Test methods for pre-filled injection pens

Pre-filled injection pens are a common medical device used to inject medications. To ensure the quality and safety of pre-filled injection pens, rigorous testing is required. The following section describes the test methods for pre-filled injection pens, including appearance, function and performance tests.

Visual inspection of pre-filled injection pens

Appearance inspection is an examination of the quality of the appearance of the prefilled injection pens, including the appearance of defects in the injection pens, the correctness of the markings and symbols, and so on.

2.1 Exterior Defect Inspection

The inspection for cosmetic defects consists of the following:

Whether there are scratches, cracks or deformation and other defects in the shell of the injection pen; the flatness and uniformity of the surface coating of the injection pen; whether the colour of the injection pen is consistent.

2.2Correctness check of markings and logos

The test for correctness of marking and labelling consists mainly of the following：

Whether the trade mark, model number, specifications and other information on the injection pen are clearly visible;

The accuracy of the scale on the injection pen;

Are the warning signs on the injection pens visible.

Functional test of pre-filled injection pens

The function test is a check of the injection function of the pre-filled injection pen, which mainly includes injection strength, injection speed and injection precision.

3.1 Injection strength test

The injection force test is mainly used to check whether the injection pen injects drugs with the appropriate force. A common method is to use a dynamometer to measure the force of injection of the pen.

3.2 Injection speed test

The injection speed test is mainly used to check whether the speed of the injection pen when injecting drugs meets the requirements. A common method is to use a timer to measure the time it takes for the pen to inject a certain amount of drug.

3.3Injection Precision Inspection

The injection accuracy test is mainly used to check whether the accuracy of the injection pen when injecting drugs meets the requirements. A common method is to use standard body fluids to simulate the drug solution and measure the deviation of the amount of drug injected by the injection pen from the preset amount of drug.

Performance testing of pre-filled injection pens

The performance test is an examination of the performance indicators of the pre-filled injection pen, including the push force, liquid capacity, and stability of injection force.

4.1 Injection force test

The push force test is mainly used to check whether the push force of the injection pen is stable. A common method is to use a force gauge to measure the change in force of the injection pen during the injection process.

4.2 Liquid volume test

The liquid volume test is mainly used to check whether the liquid volume of the injection pen meets the requirements. A common method is to use standard body fluids to simulate the liquid solution and measure the liquid volume of the injection pen.

4.3Injection strength stability test

Injection strength stability test is mainly used to check whether the strength of the injection pen in the injection process is stable or not commonly used method is to use a strength meter to measure the strength of the injection pen in the injection process.

conclude

The inspection methods of pre-filled injection pens mainly include appearance inspection, function inspection and performance inspection. By checking the appearance quality, injection function and performance index of the injection pen, it can ensure the quality and safety of the injection pen The inspection methods described above are commonly used methods, which can be adjusted and supplemented according to the specific situation to meet the actual needs.

The information is from the Internet and is for reference only.