Standard content changes to trade standard
The establishment of the new standard format and items refers to the compilation format of the Pharmacopoeia of the People's Republic of China, and the standard name is drawn up in the order of material, application and shape.
The establishment of the project highlights the content of identification, and defines the material type of glass by the thermal expansion coefficient and the content of boron trioxide. The content of the standard is clearly defined and focused, and the main performance indicators and restrictions on harmful elements are listed in the text as mandatory indicators. The appearance index stipulates that there should be no obvious defects in smoothness and smoothness. The specific appearance defects of the product such as bubbles, stones, streaks and various surface defects can be determined by the supplier and the buyer in the form of agreements, standards or contract accessories. The new standard also lists the specifications and dimensions in the appendix of the standard as a recommended item to meet the needs of market diversification, new varieties and new shapes, but the author believes that the tolerances of specifications and dimensions in the standard appendix should be mandatory. , to ensure the consistency of product specification dimensional tolerance accuracy and product performance.
Full standard
Comprehensive testing items and complete supporting testing standards
Compared with ISO related product standards and foreign related product standards, the new standard has more comprehensive testing items, mainly adding the measurement of thermal expansion coefficient and B-2O-3 content to identify the material of glass. As most medicinal glass bottle products in China still use arsenic trioxide (As-2O-3) or compound fining agent antimony trioxide (Sb-2O-3) + arsenic trioxide (As-2O-3) as the fining agent for glass melting Introduced, therefore, the new standard adds limit control on the dissolution of the above-mentioned harmful elements to ensure the safety and effectiveness of packaged drugs.
In the new standard, the testing standards for product standards are relatively complete. All indicators and items in the product standard have corresponding testing standards for selection, and the testing methods and standards for important performances adopt ISO standard testing methods.
