Page 59 - 总厂实用英语手册电子书2.0
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7.Before the packaging operation, all packaging materials drawn for use should
also be checked for correctness, and the name, strength, quantity, and quality
status of bulk products and all packaging materials should be checked to ensure
the conformity with master manufacturing documents.
包装操作前，还应当检查所领用的包装材料正确无误，核对待包装产品和
所用包装材料的名称、规格、数量、质量状态，且与工艺规程相符。
8.Each packaging container of rejected materials, intermediate, bulk and finished products
should be clearly marked, and properly stored in restricted areas.
不合格的物料、中间产品、待包装产品和成品的每个包装容器上均应当有清晰醒目的标志，
并在隔离区内妥善保存。
9.For each product batch, checks on yields and reconciliation of quantities should be carried out
to ensure that there are no discrepancies outside of the acceptable limits.
每批产品应当检查产量和物料平衡，确保物料平衡符合设定的限度。
10.Packaging operation procedures should specify the measures to minimize the risk
of contamination , cross-contamination, mix-ups or errors.
包装操作规程应当规定降低污染和交叉污染、混淆或差错风险的措施。
11.Settle plates should be exposed for the duration of operations and changed as required after 4
hours. Exposure time should be based on recovery studies and should not allow desiccation of
the media used.
沉降碟应在操作期间暴露，并在 4 小时后按要求更换。暴露时间应基于回收研究，并且不
应使所用培养基干燥。
12.Where aseptic operations are performed, microbial monitoring should be frequent using a
combination of methods such as settle plates, volumetric air sampling, glove, gown and surface
sampling (e.g. swabs and contact plates).
当进行无菌操作时，应采用多种方法经常进行微生物监测，例如沉降碟、定量空气采样、
手套、洁净服和表面采样（例如棉签擦拭和接触碟）。
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