BASF received SolVin Award Innovation Special Prize
For the fifth time Solvin has granted awards to innovative projects that promote the image of soft PVC as a versatile, commercial and safe material. The projects are divided into three categories that represent the values of the SolVin Award for PVC Innovation: Innovation, Design and Recycling.
BASF was awarded the “SolVin Award Innovation - Special Price”. The project “Medical devices with Hexamoll® DINCH in blood product applications” was nominated and recognized in the category Innovations. The non-phthalate plasticizer Hexamoll® DINCH is used as a substitute for DEHP for whole blood collection systems, platelet pooling sets and paediatric platelet storage bags. This was shown in a combined project with BASF, Sanquin and Renolit. The companies involved have proven that Hexamoll® DINCH can be used in medical devices without any technical constraints.
Plasticizers are used to soften rigid PVC and turn it from being hard and brittle to soft and flexible. They go into a wide area of applications, ranging from toys to food contact, to medical devices. The requirements for plasticizers are as diverse as the potential applications. Hexamoll® DINCH has been known as the non-phthalate plasticizer for applications with close human contact, like medical devices, for more than 10 years.
For decades, di(2-ethylhexyl)phthalate (DEHP) has been used as a phthalate plasticizer for medical devices. Immediately after the plasticizer DEHP was identified as a reproductive toxicant in animal studies, a discussion on the risks potentially associated with its use in medical applications followed. As published at the end of 2012, the European pharmacopoeia has flagged DEHP for replacement. In several countries/regions local efforts have started to replace DEHP or even plasticized PVC in medical applications. Hence, there is an urgent need to provide a viable solution to patients and the medical sector.
In the first step, a platelet bag was developed for paediatric use that contains Hexamoll® DINCH as an alternative non-aromatic, non-phthalate plasticizer instead of DEHP. Hexamoll® DINCH is the non-phthalate plasticizer marketed worldwide and combines an excellent toxicological profile with low migration. Even the high requirements involved in blood transfer, enteral nutrition and organ transfer can be met. Furthermore, Hexamoll® DINCH has been evaluated by several authorities such as EFSA, NICNAS and SCENIHR, and further independent parties. The platelet bags made from this new Hexamoll® DINCH plasticized PVC material had to keep their technical and mechanical properties to allow isolation, storage and transfusion of the platelets. With the resulting new product, the platelet stability and parameters that are critical for transfusion are not adversely affected by the plasticizer exchange. This was a challenge when developing the product.
However, for Hexamoll® DINCH it has been shown that an adequate red blood cell stabilizing effect can be achieved if the appropriate stabilizing additive is used. Using this system, also red blood cells can be stored for the standard period of 42 days without changing the relevant parameters. It was further shown that plasma storage in Hexamoll® DINCH bags does not pose any problems either and that the buffy coats could be used for platelet concentrate production without problems. Currently the new platelet bags are already used for paediatrics, while all other bags are still under research and not in regular use yet.
With these Hexamoll® DINCH based medical devices an urgently awaited solution is available for the medical device industry. The smart thing related to its use is that medical device manufacturers and the health care sector can continue to use the long known PVC materials because just the DEHP plasticizer has been replaced by Hexamoll® DINCH.