摘要
電化學法血糖檢測系統是目前糖尿病患者實施血糖自我檢測、有效控制病情的重要手段。電化學血糖試片酵素量會影響反應時產生的電流值，進而關係到試片檢測結果，因此在點膠製程的膠量控管非常重要。壓電驅動式噴射點膠系統是目前商售點膠系統中最為精密的微點膠技術，具備了高速、高頻以及全數位化可調的控制機制，非常適用在血糖試片點膠製程。田口方法是一種應用於產品設計以及製造技術改善的相關領域，主要依照設計的控制因子以及其水準值，搭配信號雜音比與變異數分析，用來取得設計參數對實驗樣本品質影響程度，以達成改善品質與降低成本之雙重效益。本研究以某生技公司新型電化學血糖試片開發專案為對象，新型試片酵素膠量期望標準為0.3mg _(-0.005)^(+0.005)，然而，傳統氣壓式噴射點膠系統單點出膠精度僅能控制在+0.01mg ~ -0.01mg範圍內，因此，本研究目的在於探討新式壓電式噴射點膠系統的出膠量能否達到期望標準，以及拆閥重組後膠量的再現性。本研究選用了：Pressure、Needle Lift、On Time、Falling Time以及Rising Time共5項控制因子，另分別訂立4個水準，採用田口方法設計出L16(45)直交表進行實驗，實驗膠量採10個膠點進行一次量測方式放大10倍來配合電子秤最高解析度。由L16(45)實驗結果建立了S/N比預測值為38.03db，透過調整實驗得到最佳參數組合為：Pressure (8.4psi)、Needle Lift (49%)、On Time (17.4ms)、Rising Time (0.9ms)、Falling (0.6ms)，實驗誤差 -3.7%，控制在±5%誤差水準內，再現性實驗的膠量平均值為2.90mg，實驗誤差-8.4%超出標準。本研究的結論是：MDS 3050+最佳膠量精度為0.301mg _(-0.001)^(+0.004)，達成某公司期望標準；再現性實驗超出標準未達研究目的，需要透過適當調整來達到目標值，建議立案研究，控制因子對膠量品質貢獻度最大為：推膠壓力22.66%，建議使用PID技術來穩壓，最小為：開閥時間9.49%，建議作為調整膠量因子使用。本研究貢獻是，Rising Time貢獻度(22.62%)、Falling Time貢獻度(22.61%)，對膠量品質有影響，程度不容小覷，Falling Time因受纏膠影響，調整時建議限制在6ms以下。 關鍵字：電化學血糖試片、血糖自我檢測、壓電式噴射點膠、田口方法、信號雜音比
並列摘要
The electrochemical blood glucose detection system is an important means for diabetic patients to implement self-diagnosis of blood glucose and effectively control the disease. The amount of enzyme in the electrochemical blood glucose test strip will affect the current value generated during the reaction, which in turn is related to the test results of the test strip. Therefore, the glue quantity control in the dispensing process is very important. The piezo-driven jet dispensing system is the most sophisticated micro-dispensing technology among commercially available dispensing systems. It has a high-speed, high-frequency and fully digitally adjustable control mechanism, which is very suitable for the dispensing process of blood glucose test strips. The Taguchi method is a related field applied to product design and manufacturing technology improvement. It is mainly based on the design control factor and its level value, combined with signal-to-noise ratio and variance analysis, to obtain the degree of influence of design parameters on the quality of experimental samples, in order to achieve Double benefit of improving quality and reducing cost. This study is based on the development project of a new electrochemical blood glucose test strip of a biotechnology company. The expected standard for the amount of enzyme glue on the new test strip is 0.3mg _(-0.005)^(+0.005). However, the traditional pneumatic jet dispensing system is only The dispensing accuracy can only be controlled within the range of +0.01mg ~ -0.01mg. Therefore, the purpose of this study is to explore whether the dispensing volume of the new piezoelectric jet dispensing system can meet the expected standard, and the disassembly and reassembly of the dispensing valve. reproducibility. In this study, 5 control factors: Pressure, Needle Lift, On Time, Falling Time and Rising Time were selected, and 4 levels were established respectively. The L16(45) orthogonal table was designed by Taguchi method for experiments, and the amount of glue used in the experiment was 10 One glue point is measured by 10 times to match the highest resolution of the electronic scale. Based on the experimental results of L16(45), the predicted value of the S/N ratio is 38.03db, and the optimal parameter combination obtained through the adjustment experiment is: Pressure (8.4psi), Needle Lift (49%), On Time (17.4ms), Rising Time (0.9ms), Falling (0.6ms), experimental error - 3.7%, controlled within ±5% error level, the average amount of glue in the reproducibility experiment was 2.90mg, experimental error -8.4% exceeded the standard. The conclusion of this study is: MDS 3050+ optimal glue volume accuracy is 0.301mg _(-0.001)^(+0.004), which meets the expected standard of a certain company; the reproducibility experiment exceeds the standard and does not meet the research purpose, and needs to be achieved through appropriate adjustments The target value is recommended to be investigated. The maximum contribution of the control factor to the glue quantity and quality is: push glue pressure 22.66%. It is recommended to use PID technology to stabilize the pressure. The minimum is: valve opening time 9.49%. It is recommended to use it as an adjustment factor for glue quantity. The contribution of this research is Rising Time contribution (22.62%) and Falling Time contribution (22.61%), which have an impact on the quality of glue quantity, and the degree should not be underestimated. Because Falling Time is affected by glue wrapping, it is recommended to limit it to less than 6ms when adjusting . Keywords: Electrochemical Blood Glucose Test Strips, Self-Monitoring of Blood Glucose, Piezoelectric Jet Dispensing, Taguchi Method, Signal-to-Noise Ratio.