The replacement of pharmaceutical glass packaging is imperative

At present, with the continuous innovation of the pharmaceutical industry and the increasing concern for drug safety in society, glass container products as drug packaging materials are also facing great challenges. 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 level water resistant neutral borosilicate glass

5.0 Glass with significant upwind

It is understood that pharmaceutical glass container products are usually used for the packaging of liquid drug injections, oral formulations, as well as solid drug powder injections (dissolved before use) and tablets. Among them, injection products have the strictest requirement for the neutrality of glass - drugs do not react chemically with glass packaging containers, and glass containers do not precipitate their constituent substances under the action of liquid drugs. In recent years, the technology and equipment level of China's pharmaceutical industry has been continuously improving, Higher requirements have been put forward for packaging materials, and the market requires high-precision first-class water-resistant glass. At the same time, the pharmaceutical industry, in conducting compatibility research between drugs and packaging products, pays special attention to the impact of the precipitation of certain substances in glass products on drugs, and the physical and chemical functions of packaging products are becoming increasingly strict. Therefore, it is urgent to produce pharmaceutical glass container products that meet the international advanced level

In developed countries, neutral borosilicate medical glass is widely used in the pharmaceutical industry at present. Neutral borosilicate medical glass is strictly defined in the USP ⅩXI edition of the United States Pharmacopoeia, and corresponding scales are formulated for the anti-aging, water resistance, alkali resistance, acid resistance, corrosion resistance and other functions of glass products. The expansion coefficient of medium borosilicate medical glass is 46-58 × 10-7/℃ (0-300 ℃), also known as "5.0 glass". Such products have high specifications and dimensional accuracy, Capable of adapting to and improving the filling equipment of predecessors; The physical and chemical functions of the product are not disorderly, and the shelf life of erotic clothing drugs is relatively long

According to industry expert Li Deyu, the pharmaceutical glass packaging containers currently 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 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", and its chemical stability does not meet the neutral requirements. When taking high pH drugs, alkaline substances in the glass are easily precipitated, which affects the quality of drugs; There is no clear regulatory requirement for heavy metal content in glass; Due to poor precision in specifications and dimensions, this type of product cannot be applied in pharmaceutical factories to improve the filling machines of predecessors. 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

Current materials urgently need to be replaced

Li Deyu has served as the technical director of Baoji Pharmaceutical Glass Factory and a specially appointed expert of Beijing Glass Instrument Factory. He has guided the establishment of China's first neutral pharmaceutical glass production line, and guided the production of solar glass tubes using the 3.3V method for borosilicate glass, which was the first in China (the project won the second prize for national technology improvement in 2000). Li Deyu is worried about the current situation of the pharmaceutical glass container industry in China "The production of 7.0 glass domestically has a phenomenon of repeated construction with low levels, high energy consumption, and low output, forming a vicious competition of low scale, low quality, and low price. This will lead to a decline in product quality and affect drug quality and medication safety."

The imperfect industry and product standards, as well as low entry barriers, have led to a vicious competition in the pharmaceutical packaging glass industry. Shen Changzhi, Director of the Glass Container Expert Committee of the China Pharmaceutical (600056) Packaging Association, pointed out that in order to regulate investment behavior in pharmaceutical glass, promote structural adjustment, reduce energy consumption, protect the environment, and achieve coordinated and sustainable development, relevant parties should accelerate the pace of formulating the entry prerequisites for the pharmaceutical glass industry

However, for the pharmaceutical industry, the top priority is to phase out "semi neutral borosilicate pharmaceutical glass" as soon as possible and replace it with high-precision "5.0 glass", narrowing the gap between China's pharmaceutical glass and the world's advanced level. While ensuring drug safety, it also creates a good premise for domestic drugs to enter the international market. According to relevant statistics, currently there is a demand for high-precision first-class water-resistant borosilicate glass (i.e. 5.0 glass) in China The annual demand is about 3000 tons, mainly relying on imports

"Indeed, our country is fully capable of producing high-precision first-class water-resistant glass," said Li Deyu. As early as the late 1980s, Baoji Pharmaceutical Glass Factory had produced high-quality 5.0 glass. At that time, the former National Medical Administration determined through bidding that Baoji Pharmaceutical Glass Factory would introduce the entire production line of neutral glass (7800) from Corning Corporation in the United States, and it was officially put into operation in November 1989, producing 7800 (5.0 glass) The neutral glass tube was sent to Corning Corporation in the United States for testing three times, fully meeting the quality standards of similar products of Corning Corporation. Later, Beijing Glass Instrument Factory introduced the complete set of NEG pharmaceutical neutral glass production technology and process equipment from Japan, and achieved rich results in practical application. It can be seen that the technology and ability to produce 5.0 glass have been developed domestically I hope that enterprises can seize the opportunity, apply existing technology at home and abroad, and make our own first-class pharmaceutical glass packaging products. Relevant departments should standardize the domestic pharmaceutical glass packaging product market, improve product quality standards, and promote high-precision 5.0 glass production. Once the production of 5.0 glass is increased, one furnace, two lines, and one furnace, three lines will emerge one after another, and their economies of scale and environmental protection effects will be demonstrated. At that time, China's pharmaceutical glass packaging will emerge The decoration industry is expected to enter the ranks of advanced professionals in the world

Cai Hong, Vice President of the China Medical Packaging Association, stated that the draft of the "Prerequisite for the Access of the Medical Glass Industry" (Discussion Draft) proposed by the China Medical Packaging Association will be determined from the aspects of production enterprise layout, process and equipment, variety and quality, energy consumption, environmental protection, etc., and the progress of the access threshold will also pave the way for the development of high-precision 5.0 glass products