PURPOSE: The compatibility of new polyolefin (VISIV) containers with seven drugs that have exhibited sorption to polyvinyl chloride (PVC) containers and sets and an additional four drugs that have exhibited leaching of plasticizer or other polymer matrix components from PVC containers and sets was studied. METHODS: For the sorption portion of the study, amiodarone hydrochloride, carmustine, regular human insulin, lorazepam, nitroglycerin, sufentanil citrate, and thiopental sodium and their respective reference standards were used. For the leaching portion of the study, docetaxel, paclitaxel, tacrolimus, teniposide, and diethylhexyl phthalate (DEHP) reference standard, were used. A 350-mL quantity of each test admixture was prepared, and 100-mL aliquots were transferred into three of the VISIV containers. The containers were stored at ambient temperature and exposed to fluorescent light. Samples for analysis were taken initially and after 24 hours for all drugs except carmustine, which was evaluated for only 6 hours because of its limited stability. High-performance liquid chromatography was used to evaluate each test solution. RESULTS: Of the seven drugs subject to sorption to PVC, only insulin showed a substantial loss in the VISIV containers. Carmustine exhibited a loss consistent with the drug's known chemical stability. None of the drugs that are known to leach plastic components, such as DEHP plasticizer, from PVC equipment exhibited any leached components in the VISIV containers. CONCLUSION: Of the drugs tested, only insulin exhibited sorption to the new VISIV polyolefin containers. No leaching of plastic components, such as plasticizer, from the containers was found with any of the surfactant-containing drugs.
PURPOSE: The compatibility of new polyolefin (VISIV) containers with seven drugs that have exhibited sorption to polyvinyl chloride (PVC) containers and sets and an additional four drugs that have exhibited leaching of plasticizer or other polymer matrix components from PVC containers and sets was studied. METHODS: For the sorption portion of the study, amiodarone hydrochloride, carmustine, regular humaninsulin, lorazepam, nitroglycerin, sufentanil citrate, and thiopental sodium and their respective reference standards were used. For the leaching portion of the study, docetaxel, paclitaxel, tacrolimus, teniposide, and diethylhexyl phthalate (DEHP) reference standard, were used. A 350-mL quantity of each test admixture was prepared, and 100-mL aliquots were transferred into three of the VISIV containers. The containers were stored at ambient temperature and exposed to fluorescent light. Samples for analysis were taken initially and after 24 hours for all drugs except carmustine, which was evaluated for only 6 hours because of its limited stability. High-performance liquid chromatography was used to evaluate each test solution. RESULTS: Of the seven drugs subject to sorption to PVC, only insulin showed a substantial loss in the VISIV containers. Carmustine exhibited a loss consistent with the drug's known chemical stability. None of the drugs that are known to leach plastic components, such as DEHP plasticizer, from PVC equipment exhibited any leached components in the VISIV containers. CONCLUSION: Of the drugs tested, only insulin exhibited sorption to the new VISIV polyolefin containers. No leaching of plastic components, such as plasticizer, from the containers was found with any of the surfactant-containing drugs.