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EBSTER SK s.r.o. - the sterilization of medical devices by ethylene oxide was initiated during March 2007 at our facility in the industrial zone on the East part of Slovakia in Michalovce. In November 2008 the company expanded production by installing a new autoclave. Our sterilization facility of 4000 m2 is equipped with: The daily capacity of the sterilization service is 132 pallets (274 m2 ) with the possibility of further enlargement.
EBSTER CZ s.r.o. - the sterilization of medical devices by ethylene oxide was initiated during July 2005 at our facility industrial zone of Košíkov in Velká Bíteš in Czech Republic – on exit 162 of highway D1. The location provides good connection to Prague and Brno, and also with surroundings states. Due to increasing demand from customers, the company decided to expand production and in 2008 began construction of the second part of industrial halls. Start of trial production was in February 2009.
Our sterilization facility of 5500 m2 is equipped with:
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4 autoclaves
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28 degassing tunnels
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6 preheating tunnels
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laboratories for microbiological, biological and chemical analysis
The daily capacity of the sterilization service is 328 m2 with the possibility of enlargement.
Our mother company is the Italian company BIOSTER S.p.A., which operates 7 sterilization facilities using ethylene oxide and 2 with electron beams in Italy. It also runs 9 sterilization centres using steam within hospitals and offers a very large range of complementary services connected with sterilization.
The sterilization facilities at Michalovce and Velká Bíteš work to the same procedures, standards and certificates of our mother companies´, BIOSTER S.p.A., facilities.
EBSTER SK, s.r.o. and EBSTER CZ s.r.o. are certified by German notification body TÜV Product Service, under ISO 9001, ISO 13485 for the design of validation procedures for ethylene oxide sterilization processes, ethylene oxide sterilization and for microbiological, biological, chemical tests and analyses. EN 550 a ISO 11135 for sterilization of medical devices, the validation and routine control of ethylene oxide sterilization.
EBSTER CZ s.r.o. is also registered by American F.D.A. under the registration number 3004784537.
The facilities are supplied with an modern thermo - catalytic burner system for the liquidation of residual ethylene oxide to ensure respect for the environment.
EBSTER SK s.r.o. and EBSTER CZ s.r.o. are subsidiaries of the Italian
BIOSTER S.p.A. - http://www.bioster.com