Study on the air tightness of ampoules

The use of ampoules to seal vaccines, serums, etc. is the last step to the market, and it is also a key step. The sealing of the packaging is very important to the quality of medical reagents, and it is also related to the health of patients and the production company. Reputation and credibility. The DK-190 headspace gas analyzer produced by Jinan Saicheng Instrument is equipped with high-precision imported sensors, which pioneered the use of handheld design, which can realize the efficient and convenient detection and analysis of the headspace of the ampoule, and then obtain the ampoule. The tightness of the bottle provides a guarantee for the quality control of ampoules. The following article introduces the principle and research method of using this product to analyze the headspace of ampoules.


1. Research background and significance

The development of modern medical technology has brought great convenience to people's healthy life, especially the emergence of vaccine technology to help humans effectively prevent and control infectious diseases. There are two main methods for making vaccines. One is to directly obtain the protective protein produced by the body when the human body is first infected with a certain infectious disease, which can help the human body to kill the infectious bacteria in the body; the other is to reduce the activity of pathogens. When this type of vaccine is imported into the human body, it will activate the body’s own immune system to produce a large number of antibodies. Because the imported pathogen is less active, it will not infect people. When the body receives the pathogen again, it can quickly produce a large number of antibodies to help. The human body resists external aggression.

Vaccines are mostly composed of protein and need to be stored in an oxygen-free environment. Modern vaccines are mainly stored in ampoules. Nitrogen is used to isolate external oxygen. Once the airtightness is not good, it may cause external oxygen leakage, vaccine denaturation, and other bacteria. Pollution and other issues. Therefore, it is very necessary to analyze the air tightness of the ampoule by testing the air composition.

2. Research status

At present, the airtightness of ampoules is mainly measured by a gas analyzer. The gas analyzers mainly used in the market are large in size, not easy to carry, and are complicated to operate and have low portability. The DK-190 headspace gas analyzer produced by Jinan Saicheng Electronic Technology Co., Ltd. adopts a handheld design and can be operated with one hand. It is suitable for testing on the production site. The built-in data storage can reach 1500, which can meet the needs of large data storage. , And can use Ethernet or USB for data transmission, which has significant advantages.

3. use DK-190 headspace gas analyzer to analyze the tightness of ampoules

1). Press the power button to start the instrument;

2). Set parameters according to actual needs;

3). Open the ampoule storing the vaccine so that the gas in the bottle touches the sensor of the gas analyzer;

4). The gas analyzer automatically detects the air composition in the bottle, and the test result is displayed on the screen;

5). When the end requirement is reached, press the switch key to end the test.

4. Conclusion

Vaccines, serum and other substances packaged in ampoules need to be stored in a sterile anaerobic environment. The airtightness of the ampoules determines the quality of storage. The DK-190 headspace gas analyzer produced by Jinan Saicheng can achieve high-precision and high-accuracy testing of oxygen, nitrogen, and carbon dioxide gas content. It has high application value in the field of ampoule tightness measurement.