It is urgent to vigorously develop high-precision water-resistant neutral borosilicate glass

Source:中国制药网

The technology and equipment level of China's pharmaceutical industry is constantly improving, which has put forward higher requirements for packaging materials. The market requires high-precision first level water resistant glass. At the same time, the pharmaceutical industry is conducting compatibility studies between drugs and packaging products, paying particular attention to the impact of the precipitation of certain substances in glass products on drugs, and the testing of the physical and chemical properties of packaging products is becoming increasingly strict.

In recent years, the technology and equipment level of China's pharmaceutical industry has been continuously improving, and higher requirements have been put forward for packaging materials. The market requires high-precision first level water resistant glass. At the same time, the pharmaceutical industry is conducting compatibility studies between drugs and packaging products, paying particular attention to the impact of the precipitation of certain substances in glass products on drugs, and the testing of the physical and chemical properties of packaging products is becoming increasingly strict. Therefore, it is urgent to produce pharmaceutical glass container products that meet the international advanced level.

It is understood that neutral borosilicate pharmaceutical glass is commonly used in the pharmaceutical industry in developed countries. The USP ⅩXI version of the United States Pharmacopoeia has strict regulations on neutral borosilicate medical glass, and has formulated corresponding standards for the anti-aging, water resistance, alkali resistance, acid resistance, corrosion resistance and other properties of glass products. The expansion coefficient of neutral borosilicate pharmaceutical glass is 46-58 × 10-7/℃ (0-300 ℃), also known as "5.0 glass". This type of product has high dimensional accuracy and can adapt to advanced filling equipment; The physical and chemical properties of the product are stable, and the shelf life of the packaged drugs is relatively long.

At present, the pharmaceutical glass packaging containers produced and used in China are referred to as "semi neutral borosilicate pharmaceutical glass" products in the industry. Except for a few developing countries, most countries internationally currently do not have this formula and its products. This type of glass has an expansion coefficient of about 70 × 10-7/℃, also known as "7.0 glass". Its chemical stability does not meet the neutral requirements. When containing drugs with high pH values, alkaline substances in the glass are easily precipitated, which affects the quality of the drugs. There are also no clear regulatory requirements for heavy metal content in the glass. Due to poor dimensional accuracy, this type of product cannot be applied on advanced filling machines in pharmaceutical factories.

Therefore, it is currently difficult for 7.0 pharmaceutical packaging glass container products to be internationally recognized, which is also one of the main reasons why it is difficult for Chinese pharmaceutical products to enter the international market. Industry experts have pointed out that China's pharmaceutical glass container products must be updated and replaced, and it is urgent to vigorously develop high-precision first-class water-resistant neutral borosilicate glass.