生物安全實驗室工程驗收規範探討

從2007~2016年生技產業營業額的複合年成長率達到5.7%，表現優於同時期的經濟成長率。生物安全實驗室是生技產業設施的必備核心，也是廠房設施中高風險的空間，生物安全實驗室依危害程度分為四個等級，在防護屏障上分為初級屏障(生物安全櫃及個人防護具)二級屏障為防護設施。台灣在生物安全規範上主要參考美國及其他國家標準，由於生技產業的發展，台灣相關規範仍在持續完善中，本研究主要分析各國在生物安全實驗室等級及生物安全防護屏障的規範及檢測標準。以生物安全實驗室第三等級(biological safety level-3,BSL3)比較加拿大與台灣規範及檢測項目，透過專家訪談及問卷調查後，「生物安全櫃測試」認為是生物安全實驗室最重要的第一道防護，重要性排名第一。加拿大14項檢測項目當中，皆是生物安全實驗室重要的防護，台灣目前僅檢測其中8項，建議可參考加拿大所多出的6項檢測項目為「水和化學淋浴系統進行測試」、「供水回流防止器測試」、「備用電源和UPS系統測試」、「聯鎖門的操作驗證」、「安全系統的操作」及「通信和電子的操作傳輸系統測試」；建議應納入台灣生物安全實驗室驗收標準，更完善生物安全屏障，確保實驗室安全，做為台灣未來修訂生物安全實驗室工程驗收標準。

關鍵字

生物安全；生物安全實驗室；生物安全等級；生物安全櫃；生物安全防護屏障；生物安全實驗室工程驗收標準

並列摘要

From 2007 to 2016, the compound annual growth rate of biotechnology industry turnover reached 5.7%, which was better than the economic growth rate in the same period. The biosafety laboratory is an essential core of the biotechnology industry facilities and a high-risk space in the bio-manufacturing facilities. The biosafety laboratory can be categorized into four levels in terms of the degree of hazard. In addition, the biosafety laboratory is classified into primary protective barriers for biological safety cabinets and personal protective equipment and the secondary protective barrier for building shell and facility systems. Taiwan often refers to the US and other national standards for established her biosafety regulations. Due to the rapid growth of the biotechnology industry, Taiwan has been continuously upgrading her relevant regulations on biosafety. This study mainly analyzed the regulations and testing items of protective barriers in biosafety laboratory during commissioning phase among various countries. Particularly, Canadian and Taiwanese latest regulation and testing items on the biological safety level-3 (BSL3) are compared. Through expert interview and questionnaire suvey, the “Biosafety Cabinet Test” is ranked the most important part of the biosafety laboratory. All the 14 Canadian required commissioning tests are important mechanism to protect comtamination of biosafety laboratory. Nevertheless, only 8 of the 14 are required commissioned items in Taiwan. It is recommended that the other 6 Canadian commissioning test items be regulated as mandatory tests at Taiwan. They are “water and chemical shower systems”, “water supply”, “Backflow Preventer Test", "Replacement Power and UPS System Test", "Operational Verification of Interlocking Doors", "Operation of Safety System" and "Communication and Electronic Operation Transmission System Test". Thus, it not only could reinforce bio-safety protective barriers, but also it could ensure safer operation of biosafety laboratory at Taiwan in the future.