控制的边界完整性测试3级 (生物安全3级) 实验室 实验室
Cory Ziegler1, Gilles Tremblay1
1Merrick & Company, Life Sciences, Greenwood Village, Colorado, USA.
概括
限制级3 (CL3) 实验室的边界完整性测试至关重要. 这项研究提出了可量化的泄漏率标准,并建议USDA ARS标准作为CL3房间的可实现标准.
科学领域:
- 生物封闭工程 生物封闭工程
- 实验室安全标准 实验室安全标准
- 设施完整性测试 设施完整性测试
背景情况:
- 封闭3级 (CL3) 实验室需要强大的边界完整性.
- 目前关于CL3房间密封的指导方针往往是主观的,缺乏明确的标准.
- 确定CL3实验室封闭的客观标准对于安全至关重要.
研究的目的:
- 对CL3实验室的全球生物控制指南和标准进行审查.
- 为了比较国际CL3设施的泄漏测试结果.
- 为CL3实验室边界完整性提出标准化,可量化的标准.
主要方法:
- 标准化比较CL3设施的泄漏测试数据与250Pa的同等测试压力.
- 全球生物控制指南和标准的审查.
- 全球多个CL3设施测试结果的分析.
主要成果:
- 使用标准CL3方法建造的房间中有55%符合拟议的测试标准.
- 美国农业部ARS温室泄漏率标准 (0.139L/s/m2在250Pa) 是具有挑战性的,但可以实现的.
- 确定了不同CL3封闭级别和建筑实践的特定泄漏率.
结论:
- 建议采用两步边界完整性测试过程:初始泄漏检测/修复,然后进行可量化的测试.
- 在没有地方指南的情况下,ARS温室泄漏率 (0.152L/s/m2在300Pa) 是典型的CL3结构的合适标准.
- 对于主要的CL3隔离室,VDI指南 (0.03620L/s/m2在250Pa) 提供了一个更严格,更合适的标准.
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