Labow R S, Tocchi M, Rock G
J Toxicol Environ Health. 1986;19(4):591-8. doi: 10.1080/15287398609530955.
Phthalate esters are the most extensively used plasticizers in the manufacture of polyvinylchloride (PVC) plastic. Many medical devices used in the collection and storage of blood components are made of PVC plastic containing di(2-ethylhexyl) phthalate (DEHP). DEHP leaches at a rate of 100 micrograms/ml X d into platelet concentrate (PC) supernatant when PCs are stored in PVC containers. It is only possible to store PCs for 72 h in this DEHP plastic, after which time the platelet function has deteriorated and they cannot be used for transfusion therapy. Since it was desirable to find a container that permitted longer storage times and because of the concern for the toxicity of DEHP, new bags, manufactured with different plastic formulations without this plasticizer, were tested for PC storage. Using these new containers, such as the PL732 [polyolefin (PO) plastic], and the CLX300 and PL1240 [tri(2-ethylhexyl) trimellitate (TEHTM) PVC plastic], it was possible to store PCs for 5 d while preserving platelet function. In spite of these new plastic bags being manufactured without DEHP, we found DEHP and its metabolite mono(2-ethylhexyl) phthalate (MEHP) as contaminants of the supernatant of the PCs stored in these containers. After analyzing the plastic material of each of these containers, we were able to identify the source of the contamination as coming from the plastic materials that were used in the manufacture of the bags. The sterilization process of the PL732 bag was investigated, since it was found that when the plastic of the PL732 bag was analyzed prior to sterilization, no contamination by DEHP was detected; however, whether the PL732 bag was sterilized together with the primary PVC bag or separately, using ethylene oxide, contamination by DEHP was found, suggesting contamination of the sterilization unit by DEHP.
邻苯二甲酸酯是制造聚氯乙烯（PVC）塑料时使用最广泛的增塑剂。许多用于采集和储存血液成分的医疗设备是由含有邻苯二甲酸二（2-乙基己基）酯（DEHP）的PVC塑料制成的。当血小板浓缩液（PC）储存在PVC容器中时，DEHP以100微克/毫升×天的速率浸出到PC上清液中。在这种含DEHP的塑料中，PC只能储存72小时，此后血小板功能会恶化，不能用于输血治疗。由于希望找到一种能允许更长储存时间的容器，并且出于对DEHP毒性的担忧，对采用不含这种增塑剂的不同塑料配方制造的新袋子进行了PC储存测试。使用这些新容器，如PL732[聚烯烃（PO）塑料]、CLX300和PL1240[偏苯三酸三（2-乙基己基）酯（TEHTM）PVC塑料]，可以在保持血小板功能的同时将PC储存5天。尽管这些新塑料袋是在不使用DEHP的情况下制造的，但我们发现储存在这些容器中的PC上清液中含有DEHP及其代谢物单（2-乙基己基）邻苯二甲酸酯（MEHP）作为污染物。在分析了每个容器的塑料材料后，我们能够确定污染物的来源是袋子制造中使用的塑料材料。对PL732袋的灭菌过程进行了研究，因为发现在对PL732袋的塑料进行灭菌前分析时，未检测到DEHP污染；然而，无论PL732袋是与初级PVC袋一起灭菌还是单独使用环氧乙烷灭菌，都发现了DEHP污染，这表明灭菌单元受到了DEHP的污染。
