additives | PVC plasticisers Right: East-
man’s 168 SG DEHT is a viable alternative to DEHP for blood bags, says new US study
excellent compatability in PVC makes Citrofol BII a well suited and recommended plasticiser for artificial leather, textile coating, flooring and many others,” it says.
Moves in medical The use of PVC in medical applications was discussed in several presentations at the Medical Tubing 2017 conference organised by AMI in Cologne, Germany, in June. Angelika Langsch, Manager of Regulatory Affairs at BASF, noted that DEHP remains the standard plasticiser for medical devices, even though it is listed as a Substance of Very High Concern (SVHC) under REACH and is included in the candidate list for authori- sation. But she said the situation is changing, and pointed out that medical devices are under increasing scrutiny, especially in Europe. “There is a lack of justification for exposure of
sensitive neonates [newborn children],” Langsch said. “Medical device producers need a competitive and technically suitable alternative plasticiser.” Langsch also drew attention to a new European
Medical Device Regulation published in May. It says that devices will need a specific justification if containing substances above 0.1% (w/w) with the following properties: CMR Category 1A or 1B (carcinogenic, mutagenic or toxic to reproduction); endocrine disrupt- ing properties for which there is scientific evidence of serious effects to human health. DEHP is a Category 1B substance. Manufacturers of currently approved medical devices will have a transition time of three years until May 26th 2020 to meet the requirements of the MDR. The European Pharmacopoeia recently proposed to
include four more non-phthalate plasticisers to provide medical device manufacturers with alternatives to DEHP. These are DINCH, BTHC (butyl tri-n-hexyl
citrate), TOTM (tris 2-ethylhexyl trimellitate, and DEHT. The updated entries are expected to be active next year. Elsewhere, Eastman Chemical and BloodCenter of
Wisconsin, US, announced last year the results of a clinical trial evaluating a new plasticiser for blood bags. They said: “While DEHP [of which Eastman is a leading supplier] has provided the medical industry with a stable orthophthalate plasticiser for many years, regulatory trends and consumer demands will inevita- bly drive the industry to non-phthalate alternatives.” The trial results are said to demonstrate that
Eastman 168 SG, a sensitive-grade DEHT, is a viable alternative for medical applications. “Blood bags are one of the most challenging applications in the plastics market,” says Eastman Market Development Manager Mark Brucks. “BCW’s research is important because it demonstrates a viable alternative for those who have concerns around using DEHP in sensitive applications like blood bags.” BloodCenter of Wisconsin Medical Director Kathleen
Puca says the DEHT trial results “offer new insight about a well-established plasticiser that has now been proven to have an even broader application within health care — providing safer blood products.” Further work is being completed on plasma to validate performance.
Figure 4: Performance characteristics of Jungbunzlauer’s Citrofol L Bll plasticiser compared to DINP, DINCH and DOTP Source: Jungbunzlauer Ladenburg
50 COMPOUNDING WORLD | August 2017
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www.exxonmobil.com ❙
www.coimgroup.com ❙
www.grupaazoty.com ❙
www.perstorp.com ❙
www.adeka.co.jp/en ❙
www.basf.com ❙
www.emeryoleo.com ❙
www.jungbunzlauer.com ❙
www.eastman.com
www.compoundingworld.com
PHOTO: SHUTTERSTOCK
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