制藥用水水中總有機(jī)物含量測(cè)試儀   隨著新藥典實(shí)施，我國(guó)的各個(gè)制藥工業(yè)，紛紛已經(jīng)開(kāi)始使用TOC(總有機(jī)碳)分析儀對(duì)制藥用水(純水和注射用水)的總有機(jī)物含量進(jìn)行監(jiān)測(cè)，以保證制藥用水能夠滿足某些強(qiáng)制的規(guī)定要求，比如美國(guó)藥典USP<643>和歐洲藥典EP2.2.44,以及中國(guó)藥典CP2005附錄VIII R的要求。滿足這些要求將可以保證通過(guò)FDA或COS認(rèn)證（見(jiàn)注釋），或者滿足我們國(guó)家所強(qiáng)制的某些認(rèn)證。

制藥用水水中總有機(jī)物含量測(cè)試儀  此外，也有很多公司試圖將TOC分析儀應(yīng)用于清潔認(rèn)證，替代HPLC檢測(cè)并證明生產(chǎn)過(guò)程中已經(jīng)過(guò)清潔處理的設(shè)備或系統(tǒng)，其潔凈程度可以滿足下一批次生產(chǎn)的要求。兩種不同的應(yīng)用該如何加以區(qū)分？

TOC與PW（純化水）/WFI（注射用水）

目前，我國(guó)大多數(shù)制藥企業(yè)在PW（純化水）/WFI（注射用水）系統(tǒng)上采用TOC監(jiān)測(cè)主要是通過(guò)FDA/COS的認(rèn)證，對(duì)于純水和注射用水出口產(chǎn)品的監(jiān)測(cè)必須有TOC指標(biāo)，這是根據(jù)美國(guó)藥典USP<643>或歐洲藥典EP2.2.44的相關(guān)要求和規(guī)定而來(lái)的。FDA按照美國(guó)藥典USP的規(guī)定對(duì)制藥用水PW/WFI制水系統(tǒng)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(dāng)?shù)丨h(huán)保署的要求和規(guī)定。

2.制造方式的要求

USP、EP和JP對(duì)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(dǎo)率的要求

對(duì)于電導(dǎo)率檢測(cè)的要求，USP規(guī)定了三步檢測(cè)法，都有相應(yīng)的限制數(shù)值對(duì)照表。而TOC則規(guī)定了50ppb或更小的檢測(cè)極限；根據(jù)制造廠商提供的方法進(jìn)行校準(zhǔn)；滿足周期性系統(tǒng)適應(yīng)性測(cè)試的要求。

4.微生物和內(nèi)毒素的要求

美國(guó)藥典USP和歐洲藥典EP對(duì)微生物和內(nèi)毒素的要求基本相同，日本藥典JP相對(duì)來(lái)說(shuō)更嚴(yán)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(jī)物氧化為二氧化碳，二氧化碳的測(cè)試采用的是直接電導(dǎo)率法，通過(guò)測(cè)試經(jīng)過(guò)氧化反應(yīng)的樣品的總碳含量和未經(jīng)過(guò)氧化反應(yīng)的樣品總無(wú)機(jī)碳的含量差值來(lái)測(cè)定總有機(jī)碳含量，即：總有機(jī)碳（TOC）=總碳（TC）-總無(wú)機(jī)碳（TIC）。

應(yīng)用范圍

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

在制藥領(lǐng)域和生物化學(xué)領(lǐng)域清潔驗(yàn)證過(guò)程中，可用于驗(yàn)證清潔效果。

該儀器具有在線檢測(cè)功能，可以在線監(jiān)測(cè)制藥工業(yè)的制水系統(tǒng)、半導(dǎo)體工業(yè)的超純水制備系統(tǒng)和晶片工藝過(guò)程、電廠去離子水制備過(guò)程等。

主要技術(shù)參數(shù)

電   源：220V?22V

電源頻率：50Hz?1Hz

額定功率：100W

基本尺寸：44cm?18cm?26cm

檢測(cè)極限：0.001mg/L

檢測(cè)精度：?5%

檢測(cè)范圍：0.001mg/L～1.000mg/L

分析時(shí)間：4min

響應(yīng)時(shí)間：15 min以內(nèi)

樣品溫度：1-95℃

環(huán)境溫度：10-40℃    溫度變化在?5℃/d以內(nèi)

內(nèi)部樣品流速：0.5 ml/min

相對(duì)濕度：≤85%

重復(fù)性誤差：≤3%

零點(diǎn)漂移：?5%

量程漂移：?5%

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使用與操作方法

開(kāi)始檢測(cè)并計(jì)入檢測(cè)次數(shù)，檢測(cè)完畢后顯示最后一次檢測(cè)結(jié)果，其中幾次檢測(cè)的結(jié)果均自動(dòng)保存在查詢記錄當(dāng)中。檢測(cè)次數(shù)的設(shè)置方式為：用“選擇”鍵移動(dòng)光標(biāo)，用“設(shè)置”鍵修改數(shù)字，按“確定”鍵進(jìn)行確認(rèn)，進(jìn)入分析界面。先進(jìn)行四次沖洗過(guò)程

主要特征:

1、高精度、高靈敏度，操作簡(jiǎn)單。

2、人性化操作界面，有一鍵運(yùn)行功能，自動(dòng)管路清洗功能。

3、高性能CPU，觸摸屏設(shè)計(jì)，超大640*480點(diǎn)陣真彩顯示器。

4、不用拆開(kāi)機(jī)箱更換UV燈和泵管。

5、檢測(cè)上限可設(shè)定，自動(dòng)上限報(bào)警功能。

6、具有RS232數(shù)據(jù)接口，歷史數(shù)據(jù)可存儲(chǔ)6個(gè)月。

7、離線檢測(cè)和在線檢測(cè)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：

1.購(gòu)機(jī)前，我們專門派技術(shù)人員為您設(shè)計(jì)的流程和方案

2.購(gòu)機(jī)后，將免費(fèi)指派技術(shù)人員為您調(diào)試安裝

3.整機(jī)保修一年，產(chǎn)品終身維護(hù)

4.常年供應(yīng)設(shè)備的易損件及耗品確保儀器能長(zhǎng)期使用

5、售后管理：我公司實(shí)現(xiàn)計(jì)算機(jī)化管理，實(shí)行客戶定期電話回訪制度，定期復(fù)查設(shè)備的工作情況，定期電話指導(dǎo)用戶對(duì)設(shè)備進(jìn)行保養(yǎng)和檢測(cè)，以便設(shè)備正常運(yùn)轉(zhuǎn)，跟蹤客戶的設(shè)備使用情況，以便及時(shí)對(duì)設(shè)備進(jìn)行維護(hù)

6、物流情況：及時(shí)提供貨源，確保全國(guó)范圍內(nèi)2-10內(nèi)到貨，持續(xù)穩(wěn)定地為代理商做全面服務(wù)工作，提供合理的運(yùn)作空間。公司有專業(yè)的技術(shù)人員為您安裝指導(dǎo)。

7、軟件升級(jí)：終生免費(fèi)提供新版本控制軟件。

8、安裝培訓(xùn):儀器包裝內(nèi)附有說(shuō)明書，專業(yè)培訓(xùn)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(xiàng)及儀器的日常維護(hù)要求；也可以根據(jù)客戶要求提供上門培訓(xùn)服務(wù)。