Characteristics of the standard for pharmaceutical glass bottles
The standard for pharmaceutical glass bottles is an important branch of the standard system for pharmaceutical packaging materials. Because medicinal glass bottles need to be in direct contact with medicines, and some need to be stored for a long time, the quality of medicinal glass bottles is directly related to the quality of medicines and involves personal health and safety. Therefore, the standard for medicinal glass bottles has special and strict requirements, which can be summarized as follows:
It is more systematic and comprehensive, which enhances the selectivity of product standards and overcomes the lag of standards on products.
The principle of formulating different standards for the same product determined by the new standard greatly expands the coverage of the standard, and enhances the applicability and selectivity of various new drugs and special drugs to products with different glass materials and different performances. The relative lag of the standard for product development in general product standards.
For example, among the 8 medicinal glass bottle products covered by the new standard, the standards of each product are divided into 3 categories according to material and performance. The first category is borosilicate glass, the second category is low borosilicate glass, and the third category is borosilicate glass. The class is soda lime glass. Although a certain product of a certain type of material has not been produced yet, the standard for this type of product has been introduced, which solves the lag problem of standard formulation after the product is usually produced. All kinds of medicines of different grades, different properties, different uses and dosage forms have more flexibility and greater choice for products and standards of various materials.
glass medicine bottle
Glass medicine bottle (9 pieces)
The definition of borosilicate glass and low borosilicate glass is clarified. International standard ISO 4802.1 - 1988 "Water resistance of glassware and glass container inner surface - Part 1: Determination and classification by titration". Glass) is defined as glass containing boron trioxide (B-2O-3) 5-13% (m/m), but ISO 12775 "Classification of glass composition and test methods for normal mass production" issued in 1997 Borosilicate glass (including neutral glass) defined in Borosilicate glass contains boron trioxide (B-2O-3) greater than 8% (m/m). According to the 1997 international standard for glass classification, the glass material of B-2O-3 6 % (m/m) that has been widely used in China's pharmaceutical glass bottle industry for many years should not be called borosilicate glass or neutral glass. Tests have proved that some of the glass particle method water resistance and inner surface water resistance test of these materials do not reach Grade 1 and HC1, or are on the edge of Grade 1 and 2. Practice has also proved that some of this kind of glass will be unqualified or delaminated in use, but this kind of glass has been produced and used in China for many years. The content of 3 should meet the requirements of 5 - 8 % (m/m), which clearly defines that this type of glass cannot be called borosilicate glass (or neutral glass), but is named low borosilicate glass.
Actively adopt ISO standards, and integrate with international standards. The new standards fully refer to ISO standards and industrial standards and pharmacopoeia of advanced countries such as the United States, Germany, and Japan, and combine with the actual situation of China's pharmaceutical glass bottle industry. From the two aspects of glass type and glass material Meet the international standards.
Glass material types: There are 4 types of glass in the new standard, including 2 borosilicate glass, including 3. 3 borosilicate glass [α=(3. 3 ±0. 1) × 10 (- 6) K(- 1) ] and 5. 0 neutral glass [α= (4～5) × 10 (- 6) K(- 1) ], low borosilicate glass [α= (6. 2～7. 5) × 10 (- 6 ) K(-1)] 1 kind, soda lime glass [α= (7.6～9.0) × 10 (-6) K(-1)]l kinds, so there are 4 kinds of glass types according to the material.
Since soda lime glass includes a large number of neutralized surface treatments in actual production and application, it is divided into 5 types according to products. The above 4 glass types and 5 glass products include international standards, US Pharmacopoeia and China-specific types of medicinal glass bottles. In addition, among the 8 types of products covered by the standard, only ampoules have developed two standards, "Borosilicate Glass Ampoules" and "Low Borosilicate Glass Ampoules", and there is only one standard in the "Borosilicate Glass Ampoules" standard α= (4～5 ) × 10 (-6) K(-1) of 5.0 borosilicate glass without α = (3.3 ± 0.1) × 10 (-6) K(-1) of 3.3 borosilicate glass , mainly because there is no such product in the world, and the softening point of 3.3 borosilicate glass is relatively high, which makes it difficult to seal the ampoules. In fact, there is only one 5.0 borosilicate glass ampoules in the international standard, but no 3.3 borosilicate glass ampoules and soda lime glass ampoules. Regarding the low borosilicate glass ampoules unique to China, due to various reasons in China, the 5.0 borosilicate glass ampoules have not yet formed a certain period of large-scale and stable production. They can only be used as a transitional product, and ultimately the use of low borosilicate glass must be restricted. Ampoules, develop 5.0 borosilicate glass ampoules, and achieve full integration with international standards and products as soon as possible.
Glass material performance: The thermal expansion coefficient α specified in the new standard, 3. 3 borosilicate glass and 5. 0 borosilicate glass are completely consistent with international standards. Low borosilicate glass is unique to China, and there is no such material in international standards. Soda lime glass is specified by ISO as α= (8～10) × 10 (- 6) K(- 1), and the new standard specifies as α= (7. 6～9. 0) × 10 (- 6) K(- 1 ), the index is slightly stricter than the international standard. In the new standard, the chemical properties of 3. 3 borosilicate glass, 5. 0 borosilicate glass and soda lime glass are consistent with international standards in terms of water resistance at 121 ℃ particle method. In addition, in the above three types of glass, the regulations on the content of the chemical component boron oxide (B-2O-3) are also completely in line with international standards.
Glass product performance: The internal surface water resistance, thermal shock resistance and internal pressure resistance specified in the new standard are consistent with international standards. The internal stress index of the ISO standard stipulates that the ampoule is 50nm/mm, and other products are 40nm/mm, and the new standard stipulates that the ampoule is 40nm/mm, so the internal stress index of the ampoule is slightly higher than the ISO standard.
