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Research on the quality of Chinese medicinal glass in line with international standards

glass has excellent chemical stability unmatched by other materials. Therefore, packaging containers made of glass are widely used in chemical reagent industry, pharmaceutical industry, food and beverage industry and wine making industry. Medicine is not only for oral use but also for injection. Therefore, the quality of such packaging containers not only affects the quality of drugs, but also relates to personal safety. In the packaging glass container industry, traditional Chinese medicine glass containers are the products with the highest technical indicators and the strictest safety and health requirements, so the production of such products must obtain the national registration certificate. Internationally, there are clear regulations and requirements on the quality of pharmaceutical glass containers. This paper will discuss and study how the quality of Chinese medicinal glass is in line with international standards

research and Discussion on the quality of China's pharmaceutical glass in line with international standards

welcome the majority of users to call for consultation business: Yuan Gongyi, the necessity of China's pharmaceutical glass quality in line with international standards

1, it is the need for the export of drugs and pharmaceutical glass

due to the development of China's pharmaceutical industry, the export of drugs is increasing. Foreign businessmen attach great importance to the quality of glass used for packaging drugs, especially for some drugs with relatively high prices. Therefore, some pharmaceutical companies often ask our glass quality inspection center for testing and certification in order to adapt to the market. In fact, China's neutral glass can only be recognized by a few countries that have helped build glass factories. According to the strict requirements of international neutral glass, it is unqualified. Therefore, it is imperative for the quality of pharmaceutical glass to be in line with international standards if drugs are to be exported

2. It is the need to further protect the health of our people.

due to the improvement of our people's life and cultural quality, people's awareness of health care has been greatly enhanced. On the other hand, there are still some problems in China's pharmaceutical neutral glass, such as the high amount of alkali metal precipitation, and some of them may also fall off. In the past, medicinal glass controlled the total amount of heavy metals. With the development of science and technology, heavy metals should be controlled quantitatively to ensure the health of our people

second, the possibility of integrating with the world

China is currently in a period of rapid economic and technological development, accelerated reform and opening up, and expanding trade. Medicinal glass is also on the rise. Especially through the national system reform and the strengthening of the administrative functions of the State Drug Administration, it has created very favorable conditions for China's pharmaceutical glass to reach or basically reach the international advanced level in a relatively short time

III. from which aspects is it in line with international standards

1. From the type of medicinal glass and international standards

international standard ISO has made it clear that there are three main types of medicinal glass:

① international neutral glass a= () × k-1。

② 3.3 borosilicate glass (3.3 ± 0.1) × k-1。

③ soda lime glass () × k-1。

sodium calcium glass is not indicated as medicinal in this international standard. However, it is stipulated in other international standards that it can be used as medicine as long as it is neutralized and its water resistance at 121 ℃ reaches grade 2. Four kinds of glass are stipulated in the industrial standard of "classification and test methods of pharmaceutical glass" approved by the State Drug Administration last year, among which neutral glass is clearly restricted in China. Focus on the development of international neutral glass

2. From the perspective of glass materials in line with international standards

of course, glass materials mainly refer to physical and chemical properties, but the most important thing is chemical stability. For example, the water resistance of international neutral glass and 3.3 borosilicate glass particle method can reach grade 1. However, the water resistance of neutral glass particle method in China is mostly grade 1, and some are grade 2. If the precipitation amount of alkali is seen from the microscopic view, the neutral glass in China is several times larger than that in the world

soda lime glass also has requirements for material after neutralization treatment. In the international standard, 121 ℃ water resistance is required to be better than or equal to grade 2. Not all soda lime glasses can be used as pharmaceutical packaging containers after neutralization treatment

3. In line with international standards in glass products

of course, this can include glass product defects and appearance quality. But for medicinal glass, it mainly refers to the water resistance of the inner surface. 3.3 the water resistance of borosilicate glass and international neutral glass is HC1, while China's neutral glass is HCI or HCB

4. In line with international standards in terms of safety and health requirements

As2O3 and Sb2O3 are often used as clarifiers in glasses, so some glasses contain as and Sb oxides. PBO and CDO are sometimes introduced into glass as components, so international or advanced national standards stipulate the precipitation of as, Sb, PD and Cd in glass after the first verification. As the highest requirement for safety and health, medicinal glass should clearly stipulate the precipitation amount of the above elements, so as to ensure that the safeguard measures proposed in the guide include five aspects to hinder personal safety, including innovating the organization and coordination mechanism, optimizing industry management services, increasing fiscal, tax and financial support, promoting the development of military civilian integration, and deepening international exchange and cooperation. Generally, the amount of solution precipitation is limited internationally, but the limits of as and Sb in glass are specified in the American federal standard. Therefore, some microwave ovens exported from China to the United States limit the content of as and sb

5. In line with international standards in terms of test methods

due to the technical progress of test methods, the current test methods have developed from qualitative and semi quantitative to quantitative and respectively quantitative. For example, for the water resistance of the inner surface, the Discoloration method of methyl red acid solution was used in the past, but now the total alkali titration method is used. Internationally, Na, K and Ca are even quantitatively measured respectively. Therefore, there are many international standard test methods to be adopted in the pharmaceutical glass industry

6. Establish the standardization system of pharmaceutical glass in China

a relatively complete standardization system of pharmaceutical glass can be summarized from iso/tc48, iso/tc76, iso/tc63, iso/tc166, DIN, ANSI, ASTM, JIS and other international and foreign advanced standards. This system can be used as a plan for China to integrate with the world

whether the above ideas can be realized depends on the efforts of all members of the glass industry on the one hand, and the cooperation of pharmaceutical enterprises on the other hand. It is hoped that China Pharmaceutical Packaging Association can also do some work for the pharmaceutical industry and jointly march towards the international advanced level

the author is simple: jiangzhongao, National Light Industry glass product quality supervision and testing center, Beijing glass ceramics quality supervision and Testing Center

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