Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care and Sciences)
Online ISSN : 1882-1499
Print ISSN : 1346-342X
ISSN-L : 1346-342X
Notes
Verification of External Surface Contamination of Japanese 5-fluorouracil Vials and Removal of Contamination by Washing the Vials
Koji HamaTohru HashidaKazusaburo Kataoka
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JOURNAL FREE ACCESS

2013 Volume 39 Issue 7 Pages 451-456

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Abstract
External surface contamination of cytotoxic drugs has been reported. In Japan, a report on the contamination of cyclophosphamide (CP) vials has already been published. Here, we verified the contamination of other vials containing 5-FU. Furthermore, the outer package contamination and removal effectiveness of 5-FU by water washing were also verified.
Wipe samples were taken from 180 vials containing 5-FU. Wiping samples were taken from one vial or from a bundle of ten vials. After vials coated with 5-FU were washed, wipe samples were taken. Then, the surface of the 5-FU outer package was wiped using the same method and the samples were analyzed.
In wipe samples from each vial, 35-82 ng was detected in 3 of 90 samples and the contamination rate was 3 percent. In a bundle with ten vials, 50-112 ng was detected in 6 of 19 samples and the contamination rate was 32 percent. The removal effectiveness of contamination by washing the 5-FU vials was 99.9-100 percent.
It was confirmed that the external surface of the 5-FU vials was contaminated. This demonstrates that the handling and touching of 5-FU vials without protection can be hazardous. It is improbable that handling of the 5-FU outer package caused occupational exposure. Washing was effective for decontaminating the vials. It is impossible to use the same verification for all cytotoxic drug products. Therefore, healthcare workers should handle such products on the premise that all vials are contaminated.
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© 2013 Japanese Society of Pharmaceutical Health Care and Sciences
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