- 學位論文
製藥用隔離裝置洩漏的研究
Study on the Leakage for Pharmaceutical Isolator
摘要
近年來由於國內醫藥產業的蓬勃發展，無塵室(cleanroom)技術進步，連帶著相關周邊設備與耗材也被廣泛的重視，早期採用的微環境是設計用來保護被處理的物質以避免受到污染，並非用來保護人員，這些潔淨台是無法處理具有傳染性的病媒，使工作人員暴露在受感染的風險。 隔離裝置(isolator)是生技廠最重要的基本安全防護，而作業環境中隔絕與空氣有害物質為重要之安全防護考量項目，與隔離裝置的氣密性與洩漏有關，會嚴重威脅工作人員與作業環境的安全。 本研究針對側回風的隔離裝置做了兩種不同的洩漏實驗，分別是(1) 粒子洩漏測試，先將隔離裝置所處背景環境的粒子數提升再將隔離裝置抽取在不同的負壓下計算粒子的洩漏；(2) SF6示蹤氣體洩漏測試，於腔體內外佈點，量測不同正壓與風速下腔體洩漏濃度的變化。(3) 再用壓力衰減洩漏測試，比較滿焊與無滿焊等兩台不同的隔離裝置，首先，先將腔體出風口與回風口密封住，在靜態情況下，用乾空氣打入腔體內，使其腔內壓力為正常工作壓力的4倍以上，比較其洩漏量與時間變化。根據實驗結果得知，(1) 側回風的隔離裝置粒子洩漏測試在(-18Pa)與(-25Pa)之間時洩漏百分比為30%~34%；(2) SF6示蹤氣體洩漏濃度，在平均風速為0.61m/s、0.51m/s、0.41m/s時洩漏百分比分別為7.8%、5.9%、3.8%。由以上的兩種不同測試方式，發現粒子測試方式，雖然快速簡單，能夠檢測出洩漏的存在但所得其洩漏值並不只是腔體外部的洩漏值，也有來自濾網上以及回流所堆積的粒子因此洩漏值百分比會偏大，而SF6示蹤氣體洩漏測試，雖然花費時間長，但敏感性與準確性高，洩漏量會受到風速與壓力的影響，腔體內洩漏濃度可視為隔離裝置滅菌階段時會造成的濃度分佈不均現象，腔體外的濃度分佈可視為污染物洩漏的擴散情形。(3) 壓力衰減洩漏測試，可得知滿焊的隔離裝置比無滿焊的隔離裝置，從初始壓力下降至最終壓力所花的時間差將近五倍，洩漏量兩者也相差了四倍，洩漏面積也差將近4.5倍以上，根據理想氣體方程式，發現腔體內的溫度與壓力必須要保持恆定，將會有效的降低洩漏量。
並列摘要
In recent years, domestic semiconductor industry is developed vigorously, cleanroom technology proceeded fast, linked with the related surrounding equipment and consumed materials that paid attention broadly. Early used clean platform to design treated material protection to avoid contamination and did not protect personnel. These clean platform could not treat infectious disease vector, therefore the staff will expose in the infected risk. Isolators is the most important basic security protection for biotechnology plant, the working environment isolated hazardous compounds of the air is an important security considerations, and related to air tight and leak of the isolator that serious threat to the security of the staff and the working environment. This study conducted two different leak test of side recirculated air isolator, (1) particles leak test, particle number of background environment of the isolator rose, then the isolator extracted at different negative pressure to calculate particle leak; (2) SF6 trace gas leak test, distributed sampling at inside and outside of the chamber to measure leak concentration change of the chamber at different positive and airflow; (3) leak test of pressure decay, compared the completed and uncompleted welding of the isolators. Firstly, sealed air outlet and return air of the chamber, threw dry air into the chamber to promote the internal pressure four times of the normal working pressure, compared the leak rate to the relate time change. In the experiment results: (1) side recirculated air isolator measured particle leak between -18Pa and -25Pa, leak ratio are 30~34%; (2) SF6 trace gas measured leak at 0.61m/s, 0.51m/s, and 0.41m/s air velocity, leak ratio are 7.8%, 5.9%, and 3.8%, respectively. From the above mentioned two different test methods, particle test detected leak while quick and easy, but its leak value is not only leakage value from outside of the chamber, and also came from the filter and returned the accumulated particles, therefore leak ratio is more larger, and; although SF6 trace gas leak test spent more time, but it had high sensitivity and accuracy. Leak quantity would be affected by air velocity and the pressure, leak concentration acted as sterilization phase of isolator that would result in concentration distributed nonhomogeneous phenomena, concentration distributed from outside of the chamber can be acted as leakage diffusion situation of contaminants leak. (3) leak test of pressure decay to compared completed and uncompleted isolator, spent time is five times from initial pressure descend to final pressure, the leak quantity had four times difference, leak area also had nearly 4.5 times. According to ideal gas equation, the temperature and pressure of the chamber need to keep constant that would effective of reduce leak quantity effectively.