Project: SafeBlood – blood bags free of PVC and plasticisers

Among health-care professionals there is a strong wish to use blood bags without plasticised poly(vinyl chloride) (PVC). This demand has recently been demonstrated in a petition among Swedish health-care professionals. Estimates of the EU market demand for non-PVC blood bag polymer sales are € 5-6 million annually, and the expected use of non-PVC blood bags is approx. 2000 tonnes per year. This demand for non-PVC products and recent EU legislation will promote an extensive market penetration and widespread replacement of conventional blood bags if blood bags free of PVC and plasticisers are developed._x000D__x000D_Conventional blood bags for storing transfusion blood are produced from PVC containing plasticisers that migrate to the surface and diffuse into the stored blood. Among the plasticisers applied in blood bags are phthalates, in particular bis(2-ethylhexyl)phthalate (DEHP). Several phthalates are on the REACH authorisation list and DEHP has recently been classified as ’substance of very high concern‘ (SVHC). This implies that DEHP cannot be used in the EU without special approval, and there is now a strong debate on the use of phthalates in medical devices. Despite their toxic properties, plasticisers in PVC have a positive effect on blood stability as they have an anti-oxidative effect on blood. Studies show that the anti-oxidative effect of the plasticisers protects blood against haemolysis, i.e. breakdown of red blood cells. This stabilising effect is not present in plasticiser-free plastics and as a consequence, there are currently no relevant alternatives to PVC-containing blood bags. Soft materials based on polyolefin plastics without plasticisers can replace PVC with regard to material properties but have no anti-oxidative effect. Hence, there is a need for alternative antioxidants in the plastic materials to avoid haemolysis. It is important that these substances have no harmful effects and are robust in order to be incorporated into plastics. Furthermore, PVC materials are environmentally undesirable due to the formation of harmful chlorine gas during incineration, which is required for blood bag waste. Substituting PVC materials with polyolefins will thereby affect the environment positively and, furthermore, reduce blood bag waste (and waste disposal costs) by 30 % by weight due to differences in material density._x000D__x000D_A substance with proven blood stabilising effects is vitamin E, which is found naturally in many foods and has a strong anti-oxidative effect. Vitamin E can, however, be degraded by e.g. light, oxygen and heat. Direct addition of vitamin E to plastic films implies a large risk for vitamin E to either evaporate or decompose as the films are extruded by melting the plastic at around 240 to 260°C. Encapsulating vitamin E can provide protection, thereby preserving the anti-oxidative effect to ensure blood stabilisation. Moreover, encapsulation will control the release of vitamin E and stabilise the blood for a longer period. Encapsulation will be performed using durable materials such as silica, PLGA, chitosan or PVA that have minimum impact on the properties of the polymer and do not migrate into the blood. Scientific literature shows several examples of vitamin E encapsulated in particles performing controlled release that preserve the anti-oxidative activity of vitamin E. By incorporating encapsulated vitamin E directly into the plastic material of the bags, the existing procedures of handling, storage and use of the blood bags will not have to be changed. This project will benefit from a strong consortium of unique market-leading companies, innovative encapsulation experts and state-of-the art analysis methods and will combine expertise and experience from each P. The project Ps include experienced developers of technologies for encapsulation and plastic materials (DTI, DK); a raw material producer specialised in polyolefins for medical devices (MELITEK, DK), and a producer of plastic films and devices to the medical and pharmaceutical industry (Haemotronic, I). In addition to specific technological development, the consortium will ensure dissemination of the knowledge achieved and promote large scale manufacturing of the developed blood bags._x000D__x000D_In summary, the project goals are:_x000D_i) Develop technology for encapsulating vitamin E in particles._x000D_ii) Compound polyolefin-based plastic containing encapsulated vitamin E._x000D_iii) Manufacture film and blood bags of the polyolefin-based plastic containing vitamin E._x000D_iv) Evaluate plastic properties, release profiles and the level of active vitamin E before and after extrusion of film and blood bags._x000D_v) Perform release studies and blood stability tests to verify the anti-oxidative properties in the final product._x000D_

Acronym SafeBlood (Reference Number: 6454)
Duration 15/11/2011 - 31/12/2014
Project Topic The project develops new technology for incorporating vitamin E in polyolefin plastic bags for blood transfusion. The technology makes it possible to produce blood bags of environmentally friendly materials and eliminates plasticisers with suspected hormone-like properties from transfusion blood.
Project Results
(after finalisation)
Experience with encapsulation technologies, specifically silica encapsulation of oil/vitamin E. Encapsulation methodology developed/modified to suit the specific needs of the active ingredient (vitamin E). Experience with determination of release profiles from encapsulated actives using relevant analysis, whether direct release from silica capsules or release from encapsulated active in plastic matrices.
Network Eurostars
Call Eurostars Cut-Off 6

Project partner

Number Name Role Country
3 Haemotronic Advanced Medical Technologies S.p.A. Partner Italy
3 Danish Technological Institute Partner Denmark
3 MELITEK A/S Coordinator Denmark