Ionisos Iberian organises the technical day 'And-beam: the alternative to the sterilisation oxide of etileno and radiation gamma'
24 May 2012
- Know the advantages of the sterilisation by electrons of high power in front of other technologies.
- Give the guidelines to be followed to realise the change of the method of sterilisation (Of oxide of etileno or radiation gamma to radiation by electrons of high power).
- Know how comport some plastic materials in front of the process of radiation, hand-held of the main suppliers of raw materials.
- Know which are the proofs that it is necessary to carry out to guarantee the esterilidad of the process and the aptitude of the materials used during the treatment of irradiation.
10:00h - 10:30h
10:30h- 11:15h. Bienvenida and presentation of the day
Speaker: Miguel Moral, (Ionisos Iberian)
Main technologies for the sterilisation of sanitary ware products, chemists and veterinary. Oxide of etileno- Gamma-And-Beam
Speaker: Olga Melero (Ionisos Iberian)
Summary: global Vision of the different technical that use for the sterilisation of sanitary ware products, chemists and veterinary.
11:15h- 12.00h. Sterilisation of sanitary ware products by irradiation. ISO 11137
Speaker: Jose Moon Valdés (Ionisos Iberian)
Summary: Description of the process of validation for a sanitary ware product (VDmax 25, VDmax 15) with special attention to the last normative novelties.
12.00h -12.30 Pause Coffee
12:30h-13.15 Compatibility of polymer materials with radiation sterilisation
Speaker:: Sophie Rouif (Ionisos Groupe)-Report in English.
Summary: Analysis of the structural change of several families of polymers, when being subjected to a process of radiation
13.15-14.00h Regulatory. Changes in technical file/marked CE and in licence manufacturer
Speaker: Xavier Canals (Tecno-med Engineers, SL)
Summary: legal and statutory Steps that requires to give of high a product esterilizado by and-beam, as well as the change of method of sterilisation (Gamma-and beam and ETO – and beam). What will ask us the Organism Notified and the AEMPS?
14.00-15.15 Breakfast
15.15-15.50. Microbiological controls
Speaker: David Ponti, Laboratories Biotecnal
Summary: Concepts and general terminology. Analysis of microbiological methods 15.50-16.25
Biocompatibilidad
Speaker: Vincent Legay, Biomatech (group NAMSA)- Report in Groins
Summary: Analysis of the studies of hygiene that carry out in a variety of biomateriales, medical devices and products related to identify the presence of toxins or the possible harmful effects of the product.
16.25-17.00 Material Innovations for medical devices- Engineering Thermoplastics for radiation sterilization
Speaker: Ton Hermans(Sabic Innovative plastics Spain SCpA)- Report in English
Summary: Characteristics of the product and study of the behaviour in front of the process of radiation
17.00-17.35 Material plastics for sanitary ware products and diagnostic
Speaker: Marcela Villegas (Styrolution GmbH)
Summary: apt medical Polymers to be esterilizados by radiation
17.35-18.00 round Table and ending of the day