Due to factors such as high threshold and high technical requirements for neutral medicinal glass, the production of neutral medicinal glass has been monopolized by foreign countries. This restricts the development of China's pharmaceutical glass industry to a certain extent. In 2018, with the successful commercial production of neutral borosilicate glass tubes in the No. 2 kiln of AHKS Medical Glass Technology Group, the problem of localization of medicinal neutral borosilicate glass tubes that had plagued China for many years was solved.
The materials used for medicinal glass bottles are mainly soda-lime glass and borosilicate glass. Borosilicate glass is an internationally recognized safe pharmaceutical packaging material. It can not only fully guarantee the safety and stability of medicines, but also prevent adverse reactions between medicines and low-grade packaging and harm human health. It is also the main choice of international pharmaceutical companies. Developed countries have all adopted neutral borosilicate glass in the production of injections.
In recent years, AHKS has been committed to the R&D and production of pharmaceutical glass, breaking the dual constraints of foreign technology and price, and realizing the localization of high-quality borosilicate glass tubes for pharmaceutical use. In September 2018, on the basis of years of research and development accumulated by the team of academician Peng Shou of the Chinese Academy of Engineering, the company's No. 2 kiln was ignited and put into production, completing high-standard expansion increments, and achieving a production capacity of 10,000 tons of neutral borosilicate glass tubes.
For medicinal glass, one of the main measures of its quality is "water resistance". The higher the water resistance of the medicine glass, the lower the risk of reaction with the medicine, and the higher the quality of the medicine glass. According to the water resistance from low to high, medicinal glass can be divided into soda lime glass, low borosilicate glass and medium borosilicate glass. In the Pharmacopoeia, glass is classified into Class I, Class II, and Class III. Class I high-quality borosilicate glass is suitable for the packaging of injection drugs, and Class III soda lime glass is used for the packaging of oral liquid and solid drugs. It is not suitable for injection drugs.
Medicinal neutral borosilicate glass is usually called Class I glass, also known as 5.0 glass or Class A material. It is a high-end pharmaceutical packaging material with high technical barriers. Neutral borosilicate glass has stable chemical structure, excellent expansion coefficient, resistance to acid and alkali corrosion, resistance to cold and heat temperature changes, and high mechanical strength. It will not react with the drug during the validity period of the drug, and will not change the quality of the drug. Because of its excellent chemical stability and thermal stability, neutral medicinal glass is favored by the pharmaceutical industry and is widely used in the field of pharmaceutical packaging. Previously, China's high-grade medicinal glass relied on foreign imports. The market has long been monopolized by Kimble, Corning, and SCHOTT in Germany. There is a huge gap in the incremental market and the market prospect is very broad.
The main components of medicinal neutral borosilicate glass are quartz sand, alumina, boron oxide, sodium/potassium oxide, barium oxide/magnesium/calcium. The main body of the glass is quartz, which has good water resistance (almost no reaction with water). However, due to the high melting point (about 2000°C) and high price of high-purity silica, it is not suitable for mass production. Adding a network modifier can lower the melting point of the glass and lower the price. Common network modifiers include sodium, calcium, etc., but the network modifier will exchange with hydrogen ions in the water, reducing the water resistance of the glass. The addition of boron and aluminum can strengthen the glass structure, the melting temperature has risen, but the water resistance has been significantly improved.
Although the technical barriers for the preparation of neutral borosilicate glass are very strong, with the collective efforts of the AHKS R&D team, after 5 years of technical research, more than 200 technological innovations have been implemented, more than 1,000 technical tests have been carried out, and high-quality melting and high-precision forming have been successfully overcome. And other core problems, developed a complete set of core technical equipment with independent intellectual property rights.
The company successfully produced China’s first high-quality borosilicate medicinal glass tube. Its performance and quality have reached the international advanced level. It has become the only one in China to use the "oxygen combustion + electric boosting" melting process and the Danner method to achieve medium boron. Enterprises that mass-produce silicon medical glass tubes have realized the solid chain and strong chain of China's borosilicate medical glass industry, and successfully broke the foreign monopoly, realized the stable mass production of borosilicate glass tubes, and made the It is possible to replace low borosilicate glass and soda lime glass with borosilicate glass.