離線線總有機碳分析儀/在線TOC測試儀  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2010版《中國藥典》規定的測試方案，可以提供 IQ/OQ/PQ 服務。

離線線總有機碳分析儀/在線TOC測試儀  參數：

TOC就是關于進行改進和如何 實施這些改進的一套管理理念和管理原則，可以幫助企業識別出在實現目標的過程中存在著哪些制約因素——TOC稱之為“約束”，并進一步指出如何實施必要的改進來一一消除這些約束，從而更有效的實現企業目標。

廢水的性質或水質是水和各種雜質組成的復雜體系所表現出來的綜合特性,這種特性在工程實...急性毒性的單位通常是以在特定暴露時間內使試驗生物死亡50%的毒物或廢水濃度，即半致死濃度LD50來表示。

從理論上對化工污水TOC與COD_a的相關性進行了分析,對在實際工作中測得的TOC和COD_a數據進行了回歸分析。結果表明,化工污水的TOC和COD_a之間有著良好的相關性。在一定條件下,利用回歸方程可以從測得的TOC值推算出COD_a值,或者從COD_a值推算出TOC值。因此,TOC值可以用來表示有機廢水的污染程度,也可做為有機污染物的一個控制指標。

有很好的相關性[Z,31一、前言在同一廢水樣中,如無其它干擾,且氧化 ,則測得的TOC值與COD值成正比例關系,長期以來,評價水體中有機物朽染的程度即COD—KTOC。因C+Oz—CO卜所以＊一都是利用經典方法測定COD和BOD。BOD/五32/12=2.667。

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.

When the concentration of the test sample exceeds the specified limit, the instrument can automatically sound an alarm and output a control signal.

8. According to the testing plan specified in the 2010 edition of the Chinese Pharmacopoeia, IQ/OQ/PQ services can be provided.

Parameters:

Measurement range: 0.01mg/L to 1.000mg/L

2 accuracy ± 4%

3 Resolution 0.001mg/L

4 analysis time 40 minutes

5 response time 8 minutes

6 detection limit 0.001mg/L

Sample temperature: 1-95 ℃

8 Power Requirements/Function 220V

9. Repetitive error ≤ 3%

10 color touch screen display

TOC is a set of management concepts and principles about making improvements and how to best implement them. It can help companies identify the constraints that exist in the process of achieving their goals, which TOC refers to as "constraints", and further point out how to implement necessary improvements to eliminate these constraints one by one, in order to more effectively achieve their corporate goals.

The nature or quality of wastewater is a comprehensive characteristic exhibited by a complex system composed of water and various impurities, which is important in engineering practice The unit of acute toxicity is usually expressed as the half lethal concentration (LD50) of the toxic substance or wastewater that causes 50% death of the test organism within a specific exposure time.

Theoretical analysis was conducted on the correlation between TOC and COD_a in chemical wastewater, and regression analysis was performed on the TOC and COD_a data measured in practical work. The results indicate a good correlation between TOC and COD_a in chemical wastewater. Under certain conditions, the COD_a value can be calculated from the measured TOC value using regression equations, or the TOC value can be calculated from the COD_a value. Therefore, TOC value can be used to indicate the degree of pollution in organic wastewater and can also be used as a control indicator for organic pollutants.

There is a good correlation [Z, 31]. Preface: In the same wastewater sample, if there is no other interference and the oxidation is complete, the measured TOC value is directly proportional to the COD value. For a long time, the degree of organic matter decay in water bodies has been evaluated as COD-KTOC. Since C+Oz-CO is calculated, the classic methods are used to determine COD and BOD. BOD/5-32/12=2.667.

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。

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.

TOC與清潔認證

FDA對于清潔認證并無通用方法或限度標準，鑒于生產設備和產品性質的多樣性，由藥品監督機構設立統一的限度標準和檢驗方法是不現實的。企業應該根據其生產設備和產品的實際情況，制定科學合理、能夠實現并能通過適當方法檢驗的限度標準。

對純水和注射用水的檢測要求的TOC是ppb級，而清潔認證中是對TOC的要求是ppm級的高濃度。

TOC在兩種檢測中是兩種 不同的概念。因為檢測的TOC范圍不同，適合采用的檢測方式不同，所依據的規則也不同。

現在的儀器廠家基于成本的考慮，不可能將低濃度和高濃度的檢測通道分開，通常都是使用同一套檢測通道、同一套計算芯片和電路，這樣必然造成高濃度和低濃度樣品的交叉污染。得出的結果必定無法通過相關標準要求。北京北廣精儀儀器設備有限公司通過多年的研究測試成功研發出了升級款的總有機碳分析儀BC-40A升級款，可有效規避交叉感染的錯誤出現，能夠分別準確、高效的測定出水質中TOC含量！

制藥公司在選擇TOC分析儀的時候，應該多考慮一下儀器的應用，是做純水和注射用水檢測還是做清潔認證，這關系到生產能否有效進行的問題。

制藥企業選擇在此款TOC分析儀是較為明智的。因為在線檢測不僅可方便地對水系統進行實時測定及實時流程控制，同時還可以防止離線測定可能帶來的二次污染，從而獲得準確值。于是在線測定儀成為了國內眾多制藥企業的 選擇。

TOC and Cleaning Certification

The FDA does not have a universal method or limit standard for cleanliness certification. Given the diversity of production equipment and product properties, it is unrealistic for drug regulatory agencies to establish unified limit standards and inspection methods. Enterprises should develop scientifically reasonable limit standards that can be implemented and verified through appropriate methods based on the actual situation of their production equipment and products.

The TOC requirement for pure water and injection water testing is ppb level, while the requirement for TOC in cleaning certification is high concentration in ppm level.

TOC is a completely different concept in two types of detection. Due to different TOC detection ranges, suitable detection methods and rules are also different.

Due to cost considerations, current instrument manufacturers cannot separate low concentration and high concentration detection channels. They usually use the same set of detection channels, computing chips, and circuits, which inevitably leads to cross contamination of high concentration and low concentration samples. The results obtained are bound to fail to meet the requirements of relevant standards. Beijing Beiguang Jingyi Instrument Equipment Co., Ltd. has successfully developed an upgraded total organic carbon analyzer BC-40A through years of research and testing. It can effectively avoid errors caused by cross infection and accurately and efficiently determine the TOC content in water quality!

When choosing a TOC analyzer, pharmaceutical companies should consider the application of the instrument, whether it is for pure water and injection water testing or for clean certification, which is related to whether production can be effectively carried out.

It is wise for pharmaceutical companies to choose this TOC analyzer. Because online detection not only facilitates real-time measurement and process control of water systems, but also prevents potential secondary pollution caused by offline measurement, thereby obtaining accurate values. So online measuring instruments have become the first choice for many pharmaceutical companies in China.

注 意 事 項

1. 更換紫外燈或蠕動泵管時，必須在打開儀器后蓋板前切斷電源，以避免發生電擊危險。

2. 非本公司維修人員或 專業人員不得隨意拆卸機箱內部的零部件及線路板，否則造成儀器損壞后果自負。

3. 更換保險絲請使用相同的規格，以免發生短路或者損壞儀器。

4. 本產品需一級安全防護，電源必須可靠接地,否則可能導致觸電事故或損壞儀器。

5. 儀器使用時，若水樣中含有可見的不溶性微粒，必須在進樣管前安裝微粒過濾器，以免儀器內部管路發生堵塞。若在線檢測的水樣中固體懸浮物含量較高，須定期更換過濾器。

6. 若先前檢測的水樣中有機碳濃度超出了儀器的檢測范圍，在檢測其它有機碳濃度相對較低的水樣之前，先用高純水或有機碳濃度較低的去離子水沖洗管路，沖洗時間參考說明書。

7．若儀器作在線檢測使用，需在離線狀態下沖洗管路和校準完畢后再連接在線檢測裝置。

注意事項1、該儀器初始的包裝材料需小心保存，安裝需由本公司的專業技術人員進行操作。2、若儀器由于任何原因必須返修，必須將其裝入原紙箱中以防運輸途中損壞。3、在開機前，操作者要首先熟悉操作方法。