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I. Necessity of China's pharmaceutical glass quality in line with international standards 1. The need for the export of pharmaceuticals and pharmaceutical glass Due to the development of China's pharmaceutical industry, pharmaceutical exports are increasing. Foreign businessmen attach great importance to the quality of glass used in packaging medicines. In particular, for some medicines with relatively high prices, some pharmaceutical companies often look for our glass quality inspection centers to require testing and issue certificates. In fact, China’s neutral glass can only be recognized by a few countries that have once helped build a glass factory. According to the strict requirements of international neutral glass, it is unqualified. Therefore, it is imperative for medicines to be exported, and the quality of medicinal glass is in line with international standards.
2. It is the need to further protect the health of the people of our country As the improvement of our people’s lives and the improvement of their cultural quality, people’s health awareness has been greatly enhanced. On the other hand, there are indeed some problems with the use of pharmaceutical neutral glass in China, such as the high amount of alkali metal precipitation, and some may appear to be dissapeared. In the past, medicinal glass has controlled the total amount of heavy metals. With the development of science and technology, quantitative control of heavy metals should now be carried out to protect the health of our people.
Second, the possibility of convergence with the international situation China is currently in a period of rapid economic and technological development, accelerated pace of reform and opening up, trade continues to expand. Medicinal glass is also rising. In particular, through the reform of the state system 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 period of time.
Third, from what aspects and international standards 1, from the type of medicinal glass and international standards International Standard ISO 12775-1997 has been clear that there are three kinds of medicinal glass:
1 International neutral glass a=(4-5)×10-6k-1.
23.3 Borosilicate glass (3.3 ± 0.1) x 10-6 k-1.
3 Soda-lime glass (8-10) x 10-6k-1.
Soda-lime glass does not indicate medicinal use in this international standard. However, in other international standards, as long as it is neutralised and has a water resistance of 121°C up to grade 2, it can be used medicinally. In China's "Pharmaceutical Glass Component Classification and Test Method" industry standard approved by the State Drug Administration last year, four types of glass are specified, of which China's neutral glass is clearly limited. Focus on the development of international neutral glass.
2, from the glass material and international standards Glass material, of course, mainly refers to the physical and chemical properties, but the most important is the chemical stability. Such as the international neutral glass and 3.3 borosilicate glass particles can reach a level of water resistance. However, most of the neutral glass particles in China are class 1 water-resistant and some are class 2 water-resistant. If we look at the amount of alkali precipitation from microscopically, our neutral glass is several times larger than international neutral glass.
Soda-lime glass is also required by the neutralization of the material. In international standards, it is required that water resistance at 121°C is better than or equal to Grade 2. Not all soda-lime glass can be made into medicinal packaging containers by neutralization.
3, from the glass products and international standards This can certainly include glass products defects and appearance quality. However, for medicinal glass, it mainly refers to the water resistance of the inner surface. 3.3 borosilicate glass and international neutral glass surface water resistance are HC1, while China's neutral glass is HCI or HCB.
4, from the safety and health requirements and international standards Glass often As2O3, Sb2O3 as a clarifying agent, so some glass contains As, Sb oxides. PbO and CdO are sometimes incorporated into glass as components, so international or advanced national standards regulate the amount of glass As, Sb, Pd, and Cd precipitated. As the highest requirement for safety and health, medicinal glass should clearly specify the amount of precipitation of these elements to ensure personal safety. In the world, the amount of solution is generally limited, but the As and Sb limits in glass are stipulated in the U.S. federal standard. Therefore, some of our microwave oven baking trays exported to the United States limit the content of As and Sb.
5, from the test method and international standards convergence As the test method of technological progress, the current test methods from the original qualitative, semi-quantitative and quantitative development. If the internal surface water resistance, in the past with the methyl red acidic solution discoloration method, now to use the total amount of alkali titration method, even the international even to Na, K, Ca, respectively, quantitative determination. Therefore, there are many international standard test methods to be used in the pharmaceutical glass industry.
6. The establishment of a standardized pharmaceutical glass system in China can be concluded from ISO/TC48, ISO/TC76, ISO/TC63, and ISO/TC166 as well as DIN, ANSI, ASTM, JIS and other international and foreign advanced standards. Glass standardization system. This system can be used as a plan for China's integration with the international community.
Whether these ideas can be realized depends on the efforts of all members of the glass industry on the one hand, and the cooperation of pharmaceutical companies on the other. It is hoped that the China Pharmaceutical Packaging Association will also be able to do some work in the pharmaceutical industry and join forces to advance to the international advanced level.
Glass has excellent chemical stability unmatched by other materials, and therefore, glass-made packaging containers are widely used in the chemical reagent industry, the pharmaceutical industry, the food and beverage industry, and the wine industry. Medicines are not only used for oral medicine but also for injection. Therefore, the quality of such packaging containers not only affects the quality of medicines but also relates to personal safety. Glass containers used for medicine in the packaging glass container industry are the products with the highest technical specifications and the strictest safety and health requirements. Therefore, the production of such products must obtain a national registration certificate. Internationally, there are relatively clear regulations and requirements for the quality of medicinal glass containers. This article will discuss and study how China's pharmaceutical glass is in line with international standards.