Blister packaging is a process through which a closed casing is created, one that is fit to contain biomedical devices to be sterilized and is such as to preserve sterility over the scheduled time period. Blister packaging of disposable medical devices is carried out by Safe-MED® in a controlled contamination area (as demanded by ISO norms), thereby limiting the level of bio-contamination of the product and optimizing its degree of cleanliness. Effect is strictly given to the standard processes relating to the packaging of medical devices by making reference to the following norms:
UNI EN ISO 11607-1:2009 Packages for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems UNI EN ISO 11607-2:2006 Packages for terminally sterilized medical devices - Part 2: Requirements for validation of format, resistance and assembly systems Safe-MED® offers a wide range of blisters, differing in format and type of medical material utilized, which suit the most disparate items destined to ethylene oxide, stem and irradiation sterilization. The blisters will then be personalized with a logo and with data supplied by the Client.