河北純水TOC水質分析儀 應用范圍

該儀器可用于檢測制藥工業中純化水、注射用水和去離子水中有機碳的濃度；也可用于半導體行業中超純水TOC的檢測。

在制藥領域和生物化學領域清潔驗證過程中，可用于驗證清潔效果。

該儀器具有在線檢測功能，可以在線監測制藥工業的制水系統、半導體工業的超純水制備系統和晶片工藝過程、電廠去離子水制備過程等。

 河北純水TOC水質分析儀   二氧化碳傳感器

儀器上安裝有兩個二氧化碳傳感器，由電導率傳感器和溫度傳感器組成。電導率測量采用雙精度技術，可以實現自動校準和溫度補償。TIC傳感器用于檢測未經氧化的水樣中二氧化碳濃度，同時檢測水樣的電導率值；TC傳感器用于檢測水樣本身含有的二氧化碳和水樣中有機物經分解后產生的二氧化碳濃度的總和。

主要技術參數

電   源：220V?22V

電源頻率：50Hz?1Hz

額定功率：100W

基本尺寸：44cm?18cm?26cm

檢測極限：0.001mg/L

檢測精度：?5%

檢測范圍：0.001mg/L～1.000mg/L

分析時間：4min

響應時間：15 min以內

樣品溫度：1-95℃

環境溫度：10-40℃    溫度變化在?5℃/d以內

內部樣品流速：0.5 ml/min

相對濕度：≤85%

重復性誤差：≤3%

零點漂移：?5%

量程漂移：?5%

TOC與PW（純化水）/WFI（注射用水）

目前，我國大多數制藥企業在PW（純化水）/WFI（注射用水）系統上采用TOC監測主要是通過FDA/COS的認證，對于純水和注射用水出口產品的監測必須有TOC指標，這是根據美國藥典USP<643>或歐洲藥典EP2.2.44的相關要求和規定而來的。FDA按照美國藥典USP的規定對制藥用水PW/WFI制水系統和TOC分析儀提出了以下要求：

1.給水要求

制藥用水PW/WFI的取水水源必須滿足當地環保署的要求和規定。

2.制造方式的要求

USP、EP和JP對于水的制造方式各有不同的要求，但總體一致的，其中：USP PW采用蒸餾、RO、DI或相同方式；USP WFI僅采用蒸餾和RO方式；EP WFI僅采用蒸餾方式；JP WFI允許采用蒸餾或RO/UF方式。

3.電導率的要求

對于電導率檢測的要求，USP規定了三步檢測法，都有相應的限制數值對照表。而TOC則規定了50ppb或更小的檢測極限；根據制造廠商提供的方法進行校準；滿足周期性系統適應性測試的要求。

4.微生物和內毒素的要求

美國藥典USP和歐洲藥典EP對微生物和內毒素的要求基本相同，日本藥典JP相對來說更嚴格些。

裝箱清單

產品特點

1.儀器采用便攜設計，使用輕便，方便移動至取樣點。

2.采用嵌入式系統，觸摸屏設計，純中文操作方便簡易。

3.針對制藥用水（TOC含量在1000ppb以下）總有機碳含量的檢測設計，進行檢測。

4.配備大量的儲存空間，能夠存儲大量的測試數據。

5.中文打印，輸出測試參數、測試結果。

6.在使用、貯存和更換過程中不需要氣體或試劑，無移動部件，減少維修和維護成本。

7.當測試樣品濃度超過規定限度，儀器能夠自動報警，并輸出控制信號。

8.符合國家《中國藥典》 CP2010規定的測試方案，可以提供IQ/OQ/PQ服務。

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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產品保修承諾：

1、免費送貨到用戶指定的地點，免費指導安裝、培訓及調試。

2、保修期內人為損壞的零部件按采購（加工）價格收費更換。

3、保修期外繼續為用戶提供優質技術服務，在接到用戶維修邀請后3天內派工程師到達用戶現場進行維修。并享有優惠購買零配件的待遇。

4、傳感器過載及整機電路超壓損壞不在保修范圍內。

5、產品質保期：自安裝正常使用日起一年；

6、軟件升級：終生免費提供新版本控制軟件。