制藥用水水中總有機物含量測試儀   隨著新藥典實施，我國的各個制藥工業，紛紛已經開始使用TOC(總有機碳)分析儀對制藥用水(純水和注射用水)的總有機物含量進行監測，以保證制藥用水能夠滿足某些強制的規定要求，比如美國藥典USP<643>和歐洲藥典EP2.2.44,以及中國藥典CP2005附錄VIII R的要求。滿足這些要求將可以保證通過FDA或COS認證（見注釋），或者滿足我們國家所強制的某些認證。

制藥用水水中總有機物含量測試儀  此外，也有很多公司試圖將TOC分析儀應用于清潔認證，替代HPLC檢測并證明生產過程中已經過清潔處理的設備或系統，其潔凈程度可以滿足下一批次生產的要求。兩種不同的應用該如何加以區分？

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。

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

本儀器采用紫外氧化的原理，將樣品中的有機物氧化為二氧化碳，二氧化碳的測試采用的是直接電導率法，通過測試經過氧化反應的樣品的總碳含量和未經過氧化反應的樣品總無機碳的含量差值來測定總有機碳含量，即：總有機碳（TOC）=總碳（TC）-總無機碳（TIC）。

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。

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%

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使用與操作方法

開始檢測并計入檢測次數，檢測完畢后顯示最后一次檢測結果，其中幾次檢測的結果均自動保存在查詢記錄當中。檢測次數的設置方式為：用“選擇”鍵移動光標，用“設置”鍵修改數字，按“確定”鍵進行確認，進入分析界面。先進行四次沖洗過程

主要特征:

1、高精度、高靈敏度，操作簡單。

2、人性化操作界面，有一鍵運行功能，自動管路清洗功能。

3、高性能CPU，觸摸屏設計，超大640*480點陣真彩顯示器。

4、不用拆開機箱更換UV燈和泵管。

5、檢測上限可設定，自動上限報警功能。

6、具有RS232數據接口，歷史數據可存儲6個月。

7、離線檢測和在線檢測可選配。

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

公司承諾：

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3.整機保修一年，產品終身維護

4.常年供應設備的易損件及耗品確保儀器能長期使用

5、售后管理：我公司實現計算機化管理，實行客戶定期電話回訪制度，定期復查設備的工作情況，定期電話指導用戶對設備進行保養和檢測，以便設備正常運轉，跟蹤客戶的設備使用情況，以便及時對設備進行維護

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7、軟件升級：終生免費提供新版本控制軟件。

8、安裝培訓:儀器包裝內附有說明書，專業培訓人員為客戶指定操作者講解儀器正常操作流程、操作注意事項及儀器的日常維護要求；也可以根據客戶要求提供上門培訓服務。