供应

制药用水水中总有机物含量测试仪   随着新药典实施，我国的各个制药工业，纷纷已经开始使用TOC(总有机碳)分析仪对制药用水(纯水和注射用水)的总有机物含量进行监测，以保证制药用水能够满足某些强制的规定要求，比如美国药典USP<643>和欧洲药典EP2.2.44,以及中国药典CP2005附录VIII R的要求。满足这些要求将可以保证通过FDA或COS认证（见注释），或者满足我们国家所强制的某些认证。

制药用水水中总有机物含量测试仪  此外，也有很多公司试图将TOC分析仪应用于清洁认证，替代HPLC检测并证明生产过程中已经过清洁处理的设备或系统，其洁净程度可以满足下一批次生产的要求。两种不同的应用该如何加以区分？

TOC与PW（纯化水）/WFI（注射用水）

目前，我国大多数制药企业在PW（纯化水）/WFI（注射用水）系统上采用TOC监测主要是通过FDA/COS的认证，对于纯水和注射用水出口产品的监测必须有TOC指标，这是根据美国药典USP<643>或欧洲药典EP2.2.44的相关要求和规定而来的。FDA按照美国药典USP的规定对制药用水PW/WFI制水系统和TOC分析仪提出了以下要求：

1.给水要求

制药用水PW/WFI的取水水源必须满足当地环保署的要求和规定。

2.制造方式的要求

USP、EP和JP对于水的制造方式各有不同的要求，但总体一致的，其中：USP PW采用蒸馏、RO、DI或相同方式；USP WFI仅采用蒸馏和RO方式；EP WFI仅采用蒸馏方式；JP WFI允许采用蒸馏或RO/UF方式。

3.电导率的要求

对于电导率检测的要求，USP规定了三步检测法，都有相应的限制数值对照表。而TOC则规定了50ppb或更小的检测极限；根据制造厂商提供的方法进行校准；满足周期性系统适应性测试的要求。

4.微生物和内毒素的要求

美国药典USP和欧洲药典EP对微生物和内毒素的要求基本相同，日本药典JP相对来说更严格些。

With the implementation of the new pharmacopoeia, various pharmaceutical industries in China have started using TOC (Total Organic Carbon) analyzers to monitor the total organic content of pharmaceutical water (pure water and injection water) to ensure that it meets certain mandatory requirements, such as the United States Pharmacopeia USP<643>and the European Pharmacopeia EP2.2.44, as well as the requirements of Appendix VIII R of the Chinese Pharmacopoeia CP2005. Meeting these requirements will ensure FDA or COS certification (see note), or meet certain certifications mandated by our country.

In addition, many companies are attempting to apply TOC analyzers to clean certification, replacing HPLC testing and proving that equipment or systems that have been cleaned during the production process can meet the requirements of the next batch of production. How to distinguish between two different applications?

TOC and PW (purified water)/WFI (injection water)

At present, most pharmaceutical companies in China use TOC monitoring on PW (purified water)/WFI (water for injection) systems mainly through FDA/COS certification. TOC indicators must be included in the monitoring of pure water and injection water export products, which is based on the relevant requirements and regulations of the United States Pharmacopeia USP<643>or the European Pharmacopeia EP2.2.44. The FDA has put forward the following requirements for pharmaceutical water PW/WFI water production systems and TOC analyzers in accordance with the regulations of the United States Pharmacopeia USP:

1. Water supply requirements

The water source for pharmaceutical water PW/WFI must meet the requirements and regulations of the local environmental protection agency.

2. Requirements for manufacturing methods

USP, EP, and JP have different requirements for the production of water, but they are generally consistent. Among them, USP PW uses distillation, RO, DI, or the same method; USP WFI only uses distillation and RO methods; EP WFI only uses distillation method; JP WFI allows the use of distillation or RO/UF methods.

3. Requirements for conductivity

For the requirements of conductivity detection, USP specifies a three-step detection method with corresponding limit value comparison tables. And TOC specifies a detection limit of 50ppb or less; Calibrate according to the method provided by the manufacturer; Meet the requirements of periodic system adaptability testing.

工作原理

本仪器采用紫外氧化的原理，将样品中的有机物氧化为二氧化碳，二氧化碳的测试采用的是直接电导率法，通过测试经过氧化反应的样品的总碳含量和未经过氧化反应的样品总无机碳的含量差值来测定总有机碳含量，即：总有机碳（TOC）=总碳（TC）-总无机碳（TIC）。

应用范围

该仪器可用于检测制药工业中纯化水、注射用水和去离子水中有机碳的浓度；也可用于半导体行业中超纯水TOC的检测。

在制药领域和生物化学领域清洁验证过程中，可用于验证清洁效果。

该仪器具有在线检测功能，可以在线监测制药工业的制水系统、半导体工业的超纯水制备系统和晶片工艺过程、电厂去离子水制备过程等。

主要技术参数

电   源：220V?22V

电源频率：50Hz?1Hz

额定功率：100W

基本尺寸：44cm?18cm?26cm

检测极限：0.001mg/L

检测精度：?5%

检测范围：0.001mg/L～1.000mg/L

分析时间：4min

响应时间：15 min以内

样品温度：1-95℃

环境温度：10-40℃    温度变化在?5℃/d以内

内部样品流速：0.5 ml/min

相对湿度：≤85%

重复性误差：≤3%

零点漂移：?5%

量程漂移：?5%

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使用与操作方法

开始检测并计入检测次数，检测完毕后显示最后一次检测结果，其中几次检测的结果均自动保存在查询记录当中。检测次数的设置方式为：用“选择”键移动光标，用“设置”键修改数字，按“确定”键进行确认，进入分析界面。先进行四次冲洗过程

主要特征:

1、高精度、高灵敏度，操作简单。

2、人性化操作界面，有一键运行功能，自动管路清洗功能。

3、高性能CPU，触摸屏设计，超大640*480点阵真彩显示器。

4、不用拆开机箱更换UV灯和泵管。

5、检测上限可设定，自动上限报警功能。

6、具有RS232数据接口，历史数据可存储6个月。

7、离线检测和在线检测可选配。

8、具有打印功能

working principle

This instrument adopts the principle of ultraviolet oxidation to oxidize organic matter in the sample into carbon dioxide. The direct conductivity method is used to test the carbon dioxide content. The total organic carbon content is determined by measuring the difference between the total carbon content of the sample that has undergone oxidation reaction and the total inorganic carbon content of the sample that has not undergone oxidation reaction, that is, total organic carbon (TOC)=total carbon (TC) - total inorganic carbon (TIC).

Application scope

This instrument can be used to detect the concentration of organic carbon in purified water, injection water, and deionized water in the pharmaceutical industry; It can also be used for the detection of TOC in ultrapure water in the semiconductor industry.

In the pharmaceutical and biochemical fields, it can be used to verify the cleaning effect during the cleaning validation process.

This instrument has online detection function, which can monitor the water production system in the pharmaceutical industry, the ultrapure water preparation system and chip process in the semiconductor industry, and the deionized water preparation process in power plants online.

Main technical parameters

Power supply: 220V?22V

Power frequency: 50Hz?1Hz

Rated power: 100W

Basic dimensions: 44cm?18cm?26cm

Detection limit: 0.001mg/L

Detection accuracy:?5%

Detection range: 0.001mg/L to 1.000mg/L

Analysis time: 4 minutes

Response time: within 15 minutes

Sample temperature: 1-95℃

Environmental temperature: 10-40℃Temperature variation within?5℃/d

Internal sample flow rate: 0.5 ml/min

Relative humidity:≤85%

Repetitive error:≤3%

Zero drift:?5%

Range drift:?5%

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Usage and operation methods

Start the detection and count the number of detections. After the detection is completed, the last detection result will be displayed, and the results of several detections will be automatically saved in the query record. The setting method for the detection frequency is: use the "Select" key to move the cursor, use the "Set" key to modify the number, press the "OK" key to confirm, and enter the analysis interface. Perform four flushing processes first

Main features:

1. High precision, high sensitivity, and easy operation.

2. Humanized operation interface, with one click operation function and automatic pipeline cleaning function.

3. High performance CPU, touch screen design, ultra large 640 * 480 dot matrix true color display.

4. No need to open the chassis to replace the UV lamp and pump tube.

5. The detection upper limit can be set, and the automatic upper limit alarm function.

6. Equipped with RS232 data interface, historical data can be stored for 6 months.

7. Offline detection and online detection are optional.

8. Equipped with printing function

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