Introduction to the sliding and leakage test of the cassette bottle piston

 

Summary :   The borosilicate glass sleeve used in the pen injector is commonly used as a cassette bottle, and is widely used in genetic engineering, bioengineering, insulin, antibiotic first aid, anesthesia and sedation, cardiac first aid, antibiotics, etc., and the sliding and sealing of the cartridge bottle piston. It is the two key indicators that are extremely critical. This article will focus on the requirements and process of the test for the sliding condition and leakage test of the bottle cylinder piston .

Key words: pen injector, chlorinated butyl rubber piston, cassette , piston sliding, leak test

 

After the bottle injection injection cassette, bottle stopper with aluminum cap seals, sealed with a rubber piston tail. In use, the cartridge is placed in a reusable pen injector. Due to its unique design, the process liquid does not come into contact with any part of the syringe, avoiding cross-contamination, and the cost of the cartridge is relatively economical. Since its introduction in China, it has been widely used, and the bottle has a very broad application field and huge market potential. According to incomplete statistics, the annual demand for bottle bottles in the international market of medicinal glass industry is about 1 billion. .

1 ,   Preparation before the cassette bottle test

1.1 Professional instruments. To have a TSL-1002 electronic tensile testing machine ( as shown in Figure 1 ) :

the amount    Process: 250N (except for other test requirements).

fine    degree:      Must not be lower than 0.5 to ensure the accuracy of the test results.

speed    Degree: 0.1-1000mm/min , it should be continuously adjustable to facilitate other non-standard tests.

Displacement accuracy: 0.01mm

Drive System:    server system

Computer control: bi-directional control, convenient test procedure; facilitate observation display shows test curves, the piston slides is determined whether there has been "chattering" occurs.

1.2 Instrument accuracy test.

Before the test, ensure that the instrument is in normal working condition, otherwise the test result will be wrong.

1.3 cassette sample preparation

     Prepare at least 10 samples for each test . Non-finished surface of the vial before injection card shall silicone oil-treated liquid; hardness rubber plunger, scaling, also shall be carried out correlation detection; Further, if considered necessary, configure the sealing machine, easy card bottle closure.

1.4 Needle preparation. The injection needle is a hypodermic needle with a cutting edge at both ends and an outer diameter of 0.4 mm .

1.5   Residual liquid collection container. During the test, the bottle will have residual liquid discharged, and the bottle may be broken. The container should be prepared and cleaned in time to prevent instrument and environmental pollution.

 

2 ,   Piston sliding test

In the "Test Project List", select "Sliding Test" and set its test parameters:

l    Test speed: 40.0mm/min (standard requirements)

l    Return speed: 300.0mm/min (high efficiency)

l    Pause time: 5 seconds   (standard requirement)

l    Other parameters can be used by default.

After the parameter setting is completed, directly click the “Test” button, the system will automatically complete the whole test process, without any manual intervention, the test curve is shown in Figure 2 .

                              Figure 1   Cassette bottle test project

 

                         Figure 2   Cylinder bottle piston sliding test curve

 

Judging the slidability results:

According to the standard requirements, at least 10 samples shall be tested, and the arithmetic mean of each of the 10 samples shall be calculated.   The “starting force” shall not exceed 30N ; the “continuous driving force” shall not exceed 15N ; the “restarting force” of re-pushing the piston after 5 seconds of suspension shall not exceed 30N ; and check that there shall be no “vibration” during continuous motion ( Refers to the phenomenon of irregular movement of the piston. The TSL-1002 electronic tension machine has an automatic judgment mode function, which can automatically switch the calculation mode according to the customer's operation and calculate the statistics such as the average value, the maximum value and the minimum value.

 

3 ,   Leak test

In the "Test Project List", select "Leak Test" and set its test parameters:

l    Test speed: 10.0mm/min (standard requirements)

l    Return speed: 300.0mm/min (high efficiency)

l    Load      Charge: 60N (set load value)

l    Hold time: 60 seconds   (standard requirement)

After the parameter setting is completed, directly click the “Test” button, the system will automatically complete the entire test process without any manual intervention. After the test, the test curve is shown in Figure 3 .

 

                          Figure 3   Cartridge leak test curve

Judging the results of the leak test:

At least 10 samples shall be tested. The arithmetic mean of 10 samples shall be calculated. The force of 60N ± 3N shall be loaded according to the standard requirements for 1 minute. After the test, there shall be no liquid leakage at the position of the piston and gasket. The TSL-1002 electronic tension machine has an automatic judgment mode function, which can automatically switch the calculation mode according to the customer's operation and calculate the statistics such as the average value, the maximum value and the minimum value.

 

5 , conclusion

    The sliding and sealing performance of the cartridge bottle piston are two key indicators. The sliding performance of the cartridge bottle piston determines the continuity and controllability of the pen injector injection, and also directly affects the user's operating experience. The leak test ensures the sealing performance, product quality and product shelf life of the bottle. With the technological innovation and progress, the cost-effective filling equipment and the bottle bottle will be more favored and selected by the market. The application of the bottle has reached a new height.

 

 

Author: Xu Li

Unit : Jinan Sike Testing Technology Co., Ltd.