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.
What is the best alternative to DEHP for medical-grade PVC
While phthalate esters such as DEHP are the most widely used plasticizers for flexible PVC medical compounds and have been for 50 years, issues concerning their possible effects on human health have caused some device manufacturers to consider compounds containing alternative plasticizers. Sometimes the pressure to do so is considerable.
Plasticisers for medical applications | PVCMed Alliance
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.
Materials degradation in PVC medical devices, DEHP leaching
Di-(2-ethylhexyl)-phthalate (DEHP) is the most widely used plasticizer in PVC medical devices. However, DEHP is not chemically bound to PVC and migrates from medical devices with time and use. The potential for DEHP to produce adverse effects in humans has been the subject of considerable discussion and debate in the scientific community.
- 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.
- Which plasticizer is used to soften PVC medical devices?
- Appropriate analytical methods are developed to quantify them in different matrices. Until 2010, diethylhexylphthalate (DEHP) was the plasticizer most commonly used to soften PVC medical devices (MDs), because of a good efficiency/cost ratio.
- 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.
- Does plasticizer release a PVC MD into a simulant solution?
- We then tested the developed method on 32 PVC MDs used in our hospital and evaluated the plasticizer release from a PVC MD into a simulant solution during a 24 h migration test. The results showed a predominance of TOTM in PVC MDs accompanied by DEHP (<0.1% w/w), DEHT, and sometimes DEHA.
- What are the alternative plasticizers for PVC MDS?
- This resulted in the commercialization of PVC MDs plasticized with the DEHP alternative plasticizers tri-octyl trimellitate (TOTM), di- (2-ethylhexyl) terephthalate (DEHT), di-isononyl cyclohexane-1,2-dicarboxylate (DINCH), di-isononyl phthalate (DINP), di- (2-ethylhexy) adipate (DEHA), and Acetyl tri- n -butyl citrate (ATBC).
- Can NMR detect traces of DEHP in PVC medical devices?
- Genay et al. used NMR to identify traces of DEHP in PVC medical devices presented as DEHP-free, i.e., with an amount lower than 0.1% . However, Lutyten et al. identified several drawbacks, including low sensitivity, while working on the quantification of different plasticizers present in PVC tubes.
