Publicity of the draft standard for gunpowder glas

The publicity of the draft standard of pharmaceutical glass helps the high-quality development of the pharmaceutical packaging industry

[industry standard of packaging and printing industry] pharmaceutical glass materials and containers have good water resistance, acid resistance and general alkali resistance, as well as good thermal stability, certain mechanical strength, bright and clean, transparent, easy to clean and disinfect, high barrier, easy to seal and other advantages. At present, they are used in the packaging of all kinds of pharmaceutical preparations

according to the difference of linear thermal expansion coefficient and boron trioxide content, pharmaceutical glass materials and containers can be divided into high borosilicate glass, medium borosilicate glass and low boron. This adhesive makes it easier to realize the recycling and reuse of products at the end of their service life, silicon glass and sodium calcium glass

according to the "China Pharmaceutical glass packaging in-depth research and investment strategy report (20 ● Jinan assay quality assurance 19th edition)", at present, domestic pharmaceutical glass products are still mainly low borosilicate glass and sodium calcium glass. Large foreign pharmaceutical companies basically use borosilicate glass to package drugs. This glass has very good chemical resistance, which can ensure the quality stability and drug safety of the packaged drugs to a greater extent

according to the data, the total amount of medicinal glass of low borosilicate glass in China is about 300000 tons in the whole year, of which the use of medium borosilicate in 2018 is about 22000 ~ 23000 tons, accounting for only about 7% - 8% in proportion

drugs are special commodities, which are related to the health and life safety of consumers. The industry pointed out that the reaction between the traditional low borosilicate glass and the liquid medicine is obvious, which makes the medicine polluted by the glass to a certain extent, and its production process is easy to become a health hazard

in recent years, with the continuous promotion of policies such as Mu15, the concept of great health in China, the increasing intensity of drug supervision, the continuous upgrading of pharmaceutical packaging, and the implementation of policies such as the promotion of consistency evaluation and related review and approval, the industry believes that upgrading from low borosilicate glass to medium borosilicate glass will be the general trend. It is expected that in the next 5-10 years, 30% - 40% of China's 300000 tons of pharmaceutical glass will be upgraded from low borosilicate glass to medium borosilicate glass. In this context, it is also crucial to formulate corresponding standards for pharmaceutical glass materials and containers, which is also the key to promote the high-quality upgrading of low borosilicate glass to medium borosilicate glass

on September 30, the Pharmacopoeia Committee announced the publicity of the draft national standard for pharmaceutical packaging materials (the second time) on the general principles of pharmaceutical glass materials and containers

the publicity shows that the Pharmacopoeia Committee plans to formulate the national drug packaging material standard of the general principles of pharmaceutical glass materials and containers. In order to ensure the scientificity, rationality and applicability of the standard, the national drug packaging material standard of the general principles of pharmaceutical glass materials and containers will be publicized for the second time to solicit opinions from all walks of life. The publicity period is one month

according to the general rules for medicinal glass materials and containers, medicinal glass materials and containers should comply with the provisions of Article 5 in production and use. The composition of medicinal glass materials and containers should meet the requirements of product performance. The formula proportion of glass, the mixing and melting quality of batch should be strictly controlled in production to ensure the uniformity and stability of glass composition

the production process of pharmaceutical glass materials and containers should be stable. Batch division should ensure product quality and how to evaluate the effect of toughening modification. Traceability of quantity, homogeneity within batches and consistency between batches

pharmaceutical glass containers should be bright, clean and transparent. Colorless glass should be selected for general drugs, and brown transparent glass can be selected for drugs with light avoidance requirements

the chemical properties of pharmaceutical glass containers should be stable and should not fall off. Drug manufacturers should choose appropriate glass materials and containers according to the compatibility research results

during use, attention should be paid to the compatibility between the glass container and the seal to ensure the sealing integrity of the drug

in addition, the glass packaging materials and containers should be subject to 121 ℃ particle water resistance, inner surface water resistance, boron trioxide content, internal stress and other aspects of the corresponding inspection

original title: Publicity of the draft pharmaceutical glass standard, helping the high-quality development of the pharmaceutical packaging industry