Parametric release can be defined as a sterility assurance release program where demonstrated control of the sterilization process enables a company to use defined critical process controls, in lieu of the sterility test.

For a product released using the Sterility Tests, once the device is terminally sterilized, there is an incubation period of several days to allow for possible microbial growth in samples before obtaining results from this test. During this waiting period, the device is placed on hold (not released for sale), potentially occupying valuable space, but more importantly delaying patient access to critical devices.

For a device released using parametric release, once the device is terminally sterilized and the acceptance criteria for the critical process parameters are documented as being met, the product can be released for commercial sale, provided that all other release test criteria have been met. In Esterilizacion,s.l. we are adapting our facilities, as well as our control software to comply with the technical specifications of parametric release, being able to offer shortly all our customers this other way to release their products.

In Esterilización we launch a website and we want to share it with all of you. We have developed a modern and functional website with the aim of offering a more current, practical, useful space and, above all, the ideal environment in which to offer the best service to our users and customers. This new version includes many innovations and improvements in design and navigation, content and technology that are summarized in: User-oriented design: the useful space that grows adapting to the most modern navigation systems (smartphone, tablet or PC) is reinforced the use of icons, graphics and illustrations and we offer a new information arrangement to facilitate the consultation of the contents in an agile and fluid way. Simplified navigation: the structure of the sections evolves and is simplified to facilitate access to the most common sections, now expanded and renewed, which allows us to easily navigate through our wide range of services. New technology: we incorporate the latest technological advances to offer a better performance of the web to the growing number of users who access our information and services by the most diverse means. Focused on your needs: all these developments are the result of months of work and research with the aim of covering the increasingly demanding needs and expectations of our users and customers.

The team of Esterilización, S.L. update and expand their knowledge of ATEX environments with a course taught by DEKRA, referring to “Design, Realization and Maintenance in ATEX” level 2EM, which accredits all attendees with the Ism certification ∙ Atex by Ineris.

Esterilización celebrates 30 years serving the medical and pharmaceutical industry. Esterilización, S.L. continues in its desire to improve and continuous improvement, immersed in a program of renovation of its facilities in order to improve sterilization production capacity, improve the energy efficiency of their processes and improve protocols and environmental responsibility systems. Our ultimate goal, to offer the best service to our customers.