Leboucher Gilles, Serratrice François, Bertholle Valérie, Thore Laurence, Bost Muriel
Service pharmaceutique, Hôpital de la Croix-Rousse, 69317 Lyon Cedex 04, France.
Bull Cancer. 2002 Nov;89(11):949-55.
In our hospital, in accordance with recommendations for personnel protection, hazardous drugs are prepared in a class II biological safety cabinet (BSC) located in a specific area of the pharmacy. The aim of this study was to validate the efficiency of this unit in personnel protection by measuring levels of platinum in the working environment (platinum being the most common antineoplastic agent used in this hospital). Two series of surface sampling were conducted, preparation guidelines were changed for parts after first results have been completed. Performance of the sampling method is about 35%. Platinum was measured by atomic absorption spectrophotometry technique. The analytical detection limit was 10 mug/L of platinum and was sufficient to detect less than one micro-drop of cisplatinum solution (1 mg/mL). Platinum was found inside the BSC at the end of the working day: 2 to 998 pg/cm2 or 2 to 20 ppm of the total cisplatinum handled. All samples outside the BSC showed little (less than the detection limit) or no contamination. Gloves were often contaminated, either by contaminated commercial drug vials or through handling errors. Working guidelines changes did not lead to the absence contamination on surfaces. Gloves should therefore be changed frequently (every 15 min), personnel training should be regularly re-evaluated, BSC and rooms should be thoroughly cleaned every day. In this way, a centralized unit provides total protection from exposure to hazardous drugs.
在我们医院,按照人员防护建议,危险药物在药房特定区域的II级生物安全柜(BSC)中配制。本研究的目的是通过测量工作环境中的铂含量(铂是本院最常用的抗肿瘤药物)来验证该装置在人员防护方面的效率。进行了两轮表面采样,在完成首轮结果后,针对部分环节更改了配制指南。采样方法的性能约为35%。采用原子吸收分光光度法测量铂含量。分析检测限为10μg/L铂,足以检测出少于1微滴的顺铂溶液(1mg/mL)。工作日结束时,在生物安全柜内检测到铂:2至998pg/cm²或占所处理顺铂总量的2至20ppm。生物安全柜外的所有样本显示污染极少(低于检测限)或未受污染。手套经常受到污染,要么是被受污染的商业药瓶污染,要么是由于操作失误。工作指南的更改并未使表面无污染。因此,应频繁更换手套(每15分钟一次),应定期重新评估人员培训情况,生物安全柜和房间应每天彻底清洁。通过这种方式,一个集中单元可提供全面防护,防止接触危险药物。