There are 17 standards for the second type of inspection methods. These inspection method standards basically cover various inspection items such as the performance and indicators of various products of medicinal glass bottles. In particular, the testing of glass chemical properties refers to ISO standards and adds new water resistance. , The detection of alkali and acid resistance provides more, more comprehensive and scientific detection methods for the identification of chemical stability in order to adapt various products of medicinal glass bottles to drugs of different properties and dosage forms. Ensuring the quality of medicinal glass bottles and thus ensuring the quality of medicines will play an important role. In addition, the detection method for the amount of leaching of harmful elements has been added to ensure the safety of medicines in the medicinal glass bottles. The inspection method standards for medicinal glass bottles need to be further supplemented and improved. For example, the test method for alkali-resistant peeling of ampoules, the test method for breaking force and the test method for freezing shock resistance, etc. all have an important impact on the quality and application of medicinal glass bottles.
The third type of basic standards consists of 3 items. Among them, the "Classification of Pharmaceutical Glass Bottles and Their Test Methods" refer to ISO 12775-1997 "Classification of Glass by Composition and Test Methods for Normal Mass-produced Glass". There is a clear definition of the bottle composition classification and its test method standards, which are formulated to distinguish the classification of glass materials from other industries. The other two basic standards respectively limit the harmful elements of lead, cadmium, arsenic, and antimony in the composition of glass materials to ensure the safety and effectiveness of all kinds of medicines.
