Page 58 - 总厂实用英语手册电子书2.0

（六）句型应用 sentence type application
1.Operation procedures should include the title, code, version number, issuing
department, effective date, distribution list, along with the dated signatures of
author, reviewer and approver, the title, content, and revision history.

操作规程的内容应当包括：题目、编号、版本号、颁发部门、生效日期、分发部门以及制
定人、审核人、批准人的签名并注明日期，标题、正文及修订历史。

2.Where the dry heat sterilization is intended to remove pyrogens, challenge tests using
endotoxins should be used as part of the validation.

干热灭菌用于去除热原时，验证应当包括细菌内毒素挑战试验。

3.The monitoring parameters of moist heat sterilization should include temperature, time and
pressure.
湿热灭菌工艺监测的参数应当包括灭菌温度、时间或压力。

4.For sterilizers fitted with a drain at the bottom of the chamber, it may also be necessary to
record the temperature at this position throughout the sterilization period

腔室底部装有排水口的灭菌柜，必要时应当测定并记录该点在灭菌全过程中的温度数据。

5.There should be regular leak tests on the chamber when a vacuum phase is part of the cycle.
灭菌工艺中包括抽真空操作的，应当定期对腔室作检漏测试。

6.Before packaging, checks should be performed to ensure that the work area, packaging lines,
printing machines and other equipment are clean or ready for use, and that they are free from
any products and documents left from the last batch, or materials not relating to the packaging
of this batch. The results should be recorded accordingly.
包装开始前应当进行检查，确保工作场所、包装生产线、印刷机及其他设备已处于清洁或
待用状态，无上批遗留的产品、文件或与本批产品包装无关的物料。检查结果应当有记录。

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