Public Announcement Of Draft Medical Glass Standards, Helping High-quality Development Of The Pharmaceutical Packaging Industry

Public Announcement Of Draft Medical Glass Standards, Helping High-quality Development Of The Pharmaceutical Packaging Industry

Date:Feb 10, 2020

Medical glass materials and containers have good water resistance, acid resistance and general alkali resistance. They also have good thermal stability, certain mechanical strength, smooth, transparent, easy to clean and disinfect, high barrier properties, and easy to seal. , Currently used for packaging of various pharmaceutical preparations.

According to the linear thermal expansion coefficient and the content of boron trioxide, medicinal glass materials and containers can be divided into four types: high borosilicate glass, medium borosilicate glass, low borosilicate glass, and soda lime glass.

According to the "In-depth Investigation and Investment Strategy Report of China's Pharmaceutical Glass Packaging (2019 Edition)", the current domestic pharmaceutical glass products are still mainly low-borosilicate glass and soda-lime glass. And large foreign well-known pharmaceutical companies basically use medium borosilicate glass to package medicines. This kind of glass has very good chemical resistance, which can ensure the quality of packaged medicines and the safety of medication to a greater extent.

The data shows that the total amount of low-borosilicate glass used in medicine in China in the whole year is about 300,000 tons, of which the medium borosilicate use data in 2018 is about 22,000 to 23,000 tons, according to the proportion, it is only about About 7% ~ 8%.

Pharmaceuticals are special commodities, which are related to consumers' physical health and life safety. The industry pointed out that the traditional low-borosilicate glass reacts significantly with the chemical solution, which makes the medicine contaminated with glass to a certain extent, and its production process is easily turned into a hidden health hazard.

In recent years, with the continuous advancement of policies such as China's great health concept, the increasing supervision of drugs, the continuous upgrade of pharmaceutical packaging, and the implementation of policies such as consistency evaluation and related review and approval, the industry believes that The upgrade of glass to medium borosilicate glass will be the general trend. It is expected that in the next 5 to 10 years, 30% -40% of China's 300,000 tons of medicinal glass will be upgraded from low borosilicate glass to medium borosilicate glass. In this context, it is also important to formulate corresponding standards for medicinal glass materials and containers, and it is also the key to promoting the high-quality upgrade of low-borosilicate glass to medium-borosilicate glass.

On September 30, the Pharmacopoeia announced the "Publication of the National Standard for Pharmaceutical Packaging Materials (General) on the General Principles of Medical Glass Materials and Containers (Second)".

The public notice shows that the Pharmacopoeia Commission plans to formulate the national pharmaceutical packaging material standards for medicinal glass materials and containers. The second public consultation solicited 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 5 provisions in production and use. Including the composition of medicinal glass materials and containers should meet the requirements of product performance. In production, the formulation ratio of glass, the mixing and melting quality of ingredients should be strictly controlled to ensure the uniformity and stability of glass components.

The production process of medicinal glass materials and containers should be stable. Batch division shall ensure traceability of product quality, uniformity within batches and consistency between batches.

Medical glass containers should be smooth, transparent. Colorless glass should be used for general drugs. Brown transparent glass can be used for drugs that require protection from light.

The chemical properties of medicinal glass containers should be stable and should not be removed. Pharmaceutical manufacturers should select suitable glass materials and containers based on the results of compatibility studies.

In the process of use, we should pay attention to the compatibility between the glass container and the seal to ensure the integrity of the seal of the drug.

In addition, glass packaging materials and containers should be inspected at 121 ° C for particle water resistance, internal surface water resistance, boron trioxide content, and internal stress.

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