Biologically active contaminants of intravenous saline in PVC packaging: Australasian, European, and North American samples.
We have previously found evidence of contaminants in 0.9% saline packaged in polyvinyl chloride (PVC) for clinical use. For this current study we asked two questions: (1) what are the organic chemical contaminants in solutions packaged in PVC? and (2) do the contaminants vary in bags manufactured in different countries? We studied samples of 0.9% saline packaged in PVC from Australasia, Europe, and North America. We analysed the saline solutions with high-resolution capillary gas chromatography - mass spectrometry. Components of the Australasian and European bags were also analysed using thermodesorption followed by gas chromatography and mass spectrometry. In three pairs of samples we found twenty-four different organic contaminants of the saline solutions. Diethylhexyl phthalate (DEHP) was found in all solutions; the concentrations were greater than 10 microg/l in the Australasian and European samples. All samples contained 2-ethyl hexanol (>50 microg/l), a DEHP breakdown product. The Australasian and North American samples contained cyclohexanone at concentrations of about 1000 microg/l. The cyclohexanone probably originated in joints at the bases of the bags. Both the Australasian and European bags contained t-butyl cyclohexanol (>500 microg/l) and t-butyl cyclohexanone (>50 microg/l). Printing ink on the outside of the bags was the most likely source for both of these contaminants. Several of the contaminants are toxic to animals. Little is known about the toxicity of combinations of contaminants.
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School of Applied Science, RMIT University, Melbourne, Victoria.
Leeder
J
J
Cullis
P
P
Bellomo
R
R
D001315:Australia; D004340:Drug Contamination; D004349:Drug Packaging; D005060:Europe; D008401:Gas Chromatography-Mass Spectrometry; D007262:Infusions, Intravenous; D009656:North America; D009930:Organic Chemicals / Q000032:analysis*; D011143:Polyvinyl Chloride; D012965:Sodium Chloride / Q000032:analysis*
D009930:Organic Chemicals; D012965:Sodium Chloride; D011143:Polyvinyl Chloride