The standard for pharmaceutical glass bottles is an important branch of the standard system for pharmaceutical packaging materials. Due to the fact that medicinal glass bottles require direct contact with drugs and some require long-term storage of drugs, the quality of medicinal glass bottles directly affects the quality of drugs and involves personal health and safety. So the standard for medicinal glass bottles has special and strict requirements, which can be summarized as follows:
Relatively systematic and comprehensive, enhancing the selectivity of product standards and overcoming the lag of standards on products
The principle of setting different standards for the same product based on different materials determined by the new standards 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 performance products, and changed the relative lag of general product standards in product development.
For example, among the 8 pharmaceutical glass bottle products covered by the new standard, each product is classified into 3 categories based on material and performance. The first category is borosilicate glass, the second category is low borosilicate glass, and the third category is sodium calcium glass. Although a certain type of product with a certain material has not yet been produced, the standards for this type of product have been introduced, solving the problem of lagging behind in setting standards after the product is usually produced. Various types of drugs with different grades, performance, uses, and dosage forms have more flexible and larger selection space for products and standards made of different materials.
Application of pharmaceutical glass bottle standards
A standardized system of vertical and horizontal interweaving of various products and materials provides sufficient basis and conditions for the selection of scientific, reasonable, and suitable glass containers for various drugs. The selection and application of pharmaceutical glass bottles for various types of drugs with different dosage forms, properties, and grades should follow the following principles:
chemical stability
Principles of good and suitable chemical stability
Glass containers used to hold various types of drugs should have good compatibility with drugs, that is, to ensure that the chemical properties of glass containers are not unstable during the production, storage, and use of drugs, and that certain substances between them undergo chemical reactions that may cause drug mutation or failure. For example, high-end drugs such as blood preparations and vaccines must choose glass containers made of borosilicate glass. Various types of strong acid and alkali water injection formulations, especially strong alkali water injection formulations, should also choose glass containers made of borosilicate glass. The widely used low borosilicate glass ampoules in China for containing water injection preparations are not suitable, and this type of glass material needs to gradually shift to 5 0 glass material transition to quickly align with international standards, ensuring that the drugs it contains do not peel off, become turbid, or deteriorate during use.
The use of low borosilicate glass or neutralized sodium calcium glass can still meet the chemical stability requirements for general powder injection, oral administration, and large infusion drugs. The degree of corrosion of drugs on glass is generally greater in liquids than in solids, and in alkalinity than acidity, especially in strong alkaline water injection formulations, which require higher chemical properties of pharmaceutical glass bottles.
Resistance to thermal shock
Good and suitable resistance to temperature sudden changes
Different dosage forms of drugs require high-temperature drying, disinfection and sterilization, or low-temperature freeze-drying processes in production, which requires glass containers to have good and suitable resistance to temperature fluctuations without bursting. The resistance of glass to temperature change is mainly related to its coefficient of thermal expansion. The lower the coefficient of thermal expansion, the stronger its ability to resist temperature changes. For example, many high-end vaccine formulations, biologics, and lyophilized formulations should generally choose 3 3 borosilicate glass or 5 Borosilicate glass. Low borosilicate glass produced in large quantities in China is prone to cracking and bottle bottoming when subjected to significant temperature fluctuations. There has been significant development in China’s 3. 3% borosilicate glass, which is particularly suitable for freeze-drying formulations because its resistance to temperature sudden changes is better than 5 Borosilicate glass.
mechanical strength
Post time: Oct-16-2023