供应

河北纯水TOC水质分析仪 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。

 河北纯水TOC水质分析仪   二氧化碳传感器

仪器上安装有两个二氧化碳传感器，由电导率传感器和温度传感器组成。电导率测量采用双精度技术，可以实现自动校准和温度补偿。TIC传感器用于检测未经氧化的水样中二氧化碳浓度，同时检测水样的电导率值；TC传感器用于检测水样本身含有的二氧化碳和水样中有机物经分解后产生的二氧化碳浓度的总和。

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%

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。

装箱清单

产品特点

1.仪器采用便携设计，使用轻便，方便移动至取样点。

2.采用嵌入式系统，触摸屏设计，纯中文操作方便简易。

3.针对制药用水（TOC含量在1000ppb以下）总有机碳含量的检测设计，进行检测。

4.配备大量的储存空间，能够存储大量的测试数据。

5.中文打印，输出测试参数、测试结果。

6.在使用、贮存和更换过程中不需要气体或试剂，无移动部件，减少维修和维护成本。

7.当测试样品浓度超过规定限度，仪器能够自动报警，并输出控制信号。

8.符合国家《中国药典》 CP2010规定的测试方案，可以提供IQ/OQ/PQ服务。

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.

Carbon dioxide sensor

There are two carbon dioxide sensors installed on the instrument, consisting of a conductivity sensor and a temperature sensor. The conductivity measurement adopts dual precision technology, which can achieve automatic calibration and temperature compensation. TIC sensors are used to detect the concentration of carbon dioxide in unoxidized water samples, while also measuring the conductivity value of the water sample; The TC sensor is used to detect the total concentration of carbon dioxide contained in the water sample itself and the carbon dioxide produced by the decomposition of organic matter in the water sample.

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%

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.

4. Requirements for Microorganisms and endotoxins

The requirements for microorganisms and endotoxins in the United States Pharmacopeia (USP) and European Pharmacopeia (EP) are basically the same, while the Japanese Pharmacopeia (JP) is relatively stricter.

Packing List

One experimental host

Two collection tubes

One power cord

One set of control system

A set of data collection system

One copy of the product user manual

One copy of product qualification certificate and warranty card

Product Features

1. The instrument adopts a portable design, which is easy to use and convenient to move to the sampling point.

2. Adopting an embedded system and touch screen design, pure Chinese operation is convenient and easy.

3. Design and conduct testing for the total organic carbon content of pharmaceutical water (TOC content below 1000ppb).

4. Equipped with a large amount of storage space, capable of storing a large amount of test data.

5. Print in Chinese and output test parameters and results.

6. No gas or reagents are required during use, storage, and replacement, and there are no moving parts, reducing maintenance and repair costs.

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产品保修承诺：

1、免费送货到用户指定的地点，免费指导安装、培训及调试。

2、保修期内人为损坏的零部件按采购（加工）价格收费更换。

3、保修期外继续为用户提供优质技术服务，在接到用户维修邀请后3天内派工程师到达用户现场进行维修。并享有优惠购买零配件的待遇。

4、传感器过载及整机电路超压损坏不在保修范围内。

5、产品质保期：自安装正常使用日起一年；

6、软件升级：终生免费提供新版本控制软件。