Calibration of liquid material quantitative filling machine

The calibration regulation for liquid material quantitative filling machines is an important basis for ensuring the accuracy and stability of filling machine measurement. The following is a detailed interpretation of the verification regulation:

1Calibration of liquid material quantitative filling machineScope of Application
This verification regulation is applicable to the type evaluation, first verification, subsequent verification, and in-service inspection of newly manufactured, used, and repaired liquid material quantitative filling machines. Liquid material quantitative filling machines are widely used in the quantitative packaging process of industries such as chemical, pharmaceutical, and food. The accuracy of their measurement directly affects product quality and enterprise efficiency.

2、 Terminology and measurement units
Fixed volume filling machine: a filling machine that performs quantitative filling based on volume, with the measurement unit being liters (L) or milliliters (mL).
Fixed weight filling machine: a filling machine that performs quantitative filling based on mass, with the unit of measurement being kilograms (kg) or grams (g).
Filling capacity: The amount of filling that a filling machine can achieve per unit time, also known as rated filling capacity or production capacity.
Filling volume qualification rate: the percentage of qualified product filling volume under rated filling capacity conditions.

3、 Measurement performance requirements
Fixed volume filling machine: Its maximum allowable error is usually ± 1%, ± 2%, ± 3%, ± 5%.

Fixed weight filling machine: Its maximum allowable error is usually ± 0.2%, ± 0.5%, ± 1%, ± 2%, ± 3%, ± 5%.

4、 General Technical Requirements
Appearance requirements: The filling machine should not have any appearance defects that affect the measuring performance, such as flowing paint, burns, cracks, and sand holes.

Filling capacity: The filling capacity of the filling machine should meet its rated filling capacity. The filling qualification rate of newly produced filling machines should not be less than 98% under rated filling capacity conditions; The filling qualification rate of the filling machine after use and repair should not be less than 95% under the rated filling capacity conditions.
Filling volume adjustment device: The filling machine should have a filling volume adjustment device and a matching packaging container adjustment device.
Coordination between filling head and conveying action: The filling head of the filling machine and the conveying action of the packaging container should be coordinated and consistent.
Health regulations require that the materials and structure of filling machines used for food and medicine comply with relevant health regulations.

5、 Verification conditions and equipment
Verification conditions: The verification of the filling machine should be carried out under the condition that the filling machine is turned on, and the verification environment temperature should be (5-40) ° C. The temperature difference of the verification medium during one verification process should be ≤ 5 ° C.
Calibration equipment: The calibration equipment must be qualified and within the calibration cycle. The accuracy of the selected standard should meet 1/3 of the maximum allowable error of the inspected filling machine. Common calibration equipment includes density measuring devices, electronic scales, standard glass measuring instrument groups, etc.

VICalibration of liquid material quantitative filling machineProjects and Methods
Filling capacity verification: Check whether the filling and conveying actions of the filling machine are coordinated after starting up, and whether the actual filling capacity of continuous operation for more than 3 minutes meets the requirements.
Filling capacity calibration: For fixed volume filling machines, the capacity comparison method is usually used for calibration. Inject the filling liquid into a standard glass measuring vessel and observe whether the liquid level is within the allowable error range. If there is a deviation, the adjustment device of the filling machine needs to be adjusted and re calibrated.

7、 Processing of verification results
According to the verification results, necessary adjustments or repairs should be made to the filling machine to ensure that its metrological performance meets the standard requirements.
Qualified filling machines should be issued with a calibration certificate or report, and the validity period should be indicated.

In summary, the calibration regulations for liquid material quantitative filling machines are important legal basis for ensuring the accuracy and stability of filling machine measurement. Enterprises should strictly follow the regulatory requirements for inspection work to ensure product quality and production efficiency.

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.