Sterilization

One of the important consumer properties of the prosthetic implant made in a quality manner lies in its package sterility. Firstly, this is convenient because the implant is ready for use (installation) straight from the package. Secondly, this does not require expenditure of time and energy from a practicing surgeon in separate sterilization of an implant before surgery. Thirdly, the quality of sterilization assured in plant conditions is practically unattainable in conditions of medical room giving good guarantees of the implant successful survival to living tissue by itself.The sterilization of our medical products, firstly the implants, assurance of their readiness for immediate use represent one of our production tasks successfully solved by the manufacturing of the ABM Technology Medical Product Plant. To do so, practically finished implants manufactured and prepackaged in the “clean room” undergo a stage of completing sterilization. Our products are sterilized with the use of radiation technique on a commercial-grade specialized equipment.

The purpose of this completion stage of treatment lies in the elimination of any microbial or bactericidal environment on the contact surfaces of implants, elimination of prerequisites for its occurrence and dissemination while further transporting and storing thereof within the entire guarantee period.

The implants made by the ABM Technology Medical Product Plant are put in the radiation sterilizer in a tight package wherein they have been put in the “clean room” and are not taken out of it until the time of intended use. This mode of implant treatment guarantees full preservation of their consumer properties acquired at the stage of sterilization.

The medical products made by the ABM Technology Medical Product Plant are subjected to a hard radioactive (ionizing) gamma-radiation of 15 to 25 kilograys (kGy)directly in the process of bactericidal sterilization. Usually, this absorbed radiation dose is for sure sufficient to attain an absolute bactericidal sterility of their contact surfaces in full concordance with thehigh industrial quality standards. However, this looks simply in only a token way. The process of radiation sterilization is rather time-consuming in and of itself; the radiation of each lot takes all the day in the average. The specialized equipment for radiation treatment is rather complicated being highly regulated in the management and service as well as in the questions of licensing. The fact of subjection of a medical product (lot) to the complete radiation sterilization is controlled by the radiation dosimeters being mandatory confirmed by the attached Certificate. However, even after subjection of the medical products to the radiation sterilization, the quality control of their condition is not ceased at our enterprise. When the next lot of sterilized implants returns, some samples are collected from it on which the quality of carried out sterilization is checked in the laboratory.

Another important point of our technological process lies in the regular procedures of validation of the sterilization quality of medical products being manufactured. The fact is that various changes are dynamically taking places in the branch as a whole and at the ABM Technology Works – the new constructions and forms of medical products are introduced (developed), the materials change, etc. That is, why the question, which dose of radiation will be sufficient to assure a required degree of sterilization of one or another medical product, will always remain topical. The task of validation procedure just lies in the determination of such absorbed radiation dose reliably assuring a required degree of product sterilization. In the process of validation, a lot of either products subsequently receives particular absorbed radiation dose followed by a check of sterilization quality in the laboratory until obtainment of optimal result in the treatment quality and the time consumed.