Mediplast Israel Ltd. is the sole provider of contract ETO sterilization services in Israel. This service is offered to more than 100 customers, part of which export their sterile products to the US, Europe, Japan and other countries.
All aspects of the sterilization activities of the company are inspected and approved by notify bodies in Israel and abroad. Such approvals and certifications have been granted by: the Standard Institution of Israel - approval for ISO-9001:2008 and EN ISO-13485, The European Common Market by mdc (Germany) - approval for ETO contract sterilization service in compliance with EN ISO-13485 and EN ISO-11135:2007. In addition, Mediplast has been inspected as part of FDA inspections carried out at Mediplast’s customers marketing their products in the U.S.A.
The company operates a comprehensive quality assurance system in compliance with the ISO-9001:2008 and EN ISO-13845 standards, in accordance to SOPs which cover all its activity domains. The sterilization processes are automatic and are being controlled by PLCs, which are connected to operating computers via advanced HMI software. The sterilizers, as well as their aucillary systems (preconditioner, aerator) undergo periodic validations (in compliance with the EN ISO-11135-1:2007 standards).
Mediplast Israel Ltd. is an essential center for the activities of a great number of manufacturing companies and of companies that developing medical devices, through the various phases of their products’ development. Amongst the developing companies are tens of start-up companies. In this context, compatibility of the product with ETO sterilization, and the feasibility of its sterilization are tested and evaluated. These are being followed by validation of the ETO sterilization of the product prior and for the clinical trials. Bacteriological and other tests (including ETO residuals) pertaining to the validation and sterilization trials, are performed by independent approved laboratories.
In addition to sterilization, Mediplast provides the following services:
microbial validation of the sterilization of the customers’ products sterilized using a specifically-tailored sterilization cycle in a specific sterilizer of the company’s sterilizers.
Measurements aimed at determining the temperature and relative humidity distribution during all the stages of the sterilization cycle (using dedicated ETO-resistant data loggers). The validation and the related measurements are performed according to the requirements of the EN ISO-11135:2007 standard, and in compliance with a validation protocol submitted to Mediplast by the customer.
Validation (temperature distribution) of temperature-based devices (such as steam sterilizers, incubators, etc). This activity is performed at the customer’s site. Protocols and derived final reports can be prepared by Mediplast.
Mediplast is the representative of the Dutch company ETIGAM, a manufacturer of chemical indicators for ETO, steam and gamma radiation sterilization, as well as biological indicators for various types of sterilization processes.
Amongst our customers: manufacturers and suppliers of disposable sterile medical devices, companies that develop medical devices, start-up companies, sterile supply departments of hospitals, medical centers, health care services, IDF and more.