Calibration of disintegration time limit tester

The disintegration time limit tester (disintegrator) is an analytical instrument that measures the disintegration time limit of solid preparations under specified conditions based on the disintegration time limit inspection method. It plays an important role in drug production and quality control. To ensure the accuracy and reliability of the disintegrator, it is necessary to perform regular calibration. Below is the translation ofCalibration of disintegration time limit testerDetailed explanation:

1Calibration of disintegration time limit testerprepare
Environmental conditions: Calibration should be carried out in an environment with a temperature of (10~35) ℃ and a relative humidity of ≤ 85%, and the operating environment should be clean and dust-free. At the same time, there are no corrosive gases or significant mechanical vibrations indoors.
Power supply: The power supply should be (220 ± 22) V, with a frequency of (50 ± 0.5) Hz.
Calibration tool:
Disintegration time limit standard substance: using certified standard substances approved by the national metrological administrative department.
Calipers or specialized measuring tools: with a division value not exceeding 0.5mm, used to measure dimensions such as the up and down movement distance of the hanging basket.
Stopwatch: with a division value not exceeding 0.1s, used to measure the round-trip frequency of the basket and timer timing error.
Temperature gauge or measuring device: with a division value not exceeding 0.1 ℃, used to measure the temperature of water in a beaker.
IICalibration of disintegration time limit testerstep
Appearance inspection: Check whether the outer shell of the disintegrator is clean, smooth, and even, whether the markings are neat, complete, and clear, whether the coating layer has fallen off, bubbles, and whether there are defects that affect its function.
Calibration of the up and down movement distance of the suspended basket:
Adjust the basket to the Zuidi point and measure the distance L ₁ between the sieve and the bottom of the beaker.
Adjust the basket to its highest point and measure the distance L ₂ between the sieve and the bottom of the beaker.
L ₂ - L ₁ is the distance that the basket moves up and down, measured continuously three times, taken the average, and calculated the error with the standard value of (55 ± 2) mm.
Hanging basket round-trip frequency calibration:
Measure the time required for the disintegrator basket to travel back and forth 31 times using a stopwatch, measure 3 times, and take the average.
According to the pharmacopoeia regulations (to=60s), calculate the relative error of the round-trip frequency of the basket.
Timer timing error calibration:
Select a calibration point (not less than 5 minutes), measure it three times with a stopwatch, and take the average as the measurement value for that point.
Calculate the relative error between the set value of the instrument and the measured value of the stopwatch. Non automatic disintegrators (without timers) do not require this calibration.
Temperature calibration:
Under the specified working conditions, set the temperature of the disintegrator to 37.0 ℃, stabilize for 0.5 hours, and then measure the temperature of the water in the beaker.
Measure once every 3 minutes, for a total of 3 measurements, and calculate the maximum allowable temperature error.
Indication error and repeatability calibration:
Place the standard substance in the basket, measure the disintegration time, take 3 measurements, take the average value, and calculate the indication error.
Repeat the measurement 6 times and calculate the repeatability error.
IIICalibration of disintegration time limit testerPrecautions
Safety issue: Before calibration, it is necessary to turn off the disintegration time limit tester and disconnect the power supply.
Initial state recording: During calibration, it is necessary to record the initial state of the disintegration time limit tester for inspection after calibration.
Accuracy adjustment: The adjustment process of the disintegration time limit tester is very important and requires precise adjustment to ensure its accuracy.
Repeated testing: During the calibration process, it is recommended to conduct multiple tests and compare the results to ensure data consistency.
Calibration time: The calibration time may vary depending on the type of disintegration time tester used. Therefore, before conducting calibration, it is necessary to pay attention to the calibration manual for the corresponding model.
4、 Calibration certificate
After calibration is completed, a calibration certificate should be issued, which should include at least the following information:

Title: "Calibration Certificate".
Laboratory name and address.
The location for calibration (if different from the laboratory address).
The Weiyi identification (such as number) of the certificate, as well as the identification of each page and the total number of pages.
The customer's name and address.
Description and clear identification of the subject being studied.
If the date of calibration is related to the validity and application of the calibration results, the date of receipt of the calibrated object should be specified.
If it is related to the validity of the calibration results, the sampling procedure for the calibrated sample should be explained.
The identification of the technical specifications on which calibration is based, including name and code.
Explanation of the traceability and effectiveness of the measurement standards used in this calibration.
Description of calibration environment.
Explanation of calibration results and their measurement uncertainty.
Explanation of deviations from calibration standards.
The signature, position, or equivalent identification of the issuer of the calibration certificate or calibration report.
The calibration result is only a valid statement for the calibrated object.
Declaration that partial replication of certificates is not allowed without written approval from the laboratory.
5、 Return time interval
The length of the interval between re calibration is determined by various factors such as the usage of the instrument, the user, and the quality of the instrument itself. It is recommended that the sending unit decide the interval for resuming school independently based on usage, but generally not exceeding one year.

In summary, the calibration of the disintegration time limit tester is an important step in ensuring its accuracy and reliability. Through a strict calibration process, it can be ensured that the disintegrator plays an accurate and reliable role in drug production and quality control.

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.