Mediplast Israel Ltd. is the leading service provider of contract ethylene oxide (ETO) sterilization in Israel. The company has 40 years of experience in ETO sterilization of medical devices.
The company operates a comprehensive Quality Management System, all its activities following Standard Operating Procedures complying to GMP standards.
The sterilization processes are automated, being controlled by programmable logic controllers (PLCs) , connected to operating computers via advanced HMI software. The sterilizers, as well as their ancillary systems (the preconditioning and accelerated aeration rooms) undergo qualification and periodic requalification in compliance with the requirements of ISO-11135:2014).
All aspects of the sterilization activities of the company are inspected and approved by Notified bodies and other Regulatory Authorities. Such approvals and certifications have been granted by: The Standards Institution of Israel – , MDC (Germany), a Notified Body on behalf of the European Community and the Japanese Ministry of Health.
Mediplast operates in compliance with the international standards:ISO-13485:2016, including ISO-11135:2014 – Sterilization of Health Care products by ethylene oxide. In addition, Mediplast has been periodically inspected and approved as a registered facility by the US FDA since 1997, most recently in August 2017.