Glass bottle quality standards

Standardization system
Glass bottle standards and standardization system
Article 52 of the Drug Administration Law of the People's Republic of China stipulates: "Packaging materials and containers that are in direct contact with drugs must comply with pharmaceutical requirements and safety standards." Article 44 of the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China stipulates: "The management methods, product catalogs, and pharmaceutical requirements and standards for packaging materials and containers that are in direct contact with drugs shall be organized and formulated and promulgated by the drug supervision and administration department of the State Council." In accordance with the requirements of the above laws and regulations, the State Drug Administration has organized and formulated and issued 113 drug packaging container (material) standards in phases and batches since 2002 (including standards planned to be issued in 2004), including 43 standards for pharmaceutical glass bottle packaging containers (materials), accounting for 38% of the total number of pharmaceutical packaging village standards, and the scope of the standards covers pharmaceutical glass bottle packaging containers for various dosage forms such as injection powder, water injection, infusion, tablets, pills, oral liquid, freeze-dried, vaccines, and blood products. A relatively complete and standardized pharmaceutical glass bottle standardization system has been initially formed. The formulation, release and implementation of these standards are of great significance and role in the renewal of pharmaceutical glass bottle packaging containers, improving product quality, ensuring drug quality, accelerating the integration with international standards and international markets, and promoting and regulating the healthy, orderly and rapid development of China's pharmaceutical glass industry.
Pharmaceutical glass bottles are packaging materials that directly contact drugs. They account for a large proportion in the field of pharmaceutical packaging materials and have irreplaceable performance and advantages. Their standards have a vital impact on the quality of pharmaceutical packaging and the development of the industry.
Medicinal system
Standardization system of pharmaceutical glass bottles
According to the principle of the State Food and Drug Administration on the classification of pharmaceutical packaging materials by material, one material (variety) one standard, there are 43 standards for pharmaceutical glass bottles that have been issued and are to be issued. There are three categories according to the standard type. There are 23 product standards in the first category, of which 18 have been released and 5 are planned to be released in 2004; there are 17 test method standards in the second category, of which 10 have been released and 7 are planned to be released in 2004; there are 3 basic standards in the third category, of which 1 has been released and 2 are to be released in 2004. There are 23 product standards in the first category, which are divided into 8 types according to product type, including 3 "molded injection bottles", 3 "controlled injection bottles", 3 "glass infusion bottles", 3 "molded pharmaceutical bottles", 3 "controlled pharmaceutical bottles", 3 "controlled oral liquid bottles", 2 "ampoules" and 3 "glass pharmaceutical tubes" (Note: This product is a semi-finished product for processing various types of controlled bottles and ampoules).
The materials for bonding are divided into three categories, including 8 items of borosilicate glass, including neutral glass with α = (4-5) × 10 (-6) K (-1) (20-300 ℃) and 3.3 borosilicate glass with α = (3.2-3.4) × 10 (-6) K (-1) (20-300 ℃). This type of glass material is international neutral glass, usually also called Class I glass or Class A material. There are 8 items of low borosilicate glass, and low borosilicate glass is α = (6.2-7.5) × 10 (-6) K (-1) (20-300 ℃). This type of glass material is a quasi-neutral glass unique to China that cannot be connected with international standards, usually also called Class B material. Soda-lime glass has 7 items, and soda-lime glass has α= (7.6 ~ 9.0) ×10 (- 6) K (- 1) (20 ~ 300 ℃). This type of glass material is generally treated with sulfurization, and the surface water resistance reaches level 2.
The second category of inspection method standards has 17 items. These inspection method standards basically cover various inspection items such as the performance and indicators of various products of pharmaceutical glass bottles. In particular, the inspection of glass chemical properties has added new water resistance, alkali resistance and acid resistance with reference to ISO standards. In order to make various products of pharmaceutical glass bottles adapt to drugs of different properties and dosage forms, more, more comprehensive and more scientific inspection methods are provided for the identification of chemical stability. These inspection methods will play an important role in ensuring the quality of pharmaceutical glass bottles and thus the quality of drugs. In addition, the inspection method for the leaching amount of harmful elements has been added to ensure the safety of pharmaceutical glass bottles for drugs. The inspection method standards for pharmaceutical glass bottles need to be further supplemented and improved. For example, the test methods for alkali-resistant peeling of ampoules, the test methods for breaking force, and the test methods for resistance to freezing shock all have an important impact on the quality and application of pharmaceutical glass bottles.
There are three basic standards in the third category, among which "Classification of components and test methods for pharmaceutical glass bottles" is formulated with reference to ISO 12775-1997 "Classification of components and test methods for normal large-scale production of glass" to have a clear definition of the classification of components and test methods for pharmaceutical glass bottles, so as to distinguish the classification of glass materials in other industries. The other two basic standards respectively limit the harmful elements of lead, cadmium, arsenic, and antimony in the components of glass materials to ensure the safety and effectiveness of various types of medicines.