In the 2015 version of the drug packaging material standards, there are mainly two standards related to ampoules, namely YBB0033202-2015 low borosilicate glass ampoule and YBB00322005-2-2015 medium borosilicate glass ampoule. Clear regulations have been made for the circular jumping of ampoules, as follows:
The requirements and methods for measuring the circular jumping of ampoules are as follows:
Instrument device
Testing instrument requirements: Ensure that when the bottom of the test sample bottle is placed horizontally, the horizontal distance between the center of the test sample bottle mouth and the vertical axis of the bottle bottom center can be measured.
The instrument requires a method or device to fix the bottom of the bottle or ensure that the bottom of the bottle is in close contact with the horizontal plane, a chassis that can rotate the bottle, or a reliable rotation method to ensure that the bottle always maintains the stability of the bottom axis during rotation. Ensure a column of sufficient height and parallel to the axis of the bottle bottom. A measuring scale, dial gauge or reading microscope can be installed on the column. The scale or dial gauge has a contact plane parallel to the outer edge of the bottle mouth to ensure sufficient contact with the axis of the bottle mouth during rotation.
Determination method
Fix the bottom of the test sample bottle onto the rotating disc of the horizontal plate, with the bottle mouth in contact with the dial gauge. Rotate 360 ° to read the maximum and minimum values. Half of the difference between the maximum and minimum values is the circular runout value. When measuring with a "V" shaped seat, place the sample tightly in the "V" groove, apply a downward force to the side with your hand at a 45 ° angle to the horizontal plane, and rotate the bottle 360 ° to read the maximum and minimum values. Half of the difference between the maximum and minimum values is the circular runout value.
The measured value should not be less than 0.1mm. The correction should be based on the measured circular runout.
The ZNCRT-01 circular jumping tester produced by Jinan Zhongnuo not only meets the above requirements, but also has the characteristics of simple structure, wide applicability, convenience and durability. It is one of the commonly used instruments in laboratories such as ampoule production enterprises, pharmaceutical companies, and quality inspection institutions.