Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care and Sciences)
Online ISSN : 1882-1499
Print ISSN : 1346-342X
ISSN-L : 1346-342X
Notes
Insoluble Microparticle Contamination and Sedimentation Occurring at Time of Opening Plastic Ampoules
Yasuyuki MasaokaYoichi KawasakiKazuhiko YamajiTomoaki SatoHisashi MatsunagaToshiaki Sendo
Author information
JOURNAL FREE ACCESS

2011 Volume 37 Issue 11 Pages 643-648

Details
Abstract

Previous studies have indicated that there is significantly less insoluble microparticle contamination with plastic ampoules than with glass ampoules. Therefore, it is recommended that plastic ampoules are used except for certain purposes such as quality management. However, no studies have been done on the effect of standing time after opening plastic ampoules, and the purpose of this study was to investigate a relationship between standing time and plastic particulate sedimentation after opening them. All of the ampoules used were snapped open by hand and left to stand undisturbed for 10, 15, 20, 25, 30, 45, 60 and 120 seconds. Liquid was aspirated from the tilted ampoules using an 18G non-filtered needle attached to a 30 mL syringe and then their contents were diluted with 20 mL distilled water and passed through a 0.20 μm membrane filter. Persistent particles were measured using a KL-04 particle counter after aspiration of the ampoule contents.
Our results suggested that accumulated plastic particulate contamination with a particle size over 2.0 μm increased significantly after 60 seconds. This finding may help reduce or prevent injection of plastic particles into patients, and the use of filters may further decrease this risk.

Content from these authors
© 2011 Japanese Society of Pharmaceutical Health Care and Sciences
Previous article Next article
feedback
Top