Summary:
The common injection glass bottles in the market are mainly ampoules and vials. An ampoule is a high-quality thin glass bottle with good sealing properties. It is often used to store drugs for injection, vaccines, serum, etc. The vial is a small bottle sealed with a rubber stopper. The neck of the bottle is thin, the thickness of the bottle is the same, and the bottle is slightly thicker than the bottle neck, slightly thinner than the bottle. Generally used as an injection bottle, oral liquid bottle, etc. Oxygen is the main factor affecting the shelf life of powder injections, water injections, oral liquids, etc. It has been found that by controlling the proportion of gas components in the package, the shelf life of the product can be effectively extended or the quality of preservation can be improved. This paper takes ampoules and vials as an example to discuss the effect of residual oxygen in the ampoule glass bottle on the shelf life of the drug and the residual oxygen test method.
Key words: injection glass bottle, vial, ampoule, residual oxygen, headspace analysis, residual oxygen detection
Author: Labthink Technology Co., Ltd.
background:
An injection refers to a pharmaceutical dosage form which is administered subcutaneously, intramuscularly or intravenously. The injection glass bottle products mainly refer to the injection medicines which are packaged in glass bottles. The common packaging on the market is ampoules and vials. Ampoules are high-quality thin glass bottles with good sealing properties. They are commonly used for storing injectable liquids, as well as vaccines, serum and other drugs. The capacity is generally 1~25ml . The vial is a small bottle sealed with a rubber stopper. It is often used for the storage of powder injection, injectable liquid and oral liquid. Depending on the content, the color is brown and transparent, and is usually made of glass. The bottle neck of the vial is thinner, the thickness below the bottleneck is the same, the bottle mouth is slightly thicker than the bottleneck, and the bottle body is slightly thinner; the drug capacity is generally smaller.
Oxygen is a necessary condition for the growth and reproduction of most microorganisms, causing slow oxidation of drugs containing low-priced iron salts, iodides, nitrites, and unsaturated carbon chains, resulting in discoloration, decomposition, odor, and deterioration of the drug. Some even produce toxicity. In the packaging of ampoules and vials , a small amount of air will remain in the bottle when the filling is completed. The actual gas composition in the bottle will differ from the expected one. Excessive oxygen residuals will affect the shelf life quality of the drug. . Therefore, it is necessary to reduce the oxygen content in ampoules and vials to improve the quality of drug preservation.
At present, the country has not yet set standards to specify specific requirements for the oxygen content inside the ampoule and vial containers. Languang Lab combines its own experience in testing these two products for many years, and with HGA-02 top air analyzer, the following describes the residual oxygen detection of ampoule and vial.
test instrument:
Due to the small overall volume of the packaging of ampoules and vials, the amount of gas in the headspace of the package is smaller. The general headspace analysis equipment cannot carry out the analysis test with small gas collection, which is also the detection of the headspace analysis of small volume packaging. difficulty. Labthink 's HGA-02 top air analyzer uses a dedicated probe sampler to sample the gas components in ampoules and vials and measure the oxygen content through an oxygen sensor for intuitive analysis of ampoules and The sealability of the vial and the amount of oxygen in the bottle.
Test Methods:
Since the ampules and vials whole package volume is relatively small, the bottle is made of glass, and the less amount of headspace gas, certain difficulties to the gas collection, the general operation likely to cause gas leakage, affect test accuracy, blue Labthink Light collects the gas in a unique way and analyzes it.
Take 5~10 bottles of ampoule or vial. Before test, place the sample in a desiccator at 23 °C ± 2 °C for 48h . Then, the gas in the sample taken is collected centrally, and the gas is injected into the HGA-02 headspace air analyzer by manual or automatic injection , and the injection time and analysis time are set, thereby easily reading the oxygen content. The test result is the average value of the oxygen content in the 5 to 10 samples taken.
When collecting gas, since the vials are generally filled with powder injection, if the top air body is directly extracted, the powder is easily injected into the device, thereby affecting the accuracy of the device. To prevent this from happening, add a Filter in front of the sampling tube to filter the powder in the headspace air.
data analysis:
Languang Lab selected three vials and ampoules for headspace analysis test, numbered separately, and the test results are shown in Table 1 :
The oxygen content of the top air in the ampoule and the vial must be controlled to a certain ratio in order to ensure the quality of the contents. According to the Languang laboratory test, the residual oxygen in the ampoule and vials is generally below 3% .
to sum up:
Through the detection and analysis of residual oxygen in powder injection and liquid packaging of ampoule bottles and vials, pharmaceutical manufacturers can adjust the production process by monitoring and testing the quality of packaging to ensure the shelf-life quality of the products, thereby avoiding packaging. Quality problems caused by quality.
Copyright statement: This article is copyrighted by Jinan Languang Electromechanical Technology Co., Ltd., and it is forbidden to reprint without permission!
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