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Annals of Occupational Hygiene Advance Access originally published online on August 26, 2005
Annals of Occupational Hygiene 2005 49(8):711-718; doi:10.1093/annhyg/mei039
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© 2005 British Occupational Hygiene Society Published by Oxford University Press

Original Article

A Test Method for Assessment of Spill and Leakage From Drug Preparation Systems

OLLE NYGREN1,*, BENGT GUSTAVSSON2 and ROBERT ERIKSSON3

1 National Institute for Working Life, Department of Work and the Physical Environment, PO Box 7654, SE-907 13 Umeå, Sweden; 2 Division for General Surgery, Sahlgrenska University Hospital/Östra, SE-416 85 Gothenburg, Sweden; 3 Radiophysiological Department, Sahlgrenska University Hospital/Östra, SE-416 85 Gothenburg, Sweden

* Author to whom correspondence should be addressed. Tel: +4690-17-60-39; fax: +4690-17-61-23; e-mail: olle.nygren{at}arbetslivsinstitutet.se

Anti-cancer drugs are reactive compounds with known adverse health effects. To prevent occupational exposure to these drugs, there are, in most countries, regulations for handling anti-cancer drugs. Many preparation systems are available, e.g. isolators, biological safety cabinets (BSCs), filter spikes (venting spikes with micro-pore filter) and closed systems (e.g. PhaSealTM). Although these systems are used, there are reports of exposure. This causes concern over how efficient these systems are to prevent spill and leakage that may cause undesired exposure when handling cytotoxic drugs. Today, this knowledge is lacking. This paper presents a method (Tc-method) for testing drug preparation systems for spill and leakage. The Tc-method is based on 99Tcm as a tracer, with which drug vials used for test preparations are spiked. Wipe samples are then collected around the working area to measure spill and leakage. The Tc-method has been validated using an independent method, showing good agreement between the methods. Spills down to 1 nl cm–2 can be determined. In an appendix, the Tc-method is described in a detailed step-by-step procedure.

Keywords: drug leakage • preparation and administration systems • technetium • test method


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O. Nygren, E. Olofsson, and L. Johansson
Spill and Leakage Using a Drug Preparation System Based on Double-Filter Technology
Ann. Hyg., March 1, 2008; 52(2): 95 - 98.
[Abstract] [Full Text] [PDF]


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