Packaging and Sterilization | Manufactoring of oem components supplier, wounded metal coils for implantable cardiac pacing leads |

Packaging and Sterilization

Dental implants are manufactured under conditions of absolute cleanliness and hygiene. Analyses conducted by external laboratories have confirmed that the level of pre-sterilization microbial contamination is very low, if not negligible, both before and after washing. The washing cycles adopted are effective both in the actual washing phase, completely eliminating the residues of processing oils and greases, and in the rinsing phase, removing all traces of the  detergents used.

The packaging of GiEsse dental implants is carried out with an implant supported by a medical-grade titanium millable mounter and a retaining screw. The plastic materials used for packaging, which consists of an internal and external vial, with the presence of two caps and a security seal, are phthalate-free, comply with current regulations, and are sustainable for gamma-ray sterilization.

The packaging of dental implants is performed within a controlled biological and particle contamination environment (clean room). The environmental contamination class has been determined so as to guarantee a constant and sufficiently low pre-sterilization bioburden on the product to ensure their sterilization.

The gamma-ray sterilization treatment has been validated according to the UNI EN 11137 standard, an is periodically subjected to control tests to verify that it always remains effective and that the sterilization parameters do not present variations from what is estabilished in the initial validation protocols.

Once the implants have been sterilized, their standard packaging is suitable to preserve the integrity of the sterile barrier system (i.e. to mantaint the sterility of the contained implant) for a period of 5 years.