Quality assessment of the cross-linking process of vascular prostheses
[ 1 ] Instytut Technologii Materiałów, Wydział Inżynierii Mechanicznej, Politechnika Poznańska | [ P ] employee
chapter in monograph / paper
- Vascular prostheses
- Process capability
- Design of Experiment
EN The object of research was the process of manufacturing of four types of synthetic vascular prostheses: straight, bifurcated (Y-shaped), straight with an arm and arch-shaped. The main purpose of the paper was to evaluate a quality assessment of this process and as it turned out to improve its quality. The main critical features affecting the quality and durability of the prosthesis are water, gelatin and glycerin. Because of a high cost of examination, control plan designed for this process assumed collecting a very small sample. Taking into account a high risk of accepting a batch that does not meet the requirements, distributions shape and capability for chosen features were assessed on the basis of previously collected data. The content of water turned out to be critical so a thesis was made that the critical operation in the entire prosthesis manufacturing process is the drying operation, both after coating and cross-linking. It takes place in a separate room where wet prostheses are placed for a specified period of time. The company tries to maintain a certain temperature and humidity in the room. Unfortunately, these are not permanent conditions. Therefore, it was decided to analyze the correlation of room temperature and humidity with the content of water, gelatin and glycerin in prostheses. After all, in order to verify the nature of the dependencies obtained in the preliminary tests, a controlled method of carrying out the drying operation after cross-linking and conducting an active experiment was proposed.
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