Qualification protocol of Compressed air system压缩空气系统验证方案 共 12 页 第 11
页 细菌数，同时用5.3.1.1.1剩余纯化水100ml做空白，所得细菌总数减去空白。
5.3.1.1.4 Visual inspect the remaining samples 其余样品进行目检。 5.3.1.2 Acceptance critera确认标准：
5.3.1.2.1 Particular matter微粒：No visual foreign matter in the sample.样品目测无可见杂质。
5.3.1.2.2 Oiliness含油：No oil contamination in the sample.样品目测无油污。
5.3.1.2.3 Total count of bacterial 细菌数： ≤ 1CFU/m3。 5.3.1.3 Record确认记录：
Position Times 使用点位置 检测次数 Particular matter颗粒 Oiliness油污 Total count of Results bacterial 细菌数 结果 Tested by测试人： Reviewed by确认人： Date测试日期： Date确认日期：
5.4 Re-validation and re-validation period拟定再验证及验证周期：
Re-validation will be performed as this protocol or supplement protocol drafted per actual Situation when there were major change or maintenance in this equipment, and any exception in manufacture process, and any trouble in the utilities etc to ensure applicability and repeatability of this equipment. 当设备和装置发生较大变更或做大检修后，在日常验证中发现重要的工艺特性出现异常，公用工程发现故障以等情况下，应按照期前验证采用的方法对设备进行
Qualification protocol of Compressed air system压缩空气系统验证方案 共 12 页 第 12
页 再验证，或根据实际情况修订补充验证方案后进行“再验证”，以确认设备的适应性和重现性。
Re-validation period should be identified per the requirement of process and operation status of this equipment by Equipment Department( See the Validation master plan). 设备部根据工艺要求、设备运行情况拟定验证周期(见“验证主计划” )。 5.5 Conclusion 验证方案结论：
Conclusion should be decided per validation results.If applicable, Analysis and summarize this problem occurred in validation process. 根据验证结果，做出验证是否通过的结论，如适用，对验证中发生的问题进行分析总结。
Conclusion see the validation report验证结论见验证报告。
6.0 Approval of validation protocol验证方案最终批准：
This validation protocol is effectively after approved by relatively department manager, Quality Director. 验证方案最终由相关部门经理，质量总监批准后生效。