Eliminating DEHP Plasticizer in Medical-Grade PVC - Tech Briefs
The plasticizers used to render PVC flexible constitute about a third of the vinyl compound by weight and have a significant effect on overall properties and performance. The most widely used plasticizer in medical applications, DEHP (di(2-ethylhexyl) phthalate), has been shown to engender biological activity when metabolized in rodents (though not in humans). As a result, there is pressure on
Eliminating DEHP Plasticizer in Medical-Grade PVC
Eliminating DEHP Plasticizer in Medical-Grade PVC The plasticizers used to render PVC flexible constitute about a third of the vinyl compound by weight and have a significant effect on overall properties and performance.
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Such plasticizer alternatives to DEHP include di-2-ethylhexyl-terephtalate ( DEHT ), trioctyl trimellitate ( TOTM ), and 1, 2-Cyclohexane dicarboxylic acid diisononyl ester ( DINCH ). Citrates such as acetyl tributyl citrate ( ATBC) are also options.
Plasticisers for medical applications | PVCMed Alliance
Safe alternatives to DEHP in medical applications. The phthalate DEHP used to be the main plasticizer in medical PVC due to its technical properties and low cost. The substance has been under increasing scrutiny by regulatory and medical authorities, and in the EU its continued use in medical devices after May 2025 requires robust justification.
- Why is DEHP used in plasticization and processing of PVC?
- The excellent performance of DEHP in the plasticization and processing of PVC explains its wide use in medical devices over the past few years. The strategy was to adjust the chemical nature of the lateral alkyl chains in order to reduce the leaching of the plasticizers into the surrounding medium.
- Does DEHP leach from medical devices?
- DEHP is not chemically bound to plastics and can thus leach from the medical devices during the use. In critically ill neonates, the urinary levels of DEHP metabolites have been correlated with the number of DEHP-containing medical devices and even exceeded the average daily adult exposure by 1–2 orders of magnitude [2, 3].
- Do medical devices leach phthalates and alternative plasticizers?
- Most of the indwelling medical devices and essential accessories were found to actively leach phthalates and alternative plasticizers.
- Are there alternative plasticizers in medical devices?
- In medical devices, the occurrence of alternative plasticizers is widely variable among various types of devices . Some plasticizers have specific uses, for example DINCH or ATBC are mainly used in red blood cell PVC bags due to their capacity to prevent excessive haemolysis during storage .
- What is diethylhexylphthalate (DEHP)?
- Until 2010, diethylhexylphthalate (DEHP) was the plasticizer most commonly used to soften PVC medical devices (MDs), because of a good efficiency/cost ratio. In flexible plasticized PVC, phthalates are not chemically bound to PVC and they are released into the environment and thus may come into contact with patients.
- What is DEHP in PVC blood bags?
- In PVC blood bags, di- (2-ethylhexyl)phthalate (DEHP) has been used for more than 50 years as the plasticizer, resulting in a functional polymer with excellent characteristics such as inertness, flexibility, transparency, and high resistance to heat and chemicals.
