Lorenz M R, Robinson J E
Kling-Lindquist Partnership, Inc., Philadelphia, Pennsylvania.
J Parenter Sci Technol. 1991 Nov-Dec;45(6):279-85.
As more potentially hazardous biopharmaceutical and powder derivative products are being processed aseptically, the term "containment" in aseptic facility design must take on a broader definition. Contamination control must address not only protection of the product, but the protection of aseptic facility workers and of the surrounding environment as well. This paper will focus on design issues related to the physical boundaries (walls, ceilings, doors, etc.) that separate aseptic areas from other spaces within a facility with particular emphasis on the design of airlocks as "control points" for contamination control.
随着越来越多具有潜在危险性的生物制药和粉末衍生产品采用无菌工艺进行加工，无菌设施设计中的“隔离”一词必须有更广泛的定义。污染控制不仅要考虑对产品的保护，还需兼顾对无菌设施工作人员以及周围环境的保护。本文将聚焦于与物理边界（墙壁、天花板、门等）相关的设计问题，这些边界将无菌区域与设施内的其他空间分隔开来，尤其着重于气闸作为污染控制“控制点”的设计。
