Sessink Paul J M, Leclercq Gisèle M, Wouters Dominique-Marie, Halbardier Loïc, Hammad Chaïma, Kassoul Nassima
Exposure Control Sweden AB, Bohus-Björkö, Sweden
Pharmacy, University Hospital Saint-Luc, Brussels, Belgium.
J Oncol Pharm Pract. 2015 Apr;21(2):118-27. doi: 10.1177/1078155214522840. Epub 2014 Feb 23.
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.
使用CytoCare机器人系统制备含环磷酰胺的静脉输液袋后,对环境污染、产品污染和技术人员暴露情况进行了测量。在CytoCare内部、洁净室环境中、从小瓶以及制备好的静脉输液袋(包括端口)采集擦拭样本,分析其中环磷酰胺的污染情况。还对环境空气以及技术人员用于处理药物的手部和手套上的环磷酰胺污染进行了测量。通过分析尿液中环磷酰胺来测量技术人员对环磷酰胺的暴露情况。环磷酰胺污染主要在CytoCare内部被观察到,包括制备前、制备后以及日常清洁后。在CytoCare外部偶然发现有污染情况。所有进入CytoCare的复溶环磷酰胺小瓶外部均被污染,但粉状环磷酰胺小瓶外部未被污染。进入CytoCare的污染输液袋在制备后仍有污染,但未受污染的输液袋制备后未被污染。在所有制备好的输液袋端口均检测到环磷酰胺。几乎所有用于制备和日常清洁的外层手套均被环磷酰胺污染。在内层手套和技术人员手上未发现环磷酰胺。在技术人员的固定空气样本、个人空气样本以及尿液样本中均未检测到环磷酰胺。CytoCare能够在低环境污染和低产品污染水平下制备环磷酰胺,且技术人员无可测量的暴露。