Carl Calibration of water content analyzer

The calibration regulation JJG1044 for Karl Fischer Coulomb method trace moisture analyzer is a standard specification for the calibration of Karl Fischer Coulomb method trace moisture analyzer, which mainly includes the following aspects:

1、 Scope

This regulation applies to the first calibration, subsequent calibration, and in-service inspection of Karl Fischer coulometric trace moisture analyzer. The requirements and testing methods for metrological performance in type evaluation can also be referenced.

2、 Overview

The Karl Fischer Coulombic method trace moisture analyzer is mainly used to determine the moisture content in products from industries such as petroleum, chemical, light industry, power, medicine, pesticides, environmental protection, geology, and food. Its working principle is based on the absorption of water when iodine oxidizes sulfur dioxide, and then reacts with Karl Fischer reagent (a mixture containing iodine, anhydrous pyridine, sulfur dioxide, and anhydrous methanol). The reaction endpoint is determined by electrode method.

3、 Measurement performance requirements（Carl Calibration of water content analyzer）

1. Indication error: The indication error should be within the specified range, usually ± (5% verification point+3) μ g.

2. Measurement repeatability: Under the same measurement conditions, when measuring the moisture content of the same standard substance repeatedly, the relative standard deviation (RSD) of the measured value should not exceed 3%.

3. Electrolysis speed: The time required to electrolyze a certain amount of water (such as 1000 μ g) should not exceed the specified value, usually 3 minutes.

4. Zero point equilibrium time: The time required for the instrument to reach equilibrium without a sample should not exceed the specified value, usually 2 minutes.

4、 General Technical Requirements

1. Appearance of the instrument: The appearance of the instrument should be free of mechanical damage that affects normal operation. The nameplate should indicate the name, model, manufacturer name, product series number, date of manufacture, etc. Domestic instruments should also have the license mark for manufacturing measuring instruments.

2. Electrolytic cell system: The electrolytic cell system should be well sealed, with smooth disassembly and assembly of electrodes, drying tubes, and grinding plugs.

3. Circuit system: The power and signal lines of the instrument should be tightly connected, and all switches, knobs, buttons, and other functions should be normal. The indicator lights should be sensitive and the display should be clear. The mixing system of the electrolytic cell is normal and can adjust the speed.

4. Display system: It should be able to display the measured value of moisture and the change value or trend of electrolysis rate normally, and have the function of using text, code, indicator light or sound to prompt the status of the instrument.

5. Safety indicators: including insulation resistance, insulation strength, and leakage current, which should meet the specified requirements.

5、 Verification conditions

1. Environmental conditions: The testing room should be clean and dust-free, free of flammable, explosive, and corrosive gases, and have good ventilation. The temperature should be within the range of (10-30) ℃, and the relative humidity should not exceed 80% RH. The power supply should be (220 ± 22) V, (50 ± 1) Hz. The instrument should be placed steadily on the workbench, with no strong mechanical vibration or electromagnetic interference sources around it, and the instrument should be well grounded.

2. Verification equipment: including stopwatch (with a division value not exceeding 0.1s), microinjector (with one full range of 10 μ L and one full range of 100 μ L), analytical balance (with a sensitivity of 0.01mg), insulation resistance meter (500V, level 10), withstand voltage tester, and leakage current tester, etc.

3. Standard substance: Certified standard substances approved and issued by the national metrology administrative department should be used, such as water methanol standard substance (water content 1mg/g, uncertainty 1.4%, k=2) and distilled water.

6、 Verification items and methods（Carl Calibration of water content analyzer）

The verification items include appearance inspection, indication error verification, measurement repeatability verification, electrolysis speed verification, zero balance time verification, and safety index verification. Each project has specific testing methods and requirements.

7、 Processing of verification results

When implementing the verification regulations, it is necessary to strictly follow the prescribed items and methods for operation, and record the verification process and results. Through regular calibration, problems with the instrument can be detected and corrected in a timely manner, ensuring its wide application in production, scientific research, and other fields.

In summary, the calibration regulation JJG1044 for Karl Fischer Coulomb method trace moisture analyzer provides a unified standard and specification for instrument calibration, ensuring the measurement accuracy and reliability of the instrument.

Company Background Introduction:

Ze Heng The advantage of Huapu in metrology calibration, verification, and confirmation is that it focuses on providing quality control services for biopharmaceuticals. It is very familiar with some special instruments, and its main team comes from pharmaceutical companies and instrument manufacturers, who are familiar with instrument and GMP regulations. For example, our team has specially developed a fluorescence quantitative PCR instrument calibration device to replace imports, which greatly reduces the cost of fluorescence quantitative/qualitative PCR instrument calibration (far lower than other peers); We have developed an internal calibration protocol for the cell counter; Developed internal calibration procedures for cell recovery instruments; The calibration procedure of gel electrophoresis scanner was developed; We have developed integrated wireless probes for lower and higher temperatures required for temperature verification, reducing the cost of users using probes extensively and replacing imports; There are many more examples, as we all come from a biological background, we pay attention to the process requirements of every biological user, focus on biopharmaceutical instruments and equipment, and strive to "go with quality and do instrument and equipment quality control" in order to make biopharmaceuticals safer.
We work closely with other units in terms of services, including mandatory inspections, special inspections, or services that cannot be done, to help customers send and collect items on their behalf, saving time, effort, and convenience.
Ze Heng Huapu is a professional service provider dedicated to providing laboratory instrument calibration, instrument and equipment validation, and factory validation for the biopharmaceutical industry. We provide pharmaceutical clients with one-stop quality control outsourcing services for QC/QA/engineering/validation/production departments.