Evaluation of a new, more oxygen-permeable, polyvinylchloride container

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Abstract
A new container made of polyvinylchloride (PVC) with diethylhexyl phthalate (DEHP) used as the plasticizer was subjected to in vitro and in vivo evaluation for prolonged platelet storage. As compared with the original PVC bag, this bag has increased gas permeability by its reduced film thickness, larger surface area (400 ml capacity), and more porous label. The oxygen permeability coefficient, K (O2), of the new container was measured to be 655 nmol per min per atm. On the basis of previous studies relating the K (02) to the maximal platelet count, it was predicted that this maximal count would be in the range of 7.9 to 8.9 .times. 1010 platelets. This prediction was confirmed by carrying out 58 studies measuring pH, pO2, and platelet count on platelet concentrations (PCs) stored for up to 7 days. After 5 days of storage all PCs with counts above 8.0 .times. 1010 had pH .ltoreq. 7.0, whereas those with counts below 8.0 .times. 1010 had pH .gtoreq. 7.0. Six units (10%) with counts above 9.0 .times. 1010 had pH levels of 6.5 or below. Thirteen of the PCs underwent extensive in vitro testing function during 7 days of storage. No significant differences were found in pH, ATP content, and decrease in platelet count, as compared in the hypotonic shock response was found: 38 percent .+-. 16 as compared to 70 percent .+-. 13 for the polyolefin bag at 5 days of storage; this finding confirmed previous studies by others about the effect of DEHP on hypotonic shock. However, the reduced hypotonic shock response was not related to any loss of in vivo viability. In eight studies using autologous Indium-111-oxine labeling, a percentage recoveries averaged 48 .+-. 6 percent, and survival averaged 155 .+-. 33 hours with 5 days of storage as determined by the multiple-hit gamma model.