Leaching of Plasticizers from and Surface Characterization of PVC Blood Platelet Bags

Abstract

The leaching of phthalate plasticizers from four types of blood platelet bags was investigated. The anticoagulant solutions used in the blood collection bags had pH values of 5.64 +/- .04 and contained no detectable amounts of phthalates. Platelet bag materials from each bag were soaked in normal salines for up to 5 days. The salines were tested for the leached phthalates from the bags but none could be found. However, di-(2-ethylhexyl) phthalate (DEHP) leached out of the PL-146 and Terumo bags into bovine calf serum used for soaking the bag materials. There was an increase in the amount of DEHP leached from about 1.1 mg at the end of one day to about 3.3 mg per gm of bag material at the end of a five day extraction with the serum. In PL-732 sets, a platelet bag made of a specialty polyolefin, the amount of DEHP leached out was less than 0.02 mg per g of bag material. CLX bags, which contained tri-(2-ethylhexyl) trimelliate (TETM) as a plasticizer, showed a negligible amount of it leaching into the calf serum. Infra-red spectra showed that PL-146 bags had been coated with a layer of a fatty acid amide while the Terumo bags contained a layer of a silicone fluid on their inner surfaces. CLX bags showed a coating of stearates, which were probably soaps of calcium or zinc. Scanning electron microscopy (SEM) showed that the inner surfaces of each brand of the bag were distinctly different morphologically. The two PVC bags were very similar whereas the surfaces morphology of PL-732 was rougher. Terumo bag had a different surface morphology than those of the other bags whereas the CLX bags had a very regular surface pattern. The exact significance of the surface morphology is not certain but excessively rough surfaces may not be desirable for the bags.

A review of alternatives to di (2-ethylhexyl) phthalate-containing medical devices in the neonatal intensive care unit

“…55 Studies have systematically found significantly less or no leaching of TETM compared with DEHP from medical devices such as hemodialysis tubing and blood platelet bags into human and calf serum, respectively. 69–73 The most common applications of TETM are in medical products, specifically blood bags and infusion sets, packing, cables, floor and wall coverings. 14,47 …”

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

“…This could result in under-dose, and a greater amount of drug to compensate for the adsorption loss may be required. Although the significance of the inner surface morphologies of IV bags is not certain, different brands of IV bags can differ very significantly [15]. Loss of Factor VIII (FVIII) activity in IV infusion systems was reported to be caused by FVIII binding to plastic surfaces [16,17]; the two reports differ in that the former reported initial drop in recovery, while the latter reported a continuous loss of activity.…”

“…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].…”

Phthalate doped PVC membranes for the inhibition of fouling

“…In this study, the same membranes were immersed in water for a 7-day period and each phthalic acid ester was then measured for absorbance before and after which gave an indication of the rate of biocidal activity. Each phthalate had the following IR-bands monitored ϑC O stretching (1727 cm −1 ), CH 2 CH 3 vibration (1291 cm −1 , 1128 cm −1 ), C-Cl (1076 cm −1 , and 976 cm −1 ) which relate to phthalic acid esters in the PVC matrix [38]. DEHP (29.45%) leached significantly lower than the other plasticizers.…”