Standardization System Of Pharmaceutical Glass Bottles

Mar 21, 2023

According to the principle of the State Drug Administration regarding the formulation of standards for pharmaceutical packaging materials divided by material, one standard for each material (variety), a total of 43 standards have been issued and will be issued for pharmaceutical glass bottles. According to the type of standards, there are three categories. The first category includes 23 product standards, of which 18 have been issued and 5 are planned to be issued in 2004; There are 17 standards for the second type of test methods, of which 10 have been issued, and 7 are planned to be issued in 2004; There are 3 basic standards in the third category, of which 1 has been issued and 2 will be issued in 2004. There are 23 product standards for the first category, which are divided into 8 types according to product types, including 3 items for "Molded Injection Bottles", 3 items for "Controlled Injection Bottles", 3 items for "Glass Infusion Bottles", 3 items for "Molded Drug Bottles", 3 items for "Controlled Oral Liquid Bottles", 2 items for "Ampoules", and 3 items for "Glass Drug Tubes" (Note: This product is a semi-finished product for processing various types of control bottles and ampoules).
The bonding materials are divided into three categories, including 8 items of borosilicate glass, and the borosilicate glass includes α= (4~5) × 10 (- 6) K (- 1) (20 to 300 ℃) neutral glass and α= (3. 2~3. 4) × 3 Borosilicate glass. This type of glass is made of international neutral glass, commonly referred to as Class I glass or Grade A material. 8 items of low borosilicate glass α= (6. 2~7. 5) × 10 (-6) K(- 1) (20~300 ℃)。 This type of glass is made of quasi neutral glass that is unique to China and cannot meet international standards, commonly referred to as Grade B material. 7 items of soda-lime glass α= (7. 6 ~ 9. 0) × 10 (- 6) K (- 1) (20~300 ℃), this type of glass material is generally vulcanized, and its surface water resistance reaches Level 2

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