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project info
Start date: 27 September 2016
End date: 26 September 2023
funding
Fund: European Regional Development Fund (ERDF)
Total budget: 1 845 000,00 €
EU contribution: 1 230 731,40 € (66,706%)
programme
Programming period: 2014-2021
Managing authority: Ministerul Dezvoltarii Regionale, Administratiei Publice si Fondurilor Europene

Increase competitiveness through innovation and improve manufacturing processes with gamma technological irradiation

The GAMMA PLUS project aims to support companies in the field of medicine-pharmaceuticals to use the infrastructure and competences of the Multiple Purpose Irradiation Department (IRASM) of IFIN-HH in their production processes and in the development of innovative products or services. IFIN-HH provides Romanian manufacturers with all sizes of irradiation technology with ionising radiation as well as a wide range of physical, chemical and biological tests and tests to investigate the effects of irradiation and/or product certification. Besides the irradiation and testing infrastructure (laboratories), IFIN-HH provides competent staff, with extensive experience in the field of services offered and with more than 10 years of experience in collaboration with enterprises. The transfer of knowledge proposed for the implementation of the project includes: Knowledge of the selection of materials at the design of the medico-pharmaceutical product. Technological irradiation, in particular sterilisation with ionising radiation, offers substantial competitive advantages over other manufacturing procde, in terms of energy consumption, ecological aspects and, last but not least, manufacturing cost. The compatibility of the materials with this technological process is considered. There is currently no international standard or guide on the compatibility of materials with ionising radiation sterilisation. There are manufacturers that indicate in the specification of the material this compatibility (or its absence), but the general recommendation is that the materials must be tested in the manufacturing conditions of the respective product (processing, generally thermal, modify the properties of the polymer material). In the case of materials of biological origin (biopolymers), the lack of compatibility specifications with ionising radiation treatment is even more acute. The IRASM Department of IFIN-HH has extensive knowledge of the radiation resistance of materials, their compatibility with gamma irradiation processing and methods to reduce the degrading effect, when appropriate. This knowledge was acquired through own experiments or from literature. In addition, the IRASM department has an irradiation qualification laboratory that offers physico-chemical testing services to establish the compatibility of a particular material or product with irradiation processing. — Knowledge of process validation. In the particular case of sterilisation of medical devices, the result of the process cannot be quantified by direct measurement (microbiological testing is destructive) and the validation of sterilisation is an essential requirement for obtaining the CE marking. The IRASM Department of IFIN-HH has microbiological testing laboratory and experimental irradiation infrastructure, which allow the performance of validation tests in competitive and efficient conditions. Microbiological laboratory is a needle

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