离线线总有机碳分析仪/在线TOC测试仪  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2010版《中国药典》规定的测试方案，可以提供 IQ/OQ/PQ 服务。

离线线总有机碳分析仪/在线TOC测试仪  参数：

TOC就是关于进行改进和如何 实施这些改进的一套管理理念和管理原则，可以帮助企业识别出在实现目标的过程中存在着哪些制约因素——TOC称之为“约束”，并进一步指出如何实施必要的改进来一一消除这些约束，从而更有效的实现企业目标。

废水的性质或水质是水和各种杂质组成的复杂体系所表现出来的综合特性,这种特性在工程实...急性毒性的单位通常是以在特定暴露时间内使试验生物死亡50%的毒物或废水浓度，即半致死浓度LD50来表示。

从理论上对化工污水TOC与COD_a的相关性进行了分析,对在实际工作中测得的TOC和COD_a数据进行了回归分析。结果表明,化工污水的TOC和COD_a之间有着良好的相关性。在一定条件下,利用回归方程可以从测得的TOC值推算出COD_a值,或者从COD_a值推算出TOC值。因此,TOC值可以用来表示有机废水的污染程度,也可做为有机污染物的一个控制指标。

有很好的相关性[Z,31一、前言在同一废水样中,如无其它干扰,且氧化 ,则测得的TOC值与COD值成正比例关系,长期以来,评价水体中有机物朽染的程度即COD—KTOC。因C+Oz—CO卜所以＊一都是利用经典方法测定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.

随着新药典实施，我国的各个制药工业，纷纷已经开始使用TOC(总有机碳)分析仪对制药用水 (纯水和注射用水)的总有机物含量进行监测，以保证制药用水能够满足某些强制的规定要求，比如美国药典USP<643>和欧洲药典EP2.2.44, 以及中国药典CP2005附录VIII R的要求。满足这些要求将可以保证通过FDA或COS认证（见注释），或者满足我们国家所强制的某些认证。

此外，也有很多公司试图将TOC分析仪应用于清洁认证，替代HPLC检测并证明生产过程中已经过清洁处理的设备或系统，其洁净程度可以满足下一批次生产的要求。两种不同的应用该如何加以区分？

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。

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与清洁认证

FDA对于清洁认证并无通用方法或限度标准，鉴于生产设备和产品性质的多样性，由药品监督机构设立统一的限度标准和检验方法是不现实的。企业应该根据其生产设备和产品的实际情况，制定科学合理、能够实现并能通过适当方法检验的限度标准。

对纯水和注射用水的检测要求的TOC是ppb级，而清洁认证中是对TOC的要求是ppm级的高浓度。

TOC在两种检测中是两种 不同的概念。因为检测的TOC范围不同，适合采用的检测方式不同，所依据的规则也不同。

现在的仪器厂家基于成本的考虑，不可能将低浓度和高浓度的检测通道分开，通常都是使用同一套检测通道、同一套计算芯片和电路，这样必然造成高浓度和低浓度样品的交叉污染。得出的结果必定无法通过相关标准要求。北京北广精仪仪器设备有限公司通过多年的研究测试成功研发出了升级款的总有机碳分析仪BC-40A升级款，可有效规避交叉感染的错误出现，能够分别准确、高效的测定出水质中TOC含量！

制药公司在选择TOC分析仪的时候，应该多考虑一下仪器的应用，是做纯水和注射用水检测还是做清洁认证，这关系到生产能否有效进行的问题。

制药企业选择在此款TOC分析仪是较为明智的。因为在线检测不仅可方便地对水系统进行实时测定及实时流程控制，同时还可以防止离线测定可能带来的二次污染，从而获得准确值。于是在线测定仪成为了国内众多制药企业的 选择。

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 项

1. 更换紫外灯或蠕动泵管时，必须在打开仪器后盖板前切断电源，以避免发生电击危险。

2. 非本公司维修人员或 专业人员不得随意拆卸机箱内部的零部件及线路板，否则造成仪器损坏后果自负。

3. 更换保险丝请使用相同的规格，以免发生短路或者损坏仪器。

4. 本产品需一级安全防护，电源必须可靠接地,否则可能导致触电事故或损坏仪器。

5. 仪器使用时，若水样中含有可见的不溶性微粒，必须在进样管前安装微粒过滤器，以免仪器内部管路发生堵塞。若在线检测的水样中固体悬浮物含量较高，须定期更换过滤器。

6. 若先前检测的水样中有机碳浓度超出了仪器的检测范围，在检测其它有机碳浓度相对较低的水样之前，先用高纯水或有机碳浓度较低的去离子水冲洗管路，冲洗时间参考说明书。

7．若仪器作在线检测使用，需在离线状态下冲洗管路和校准完毕后再连接在线检测装置。

注意事项1、该仪器初始的包装材料需小心保存，安装需由本公司的专业技术人员进行操作。2、若仪器由于任何原因必须返修，必须将其装入原纸箱中以防运输途中损坏。3、在开机前，操作者要首先熟悉操作方法。