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- Nygren, Olle, et al.
(författare)
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A test method for assessment of spill and leakage from drug preparation systems
- 2005
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Ingår i: Ann Occup Hyg. - : Oxford University Press. - 0003-4878 .- 1475-3162. ; 49:8, s. 711-8
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Tidskriftsartikel (refereegranskat)abstract
- 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. PhaSeal). 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 99Tc(m) 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.
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| 2. |
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| 3. |
- Nygren, Olle, et al.
(författare)
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Spill and Leakage Using a Drug Preparation System Based on Double-Filter Technology
- 2008
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Ingår i: Annals of Occupational Hygiene. - : Oxford University Press. - 0003-4878 .- 1475-3162. ; 52:2, s. 95-98
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Tidskriftsartikel (refereegranskat)abstract
- Occupational exposure to cytotoxic drugs has frequently been reported during recent years. Various drug-handling systems have been applied to reduce the spill and leakage that cause this exposure. Some of these systems have also been tested for spill and leakage using independent test methods. In this paper, a new drug-handling system has been tested for spill and leakage during drug preparation. The handling system, TevadaptorTM, was tested using a modification of an independent test method, the Technetium test method, based on the use of Technetium m-99 as tracer substance. The test results showed that the spill was <100 nl for all 75 preparations and was <1 nl for 70 of the preparations. This is comparable with other tested drug-handling system, e.g. isolators, PhaSealTM. The test shows that the Tevadaptor drug-handling system has similar performance as drug-handling systems regarded as closed systems.
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