The State Food and Drug Administration has clearly pointed out the testing items for ampoule in YBB00332002 and YBB00322005 from the 2002 edition of the "Compilation of Standards for Packaging Materials and Containers for Direct Contact with Drugs", in which the measurement of round beating is based on the measurement method of GB2637-1995. measuring.
Ampoule rounding measurement method and working principle
Ampoules are one of the most widely used direct contact pharmaceutical packaging containers in liquid pharmaceutical packaging. They are classified into low borosilicate glass ampoule, neutral borosilicate glass ampoule and high borosilicate glass ampoule according to the materials used in the ampoule. Today's production companies generally use low borosilicate glass ampoule. From the perspective of cost performance, some common drugs can be satisfied with low borosilicate ampoules, but for some acidic and alkaline varieties, low borosilicate glass ampoules are not. To the request, the strong acid and alkali resistance of the neutral borosilicate glass ampoule enhances its performance. Regardless of the material's ampoule, the measurement of his circular runout is measured. The so-called round jump is the maximum change in the outer diameter of the wire that is rotated around the axis.
The State Food and Drug Administration has clearly pointed out the testing items for ampoule in YBB00332002 and YBB00322005 from the 2002 edition of the "Compilation of Standards for Packaging Materials and Containers for Direct Contact with Drugs", in which the measurement of round beating is based on the measurement method of GB2637-1995. measuring. The maximum allowable for the circular runout according to the size of the ampoule should meet the parameters in the following table:
Excessive deviation of the circular runout will not only affect the appearance of the ampoule itself, but also cause the waste of liquid medicine to cause pollution of the production countertops and medicines, and even the dumping of the ampoule will affect the work of the entire production line. Therefore, the production enterprises must strictly control the safety of Guan'an bottle quality, so that the quality indicators of the ampoule meet the national requirements. According to the standard, the measurement of YTD-80 with an accuracy of 0.01mm is recommended. The resolution of YTD-80 produced by Jinan Sanquan Zhongshi Experimental Instrument Co., Ltd. can reach 0.001mm to ensure measurement. The accuracy. Test principle: the bottom of the bottle is fixed on the rotating plate of the horizontal plate, so that the bottle mouth is in contact with the dial gauge, and the maximum and minimum values ​​are read by rotating 360° and the maximum change amount is calculated as the circle runout value. The instrument makes clever use of the three-claw self-centering chuck with high concentricity. With a set of high-degree-of-freedom brackets that can adjust the height and orientation freely, it can not only measure the round jump value of the ampoule, but also meet some vials and small. Vertical axis deviation measurement of infusion bottles and various small control bottles.
The above is a description of the measurement method of the roundness of the ampoule. In addition, the ampoule needs to be tested for its breaking force, internal stress and wall thickness. If you have other needs, please feel free to contact us.
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