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BIOFLEX
Biocompatible flexible polymer alloys based on polyesters from renewable resources for mass-consumer applications involving contact with human fluids and tissues

The massive consumption of crude fossil fuel, both as an energy source and raw material supply, results in environmental penalties incompatible with the concept of sustainable growth in a modern society. In this context, the production of fine chemicals through natural synthesis by fermentation of excess agricultural products, or agro-industrial sub-products, is a very appealing alternative compared to their conventional production from petrochemical sources. In particular, the synthesis of polymers from natural resources, which could be blended with poly (vinyl chloride), PVC, for the production of polymer alloys with properties comparable to plasticised PVC grades, could lead to a total replacement of phthalate PVC plasticisers. These are heavily criticised by both the medical and environmental professions, especially in applications such as blood and plasma bags, medical tubing or toys. This will be an extremely successful development, due to the very high volumes of production involved and the resulting safety improvements.

Objectives
The objective of this project is to develop a suitable industrial technology for the production of polymeric plasticisers, capable of replacing phthalates in flexible PVC grades for mass-consumer applications involving contact with human fluids and tissues from renewable sources.
The technology developed will be validated through the design and compounding of four different grades of phthalate-free P-PVC, based on the plasticiser developed, targeted and optimised for the production of medical tubing, blood and plasma bags, small injection toys and medium hollow toys respectively. The cost-effective manufacture of prototypes of all the referred products, with a subsequent technical, medical, environmental and economical evaluation of the technique will also be covered.

Progress to Date
Two right polymer synthesis 'polytrimethylene-co-polycaprolactone polycarbonate' with different PTMC content have been developed by INSTM. P(PTMC15%-PCL) and P(PTMC20%-PCL) monomer from renewable sources have been used as the starting material in the PTMC synthesis. Both of these 'polymeric plasticizers' have produced results in laboratory tests (mix.PVC/Bioflex by EVC). P(PTMC 15%-PCL) has been chosen for the up-scaling process by Polymer laboratories. EVC has mixed this new Polymeric plasticiser with PVC.

Results
Polymer Laboratories made a large effort to supply EVC with approximately 42kg of P(PTMC15%-PCL). EVC has developed more than 110kg of compounds with this material, shared in three different formulations (ST336/C46, ST336/C47, ST336/C48), two different K-PVC values, three different types of hardness, and two different shapes of granules for four different final applications (hoses, bags, toys and dolls).
Excellent results have been obtained for extrusion hoses, as the compound PVC/Bioflex behaves like PVC/DOP. There were sound mechanical properties before and after ageing, and good results from the chemical analyses were obtained, according to the most demanding standard. The gluing properties were found reliable and good behaviour in sterilisation 'ETO' and 'BETA RAYS' was obtained.

Good results were obtained for injection moulding, without any defects. Roto-moulding produced unsatisfactory results, but a revised process is expected to work. Other tests are underway. After significant tests made by the industrial partners, it is anticipated that the project will be successful.

Classified in NON-FOOD PRODUCTS, HUMAN HEALTH AND WELLBEING

Scientist responsible for the project

Mr SILVANO ROLLA
Via Leonardo Da Vinci, 5 Box 58
44011 Argenta Ferrara
Italy - IT

Phone: +39 0532 804295
Fax: +39 0532 852100
E-mail: silvano.rolla@evc-compounds.com

References

Project ID QLRT-1999-01355
Organisation EVC Compounds Italia
Area 5.2
Start date 01 February 2000
Duration (months) 48
Total cost 4 490 000 €
Total EC contribution   2 399 981 €
Status Ongoing

The partners

  • G.I.E. Lesaffre Developpement (Patrick Taillade), France - FR
    pt@safisis.fr
  • Azienda Ospedaliera Antonio Di Summa (Latini Giuseppe), Italy - IT
    gilatini@tin.it
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