Why do medicinal glass bottles need to be upgraded to medium borosilicate glass in large numbers?

2021-05-28 15:23

Affected by the new crown pneumonia epidemic, the demand for some pharmaceuticals and diagnosis and treatment products has increased significantly, which has promoted the requirements for relevant pharmaceutical packaging materials, such as medicinal glass bottles commonly used for injection.

The proportion of medicinal glass bottles in the pharmaceutical packaging sales market is not small. According to the report of the securities brokerage firm of Guojin Securities, the market capacity of China's pharmaceutical packaging manufacturing industry in 2018 reached 106.8 billion yuan, an increase of 10.6% from the previous year. Among them, the 2018 market volume of medicinal glass bottles reached 21.94 billion yuan, accounting for about 20% of the pharmaceutical packaging manufacturing industry. .

The quality of medicinal glass bottles is immediately related to the safety factor and reliability of the drug. According to statistics, the medicinal glass bottles on the Chinese sales market are mainly made of low borosilicate glass and soda-lime glass, which are relatively more reflective of the syrup, which promotes the environmental pollution of the laminated glass on the drug at a certain level. Under these circumstances, China's medicinal glass bottles are in urgent need of "shifting and upgrading" before they can consider the requirements of pharmaceutical manufacturing companies. Borosilicate glass that is not easy to break and is more stable is the key aspect that must be upgraded at this stage.

According to the "In-depth Research and Investment Strategy Report on China's Pharmaceutical Glass Packaging (2019 Edition)", in 2018, the demand for medium borosilicate glass only accounted for 7%-8% in the sales market of China's pharmaceutical glass bottles. And in the perfect sales markets in foreign countries, Europe, etc., it has long been mandatory to inject all borosilicate glass packaging in the application of Chinese medicine preparations and biological products.

With the promotion of current policies such as consistency evaluation, relationship review and review, and quantity procurement, biomedicine in my country continues to be upgraded, and regulations for pharmaceutical packaging are also continuously improved. Among them, the "Technical Requirements for the Quality and Efficacy Consistency Evaluation of Generic Drug Injections for Chemical Drug Injections (Draft for Comment)" and "Requirements for the Application Documents for the Quality and Efficacy Consistency Evaluation of Generic Drugs for Chemical Injections on the Market (Draft for Comments) 》It is clearly pointed out that “the quality and characteristics of packaging products and utensils used for generic drug injections shall not be less than those of the reference preparation to ensure that the safety of the drug is consistent with that of the reference preparation."

The industry feels that from the current policy and new trends, pharmaceutical companies will continue to gradually upgrade quality, reduce costs, and indirectly promote the upgrading of China's pharmaceutical glass bottle industry structure. The medium and high-level pharmaceutical glass sales market will enter a new level. However, it also requires Chinese medicine preparation companies and upstream pharmaceutical packaging materials companies to further reduce costs.

Medium borosilicate glass is far better than 7.0 low borosilicate glass in terms of abrasion resistance, acid resistance, acid resistance, cold storage resistance, heat resistance, and canning rate. It is not easy to cause "flaking off" due to drug intrusion and corrosion. "The situation, compared with other medicinal glass bottles, has incomparable advantages in terms of ensuring drug safety, and is an internationally recognized packaging material for safe medicinal value.

However, in my country, the application of neutralized borosilicate glass accounts for less than 15%, and there is a very large safety risk of medication. For a long time, the production and manufacture of neutralized chemical laminated glass has been monopolized by foreign countries. In order to import and export drugs to European countries, some pharmaceutical factories in my country are forced to import 5.0 neutralized borosilicate glass test tubes and glass bottles from overseas at a high price. , Doing a good job of 5.0 medium borosilicate glass will greatly benefit the product quality improvement and modernization development trend of my country's pharmaceutical industry.

For medicinal glass bottles, one of the key evaluation indicators for their quality is "wear resistance": the higher the abrasion 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 wear resistance from low to high, medicinal glass bottles can be divided into: soda lime glass, low borosilicate glass and medium borosilicate glass. In the Chinese Pharmacopoeia, laminated glass is classified into Class I, Class II, and Class III. Class I high-quality borosilicate glass is suitable for the packaging of injection medicines, and Class III soda lime glass is used for packaging of puree, oil and solid medicines. Suitable for injection medicine. The main components of neutralized borosilicate glass for medical equipment are quartz sand, aluminum oxide, boron oxide, sodium/potassium oxide, barium oxide/magnesium/calcium.

Analysis of processing technology and raw materials: The main body of laminated glass is quartz stone. Quartz stone has excellent wear resistance (that is, it hardly reacts with water), but because of the high melting point of high-purity silica (about 2000°C), the price High, causing discomfort for mass production; In addition, Internet modified materials can reduce the melting point of glass and reduce the price. Common Internet modified materials include sodium, calcium, etc., but Internet modified materials will interact with hydrogen and oxygen in water. Exchange of root ions reduces the wear resistance of laminated glass; adding boron and aluminum can improve the structure of laminated glass, the melting temperature is increased to a certain extent, but the wear resistance is significantly enhanced.

In terms of composition, the approximate proportion of 5.0 pharmaceutical glass is: silica composition is about 72~75%, boron oxide is about 10%, aluminum oxide is 5~7%, sodium oxide/potassium 6-9%, barium oxide/ Magnesium/calcium 1-3, because its boron content is more than 10%, and the aluminum oxide composition is close to 7%, so in the whole process of melting the laminated glass, it encounters the problems of high viscosity and high melting temperature.

In addition, because the standard tolerances of the glass test tube are very high during forming, the vapor bubble composition of the laminated glass, the organic chemical uniformity of the laminated glass melt, and the uniform temperature and heat resistance are much higher than those of general glass, so this type of interlayer is melted. When glass is used overseas, all-oxygen ignition is often used and the auxiliary electric flux processing technology is used to carry out the melting work, and then it is assisted by the compound type responder. Therefore, the furnaces selected are also mostly all-oxygen electric flux furnaces, and the scale of operation of the furnace is mostly 10-30 Tons/day up and down.

How big is the sales market for borosilicate glass bottles in China? Regarding the application status of medicinal glass bottles in my country's market at this stage, because of the relatively large population of my country, in the use of 5.0 laminated glass, my country has already become the second in the world, second only to and very close to the global usage. Integrating China’s current policies and the core concept of national health, its forecast and analysis, "In the next 5 to 10 years, 30%-40% of my country’s 300,000-ton-class medicinal glass bottles will have low boron content. Silica glass is upgraded to medium borosilicate glass."

More medicinal glass bottle knowledge pays attention to medical glass bottle manufacturers. The company's products are produced in accordance with GMP medical standards, and the product quality is better than national standards. At present, our company has established cooperative relations with more than 100 outstanding domestic pharmaceutical companies, and exported to many countries, and the product quality has been unanimously praised by customers.