用于清洁验证的Sievers TOC分析仪
Total organic carbon (TOC) analysis is a simple and highly effective analytical tool commonly used to validate the effective cleaning of manufacturing equipment in industries such as pharmaceuticals, biopharmaceuticals, cosmetics, personal care, food & beverage, and medical devices. Cleaning validation involves demonstrating that the documented cleaning process effectively removes contaminants to a pre-defined, suitable level to prevent the possibility of cross-contamination during manufacturing. TOC is often the method of choice for cleaning validation and cleaning process control, enabling companies to operate more efficiently, reduce risks, and improve quality control.
测试可以在实验室、生产车间（现场）进行，也可以在自动清洁循环的最后冲洗（在线）支流中进行（附在CIP模块上）。借助Sievers M9实验室、便携式和在线TOC分析仪，您可以根据生产工艺和需求设计清洁方案。
Download our comparison guide for Lab vs At-line vs Online TOC analysis for cleaning validation.
Sievers TOC Options for Cleaning Validation
- 实验室
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TOC and conductivity analysis are routine tests that can be found in most Quality Control (QC) laboratories supporting cGMP operations. Benchtop TOC analyzers and software are available that allow users to stack protocols, run system protocols, run large volumes of samples at a time, manage data, and electronically sign and export data. Sievers experts can help support the start-up of a TOC analyzer in QC or the transition from analytical methods such as HPLC or UV-vis (i.e., specific methods) to non-specific methods such as TOC for cleaning validation practices.
入门资源：
Sievers Laboratory TOC portfolio and consumables:
- 旁线
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用于清洁验证的旁线TOC检测能够显著提高流程效率，尤其适用于有时间限制的清洁程序。旁线部署使用便携式TOC分析仪，直接将其置于要监测的流程旁边，清洁过程完成后即可采集所需样本并进行分析。传统的实验室测试依赖于QC工作、采样、分析以及数据发布的协调，通常会使设备闲置一段时间。相比之下，旁线分析允许采集样本后立即在触手可及的便携式TOC分析仪上进行分析，因此可以在清洁后更快地周转设备。旁线清洁验证可以减少清洁保持时间，从而减少不必要的设备停机时间。擦拭和冲洗样品结果可在几分钟内生成并供审查，避免了与QC工作流程相关的任何延迟，而且减少了设备停滞时间。
入门资源：
Sievers TOC 产品组合 and consumables for at-line cleaning validation:
- 在线
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由于采样和样本分析工作而导致设备停机是清洁验证的一个痛点。直接集成到就地清洗（CIP）撬装块中的TOC分析仪可在得到数据后实时放行，从而将设备停机时间从几天缩短到几分钟。程序化的自动化流程可将CIP冲洗样本从撬装块直接转移到分析仪进行分析。分析样本后，数据会自动导出至站点数据主机。
Online cleaning validation with TOC offers process understanding, process control, risk management, efficiency gains, and optimization that cannot be achieved with laboratory monitoring. Additionally, online cleaning validation can be used in multiple applications:
- 清洗残留物表征
- 通过可视化冲洗曲线优化清洁周期
- 连续清洁验证程序
入门资源：
Sievers TOC portfolio for online cleaning validation:
