尿液中的环磷酰胺,测定技术人员对环磷酰胺的暴露量。主要在CytoCare内部、制备前、制备后和日常清洁后观察到环磷酰胺污染。偶然发现CytoCare外部污染。进入CytoCare的所有复溶环磷酰胺小瓶外部均受到污染,但装有粉末状环磷酰胺的小瓶外部未受到污染。进入CytoCare的污染袋在制备后也被污染,但未污染袋在制备后未被污染。在所有制备袋的端口上均检测到环磷酰胺。几乎所有用于准备和日常清洁的外层手套都被环磷酰胺污染。在内手套和技术人员手上未发现环磷酰胺。在固定和个人空气样本以及技术人员的尿液样本中未检测到环磷酰胺。CytoCare使环磷酰胺的制备具有低水平的环境污染和产品污染,并且技术人员没有可测量的暴露。
Environmental contamination, product contamination and technicians exposure were measured following preparation of iv bags with cyclophosphamide using the robotic system CytoCare. Wipe samples were taken inside CytoCare, in the clean room environment, from vials, and prepared iv bags including ports and analysed for contamination with cyclophosphamide. Contamination with cyclophosphamide was also measured in environmental air and on the technicians hands and gloves used for handling the drugs. Exposure of the technicians to cyclophosphamide was measured by analysis of cyclophosphamide in urine. Contamination with cyclophosphamide was mainly observed inside CytoCare, before preparation, after preparation and after daily routine cleaning. Contamination outside CytoCare was incidentally found. All vials with reconstituted cyclophosphamide entering CytoCare were contaminated on the outside but vials with powdered cyclophosphamide were not contaminated on the outside. Contaminated bags entering CytoCare were also contaminated after preparation but non-contaminated bags were not contaminated after preparation. Cyclophosphamide was detected on the ports of all prepared bags. Almost all outer pairs of gloves used for preparation and daily routine cleaning were contaminated with cyclophosphamide. Cyclophosphamide was not found on the inner pairs of gloves and on the hands of the technicians. Cyclophosphamide was not detected in the stationary and personal air samples and in the urine samples of the technicians. CytoCare enables the preparation of cyclophosphamide with low levels of environmental contamination and product contamination and no measurable exposure of the technicians.