醫療器材射出成型件製程穩定之參數研究

本文最主要是透過實驗設計Design of Experiments(DOE)的方法找出較適合成型參數，並將運算結果導入生產中，可減少試模次數並提供穩定生產製程。量測數值以先進的成型機台、輔助的三維度量測儀和掃描機及統計軟體Minitab分析結果而來，透過數值分析了解生產內容及減少成本浪費。將實驗數值運算轉成各種圖表分析並加以比對分析參數並加入長期製程能Process Performance Index(PPK)計算，獲得較佳成型參數模組代入生產製程，可確保成型件製程穩定及品質一致性，是本次實驗目的。從各種圖表顯示分析的參數適合製程生產，其運算的總體平均PPK及中間值PPK皆≧1.67，且製程Dimension 04(Dim04)/ Dimension 10(Dim10)/ Dimension 14(Dim14)分析結果皆在公差內，3Dimensions(3D)綠色掃描無顯示缺料等外觀問題，證明本實驗所運算出結果不僅是穩定的射出成型參數而且實際運用在生產可提供長期製程穩定。實驗過程不僅證明成型參數的實用性且經小量生產實驗所統計的結果，找出較佳的生產參數並符合長期製程生產。相關射出成型件，如用相同手法都可找出最適合的成型參數。

關鍵字

成型參數模組

並列摘要

This study utilizes Design of Experiments methods to find more stable and suitable injection molding parameters. These results are imported from exper-iments designed to have all parameters covered and calculated to obtain a more adequate parameter set. This method helps to reduce trial shots and provide a stable production process, where the trial shots in real field application, can be very costly. Advance injection molding machine, auxiliary Coordinate Measurement Ma-chine (3D CMM) and Minitab software package are used to analyze experiment results, they can solve abnormal production and reduce cost by setting the production parameters to an optimal. This method reduces the sensitivity of parameters which reduces quality variance due to parameter variation. The main idea of this thesis is to obtain an optimal processing condition. From results of the trial experiments defined by the DOE method and put into Process Performance Index (PPI) calculation to generate a better molding parameter set for production process. It can ensure stable production process and uniform quality for components. The experimental process is not only to search root cause of component defect but also to provide long-term stable production conditions by statistical data. Medical equipment requires stable part quality, hence this method can help to stabilize the part quality greatly by finding an optimal processing condition set. As like that, all plastic injection-molding can use DOE to find the best param-eter for production processing too.