Page 60 - 总厂实用英语手册电子书2.0
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13.Continuous viable air monitoring in the Grade A zone (e.g. air sampling or
settle plates) should be undertaken for the full duration of critical processing,
including equipment (aseptic set-up) assembly and filling operations. A similar
approach should be considered for Grade B cleanrooms based on the risk of
impact on the aseptic processing.
A 级区的关键工艺（包括设备装配（无菌安装）和灌装操作）的整个持续期间都应连续监
测空气活性微粒（例如空气采样或沉降碟）。对于 B 级洁净室，应基于对无菌工艺的影响
风险，考虑类似的方式。
14.The monitoring should be performed in such a way that all interventions, transient events
and any system deterioration would be captured and any risk caused by interventions of the
monitoring operations is avoided.
监测方式应能捕获所有干扰、瞬态事件和任何系统恶化，并且避免由监测操作的干预引起
的任何风险。
15.Personnel gloves and any part of the gown that may potentially have direct impact on the
product sterility (e.g. the sleeves if these enter a critical zone) should be monitored for viable
contamination after critical operations and on exit from the cleanroom. Other surfaces should be
monitored at the end of an operation.
应在关键操作后以及离开洁净室时监测人员手套以及可能对产品无菌性产生直接影响的
工作服的任何部分（例如，进入关键区域的袖套）上的活性微粒污染。在操作结束时应监
测其它表面。
16.The clothing and its quality should be appropriate for the process and the grade of
the working area.
工作服及其质量应当与生产操作的要求及操作区的洁净度级别相适应。
17. Test results that fall outside of established acceptance criteria which have been
established in official compendia and/or by company documentation.
超标数据（OOS）：指不符合预定标准的检验结果。任何落在已经建立的规格标准，包括
括药典、注册标准、法定标准；
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