Studies on contamination of intravenous solutions from PVC-bags with dynamic headspace GC-MS and LC-diode array techniques

Arbin, Astrid; Jacobsson, Sven P.; Hänninen, Kaarina; Hagman, Anders; Östelius, Jan

doi:10.1016/0378-5173(86)90247-4

Cited by 41 publications

(10 citation statements)

References 8 publications

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“…There are numerous reports on the leachables, such as metals, DEHP, cyclohexanone, and other organic and acidic compounds, found in the solution of PVC bags [15,[18][19][20][21][22]. The leachables have the potential to interact with and alter the drug to be administered [23,24].…”

Section: Introductionmentioning

confidence: 99%

Leachables from Saline-Containing IV Bags Can Alter Therapeutic Protein Properties

Chang

Xiao

Zhu³

et al. 2010

Pharm Res

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Section: Introductionmentioning

confidence: 99%

Leachables from Saline-Containing IV Bags Can Alter Therapeutic Protein Properties

Chang

Xiao

Zhu³

et al. 2010

Pharm Res

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“…It is known that the phthalate DEHP leaches from polyvinyl chloride (PVC) into blood products that come •into contact with the plastic [10,20] and into intravenous solutions in PVC bags [1][2][3].…”

Section: Introductionmentioning

confidence: 99%

Exposure of Patients to Phthalates from Polyvinyl Chloride Tubes and Bags during Dialysis

Nässberger

Arbin

Östelius

1987

Nephron

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The exposure of patients to the plasticizer di-(2-ethylhexyl)phthalate (DEHP) from polyvinyl chloride (PVC) tubes and bags during dialysis has been investigated. In vitro studies of the migration of DEHP from hemodialysis tubes into plasma revealed a migration coefficient of 7.7 μg/ml/h. An artificial kidney did not influence the plasma concentration of DEHP. The calculated exposure from a single hemodialysis can be as much as the total annual exposure using continuous ambulatory peritoneal dialysis (CAPD). CAPD fluids in PVC bags contain low concentrations of DEHP and its hydrolysis product mono-(2-ethylhexyl)phthalate (MEHP). These phthalates were analyzed in serum from patients receiving both CAPD and hemodialysis using gas chromatography. A group of patients not yet on dialysis treatment was used as control. In no case could MEHP be detected. The DEHP concentration was 0.8–4.2 μg/ml serum in the 17 hemodialysis patients after dialysis and 0.1–0.9 μg/ml in 4 of the CAPD patients. In 3 of the CAPD and all of the predialysis patients, DEHP could not be detected ( < 0.1 μg/ml).

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“…The two most widely used plastics in IV bags in the US are polyvinyl chloride (PVC) and polyolefin (PO). There are several reports documenting the presence of metals, cyclohexanone, DEHP, and other organic and acidic compounds due to leaching from PVC IV bag surfaces (Arbin, Jacobson, Hanniene, Hagman, & Ostelius, 1986;Borchert et al, 1986;Cheung, Hallock, Vishnuvajjala, Nguyenle, & Wang, 1998;Demore, Vigneron, Perrin, Hoffman, & Hoffman, 2002;Pearson & Trissel, 1993;Ulsaker & Korsnes, 1977). Manufacturers have claimed that PO bags and infusion sets are free of DEHP and other plasticizers, but other leachates such as organic acids and antioxidants have been reported (Jenke, 2005(Jenke, , 2007Jenke et al, 2005;Labo, Tocchi, & Rock, 1984;Labow, Tocchi, & Rock, 1986).…”

Section: Extractables and Leachables From IV Bags And Impact On Protementioning

confidence: 98%

Challenges in the intravenous (IV) administration of monoclonal antibodies (mAbs)

Shire¹

2015

Monoclonal Antibodies

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Studies on contamination of intravenous solutions from PVC-bags with dynamic headspace GC-MS and LC-diode array techniques

Cited by 41 publications

References 8 publications

Leachables from Saline-Containing IV Bags Can Alter Therapeutic Protein Properties

Leachables from Saline-Containing IV Bags Can Alter Therapeutic Protein Properties

Exposure of Patients to Phthalates from Polyvinyl Chloride Tubes and Bags during Dialysis

Challenges in the intravenous (IV) administration of monoclonal antibodies (mAbs)

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