Characteristics Of Pharmaceutical Glass Bottle Standards

The standard for pharmaceutical glass bottles is an important branch of the standard system for pharmaceutical packaging materials. Due to the fact that pharmaceutical glass bottles require direct contact with drugs, and some require long-term storage of drugs, the quality of pharmaceutical glass bottles is directly related to the quality of drugs, involving personal health and safety. Therefore, the standard for pharmaceutical glass bottles has special and strict requirements, which can be summarized as follows:
More systematic and comprehensive, enhancing the selectivity of product standards and overcoming the lag of standards on products
The principle of formulating different standards for the same product based on different materials as determined by the new standard has greatly expanded the scope of standard coverage, enhanced the applicability and selectivity of various new drugs and special drugs for different glass materials and products with different performance, and changed the relative lag of product development in general product standards.
For example, among the eight pharmaceutical glass bottle products covered by the new standard, each product is divided into three categories based on its material and performance. The first category is borosilicate glass, the second category is low borosilicate glass, and the third category is soda-lime glass. Although a product of a certain type of material has not yet been produced, standards for this type of product have been issued, solving the problem of lagging behind in the development of standards after the product is usually produced. Various types of drugs with different grades, properties, uses, and dosage forms have a more flexible and greater choice of products and standards made of different materials.
The definition of borosilicate glass and low borosilicate glass is clarified in the international standard ISO 4802 "Water resistance of the inner surfaces of glassware and glass containers - Part 1: Determination and classification by titration" from 1 to 1988 defines borosilicate glass (including neutral glass) as glass containing 5 to 13% (m/m) of boron trioxide (B-2O-3), However, ISO 12775, "Classification of Glass Components and Test Methods for Normal Mass Production," published in 1997, defines borosilicate glass (including neutral glass) as containing boron trioxide (B-2O-3) greater than 8% (m/m). According to the 1997 international standard for glass classification principles, the glass material of about B-2O-36% (m/m) widely used in the pharmaceutical glass bottle industry in China for many years should not be referred to as borosilicate glass or neutral glass. Tests have shown that some glass particle method water resistance and internal surface water resistance tests for this type of material do not reach levels 1 and HC1, or have edges between levels 1 and 2. Practice has also proven that some of these glasses may experience neutral disqualification or delamination during use, but this type of glass has been produced and used in China for many years. The new standard retains the glass made of this material and stipulates that its B-2O-3 content should meet the requirement of 5-8% (m/m), clearly defining that this type of glass cannot be called borosilicate glass (or neutral glass), and naming it low borosilicate glass.
Actively adopting ISO standards and aligning with international standards The new standard fully refers to ISO standards and the industrial standards and pharmacopoeia of advanced countries such as the United States, Germany, and Japan. In combination with the actual situation of the pharmaceutical glass bottle industry in China, it has achieved compliance with international standards in terms of glass type and glass material.