18.8.2019
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FDA Registration number
11.2012: We are pleased to announce that Mediplast Israel has FDA Registration Number: 3008729892

Catalytic burner for the decomposition of ETO withdrawn from the sterilizers
3.2009 - An Emission Control System, using today’s most advanced technology, has been installed and first operated at Mediplast.

New and advanced sterilizer – installation and operation for the sterilization of customers’ products.

 9.2009 - A new and a technologically-advanced sterilizer, having a volume of 41m3, was added to the existing sterilizers at Mediplast.



 

Mediplast Israel Ltd. is the sole supplier in Israel of ethylene oxide (ETO) contract sterilization services of medical devices. The company and its sterilization activities are approved by European, Japanese and other notify bodies, of being in compliance with the EN ISO-11135:2007, EN ISO-13485, ISO-9001:2008 standards. The company has been undergoing FDA inspections since 1997. The company offers its customers (manufacturers, start-up companies etc.) additional services related to the ETO sterilization, such as:

  • Consultancy and guiding for the development of sterilization cycle suitable for a specific product

  • Documented preliminary sterilization trials for the evaluation of sterilization feasibility and its impact on the product - materials, functionality etc.

  • Validation of sterilization of customer’s product(s) in compliance with relevant ISO standards.

In addition, the company performs for customers at their sites, measurements of temperature and humidity for steam sterilizers, fermentors, ovens etc., aiming at determing the temperature and relative humidity profiles of such types of equipment. These activities include preparation of protocols and the derived validation reports.

 

 

 

 

Mediplast Israel Ltd. 7 Ha'yarkon St., Building 4, Industrial Area, P.O.Box 13214 Yavne, zip 81227
Tel: +972-8-9327766 Fax: +972-8-9327992 E-mail:info@mediplast.co.il