Production of medical grade hydroxyapatite Powder using bio-engineering methods and microbiological processes in conditions Medtronic sofamor damek deggendorf (Germany)

Abstract

Bachelor thesis contains 72 pages of printed text, including 76 bibliographic references of specialized reference literature, work instructions and periodicals. The work includes 33 figures and 7 tables and 2 attachments. The topic of qualification work is: «Production of medical grade Hydroxyapatite powder using bio-engineering methods and microbiological processes». Study was performed by Medtronic Sofamor Danek Deggendorf, Germany. This bachelor thesis deals with the design and setup of a bioengineering process to produce pure Hydroxyapatite according to ASTM F1185 (Standard Specification for Composition of Medical-Grade Hydroxyapatite for Surgical Implants) and ISO 13779 (Implants for surgery). The purpose of the work was to develop and optimize the technological process for production of medical-grade Hydroxyapatite powder using bioengineering methods and microbiological processes. The study object was: Medical-grade Hydroxyapatite powder production process. The subject of the study: The use of bioengineering methods and microbiological processes in the production of medical Hydroxyapatite powder and evaluation of products made from it. The following tasks were defined and resolved: - Conduct an analysis of the literature on the topic of qualification work on the following issues: 1) features engraftment of calcium phosphate ceramics; 2) technologies for the manufacture of Hydroxyapatite; 3) methods of control and testing of finished products. - Give a short information about the company Medtronic Sofamor Danek Deggendorf respectively to the requirements, to characterize the object of research, and to provide methods getting the studies done. - Analyze the results of microbiological studies, to develop and describe the technology for the production of Hydroxyapatite, conduct, investigate and analyze the results of testing and verification of the purity of products.

As a result, based on Hydroxyapatite process development findings, an acceptable range was established to ensure consistency and reliability in the production process. After purity testing and verification of product, all outcomes were acceptable according to international standards for medical devices. In vitro testing using cytotoxicity test showed that the product meets stringent safety standards and can be confidently utilized without posing any harm to the body. In vitro testing for biodegradation kinetics confirmed the advantages of the morphology of the final HA/-TCP ceramics. During in vivo study the tested material showed good ossteointegration and osseoconduction properties after short and mid term intraosseous implantation in the sheep with a non significant material degradation process.