At the end of 1995, ISO/TC48 and its SC1-5 convened the tenth annual meeting in Frankfurt, Germany, and proposed the main chemical composition, chemical stability and physical properties of 3.3-borosilicate glass and neutral glass. Among them, 3.3-borosilicate glass and China's special hard material, GG17 material chemical composition and physical and chemical properties are basically the same, the main difference is that the line thermal expansion coefficient control range is inconsistent, China's two kinds of glass is not strictly specified line thermal expansion coefficient control range. The difference between international neutral glass and China's "neutral" glass is obvious. Actively developing international neutral glass production and gradually limiting the use of China's "neutral" glass is becoming a consensus among people in the industry.
Different names are similar in quality
In China, low-borosilicate glass is a so-called “neutral†glass that has been used for many years. Compared with international neutral glass, the difference in chemical composition between the two is very large. China's "neutral" glass contains a relatively low amount of boron, so the coefficient of thermal expansion is greater than that of the line. 98 grains of water cannot maintain HGB1. Because China's "neutral" glass material is poor, so reflected on the internal surface water resistance is also poor - the international neutral glass surface water resistance can guarantee ISO4802-HC1, and China "neutral" glass ISO4802-HC1 or HCB. And in the international standard ISO12775-1997 "normally large-scale production of glass by component classification and test methods", it is clear that medical glass is divided into three types: international neutral glass a = (4-5) × 10 -6k-1, 3.3 borosilicate glass (3.3 ± 0.1) x 10-6 k-1, soda-lime glass (8-10) x 10-6 k-1.
In this international standard, soda-lime glass is not indicated for medicinal purposes, and international neutral glass is the glass of choice for pharmaceutical packaging materials recognized in the world. In the domestic pharmaceutical industry, it is also referred to as grade A amber glass, 5.0 Glass or grade A, 5.0 here means that the coefficient of expansion is not greater than 5.0 x 10-6. Because this glass is water-resistant, acid-resistant and alkali-resistant, it can be said to have excellent chemical stability and thermal stability. As a drug packaging material, it has unparalleled superiority in ensuring the quality of drugs.
After decades of efforts, China's pharmaceutical packaging industry has made considerable progress, but compared with the international level, there is still a wide gap in some areas. Take the pharmaceutical glass control bottle as an example. At present, developed countries have generally adopted a neutral glass control bottle with a coefficient of expansion of 5.0 in the world. However, due to the relatively late start of the pharmaceutical glass industry in China, due to various conditions, it has so far been able to produce only The borosilicate glass and soda-lime glass control bottles have an expansion coefficient of 7.0 or higher.
In recent years, with the rapid development of China's medical and health undertakings, people have become increasingly demanding on the quality of pharmaceutical products, and the quality requirements for pharmaceutical packaging materials have also risen. In China, more and more pharmaceutical companies have begun to adopt international neutral glass tubes, especially those with high technological content and high added value, as well as various types of biological agents, blood products, vaccines, freeze-dried preparations, etc. High-grade drugs, but international neutral glass has long relied on imports, mainly because only a few countries have mastered related technologies. The technology for melting such glass is very difficult. At present, there are only a handful of companies such as SCHOTT in Germany, Kemburg in the United States, and NEG in Japan. Can produce this product.
Qi strives to build a system
To allow more common drugs to use international neutral glass, to avoid changes in the liquid due to problems with glass materials, such as the phenomenon of dislodging, freeze-drying and bursting, and eliminate the hidden dangers that may affect the quality of drugs. China should be in the category of medicinal glass. With international standards, focusing on the development of international neutral glass. Domestic related companies and scientific research institutes have also been making active efforts. For example, Hebei Quzhou Four Star Glass Co., Ltd. has joined hands with experts from all walks of life to research and develop 5.0 glass on its own and has achieved breakthroughs. If it can achieve mass production, it will break imported products in this area. The monopoly position in the field and the gradual restriction of China’s “neutral†glass will be possible.
In fact, the link with international standards should be more directly reflected in the issue of glass materials. Because the glass material determines its main physical and chemical properties. As a drug packaging material, the most important indicator of glass is chemical stability. The chemical properties of domestically produced low borosilicate glass, especially alkali resistance, are significantly lower than those of international neutral glass. International standards, the United States Pharmacopoeia, the European Pharmacopoeia, and the Japanese Pharmacopoeia have strict regulations on the water and alkali resistance of liquid injections. From the market point of view, glass materials used as pharmaceutical packaging materials must be integrated into the international pharmaceutical industry. It is imperative to be in touch with the international community.
In addition, the establishment of China's glass industry standardization system for the pharmaceutical industry is imminent. Although in recent years the development of various packaging materials is changing with each passing day, such as plastic packaging, it seizes a share of glass bottles in the pharmaceutical packaging market. However, because pharmaceutical glass has excellent physical and chemical properties, it is still one of the most important pharmaceutical packaging materials at present. . To promote the healthy and rapid development of this industry, it is inseparable from the management departments and industry experts, and on the basis of absorbing international standards and foreign advanced experience, establish a pharmaceutical glass standardization system with Chinese characteristics. For example, there is no direct ISO/TC in the international market for glass pharmaceutical packaging materials, but it is scattered among several different TCs (technical committees). Therefore, it is necessary to gradually establish a complete and relatively centralized glass standard system in accordance with national conditions.
Different names are similar in quality
In China, low-borosilicate glass is a so-called “neutral†glass that has been used for many years. Compared with international neutral glass, the difference in chemical composition between the two is very large. China's "neutral" glass contains a relatively low amount of boron, so the coefficient of thermal expansion is greater than that of the line. 98 grains of water cannot maintain HGB1. Because China's "neutral" glass material is poor, so reflected on the internal surface water resistance is also poor - the international neutral glass surface water resistance can guarantee ISO4802-HC1, and China "neutral" glass ISO4802-HC1 or HCB. And in the international standard ISO12775-1997 "normally large-scale production of glass by component classification and test methods", it is clear that medical glass is divided into three types: international neutral glass a = (4-5) × 10 -6k-1, 3.3 borosilicate glass (3.3 ± 0.1) x 10-6 k-1, soda-lime glass (8-10) x 10-6 k-1.
In this international standard, soda-lime glass is not indicated for medicinal purposes, and international neutral glass is the glass of choice for pharmaceutical packaging materials recognized in the world. In the domestic pharmaceutical industry, it is also referred to as grade A amber glass, 5.0 Glass or grade A, 5.0 here means that the coefficient of expansion is not greater than 5.0 x 10-6. Because this glass is water-resistant, acid-resistant and alkali-resistant, it can be said to have excellent chemical stability and thermal stability. As a drug packaging material, it has unparalleled superiority in ensuring the quality of drugs.
After decades of efforts, China's pharmaceutical packaging industry has made considerable progress, but compared with the international level, there is still a wide gap in some areas. Take the pharmaceutical glass control bottle as an example. At present, developed countries have generally adopted a neutral glass control bottle with a coefficient of expansion of 5.0 in the world. However, due to the relatively late start of the pharmaceutical glass industry in China, due to various conditions, it has so far been able to produce only The borosilicate glass and soda-lime glass control bottles have an expansion coefficient of 7.0 or higher.
In recent years, with the rapid development of China's medical and health undertakings, people have become increasingly demanding on the quality of pharmaceutical products, and the quality requirements for pharmaceutical packaging materials have also risen. In China, more and more pharmaceutical companies have begun to adopt international neutral glass tubes, especially those with high technological content and high added value, as well as various types of biological agents, blood products, vaccines, freeze-dried preparations, etc. High-grade drugs, but international neutral glass has long relied on imports, mainly because only a few countries have mastered related technologies. The technology for melting such glass is very difficult. At present, there are only a handful of companies such as SCHOTT in Germany, Kemburg in the United States, and NEG in Japan. Can produce this product.
Qi strives to build a system
To allow more common drugs to use international neutral glass, to avoid changes in the liquid due to problems with glass materials, such as the phenomenon of dislodging, freeze-drying and bursting, and eliminate the hidden dangers that may affect the quality of drugs. China should be in the category of medicinal glass. With international standards, focusing on the development of international neutral glass. Domestic related companies and scientific research institutes have also been making active efforts. For example, Hebei Quzhou Four Star Glass Co., Ltd. has joined hands with experts from all walks of life to research and develop 5.0 glass on its own and has achieved breakthroughs. If it can achieve mass production, it will break imported products in this area. The monopoly position in the field and the gradual restriction of China’s “neutral†glass will be possible.
In fact, the link with international standards should be more directly reflected in the issue of glass materials. Because the glass material determines its main physical and chemical properties. As a drug packaging material, the most important indicator of glass is chemical stability. The chemical properties of domestically produced low borosilicate glass, especially alkali resistance, are significantly lower than those of international neutral glass. International standards, the United States Pharmacopoeia, the European Pharmacopoeia, and the Japanese Pharmacopoeia have strict regulations on the water and alkali resistance of liquid injections. From the market point of view, glass materials used as pharmaceutical packaging materials must be integrated into the international pharmaceutical industry. It is imperative to be in touch with the international community.
In addition, the establishment of China's glass industry standardization system for the pharmaceutical industry is imminent. Although in recent years the development of various packaging materials is changing with each passing day, such as plastic packaging, it seizes a share of glass bottles in the pharmaceutical packaging market. However, because pharmaceutical glass has excellent physical and chemical properties, it is still one of the most important pharmaceutical packaging materials at present. . To promote the healthy and rapid development of this industry, it is inseparable from the management departments and industry experts, and on the basis of absorbing international standards and foreign advanced experience, establish a pharmaceutical glass standardization system with Chinese characteristics. For example, there is no direct ISO/TC in the international market for glass pharmaceutical packaging materials, but it is scattered among several different TCs (technical committees). Therefore, it is necessary to gradually establish a complete and relatively centralized glass standard system in accordance with national conditions.
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