生物安全櫃性能之量測

Performance Tests of Biological Safety Cabinets

生物安全櫃為生物性研究中普遍用到的實驗設備之一，於實驗操作時它可保護人員及產品免於生物性的危害或污染。為瞭解國內生物安全櫃的操作性能狀態，本研究依據美國 NSF 49（National Sanitation Foundation，簡稱NSF）的現場測試（field tests）標準，針對國內最常使用的class II A1型或 A2 型生物安全櫃進行量測，測試方項目包括 HEPA 過濾器洩漏、下吹氣流、入口氣流、煙流型態、噪音、照明度、漏電流等測試。測試櫃體共有 23 台，包含 21 台未經 NSF 認證的國產安全櫃，以及 2 台經過 NSF 認證的進口美製生物安全櫃。結果發現國產無認證的生物安全櫃在 HEPA 過濾器洩漏、下吹氣流、入口氣流、煙流型態、照明度等測試項目的不合格率極高，尤其在入口氣流與煙流型態測試的不合格率為 100%。美製有認證的生物安全櫃則僅有一台櫃體的照明不合格。由於國產生物安全櫃的不合格率極高，以致操作人員在進行生物性實驗時遭受櫃內溢出的生物性感染風險極高，實有立即改善之必要。同時國產生物安全櫃製造商的設計能力也應立即提昇。另外安全櫃使用者對生物安全櫃的分級、確效標準、操作、維護與測試等認知不足，須有更進一步的瞭解。

Biological Safety Cabinets (BSCs)are widely used in biological research for protecting personnel and product from biohazard or contamination. This study presents the results of the BSCs performance tests against NSF 49 (National Sanitation Foundation, NSF) field test standard. The tested cabinets were class II A1 or A2 type. Test items included the HEPA filters leak, downflow velocity, inflow velocity, airflow smoke patterns, noise, lighting intensity and electrical leakage tests. A total of 23 BSCs was tested, among which 21 BSCs were locally made without NSF certification and the other two with NSF certification were imported from the U.S. Test results indicated that the BSCs without NSF certification failed in the tests of the HEPA filters leak, downflow velocity, inflow velocity, airflow smoke pattern and lighting intensity. Especially all of the non-certified locally made BSCs failed in inflow velocity and airflow smoke pattern tests indicating the potential of biohazard risk to the personnel using the BSCs. Immediate improvement is recommended for such products. In contrast, only one of the certified BSCs failed in the lighting intensity test. It is recommended that domestic BSCs manufacturers improve their design capability and the BSC obtain the knowledge of BSCs classification, certification, operation, maintenance and validation tests.