Ybb00292002 Borosilicate Glass Control Injection Bottle

- Nov 01, 2018-

The standard was formulated in accordance with the relevant requirements of the “Guidelines for the Issuance of the 2005 Standard System for the Preparation of Pharmaceutical Packaging Materials (Revised)” issued by the Drug Registration Department of the State Food and Drug Administration [2005] No. 3. This standard has been abolished from the original ybb00292002 borosilicate glass controlled injection bottle standard since the implementation date.


Neutral glass was first proposed in the normal mass production of glass in iso12775 in 1997 according to the composition classification and test method guidelines. In 2000, China formulated the first draft of medicinal glass according to the classification of components and its test method. Because of its good chemical stability and low softening point, this glass is the first choice for medicinal glass. Through the joint efforts of the medicinal glass industry, China now not only imports a large number of neutral borosilicate glass tubes to produce various medicinal packaging bottles, but also has its own neutral borosilicate glass packaging materials. For this reason, the standard of neutral glass drug packaging materials and 3.3 borosilicate glass drug packaging products have been separately established, which is conducive to the development of high quality pharmaceutical packaging materials in China.


 In order to effectively strengthen the quality control of pharmaceutical packaging products and facilitate the use of pharmaceutical manufacturers, the establishment of the quality standard for neutral glass controlled injection bottles is based on the Pharmacopoeia of the People's Republic of China and the control of antibiotic glass bottles (gb 2641-90). On the basis of the drafting of the Pharmacopoeia of the People's Republic of China. The items, methods and indicators of this standard refer to the relevant requirements of iso8362-1:2003 controlled glass injection bottle and iso12775-1997 normal mass production of glass according to the classification of components and test methods, according to the neutral glass control injection bottle The performance requirements increase the heat resistance and freeze resistance requirements, and increase the linear expansion coefficient of the identification test items; the content of boron trioxide; the determination of arsenic, antimony, lead and cadmium leaching.